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University of Pittsburgh of the Commonwealth System of Higher Education v. Varian Medical Systems

December 30, 2011

UNIVERSITY OF PITTSBURGH OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION,
PLAINTIFF,
v.
VARIAN MEDICAL SYSTEMS, INC.,
DEFENDANT.



The opinion of the court was delivered by: Arthur J. Schwab United States District Judge

ELECTRONICALLY FILED

Memorandum Opinion on Cross-Motions for Summary Judgment

I. Introduction

This is an action in patent infringement. Plaintiff, University of Pittsburgh of the Commonwealth System of Higher Education (hereinafter "Pitt" or "plaintiff"), alleges that defendant Varian Medical Systems, Inc. (hereinafter "Varian" or "defendant") has infringed its patent (U.S. Patent No. 5,727,554) (hereinafter "the patent," or "the ‗554 Patent") by making and selling the RPM Respiratory Gating System (hereinafter "the RPM System"). Varian denies that its product (and/or modified product) infringes Pitt's patent,*fn1 and further argues that Pitt cannot establish willful infringement. Defendant also contends that the asserted patent is invalid, for lack of enablement, and that Pitt's measure of damages is improper.*fn2

Before this Court is Pitt's Motion for Partial Summary Judgment, and Varian's Motion for Summary Judgment, respectively (doc. nos. 363 and 364). After careful consideration of the voluminous summary judgment records, and the legal arguments of the parties, the Court has GRANTED and entered partial summary judgment in Pitt's favor, finding as a matter of law that Varian's RPM System (and The Modified RPM System) infringes the ‗554 Patent. See Doc. No. 425. The Court has DENIED Defendant's Motion for Summary Judgment with respect to invalidity, damages, and willful infringement. This issue of willfulness will be the sole subject of the jury trial set to commence on January 23, 2012. See Doc. No. 426.

II. Procedural History

This particular lawsuit has a lengthy procedural history dating back to June 16, 2008, when Pitt filed the instant action against Varian alleging that Varian's product, the RPM Gating System, which is radiotherapy equipment for the treatment of cancer, infringes Pitt's ‗554 Patent, which also concerns an application for radiation therapy. This lawsuit ("Varian II") is the second action which Pitt has commenced against Varian claiming an alleged infringement of the ‗554 patent. This Court dismissed the first action ("Varian I") for lack of standing. See Civil Action 07-cv-491. During the pendency of the appeal to the United States Court of Appeals for the Federal Circuit in Varian I, Pitt filed the instant action (Varian II). This Court dismissed Varian II on res judicata grounds (doc. no. 106). Pitt then appealed this decision (doc. no. 120). While Varian II was on appeal, the Court of Appeals reversed this Court's judgment and remanded Varian I. (07-cv-491, doc. no. 344). The parties then reached an agreement pursuant to which the dismissal of Varian II would be vacated, the appeal in Varian II would be dismissed, and this case would proceeds on the merits (doc. no. 152).

During the pendency of the appeals in Varian I and II, Varian filed an ex parte request with the United States Patent and Trademark Office ("PTO") requesting a reexamination of all of the "disputed" claims. The PTO reexamined the ‗554 Patent in light of the prior art, which Varian claimed rendered the disputed patent claims invalid. The PTO issued a reexamination certificate confirming the claims that were under reexamination, and added additional patent claims (Claims 23-28) that Pitt had submitted during the reexamination proceedings. At the conclusion of the reexamination proceedings, Claims 20-22 of the ‗554 Patent were deemed valid.

