Free Motion for Summary Judgment - District Court of California - California

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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 NOTICE OF MOTION AND MOTION FOR PARTIAL SUMMARY JUDGMENT OF NONINFRINGEMENT ('813 PATENT, CLAIMS 11 & 12; '204 PATENT, CLAIMS 4 & 17; AND '142 PATENT CLAIM 6)

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

Date: June 25, 2008 Time: 2:00 p.m. Courtroom: 6, 4th Floor Judge: Hon. Ronald M. Whyte

SENORX, INC.'S NOTICE OF MOTION AND MOTION FOR PARTIAL SUMMARY JUDGMENT OF NON-INFRINGEMENT

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TABLE OF CONTENTS Table of Authorities ........................................................................................................................ii

3 Notice of Motion and Motion..........................................................................................................1 4 Memorandum of Points and Authorities .........................................................................................1 5 Issues To Be Decided ......................................................................................................................2 6 Legal Standard.................................................................................................................................2 7 A. 8 B. 9 Statement of Relevant Facts Regarding the Contura Device ..........................................................3 10 Argument.........................................................................................................................................4 11 A. 12 1. 13 2. 14 B. 15 16 17 18 a. 19 20 21 c. 22 23 24 Conclusion.....................................................................................................................................17 25 26 27 28
SENORX, INC.'S NOTICE OF MOTION AND MOTION FOR PARTIAL SUMMARY JUDGMENT OF NON-INFRINGEMENT

Summary Judgment.................................................................................................2 Non-Infringement....................................................................................................2

The Contura Does Not Meet the "Plurality" Claim Limitations. ............................4 Plaintiffs' Infringement Contentions...........................................................4 The Contura Does Not Meet the "Plurality" Limitations............................5

The Contura Does Not Meet the Predetermined Spacing Limitations of the '813 and '204 Patents..............................................................................................9 1. 2. Plaintiffs' Infringement Contentions.........................................................10 There Is No Infringement of the Predetermined Spacing Limitations Under SenoRx's Proposed Construction...................................................10 The Contura's Lumens, Taken Individually, Do Not Meet the Predetermined Spacing Limitations. .......................................11 The Contura's Lumens, Taken Together, Do Not Meet the Predetermined Spacing Limitations. .............................................13 The Radionuclide Used With the Contura Does Not Meet the Predetermined Spacing Limitations. .............................................14

b.

3.

There Is No Infringement of the '813 Patent Under Plaintiffs' Proposed Construction. .............................................................................16

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TABLE OF AUTHORITIES FEDERAL CASES Asyst Techs., Inc. v. Emtrak, Inc., 402 F.3d 1188 (Fed. Cir. 2005) ................................................................................................. 5 Celotex Corp. v. Catrett, 477 U.S. 317 (1986) .................................................................................................................. 2 Cross Medical Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293 (Fed. Cir. 2005) ............................................................................................. 7, 8 Dayco Prods., Inc. v. Total Containment, Inc., 258 F.3d 1317 (Fed. Cir. 2001) ................................................................................................. 8 Dynacore Holdings Corp. v. U.S. Philips Corp., 363 F.3d 1263 (Fed. Cir. 2004) ................................................................................................. 8 Ethicon Endo-Surgery, Inc. v. U.S. Surgical Corp., 149 F.3d 1309 (Fed. Cir. 1998) ................................................................................................. 2 Freedman Seating Co. v. American Seating Co., 420 F.3d 1350 (Fed. Cir. 2005) ................................................................................................. 5 Novartis Corp. v. Ben Venue Labs., Inc., 271 F.3d 1043 (Fed. Cir. 2001) ................................................................................................. 3 PC Connector Solutions LLC v. SmartDisk Corp., 406 F.3d 1359 (Fed. Cir. 2005) ............................................................................................. 2, 3 Playtex Prods., Inc. v. Procter & Gamble Co., 400 F.3d 901 (Fed. Cir. 2005) ................................................................................................... 2 Scripps Clinic & Res. Found. v. Genentech, Inc., 927 F.2d 1565 (Fed. Cir. 1991) ................................................................................................. 2 Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17 (1997) .................................................................................................................... 5 Wolverine World Wide Inc. v. Nike Inc., 38 F.3d 1192 (Fed. Cir. 1994) ......................................................................................... 6, 9, 16 OTHER AUTHORITIES

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Fed. R. Civ. P. 56 ............................................................................................................................ 2

