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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 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.

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Case No. 08-CV-0133 RMW DEFENDANT SENORX, INC.'S REPLY MEMORANDUM IN SUPPORT OF ITS MOTION FOR PARTIAL SUMMARY JUDGMENT OF NON-INFRINGEMENT ('813 PATENT, CLAIMS 11 & 12; '204 PATENT, CLAIMS 4 & 17) Date: June 25, 2008 Time: 2:00 p.m. Courtroom: 6, 4th Floor Judge: Hon. Ronald M. Whyte

SENORX, INC.'S REPLY IN SUPPORT OF MOTION FOR PARTIAL SUMMARY JUDGMENT OF NON-INFRINGEMENT

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

3 Argument In Reply..........................................................................................................................1 4 I. 5 6 7 8 B. 9 10 11 12 2. 13 14 15 Conclusion.....................................................................................................................................13 16 17 18 19 20 21 22 23 24 25 26 27 28
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A Device Does Not Infringe If It Is Merely "Capable" of Being Used In An Infringing Way. ...................................................................................................................2 Plurality. ..............................................................................................................................4 A. There Is No Dispute of Material Fact That the Contura Does Not Literally Infringe the "Plurality" Limitations. .......................................................................4 The Contura Does Not Infringe the "Plurality" Limitations Under the Doctrine of Equivalents As a Matter of Law. .........................................................6

II.

III.

The Contura Does Not Meet the Predetermined Spacing Limitations................................9 1. Treatment Plans That Do Not Use the Central Lumen, Central Dwell Position......................................................................................................10 Treatment Plans Utilizing Multiple Dwell Positions Including the Central Lumen, Central Dwell Position. ...................................................10 Treatment Plans Utilizing Only the Central Lumen, Central Dwell Position......................................................................................................12

3.

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TABLE OF AUTHORITIES FEDERAL CASES Asyst Techs., Inc. v. Emtrak, Inc., 402 F.3d 1188 (Fed. Cir. 2005) ................................................................................................. 8 Athletic Alternatives, Inc. v. Prince Mfg., Inc., 73 F.3d 1573 (Fed. Cir. 1996) ............................................................................................... 2, 8 Bicon, Inc. v. Straumann Co., 441 F.3d 945 (Fed. Cir. 2006) ............................................................................................... 5, 8 Conopco, Inc. v. May Dept. Stores Co., 46 F.3d 1556 (Fed. Cir. 1994) ................................................................................................... 7 Cook Biotech Inc. v. ACell, Inc., 460 F.3d 1365 (Fed. Cir. 2006) ................................................................................................. 9 Cooper Cameron Corp. v. Kvaerner Oilfield Products, Inc., 291 F.3d 1317 (Fed. Cir. 2002) ................................................................................................. 7 Cross Medical Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293 (Fed. Cir. 2005) ............................................................................................. 2, 3 Dolly, Inc. v. Spalding & Evenflo Companies, Inc., 16 F.3d 394 (Fed. Cir. 1994) ................................................................................................. 7, 8 Ethicon Endo-Surgery, Inc. v. U.S. Surgical Corp., 149 F.3d 1309 (Fed. Cir. 1998) ................................................................................................. 8 Fantasy Sports Props, Inc. v. SportsLine.com, Inc., 287 F.3d 1108 (Fed. Cir. 2002) ................................................................................................. 3 Freedman Seating Co. v. Am. Seating Co., 420 F.3d 1350 (Fed. Cir. 2005) ............................................................................................. 7, 8 Hewlett-Packard Co. v. Bausch & Lomb, Inc., 909 F.2d 1464 (Fed. Cir. 1990) ................................................................................................. 3 High Tech Med. Instrumentation, Inc. v. New Image Inds., Inc., 49 F.3d 1551 (Fed. Cir. 1995) ................................................................................................... 3 In re Michlin, 256 F.2d 317 (CCPA 1958)....................................................................................................... 3 Intel Corp. v. U.S. Int'l Trade Commission, 946 F.2d 821 (Fed. Cir. 1991) ................................................................................................... 3
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Moore U.S.A. v. Std. Register Co., 229 F.3d 1091 (Fed. Cir. 2000) ............................................................................................. 6, 7 NTP, Inc. v. Research in Motion, Ltd., 418 F.3d 1282 (Fed. Cir. 2005) ................................................................................................. 3 Planet Bingo, LLC v. Gametech Int'l, Inc., 472 F.3d 1338 (Fed. Cir. 2006) ................................................................................................. 9 Sage Products, Inc. v. Devon Industries, Inc., 126 F.3d 1420 (Fed. Cir. 1997) ................................................................................................. 7 SciMed Life Systems, Inc. v. Advanced Cardiovascular Systems, Inc., 242 F.3d 1337 (Fed. Cir. 2001) ................................................................................................. 8 Tronzo v. Biomet, Inc., 156 F.3d 1154 (Fed. Cir. 1998) ................................................................................................. 8 Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555 (Fed. Cir. 1991) ................................................................................................. 5 Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17 (1997) .................................................................................................................... 6 Zygo Corp. v. Wyko Corp., 79 F.3d 1563 (Fed. Cir. 1996) ................................................................................................... 3