By Order of this Court of June 18, 2010 (doc. no. 182), pursuant to Fed. R. Civ. Pro. 53, this Court appointed the Honorable Donald E. Ziegler as Special Master in this action to conduct a claim construction hearing, and to set forth his findings in a Report and Recommendation, which the Court received on April 6, 2011 (doc. no. 283). After hearing the objections of the parties, and the motions to adopt/modify the Report and Recommendation, on May 16, 2011, this Court issued a Memorandum Opinion and Order thereon (doc. nos. 302 and 303). This Court affirmed and adopted the Report and Recommendation of the Special Master as the Opinion of the Court with only three (3) modifications (doc. no. 303). The Court then set a status conference to discuss scheduling matters, and the parties elected that this Court, rather than a Special Master (in the first instance), hear the instant summary judgment motions. During the status conference, in addition to setting deadlines for the instant motions, the Court asked the parties to brief the issue of whether a ruling on the liability aspects of the summary judgment motions would compel an appeal to the Federal Circuit as a final order, and/or whether any such ruling would constitute an Interlocutory Order (which the Court would need to "certify" as interlocutory, and would be subject to the discretion of the Federal Circuit) (doc. no. 307). Following the status conference, the parties submitted a joint brief (doc. no. 315), essentially concluding the following:

The Court's ruling on the parties' summary judgment motions could result in an appealable judgment, either because it is final (in favor of Varian) or final except for damages issues (in favor of Pitt) within the meaning of 28 U.S.C. § 1292(c)(2). The Court has the power to certify other interlocutory orders for appeal under 28 U.S.C. § 1292(b), but the Federal Circuit is unlikely to accept such a certified order for appeal. In any event, the Court's ruling on motions related to damages will not hinder either party's ability to appeal any of the Court's rulings.

The parties then filed a stipulation setting forth the briefing schedule for the pending motions for summary judgment (doc. no. 316), and the motions were ordered to be fully briefed as of December 19, 2011. However, all replies were not received until December 20, 2011.

III. Factual Background

A summary of the factual and technical background of this case can be found in the Special Master's Report and Recommendation on Claim Construction (doc. no. 283) and this Court's Opinion affirming the Report and Recommendation. Doc. No. 302. The parties have amassed over 100 pages of facts, but the factual background may be fairly stated as follows. See Doc. Nos. 380, 389. 401, 421.

The "554 Patent

On March 17, 1998, U.S. Patent No. 5,727,554 (the ‗554 Patent) was duly issued by the Patent and Trademark Office. Plaintiff, Pitt, owns the ‗554 Patent which is the subject of this lawsuit.

The ‗554 Patent claims an apparatus for turning on and off a radiation treatment beam synchronously with a patient's breathing. The claimed apparatus comprises a system that uses a video camera and imaging process equipment to monitor patient movement, including breathing. The system identifies and tracks in a video image certain markers on a patient's body ("fiducials"). The markers, or fiducials, may be reference markers placed on the patient ("artificial fiducials") or natural features on the patient's body ("natural fiducials"). The invention claimed by the ‗554 Patent turns off a radiation treatment beam when the cancerous tumor that is the subject of treatment moves out of the beam's path, as a result of breathing, and turns back on when the tumor re-enters the path of the beam.

The RPM System

Varian manufactures, sells, and services equipment and software for the medical use of radiation for treatment and diagnosis. The alleged infringing system, entitled the Real-Time Position Management ("RPM") Respiratory Gating System ("RPM System"), has been sold by Varian in the United States and abroad since approximately June 10, 1999. Varian's RPM Respiratory Gating System has been manufactured and partially assembled at Varian's manufacturing plant in Palo Alto, CA from 2001, until the present. The remaining assembly occurs at the customer sites, including abroad (there appears to be no genuine dispute that the Systems are made and sold in the United States). See Doc. No. 400-31 at 48 ("RPM System manufactured and assembled in Palo Alto, CA.")

Varian's RPM System is a video-based system that monitors and tracks patient respiratory movement during radiotherapy treatment. It generates gating signals that turn on and off a radiotherapy treatment beam in synchronization with respiratory motion. Non-Treatment RPM Systems are used with CT and PET scanners to locate and identify a tumor to be subjected to radiotherapy treatment. Treatment RPMs are used with beam generators, one component of linear accelerator systems, in the radiotherapy treatment process itself.

Specifically, the RPM System (designed for use with Varian's Clinac and Trilogy radiotherapy treatment machines) using an infrared tracking camera, infrared illuminator rings, and reflective markers on the marker block system, measures the patient's respiratory pattern and range of motion and displays them as a waveform on a work station monitor. The parties contest whether the Non-Treatment RPMs infringe the ‗554 Patent because, unlike the Treatment RPMs, they are not used for radiotherapy treatment.

