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F.T. Alexandra Mahaney, State Bar No. 125984 WILSON SONSINI GOODRICH & ROSATI Professional Corporation 12235 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: (858) 350-2300 Facsimile: (858) 350-2399 Email: [email protected] Bruce R. Genderson (admitted pro hac vice) Aaron P. Maurer (admitted pro hac vice) Rachel Shanahan Rodman (admitted pro hac vice) Adam D. Harber (admitted pro hac vice) WILLIAMS & CONNOLLY LLP 725 Twelfth St. NW Washington, DC 20005 Telephone: (202) 434-5000 Facsimile: (202) 434-5029 Attorneys for Defendant and Counterclaimant SENORX, INC. IN THE UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA SAN JOSE DIVISION HOLOGIC, INC., CYTYC CORP., and HOLOGIC L.P., Plaintiffs, v. SENORX, INC., Defendant. ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) CASE NO.: 08-CV-0133 RMW DEFENDANT SENORX, INC.'S OPPOSITION TO PLAINTIFFS' MOTION FOR A PRELIMINARY INJUNCTION REDACTED VERSION

SENORX, INC., Counterclaimant, v. HOLOGIC, INC., CYTYC CORP., and HOLOGIC L.P., Counterdefendants.

Date: April 21, 2008 Time: 2:00 p.m. Courtroom: 6, 4th Floor Judge: Hon. Ronald M. Whyte

DEFENDANT SENORX, INC.'S OPPOSITION TO PLAINTIFFS' MOTION FOR A PRELIMINARY INJUNCTION

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TABLE OF CONTENTS TABLE OF AUTHORITIES .........................................................................................................iii INTRODUCTION...........................................................................................................................1 BACKGROUND.............................................................................................................................1 ARGUMENT ..................................................................................................................................3 I. Plaintiffs Cannot Show a Reasonable Likelihood of Success on the Merits. .....................4 A. The '204 Patent ­ Claim 36 Is Not Infringed and Is Invalid...................................4 1. The Contura Does Not Infringe Claim 36 of the '204 Patent as It Lacks an "Inner Spatial Volume."...............................................................5 Claim 36 of the '204 Patent Is Rendered Invalid by the Prior Art..............7

The '142 Patent ­ Claim 1 Is Not Infringed and Is Invalid...................................11 1. 2. The Plain Meaning of "Apparatus Volume." ............................................11 The Contura Does Not Infringe Claim 1 of the '142 Patent as It Lacks a Radiation Source "Located so as To Be Spaced Apart from the Apparatus Volume." ............................................................................13 Claim 1 of the '142 Patent Is Inoperable and Invalid. ..............................14 The Contura Does Not Infringe Claim 1 of the '142 Patent as It Lacks a Radiation Source "Disposed Completely Within" the Expandable Outer Surface.........................................................................16 a. "Disposed Completely Within" Does Not Mean "Replaceably Disposable Within."................................................16 The Contura Is Used with a "Replaceably Disposable" Radiation Source and Lacks a Radiation Source "Disposed Completely Within" the Outer Surface. ........................................18

Claim 1 of the '142 Patent Is Rendered Invalid by the Prior Art..............19

The Remaining Factors all Support Denial of an Injunction.............................................20 A. An Injunction Is Contrary to the Public Interest. ..................................................21 1. The Contura Enables Critical Cancer Treatment for Women Otherwise Not Treatable by Balloon Brachytherapy. ...............................21 The Contura Is Safe and Effective. ...........................................................22 i
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B.

Plaintiffs Will Not Suffer Irreparable Harm. ........................................................24 1. Plaintiffs' Own Actions Show There Is No Irreparable Harm..................25 a. b. 2. 3. 4. 5. Plaintiffs' Delay in Seeking Injunctive Relief Undermines Their Claim of Urgency. ...............................................................25 Plaintiffs' Willingness To License a Competitor Under the Patents-In-Suit Shows There Is No Irreparable Harm. .................25

The Contura Will Expand, Not Harm, the Market. ...................................27 Plaintiffs' "Concerns" About Off-Label Promotion Do Not Justify the Injunction They Seek...........................................................................28 The Economic Harm Alleged by Plaintiffs Is Not Irreparable..................30 Plaintiffs' Reputation as an Innovator Will Not Be Harmed if an Injunction Does Not Issue. ........................................................................32

C.

The Balance of Harms Favors SenoRx. ................................................................33

CONCLUSION .................................................................................................................35