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ARGUMENT IN REPLY There are only two issues presented in SenoRx's motion for summary judgment of noninfringement: 1) can a device using only one radiation source infringe a claim requiring a "plurality" of radiation sources; and 2) can a device where the spacing between the radionuclide and the balloon changes infringe a claim requiring that the spacing be constant. As a matter of law, the answer to both questions is no. Despite Plaintiffs' disjointed brief in opposition ­ which careens back and forth through irrelevant questions of direct and indirect infringement, the alleged development of Plaintiffs' device, and other tangents that were not raised by SenoRx in its motion for summary judgment ­ there are no disputed facts relevant to the two issues here. First, there is no factual dispute that only one radiation source is ever placed in the Contura during use, and never two or more. See Pls. Opp. at 3. This requires a finding of noninfringement of claim 12 of the '813 patent and claim 17 of the '204 patent as a matter of law.1 Plaintiffs' position is that because this single source is moved to different locations in the device during a patient's treatment, it is thereby transformed into a "plurality" of radiation sources. That is nonsense ­ placing a single radiation source in multiple locations in a device no more transforms a single source into multiple sources than parking the same car in different parking spaces means that someone has two cars. Second, there is no factual dispute that Contura users "typically employ more than one `dwell point' during a procedure." Pls. Opp. at 3. As to those uses, Plaintiffs argue that a radioactive source moving within a balloon can satisfy claim limitations requiring constant spacing between the source and the balloon if there exists a single snapshot in time in which the source is located in the center of the balloon. That is wrong. The predetermined spacing claim limitations require not only that the closest distance from any point on the source to the balloon be the same (i.e., the inner and outer volumes must have the same shape and be concentric), but also that it is unchanging (i.e., fixed) rather than variable. Because it is undisputed that the

Plaintiffs have dropped their assertions that claim 6 of the '142 patent is infringed, and accordingly that claim is not further discussed herein. -1-

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radionuclide moves among the dwell positions in the Contura during its use, thereby changing the spacing between the radiation source and the balloon, summary judgment of noninfringement on the predetermined spacing limitations for those uses should be granted. Nor are the predetermined spacing limitations met for the handful of remaining uses (literally a dozen or so performed in limited pre-launch, post-approval testing of the Contura), in which the radiation source was placed in the center of the balloon, as there cannot be constant spacing between a cylindrical source and a spherical balloon as a matter of fact or law. Notably, Plaintiffs' theories as to the plurality and predetermined spacing limitations are completely inconsistent. Because claim 12 of the '813 patent is a dependent claim, it requires both a predetermined constant spacing (claim 1) and a plurality of sources (claim 12). Plaintiffs "snapshot" theory of infringement for purposes of satisfying the constant spacing limitation would mean that there is not a plurality of sources; the single source used in the Contura cannot be in two locations simultaneously. Conversely, Plaintiffs' plurality argument requires the radionuclide to be in motion, which by definition means there is no constant spacing. Plaintiffs' arguments here fatally undermine function of patent claims of "`appris[ing] the public of what is still open to them.'" Athletic Alternatives, Inc. v. Prince Mfg., Inc., 73 F.3d 1573, 1581 (Fed. Cir. 1996) (quoting McClain v. Ortmayer, 141 U.S. 419, 424 (1891)). This Court should, as a matter of law, reject Plaintiffs' attempts to escape the consequence of the application of the undisputed facts to this claim language, and grant summary judgment of noninfringement of the subject claims to SenoRx. I. A DEVICE DOES NOT INFRINGE IF IT IS MERELY "CAPABLE" OF BEING USED IN AN INFRINGING WAY. Rather than respond to SenoRx's arguments and evidence, Plaintiffs wish to focus on a

