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1 Henry C. Su (SBN 211202; [email protected]) Katharine L. Altemus (SBN 227080; [email protected]) 2 HOWREY LLP 1950 University Avenue, 4th Floor 3 East Palo Alto, California 94303 Telephone: (650) 798-3500 4 Facsimile: (650) 798-3600 5 Robert Ruyak Matthew Wolf (Admitted Pro Hac Vice) 6 Marc Cohn (Admitted Pro Hac Vice) HOWREY LLP 7 1299 Pennsylvania Avenue, NW Washington, DC 20004 8 Telephone: (202) 783-0800 Facsimile: (202) 383-6610 9 Attorneys for Plaintiffs 10 HOLOGIC, INC., CYTYC CORPORATION and HOLOGIC L.P. 11 12 13 UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA SAN JOSE DIVISION Case No. C08 00133 RMW (RS) PLAINTIFFS' OPPOSITION TO DEFENDANT SENORX, INC.'S MOTION FOR PARTIAL SUMMARY JUDGMENT OF NON-INFRINGEMENT (`813 PATENT, CLAIMS 11 & 12; `204 PATENT, CLAIMS 4 & 17; AND `142 PATENT, CLAIM 6 ) Date: Time: Ctrm: Judge: June 25, 2008 2:00 p.m. 6, 4th Floor Hon. Ronald M. Whyte

14 HOLOGIC, INC., CYTYC CORPORATION, and HOLOGIC L.P., 15 Plaintiffs, 16 vs. 17 SENORX, INC., 18 Defendant. 19 20 AND RELATED COUNTERCLAIMS. 21 22 23 24 25 26 27 28
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 IV. 26 27 28 III. B. C. 4. 3. 2.

TABLE OF CONTENTS
Page(s) PRELIMINARY STATEMENT ......................................................................................................... 1 ARGUMENT...................................................................................................................................... 4 I. II. LEGAL STANDARD FOR SUMMARY JUDGMENT........................................................... 4 SENORX'S ACCUSED DEVICE MEETS THE "PREDETERMINED CONSTANT SPACING" LIMITATION OF THE `813 PATENT (CLAIMS 11 & 12) ................................................................................................................. 5 A. The Contura Directly Infringes the Asserted Claims of the `813 Patent........................................................................................................................... 6 1. The Contura Meets the "Predetermined Constant Spacing" Limitation Because It Can Emit Radiation from a Central Dwell Point ...................................................................................................... 6 Not Only Is the Contura Capable of Performing Brachytherapy From a Central Dwell Position ­ SenoRx and Others Have Used It In That Way............................................................... 8 In Addition to Using a Central Dwell Point During a MultiDwell Point Procedure, Users Can and Have Used the Contura To Deliver Radiation From a Single, Central Position ............................................................................................................ 9 Whether SenoRx's I-192 Seeds Are "Cylindrical" Rather Than Spherical Is Irrelevant ............................................................................ 11

SenoRx Induces Others to Infringe the Asserted Claims of the `813 Patent......................................................................................................................... 13 SenoRx Is Liable for Contributory Infringement of the `813 Patent ............................ 13

SENORX'S ACCUSED PRODUCT MEETS THE "PREDETERMINED SPACING" LIMITATION OF THE `204 PATENT (CLAIM 4) ........................................... 14 A. B. SenoRx Has Not Moved for Summary Judgment Under Hologic's Construction............................................................................................................... 15 SenoRx Meets the "Predetermined Spacing . . ." Limitation Even Under Its Own Construction....................................................................................... 15

THE CONTURA MEETS THE "PLURALITY OF RADIOACTIVE SOLID PARTICLES" ELEMENT OF CLAIM 12 OF THE `813 PATENT, AND THE "PLURALITY OF SOLID RADIATION SOURCES" ELEMENT OF CLAIM 17 OF THE `204 PATENT .......................................... 16 A. SenoRx Literally Infringes Under Hologic's Claim Construction ............................... 16
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1 2 3 4 5 6 7 V. VI.

B.

Under SenoRx's Claim Construction, SenoRx Infringes Under the Doctrine of Equivalents.............................................................................................. 18 1. 2. Legal Standard for Doctrine of Equivalents .................................................... 18 SenoRx Meets the "Plurality of Radioactive Solid Particles" and "Plurality of Solid Radiation Sources" Elements Under the Doctrine of Equivalents................................................... 19

IN ANY EVENT, SENORX'S MOTION MUST BE DENIED ............................................. 21 HOLOGIC REQUESTS THE RIGHT TO SUPPLEMENT ITS OPPOSITION WITH RELEVANT EVIDENCE ................................................................... 22 CONCLUSION ..................................................................................................................... 22

8 VII. 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28

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1 2 3 CASES

TABLE OF AUTHORITIES
Page(s)

4 AdvanceMe Inc. v. RapidPay, LLC, 509 F. Supp. 2d 593 (E.D. Tex 2007)..................................................................................... 17 5 Anderson v. Liberty Lobby, Inc., 477 U.S. 242 (1986) ................................................................................................................ 4 6 7 Arizona v. Maricopa County Medical Soc., 457 U.S. 332 (1982) ................................................................................................................ 4 8 Bell Comm's Research, Inc. v. Vitalink Comm's Corp., 55 F.3d 615 (Fed. Cir. 1995)................................................................................................ 7, 9 9 10 Caterpillar, Inc. v. Deere & Co., 224 F.3d 1374 (Fed. Cir. 2000).............................................................................................. 18 11 Depuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 469 F.3d 1005 (Fed. Cir. 2006).............................................................................................. 18 12 13 Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722 (2002) .............................................................................................................. 18 14 Glaverbel Societe Anonyme v. Northlake Mktg. & Supply, Inc., 45 F.3d 1550 (Fed. Cir. 1995).................................................................................................. 4 15 16 Hewlett-Packard Co. v. Bausch & Lomb, Inc., 909 F.2d 1464 (Fed. Cir. 1990)................................................................................................ 6 17 Hewlett-Packard Co. v. Mustek Systems, Inc., 340 F.3d 1314 (Fed. Cir. 2003)................................................................................................ 9 18 19 Hilgraeve Corp. v. Symantec Corp., 265 F.3d 1336 (Fed. Cir. 2001)................................................................................................ 9 20 In re Michlin, 256 F.2d 317 (C.C.P.A. 1958).................................................................................................. 6 21 22 Intel Corp. v. U.S. Int'l Trade Commission, 946 F.2d 821 (Fed. Cir. 1991)............................................................................................ 9, 10 23 NTP, Inc. v. Research in Motion, Ltd., 418 F.3d 1282 (Fed. Cir. 2005)................................................................................................ 6 24 25 Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321 (Fed. Cir. 2007).............................................................................................. 21 26 Paper Converting Machine Co. v. Magna-Graphics Corp. 745 F.2d 11 (Fed. Cir. 1984).................................................................................................... 9 27 28 Phillips v. AWH Corp.,
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1