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TABLE OF AUTHORITIES FEDERAL CASES 3M Unitek Corp. v. Ormco Co., 96 F. Supp. 2d 1042 (C.D. Cal. 2000) ....................................... 26 800 Adept, Inc. v. Murex Securities, Ltd., No. 6:02-cv-1354 (M.D. Fla. 2007) ........................... 31 Abbott Labs. v. Andrx Pharms., Inc., 452 F.3d 1331 (Fed. Cir. 2006) ........................................... 4 Al-Site Corp. v. Cable Care Sunglasses, 911 F. Supp. 410 (N.D. Cal. 1994) ........................ 32, 34 Allen Engineering Corp. v. Bartell Industries, Inc., 299 F.3d 1336 (Fed. Cir. 2002) .................. 14 Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343 (Fed. Cir. 2001) ..................... 3, 4 Applera Corp. v. Illumina, Inc., No. C-07-02845, (N.D. Cal. 2008) ............................................ 15 Atari Corp. v. Sega of Am., Inc., 869 F. Supp. 783 (N.D. Cal. 1994) ..................................... 27, 34 Biagro Western Sales, Inc. v. Helena Chem. Co., 160 F. Supp. 2d 1112 (E.D. Cal. 2001).......... 32 Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001) ................................................... 29 Chamberlain Group, Inc. v. Lear Corp., No. 05-C-3449 (N.D. Ill. 2007) ................................... 24 Chef America v. Lamb-Weston, Inc., 358 F.3d 1371 (Fed. Cir. 2004).......................................... 14 City of Los Angeles v. Lyons, 461 U.S. 95 (1983)......................................................................... 29 Competitive Techs., Inc. v. Fujitsu Ltd., 185 Fed. Appx. 958 (Fed. Cir. 2006) ............................ 15 Datascope Corp. v. Kontron, Inc., 611 F. Supp. 889 (D. Mass. 1985) ......................................... 22 Docusign, Inc. v. Sertifi, Inc., 468 F.Supp.2d 1305 (W.D. Wash. 2006) ...................................... 24 eBay, Inc. v. MercExchange L.L.C., 547 U.S. 388 (2006)........................................................ 3, 30 Engel Industries, Inc. v. Lockformer Co., 96 F.3d 1398 (Fed. Cir. 1996) .................................... 14 Entegris, Inc. v. Pall Corp., 490 F.3d 1340 (Fed. Cir. 2007).......................................................... 4 Gemveto Jewelry Co. v. Jeff Cooper Inc., 800 F.2d 256 (Fed. Cir. 1986) .................................... 29 High Tech Med. Instr., Inc. v. New Image Indus., Inc., 49 F.3d 1551 (Fed. Cir. 1995) ......... 25, 26 Hybritech, Inc. v. Abbott Labs., No. CV 86-7461 (C.D. Cal. 1987) ............................................. 22 Illinois Tool Works Inc. v. Grip-Pak Inc., 906 F.2d 679 (Fed. Cir. 1990) .................................... 34 Lamb-Weston, Inc. v. McCain Foods, Ltd., 941 F.2d 970 (9th Cir. 1991) ................................... 30 National Steel Car, Ltd. v. Canadian Pacific Ry., Ltd., 357 F.3d 1319 (Fed. Cir. 2004) ........... 3, 4 Natural Res. Def. Council, Inc. v. Winter, 508 F.3d 885 (9th Cir. 2007)..................................... 30
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Nelson v. Nat'l Aeronautics & Space Admin., 512 F.3d 1134 (9th Cir. 2008) ............................. 30 Nutrition 21 v. United States, 930 F.2d 867 (Fed. Cir. 1991) ................................................. 24, 30 In re Orthopedic Bone Screw Prod. Liab. Litig., 264 F.3d 344 (3d Cir. 2001) ............................ 23 Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005)............................................................... 11 Polymer Techs., Inc. v. Bridwell, 103 F.3d 970 (Fed. Cir. 1996) ................................................. 25 Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350 (Fed. Cir. 1999).......... 13, 14, 15, 16 RasterOps v. Radius, Inc., 861 F. Supp. 1479 (N.D. Cal. 1994)................................................... 30 Raytheon Co. v. Roper Corp., 724 F.2d 951 (Fed. Cir. 1983) ...................................................... 16 Reiffin v. Microsoft Corp., 158 F. Supp. 2d 1016 (N.D. Cal. 2001) ....................................... 24, 26 Riles v. Shell Exploration and Prod. Co., 298 F.3d 1302 (Fed. Cir. 2002) ............................ 29, 30 Sofamor Danek Group, Inc. v. DePuy-Motech, Inc., 74 F.3d 1216 (Fed. Cir. 1996) ................... 24 Sun Optics, Inc. v. FGX Int'l, Inc., No. Civ-07-137 (D. Del. 2007).............................................. 24 Tiber Labs., LLC v. Hawthorn Pharm., Inc., 527 F. Supp. 2d 1373 (N.D. Ga. 2007)............ 24, 26 TiVo, Inc. v. Echostar Communicators Corp., 446 F. Supp. 2d 664 (E.D. Tex. 2006) ................ 31 Torspo Hockey Int'l, Inc. v. Kor Hockey Ltd., 491 F. Supp. 2d 871 (D. Minn. 2007) .................. 24 Visto Corp. v. Sproqit Technologies, Inc., 413 F. Supp. 2d 1073 (N.D. Cal. 2006) ............... 27, 34 Voile Mfg. Corp. v. Louis Dandurand et al., No. 07-CV-396 (D. Utah 2008) ............................. 24 z4 Techs., Inc. v. Microsoft Corp., 434 F. Supp. 2d 437 (E.D. Tex. 2006)................................... 24

FEDERAL STATUTES AND REGULATIONS 21 U.S.C. § 337 ............................................................................................................................. 30 21 U.S.C. § 360aaa.................................................................................................................. 23, 29 21 U.S.C. § 396 ............................................................................................................................. 29 35 U.S.C. § 101 ............................................................................................................................. 16 35 U.S.C. § 112 ............................................................................................................................. 16 21 C.F.R. § 807 ............................................................................................................................. 23

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INTRODUCTION Plaintiffs' request for a preliminary injunction should be denied. Defendant SenoRx, Inc. ("SenoRx") markets a device used to treat women with breast cancer, called the Contura MLBTM ("Contura"). The Contura represents a significant advance in the field of balloon brachytherapy. Its technology and design open the possibility of balloon brachytherapy ­ an important treatment option ­ to women who otherwise are not treatable by existing prior-generation balloon brachytherapy devices. These existing devices include one sold by Plaintiffs, under the tradename "MammoSite."

Plaintiffs' request for a preliminary injunction not only lacks urgency, it lacks merit. SenoRx will show: (1) Plaintiffs are not likely to succeed on the merits, as the asserted patent claims are not infringed and invalid, or, at the very least, there exists a substantial question as to whether the Contura infringes any valid claim of the patents-in-suit; (2) the proposed injunction will harm the public interest because the Contura safely and effectively treats women the MammoSite cannot; (3) Plaintiffs' alleged "irreparable harms" are anything but, as evidenced by, inter alia, Plaintiffs' grant of a license of the very patents at issue to a competitor in the field; and (4) the hardships to SenoRx outweigh any alleged harm to Plaintiffs. Consequently, Plaintiffs' request for the extraordinary relief of a preliminary injunction should be denied. BACKGROUND Balloon catheter breast brachytherapy has real advantages in targeting the tissue needing treatment, thereby minimizing the potential for side effects. Declaration of Douglas Arthur, M.D. ("Arthur Decl."), ¶¶ 14-20; Declaration of Philip Z. Israel, M.D. ("Israel Decl."), ¶¶ 21-25, 27. It also can be completed in just a few days with less trauma to the patient's breast than other methods. Arthur Decl. ¶¶ 14-20; Israel Decl. ¶ 12. Declaration of Aaron P. Maurer ("Maurer
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Decl.")1,

. The general structure and use of the MammoSite

and Contura are the same. Both devices consist of a catheter body with a balloon on the end. The Contura is pictured below, and a detailed description of the Contura's structure is found in ¶ 9 of the Declaration of William F. Gearhart ("Gearhart Decl.").

The catheter body has either a single lumen2 (MammoSite) or multiple lumens (Contura) into which a radioactive seed may be inserted for treatment purposes by a machine called an

11 "afterloader." Arthur Decl. ¶¶ 25, 27-28, 31-32. In use, the devices are inserted into a 12 lumpectomy cavity of a woman, where the balloon portion is inflated with a contrast fluid to 13 hold it in place and conform the cavity to the balloon shape. Id. ¶ 21. A CT scan of the device in 14 situ is then made, and a physician and physicist determine how to best deliver radiation to the 15 patient. Id. ¶¶ 22-23. The ideal dose profile delivers 100% of the target dose of radiation to the 16 target tissue surrounding the cavity while minimizing the exposure of other tissues (especially 17 sensitive tissues such as the skin and ribs). In practice, the ideal dosing profile is difficult to 18 achieve, as the location of the lesion may be too close to the skin or ribs, or the cavity may not 19 match the shape of the balloon. Israel Decl. ¶ 18-19. After a dose plan is optimized and 20 approved, the afterloader is connected to the catheter by the lumen(s) at the proximal end of the 21 device. Arthur Decl. ¶¶ 25-26. The radiation source is inserted into the device's lumen(s) by the 22 23 24 25 26 27 28
DEFENDANT SENORX, INC.'S OPPOSITION TO PLAINTIFFS' MOTION FOR A PRELIMINARY INJUNCTION