Nonetheless, the parties agree that the RPM System (at least the Treatment RPMs) is used to obtain tracking of the subject respiratory patent for respiratory image acquisition, and radiation therapy treatment. The RPM System can also be used to monitor the patient position during the image acquisition, simulation, and treatment.

The RPM System includes a charge-coupled device ("CCD") camera referred to as a tracking camera, which is sensitive to infrared and visible light. Although the parties dispute whether the use of a marker is inherent to, or only one feature of, the RPM System, they agree that a marker block is placed on the patient's chest or abdomen and the video camera generates images of the patient with the marker block. The parties agree that the RPM System tracks patient respiration motion using a video camera connected to a PC workstation. However, the parties dispute whether movement of the marker block serves as a surrogate for movement of the tumor. While Pitt claims that it does, Varian contends that the marker block can only be considered a surrogate for movement of the tumor if additional equipment beyond the RPM System is used to correlate marker block motion with tumor motion.

The parties agree that the RPM System includes a video-frame grabber board, which is a digitizer that functions to digitize the incoming video signal and generates a "digital image." The frame-grabber generates a digitized video signal having an array of 640 x 480 pixels, with each pixel represented in eight (8) bits. The RPM System includes a Windows-based workstation with an Intel Pentium processor. The RPM workstation runs software that processes the digitized video signal from the video camera and generates a signal, albeit they dispute that it is termed a "gating signal."

The RPM System is programmed to identify fiducials in the "image signals." Varian disputes use of the term "image signals" to the extent that the term is intended to include digital images of the patient, and claims that the RPM System does not use images of the patient, and instead uses coordinates of the marker centroids, whereby only the reflective markers remain.

The parties agree that the RPM System includes a marker block having multiple two (2) or six (6) reflective markers on a plastic base, and these markers are "artificial" reflective markers. The retroreflective markers on the marker block are fiducials. The parties, however, dispute whether the marker block itself is a fiducial. The marker block, including the markers, is placed on the patient, the patient is positioned on the couch in the field of view of the camera and the marker block is placed on the patient and moves with the patient's breathing.

The RPM System tracks the motion of the (conceptualized) marker block to determine breathing motion of the patient. While Pitt contends that the RPM System determines the coordinates of the marker block, Varian denies that statement and claims that the RPM System "merely determines the coordinates of individual marker centroids and uses that information to calculate the coordinates of a single point." Doc. No. 389 at 7, ¶ 26. The images captured by the camera of the RPM System include the markers placed on the patient, and the reflective markers appear in the video signals that the camera sends to the workstation computer. The parties debate whether all patient motion data is calculated based on the motion of the markers. The RPM System displays the patient's breathing motion in the amplitude-based display, which provides a real-time graph of the patient's breathing. While Pitt contends that the RPM System determines patient breathing by using the movement of the marker as a surrogate, Varian argues that the System determines the position of a single calculated point at different points in time based on coordinates of the marker centroid. The parties also debate whether or not the RPM System senses the respiration motion of the patient by tracking two or six passive reflective markers on a marker block.

In gated radiotherapy, the RPM Respiratory Gating System sends a signal to the Clinac accelerator to stop the radiation beam (Varian admits this statement only with respect to Treatment RPM's not with respect to Non-Treatment RPM's such as those used with PET and CT scanners (RPM-PET/CT)). While Pitt claims that this switching on and off of the treatment beam with respiration motion synchronizes treatment delivery with respiration, Varian denies this alleged fact on the basis that the RPM does not "switch on" the treatment beam. According to Pitt, the RPM System includes run by the PC workstation that generates "gating signals" synchronized to actuate the treatment beam of the Clinac accelerator in synchronism with patient breathing. Varian denies that the RPM generates "gating signals," and argues that there are no RPM signals that "actuate" the treatment beam of the Clinac accelerator.