23 different inquiry. According to Plaintiffs, the issue is whether the Contura is capable of being 24 configured in an infringing way. Thus, Plaintiffs place great weight on their erroneous 25 contention that "[i]nfringement of an apparatus claim is determined based on the capabilities of 26 an accused device's structure not its actual method(s) of use." See Pls. Opp. at 6. This 27 proposition is a plain misstatement of the law. The controlling authority on this point, Cross 28
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Medical Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1311-12 (Fed. Cir. 2005), directly contradicts Plaintiffs' position, as discussed in SenoRx's opening brief. See SenoRx Br. at 7-8. Cross Medical specifically rejected the argument that infringement occurred if an accused device was "capable" of being configured to infringe. 424 F.3d at 1311. Rather, the court held that the device must actually contain all of the structural limitations of the claim: "to infringe an apparatus claim, the device must meet all of the [claim's] structural limitations." Id. (emphasis added). Plaintiffs do not even mention, much less attempt to distinguish, Cross Medical. Instead, Plaintiffs cite cases either distinguished by Cross Medical (Intel) or relied on by Cross Medical in support of the Federal Circuit's conclusion that a device does not infringe a claim if it is merely capable of infringing (NTP, Hewlett-Packard, and In re Michlin). See Cross Medical, 424 F.3d at 1311-12.2

NTP, Inc. v. Research in Motion, Ltd., 418 F.3d 1282, 1317-18 (Fed. Cir. 2005) stands for the unremarkable proposition that, for purposes of determining whether infringement has occurred "within the United States," the concept of "use" in method claims is different than in apparatus claims. In Hewlett-Packard Co. v. Bausch & Lomb, Inc., 909 F.2d 1464, 1468 (Fed. Cir. 1990), the court, in discussing an apparatus claim in a prior art reference, noted that "[a]pparatus claims cover what a device is, not what a device does." SenoRx agrees ­ but here, to know what the device is, one has to know how it is actually configured when it is used. Third, in In re Michlin, 256 F.2d 317, 320 (CCPA 1958), the CCPA noted that "[i]t is well settled that patentability of apparatus claims must depend upon structural limitations and not upon statements of function." Again, this is entirely consistent with the requirement in Cross Medical that an accused device, in order to infringe, must meet all of the claim's structural limitations. See Cross Medical, 424 F.3d at 1311-12. Plaintiffs also rely heavily on Intel Corp. v. U.S. Int'l Trade Commission, 946 F.2d 821, 832 (Fed. Cir. 1991) to support their erroneous contention that "[i]nfringement of an apparatus claim is determined based on the capabilities of an accused device's structure." Pls. Opp. 6, 910. The Federal Circuit in Cross Medical and other cases has distinguished Intel based on the claim language, explaining that because the claim at issue in Intel called for a "programmable selection means," this claim language required only that an accused device included the means that made it capable of operating in the enumerated mode. 424 F.3d at 1311; see also Fantasy Sports Props, Inc. v. SportsLine.com, Inc., 287 F.3d 1108, 1117-18 (Fed. Cir. 2002) (emphasizing the programmable claim language in Intel and holding that Intel "does not stand for the proposition . . . that infringement may be made based upon a finding than an accused product is merely capable of being modified in a manner that infringes the claims of a patent); Zygo Corp. v. Wyko Corp., 79 F.3d 1563, 1570 (Fed. Cir. 1996) (noting that the patentee overread Intel since the claim "[b]y its literal terms" only required "capability"); High Tech Med. Instrumentation, Inc. v. New Image Inds., Inc., 49 F.3d 1551, 1555-56 (Fed. Cir. 1995) (distinguishing Intel based on the "programmable" claim limitation). -3-

