DCT
2:05-cv-01645
Varian Medical Systems Inc v. Resonant Medical Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Varian Medical Systems, Inc. (Delaware) and SAS Praxim (France)
- Defendant: Resonant Medical, Inc. (Canada)
- Plaintiff’s Counsel: Heller Ehrman LLP
- Case Identification: 2:05-cv-01645, W.D. Wash., 09/29/2005
- Venue Allegations: Venue is based on Defendant transacting business in the district, a substantial part of the events giving rise to the complaint occurring in the district, and Defendant’s status as an alien corporation.
- Core Dispute: Plaintiffs allege that Defendant’s Restitu™ system induces and contributes to the infringement of a patent related to a method for accurately determining the position of a patient’s organ for medical procedures.
- Technical Context: The technology concerns the field of medical imaging and image-guided therapy, specifically methods to register pre-operative 3D images with a patient's real-time position to improve the accuracy of treatments like radiotherapy.
- Key Procedural History: The complaint details a chain of licensing: the patent was assigned to Université Joseph Fourier, which granted an exclusive world-wide license to Plaintiff Praxim. Praxim, in turn, granted an exclusive field-of-use license to Zmed, Inc. Plaintiff Varian acquired all of Zmed's assets and interests in the patent in a 2003 transaction, which Plaintiffs allege provides Varian the right to enforce the patent.
Case Timeline
| Date | Event |
|---|---|
| 1992-07-31 | '154 Patent Priority Date |
| 1995-09-05 | U.S. Patent No. 5,447,154 Issued |
| 2003 | Varian acquires Zmed and its license rights to the '154 patent |
| 2005-09-29 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 5,447,154, "Method for Determining the Position of an Organ," Issued September 5, 1995
The Invention Explained
- Problem Addressed: The patent's background describes the significant challenge in accurately and repeatedly positioning a patient for medical interventions like radiotherapy. (’154 Patent, col. 1:30-38). Conventional methods, such as relying on skin markings, are often inaccurate, forcing clinicians to irradiate a larger-than-necessary area to ensure a tumor is targeted, which risks harming healthy adjacent tissue. (’154 Patent, col. 1:49-61, col. 2:1-6).
- The Patented Solution: The invention provides a method to correlate a high-quality, pre-operative three-dimensional (3D) image (e.g., from an MRI or CT scanner) with the patient's actual position during a surgical or therapeutic procedure. (’154 Patent, Abstract). This is achieved by using a second, on-site imaging device (such as an echography probe) to generate a "second image" corresponding to a "cloud of points" on the surface of the organ or skin, and then "matching" this on-site image with the pre-operative 3D image. (’154 Patent, col. 16:11-29). This allows a third device, such as a radiotherapy tool, to be precisely guided based on the detailed pre-operative data without relying on insecure physical marks. (’154 Patent, col. 16:30-43).
- Technical Importance: The described method sought to improve the precision of image-guided therapies by creating a reliable link between detailed pre-operative plans and the real-time position of the patient and surgical tools. (Compl. ¶9).
Key Claims at a Glance
- The complaint alleges infringement of "one or more claims" without specifying which ones (Compl. ¶8). The first independent claim is Claim 1.
- Independent Claim 1 requires a method comprising the steps of:
- making at least one 3D first image of an organ of a patient having a first coordinate system and of a surface of the organ or skin region with a first imaging device while the patient is in a pre-operation site without fixing any mark to the patient;
- placing the patient in an operation site having a second coordinate system;
- determining a first position of a second imaging device with respect to the second coordinate system of the operation site;
- making a second image with said second imaging device, the second image corresponding to a cloud of points of the surface of the organ or skin region;
- matching the at least one 3D first image and the second image; and
- providing a third device... and determining a first position of the third device with respect to the second image... whereby the third device is positioned with respect to the... first image.
III. The Accused Instrumentality
Product Identification
- Defendant's Restitu™ system (Compl. ¶10).
Functionality and Market Context
- The complaint alleges that the Restitu™ system is a product used to practice a "method of locating an organ within a patient's body," particularly for applications such as radiotherapy (Compl. ¶¶ 3, 9). Defendant allegedly manufactures the system in Canada and imports it into the United States for sale or offers it for sale (Compl. ¶4). The complaint does not provide specific technical details regarding the operation of the Restitu™ system.
IV. Analysis of Infringement Allegations
The complaint alleges infringement in a general manner, asserting that the use of the Restitu™ system by Defendant's customers constitutes a direct infringement of the method claimed in the ’154 Patent. No probative visual evidence provided in complaint.