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NOTICE OF MOTION AND MOTION TO ALL PARTIES AND THEIR ATTORNEYS OF RECORD HEREIN: PLEASE TAKE NOTICE that on June 25, 2008 at 2:00 p.m. (in connection with the claim construction hearing scheduled in this matter), or as soon thereafter as may be heard, in the courtroom of the Honorable Ronald M. Whyte, Courtroom 6, 4th Floor, 280 South 1st Street, San Jose, California, Defendant SenoRx, Inc. ("SenoRx") will and hereby does move for partial summary judgment of non-infringement of claims 11 and 12 of U.S. Patent No. 5,913,813 (the "'813 patent); claims 4 and 17 of U.S. Patent No. 6,413,204 (the "'204 patent"); and claim 6 of U.S. Patent No. 6,482,142 (the "'142 patent"). SenoRx requests the Court hold claim 12 of the '813 patent, claim 17 of the '204 patent, and claim 6 of the '142 patent not infringed because SenoRx's ConturaTM Multi-Lumen Balloon ("Contura") does not contain a plurality of solid radiation sources. SenoRx further requests the Court hold claims 11 and 12 of the '813 patent and claim 4 of the '204 patent not infringed because, applying SenoRx's proposed construction of predetermined spacing, there is not a predetermined constant spacing between the alleged "inner spatial volume" (under any definition) of the Contura and the outer surface of the Contura, i.e., the Contura does not contain an inner spatial volume that is concentric with and the same shape as its outer volume. Alternatively, SenoRx requests that the Court hold claims 11 and 12 of the '813 patent not infringed under Plaintiffs' proposed construction of "predetermined constant spacing" because the spacing between the alleged "inner spatial volume" (under any definition) of the Contura and the outer surface of the Contura is not constant in all directions. This Motion, if granted, would dispose of all asserted claims of the '813 and '204 patents, as well as one of three asserted claims of the '142 patent. SenoRx brings the present Motion for Partial Summary Judgment of Non-Infringement because by resolving these issues as a matter of law, the case will be greatly simplified and appropriately streamlined for the jury. This Motion is made pursuant to Fed. R. Civ. P. 56, Local Rule 56-1, and Judge Whyte's Standing Orders. SenoRx bases its Motion upon this Notice of Motion and Motion, the accompanying Memorandum of Points and Authorities in Support thereof, the Declaration of
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Colin G. Orton, Ph.D. in Support of SenoRx's Opening Claim Construction Brief and Motion for Partial Summary Judgment of Non-Infringement, the Declaration of Williams F. Gearhart in Support of SenoRx's Motion for Partial Summary Judgment of Non-Infringement, the Declaration of Adam Harber in Support of SenoRx's Motion for Partial Summary Judgment of Non-Infringement, and exhibits thereto. MEMORANDUM OF POINTS AND AUTHORITIES Defendant SenoRx respectfully submits that based on the claim construction proposed by either Plaintiffs or Defendant in the Markman briefs filed simultaneously herewith, claim 12 of the '813 patent, claim 17 of the '204 patent, and claim 6 of the '142 patent are not infringed because there is no dispute that SenoRx's Contura does not contain a plurality of solid radiation sources.1 In addition, claims 11 and 12 of the '813 patent and claim 4 of the '204 patent are not infringed under SenoRx's proposed construction of predetermined spacing because there is not a predetermined constant spacing between the alleged "inner spatial volume" (under any definition) of the Contura and the outer surface of the Contura, i.e., the Contura does not contain an inner spatial volume that is concentric with and the same shape as its outer volume. Alternatively, even under Plaintiffs' proposed construction of predetermined spacing, claims 11 and 12 of the '813 patent are not infringed because the spacing between the alleged "inner spatial volume" (under any definition) of the Contura and the outer surface of the Contura is not constant in all directions. Therefore, this Court is respectfully requested to enter summary judgment of non-infringement of claims 11 and 12 of the '813 patent, claims 4 and 17 of the '204 patent, and claim 6 of the '142 patent.

All exhibits ("Ex.") referenced herein are exhibits to the Declaration of Adam D. Harber in Support of SenoRx's Motion for Partial Summary Judgment of Non-Infringement, unless otherwise specified. The '813 patent is Ex. 1, the '204 patent is Ex. 2, and the '142 patent is Ex. 3.

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ISSUES TO BE DECIDED Whether claim 12 of the '813 patent, claim 17 of the '204 patent, and claim 6 of the '142 patent are not infringed because the Contura does not meet the claim limitations requiring a "plurality" of solid radiation sources. Whether claims 11 and 12 of the '813 patent and claim 4 of the '204 patent are not infringed because the Contura does not meet the claim limitations requiring "a predetermined constant spacing" ('813 patent) and "a predetermined spacing" ('204 patent) between the inner and outer spatial volumes. LEGAL STANDARD Summary Judgment.

Summary judgment is appropriate "if the pleadings, the discovery and disclosure materials on file, and any affidavits show that there is no genuine issue as to any material fact and that the movant is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(c); Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986); Ethicon Endo-Surgery, Inc. v. U.S. Surgical Corp., 149 F.3d 1309, 1315 (Fed. Cir. 1998). Summary judgment is a useful tool to promote judicial economy and avoid unnecessary trials. Scripps Clinic & Res. Found. v. Genentech, Inc., 927 F.2d 1565, 1570 (Fed. Cir. 1991). B. Non-Infringement.

Determining whether a claim has been infringed requires a two-step analysis. PC Connector Solutions LLC v. SmartDisk Corp., 406 F.3d 1359, 1362 (Fed. Cir. 2005). First, the court must construe the claim to determine its scope and meaning. Id. Second, the construed claim must be compared to the accused device. Id. "To prove infringement, the patentee must show that the accused device meets each claim limitation, either literally or under the doctrine of equivalents." Playtex Prods., Inc. v. Procter & Gamble Co., 400 F.3d 901, 906 (Fed. Cir. 2005). An "accused infringer seeking summary judgment of noninfringement may meet its initial responsibility either by providing evidence that would preclude a finding of infringement, or by showing that the evidence on file fails to establish a material issue of fact essential to the
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patentee's case." Novartis Corp. v. Ben Venue Labs., Inc., 271 F.3d 1043, 1046 (Fed. Cir. 2001). Summary judgment of non-infringement is proper when no reasonable jury could find that the accused device contains every limitation recited in the properly construed claim. PC Connector, 406 F.3d at 1364. STATEMENT OF RELEVANT FACTS REGARDING THE CONTURA DEVICE The accused device, the Contura, is pictured below:

The Contura is a balloon catheter device for delivering therapeutic radiation to target tissue. The balloon is labeled "A" in the depiction above and is spherical. The balloon is attached to the end of a catheter body, labeled "B." There are a number of lumens that run through the catheter body from one end of the Contura (the proximal end, "C") through to the other end (the distal end, "D"). Five of these lumens (the "treatment lumens") are designed to have a radiation source inserted into them; one is positioned in the center of the catheter body, and the other four are offset from the center lumen and spaced at 90 degree increments (so that one is located above, one below, and one to either side of the central lumen). See Declaration of William F. Gearhart ("Gearhart Decl.") ¶ 6. In use, the device is inserted into a lumpectomy cavity of a woman, where the balloon portion is inflated with a contrast fluid. Declaration of Colin G. Orton ("Orton Decl.") ¶ 18. A CT scan of the device in situ is then made, and a radiation oncologist and radiation physicist determine how to best deliver radiation to the patient. Id. After a dose plan is optimized and approved, an afterloader is connected to the catheter by the lumen(s) at the proximal end of the device. Id. ¶ 19. Afterloaders used with the Contura are machines that are shielded and contain a single radiation source, generally Iridium 192 ("Ir-192"). Id. The radiation source used with
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the Contura is cylindrically shaped. Id. During treatment, the radiation source generally is inserted sequentially by the afterloader into multiple lumens of the Contura, although a single lumen has been used on rare occasions. Id.; Gearhart Decl. ¶ 8. Radiation is delivered at precise locations along the distal end of each lumen by pausing and moving the radiation source according to the dose plan. Id. The radiation source is withdrawn back into the afterloader after treatment is delivered. Id. Treatment with the Contura typically takes approximately five days, after which the device is surgically removed from the patient. Id. As used by physicians, the Contura device utilizes only one radioactive solid source. Orton Decl. ¶ 47. This is because the afterloaders compatible with the Contura hold only one radioactive source at a time, and thus can place only one radiation source at a time into the Contura device. Id. ¶¶ 46-47. Indeed, none of the commercially available afterloaders in the United States today are capable of placing more than one radiation source at a time. Id. ¶ 46. Each radiation source remains in the afterloader for approximately 90 days before it is replaced, which is far longer than the approximately five-day duration of Contura therapy. Id. ¶¶ 19, 47. ARGUMENT A. The Contura Does Not Meet the "Plurality" Claim Limitations.