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Similarly, Plaintiffs accuse SenoRx of improperly treating their apparatus claims as "method" claims. But it is undisputed that until the device is configured with a radioactive source in the body of a patient, all of the elements required for direct infringement do not exist. The fact that the claims provide that the apparatus only exists when a radiation source is inside a balloon during treatment of a patient does not convert the claims to method claims. And SenoRx does not argue to the contrary. SenoRx's argument is that an infringing apparatus never exists. In an attempt to create a factual issue, Plaintiffs spend much of their brief citing to SenoRx marketing materials and arguing that SenoRx infringes either directly and indirectly. While this is factually wrong, it is completely irrelevant to this motion and misses the point. What SenoRx does or does not do is immaterial where, as here, at no point is the Contura (as used by anyone) configured to fall under the claims. This motion is based solely on the fact that there never is a plurality of sources and that there never is a predetermined spacing in the Contura as required by the claims. II. PLURALITY. A. There Is No Dispute of Material Fact That the Contura Does Not Literally Infringe the "Plurality" Limitations.

The "plurality of radioactive solid particles" limitation of the '813 patent and the "plurality of solid radiation sources" limitation of the '204 patent require that the claimed devices contain two or more radiation sources. Plaintiffs do not dispute that the Contura uses only a single source. It therefore does not infringe. Plaintiffs' response to the undisputed facts is to ignore the claim limitations and try to rewrite them. Plaintiffs assert that the Contura literally infringes the claims because: a solid radionuclide on a source wire can be (and is) inserted sequentially into multiple predetermined locations within one or more of the Contura's treatment lumens to provide a "desired composite radiation profile" within the targeted tissue. Pls. Opp. 15. But the claims do not require "a solid radionuclide on a source wire." They require a "plurality" of "solid radiation sources" (claim 17) or "solid particles" (claim 12). And, contrary to Plaintiffs' assertions, the claims do not merely require that radiation is emitted from
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multiple locations, but rather that there are multiple radiation sources: claim 12 specifically recites an apparatus with "a plurality of radioactive solid particles placed at predetermined locations." Plaintiffs would read claim 12 as requiring "a radioactive solid particle placed at predetermined locations," reading out the term "plurality" entirely and erroneously rendering it wholly superfluous. See Bicon, Inc. v. Straumann Co., 441 F.3d 945, 950 (Fed. Cir. 2006) ("Allowing a patentee to argue that physical structures and characteristics specifically described in a claim are merely superfluous would render the scope of the patent ambiguous, leaving examiners and the public to guess about which claim language the drafter deems necessary to his claimed invention and which language is merely superfluous, nonlimiting elaboration."). Plaintiffs criticize SenoRx for importing aspects of the preferred embodiments into the claims. Pls. Opp. at 16. SenoRx has done nothing of the sort. The claims themselves require a "plurality" of "sources" or "particles." Moreover, the specification itself makes clear that Plaintiffs construction is incorrect, expressly distinguishing between a "single" radiation source and a "plurality" of sources in a manner fundamentally inconsistent with Plaintiffs' position (and consistent with SenoRx's): the radiation source "instead of comprising a single solid sphere, may comprise a plurality of radiation emitting particles strategically placed . . . ." Ex. 1 ('813 patent), col. 2:66-3:1; Ex. 2 ('204 patent), col. 5:2-4. Thus, both the claims and the specification preclude Plaintiffs interpretation of "plurality." Plaintiffs also argue that "the focus of the `plurality' claim terms is on emitting radiotherapeutic rays from multiple locations," Pls. Opp. at 3, and the "objective of these claims" is to provide for emitting radiation from "multiple locations." Pls. Opp. at 16. Put another way, pay no attention to what the inventors actually claim, just focus on the gist of what they must have meant. That is not how the patent system works. "`The invention' is defined by the claims," Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1565 (Fed. Cir. 1991), and both the claims here require a plurality of sources, not simply a plurality of locations. Plaintiffs are asking this Court to rewrite the claims in a manner that contradicts the express language of the claims to cover a competitor's device that falls outside the claim's scope. That Plaintiffs need to do so speaks volumes about the fact that the Contura does not infringe the claims as actually written.
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Because the insertion of a single solid radionuclide into multiple locations does not literally infringe claims requiring a "plurality" of radiation sources or particles, the Contura does not infringe. B. The Contura Does Not Infringe the "Plurality" Limitations Under the Doctrine of Equivalents As a Matter of Law.