415 F.3d 1303 (Fed. Cir. 2005).............................................................................................. 16

2 University of California v. Hansen 54 USPQ 2d 1473 at *25-26 (1999, E.D. CA)........................................................................ 13 3 Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17 (1997) ................................................................................................................ 18 4 5 Wood-Paper Patent, (1874) 90 U.S. 566, 23 Wall 566 L. Ed. 31 .............................................................................. 8 6 STATUTES 7 35 U.S.C. § 271...........................................................................................................................passim 8 Fed. R. Civ. P. 56(c)...................................................................................................................... 4, 21 9 N.D. Cal. Pat. L.R. 3-6(a)(1) (Jan. 1, 2001 rev.) ................................................................................ 18 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28
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1

Plaintiffs Hologic, Inc., Cytyc Corp., and Hologic L.P. (collectively, "Hologic") hereby oppose

2 SenoRx, Inc.'s ("SenoRx") Motion for Summary Judgment of Non-Infringement of claims 11 and 12 3 of U.S. Patent No. 5,913,813 (the "`813 patent") and claims 4 and 17 of U.S. Patent No. 6,413,204 (the 4 "`204 Patent").1 5 6 PRELIMINARY STATEMENT In its Motion for Summary Judgment of Non-Infringement (Dkt. No. 131), SenoRx asks this

7 Court to declare as a matter of law that its accused Contura Multi-Lumen Balloon Applicator does not 8 meet specific claim elements of the `813 and `204 patents.2 On all counts, SenoRx is wrong. Far from 9 showing non-infringement, even the scant evidence produced to date establishes that SenoRx's 10 Contura meets each element of the disputed claims. SenoRx does nothing more than argue that the 11 Contura can be used in non-infringing ways, and that SenoRx and others have used it in ways that do 12 not infringe. Under fundamental principles of patent law, that is irrelevant to infringement of 13 apparatus claims. 14 Hologic's patents-in-suit 3 all relate to life-saving, radionuclide-based devices for treating

15 proliferative tissue diseases, such as cancer, following the surgical removal of a tumor (known as a 16 "resection") ­ for example, in a woman's breast. The specific treatment technique is called "interstitial 17 brachytherapy," an alternative to whole breast irradiation, in which a balloon catheter is inserted into a 18 cavity created by the resection of diseased tissue to enable doctors to irradiate the remaining cancer 19 cells along the cavity margins at close range. Emitting radio-therapeutic rays from close range allows 20 precise targeting of the diseased tissue while minimizing the necrosis of healthy tissue. In the 1990s, 21 engineers from a start-up company called Proxima Therapeutics, Inc. (Hologic's predecessor) 22 23 24 25
1

REDACT ED

Hologic has agreed to withdraw its assertion of claim 6 of the `142 patent. Therefore, it is not discussed herein.
2

The claim elements at issue are "predetermined constant spacing" (as used in the '813 patent); "predetermined spacing" (as used in the '204 patent); "plurality of radioactive solid particles" (the `813 26 patent); and "plurality of solid radiation sources" (the `204 patent). 27 28
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All three patents are related. The `813 patent is the parent. The `204 and `142 patents are both continuations-in-part of the `813 patent.

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1 researched and developed improved devices and methods for performing brachytherapy. In the end, 2 Proxima revolutionized interstitial breast brachytherapy with its development of a novel balloon 3 catheter system, later commercialized as MammoSite, for delivering a radiation source directly to the 4 target breast tissue. The patents-in-suit are the fruits of those collective efforts, describing and 5 claiming many different device configurations, embodiments, and techniques for performing these 6 procedures. REDACTED 7 8 Motion for Preliminary Injunction). 9 The claimed inventions are broad. Proxima's inventors conceived of and claimed, for example, See Dkt. No. 8 at 3-6 (Hologic's

10 an apparatus that comprises an "inner spatial volume" located inside an outer, expandable surface (e.g., 11 a balloon) in which the spacing between the inner and outer volumes remains generally constant during 12 treatment to produce a substantially uniform radiation dose profile or shape. See, generally, the 13 asserted `813 and `204 patent claims. The inventors also envisioned procedures in which, depending 14 on the shape of the surgical cavity and the target tissue, it would be advantageous to produce an 15 asymmetric radiation dose profile. Their efforts in the latter regard culminated in the `142 patent ­ 16 which claims an apparatus capable of producing asymmetrically-shaped dose profiles. The end result 17 of Proxima/Hologic's R&D is a family of patents covering a wide variety of devices for performing 18 interstitial brachytherapy. They describe, for example, emitting rays from a centrally-located position 19 within the balloon, using an asymmetrical position, using a single emission location, and emitting rays 20 from multiple locations, among others. 21 By any objective analysis, and largely by SenoRx's own admissions, the Contura is a

22 combination of many of the above-described inventions. Conceptually, the gist of SenoRx's argument 23 is that although Hologic owns patents covering devices that do A, B, C, and D, the Contura does not 24 infringe because, when it performs A, it does not simultaneously perform B, C, or D. SenoRx also 25 asserts that the Contura does not infringe because, when the Contura does B, it does something else 26 that is not patented. These arguments have no merit. The fact that the Contura does not infringe all of 27 28
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1 the asserted claims all of the time or at the same time does not mean that it does not infringe any of 2 them. To the contrary, as designed and intended for use, it infringes all of the asserted claims. 3 SenoRx's non-infringement arguments regarding the "predetermined spacing" elements are

4 flawed on multiple grounds. First, SenoRx applies a method claim analysis to apparatus claims ­ i.e., 5 SenoRx ignores the Contura's structure and focuses on one specific way in which it can be used. 6 However, except in a means plus function context, infringement of an apparatus claim depends on 7 structural limitations, not upon statements of function. Second, SenoRx insists that Contura users 8 typically employ more than one "dwell point" during a procedure, and that some users employ the 9 outer, asymmetrically-positioned lumens. Hologic does not dispute that. The point, however, is that if 10 even one of the dwell positions is located in the center of the central treatment lumen (which is not 11 only possible, but is typically the case), the device exhibits a "constant spacing" between the "inner 12 spatial volume" and the Contura's balloon wall ­ and SenoRx infringes.4 SenoRx even concedes that 13 at each dwell location (including at the balloon center), the radionuclide stops to deliver radiation. 14 Thus, even under its own flawed claim construction, SenoRx infringes. In short, the Contura can be 15 (and is) used with a radionuclide at a central location within the balloon, thereby meeting the "constant 16 spacing" limitation. For purposes of infringement, whether the user also employs other lumens or 17 dwell points does not matter. 18 SenoRx's further non-infringement argument with respect to the terms "plurality of radioactive