Plaintiffs assert that SenoRx's Contura literally infringes claim 12 of the '813 patent, claim 17 of the '204 patent, and claim 6 of the '142 patent. This assertion fails as a matter of undisputed fact. The Contura does not contain a plurality of solid radiation sources, a required element for each of these claims. Summary judgment of non-infringement therefore should be entered. 1. Plaintiffs' Infringement Contentions.

Plaintiffs offer two theories of infringement, both asserted to be based on literal infringement.2 First, Plaintiffs contend that multiple treatment lumens of the Contura "allow

Although Plaintiffs in their Infringement Contentions assert infringement based on the doctrine of equivalents for many of the claim elements, they do not assert infringement under the doctrine of equivalents for any of the "plurality" claim limitations, and for good reason. Any (continued...) SENORX, INC.'S MEMORANDUM OF CASE NO. 08-CV-0133 RMW -4POINTS AND AUTHORITIES IN SUPPORT OF MOTION FOR PARTIAL SUMMARY JUDGMENT OF NON-INFRINGEMENT

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multiple solid radiation sources . . . to be arrayed simultaneously within" separate lumens. See Ex. 4 (Plaintiffs' Preliminary Infringement Contentions ("Pls' Infr. Cont.")) Appendix A at 15; id. Appendix B at 16; id. Appendix C at 13 (emphasis added). Second, in the alternative, Plaintiffs argue that the Contura literally infringes because "a single solid radionuclide on a source wire can be inserted sequentially into one or more predetermined locations within multiple treatment lumens." See id. Appendix A at 15; id. Appendix B at 16-17; id. Appendix C at 13. These contentions fail as a matter of law based on the undisputed facts. Because the Contura does not satisfy the "plurality" claim limitations of the three patents-in-suit, summary judgment of non-infringement should be granted. 2. The Contura Does Not Meet the "Plurality" Limitations.

Dependent claim 12 of the '813 patent requires that the claimed apparatus contain a "plurality of radioactive solid particles." Ex. 1 ('813 patent), claim 12. Similarly, dependent claim 17 of the '204 patent and independent claim 6 of the '142 patent require a "plurality of solid radiation sources."3 Ex. 2 ('204 patent), claim 17; Ex. 3 ('142 patent), claim 6.

(...continued from previous page) argument that the Contura's single solid radiation source is equivalent to two or more solid radiation sources would impermissibly vitiate the "plurality" claim limitation, in direct contravention of the well-established "all limitations" ("all elements") rule. Under that rule, "an element of an accused product or process is not, as a matter of law, equivalent to a limitation of the claimed invention if such a finding would entirely vitiate the limitation." Freedman Seating Co. v. American Seating Co., 420 F.3d 1350, 1358 (Fed. Cir. 2005); see also Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 29 (1997) ("Each element contained in a patent claim is deemed material to defining the scope of the patented invention . . . . It is important to ensure that the application of the doctrine [of equivalents], even as to an individual element, is not allowed such broad play as to effectively eliminate that element in its entirety."). Moreover, under the principle of specific exclusion, a corollary to the all elements rule, use of the term "plurality of solid radiation sources" specifically excludes devices containing only "single solid radiation sources." See Asyst Techs., Inc. v. Emtrak, Inc., 402 F.3d 1188, 1195 (Fed. Cir. 2005) (under the specific exclusion principle, "the term `mounted' can fairly be said to specifically exclude objects that are `unmounted'"). The phrases "radioactive solid particles" and "solid radiation sources" are synonymous. The terms "particles" and "sources" are used interchangeably in all three patents, Compare Ex. 3 ('142 patent), col. 3:7-8 ("radiation source comprises a plurality of spaced apart solid radioactive particles") with id., col. 9:50­10:1 ("radiation source comprising a plurality of solid radiation sources"), and all three patents state that "radioactive micro spheres of the type available from 3M Company of St. Paul, Minn., may be used" as the "solid radioactive particles" or the (continued...) SENORX, INC.'S MEMORANDUM OF CASE NO. 08-CV-0133 RMW -5POINTS AND AUTHORITIES IN SUPPORT OF MOTION FOR PARTIAL SUMMARY JUDGMENT OF NON-INFRINGEMENT
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As explained in SenoRx's Markman Brief, filed simultaneously herewith, the claim limitation "plurality of solid radiation sources" means "two or more separate radioactive solid sources placed in the inner spatial volume at the same time." See Def. Markman Br. at 26. SenoRx's Contura, however, does not use two or more radioactive solid particles or sources. Orton Decl. ¶¶ 46-47. In all configurations of the Contura, only a single solid radiation source is inserted into the device. Id. In fact, the afterloader devices used to load the radiation source into the Contura are only capable of placing one radiation source into the Contura at any one time. Id. Additionally, the claim limitations require that the "plurality of solid radiation sources" be present at the same time. It is undisputed that this does not occur in the use of the Contura, and Plaintiffs do not and cannot demonstrate otherwise. Thus, under SenoRx's proposed claim construction, the claims containing the "plurality" limitation are not infringed as a matter of law because the Contura only uses a single source, not two or more sources, and because more than one source is not placed into the device at the same time. See Wolverine World Wide Inc. v. Nike Inc., 38 F.3d 1192, 1199 (Fed. Cir. 1994) (When an "express claim limitation is absent from the accused product, there can be no literal infringement as a matter of law."). Plaintiffs have not offered any construction of the "plurality" limitations. In their Preliminary Claim Construction, Plaintiffs simply state "No construction necessary" for the limitations "plurality of radioactive solid particles" and "plurality of solid radiation sources." Ex. 5 (Pls' Cl. Constr.) Appendix A at 3; id. Appendix B at 4; id. Appendix C at 4. Presumably, therefore, Plaintiffs agree that the ordinary and customary meaning of "plurality" should be applied. That ordinary meaning is "two or more." See Dayco Prods., Inc. v. Total Containment, Inc., 258 F.3d 1317, 1327-28 (Fed. Cir. 2001) ("`plurality,' when used in a claim, refers to two or more items, absent some indication to the contrary"). Accordingly, even if the Court agrees that no construction is necessary, the plurality limitation would still be missing and the claims