All exhibits ("Ex.") referenced herein are exhibits to the Declaration of Aaron P. Maurer, unless otherwise specified. A lumen is a hollow tube. See Ex. 2 (Merriam-Webster's Dictionary), at 692 (defining lumen as "the bore of a tube (as of a hollow needle or catheter)"). In addition to the lumen(s) into which a radioactive source is inserted, both catheters also have an additional lumen leading to the balloon portion of the device. This lumen allows for the inflation and deflation of the balloon. The Contura has one additional lumen connecting to suction ports at the distal end of the device.
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afterloader, and radiation is delivered at precise locations along the distal end of the lumen(s) by pausing and moving the radiation source according to the plan. The radiation source then is withdrawn back into the afterloader. Id. Despite their similarities, the Contura offers significant advantages over the MammoSite. Arthur Decl. ¶¶ 31-37; Israel Decl. ¶¶ 20-25. The MammoSite has only a single treatment lumen, which is centrally located in the balloon. This design can preclude treatment of certain women, such as those with small breasts or whose tumors are located too close to the skin or near the ribs. Arthur Decl. ¶ 30; Israel Decl. ¶¶ 22, 32. The Contura, on the other hand, has five lumens ­ one central and four offset ­ into which the radiation source may be inserted. This allows the radiation dose to be tailored by positioning the radioactive seed at locations offset from the center of the Contura balloon to "push" or "pull" the resulting dose. Arthur Decl. ¶ 32; Israel Decl. ¶ 21. Physicians have found this flexibility to offer great advantages in treating patients with balloon brachytherapy. The Contura has allowed them to treat many women who could not be treated with Plaintiffs' devices and to achieve closer to ideal-dosing in others. Arthur Decl. ¶¶ 31-37; Israel Decl. ¶¶ 21-25, 32-33. The advantages of the Contura are but one of many reasons Plaintiffs' request for a preliminary injunction should be denied. ARGUMENT A preliminary injunction is a "drastic and extraordinary remedy that is not to be routinely granted." Nat'l Steel Car, Ltd. v. Canadian Pacific Ry., Ltd., 357 F.3d 1319, 1324 (Fed. Cir. 2004). To obtain such "extraordinary relief," Plaintiffs must establish: (1) a reasonable likelihood of success on the merits; (2) irreparable harm if an injunction is not granted; (3) a balance of hardships tipping in their favor; and (4) the injunction's favorable impact on the public interest. Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343, 1350 (Fed. Cir. 2001); cf. eBay, Inc. v. MercExchange L.L.C., 547 U.S. 388, 391 (2006). Here, Plaintiffs fail to satisfy the foregoing factors, and no injunction should issue. Plaintiffs assert infringement of two claims: claim 36 of U.S. Patent No. 6,413,204 (the "'204 patent"); and claim 1 of U.S. Patent No. 6,482,142 (the "'142 patent"). As set forth below, Claim 36 is not infringed and is invalid over the prior art. Claim 1 of the '142 patent likewise is
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not infringed and is invalid over the prior art, and also is invalid because it recites an inoperable invention. Moreover, continued availability of the Contura is in the public interest and does not irreparably harm Plaintiffs, and the balance of harms likewise supports denial of Plaintiffs' request for an injunction. I. PLAINTIFFS CANNOT SHOW A REASONABLE LIKELIHOOD OF SUCCESS ON THE MERITS. To establish a reasonable likelihood of success on the merits, Plaintiffs must show that

7 SenoRx infringes a valid claim of Plaintiffs' patents-in-suit. Amazon, 239 F.3d at 1350. A 8 "substantial question concerning either infringement or validity" precludes Plaintiffs from 9 satisfying this standard. Nat'l Steel Car, 357 F.3d at 1334. As to validity, the question is not 10 whether SenoRx will prevail at trial, but whether Plaintiffs' patent is "vulnerable" to an invalidity 11 challenge. Amazon, 239 F.3d at 1359; see also Entegris, Inc. v. Pall Corp., 490 F.3d 1340, 1351 12 (Fed. Cir. 2007) (less than clear and convincing evidence will suffice); Abbott Labs. v. Andrx 13 Pharms., Inc., 452 F.3d 1331, 1335 (Fed. Cir. 2006) (same). Here, the evidence presents a 14 substantial question as to the validity and infringement of the asserted claims. 15 A. 16 17 18 19 20 21 22 23 24 25 26 27 28
DEFENDANT SENORX, INC.'S OPPOSITION TO PLAINTIFFS' MOTION FOR A PRELIMINARY INJUNCTION

The '204 Patent ­ Claim 36 Is Not Infringed and Is Invalid.

This Court previously construed the '204 Patent in Xoft, Inc. v. Cytyc Corp., No. C-0505312 RMW (the "Xoft case").3 See Ex. 3 (Cl. Constr. Order). Plaintiffs assert that application of the Court's prior claim construction necessitates a finding of infringement in this case. Pl. Br. at 10. That is incorrect. This Court's prior construction shows SenoRx does not infringe claim 36, and that claim 36 is anticipated by the prior art.

The claim construction in the Xoft case was based on arguments made in part by a different party with respect to a different allegedly infringing device. Because the SenoRx device does not infringe based on the Court's construction in Xoft, SenoRx accepts the construction for purposes of this expedited proceeding, but it reserves the right to request that the Court construe certain of the terms of the '204 patent at a later date.

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1.

The Contura Does Not Infringe Claim 36 of the '204 Patent as It Lacks an "Inner Spatial Volume."

Plaintiffs' proposed application of this Court's prior construction of the "inner spatial volume" claim limitation of claim 36 is contrary to this Court's claim construction order, and the disclosure and claims of the '204 patent. Correctly applied, this Court's prior construction means the Contura does not infringe claim 36. The '204 patent claims a balloon catheter-based brachytherapy device. Several specific embodiments of that device are described in the patent specification. As this Court observed in the Xoft case, "[i]n most embodiments of the invention disclosed in the patent specification, the inner spatial volume is a region of space surrounded by an outer spatial volume that is defined by a closed inflatable chamber." Ex. 3 (Cl. Constr. Order), at 4. This configuration is depicted, for example, in the "balloon within a balloon" embodiment shown in Figures 1 and 2.