Understandably concerned that the Court will not construe a requirement for two or more radiation sources to cover a single radiation source, Plaintiffs belatedly seek to assert the doctrine of equivalents.3 But they cannot do so as a matter of law. First, employing the doctrine of equivalents here would vitiate the "plurality of . . . sources" limitation of the claims and violate the "all elements rule." Put simply, Plaintiffs may not ignore completely the requirement they inserted into their claims that there be a plurality of radiation sources in the claimed devices under the guise of asserting infringement by equivalents. See, e.g., 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."). For example, in Moore U.S.A. v. Std. Register Co., 229 F.3d 1091, 1106 (Fed. Cir. 2000), one of the patents-in-suit related to a "mailer type business form," and the claim limitation required that "strips of adhesive . . . extend the majority of the lengths" of the mailer. Id. at 1094. In the accused product, the strips extended 47.8% of the total margin length. Id. at 1097. The Federal Circuit held, as a matter of law, that the "majority" claim limitation could not reach the accused product under the doctrine of equivalents:
3

As explained in SenoRx's accompanying Motion to Strike, Plaintiffs' eleventh-hour change in course comes far too late and would unfairly prejudice SenoRx if allowed. Plaintiffs served infringement contentions on May 6, 2008, and for the "plurality" claim elements, asserted only literal infringement, even though the doctrine of equivalents was asserted for many other claim limitations. Ex. 4 (Pls' Infr. Cont. Appx. A) at 4, 9, 15; (Pls' Infr. Cont. Appx. B) at 4-5, 7, 1617. If the Court permits Plaintiffs to belatedly assert infringement under the doctrine of equivalents, SenoRx will suffer unfair prejudice given that the six inventors of the patents have been deposed, the deadline to serve new discovery has passed, expert reports have been served, and the parties are one month from trial.
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[T]o allow what is undisputedly a minority (i.e., 47.8%) to be equivalent to a majority would vitiate the [claim] requirement. . . . [I]t would defy logic to conclude that a minority -- the very antithesis of a majority -- could be insubstantially different from a claim limitation requiring a majority, and no reasonable juror could find otherwise. Id. at 1106. Accord Cooper Cameron Corp. v. Kvaerner Oilfield Prods., Inc., 291 F.3d 1317,