(...continued from previous page) "radioactive source." See Ex. 3 ('142 patent), col. 4:60-62, Ex. 1 ('813 patent), col. 4:1-3; Ex. 2 (`204 patent), col. 4:49-51.

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are not infringed as a matter of law ­ the Contura device utilizes only a single radioactive solid source. To get around their "plurality" problem, Plaintiffs make two arguments, both of which fail as a matter of law. First, Plaintiffs contend that multiple treatment lumens of the Contura "allow multiple solid radiation sources . . . to be arrayed simultaneously within" the lumens. See Ex. 4 (Pls' Infr. Cont.) Appendix A at 15; id. Appendix B at 16; id. Appendix C at 13 (emphasis added). This argument misses the point. It is legally irrelevant whether the Contura is capable of being used with multiple radiation sources (even assuming, contrary to the undisputed evidence, that there were compatible afterloaders available in the United States that could load multiple radiation sources), when, as discussed above, the undisputed evidence is that SenoRx's Contura is not used with two or more radioactive solid particles or sources. See Orton Decl. ¶¶ 46-47. An apparatus claim is not infringed simply because the accused device is "capable" of being made into an infringing device. Cross Medical Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1311-12 (Fed. Cir. 2005). Rather, "to infringe an apparatus claim, the device must meet all of the [claim's] structural limitations." Id. (emphasis added). That is, the device must actually be made and used in such a manner as to satisfy all the claim elements. In Cross Medical, the Federal Circuit expressly rejected the argument that an accused device need only be capable of infringing. The issue in that case was whether the claim limitation "operatively joined" was met by the accused orthopedic surgical implant. Despite the court's construction that "operatively joined" meant "the interface and the bone segment are connected and in contact," 424 F.3d at 1306, the patentee, like Plaintiffs here, argued that there was infringement so long as the accused device was "capable" of being configured to meet all of the structural limitations of the apparatus claim. Id. at 1310. The court rejected this argument, finding that "the claim does not require that the interface be merely `capable' of contacting bone; the claim has a structural limitation that the anchor seat be in contact with bone." Id. at 1311. Accordingly, the court found no direct infringement by the accused infringer because there was

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no evidence that the manufacturer itself made "an apparatus with the `interface' portion in contact with bone." Id. The same is true here. The claims at issue do not require the apparatus to be "capable" of containing a plurality of solid radiation sources. Rather, the claims include a structural limitation requiring that the claimed apparatus contain a plurality of solid radiation sources. SenoRx does not directly infringe because it manufactures the device without any radiation source. Because physicians using the Contura do not use it with two or more solid radiation sources, see Orton Decl. ¶¶ 46-47, the "plurality" claim limitation is never met, and there is no direct infringement by anyone. And because there is no direct infringement, there can be no inducement of infringement or contributory infringement. See Dynacore Holdings Corp. v. U.S. Philips Corp., 363 F.3d 1263, 1277 (Fed. Cir. 2004) ("absent direct infringement of the claims of a patent, there can be neither contributory infringement nor inducement of infringement") (quoting Met-Coil Sys. Corp. v. Korners Unlimited, Inc., 803 F.2d 684, 687 (Fed. Cir. 1986)). Second, Plaintiffs contend that the Contura literally infringes because "a single solid radionuclide . . . can be inserted sequentially into . . . multiple treatment lumens." See Ex. 4 (Pls' Infr. Cont.) Appendix A at 15. Under SenoRx's proposed construction, this contention fails as a matter of undisputed fact, because two or more radionuclides must be present at the same time, and it cannot be disputed that this does not occur with the use of a single radionuclide. But even if SenoRx's construction is not adopted, Plaintiffs' argument still fails as a matter of law. The act of moving a single radionuclide to multiple locations does not transform the single object into two or more objects; the claim is to plural radiation sources. The lynchpin of Plaintiffs' argument in this respect is that "two or more" includes "single" or "one." Merely to state the argument is to refute it. Indeed, inserting a single radionuclide sequentially necessarily means that only the one radionuclide ever is present. These are apparatus claims, and if all of the elements do not exist together, the claimed apparatus does not exist. See Cross Medical, 424 F.3d at 1311-12. Because there never are two or more radionuclides, the claimed apparatus never exists, and there is no infringement.
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To be sure, if the inventors had wanted their patents to encompass sequential insertion of a radionuclide, they easily could have included such language within their claims. At the time of filing, the inventors certainly were well aware that afterloaders were available that had the ability to insert solid radiation particles into a brachytherapy apparatus. See Ex. 3 ('142 patent), col. 5:8-10 ("solid radiation emitting material 36 can be inserted through lumen 14 on a wire 34, for example using an afterloader"); Ex. 2 ('204 patent), col. 4:54-56 (same). At least since the early 1990s, it was well known that afterloaders had the ability to move radionuclides from one dwell position to another within a radiation therapy apparatus. Orton Decl. ¶ 45. The inventors, however, did not claim such a device. Rather, the claims as written require that two or more radioactive sources be present at the same time. Because this limitation is not met by the Contura device, the claims are not literally infringed. For all of these reasons, this Court should enter summary judgment of non-infringement of claim 12 of the '813 patent, claim 17 of the '204 patent, and claim 6 of the '142 patent. See Wolverine World Wide, 38 F.3d at 1199 ("If an express claim limitation is absent from the accused product, there can be no literal infringement as a matter of law."). B. The Contura Does Not Meet the Predetermined Spacing Limitations of the '813 and '204 Patents.