'204 Patent, Figure 1

'204 Patent, Figure 2

Ex. 4 ('204 patent), at Fig. 1, Fig. 2. This Court also recognized, "however, the patentee drafted the claims in such a way as to make clear that the inner spatial volume was not necessarily so limited." Ex. 3 (Cl. Constr. Order), at 5 ("[I]nstead of having the inner spatial volume 30 defined by a generally spherical polymeric film wall as at 32, the catheter body member 12 may have a solid spherical radiation emitting material 44 as the inner spatial volume 30." (emphasis added)); see Ex. 4 ('204 patent), at 4:44-5:12. All of the claims of the '204 patent, including claim 36, recite an "inner spatial volume." In the Xoft case, this Court discussed the disclosure of the patents in detail, and concluded that "[i]n all embodiments . . . the boundary of the inner volume is either a polymeric film wall or the edge of a solid sphere." Ex. 3 (Cl. Constr. Order), at 5; see also id. at 16. Accordingly, this
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Court construed an "inner spatial volume" to be "a region of space surrounded by an outer spatial volume and either enclosed by a polymeric film wall or defined by the outside surface of a solid radionuclide sphere." Id. at 5, 16. However, Plaintiffs now seek to dissociate the Court's construction ­ which was firmly grounded in the claims and disclosure of the patent ­ from its reasoning by asserting that the lumens of the Contura are an "inner spatial volume." Plaintiffs state that "[e]ach of the five treatment lumens inside the Contura MLB constitutes an inner spatial volume . . . . Alternatively, the five treatment lumens and the area within the balloon between and surrounded by those lumens together define one inner spatial volume." Pl. Br. at 13. But Plaintiffs' argument is refuted by the '204 patent and this Court's claim construction ruling in Xoft. First, the '204 patent makes clear that lumens and the "inner spatial volume" are different things. For instance, in its description of the "balloon-within-a-balloon" embodiment, the patent explicitly labels the inner spatial volume as item number 30, defined by polymeric film wall 32. That same embodiment separately contains lumens, labeled as numbers 14 and 16. The lumens are not described or depicted as being the inner spatial volume, but instead are parts of the tubular catheter body that are in "fluid communication" with the inner spatial volume: A surgical instrument 10 . . . is illustrated in Fig. 1. Surgical instrument 10 includes a tubular body member 12 having first and second lumens 14 and 16 (FIG. 2) extending from proximal ports 18 and 20 in a molded plastic hub 22 to inflation ports 24 and 26 formed through the side wall of the tube 12 and intersecting with the lumens 14 and 16, respectively. Affixed to the tubular body 12 proximate the distal end 28 thereof is an inner spatial volume 30 which may be defined by a generally spherical polymeric film wall 32. The interior of the inner volume 30 is in fluid communication with the inflation port 26. Ex. 4 ('204 patent), at 3:49-61 (emphasis added). Claim 36 maintains the distinction between the catheter body (element [a], having lumens as part thereof) and the inner spatial volume (element [b]). The same is true for the solid radionuclide embodiment. Instead of equating the inner spatial volume and the lumen, as Plaintiffs suggest, the patent plainly distinguishes between a lumen in the catheter body and the "inner spatial volume" inserted through that lumen:
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In a further embodiment, illustrated in FIG. 3, instead of having the inner spatial volume 30 defined by a generally spherical polymeric film wall as at 32, the catheter body member 12 may have a solid spherical radiation emitting material 44 as the inner spatial volume 30. . . . The solid radiation emitting material 44 can be inserted through catheter 12 on a wire 46 . . . . Id. at 4:44-48 (emphasis added). Plaintiffs' infringement contentions ignore the distinction in

5 their own patent between the lumens of the device that are part of the catheter body, and the 6 "inner spatial volume" of the device that is separate and apart from the catheter body. They are 7 not the same thing. 8 Second, as this Court recognized in its claim construction ruling, the inner spatial volume 9 must be "surrounded by" the outer spatial volume. The lumens in the Contura (as in the patent) 10 do not meet this requirement. Instead, the five lumens in the Contura device are contiguous 11 tubes that run from the external (proximal) end of the Contura device through to the end of the 12 balloon at the internal (distal) end of the Contura device. They are not "surrounded by" the 13 volume defined by the Contura balloon (i.e., the "outer spatial volume"), but instead extend out 14 of the outer spatial volume. In this respect, the lumens of the Contura again are like the lumens 15 of the '204 patent. See id. at 3:51-56 ("first and second lumens 14 and 16 . . . extending from 16 17 "outer spatial volume," they cannot be (either individually or collectively) "an inner spatial 18 volume." 19 2. 20 21 22 23 24 25 26 27 28
DEFENDANT SENORX, INC.'S OPPOSITION TO PLAINTIFFS' MOTION FOR A PRELIMINARY INJUNCTION

proximal ports 18 and 20 . . . to inflation ports 24 and 26").4 As these lumens extend beyond the

Claim 36 of the '204 Patent Is Rendered Invalid by the Prior Art.

Despite their assertions to the contrary, Plaintiffs did not invent brachytherapy using balloon catheters. Instead (if anything), they invented very particular embodiments of one such

Plaintiffs incorrectly suggest there are two sets of lumens in the Contura ­ "radiation source lumens" that extend from the end of the device up to the balloon, and separate "treatment lumens" inside of the balloon. See Pl. Br. at 12-13. In fact, there is only one set of lumens in the Contura into which the radiation source is inserted, consisting of five tubes extending from one end of the Contura through to the other. See Gearhart Decl. ¶ 9; Gearhart Decl. Ex. 1 (picture of Contura MLB).

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catheter. Given the broad interpretation Plaintiffs have assigned claim 36, there exists a wealth of invalidating prior art. For example, claim 36 is anticipated by a 1990 article entitled "A New Technique of Brachytherapy for Malignant Gliomas with Caesium-137: A New Method Utilizing a Remote Afterloading System," authored by Ashpole, et al. ("Ashpole"). Ashpole describes the irradiation of a brain tumor site5 using a modified endotracheal tube that has a catheter body with a lumen and a balloon at the far end. Ex. 5 (Ashpole), at 334 & Fig. 1 (below).6

Ashpole Figure 1 Ashpole inserted the balloon-end of the device into the patient's tumor cavity and filled the balloon with fluid "so that the inflated balloon filled the postsurgical cavity." Id. The patient was transferred to a radiotherapy center, and a radiation afterloader applicator was inserted into the central lumen of the catheter of the Ashpole device. Id. at 334-35. The afterloader was programmed to place a series of active and inactive spherical radioactive beads into the Ashpole catheter, locating them inside the portion of the lumen within the balloon in order to achieve the required dose for treatment of the margins surrounding the surgical cavity. Id. at 335-336. The

