Free Motion to Strike - 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 SENORX, INC. IN THE UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA SAN JOSE DIVISION ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) Case No. 08-CV-0133 RMW DEFENDANT SENORX, INC.'S OBJECTIONS TO AND MOTION TO STRIKE IMPROPER DOCTRINE OF EQUIVALENTS ARGUMENT Date: June 25, 2008 Time: 2:00 p.m. Courtroom: 6, 4th Floor Judge: Hon. Ronald M. Whyte

HOLOGIC, INC., CYTYC CORP. and HOLOGIC L.P., Plaintiffs, v. SENORX, INC., Defendant.

SENORX, INC.'S MOTION TO STRIKE IMPROPER DOCTRINE OF EQUIVALENTS ARGUMENT

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Pursuant to Patent Local Rules 3-1, 3-6, and 3-7, Defendant SenoRx, Inc. ("SenoRx") hereby objects to and moves to strike the portions of Plaintiffs' Opposition to Defendant SenoRx, Inc.'s Motion for Partial Summary Judgment of Non-Infringement which assert, without proper notice and without leave of Court, that SenoRx infringes the elements in claim 12 of the '813 patent and claim 17 of the '204 patent under the doctrine of equivalents. In their Preliminary Infringement Contentions, Plaintiffs asserted only literal infringement of these claims. Allowing them to add an assertion of infringement by equivalents at this late stage of this expedited litigation would prejudice SenoRx and impede the timely resolution of this matter. This District's Local Rules are clear. If a party wishes to assert infringement under the doctrine of equivalents, it must specify which elements are allegedly infringed under that doctrine and where each element is found in the accused device. Plaintiffs did not do that for the claim elements at issue. By contrast, Plaintiffs did specifically assert infringement under the doctrine of equivalents for other claim elements. After receiving Plaintiffs' Infringement Contentions, SenoRx deposed all six inventors of the patents-in-suit, filed summary judgment motions, submitted expert reports, and served its final written discovery allowed under the schedule, all without notice that it was defending against a doctrine of equivalents allegation for the claim elements at issue. This case is on an extremely expedited schedule at the insistence of Plaintiffs. The claim construction and summary judgment hearing will take place on June 25. Discovery closes that same date. And the trial is scheduled to begin less than three weeks later, on July 14. To allow Plaintiffs at this late date to assert new theories of infringement would unfairly prejudice SenoRx's ability to defend itself and adequately prepare for trial of this matter. Accordingly, this Court should strike the portions of Plaintiffs' Opposition asserting the doctrine of equivalents for the elements in claim 12 of the '813 patent and claim 17 of the '204 patent. BACKGROUND The relevant timeline underlying this motion is clear and undisputed. On May 6, Plaintiffs served their Preliminary Infringement Contentions on SenoRx. Those contentions
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asserted that the elements in claim 12 of the '813 patent and claim 17 of the '204 patent were "literally infringed." Ex. 1 (Preliminary Infringement Contentions), at Appx. A, p. 15; Appx. B, p. 17 (emphasis in original). These claims require "a plurality of radioactive solid particles" (claim 12) and "a plurality of solid radiation sources" (claim 17). Plaintiffs did not assert infringement of these elements under the doctrine of equivalents, although they expressly asserted infringement by equivalents for other claim elements. See, e.g., id. at Appx. A, p. 4. On May 21, SenoRx moved for summary judgment of non-infringement on claims 12 and 17, asserting that the Contura does not contain either a "a plurality of radioactive solid particles" or "a plurality of solid radiation sources." See Dkt. No. 131. After receiving SenoRx's motion establishing that the Contura does not infringe those claims, Plaintiffs sent a letter on May 28 stating generally that "to the extent that any of the elements of any of the asserted claims is determined not to be literally present in SenoRx's Contura MLB, Hologic will be asserting infringement under the doctrine of equivalents." Ex. 2 (May 28 Letter). The letter did not identify for which claims Plaintiffs were asserting the doctrine of equivalents or provide any of the information required to state an infringement contention under Patent L.R. 3-1. That same week, SenoRx responded that it was too late for Plaintiffs to add unspecified infringement contentions for unidentified claim terms. See Ex. 3 (May 30 Letter). Plaintiffs did not seek leave of Court to amend their Infringement Contentions. On June 4, after SenoRx had deposed all six inventors of the patents-in-suit, filed expert reports, and served its final written discovery requests, Plaintiffs filed their Opposition to SenoRx's Motion for Summary Judgment of Non-Infringement. In that Opposition, Plaintiffs articulate for the first time their allegation that the Contura infringes the elements in claims 12 and 17 under the doctrine of equivalents. To date, Plaintiffs have not sought leave to amend their Preliminary Infringement Contentions. ARGUMENT The Local Rules of this District require that a party claiming patent infringement state and define the basis for its claims early in litigation. "The rules are designed to require parties to
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crystallize their theories of the case early in litigation and to adhere to those theories once they have been disclosed." Bd. of Tr. of the Leland Stanford Junior Univ. v. Roche Molecular Sys., Inc., No. C05-04158, 2008 WL 624771, *2 (N.D. Cal. Mar. 4, 2008) (quoting Integrated Circuit Sys., Inc. v. Realtek, 308 F. Supp. 2d 1106, 1107 (N.D. Cal. 2004)). They advance this purpose "by making it difficult subsequently to revise claim charts through eleventh hour `discovery' of facts. Unlike the liberal policy for amending pleadings, the philosophy behind claim charts is decidedly conservative, and designed to prevent the `shifting sands' approach to claim construction [and] ensure that litigants put all their cards on the table up front." Id.; see also Berger v. Rossignol Ski Co., Inc., No. C05-02523, 2003 WL 1095914, *3 (N.D. Cal. Apr. 25, 2006) (hereinafter "Berger I") ("Although federal courts are generally lenient in allowing parties to amend pleadings, such is not the case with amending preliminary infringement contentions."). Preventing the "shifting sands" approach is particularly important in a case like this one, where SenoRx has had only minimal time to prepare its defense under the schedule insisted on by Plaintiffs. As explained below, Plaintiffs' attempt to change their theory of infringement for the elements at issue is improper and directly contrary to both the spirit and letter of the Local Rules. I. PLAINTIFFS' PRELIMINARY INFRINGEMENT CONTENTIONS DO NOT ASSERT INFRINGEMENT UNDER THE DOCTRINE OF EQUIVALENTS FOR THE ELEMENTS IN CLAIM 12 OF THE '813 PATENT AND CLAIM 17 OF THE '204 PATENT To assert infringement under the doctrine of equivalents, a party must in its Preliminary Infringement Contentions "identify `where each element of each asserted claim is found within