Plaintiffs assert that SenoRx's Contura literally infringes the "predetermined constant spacing" limitation of asserted claims 11 and 12 of the '813 patent, and the "predetermined spacing" limitation of asserted claim 4 of the '204 patent.4 Because the claims as properly construed require constant spacing between the surfaces of the inner and outer volumes, and the Contura device fails to satisfy such a limitation, summary judgment of non-infringement should

Claims 11 and 12 of the '813 patent depend from claim 1, which requires "a predetermined constant spacing between said inner spatial volume and the radiation transparent wall." Ex. 1 ('813 patent), claims 1, 11, 12. Claim 4 of the '204 patent depends from claim 3, which requires "a predetermined spacing . . . between said inner spatial volume and the expandable surface element." Ex. 2 ('204 patent), claims 3-4.

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be entered on claims 11 and 12 of the '813 patent and claim 4 of the '204 patent.5 Additionally, even under Plaintiffs' construction, there is no infringement of the claims of the '813 patent because the spacing between the inner spatial volume and outer spherical balloon of the Contura is not "constant in all directions." See Def. Markman Br. at 4. 1. Plaintiffs' Infringement Contentions.

For the '813 patent, Plaintiffs state that the "predetermined constant spacing" element of claim 1(c) (incorporated into claims 11 and 12) is met because "the central treatment lumen is located within the balloon . . . along the longitudinal axis of the applicator. . . . The ConturaTM balloon surrounds and contains the inner spatial volume(s) discussed above. The spacing (predetermined by one of skill in the art) between the inner spatial volume and the wall of the ConturaTM balloon is constant. This claim element is thus literally infringed." Ex. 4 (Pls' Infr. Cont.) Appendix A at 5 (emphasis in original). For the '204 patent, Plaintiffs similarly state that "The ConturaTM balloon surrounds and contains the inner spatial volume(s) (discussed above). The spacing between the inner spatial volume and the wall of the ConturaTM balloon is constant. This claim element is thus literally infringed." Ex. 4 (Pls' Infr. Cont.) Appendix B at 12-13 (emphasis in original). 2. There Is No Infringement of the Predetermined Spacing Limitations Under SenoRx's Proposed Construction.

The goal of the '813 and '204 patents is to provide a uniform, symmetric radiation dose profile that has the same shape as the outer balloon. As discussed in SenoRx's Markman brief at 4-8, the asserted claims achieve this goal and avoid hot spots in the tissue by separating the surface of the inner volume (in which radioactive material is placed) from the surface of the outer balloon by a predetermined fixed distance. As demonstrated in the declaration of Dr.

Plaintiffs have not asserted equivalency of these limitations under the doctrine of equivalents, and again there is good reason: prosecution history estoppel based on amendment and argument over the prior art precludes Plaintiffs' reliance on the doctrine of equivalents to reach a device in which there is not constant spacing between surfaces of the inner and outer volumes.

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Orton, as a matter of geometry, this means that the inner spatial volume must have the same shape and be concentric with the outer balloon (i.e., the two structures must share the same center and orientation). See Orton Decl. ¶ 27. Accordingly, SenoRx's proposed construction of the predetermined spacing limitations in the '813 and '204 patents6 is: Fixed spacing, predetermined by one skilled in the art before administering radiation, between the wall or edge of the inner spatial volume and the radiation transparent wall of the outer, closed inflatable chamber, when inflated, which for each point on the wall or edge of the inner spatial volume, the distance to the closest point on the outer chamber is the same (i.e., the inner spatial volume and outer chamber are concentric and the same shape). To determine if the predetermined spacing limitations of the '813 and '204 patents are infringed, the Court must examine the relationship between the inner and outer volumes of the Contura. There is no dispute as to the shape and location of the surface of the outer volume once the spherical outer balloon of the Contura is expanded. The issue therefore turns on what is the "inner spatial volume" of the Contura, and how that inner volume relates to the outer balloon. Plaintiffs have identified three mutually contradictory theories regarding the identity of the inner spatial volume in the Contura. They claim the inner spatial volume is (1) each treatment lumen taken individually, (2) under the doctrine of equivalents, the treatment lumens taken collectively and the space surrounding them, and (3) the solid radionuclide source. Regardless what Plaintiffs call the inner spatial volume,7 the Contura does not meet the requirements of the predetermined spacing limitation. a. The Contura's Lumens, Taken Individually, Do Not Meet the Predetermined Spacing Limitations.

The '204 patent ­ and SenoRx's proposed construction thereof ­ uses the term "expandable surface element" in place of "radiation transparent wall of the outer, closed inflatable chamber." There is no dispute, however, that the two phrases reference the same structure in the claimed devices as relates to this claim element. SenoRx disagrees that any of the structures relied on by Plaintiffs constitute "inner spatial volumes" but will accept Plaintiffs definitions for purposes of this motion.
7

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Plaintiffs contend that each of the five treatment lumens comprise an inner spatial volume (i.e., they argue that the Contura has five separate inner spatial volumes). See Ex. 4 (Pls' Infr. Cont.) Appendix A at 4, 9; id. Appendix B at 4. First, there is not a predetermined constant spacing between any of these lumens and the outer surface. The four outer lumens in the balloon are arc-shaped, and arranged so as to be 5 mm offset from the central axis of the catheter at their central point. This clearly means that they are located so that the closest distance to the outer balloon is not the same for each point on any lumen, as depicted below in Figure 1. See Orton Decl. ¶ 34.

Figure 1 (Individual Offset Lumens) Nor is the central lumen a fixed distance from the surface of the balloon. As seen in Figure 2, below, the central lumen is much closer to the balloon at its ends than at its central portion, and thus, the distance from each point in the edge of the central lumen to the closest point on the outer balloon is not the same. See id.