19 solid particles" (`813 patent) and "plurality of solid radiation sources" (`204 patent) likewise has no 20 merit. SenoRx wrongly couches the dispute as a disagreement over the meaning of the word 21 "plurality." That is not the issue. The focus of the "plurality" claim terms is on emitting 22 radiotherapeutic rays from multiple locations so as to achieve a "desired composite profile" ­ as 23 distinguished from embodiments that emit radiation from a single location. Under the plain meaning 24 of these terms as used by the patentee, the Contura literally infringes because it can (and does) provide 25 While not at issue in this Motion, Hologic agrees that in some instances, SenoRx and others may use only the Contura's outer, asymmetrically-placed lumens. But the device is still capable of being 27 used, and is typically used, with a radionuclide in the central lumen. It therefore infringes all the asserted claims. 28 26
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1 for the positioning of the radiation source in multiple locations to achieve a desired resultant profile. 2 In any event, even under SenoRx's claim construction, as set forth below, the Contura meets these 3 claim elements under the doctrine of equivalents.5 4 Viewing the evidence in a light most favorable to Hologic, and resolving all inferences in favor

5 of Hologic, SenoRx has not and cannot meet its burden of establishing as a matter of law that the 6 Contura device does not meet the disputed claim elements. The Motion must be denied. 7 8 I. 9 ARGUMENT LEGAL STANDARD FOR SUMMARY JUDGMENT A court may grant a motion for summary judgment only if the moving party shows that there is

10 "no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter 11 of law." Fed. R. Civ. P. 56(c). A genuine issue exists if the evidence is such that a reasonable jury 12 could find for the nonmoving party. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). To 13 defeat SenoRx's Motion, Hologic is not required to present evidence resolving all material factual 14 issues in its favor; "rather, all that is required is that sufficient evidence supporting the claimed factual 15 dispute be shown." Id. at 249; Glaverbel Societe Anonyme v. Northlake Mktg. & Supply, Inc., 45 F.3d 16 1550, 1560-61 (Fed. Cir. 1995). At the summary judgment stage, the nonmoving party's version of 17 any disputed issue of fact is presumed correct. Arizona v. Maricopa County Medical Soc., 457 U.S. 18 332, 339 (1982). Thus, the evidence of the nonmovant, Hologic, is to be accepted, and all justifiable 19 inferences are to be drawn in Hologic's favor. Anderson, 477 U.S. at 255. 20 21 22 23 24 25 26 27 28
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1 II. 2 3

SENORX'S ACCUSED DEVICE MEETS THE "PREDETERMINED CONSTANT SPACING" LIMITATION OF THE `813 PATENT (CLAIMS 11 & 12)6 In the Xoft case7, the Court construed the term "predetermined constant spacing" in the `813

4 patent. Su Decl., Ex. B at 6-7 (Claim Construction Order in Xoft litigation). Hologic agrees with the 5 Court's construction. SenoRx argues that the Court is wrong and seeks to narrow the claim by adding 6 extra limitations, emphasized below: 7 8 9 10 11 12 13 14 15 16 17 Term "predetermined constant spacing . . . between said inner spatial volume and the radiation transparent wall"
(the Court's prior construction)

Hologic's Construction

SenoRx's Construction Fixed spacing, predetermined by one skilled in the art before administering radiation, between the wall or edge of the inner spatial volume and the wall of the expandable surface element, when inflated, which for each point on the wall or edge of the inner spatial volume, the distance to the closest point on the expandable surface element is the same (i.e., the inner spatial volume and expandable surface element are concentric and the same shape).

Spacing predetermined by one skilled in the art between the wall or edge of the inner spatial volume and the radiation transparent wall of the outer closed, inflatable chamber, when inflated, which is constant in all directions if the outer chamber is spherical or constant along a radial plane if the outer chamber is not spherical.

In its Motion, SenoRx asks the Court to declare as a matter of law that SenoRx does not

18 infringe the "predetermined constant spacing" limitation of the `813 patent ­ suggesting that no 19 reasonable jury could conclude otherwise. In fact, the opposite is true. Based on SenoRx's own 20 documents and admissions, under either party's proposed claim construction, the Contura meets the 21 "predetermined constant spacing" limitation in multiple ways. Because direct, contributory, and 22 induced infringement is manifest, SenoRx's Motion must be denied. 23 24
6 Claims 11 and 12 of the `813 patent both depend from claim 1, which contains the "predetermined 25 constant spacing" language.

Two of the three patents-in-suit (the `813 and `204 patents) were asserted in a prior action in this Court entitled Xoft, Inc. v. Cytyc Corp. et. al., Case No. C-05-05312 RMW ["Xoft litigation"]). Each 27 of the terms disputed in this Motion was already litigated, briefed, and construed by the Court in that case. Su Decl., Ex. B (Claim Construction Order in Xoft litigation). 28 26
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A.

The Contura Directly Infringes the Asserted Claims of the `813 Patent 1. The Contura Meets the "Predetermined Constant Spacing" Limitation Because It Can Emit Radiation from a Central Dwell Point

SenoRx's contention that the Contura does not meet the "predetermined constant spacing"

5 limitation of the `813 patent is based on the false premise that the asserted claims are "method" rather 6 than "apparatus" claims. SenoRx appears to admit that where multiple dwell points are used during 7 radiotherapy, the radionuclide stops for a period of time at each location ­ and that where the central 8 lumen is used, one of those locations may be in the center of the balloon. Nonetheless, SenoRx 9 contends it does not infringe because the radionuclide might also emit radiation from other dwell 10 points if other dwell points are used. In other words, a user can employ a method of use by which the 11 spacing between the radionuclide and the balloon wall changes, i.e., because the radionuclide is 12 stepped through different dwell points rather than emitting radiation from a single point. But that 13 argument is fundamentally flawed and ignores important distinctions between apparatus and method 14 claims. 15 Infringement of an apparatus claim is determined based on the capabilities of an accused