Again, the parties debate whether the technique of respiratory gating "starts and stops" a treatment beam - - metaphorically speaking, opening and shutting a gate that holds in radiation according to a pattern of breathing. While Pitt contends that the "gating signal" created by the RPM System is the signal from which the RPM Respiratory Gating System to Varian's Clinac machine turns the radiation beam on or off, Varian counters that the RPM System does not create a "gating signal" and RPM does not send a signal to the Clinac machine which turns on the radiation beam. In addition, according to Varian, RPM-PET/CT lacks hardware needed to enable it to operate together with a treatment beam. Nonetheless, through an interface provided by the workstation, the clinician is able to set a threshold that, if exceeded, will generate a beam hold signal (again, Varian denies this as a "gating signal") to turn off the treatment beam produced by the beam generator.

According to Pitt, if the patient returns to the proper position within the threshold, the RPM will generate a signal to turn "on" the treatment beam, and the RPM System can turn the treatment beam on and off. Varian disagrees with Pitt and claims that the RPM does not generate a signal to turn "on" the beam. Once gating is enabled, the system begins sending beam-on and beam-off signals to the Clinac machine according to the thresholds established in the reference session; but again, Varian claims that the RPM does not send signals to the Clinac that turn on the radiation beam. Pitt contends that if the other safety or operation features of the Clinac accelerator are not causing a beam hold, the RPM System will act to both turn the beam on and off. Varian posits that the RPM does not "turn on" the beam "but merely asserts or does not assert a beam hold." Doc. No. 389 at 12, ¶ 40.

Enabling gating makes the RPM Respiratory Gating System send a pre-established signal to Varian's Clinac to trigger beam-enable at the start of the specified respiratory phase and a signal to either "trigger beam-hold" (as Pitt claims) or "stop asserting beam hold" (as Varian claims) during the part of the respiration cycle that is outside the gated interval.

All versions of the RPM System had the same basic functionality - - to identify and track markers and set thresholds for gating. The RPM System is used during treatment of the patient with Varian's Clinac accelerator. The RPM workstation includes two monitors. According to Pitt, the workstation computer causes the in-room monitor to display a section of green light when the movement of the markers, due to the patient's breathing, is within a preferred tolerance. The workstation computer turns off the green light when the movement of the marker, due the patient's breathing, is outside a preferred tolerance. Varian disputes these facts and claims that any green light on the monitor is based upon the position of a single calculated point, not "movement of the marker," and that, in any event, defendant does not "supply the monitor to which Pitt refers." Doc. No. 389. at 13, ¶¶ 45-46.

Varian‟s Clinac and Trilogy Systems

Varian has sold (in the United States and abroad) its Clinac linear accelerator at least as long as it has been selling its RPM Respiratory Gating System. The Clinac beam generator is manufactured and partially assembled in Palo Alto, CA, and, like the RPM System, requires further assembly at the customer site.

Varian's Trilogy Systems is composed of a suite of Varian products including the Clinac iX linear accelerator. The RPM System and beam generator "component" of Trilogy (as "bundled with Trilogy at one time") are manufactured and partially assembled in Palo Alto, CA, and also require further "final" assembly at the customer site. Varian's Clinac and Trilogy devices are designed to deliver radiation therapy to treat tumors, and according to Varian, "is just one component of the complete Clinac and Trilogy systems." Doc. No. 389 at 15, ¶ 51.

Varian's Clinac and Trilogy devices are used with the RPM System, but they can also be purchased and/or used without an RPM system. Varian's RPM System is sold as an option to Varian's Clinac devices, but Varian denies that statement with respect to Non Treatment RPM Systems (those used with PET/CT scanners), which Varian claims lacks the hardware needed to enable it to operate together with Clinac or Trilogy. Varian's RPM Respiratory Gating System (minus Non Treatment RPM-PET/CT) was bundled with Trilogy between 2005 and 2007, but also has been available as "an option" with Trilogy.

Varian's Clinac accelerator is a medical linear accelerator used to provide radiotherapy treatment to patients. Accelerators include beam generators. Other components of the Clinac accelerators include a workstation, console computer, electronics cabinet, gantry, collimator, and multi-leaf collimator, and treatment couch. C-series, Clinac iX, and Trilogy accelerators are controlled using C-series control software.