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SENORX, INC.'S MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF MOTION FOR PARTIAL SUMMARY JUDGMENT OF NON-INFRINGEMENT

Figure 2 (Individual Central Lumen) Accordingly, the Contura's individual lumens are not separated from the balloon by a predetermined spacing, and do not meet the predetermined spacing claim elements. Second, the predetermined spacing elements also are not met because none of the individual lumens have the same shape as the outer balloon. Orton Decl. ¶ 34. Finally, the four offset lumens do not share a common center with the outer balloon. Id. Accordingly, there is no "predetermined constant spacing" or "predetermined spacing" between any of the four offset lumens and the outer balloon. b. The Contura's Lumens, Taken Together, Do Not Meet the Predetermined Spacing Limitations.

Invoking the doctrine of equivalents, Plaintiffs argue the "five treatment lumens and the area within the balloon between and surrounding those lumens" comprise the inner spatial volume. See Ex. 4 (Pls' Infr. Cont.) Appendix A at 4, 9; id. Appendix B at 4. This irregularly shaped area ­ allegedly consisting of the "five treatment lumens and the area within the balloon between and surrounding those lumens," id. ­ likewise is not spaced a constant distance from the Contura's balloon, as shown in Figure 3. Therefore, this proposed configuration does not infringe the predetermined spacing claim elements for the same reasons discussed above. Orton Decl. ¶ 35.

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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 Figure 3 (Lumens (collectively)) In addition, as clearly evidenced in Figure 3, the irregular, unbounded region within the balloon between and surrounding the five "treatment" lumens has a different shape from the outer balloon. Id. Accordingly, the predetermined spacing claim limitation is not satisfied under Plaintiffs' second proposed interpretation of the inner spatial volume. c. The Radionuclide Used With the Contura Does Not Meet the Predetermined Spacing Limitations.

Plaintiffs' final theory is that the solid cylindrical radionuclide source used with the Contura is itself the inner spatial volume. See Ex. 4 (Pls' Infr. Cont.) Appendix A at 4; id. Appendix B at 4. But as explained below, the radionuclide does not satisfy this claim element because (1) there is no fixed spacing between the radionuclide and the balloon, and (2) the radionuclide has a different shape from the outer balloon and therefore there is no constant spacing over its entire surface. Thus, the Contura does not satisfy this limitation. The radionuclide is not part of the Contura device. It is instead part of the afterloader. During treatment of a patient, the radiation source is inserted into the Contura's lumens by the afterloader, and radiation is delivered at precise locations along the distal end of the lumens (called "dwell positions") by pausing and moving the radiation source through the lumens. Orton Decl. ¶ 19. An exemplary treatment plan using an afterloader in the Contura device is shown in Figure 4 below. Gearhart Decl. ¶ 10. Each rectangular box represents a possible dwell position; the green boxes depict the positions where the radionuclide would dwell during this exemplary treatment plan, and the gray boxes are positions that are not used. Id.
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SENORX, INC.'S MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF MOTION FOR PARTIAL SUMMARY JUDGMENT OF NON-INFRINGEMENT

Figure 4 (Exemplary Contura Treatment Plan - Multiple Dwell, Multiple Lumen) The undisputed evidence is that in every case of patient treatment since the commercial launch of the Contura in January 2008, the dose was delivered with multiple dwell positions. Gearhart Decl. ¶ 8. And, in the vast majority of those cases, the dose also was delivered with multiple lumens. Id. This means the radionuclide is moved around during treatment. Accordingly, post-launch use of the Contura does not infringe the asserted claims discussed here because the spacing is not fixed. Orton Decl. ¶ 36. Put another way, there is no constant spacing for a moving radionuclide source (i.e., an inner spatial volume that moves relative to the outer expandable surface cannot have constant spacing). Furthermore, the Contura does not satisfy this claim limitation (based on SenoRx's proposed construction) for the independent reason that the radionuclide used with the Contura is not the same shape as the outer balloon. The radionuclide is cylindrical, not spherical. Orton Decl. ¶ 36. As a result, regardless of where the radionuclide is located, the spacing between the ends of the radionuclide and the balloon is less than the spacing between the cylindrical surface of the radionuclide and the balloon. Id. ***

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In sum, the accused device does not read on the predetermined spacing limitation of claim 1 of the '813 and claim 3 of the '204 patents under any of Plaintiffs' three theories of inner spatial volume. Accordingly, there is no infringement of asserted claims 11 and 12 of the '813 patent, both of which depend from claim 1, and asserted claim 4 of the '204 patent, which depends from claim 3. See Wolverine World Wide, 38 F.3d at 1199 (When an "express claim limitation is absent from the accused product, there can be no literal infringement as a matter of law."). 3. There Is No Infringement of the '813 Patent Under Plaintiffs' Proposed Construction.

Plaintiffs propose that the "predetermined constant spacing" element of claim 1[c] of the '813 patent should be understood as follows: 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. Def. Markman Br. at 4. There is no factual dispute that the Contura has a spherical outer balloon. Gearhart Decl. ¶ 6; Ex. 4 (Pls' Infr. Cont.) Appendix B at 5 ("[t]he inflatable spherical balloon is an `expandable surface element'"); id. at 7 ("the wall of the spherical ConturaTM balloon"); id. Appendix C at 3 ("[t]he outer surface of the inflatable spherical ConturaTM multilumen balloon"); id. at 12 ("[t]he outer surface of the inflatable spherical ConturaTM multi-lumen balloon"); see also id. Appendix B at 3, 6, 8, 15; id. Appendix C at 5, 8. Thus, even under Plaintiffs' construction, the spacing between the surface of the inner spatial volume and the wall of the Contura balloon must be "constant in all directions." For the same reasons discussed above, and as depicted in Figures 1-4, the spacing between the "inner spatial volume" of the Contura and the balloon is not "constant in all directions," regardless of the definition of inner spatial volume. Accordingly, even if Plaintiffs' construction is adopted, summary judgment of no infringement is appropriate for claims 11 and 12 of the '813 patent.

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1 2 3 4 Dated: May 21, 2008 5 6

CONCLUSION For the foregoing reasons, the Court should grant SenoRx's Motion for Partial Summary Judgment of Non-Infringement. Respectfully submitted,

By: __/s/ F.T.Alexandra Mahaney___________ 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28
SENORX, INC.'S MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF MOTION FOR PARTIAL SUMMARY JUDGMENT OF NON-INFRINGEMENT

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.

