Prowess, Inc. v. Laboratories

[953 F.Supp.2d 643]

Gretchen P. Miller, Rachel Mindy Hofstatter, Baldine B. Paul, John M. Caracappa, Paul A. Gennari, Scott Melvin Richey, Steptoe and Johnson LLP, Washington, DC, Jacob D. Flesher, Flesher Broomand McKague LLP, Folsom, CA, for Plaintiff.

Brianna Lynn Silverstein, John Daniel Victor Ferman, Nick Colic, Ronald L. Grudziecki, Stephen Jerome Wallace, Michael J. McManus, Drinker Biddle and Reath LLP, Washington, DC, for Defendants.

Prowess, Inc. (“Prowess”) sued RaySearch Laboratories, AB (“RaySearch”) and others ¹ (collectively, the “Defendants”) for patent infringement. A claim construction hearing was held on December 14, 2012 (“Hr'g”). Pending are the Defendants' motions for leave to file amended answers to the second amended complaint, and counterclaims, and to supplement the record in support of their opening claim construction brief. Also pending are the disputed claim construction issues. For the following reasons, the Defendants' motion for leave to file amended answers will be denied; the Defendants' motion to supplement the record will be granted; and the disputed claims will be construed as discussed herein.

Prowess is a California healthcare technology company with its principal place of business in Concord, California. Second Am. Compl. ¶ 1. Prowess and RaySearch, a Swedish healthcare technology company,³ develop software for the optimization of cancer radiation therapy. Second Am. Compl. ¶ 1; RaySearch Answer to Second Am. Compl. ¶ 2. Nucletron manufactures cancer radiation therapy equipment and is allegedly a licensee of RaySearch's software. Second Am. Compl. ¶ 3; Nucletron Answer to Second Am. Compl. ¶ 3. Effective March 1, 2012, Nucletron was merged into Elekta, Inc. (“Elekta”), a Georgia corporation with its principal place of business in Norcross, Georgia. Nucletron Answer to Second Am. Compl. ¶ 3.⁴ Philips is a California company with its principal place of business in Cleveland, Ohio. Philips Answer to Second Am. Compl. ¶ 4. Philips manufactures cancer radiation therapy equipment and is allegedly a licensee of RaySearch's software. Second Am.

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Compl. ¶ 4; Philips Answer to Second Am. Compl. ¶ 4.

Radiation therapy for cancer treatment involves shooting a beam of radiation at a tumor to destroy the cancerous cells' ability to reproduce. Second Am. Compl. ¶ 12. The radiation is emitted from a linear accelerator (“linac”), which is mounted on a gantry—essentially, a rotating base—and equipped with a collimator (“MLC”) whose moving “fingers” form an aperture ⁵ to shape the radiation beam, thereby varying the dose received by the tumor. Second Am. Compl. ¶ 15; Joint Claim Constr. Statement (SEALED) at 1; Popple Decl.⁶ (SEALED) ¶ 20; Claim Constr. Hr'g Tr. 6:22–25 to 7:1–4, 7:20–22, Dec. 14, 2012 [hereinafter, “Hr'g”].⁷ Typically, the gantry remains stationary (in a “fixed-field” position) while the radiation is delivered. Popple Decl. (SEALED) ¶ 21.⁸ In intensity-modulated radiotherapy (“IMRT”), the intensity of the radiation ⁹ is modulated within each delivered field. ' 008 patent col. 1 ll. 64–66. A gantry may also deliver radiation while moving in arcs (“intensity modulated arc therapy,” or “IMAT”). See id. col. 2 ll. 55–56. In IMAT, the radiation beam remains “on” while the gantry is moving. See Hr'g 7:14–15.

In the process of delivering radiation, adjacent healthy organs and tissue may suffer collateral damage. Second Am. Compl. ¶ 12. To decrease this risk, physicians use computer software to develop treatment plans that adjust the intensity, shape, and angle of the radiation beam. Id. ¶ 13;see also Hr'g 8:6–14. There are two methods of planning radiation treatment: “forward” ¹⁰ and “inverse.” Popple Decl. (SEALED) ¶ 23. “Forward” planning describes a manual “trial-and-error” approach, and is “best suited for cases in which the tumor has a simple shape and is not near any critical organs.” Id. ¶¶ 24–25. By contrast, in “inverse” planning, a radiation oncologist “defines a patient's critical organs and target tumor and specifies the target dose and dose limitations to surrounding structures.” Id. ¶ 26. The treatment planning system then uses an optimization program to determine optimal treatment “fields” (i.e., beams of radiation from a particular direction). Id.

Prowess alleges that inverse planning treatment was historically “limit[ed],” because optimization programs did not account for specific equipment limitations, or—with respect to the IMAT mode of delivery—the velocity of the MLC leaves and gantry. Second Am. Compl. ¶ 15; see Popple Decl. ¶¶ 27–28. Manual reconfiguration by the individual radiologist was required to render the treatment plan deliverable. See generally Hr'g 9–10.