16 device's structure, not its actual method(s) of use. See Hewlett-Packard Co. v. Bausch & Lomb, Inc., 17 909 F.2d 1464, 1468 (Fed. Cir. 1990) ("Apparatus claims cover what a device is, not what a device 18 does."); In re Michlin, 256 F.2d 317, 320 (C.C.P.A. 1958) ("It is well settled that patentability of 19 apparatus claims must depend upon structural limitations and not upon statements of function."); NTP, 20 Inc. v. Research in Motion, Ltd., 418 F.3d 1282 (Fed. Cir. 2005) (distinguishing between 21 method claims and apparatus claims for the purpose of determining infringement under section 22 271(a)). 23 Here, it is undisputed that the Contura contains five treatment lumens, one of which is centrally

24 located along the balloon's longitudinal axis. Dkt. No. 131 at 12-14 (Motion); see figure below. In 25 one method of use, the radiation source may be stepped-through multiple dwell points, stopping for a 26 27 28
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28

REDACTED

predetermined period of time at each location to emit radiation. Dkt. No. 131 at 14-15 (Motion). RED
ACT ED

Users can decide which lumen(s) to use, which dwell position(s) to employ within the lumen(s), and the duration of each dwell time. Su Decl., Ex. C at SRXHOL00002232 (Contura's "Instructions for Use" ­ stating that users determine the appropriate source lumens, dwell positions and dwell times). Indeed, SenoRx markets the Contura as a device capable of operating in the same way as Hologic's MammoSite from a central dwell position. Su Decl., Ex. D at SRX-HOL00006665 REDACTED

For this reason, SenoRx suggests that physicians use the Contura REDACTED Su Decl., Ex. E at SRX-HOL000006684, 86 (SenoRx Sales Training Manual and FAQs). Whatever the Contura's typical use may be ­ and in fact, the evidence suggests that employing a central dwell point is a typical use ­ the evidence demonstrates that SenoRx manufactures a device that provides for the placement of a radionuclide at the balloon's center point to perform brachytherapy. From that location, the spacing between the inner spatial volume and the Contura balloon wall is "constant in all directions" (Hologic's construction of "constant spacing"). Because the user can stop the radionuclide in that central location for however long (s)he chooses, the Contura exhibits a "fixed" spacing such that, for each point on the radionuclide, the distance to the nearest point on the balloon wall is "the same" (SenoRx's construction of "constant spacing"). Thus, SenoRx infringes under either party's construction. The fact that the Contura may not infringe if used to
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1 irradiate tissue from other locations (i.e., that SenoRx infringes the "predetermined constant spacing" 2 claims only part of the time) is irrelevant. Bell Comm's Research, Inc. v. Vitalink Comm's Corp., 55 3 F.3d 615, 622-3 (Fed. Cir. 1995) (an accused product that sometimes, but not always, embodies a 4 claim nonetheless infringes). 5 6 7 2. Not Only Is the Contura Capable of Performing Brachytherapy From a Central Dwell Position ­ SenoRx and Others Have Used It In That Way

In addition to manufacturing a device meeting the "predetermined constant spacing" claim

8 term, SenoRx and others have used the Contura to emit radiation from a central dwell position within 9 the balloon wall. Therefore, SenoRx has infringed by both (a) making an apparatus meeting the 10 elements of claim 1 ­ including the "constant spacing" limitation, and (b) using the device to irradiate 11 tissue from a central dwell position. 35 U.S.C. § 271(a) (". . . whoever without authority makes, uses 12 . . . any patented invention . . . infringes the patent."). 13 14 15 16 17 18 19 20 21 22 23 24 25 As stated, from a dwell point at or near the center of the Contura's central treatment lumen, the
REDACTED

26 Contura exhibits a constant spacing in all directions between the inner spatial volume and the balloon 27 wall (Hologic's construction). From that dwell position, it also exhibits a "fixed" spacing such that, 28
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1 for each point on the radionuclide, the distance to the nearest point on the balloon is substantially the 2 same in all directions (SenoRx's construction). Thus, not only can the Contura be used in a manner 3 that meets the "constant spacing" limitation, SenoRx, its paid consultants, and others have undeniably 4 used it in this manner. Therefore, the Contura meets the "constant spacing" limitation of the `813 5 patent. 35 U.S.C. § 271(a); Wood-Paper Patent (1874) 90 U.S. 566, 23 Wall 566, 23 L. Ed. 31 (a 6 single instance of unauthorized use constitutes infringement). 7 8 9 3. In Addition to Using a Central Dwell Point During a Multi-Dwell Point Procedure, Users Can and Have Used the Contura To Deliver Radiation From a Single, Central Position

The fact that medical professionals decide which lumens, dwell positions, and dwell times to

10 employ depending on the desired radiation dose profile, means that a user can opt for a single, fixed 11 dwell position at the center of the Contura balloon. Using such a treatment plan, the Contura clearly 12 meets the "predetermined constant spacing" limitation of claim 1 of the `813 patent. 13 It is well-established that imperfect practice of an invention does not avoid infringement.

14 Hewlett-Packard Co. v. Mustek Systems, Inc., 340 F.3d 1314, 1326 (Fed. Cir. 2003) (citing Bell 15 Comm's Research, Inc. v. Vitalink Comm's Corp., 55 F.3d 615, 622-3); Hilgraeve Corp. v. Symantec 16 Corp., 265 F.3d 1336, 1343 (Fed. Cir. 2001) (an accused device may be found to infringe if it is 17 reasonably capable of satisfying the claim limitations, even though it may also be capable of non18 infringing modes of operation); Intel Corp. v. U.S. Int'l Trade Commission, 946 F.2d 821, 832 (Fed. 19 Cir. 1991) (regardless the intended use, an accused device infringes if capable of being used in 20 infringing manner); Paper Converting Machine Co. v. Magna-Graphics Corp. 745 F.2d 11, 20 (Fed. 21 Cir. 1984) ("that the machine was not operated in its optimum mode is inconsequential; imperfect 22 practice of an invention does not avoid infringement"); 35 U.S.C. § 271(a) (prohibiting any and all 23 uses of a patent invention). 24 In Intel, the patentee alleged infringement of a claim disclosing an integrated circuit of read-

25 only memory with a programmable selection means for selecting an alternative addressing mode. 946 26 F.2d at 831. The International Trade Commission ruled that defendant infringed the asserted claim 27 because the accused device was capable of being used in a manner that embodied each claim 28
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1 limitation, even though the device was not intended for such use. Id. at 831-32. On appeal, defendant 2 challenged the finding of infringement on the grounds that defendant never contemplated or intended 3 for the accused device to be sold or operated in an infringing manner. Id. In affirming the judgment, 4 the Federal Circuit stated: 5 6 7 8 9 10 11 [Defendant] also contends that the Commission's finding of infringement . . . is incorrect because, although [defendant's devices] are capable of performing page mode addressing, the [devices] were never sold to operate in page mode. No customer was ever told how to convert the chip to page mode operation ­ or even that such conversion was possible. [Defendant] argues that an alleged infringer must intend its parts to be used in an infringing fashion . . . . There is no intent element to direct infringement . . . . [T]he accused device, to be infringing, need only be capable of operating in the page mode. Contrary to [defendant's] argument, actual page mode operation in the accused device is not required. (Id. [emphasis added].) Here, as in Intel, there can be no genuine dispute that Contura users can select a treatment