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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 DECLARATION OF ADAM D. HARBER IN SUPPORT OF DEFENDANT SENORX, INC.'S MOTION FOR PARTIAL SUMMARY JUDGMENT OF NONINFRINGEMENT ('813 PATENT, CLAIMS 11 & 12; '204 PATENT, CLAIMS 4 & 17; AND '142 PATENT CLAIM 6)

SENORX, INC., Counterclaimant, v. HOLOGIC, INC., CYTYC CORP., and HOLOGIC L.P., Counterdefendants.
DECLARATION OF ADAM D. HARBER IN SUPPORT
OF DEFENDANT SENORX, INC.'S MOTION FOR

Date: June 25, 2008 Time: 2:00 p.m. Courtroom: 6, 4th Floor Judge: Hon. Ronald M. Whyte

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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' DISCLOSURE OF ASSERTED CLAIMS AND PRELIMINARY INFRINGEMENT CONTENTIONS UNDER PATENT LOCAL RULE 3-1

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
HOWREY LLP

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1

Plaintiffs Hologic, Inc, Cytyc Corporation, and Hologic L.P. (collectively, "Hologic"), by

2 counsel and pursuant to Patent Local Rule 3-1 of this Court, hereby submits its disclosure of asserted 3 claims and preliminary infringement contentions relating to U.S. Patents Nos. 5,913,813 (the ```813 4 patent"), 6,413,204 (the "`204 patent"), and 6,482,142 (the "`142 patent"). Hologic reserves the right 5 to supplement or amend its identification of asserted claims, accused instrumentalities and 6 infringement contentions contained herein (a) based on additional information concerning Defendant 7 SenoRx, Inc.' s ("SenoRx") products and methods obtained through discovery or other means, (b) as 8 appropriate, in response to the Court's determination of legal issues, including without limitation the 9 construction of disputed terms, phrases and clauses identified by either party, or (c) for any other good 10 cause shown. See Pat. L.R. 3-6 & 3-7. 11 I. 12 13 INFRINGEMENT CHARTS FOR EACH ASSERTED CLAIM (Patent L.R. 3-1(c)) A. U.S. Patent No. 5,913,813

Attached as Appendix A is a chart identifying specifically where each element of each

14 asserted claim of the `813 patent (claims 11 and 12) is found within SenoRx's ConturaTM Multi-Lumen 15 Balloon Source Applicator for Brachytherapy, models B001-45 and B011-45. 16 17 B. U.S. Patent No. 6,413,204

Attached as Appendix B is a chart identifying specifically where each element of each

18 asserted claim of the `204 patent (claims 4 and 17) is found within SenoRx's ConturaTM Multi-Lumen 19 Balloon Source Applicator for Brachytherapy, models B001-45 and B011-45. Each asserted claim is 20 entitled to a priority date of July 4, 1997. 21 22 C. U.S. Patent No. 6,482,142

Attached as Appendix C is a chart identifying specifically where each element of each

23 asserted claim of the `142 patent (claims 1, 6, and 8) is found within SenoRx's ConturaTM Multi24 Lumen Balloon Source Applicator for Brachytherapy, models B001-45 and B011-45. The first two 25 claim elements of claim 1 (as tabled in Appendix C) are entitled to a priority date of July 4, 1997. 26 \\ 27 28
HOWREY LLP

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APPENDIX A INFRINGED CLAIMS OF U.S. Patent No. 5,913,813 Asserted Claim1
1. Apparatus for delivering radioactive emissions to a body location with a uniform radiation profile, comprising:

ConturaTM Multi-Lumen Balloon Source Applicator 2
CONTENTION: The ConturaTM Multi-Lumen Balloon Source Applicator ("ConturaTM") (formerly marketed under the product name SenoRad) is an interstitial brachytherapy apparatus designed to deliver intracavity radiation to the margins of the cavity remaining after surgical resection of breast cancer. SenoRx Inc. ("SenoRx") makes, uses, offers for sale, and sells an interstitial brachytherapy applicator marketed under the product name ConturaTM Multi-Lumen Balloon Source Applicator for Brachytherapy. See Ref. No. 7; Ref. No. 8; Ref. No. 10 at SRX-HOL00002354; Ref. No. 11 at SRX-HOL00002360-2362; Ref. No. 12 at 1, 2; Ref. No. 13 at 39; Ref. No. 14 at SRX-HOL00002371, 2373; Ref. No. 15 at SRXHOL00007179-7186; Ref. No. 17; Ref. No. 23 at SRX-HOL00005396, 5404; Ref. No. 25 at SRX-HOL00003386; Ref. No. 27; Ref. No. 28 at SRX-HOL00004140-4149, 4163-4195; Ref. No. 28 at SRX-HOL00004163-4195; Ref. No. 29 at SRXHOL00004197-4215; Ref. No. 30; Ref. No. 33 at SRX-HOL00004457-4459; Ref. No. 35; Ref. No. 36; Ref. No. 37 at SRX-HOL00004778; Ref. No. 38; Ref. No. 40 at SRXHOL00001675-1688, 1692-1702; Ref. No. 41 at SRX-HOL00001784-1788; Ref. No. 42 at SRX-HOL00002016-2019, 2030. SenoRx also induces and contributes to direct infringement by others of claim 1 by making, using, marketing, offering for sale, selling, supplying, and distributing the ConturaTM to physicians and health care facilities for use in treating breast cancer patients. See Ref. No. 7; Ref. No. 8; Ref. No. 10 at SRX-HOL00002354; Ref. No. 11 at SRX-HOL00002360-2362; Ref. No. 12 at 1, 2; Ref. No. 13 at 39; Ref. No. 14 at SRX-HOL00002371, 2373; Ref. No. 15 at SRX-HOL00007179-7186; Ref. No. 16 at SRX-HOL00006591-6601; Ref. No. 17; Ref. No. 22; Ref. No. 26; Ref. No. 34 at SRX-

1

Asserted Claims 11 and 12 depend from unasserted Claims 1, 2, and 8 (for which, therefore, the elements are matched to features of the accused instrumentality).
2

The "Support" cited herein is exemplary, and although sufficient to support a claim of infringement, is not the complete factual record on which Hologic intends to rely to prove infringement at trial. To the extent that further discovery shows any element of an asserted claim is not present literally, Hologic will rely at least on the identified evidence to show that the element is present under the doctrine of equivalents.
APPX. A TO HOLOGIC'S PRELIM . INFRINGEMENT CONTENTIONS CASE NO. CV 08-0133 RMW (RS) DM_US:21210534_1