On January 9, 2007 and February 19, 2008,

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U.S. Patent Nos. 7,162,008 (the “'008 patent”) and 7,333,591 (the “'591 patent”) were issued to inventors Matt A. Earl, David M. Shepard, and Xingsheng (Cedric) Yu (collectively, the “inventors”). See generally '008 patent; '591 patent (ECF No. 87–2 (SEALED)).¹¹ According to Prowess, the patents “disclose[ ] and claim[ ] innovative and valuable improvements in the process of developing treatment plans using IMAT and IMRT.” Second Am. Compl. ¶¶ 18, 24; see also Hr'g 6:21–22. Specifically, the patents are “directed to methods and software of directly taking machine parameters (i.e., MLC motion speed, gantry speed, and the range of dose rates) into account.” ECF No. 92 (SEALED) at 14 (bold and italic emphasis in original). This technique—which the inventors named “direct aperture optimization” (“DAO”) ¹²

requires just one step: the treatment planner simply enters in the dose prescriptions for the tumor and restrictions for surrounding structures, and the output of the inventors' patented algorithm is an aperture configuration that is automatically generated by the computer software, ... which is readily deliverable.
ECF No. 92 (SEALED) at 14 (emphasis in original). The invention “allows for” the planning for IMRT, IMAT, or a “new type” of intensity-modulated radiotherapy that combines IMRT and IMAT. '008 patent col. 2 l. 67 to col. 3 l.3. “Hybrid IMRT” “provides the ability to incorporate into each treatment plan the dosimetric advantages of both IMRT and IMAT.” Id. col. 3 ll. 4–6.

The '008 and '591 patents were assigned to the University of Maryland (“UMD”) and exclusively licensed to Prowess. E.g., Hr'g 6:15–20.

On May 18, 2011, Prowess filed suit for patent infringement against Nucletron, RaySearch, and Philips Healthcare Informatics, Inc. ECF No. 1. On June 3, 2011, Prowess amended the complaint to add Philips as a defendant. ECF No. 5. On August 19 and 22, 2011, the Defendants answered the amended complaint and counterclaimed. ECF Nos. 13, 14, 17. On September 8, 2011, Prowess answered. ECF Nos. 29–31.

On March 15, 2012, Prowess filed a second amended complaint alleging that RaySearch “has been and is offering” certain software ¹³ that employs algorithms which infringe upon “most, if not all” of the '008 and ' 591 patent claims. Second Am. Compl. ¶¶ 19, 25. Prowess further alleged that RaySearch has contributed to infringement of the patents by providing the SmartArc module to radiation therapy equipment manufacturers like Nucletron and Philips. Id. Prowess alleged that Nucletron and Philips are infringing the patents by selling radiation therapy equipment that “includes and employs” RaySearch's software. Id. ¶¶ 20, 26. Finally, Prowess alleged that the Defendants willfully infringed the patents by “continuing their acts of infringement after having been provided notice of the

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Patent by Prowess.” Id. ¶¶ 21, 27.¹⁴ On April 4, 2012, the Defendants answered and counterclaimed, seeking declarations of noninfringement and patent invalidity. ECF Nos. 66–68. On April 30, 2012, Prowess answered. ECF Nos. 70–72.

On September 7, 2012, the parties filed a Joint Claim Construction Statement. ECF No. 91 (SEALED).¹⁵ Also on September 7, the parties filed their respective opening claim construction briefs (individually, “opening brief”). ECF Nos. 87 (SEALED), 92 (SEALED). On October 12, 2012, the parties filed their respective responsive claim construction briefs (individually, “responsive brief”). ECF Nos. 105 (SEALED), 106 (SEALED). On October 22, 2012, Prowess moved to strike the Defendants' responsive brief and requested an expedited briefing schedule. ECF No. 114 (SEALED).¹⁶ On November 5, 2012, the Defendants opposed the motion to strike. ECF No. 116. On November 15, 2012, Prowess replied. ECF No. 121.

On November 30, 2012, the Defendants moved for leave to file amended answers and defenses to the second amended complaint, and counterclaims. ECF Nos. 126, 127 (SEALED). On December 13, 2012, the Court denied Prowess's motion to strike the Defendants' responsive brief on claim construction. ECF NOS. 146 (SEALED), 147 (SEALED). On December 14, 2012, the Court held a claim construction hearing. ECF No. 148. On December 17, 2012, the Defendants moved to supplement the record in support of their opening brief. ECF No. 14 9. Also on December 17, Prowess opposed the Defendants' motion for leave to file amended answers. ECF No. 151 (SEALED). On January 7, 2013, the Defendants replied. ECF No. 164 (SEALED). That day, Prowess opposed the Defendants' motion to supplement the record. ECF No. 168 (SEALED). On January 24, 2013, the Defendants replied. ECF No. 179 (SEALED).

Before reaching the merits of the claim construction issues, the Court will address the Defendants' pending motions.