20 each Accused Instrumentality' and [ ] indicate `whether each element of each asserted claim' is 21 present under the doctrine of equivalents." MEMC Electronic Materials v. Mitsubishi Materials 22 Silicon Corp., No. C01-4925, 2004 WL 5363616, *5 (N.D. Cal. Mar. 2, 2004) (quoting Patent 23 L.R. 3-1(c) & (d)). As noted above, for the two claim terms at issue, Plaintiffs did not make such 24 contentions. Rather, they alleged only that both claim elements are "literally infringed." Ex. 1 25 (Preliminary Infringement Contentions), at Appx. A, p. 15; Appx. B, p. 17 (emphasis in 26 original). 27 28
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While Plaintiffs did include in their Infringement Contentions a boilerplate footnote purportedly reserving the right to assert the doctrine of equivalents in the future for any of the asserted claim elements, this is plainly insufficient to put SenoRx on notice of the claim or to preserve Plaintiffs' recently announced new contentions. In a footnote on the first page of their claim charts, Plaintiffs state that "[t]o 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."1 Ex. 1 (Preliminary Infringement Contentions), at Appx. A, p. 1 n.2; Appx. B, p. 1 n.2. In MEMC, this Court rejected the notion that such a statement preserves a litigant's right to assert the doctrine of equivalents, noting that the plaintiff's indication in its preliminary infringement contentions that it "expressly reserves the right to augment and supplement its position on whether there is infringement under the doctrine of equivalents of any element of the asserted claims after discovery from defendants" was not sufficient to assert infringement on this theory. 2004 WL 5363616, at *4. As the court held, such statements do not "identify `where each element of each asserted claim is found within each Accused Instrumentality' and [ ] indicate `whether each element of each asserted claim' is present under the doctrine of equivalents," as the Local Rules require. Id. at *5. Moreover, any assertion by Plaintiffs that they "`qualified' their contentions by stating that they were subject to revision is immaterial; a party cannot unilaterally amend the Patent Local Rules." Berger I, 2006 WL 1095914, at *4.

In contrast to how Plaintiffs handled the claim elements at issue in this motion, they were explicit in identifying where other claim elements were alleged to be infringed under the doctrine of equivalents. For instance, with respect to claim 1(b) of the '813 patent, Plaintiffs provided an entire paragraph of explanation for their allegation that the five treatment lumens of the Contura and the area between and surrounding these lumens constitutes an inner spatial volume under the doctrine of equivalents. The conclusion of the paragraph is: "This claim element is thus infringed under the doctrine of equivalents." Ex. 1 (Preliminary Infringement Contentions), at Appx. A, p. 4 (emphasis in original).
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Accordingly, Plaintiffs' Preliminary Infringement Contentions do not assert infringement of the elements in claim 12 of the '813 patent and claim 17 of the '204 patent under the doctrine of equivalents. II. PLAINTIFFS HAVE NO BASIS TO AMEND THEIR PRELIMINARY INFRINGEMENT CONTENTIONS Under this District's Local Rules, a "party's `Preliminary Infringement Contentions' . . . shall be deemed to be that party's final contentions" unless "a party claiming patent infringement