The claims at issue in this proceeding are not limited to treatment of breast cancer, but are generic to "interstitial brachytherapy" in any tissue. Ashpole is discussed in detail in the Declaration of Dr. Colin Orton. See Orton Decl., ¶¶ 11-29.
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dose delivered was chosen to effectively treat the tumor margins, while taking into account the tolerance of the surrounding tissue in order to minimize harm to healthy tissue. Id. at 336. Accordingly, Ashpole anticipates every element of claim 36, as set out in the claim chart below. Claim 36 An interstitial brachytherapy apparatus for delivering radioactive emissions to an internal body location comprising: Ashpole, "A New Technique of Brachytherapy . . . " (1990) Ashpole describes an apparatus for interstitial brachytherapy. Ex. 5 (Ashpole), at 334 & Fig. 1; Declaration of Colin Orton, Ph.D. ("Orton Decl."), at ¶¶ 12, 14. (a) a catheter body member having a proximal end and distal end; The Ashpole device has a catheter body having proximal and distal ends. See Ex. 5 (Ashpole), at 334 & Fig. 1; Orton Decl. ¶¶ 12-13, 15. (b) an inner spatial volume disposed proximate to the distal end of the catheter body member; If a lumen is considered to be an "inner spatial volume," the Ashpole device contains an inner spatial volume at or near the distal end of the catheter. See Ex. 5 (Ashpole), at 334 & Fig. 1; Orton Decl. ¶ 13. Alternatively, Ashpole contains an inner spatial volume defined by the outside surface of a radionuclide bead in the Ashpole source train. See Ex. 5 (Ashpole), at 334-35 ("active bead . . . encapsulated in stainless steel to form a sphere") & Fig. 3; Orton Decl. ¶¶ 17-18, 22. (c) an outer spatial volume defined by an expandable surface element disposed proximate to the distal end of the body member in a surrounding relation to the inner spatial volume; and The balloon disposed on the far end of the Ashpole device constitutes an outer spatial volume. See Ex. 5 (Ashpole), at 334 & Fig. 1; Orton Decl. ¶¶ 12-13, 16. If the balloon of the Contura surrounds an "inner spatial volume" by surrounding portions of the Contura lumens, the balloon of

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Claim 36

Ashpole, "A New Technique of Brachytherapy . . . " (1990) Ashpole likewise surrounds an inner spatial volume. Id. Alternatively, the outer expandable balloon of the Ashpole device surrounds an "inner spatial volume" by surrounding any one of the radioactive beads in the source train. See Ex. 5 (Ashpole), at 335 & Fig. 3; Orton Decl. ¶¶ 12-13, 16-18, 22.

(d) a radiation source disposed in the inner spatial volume;

If a lumen is an inner spatial volume, a radiation source (radioactive bead) is disposed in the inner spatial volume of the Ashpole device. See Ex. 5 (Ashpole), at 335 & Fig. 3; Orton Decl. ¶¶ 17-18, 22. Alternatively, the interior of a

12 radioactive bead satisfies this limitation. Orton Decl. ¶ 17. 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 wherein the inner and outer spatial volumes are configured to provide a minimum prescribed absorbed dose for delivering therapeutic effects to a target tissue, the target tissue being defined between the outer spatial volume expandable surface and a minimum distance outward from the outer spatial volume expandable surface, the apparatus providing a controlled dose at the outer spatial volume expandable surface to reduce or prevent necrosis in healthy tissue proximate to the expandable surface. Ashpole describes varying the balloon configuration, as well as the configuration of the radioactive sources with respect to the balloon, to achieve an acceptable dose in the target tissue, while reducing and preventing necrosis in healthy tissue. Ex. 5 (Ashpole), at 336 ("The dose . . . depends on the number and arrangement of sources as well as the balloon diameter . . . . The configuration of the balloon plays a key role in producing an acceptable dose distribution."); id. at 335 ("We aim to produce . . . . a total dose of 50 Gy to the tumour bed."); id. at 336 (the dose "takes into account the known tolerance of normal brain"); Orton Decl. ¶¶ 20-29. This means that the volumes are configured to produce a minimum prescribed dose to the target tissue while limiting the dose received by the healthy tissue proximate the expandable surface. Id.
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*** Plaintiffs cannot show a substantial likelihood of success of proving that claim 36 is valid and infringed. The claim is not infringed by the Contura, for at least the reason that the Contura lacks an "inner spatial volume." Additionally, the claim is anticipated by (and obvious over) the Ashpole reference. B. The '142 Patent ­ Claim 1 Is Not Infringed and Is Invalid.

The only other claim asserted by Plaintiffs in their Motion is claim 1 of the '142 Patent. 8 The '142 patent, unlike the '204 patent, was not at issue in the Xoft case. However, Plaintiffs 9 suggest the construction of terms in the Xoft case is relevant to the '142 patent, given the close 10 relationship between the '142 and '204 patents. Pl. Br. at 11. SenoRx agrees. The application 11 of the plain meaning of the terms in claim 1, especially in light of the Court's construction of 12 related terms in the Xoft case, shows there is no infringement by SenoRx of claim 1 of the '142 13 patent, and that claim 1 is invalid. 14 1. 15 The first element of claim 1 requires "an expandable outer surface defining a three16 17 18 19 20 21 22 23 24 25 26 SenoRx Interrs.), at 9 (emphasis added). The plain meaning of "three-dimensional apparatus 27 volume" is the three-dimensional region of space within the expandable outer surface. This 28
DEFENDANT SENORX, INC.'S OPPOSITION TO PLAINTIFFS' MOTION FOR A PRELIMINARY INJUNCTION

The Plain Meaning of "Apparatus Volume."

dimensional apparatus volume configured to fill an interstitial void created by the surgical extraction of diseased tissue and define an inner boundary of the target tissue being treated." Ex. 6 ('142 patent), at 8:63-67 (emphasis added). As an initial matter, this Court should construe "three-dimensional apparatus volume" consistent with its ordinary meaning. See Phillips v. AWH Corp., 415 F.3d 1303, 1312-14 (Fed. Cir. 2005) (en banc). This is not a situation where the inventor used an idiosyncratic term or where the plain meaning of the term is difficult to divine. See id. The inventors used common-place words to precisely define the meaning of the phrase in the claim itself. Plaintiffs concede this point, stating in their verified response to SenoRx's interrogatory on claim construction that "three-dimensional apparatus volume" should be construed according to its "Plain meaning (no construction necessary)." Ex. 7 (Pl. Resp. to

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region of space is "defin[ed]" by the "expandable outer surface" and "fill[s] [the] interstitial void created by the created by the surgical extraction." Ex. 6 ('142 patent), at claim 1, 8:64-65. The concept of an outer "surface" defining a "volume" is consistent with this Court's claim construction in the Xoft case. In that case, Xoft asked the Court to equate the claim term "inner spatial volume" with either an "inner balloon" or a "spherical radionuclide." The Court declined to do so, stating: As Cytyc points out, Xoft's construction conflates the boundary of the volume with the volume itself. . . . In all embodiments of the invention disclosed in the '813 patent, the boundary of the inner volume is either a polymeric film wall or the edge of a solid sphere. ***