’154 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| making at least one 3D first image of an organ of a patient... with a first imaging device while the patient is in a pre-operation site without fixing any mark... | The complaint alleges that customers' use of the Restitu™ system practices a method covered by the patent, which includes this step. | ¶¶ 3, 8, 9 | col. 16:11-17 |
| placing the patient in an operation site having a second coordinate system; | The complaint’s general allegation that the patented method is practiced by users of the Restitu™ system implies the performance of this step. | ¶¶ 3, 8, 9 | col. 16:18-19 |
| determining a first position of a second imaging device with respect to the second coordinate system of the operation site; | The complaint’s allegation that the patented method is practiced using "at least two imaging devices" implies the performance of this step. | ¶¶ 3, 8, 9 | col. 16:20-22 |
| making a second image with said second imaging device, the second image corresponding to a cloud of points of the surface of the organ or skin region; | The complaint alleges a method using "at least two imaging devices" for locating an organ, which would require this image capture step. | ¶¶ 3, 8, 9 | col. 16:23-25 |
| matching the at least one 3D first image and the second image... | The complaint alleges the purpose of the accused method is "accurately locating an organ," which is the function of the claimed matching step. | ¶9 | col. 16:26-29 |
| providing a third device... and determining a first position of the third device with respect to the second image... whereby the third device is positioned with respect to the... first image... | The complaint identifies "radiation treatment or 'radiotherapy'" as an application, which would involve a "third device" being positioned according to the method. | ¶9 | col. 16:30-43 |
Identified Points of Contention
- Technical Questions: A primary question will be evidentiary. The complaint makes a general allegation that the accused method infringes but provides no technical facts about how the Restitu™ system operates. The core of the case will depend on whether discovery shows that use of the Restitu™ system involves the specific steps of generating a "cloud of points" image and "matching" it to a pre-operative 3D image as required by the claim.
- Scope Questions: The complaint's lack of specificity raises the question of whether the full, multi-step method of Claim 1 is actually performed by users of the Restitu™ system, or if the system is used in a way that omits one or more of the claimed steps.
V. Key Claim Terms for Construction
The Term: "matching"
Context and Importance: This term defines the central data-processing step of the invention. The infringement analysis will depend entirely on whether the process facilitated by the Restitu™ system constitutes "matching" as understood in the patent. Practitioners may focus on this term because the patent's validity and infringement positions hinge on its scope.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language itself is broad, simply reciting "matching the at least one 3D first image and the second image" without specifying a particular algorithm or technique (col. 16:26-27). This could suggest any form of image registration or correlation.
- Evidence for a Narrower Interpretation: The specification repeatedly describes the "second image" as a "cloud of points of the surface of the organ or of the skin region" (col. 5:14-16) and discusses matching this surface data to the 3D pre-operation image. A defendant might argue that "matching" is not just any image alignment but specifically requires this surface-based registration technique.
The Term: "imaging device"
Context and Importance: The claim recites a "first," "second," and "third" device. The interpretation of what qualifies as an "imaging device" versus a "tool" (a "third device") is critical to understanding the claim's boundaries and whether the Restitu™ system and its associated components meet these limitations.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification lists a wide array of potential devices, including X-ray scanners, MRI apparatus, echography probes, and optical scanners, suggesting "imaging device" is a broad term encompassing various medical imaging modalities (’154 Patent, col. 1:18-22, col. 3:24-28).
- Evidence for a Narrower Interpretation: The detailed embodiments place significant emphasis on the use of an echography (ultrasound) probe as the "second imaging device" for generating on-site surface data (’154 Patent, col. 3:22-23, col. 16:40-42). One might argue that the context of solving problems related to "soft organs" implies a narrower scope tied to the capabilities of the disclosed embodiments.
VI. Other Allegations
- Indirect Infringement: Plaintiffs allege both inducement and contributory infringement. The inducement claim is based on allegations that Defendant knowingly encourages its customers' direct infringement through "advertising, demonstrating and providing instructional materials" (Compl. ¶14). The contributory infringement claim is based on allegations that the Restitu™ system is a "non-staple article of commerce" and that its use is a "material part of the process claimed" (Compl. ¶21).
- Willful Infringement: Plaintiffs allege that Defendant's infringement is "willful and deliberate" (Compl. ¶¶ 16, 23). This allegation is predicated on the claim that Defendant "has and at all time relevant... had knowledge of the '154 patent" (Compl. ¶¶ 12, 18).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be evidentiary: given the complaint's lack of technical detail, can Plaintiffs produce evidence to demonstrate that the standard operation of the accused Restitu™ system by its users meets every limitation of the asserted method claims? The outcome will likely depend on the specific functions of the accused system as revealed during discovery.
- The case will also turn on a question of claim construction: will the term "matching" be interpreted broadly to cover any form of image registration, or will it be narrowly construed to require the specific technique of registering a "cloud of points" from a surface image against a pre-operative 3D volume, as described in the patent’s preferred embodiments? The answer will define the scope of the patent and likely determine the outcome of the infringement analysis.