5 1321-22 (Fed. Cir. 2002) (affirming summary judgment of no infringement under doctrine of 6 equivalents where the claim required a port to be located "between" two plugs and the accused 7 product had its port located "above" the plug, holding that the patentee "cannot escape 8 application of the all-limitations rule by recharacterizing its claim so as to ignore a material 9 limitation"); Sage Prods., Inc. v. Devon Indus., Inc., 126 F.3d 1420, 1424 (Fed. Cir. 1997) 10 (holding that the doctrine of equivalents does not grant a license to remove structural limitations 11 contained in the patent claims); Conopco, Inc. v. May Dept. Stores Co., 46 F.3d 1556, 1562 (Fed. 12 Cir. 1994) ("The doctrine of equivalents cannot be used to erase meaningful structural and 13 functional limitations of the claim on which the public is entitled to rely in avoiding 14 infringement."); Dolly, Inc. v. Spalding & Evenflo Cos., 16 F.3d 394, 398 (Fed. Cir. 1994) ("The 15 doctrine of equivalents is not a license to ignore claim limitations."). 16 In the present case, Plaintiffs' claims require as a structural element of the claimed device 17 that there be multiple radiation sources. Just as a "minority" cannot be the equivalent of a 18 "majority," it cannot be, as a matter of law, that a device that uses only one radiation source is 19 the equivalent of having multiple radiation sources. To allow such equivalence completely 20 eliminates the structural requirement that there be more than one radiation source, and is the 21 "precise type of overextension of the doctrine of equivalents that the claim vitiation doctrine is 22 intended to prevent." Freedman Seating Co. v. Am. Seating Co., 420 F.3d 1350, 1362 (Fed. Cir. 23 2005). 24 The principle of specific exclusion (a corollary of the all elements rule), requires the 25 same result. The concept underlying the specific exclusion principle is the common sense notion 26 that when a patentee affirmatively chooses a claim term whose very meaning restricts the scope 27 28
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of the claim, a patentee cannot then recapture under the doctrine of equivalents the claim scope specifically excluded. The Federal Circuit has explained: [I]f a patent states that the claimed device must be "nonmetallic," the patentee cannot assert the patent against a metallic device on the ground that a metallic device is equivalent to a non-metallic device. The unavailability of the doctrine of equivalents could be explained either as the product of an impermissible vitiation of the "nonmetallic" claim limitation, or as the product of a clear and binding statement to the public that metallic structures are excluded from the protection of the patent. SciMed Life Systems, Inc. v. Advanced Cardiovascular Systems, Inc., 242 F.3d 1337, 1346-47

8 (Fed. Cir. 2001). Thus, in a case with a claim limitation strikingly similar to "plurality," the 9 Federal Circuit applied this doctrine to hold that a claim requiring "at least three values" 10 specifically excludes a system with "only two" values, and that accordingly there was no 11 equivalence as a matter of law. Athletic Alternatives v. Prince Mfg., 73 F.3d 1573, 1382-83 12 (Fed. Cir. 1996). Likewise, the Federal Circuit held that a claim requiring that objects be 13 "mounted" specifically excludes coverage under the doctrine of equivalents of objects that are 14 "unmounted." Asyst Techs., Inc. v. Emtrak, Inc., 402 F.3d 1188, 1195 (Fed. Cir. 2005); see also, 15 e.g., Freedman Seating Co., 420 F.3d at 1362 (holding that "slidably mounted" could not be 16 equivalent to "rotatably mounted," and noting that members of the public were justified in 17 relying on the specific claim language: "to now say that the claims include [an element of the 18 accused product] under the doctrine of equivalents would unjustly undermine the reasonable 19 expectations of the public"); Bicon, Inc., 441 F.3d at 955 (holding as a matter of law that 20 "concave" could not be equivalent to "convex"); Tronzo v. Biomet, Inc., 156 F.3d 1154, 1160 21 (Fed. Cir. 1998) (to hold that a device with a hemispherical shape infringes a patent requiring 22 that the device have a "generally conical outer surface" would "write the `generally conical outer 23 surface' limitation out of the claims"); Ethicon Endo-Surgery, Inc. v. U.S. Surgical Corp., 149 24 F.3d 1309, 1317 (Fed. Cir. 1998) (subject matter is "specifically excluded" from coverage under 25 the doctrine of equivalents if its inclusion is "inconsistent with the language of the claim"). 26 Here, Plaintiffs' choice to claim a device having a "plurality" of solid sources specifically 27 excludes devices containing only a "single" solid radiation source, and that exclusion cannot be 28
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recaptured under the doctrine of equivalence without erasing the requirement altogether. "The patents contain a distinct limitation, which was part of the bargain when the patent issued," and this Court "cannot overlook a distinct claim limitation or expand the doctrine of equivalents beyond its purpose to allow recapture of subject matter excluded by a deliberate and foreseeable claim drafting decision." Planet Bingo, LLC v. Gametech Int'l, Inc., 472 F.3d 1338, 1344 (Fed. Cir. 2006). Plaintiffs must be held to their "deliberate and foreseeable claim drafting decision." Id. As such, there is "no . . . material issue for the jury to resolve, and a judgment of noninfringement under the doctrine of equivalents . . . is appropriate." See Cook Biotech Inc. v. ACell, Inc., 460 F.3d 1365, 1379 (Fed. Cir. 2006). Thus, to the extent Plaintiffs are allowed to belatedly assert this doctrine, summary judgment of non-infringement under the doctrine of equivalents should be entered as to claim 12 of the '813 patent and claim 17 of the '204 patent. III. THE CONTURA DOES NOT MEET THE PREDETERMINED SPACING LIMITATIONS. Plaintiffs' Opposition abandons their contention that there is predetermined spacing