12 program calling for the emission of radiation from a single location directly or nearly directly in the 13 center of the balloon. Indeed, SenoRx's own marketing materials expressly contemplate such use. As 14 the figure below depicts, REDACTED 15 16 17 18 19 20 21 22 23 24 25 26 27 28
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1 REDACTED For this additional reason, SenoRx's device meets the "constant spacing" limitation of the 2 `813 patent because, regardless of its intended or typical use, 8 users can use it to perform radiotherapy 3 from a single, stationary location, including a point directly or nearly directly at the balloon's center. 4 From that location, the Contura exhibits a constant spacing between the inner spatial volume and the 5 balloon wall in all directions (Hologic's construction). Further, from each point on the radionuclide to 6 the nearest point on the balloon wall ­ the distance is the same (SenoRx's construction). Therefore, 7 SenoRx infringes under either party's construction. 8 9 10 4. Whether SenoRx's I-192 Seeds Are "Cylindrical" Rather Than Spherical Is Irrelevant

Recognizing that both it and other users can use (and have used) the device to perform

11 radiotherapy from a centrally-located position within its central treatment lumen (whether solely from 12 that location or in conjunction with other dwell points), SenoRx argues that the Contura nonetheless 13 cannot meet the "constant spacing" element because the Ir-192 radionuclides used with the Contura are 14 cylindrical rather than spherical in shape. Dkt. No. 131 at 15 (Motion). According to this argument, if 15 the Court adopts SenoRx's construction of "inner spatial volume" (which requires a radionuclide 16 sphere), SenoRx cannot infringe the "constant spacing" limitation because the distance from each 17 point on the radionuclide to the nearest point on the Contura's spherical balloon wall will not be "the 18 same." Id. at 14. This argument has no merit. Even if the Court were to adopt SenoRx's constructions 19 of both (1) the term "predetermined constant spacing . . ." and (2) the term "inner spatial volume" ­ 20 SenoRx would still infringe. 21 First, in distinguishing between cylindrical and spherical radionuclides, SenoRx attempts to

22 impose a degree of exactitude that both the `813 and `204 patents expressly state is not necessary. 23 Both patents refer to an apparatus exhibiting a "substantially" or "generally" constant spacing between 24 the inner spatial volume and the outer wall. `813 Patent, col. 1:55-57 ("the distance from the spatial 25 volume and the wall is maintained substantially constant over their entire surfaces."); col. 3:10-13 26 27 28
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Indeed, as shown above, SenoRx's own marketing documents indicate that such infringing use is, in fact, intended and recommended.

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1 (spacing should be "generally constant"); col. 4:13-16 ("In either the concentric spherical embodiment 2 of FIG. 1 or the non-spherical configuration of FIG. 3, the spacing between the inner and outer 3 chambers needs to be held somewhat constant to avoid "hot spots."); `204 Patent, col. 5:25-26 (spacing 4 should be "generally constant"). By definition, the words "substantially," "generally" and 5 "somewhat" do not require exactitude. In the same way that the `813 patent term "uniform" does not 6 mean exactly uniform, the `813 patent term "constant" does not mean exactly constant. Thus, under 7 Hologic's construction of "predetermined constant spacing," using cylindrical radionuclides still 8 infringes because, from a central location within the central lumen, the distance from each point on the 9 surface of the radionuclide to the balloon wall is substantially constant in all directions. Likewise, 10 under SenoRx's construction, the distance from each point on the radionuclide surface to the balloon 11 wall is substantially the same in all directions. 12 Further, from the perspective of one of ordinary skill in the art, the distance from each point on

13 the outer edge of a cylindrical radionuclide to the balloon wall is effectively the same in all directions. 14 Dkt. No. 145, ¶¶ 5, 12 (Verhey declaration). The radioactive sources contemplated in the `813 patent, 15 whether spherical or cylindrical, are very small compared to the typical 40-60 mm diameter of a 16 surgical cavity. Id; Su Decl., Ex. N (5/20/08 Stubbs Depo. Tr. at 60:19-61:07) (standard brachytherapy 17 radionuclides can be as small as 1 millimeter in width and 3 millimeters in length); see also Ex. J at 18 SRX-HOL00006598-9 REDACTED No matter the shape, the

19 radionuclides that the Contura uses are effectively point sources relative to the diameter of the inflated 20 balloon. Dkt. No. 145, ¶ 12 (Verhey declaration). Indeed, brachytherapy balloons and the 21 lumpectomy margins into which they are inserted may be generally spherical in shape, but are never 22 perfect spheres. Id. at ¶ 5. Therefore, the distances from different points on a radionuclide to the outer 23 balloon will never be exactly the same. Id. From a dosimetric standpoint, however, one skilled in the 24 art would consider the minute differences in distance from each point on the outer edge of a cylinder25 shaped radionuclide to the balloon wall to be trivial and insignificant ­ i.e., the distances for all intents 26 and purposes are the same. Id. 27 28
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1

Accordingly, regardless the outcome of claim construction, SenoRx's accused device meets the

2 "predetermined constant spacing" limitation of claim 1 of the `813 patent. 3 4 B. SenoRx Induces Others to Infringe the Asserted Claims of the `813 Patent

In addition to directly infringing, SenoRx induces others to infringe. 35 U.S.C. § 271(b).