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Asserted Claim1

ConturaTM Multi-Lumen Balloon Source Applicator 2
HOL00006734, 6780-3784; Ref. No. 28 at SRX-HOL00004163-4195; Ref. No. 29 at SRX-HOL00004197-4215; Ref. No. 33 at SRX-HOL00004457-4459; Ref. No. 34 at SRX-HOL00006734, 6740, 6743-6745, 6760-6773, 6780-3784; Ref. No. 37 at SRXHOL00004778; Ref. No. 39 at SRX-HOL00001540; Ref. No. 41 at SRXHOL00001792-1794; Ref. No. 40 at SRX-HOL00001675-1688, 1692-1702; Ref. No. 42 at SRX-HOL00002016-2019, 2030. SenoRx has made, used, marketed, offered for sale, sold, supplied, and distributed the Contura knowing that it is especially made or especially adapted for infringing use. Ref. No. 23 at SRX-HOL5408-5429; Ref. No. 31 at HOLOGIC0048742; Ref. No. 32 at HOLOGIC0048754-55. The Contura is not a staple article or commodity of commerce suitable for substantial non-infringing use. SUPPORT: "The SenoRad Multi-Lumen Balloon Source Applicator for Brachytherapy is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer." Ref. No. 1 at Device description. "The ConturaTM MLB Applicator is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer." Ref. No. 2 at 2232. "SenoRx, Inc. (NASDAQ:SENO) today announced that it has launched ConturaTM, its Multi-Lumen Balloon (MLB) Catheter for delivering brachytherapy to the surgical margins following lumpectomy for breast cancer." Ref. No. 5. See also evidence attached to Plaintiffs' Motion For Preliminary Injunction, Plaintiffs' Reply Brief In Support of Motion For Preliminary Injunction, and evidence cited in Judge Whyte's Order Denying Plaintiffs' Motion For Preliminary Injunction. See also Ref. No. 7; Ref. No. 8; Ref. No. 10 at SRX-HOL00002354; Ref. No. 11 at SRX-HOL00002360-2362; Ref. No. 12 at 1, 2; Ref. No. 13 at 39; Ref. No. 14 at SRXHOL00002371, 2373; Ref. No. 15 at SRX-HOL00007179-7186; Ref. No. 16 at SRXHOL00006591-6601; Ref. No. 17; Ref. No. 23 at SRX-HOL00005396, 5404, 54085429; Ref. No. 22; Ref. No. 25 at SRX-HOL00003386; Ref. No. 26; Ref. No. 34 at SRX-HOL00006734, 6780-3784; Ref. No. 27; Ref. No. 28 at SRX-HOL000041404149, 4163-4195; Ref. No. 29 at SRX-HOL00004197-4215; Ref. No. 30; Ref. No. 31

APPX. A TO HOLOGIC'S PRELIM . INFRINGEMENT CONTENTIONS CASE NO. CV 08-0133 RMW (RS) DM_US:21210534_1

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Asserted Claim1

ConturaTM Multi-Lumen Balloon Source Applicator 2
at HOLOGIC0048742; Ref. No. 32 at HOLOGIC0048754-55; Ref. No. 33 at SRXHOL00004457-4459; Ref. No. 34 at SRX-HOL00006734, 6740, 6743-6745, 67606773, 6780-3784; Ref. No. 35; Ref. No. 36; Ref. No. 37 at SRX-HOL00004778; Ref. No. 38; Ref. No. 39 at SRX-HOL00001540; Ref. No. 40 at SRX-HOL00001675-1688, 1692-1702; Ref. No. 41 at SRX-HOL00001784-1788, 1792-1794; Ref. No. 42 at SRXHOL00002016-2019, 2030.

(a) a catheter body member having a proximal end and distal end;

CONTENTION: The ConturaTM has a catheter with a proximal and distal end, with proximal ports for inflation and vacuum, as well as a distal "vacuum port." "Radiation source lumens" also run from the proximal end of the applicator into the treatment lumens at the distal end of the catheter. This claim element is thus literally infringed. SUPPORT: "The SenoRad applicator consists of a multi-lumen catheter connected to an inflatable spherical balloon that can be attached to commercially available High Dose Rate remote afterloader equipment for passage of the radiation source delivery wire." Ref. No. 1 at Device description. "The ConturaTM MLB Applicator consists of a multi-lumen catheter attached to an inflatable spherical balloon (Figure 1)." Ref. No. 2 at 2232. Illustrations of the SenoRx Multi-Lumen Balloon Source Applicator show a catheter with a proximal and distal end, with proximal ports for inflation ("inflation luer") and vacuum ("vacuum luer"), as well as a distal "vacuum port". "Radiation source lumens" are also run from the proximal end of the applicator into the treatment lumens at the distal end of the catheter. Ref. No. 2 at Figure 1; Ref. No. 3. "Two proximal ports are also provided with Luer-type connectors for balloon inflation/deflation and for application of intracavitary vacuum." Ref. No. 2 at 2232. See generally Ref. No. 4. See also evidence attached to Plaintiffs' Motion For Preliminary Injunction, Plaintiffs'

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Asserted Claim1

ConturaTM Multi-Lumen Balloon Source Applicator 2
Reply Brief In Support of Motion For Preliminary Injunction, and evidence cited in Judge Whyte's Order Denying Plaintiffs' Motion For Preliminary Injunction.

(b) an inner spatial volume disposed proximate the distal end of the catheter body member;

CONTENTION: Each of the five treatment lumens inside the ConturaTM balloon comprises a region of space surrounded by an outer spatial volume and enclosed by a polymeric film wall and therefore embodies an inner spatial volume proximate to the distal end of the ConturaTM catheter. Ref. No. 24 at 28. Alternatively, the radionuclide itself comprises a region of space surrounded by an outer spatial volume and defined by the outside surface of a solid radionuclide sphere and therefore embodies an inner spatial volume. Id. This claim element is thus literally infringed. Alternatively, the five treatment lumens and the area within the balloon between and surrounding those lumens are insubstantially different from 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. The