14 between the treatment lumens (either individually or together) and the balloon of the Contura. 15 Plaintiffs defend only their third theory of how the predetermined spacing limitations are 16 satisfied, which requires that the radionuclide source in the Contura be deemed the inner spatial 17 volume. Plaintiffs' position is that if the radionuclide in the Contura stops at the center of the 18 Contura's central lumen, at that moment, there is infringement. Plaintiffs do not contend that 19 there is infringement under treatment plans where the radionuclide does not stop in the center of 20 the central lumen. 21 Plaintiffs devote a great deal of effort to describing ways the Contura could be used, in 22 hopes of establishing a fact issue as to infringement. But Plaintiffs have not presented evidence 23 that raises a dispute of fact about how the Contura is actually used, which is the pertinent 24 inquiry, and none of the treatment plans utilized with the Contura meet the predetermined 25 spacing limitations. Accordingly, summary judgment on predetermined spacing is warranted. 26 Fundamentally, there are three relevant categories of treatment plans: (1) plans that do 27 not utilize the central lumen, central dwell position, (2) plans utilizing the central lumen, central 28
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dwell position as one of multiple dwell positions, and (3) plans utilizing only the central lumen, central dwell. SenoRx's construction of the '813 and '204 patents is identical, and if adopted, summary judgment is appropriate as to each of the three categories. Plaintiffs' construction differs between the two patents. If Plaintiffs' construction is adopted with respect to the '813 patent, summary judgment nonetheless still is appropriate. If Plaintiffs' construction is adopted with regard to the '204 patent, SenoRx acknowledges that there is a factual dispute as to each of the three treatment plans and that summary judgment therefore is not appropriate. These are addressed in turn below. 1. Treatment Plans That Do Not Use the Central Lumen, Central Dwell Position.

If SenoRx's construction is adopted, Plaintiffs do not dispute that the first category of treatment plans do not meet the predetermined spacing limitations of either patent because the radionuclide never comes to rest at the central lumen, central dwell position, which is required by Plaintiffs' theory of infringement. Even under Plaintiffs' construction, the '813 patent is not infringed because the only basis for infringement is the central lumen, center dwell position, which is not used in this category.

Accordingly, this category need not be discussed further and the Court should enter partial summary judgment of non-infringement of the '813 patent for this category of use, and if SenoRx's construction of the '204 patent is adopted, as to the '204 patent as well. 2. Treatment Plans Utilizing Multiple Dwell Positions Including the Central Lumen, Central Dwell Position.

If SenoRx's construction is adopted and the spacing must be "fixed," summary judgment of non-infringement of both patents is appropriate because the spacing changes as the radionuclide moves from dwell position to dwell position and, accordingly, is not fixed. -10-

SENORX, INC.'S REPLY IN SUPPORT OF MOTION FOR PARTIAL SUMMARY JUDGMENT OF NON-INFRINGEMENT

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SENORX, INC.'S REPLY IN SUPPORT OF MOTION FOR PARTIAL SUMMARY JUDGMENT OF NON-INFRINGEMENT
4

Plaintiffs respond that as long as the source dwells in the center of the central lumen, at that point in time the spacing is "fixed," even if the radiation source also dwells in other positions during treatment. Plaintiffs reason that at the moment the radionuclide stops at this center position, there is constant spacing in all directions from the radionuclide to the balloon. Pls. Op. 8. Plaintiffs stop their analysis here, deeming it irrelevant whether before or after stopping in the center of the device, the radionuclide is in other locations where the distances to the balloon are not the same. Plaintiffs are wrong. The spacing between a radiation source and a balloon is not "constant" if that spacing changes as the radionuclide moves to different points within the balloon. To say, as Plaintiffs' theory requires, that the spacing is constant for the period of time until the spacing changes ignores the concept that the spacing must be constant. Thus, the issue with regard to this element is not simply whether there is a moment where the spacing between the radionuclide and the balloon is the same in all directions, but also whether this spacing stays the same during use of the device. If it does not, then the spacing is not constant. Put another way, to meet this limitation the spacing between the radiation source and the balloon must be fixed and unchanging.