10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 The "outer spatial volume" is also explained in a similar manner; it is "defined by an expandable surface element disposed proximate to the distal end of the body member in a surrounding relation to the inner spatial volume." '204 patent, col. 8, ll. 22-25. Xoft again confuses the concepts of a volume with the boundary of a volume. Ex. 3 (Cl. Constr. Order), at 5, 17 (emphasis added). The Court thus construed the "volumes" at issue to be "regions of space" bounded or defined by some physical structure, i.e., the surface of a balloon or outer surface of the radionuclide. Id. This claim construction is the one Plaintiffs pressed the Court to adopt in the Xoft case. Discussing the "inner spatial volume" limitation of the related '813 patent, Plaintiffs cited the dictionary definition for "volume" and argued that: More fundamentally, Xoft confuses the tangible structure that defines the inner spatial volume with the volume itself. The specification provides that the inner spatial volume 30 "may be defined by a generally spherical polymeric film." The film defines the boundary of the volume but the volume is the region of space within that boundary. (Exhibit C to the Declaration of Henry C. Su (American Heritage College Dictionary ("AHC")) at 1513.) Ex. 8 (Pl. Cl. Constr. Br.), at 9 (emphasis added). Plaintiffs reemphasized the same point in the construction of the terms of the '204 patent: "The film defines the boundary of the volume but the volume is the region of space within that boundary." Id. at 18. The Court's construction and Plaintiffs' arguments in the Xoft case match the language of claim 1 of the '142 patent. Claim 1 requires "an expandable outer surface defining a threeDEFENDANT SENORX, INC.'S OPPOSITION TO PLAINTIFFS' MOTION FOR A PRELIMINARY INJUNCTION

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dimensional apparatus volume," that is, a three-dimensional volume (region of space), defined by and within the outer surface of the balloon. This "three-dimensional apparatus volume" is configured to "fill" the interstitial void created by the surgical extraction of diseased tissue. Plaintiffs apparently agree, as they have explicitly so stated in their infringement contentions in their brief in this case. See Pl. Br. at 17 ("The outer surface of the inflatable spherical Contura MLB . . . defines the three-dimensional apparatus volume that fills the resection cavity." (emphasis added)). 2. The Contura Does Not Infringe Claim 1 of the '142 Patent as It Lacks a Radiation Source "Located so as To Be Spaced Apart from the Apparatus Volume."

Claim 1 requires that the radiation source of the device be "located so as to be spaced apart from the apparatus volume." Plaintiffs admit that the radiation source of the Contura is located inside the expandable outer surface of the device. Pl. Br. at 18. Because the expandable outer surface defines the three-dimensional apparatus volume ­ that is, the volume is the region of space within the expandable outer surface ­ the Contura therefore does not infringe the claim as a radiation source that is inside a volume plainly is not "located so as to be spaced apart from" the volume. Recognizing this, Plaintiffs now seek to re-write the claim to read a radiation source "located so as to be spaced apart from the apparatus surface." They do this by equating the apparatus volume with the surface that defines that volume: All of the treatment lumens [of the Contura] are spaced apart from the apparatus volume (e.g., not touching the interior surface of the expandable surface of the balloon) . . . . Pl. Br. at 18 (emphasis added).7 Plaintiffs' attempt to re-write the claim by redefining the volume as the surface must fail. See Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1356-57 (Fed. Cir. 1999). Indeed, it is precisely the argument that this Court rejected in Xoft, as discussed in Section I.B.1 above. It is contrary to:
7

In essence, Plaintiffs' construction would have the claim read "located so as to not be spaced apart from the apparatus volume."
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·

the explicit definition of "apparatus volume" in claim 1 ­ "an expandable outer surface defining a three-dimensional apparatus volume" that fills the void left by the removal of the tumor. Ex. 6 ('142 patent), at 8:63-67 (emphasis added); the holding and reasoning of this Court's Claim Construction Order in the Xoft case ­ "[Plaintiff's] construction conflates the boundary of the volume with the volume itself . . . ." Ex. 3 (Cl. Constr. Order), at 5; Plaintiffs' own arguments in the Xoft case ­ "The film defines the boundary of the volume but the volume is the region of space within that boundary." Ex. 8 (Pl. Cl. Constr. Br.), at 9, 18; and, Plaintiffs' construction of the "outer surface" and "apparatus volume" limitations as applied to the Contura on the immediately previous page of their preliminary injunction brief in this case: "The outer surface of the inflatable spherical Contura MLB (an `expandable outer surface') defines the three-dimensional apparatus volume that fills the resection cavity." Pl. Br. at 17 (emphasis added).

·

·

·

Neither Plaintiffs nor this Court may rewrite the claims. Process Control Corp., 190 F.3d at 1356-57. Every limitation of the claim as written and properly construed must be satisfied for a finding of infringement. Engel Indus., Inc. v. Lockformer Co., 96 F.3d 1398, 1405 (Fed. Cir. 1996). Because the Contura lacks a "radiation source . . . located so as to be spaced apart from the apparatus volume," the Contura does not infringe claim 1, and Plaintiffs cannot show a likelihood of proving otherwise. 3. Claim 1 of the '142 Patent Is Inoperable and Invalid.

For much the same reason that claim 1 is not infringed, it is invalid. Claim 1 requires that the radiation source be "disposed completely within the expandable outer surface," but at the same time that the radiation source be "located so as to be spaced apart from the apparatus volume" defined by the outer surface. Since the radiation source cannot simultaneously be "within" the outer surface and "spaced apart" from the volume defined by that surface, the claim is inoperable and invalid. See Process Control Corp., 190 F.3d at 1359. By seeking to rewrite the claim, Plaintiffs ask this Court to fix their error. But "[c]ourts may not redraft claims, whether to make them operable or to sustain their validity." Chef Am. v. Lamb-Weston, Inc., 358 F.3d 1371, 1374 (Fed. Cir. 2004). Even "a nonsensical result does not require the court to redraft the claims." Process Control Corp., 190 F.3d at 1357; see also Allen Eng'g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1349 (Fed. Cir. 2002) ("Allen argues that one
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of skill in the art would understand that the term `perpendicular' in the claim should be read to mean `parallel.' Allen stretches the law too far. It is not our function to rewrite claims to preserve their validity. . . ."); Competitive Techs., Inc. v. Fujitsu Ltd., 185 Fed. Appx. 958, 96566 (Fed. Cir. 2006) ("Because the `address means' limitation of claim 5 requires ISA structures, and the `sustain means' limitation of that same claim excludes ISA structures, a person of ordinary skill in the art would be unable to determine the scope of the claims. They are internally inconsistent. . . . [C]laims 5-11 are invalid because of indefiniteness."). For the reasons stated above, this Court should reject Plaintiffs attempt to redefine "apparatus volume" to mean the "surface" that defines the apparatus volume. See supra, Section I.B.1. In Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350 (Fed. Cir. 1999), the Federal Circuit faced a similar issue. As here, the claim explicitly defined a term that, given the term's definition, meant the claim recited an impossibile, nonsensical invention. The Federal Circuit rejected the patentee's request to construe the term in accordance with the specification, or in accordance with "the natural manner in which [the term] make[s] sense." Id. at 1356. Instead, the Federal Circuit held that the term as defined in the claim trumped any other evidence allegedly supporting a contrary construction: The district court's attempt to use the written description to circumvent the plain language of the claim and the clear definition of the disputed claim language found therein was inappropriate. . . . [W]e do not permit courts to redraft claims. . . . Where, as here, the claim is susceptible to only one reasonable construction, the canons of claim construction cited by [the patentee] are inapposite, and we must construe the claims based on the patentee's version of the claim as he himself drafted it. Process Control, 190 F.3d 1356-57 (emphasis added); see also Applera Corp. v. Illumina, Inc.,