5 SenoRx cannot dispute that it makes, markets, and actively encourages breast surgeons, radiation 6 oncologists, radiation physicists and others to use the Contura for brachytherapy in accordance with 7 the Instructions for Use, which teach several infringing uses. Su Decl., Ex. C at SRX-HOL2232-2233 8 (Contura Instructions for Use: "the SenoRx Multi-Lumen Balloon is intended to provide 9 brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins 10 following lumpectomy for breast cancer," and indicating the user's ability to determine "the 11 appropriate source lumens, source dwell positions and dwell times . . ."); Ex. O at SRX-HOL660512 6606 REDACTED ­ intended for physicians to use to provide

13 brachytherapy); Ex. P at SRX-HOL00005564-65 (Contura intended for brachytherapy ­ and 14 explaining how to use it); Ex. E at SRX-HOL000006684, 86 REDACTED 15 16 17 see also Ex. Q

18 (SenoRx's CTO Paul Lubock's November 6, 2002 patent application discussing Hologic's 19 MammoSite and the related patents ­ demonstrating that SenoRx had knowledge of the `813 and `204 20 patents at least as early as November 2002); Ex. R (July 22, 2004 Information Disclosure Statement 21 citing all three patents-in-suit to the PTO as potential prior art ­ further demonstrating SenoRx's 22 knowledge of the patents at the time of inducement). 23 24 C. SenoRx Is Liable for Contributory Infringement of the `813 Patent

Much of the same evidence demonstrates that SenoRx is also liable for contributory

25 infringement. 35 U.S.C. § 271(c) ("whoever offers to sell or sells . . . a component of a patented 26 machine . . . or apparatus . . . constituting a material part of the invention . . . shall be liable as a 27 contributory infringer.") The Contura has been approved by the FDA for marketing and sale as a 28
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1 brachytherapy device; it is specially designed for the purpose of being combined by users with a 2 radiation source to create the patented invention. Su Decl., Ex. O REDACTED Customers do

3 not buy the Contura unless they intend to use it as a device for the delivery of radiation. SenoRx 4 contemplates the use of commercially available remote afterloaders with the Contura device for 5 placement of the radionuclides. Su Decl., Ex. C at SRX-HOL00002232 (Contura Instructions for Use: 6 "Lumens are provided for attachment to commercially available HDR remote afterloader equipment 7 for passage of the radiation source delivery wire"). 8 The substantial non-infringing use exception to § 271(c) does not apply. That exception

9 applies to staple articles of commerce ­ which the Contura is not. University of California v. Hansen 10 54 USPQ 2d 1473 at *25-26 (1999, E.D. CA) (occasional aberrant use of product that is clearly 11 designed to be used in particular matter [sic] does not make defendant's device staple article or 12 commodity of commerce suitable for substantial non-infringing use) (finding defendants liable for 13 infringement under § 271(a), (b), and (c)). In any event, minus the radiation, the Contura has no 14 substantial non-infringing uses because its only utility is as a radiation therapy device in accordance 15 with the invention. 16 Based on the foregoing, far from militating against infringement, a reasonable jury could and

17 would conclude that SenoRx infringes the asserted claims, both directly and indirectly. 18 III. 19 20 SENORX'S ACCUSED PRODUCT MEETS THE "PREDETERMINED SPACING" LIMITATION OF THE `204 PATENT (CLAIM 4)9 Unlike the `813 patent, which requires a "predetermined constant spacing," the `204 patent

21 requires only a "predetermined spacing . . . ." col. 8:40. SenoRx contends these two terms mean the 22 same thing. They do not. The Court previously construed both terms and found that they convey 23 different meanings. Su Decl., Ex. B at 6-7, 24-25. The Court's prior construction and the parties' 24 proposed constructions are set forth below: 25 26 27 28
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Claim 4 of the `204 patent depends from claim 3, which contains the "predetermined spacing" language.

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1 2 3 4 5 6 7 8 9 10 11 12 A.

Term "predetermined spacing ...between said inner spatial volume and the expandable surface element" (claim 3)

(the Court's prior construction)

Hologic's Construction

SenoRx's Construction Fixed spacing, predetermined by one skilled in the art before administering radiation, between the wall or edge of the inner spatial volume and the wall of the expandable surface element, when inflated, which for each point on the wall or edge of the inner spatial volume, the distance to the closest point on the expandable surface element is the same (i.e., the inner spatial volume and expandable surface element are concentric and the same shape).

the distance between the inner spatial volume and the expandable surface element is determined in advance

SenoRx Has Not Moved for Summary Judgment Under Hologic's Construction.

If the Court adopts Hologic's construction of the term "predetermined spacing . . ." (i.e., if the

13 Court adopts its own prior construction), SenoRx's Motion with respect to claim 4 of the `204 patent is 14 moot. SenoRx has not moved for summary judgment under Hologic's construction. 15 16 17 Because SenoRx believes the terms "predetermined constant spacing . . ." (`813 patent) and B. SenoRx Meets the "Predetermined Spacing . . ." Limitation Even Under Its Own Construction

18 "predetermined spacing . . ." (`204 patent) mean the exact same thing, the same infringement analysis 19 discussed above (regarding direct and indirect infringement) applies to both. Under SenoRx's 20 proposed construction, the Contura meets the "predetermined spacing" limitation of the `204 patent 21 because (1) SenoRx manufacturers the Contura (Section II(A)(1), above); (2) SenoRx and others have 22 used the Contura with a central dwell position in its central treatment lumen (Section II(A)(2), above); 23 and (3) SenoRx and others can and have performed radiotherapy with the Contura using a single, 24 central location in the central treatment lumen (Section II(A)(3), above). Therefore, under SenoRx's 25 proposed construction, the "predetermined spacing" limitation of the `204 patent is met. See also 26 sections II(B) and II(C), above (discussing SenoRx's indirect infringement of the asserted claims). 27 28
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1 IV. 2 3 4 5

THE CONTURA MEETS THE "PLURALITY OF RADIOACTIVE SOLID PARTICLES" ELEMENT OF CLAIM 12 OF THE `813 PATENT, AND THE "PLURALITY OF SOLID RADIATION SOURCES" ELEMENT OF CLAIM 17 OF THE `204 PATENT A. SenoRx Literally Infringes Under Hologic's Claim Construction

SenoRx's Contura device literally meets the "plurality of radioactive solid particles / solid

6 radiation sources" claim elements of the `813 and `204 patents because a solid radionuclide on a source 7 wire can be (and is) inserted sequentially into multiple predetermined locations within one or more of 8 the Contura's treatment lumens to provide a "desired composite radiation profile" within the targeted 9 tissue. See Dkt. No. 131-6, Ex. A at 15 (Hologic's Infringement Contentions). 10 SenoRx's misguided argument that use of the word "plurality" requires the presence of "two or

11 more" separate and distinct radionuclides in the device "at the same time" (and its mischaracterization 12 of Hologic's position as being that "plurality" means "one") is a classic example of attempting to 13 construe a claim term in isolation ­ divorced from both the claim language in which it appears and the 14 remainder of the specification. See Dkt. No. 144 at 22-25 (Hologic's Reply Claim Construction Brief); 15 Dkt. No. 131 at 8 (SenoRx's Motion, arguing that even under SenoRx's construction of these terms, 16 ". . .[t]he act of moving a single radionuclide to multiple locations does not transform the single object 17 into two or more objects . . .) The argument has no merit.10 18 SenoRx's non-infringement argument violates a fundamental principle of claim construction