If, on the other hand, Plaintiffs' construction is adopted, the analysis is the same as that stated below in category 3 for the '813 patent, and summary judgment with respect to category 2 is appropriate for that reason as well.

The reasons stated below with respect to category 3 provide an independent reason why summary judgment is appropriate under SenoRx's construction for category 2. -11-

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3.

Treatment Plans Utilizing Only the Central Lumen, Central Dwell Position.

The final category of Contura treatment plans are those in which only the central dwell of the central lumen is used. Plaintiffs argue that a treatment plan utilizing only this central position meets the predetermined spacing limitations. Pls. Opp. 9-11. While Plaintiffs have no evidence that such treatment plans have actually been used since the January 2008 commercial launch, that is beside the point. 5 The Contura still does not infringe the predetermined spacing limitations as a matter of law. Under either side's construction, the '813 patent is not infringed because it is undisputed that the radionuclide used with the Contura is cylindrical. See Pls. Opp. 11-12.

Even assuming a treatment plan making exclusive use of the central lumen, central dwell position, there still would not be infringement because there cannot be constant spacing between a cylindrical radionuclide and a spherical balloon. See Orton Decl. ¶ 36. That is because the cylindrical radionuclide is not the same shape as the spherical outer balloon, (SenoRx's construction), nor is the radionuclide the same distance in all directions from the outer balloon because the radionuclide cylinder is three times longer than it is wide (Plaintiffs' construction of claims 11, 12 of the '813 patent). SenoRx Br. 14-15.

SenoRx does not dispute that there was limited use of the Contura in this manner in the past (although it is not being used that way by anyone any more). Although it is not necessary to our motion that the Court so find, the undisputed evidence is that this is not how the Contura is used. Gearhart Decl. (5/20/08) ¶ 8.

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Citing language in the specification absent from the claims, Plaintiffs argue that the spacing required by the claim is merely "substantially," "generally," and "somewhat," constant. But this misses the point. The issue is not whether a radiation source and balloon must both be perfectly spherical, such that there is exactly the same distance between them in all directions. The reason the Contura does not infringe this claim element is more fundamental. It is clear from the specification and prosecution history that the spacing limitation requires that the radionuclide and the balloon be the same shape. In each embodiment of both patents, the inner spatial volume and the outer balloon are the same shape, and in the prosecution history of both patents, Plaintiffs distinguish prior art on the basis that the shapes of the two volumes are different. See SenoRx Br. 14-15; Ex. 8 (Sept. 1, 1998 Am., '813 Prosecution History), at 5,7; Ex. 9 (Dec. 20, 2000 Am., '204 Prosecution History), at 12. Because a cylinder is not the same shape as a sphere, this requirement is not met even as to central lumen, central dwell position. * * * * * * * *

In sum, as a matter of law, the "predetermined constant spacing" and "predetermined spacing" limitations are not met by the Contura. The device has multiple lumens and multiple dwell positions through which the radionuclide is moved throughout the treatment. As a result, the spacing is not constant. And because the shape of the radionuclide is different than the shape of the balloon, the spacing is not constant even if it were not moved from the central position. CONCLUSION For the foregoing reasons, the Court should grant SenoRx's Motion for Partial Summary Judgment of Non-Infringement. Dated: June 11, 2008 Respectfully submitted,

23 24 By: __/s/ F.T.Alexandra Mahaney___________ 25 26 27 28
SENORX, INC.'S REPLY 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 -13CASE NO. 08-CV-0133 RMW

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SENORX, INC.'S REPLY IN SUPPORT OF MOTION FOR PARTIAL SUMMARY JUDGMENT OF NON-INFRINGEMENT

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 SENORX, INC.

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