22 No. C-07-02845, 2008 WL 501391 at *5 (N.D. Cal. Feb. 21, 2008) (stating, in construing 23 inoperable claim language, that "[w]hile it is tempting to just fix it up in the claim construction 24 process, that temptation would be a dangerous course, for it should be up to the PTO in the first 25 instance to amend claims"). As a result, the claim in Process Control was held to recite an 26 impossibility and invalidated on the basis of inoperability. 190 F.3d at 1359 ("[W]hen an 27 28
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impossible limitation, such as a nonsensical method of operation, is clearly embodied within the claim, the claimed invention must be held invalid."). Here, as in Process Control, the language of claim 1 of the '142 patent explicitly defines the relevant terms and is plainly inoperative on its face.8 Given its explicit language, claim 1 is invalid for at least two reasons. It is not enabled, see Raytheon Co. v. Roper Corp., 724 F.2d 951, 956 (Fed. Cir. 1983) ("Because it is for the invention as claimed that enablement must exist, and because the impossible cannot be enabled, a claim containing a limitation impossible to meet may be held invalid under § 112."), and it is inoperable, id., ("Moreover, when a claim requires a means for accomplishing an unattainable result, the claimed invention must be considered inoperative as claimed and the claim must be held invalid under either § 101 or § 112 of 35 U.S.C."). Accordingly, claim 1 should be held to be invalid, or, at the very least, it should be held a substantial question exists as to its validity. 4. The Contura Does Not Infringe Claim 1 of the '142 Patent as It Lacks a Radiation Source "Disposed Completely Within" the Expandable Outer Surface.

The Contura fails to meet a second limitation of claim 1 because it does not contain a radiation source "disposed completely within" the balloon. Instead, SenoRx uses a radiation source "replaceably disposable within" the balloon, a limitation Hologic explicitly abandoned and disclaimed from claim 1. a. "Disposed Completely Within" Does Not Mean "Replaceably Disposable Within."

Claim 1, as originally filed, contained the limitation that the radiation source was "replaceably disposable within" the expandable surface of the device. Ex. 9 ('142 Patent
8

Plaintiffs may state in reply that the prosecution history suggests the inventors meant something different than they actually claimed, e.g., that they meant to claim that the radiation source is "located so as to not be spaced apart from the apparatus volume," or that the radiation source is "disposed completely within and spaced apart from the expandable outer surface" (as claimed in claim 9). However, Process Control specifically precludes looking to the prosecution history or other evidence "where, as here, the claim is susceptible to only one reasonable construction." Id. at 1357. And the prosecution history is less than clear in any event, simply parroting the language of the claims in some cases, and in others conflating the language of claim 1 and the clearly distinguishable language of claim 9.
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Application), at 15. On its face, the plain meaning of "replaceably disposable within" refers to a radiation source that is able to be located in and withdrawn from the balloon (the suffixes "-ably" and "-able" meaning that the radiation source is susceptible to or capable of being both replaced and disposed). During the prosecution of the patent, however, (and after claim 1's rejection over prior art using "replaceably disposable" sources) the word "replaceably" was deleted from the claim limitation, and the limitation amended to read "disposed completely within." There is one conclusion that can be drawn from this ­ "disposed completely within" does not and cannot mean "replaceably disposable within." The distinction between these terms is supported by the specification of the '142 patent, which describes two ways in which the radiation source can be loaded into the device: The radioactive source 24 can either be preloaded into the catheter at the time of manufacture, or loaded into the device after it has been implanted into the space formerly occupied by the excised tumor. If loaded after implantation, the solid radiation emitting material 36 can be inserted through lumen 14 on a wire 34, for example using an afterloader (not shown). Ex. 6 ('142 patent), at 5:5-11 (emphasis added). That is, according to the specification, a

15 radiation source may be "replaceably disposable" in the device, i.e., sometimes within the device 16 and sometimes not (e.g., when the device is used with an afterloader). Or, alternatively, the 17 radiation source may be "preloaded into the catheter at the time of manufacture," i.e., invariably 18 located within the expandable outer surface, and thus "disposed completely within." 19 This distinction is further supported by the prosecution history. As set forth above, claim 20 1 initially recited the "replaceably disposable within" limitation. Ex. 9 ('142 Patent 21 Application), at 15. However, this soon changed. On October 31, 2001, the United States Patent 22 & Trademark Office ("PTO") rejected claim 1 as anticipated over U.S. Patent No. 6,036,631 to 23 McGrath ("McGrath"), citing in particular Fig 2B. See Ex. 10 ('142 Patent Office Action), at 2. 24 Figure 2B of McGrath depicts a device with an insertable radiation source, consisting of 25 radioactive seeds, located within a lumen in a catheter. McGrath states that the radiation source 26 may be "implemented in such a manner that the seeds are movable along the axial length of 27 probe 28b within energy delivery lumen 34." Ex. 11 (McGrath), at Fig. 2B & col. 5:32-40. 28
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In response, on March 11, 2002, the Hologic inventors amended claim 1 to delete the requirement that the source be "replaceably" disposable in the balloon. Ex. 12 ('142 Patent Response to Office Action), at 11. The inventors explained McGrath is different from claim 1, as amended, because of a "number of key differences in structure," including that claim 1's "radiation source is disposed completely within the expandable surface." Id. at 6. The inventors continued: The device of McGrath is not configured for use interstitially, it is configured for use interluminally, with balloons provided only to hold its catheter within a lumen, or to dilate a lumen. Accordingly, the radiation source in McGrath is not located completely within any of the disclosed balloons . . . . Rather, McGrath provides an x-ray tube that slides within a catheter, or a plurality of radiationemitting seeds 52 `essentially forming a linear source.' Id. at 7 (emphasis added).9 That is, to avoid prior art encompassing an insertable radiation source, the inventors modified claim 1 to require that the radiation source invariably be located within the balloon (as opposed to "replaceably" located in it). In view of the claim language, patent specification and prosecution history, claim 1 clearly excludes "replaceably disposable" radiation sources. b. The Contura Is Used with a "Replaceably Disposable" Radiation Source and Lacks a Radiation Source "Disposed Completely Within" the Outer Surface.

The radiation source used with the Contura is not preloaded in the balloon. See Arthur Decl. ¶ 25. Instead, it is delivered by way of an afterloader at the time of treatment. The afterloader inserts the radiation source into the Contura's lumens to preprogrammed positions, for predetermined periods of time, before being withdrawn back into the afterloader. Id. This sequence of events ­ the placement and withdrawal of the radiation source into the Contura balloon ­ occurs for each "fraction" of the treatment received by the patient, and also usually is repeated several times during each fraction. This constitutes precisely the "replaceably

The same distinctions, and essentially the same arguments, were made with respect to other balloon catheter prior art that the Examiner had cited for obviousness. Ex. 12 ('142 Patent Response to Office Action), at 8-9.