19 reaffirmed by the Federal Circuit in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005), that one 20 cannot import aspects of preferred embodiments into the claims by requiring that discrete radiation 21 sources be present and used simultaneously. Id. at 1323; see Dkt. No. 144 at 23 (Hologic's Reply 22 Claim Construction Brief). Read together with the surrounding claim language and in light of the 23 specification, the objective of these claims (claim 12 of the `813 and claim 17 of the `204) is to 24 25 SenoRx takes issue with the Court's previous ruling regarding the meaning of this claim language. The Court previously considered the phrase "plurality of radioactive solid particles placed at 26 predetermined locations . . . to provide a desired composite radiation profile" (`813 patent, claim 12) 27 and decided that it means what it says ­ i.e., no construction is necessary. Su Decl., Ex. B at 11-12. Hologic agrees. 28
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1 differentiate embodiments in which (1) diseased tissue is irradiated from a single location from (2) an 2 embodiment in which radiation is emitted from multiple locations (hence the use of the term 3 "plurality") in order to achieve a "composite radiation profile" (`813 patent, claim 12) and a "desired 4 resultant profile" (`204 patent, col. 5:12). SenoRx's contention that the Contura cannot meet these 5 claim elements because Figure 5 of the `813 patent and Figure 4 of the `204 patent show multiple solid 6 radionuclides present at the same time violates the Federal Circuit's clear mandate in Phillips. 415 7 F.3d 1303. If SenoRx's reasoning were sound, any patent defendant could simply scour the 8 specification for a disclosed embodiment that differs from the accused product ­ and proceed to argue 9 non-infringement as a matter of law. 10 The admissions and diagrams in SenoRx's own Motion illustrate that the Contura meets the

11 "plurality . . ." claim elements. SenoRx states that "the undisputed evidence is that in every case of 12 patient treatment since the commercial launch of the Contura in January 2008, the [radiation] dose was 13 delivered with multiple dwell positions." Dkt. No. 131 at 15 (Motion) (see Figure 4, illustrating how 14 the Ir-192 radionuclides used with the Contura can be moved sequentially to multiple locations within 15 the balloon ­ such that radiotherapeutic rays may be emitted from numerous positions to achieve a 16 desired composite radiation profile). Thus, under the plain meaning of claim 12 of the `813 patent and 17 claim 17 of the `204 patent, by SenoRx's own admission, the Contura reads on the claim language 18 directly ­ thereby literally infringing the claims. 19 SenoRx inserts a secondary argument (Dkt. No. 131 at 8) that it does not manufacture the

20 iridium-192 radionuclides used with the Contura and therefore does not meet the disputed claim terms. 21 This argument is spurious ­ the very purpose of the Contura is to "deliver therapeutic radiation to 22 target tissue." Dkt. No. 131 at 3 (SenoRx's Motion). SenoRx only manufactures, markets and sells the 23 Contura so that it can be used with radionuclides to perform brachytherapy; it has no purpose or 24 usefulness without them. In any event, under 35 U.S.C. § 271(a), SenoRx infringes if it "makes, uses, 25 offers to sell, or sells . . ." an infringing device in the United States. Even under SenoRx's argument 26 that it does not "make" radionuclides ­ it still infringes because both it REDACTED have used the

27 Contura with Ir-192 radionuclides. Su Decl., Ex. J at SRX-HOL00006598 REDACTED 28
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1 REDACTED 2 HOL00006684 REDACTED

Ex. E at SRX-

3 AdvanceMe Inc. v. RapidPay, LLC, 509 F. Supp. 2d 593, 605 (E.D. Tex 2007) ("Liability for direct 4 infringement cannot be avoided by interposing an agent or independent contractor between the 5 defendant and the infringing acts.") Thus, SenoRx has both "made" and "used" the patented invention. 6 35 U.S.C. § 271(a). Viewing the evidence of SenoRx's testing and use of the device in a light most 7 favorable to Hologic, and resolving all inferences in its favor, SenoRx infringes. 8 Further, and for the same reasons it indirectly infringes the asserted claims of the `813 and `204

9 patents containing the "predetermined constant spacing" and "predetermined spacing" limitations, 10 SenoRx indirectly infringes the asserted claims containing the "plurality" limitations. 35 U.S.C. § 11 271(b) and (c). See sections II(B) and II(C), above. 12 13 14 15 B. Under SenoRx's Claim Construction, SenoRx Infringes Under the Doctrine of Equivalents11 1. Legal Standard for Doctrine of Equivalents

A product that does not literally infringe may nonetheless be found to infringe if there is

16 "equivalence" between the elements of the accused product and the claimed elements of the patented 17 invention. Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 21 (1997). The doctrine 18 applies where the differences between the patented invention and the accused device are insubstantial. 19 Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 726 (2002). One way to make 20 this determination is to consider whether the accused device performs substantially the same function 21 in substantially the same way to obtain substantially the same result. See Depuy Spine, Inc. v. 22 Medtronic Sofamor Danek, Inc., 469 F.3d 1005, 1019-1020 (Fed. Cir. 2006) (reversing judgment of 23 24 25 Hologic has reserved its right to amend its preliminary infringement contentions to the extent that any element of any asserted claim is determined not to be literally present after a final 26 ruling on claim construction. Dkt. No. 131-6, Ex. A at 1, fn 2 (Hologic's Preliminary Infringement Contentions); see N.D. Cal. Pat. L.R. 3-6(a)(1) (Jan. 1, 2001 rev.) (granting right to amend without 27 leave the information under Patent Local Rule 3-1(d) based on the Court's claim construction) (the March 1, 2008 Patent Local Rules do not apply to this case). 28
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1 non-infringement and finding that triable issue of fact existed as to whether accused device infringes 2 under the doctrine of equivalents). 3 Equivalence is not the prisoner of formula and is not an absolute to be considered in a vacuum.