Clinac accelerators operate with the RPM System to turn the treatment beam on and off based on respiratory motion (with respect to "Treatment RPMs"). At least with respect to Treatment RPMs, the RPM System is physically connected to the Clinac accelerator during installation. As part of the system verification procedure, according to Pitt, the installer will operate the RPM System causing the Clinac accelerator to turn the treatment beam on and off. As noted above, Varian debates the contention that the accelerator turns "on and off," and it claims that the RPM System does not cause the Clinac to turn the treatment beam on, rather it merely stops asserting beam hold. Nonetheless, the parties agree that the Clinac accelerator includes a beam hold icon that indicates when the treatment beam is being held, and the beam hold icon is displayed on the monitor of the Clinac console. A black-on-yellow "beam hold" message is displayed instead of the "beam on" message to indicate when the RPM System is being held (according to Varian), or withholding the beam (according to Pitt).

Clinac accelerators are generally equipped with a multileaf collimator (hereinafter "MLC"). The Trilogy systems generally include the Millennium MLC. The MLC is a device that shapes the treatment beam to conform to the shape of the tumor. Treatment that conforms to the shape of the tumor is referred to as conformal radiotherapy. Clinac accelerators are capable of operating with the RPM System while providing conformal radiotherapy. Clinac accelerators are capable of generating multiple beams from different directions in a conformal therapy.

During installation (at least with respect to Treatment RPMs) the technician ensures that the dynamic MLC mode of the Clinac is enabled so that the RPM System will operate to hold the treatment beam or not hold the beam. With version 8.0 of the C-series control software (at least with respect to Treatment RPMs), the Clinac accelerator can implement Gated RapidArc treatment deliveries in which RapidArc treatment deliveries are gated using the RPM System. Gated RapidArc Treatment is a computer-controlled conformal treatment that involves movement of the gantry to deliver different treatment beams to the patient from different angles.

Clinac accelerators are capable of operating with the RPM System to work with intensity-modulated radiotherapy ("IMRT"). IMRT is a type of conformal radiotherapy. IMRT is a treatment modality that better conforms to the shape of the tumor by modulating the intensity of the radiation beam. The Clinac accelerator may be operated in a segmental IMRT treatment mode, also known as "step-and-shoot." In the "step-and-shoot" mode, the MLC is moved in a series of positions while the treatment beam is off, and when a position is reached, the treatment beam is turned on. While Pitt contends that Clinac accelerators are also capable of operating with the RPM System to provide dose dynamic radiotherapy, Varian denies that contention and claims that Clinac independently provides dose dynamic radiotherapy and the RPM System merely offers the option of gating the beam during dose dynamic radiotherapy.

Dose dynamic treatment is a type of dynamic therapy in which the leaves of the MLC move while the beam is being generated, but Varian emphasizes that dynamic treatment does not always operate in that manner. While Pitt argues that dose dynamic therapy is a form of IMRT, Varian denies that statement on the basis that there is an "intersection" between dose dynamic therapy and IMRT, but one is not a subset of the other. Clinac accelerators are configured to provide radiation therapy treatment under computer control, and are capable of generating multiple beams from different directions in a conformal therapy. Although not all Clinac systems include a MLC, Clinac accelerators include a gantry that contains the MLC for shaping the beam and can rotate around the treatment couch to deliver treatments.

IV. Standard of Review

The summary judgment standard in a patent case is the same as in other civil cases.

Summary Judgment is appropriate when it is apparent from the entire record, viewed in the light most favorable to the non-moving party, that there are no genuine issues of material fact. Celotex Corp. v. Catrett, 477 U.S. 317, 322-24 (1986). One of the principal purposes of the summary judgment rule is to isolate and dispose of factually unsupported claims or defenses. Therefore, summary judgment is required, "against a party who fails to make a sufficient showing to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial." Id. at 322. The summary judgment inquiry asks whether there is a need for trial -- "whether, in other words, there are any genuine factual ...


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