9

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disposable" method of radiation insertion that Plaintiffs struck from claim 1 in the face of the prior art in favor of a limitation specifying a radiation source located "completely within" the device. Accordingly, the Contura does not infringe claim 1. 5. Claim 1 of the '142 Patent Is Rendered Invalid by the Prior Art.

If Plaintiffs' flawed claim interpretation of "apparatus volume" is accepted, claim 1 of the '142 patent suffers another flaw ­ it is anticipated by, or obvious over, the prior art. United States Patent No. 5,931,774 to Williams (the "'774 patent") is one such reference. See Ex. 13 ('774 patent). As seen from Figure 3 of the '774 patent, and as discussed in detail in the Declaration of Dr. Colin Orton (¶¶ 30-50), the patent discloses a balloon catheter, including an asymmetrically-placed radiation source (consisting of an inner balloon (40) filled with radioactive treatment fluid (42)) within the outer balloon (24):

Figure 3 and the corresponding disclosure of the '774 patent anticipate every element of claim 1, as set forth in the chart below: Claim 1 1. An interstitial brachytherapy apparatus for treating target tissue surrounding a surgical extraction comprising: United States Patent No. 5,931,774 (Williams, 1999) The '774 patent describes an apparatus for interstitial brachytherapy for treating target tissue surrounding a surgical extraction. Ex. 13 ('774 patent), at Fig. 3 & col. 2:1-3, 3:6-10, 3:22-28; Orton Decl. ¶¶ 30-34, 43-44. an expandable outer surface defining a threedimensional apparatus The device of the '774 patent consists of an expandable

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Claim 1 volume configured to fill an interstitial void created by the surgical extraction of diseased tissue and define an inner boundary of the target tissue being treated;

United States Patent No. 5,931,774 (Williams, 1999) balloon defining a volume configured to fill the interstitial void created by the extraction of diseased tissue and defining the inner boundary of target tissue being treated. Ex. 13 ('774 patent), at Fig. 3 & col. 7:41-60, 8:54-59; Orton Decl. ¶¶ 35-37, 44-45.

a radiation source disposed completely within the expandable outer surface and located so as to be spaced apart from the apparatus volume,

Applying (without agreeing to) Plaintiffs' constructions, the device of the '774 patent has a radiation source disposed completely within the balloon, and spaced apart from the surface of the balloon. Ex. 13 ('774 patent), at Fig. 3 & col. 8:35-63; Orton Decl. ¶¶ 36, 40-42, 46.

12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 *** In sum, Plaintiffs cannot show they likely will succeed in proving claim 1 of the '142 patent is infringed and valid. The claim is not infringed by the Contura, for at least the reason that the Contura lacks a "radiation source . . . located so as to be spaced apart from the apparatus volume." It also is not infringed because the Contura utilizes a "replaceably disposable" radiation source, not one located completely within the balloon. Alternatively, claim 1 is inoperable, or anticipated by (and obvious over) the '774 patent. II. THE REMAINING FACTORS ALL SUPPORT DENIAL OF AN INJUNCTION. The availability of the Contura on the market clearly serves the public interest by allowing treatment of patients requiring balloon brachytherapy that the MammoSite cannot treat.
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the radiation source further being asymmetrically located and arranged within the expandable surface to provide predetermined asymmetric isodose curves with respect to the apparatus volume.

The radiation source of the '774 patent is asymmetrically located and arranged within the balloon. Ex. 13 ('774 patent), at Fig. 3; Orton Decl. ¶¶ 47-50. This provides predetermined asymmetric isodose curves with respect to the apparatus volume. Orton Decl. ¶¶ 47-50.

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Thus, Plaintiffs' efforts to link the Contura to harm to the balloon brachytherapy marketplace fail. There is no harm to Plaintiffs that could not be compensated by monetary damages if necessary, nor can Plaintiffs show that the balance of harms tips in their favor. A. An Injunction Is Contrary to the Public Interest.

The Contura allows physicians to offer the advantages of balloon brachytherapy in connection with breast conserving surgery to many women who cannot be treated by the MammoSite. And, even for patients for whom the MammoSite could be an option, the Contura allows physicians in a number of cases to offer better treatment. The reason is simple ­ balloon brachytherapy depends on accurate placement of the radiation dose. The Contura's multi-lumen design allows tremendous flexibility in the placement of that dose as compared to the singlelumen MammoSite. The Contura is simply the next generation device in balloon brachytherapy. It solves the weaknesses of the MammoSite while maintaining the strengths of balloon brachytherapy. 1. The Contura Enables Critical Cancer Treatment for Women Otherwise Not Treatable by Balloon Brachytherapy.

A primary limiting factor in the use of balloon brachytherapy is the need to limit the dose of radiation to critical and highly radiation sensitive areas such as the skin, ribs, heart and lungs, while still meeting the target goals of irradiating the area of tissue in which tumor recurrence is most likely. See Arthur Decl. ¶¶ 23, 30; Israel Decl. ¶¶ 17-19. In single-lumen devices such as the MammoSite, physicians have a limited ability to shape the dose of radiation. Thus, if a patient's tumor is located too near her chest wall and ribs, or too near her skin, as is often the case for women with relatively small breasts, treatment with the MammoSite device would not be undertaken. See Arthur Decl. ¶ 30; Israel Decl. ¶¶ 22-23, 32. In contrast, the multi-lumen design of the Contura allows a great degree of flexibility in prescribing and delivering a three-dimensional radiation dose to a woman's breast. See Arthur Decl. ¶¶ 31-32; Israel Decl. ¶¶ 21-25, 27. Radiation oncologists and physicists using the Contura are able to deliver a highly specific, targeted and contoured dose profile that limits radiation overexposure of critical tissue while ensuring that the target tissue receives an appropriate dose.
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CASE NO. 08-CV-0133 RMW

Case 5:08-cv-00133-RMW

Document 51

Filed 03/28/2008

Page 27 of 41

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See Arthur Decl. ¶¶ 31-33; Israel Decl. ¶¶ 21-25, 27. Although estimates of how many more women are treatable with the Contura vary, they all make clear that there is a significant number of women who will benefit from the availability of the Contura. For example, one renowned breast surgeon who has worked extensively with the MammoSite and the Contura believes that the Contura's design will allow the device to treat between 20% and 30% more women than the MammoSite. See Israel Decl. ¶ 33; see also Arthur Decl. ¶ 33. Similarly, a multi-institutional clinical study (currently undergoing Investigational Review Board review) designed to scientifically compare the results of single-lumen versus multi-lumen treatment hypothesizes that the multi-lumen design will result in the ability to improve dosimetry in a minimum of 15% of patients. See Arthur Decl. ¶ 36. Dr. Arthur believes the results likely will be higher, showing an ability to improve dosimetry in 20% or more of patients. Id.