4 Warner-Jenkinson, 520 U.S. at 24. It does not require complete identity for every purpose and in 5 every respect. Id. Even things that are, for most purposes, different, may sometimes be equivalents. 6 Id; Caterpillar, Inc. v. Deere & Co., 224 F.3d 1374, 1379 (Fed. Cir. 2000) (as with literal 7 infringement, whether an accused device infringes under the doctrine of equivalents is a question of 8 fact). 9 10 11 12 If the Court were to adopt SenoRx's construction of the terms "plurality of radioactive solid 2. SenoRx Meets the "Plurality of Radioactive Solid Particles" and "Plurality of Solid Radiation Sources" Elements Under the Doctrine of Equivalents

13 particles" (`813 patent) and "plurality of solid radiation sources"(`204 patent), summary judgment 14 would still be improper because under SenoRx's constructions, the Contura meets these elements 15 under the doctrine of equivalents. 16 Function. The function of having "a plurality of radioactive solid particles placed at

17 predetermined locations within the inner spatial volume to provide a desired composite radiation 18 profile" is to provide a therapeutic dose of radiation to treat proliferative tissue disease. (`813 patent, 19 claim 12; `204 patent, col. 5:10-12). The `813 and `204 patents state: "This invention relates generally 20 to [an] apparatus for use in treating proliferative tissue disorders, and more particularly to an apparatus 21 for the treatment of such disorders in the body by the application of radioactive material and/or 22 radiation emissions." Dkt. No. 135-2 (`813 patent, col. 1:7-11); Dkt. No. 135-3 (`204 patent, col. 1423 17 [same, using slightly different language].) Further, the purpose of an embodiment emitting 24 radiation from more than one location is to achieve a "desired composite radiation profile." See `813 25 patent, claim 12, Figure 5; `204 patent, col. 5:1-12 (radiation emitted from multiple locations "to 26 generate a desired resultant profile"); Fig. 4. 27 28
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1

The function of the Contura is the same -- to deliver radiation to target tissue to treat

2 proliferative tissue disease. Su Decl., Ex. C at SRX-HOL00002232 (Instructions for Use: "Contura ... 3 is intended to provide brachytherapy . . . to deliver intracavitary radiation to the surgical margins 4 following lumpectomy for breast cancer"). Where a treatment plan calls for multiple dwell points, the 5 Contura serves to generate a desired resultant profile. See Dkt. No. 131 at 14-15 (SenoRx's Motion 6 describing Contura radionuclide moving to different locations within the balloon); Su Decl., Ex. S at 7 SRX-HOL00005403 (Contura MLB Brachytherapy Applicator Clinical Data Report - REDACTED 8 9 10 REDACTED 11 12 Way. The claimed apparatus and the Contura serve to generate a desired composite radiation Su Decl., Ex. J at SRX-HOL00006598-6601 (Contura

13 profile in substantially (if not exactly) the same way. As set forth in the written descriptions and as 14 illustrated by the drawings (`813 patent, Fig. 5; `204 patent, Fig. 4), one way to generate a desired 15 resultant profile is to mount multiple particles 44 on the distal ends of a plurality of wires 46 that are 16 routed through the catheter body 12 . . . reaching the lumen. `204 patent, col. 5:1-12. As SenoRx 17 concedes, depending on the chosen treatment plan, the Contura may step an iridium-192 radionuclide 18 through multiple locations within one or more treatment lumens ­ the cumulative result constituting 19 the desired composite radiation profile. See Dkt. No. 131 at 12-15 (including Figs. 2-4) (describing 20 how the Contura may employ multiple dwell points); Su Decl., Ex. E at SRX-HOL00006685 REDACT
ED

21 22 23 As Dr. Verhey has explained, the Contura achieves a composite profile in the same way ­ or at

24 a minimum, in substantially the same way. Dkt. No. 145 at ¶¶ 27-31 (Verhey declaration supporting 25 Hologic's Reply Claim Construction Brief). One of ordinary skill in the art would understand that one 26 can achieve a "desired composite radiation profile" by using a single particle or source and moving it 27 to multiple locations, or using multiple particles or sources in predetermined locations. Id. at ¶ 28. 28
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1 From a dosimetric standpoint, there is no distinction between moving one radionuclide to multiple 2 locations versus the embodiment depicted in Figure 5 of the `813 patent and Figure 4 of the `204 3 patent. Id. 4 Result. Finally, both the claimed inventions and the Contura actually result in a composite

5 radiation profile that serves to kill proliferative tissue cells such as cancer cells without causing an 6 undue risk of tissue necrosis. `813 patent, col. 1:42-46 (the instrument "may be used to deliver 7 radiation from a radioactive source to target tissue within the human body of a desired intensity . . . 8 without overexposure of body tissues disposed between the radiation source and the target"); `204 9 patent, col. 2:28-33 (same); Su Decl., Ex. T at SRX-HOL00001536-7 (Contura Product Overview and 10 Dosimetry - REDACTED 11 12 In light of the evidence produced to date, a reasonable jury would find (or certainly could find)

13 that the Contura performs substantially the same function as the inventions set forth in claim 12 of the 14 `813 patent and claim 17 of the `204 patent, in substantially the same way, to achieve substantially the 15 same result. 16 V. 17 IN ANY EVENT, SENORX'S MOTION MUST BE DENIED Even if the Court were to disagree with each of Hologic's infringement arguments set forth

18 above and conclude that SenoRx's accused device does not meet the disputed claim terms, SenoRx's 19 Motion would still lack merit. Infringement, whether literal or under the doctrine of equivalence, is a 20 question of fact. Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326 (Fed. 21 Cir. 2007). All justifiable inferences must be drawn in Hologic's favor. Id. The evidence produced by 22 SenoRx to date indicates, if it does not conclusively show, that the Contura meets the "predetermined 23 spacing" and "plurality . . ." elements of the patents-in-suit. Therefore, SenoRx's Motion must be 24 denied. While the jury ultimately may reject Hologic's arguments at trial, the infringement decision 25 should not be taken from them. Id. 26 27 28
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1 VI. 2 3

HOLOGIC REQUESTS THE RIGHT TO SUPPLEMENT ITS OPPOSITION WITH RELEVANT EVIDENCE While Hologic believes the evidence presented definitively precludes summary judgment in

4 favor of SenoRx, Hologic requests the right to supplement its Opposition with evidence discovered 5 prior to the June 25, 2008 hearing. See Fed. R. Civ. P. 56(c) (permitting an opposing party to serve 6 opposing affidavits before the hearing day). 7 VII. 8 CONCLUSION For the foregoing reasons, SenoRx's Contura meets the "predetermined constant spacing. . .,"

9 "predetermined spacing . . .," "plurality of radioactive solid particles . . .," and "plurality of solid 10 radiation sources" limitations of the `813 and `204 patents. At the very least, the evidence precludes 11 entry of summary judgment for SenoRx. Hologic respectfully requests that SenoRx's Motion be 12 denied. 13 Dated: June 4, 2008 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28
Plaintiffs' Opposition To Defendant's Motion For Partial Summary Judgment Of Non-Infringement Case No. C08 00133 RMW (RS) -22-

HOWREY LLP

By:

/s/ Henry C. Su

HOWREY LLP Attorneys for Plaintiffs Hologic, Inc., Cytyc Corporation, and Hologic LP

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