7 believes in good faith that (1) the Court's Claim Construction Ruling or (2) the documents 8 produced pursuant to Patent L.R. 3-4 [ ] require[ ], not later than 30 days after service by the 9 Court of its Claim Construction Ruling, that [the] party [ ] serve `Final Infringement 10 Contentions' without leave of court." Patent L.R. 3-6. "If the amendment does not fall into this 11 exception, then amendments of preliminary or final infringement contentions `may be made only 12 by order of the Court, which shall be entered only upon a showing of good cause.'" Stanford 13 Univ., 2008 WL 624771, at *2 (quoting Patent L.R. 3-7). 14 None of these exceptions apply here. And given the pace of this case, allowing Plaintiffs 15 to change their infringement contentions at this late stage would unfairly prejudice SenoRx. 16 17 18 19 20 21 22 23 24 25 26 27 28 SenoRx notes that the timing and operation of Patent L.R. 3-6(a) is clearly directed to cases proceeding under a normal schedule. In such cases, there would be little prejudice to a defendant if a plaintiff amended its preliminary infringement contentions for the reasons stated in Rule 36(a) within 30 days of the court's claim construction order. Plainly, given the expedited schedule here, this is far from the typical case contemplated in the Patent Local Rules.
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A.

Plaintiffs Have No "Good Faith" Basis For Amending Their Infringement Contentions Under Patent L.R. 3-6(a).

As explained above, a party may only modify its preliminary infringement contentions without leave of court if it "believes in good faith that (1) the Court's Claim Construction Ruling or (2) the documents produced pursuant to Patent L.R. 3-4 so requires," and it "serve[s] `Final Infringement Contentions' with respect to the information required by Patent L.R. 3-1(c) and (d)." Patent L.R. 3-6(a).2

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As an initial matter, Plaintiffs have not served amended infringement contentions, either when they filed their Opposition to SenoRx's Summary Judgment Motion, which asserted for the first time that the elements in claim 12 of the '813 patent and claim 17 of the '204 patent were infringed under the doctrine of equivalents, or since. This is for good reason. Plaintiffs cannot file amended infringement contentions under Patent L.R. 3-6(a) because they have no good faith basis to do so based on either of the two justifications provided in that rule. The Court has not issued its claim construction ruling, and the documents produced pursuant to Patent L.R. 3-4 do not provide any information about how the Contura is used that Plaintiffs did not know beforehand. See Berger v. Rossignol Ski Co., Inc., No. C05-2523 CRB, 2006 WL 2038324, *2 (N.D. Cal. July 17, 2006) (stressing that when "[n]either of th[e] exceptions [specifically noted in Patent L.R. 3-6(a)] applies to the circumstances alleged by plaintiffs . . . a party must show good cause for amendment"). Plaintiffs knew when they filed their preliminary contentions that the Contura was used with a single radionuclide at multiple locations. See Ex. 1 (Preliminary Infringement Contentions), at Appx. A, p. 15; Appx. B, p. 17. Nevertheless, they made the express and volitional decision to assert only literal infringement for these claims. Nothing has happened, or can happen, that would provide a basis to relieve Plaintiffs from the consequences of that decision. B. Plaintiffs Do Not Have "Good Cause" To Amend Their Infringement Contentions Under Patent L.R. 3-7.

Given that Plaintiffs have no good faith basis to amend their infringement contentions under Patent L.R. 3-6(a), they must obtain leave to amend under Patent L.R. 3-7 by showing 21 "good cause." They have not even sought the required leave, nor could they as the standard of 22 good cause is not met. A determination of "good cause" turns on "whether plaintiff was diligent 23 in amending its contentions" and the "prejudice to the non-moving party" as a result of the 24 amendment. Stanford Univ., 2008 WL 624771, at *2. 25 26 27 28
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1.

Plaintiffs Did Not Act Diligently To Amend Their Preliminary Infringement Contentions.

As explained above, Plaintiffs have learned no new information about the Contura since serving their Preliminary Infringement Contentions that would justify their decision to wait until all of their inventors had been deposed, summary judgment motions had been filed, expert reports had been submitted, and the deadline for serving written discovery requests had passed before asserting the doctrine of equivalents. It is not the case that Plaintiffs "had no reason to believe that [they] had any basis on which to assert the doctrine of equivalents" before June 4. See MEMC, 2004 WL 5363616, at *5 (emphasis in original). To the contrary, Plaintiffs were well aware when they served their contentions that the Contura was not used with multiple radionuclides at the same time. One of their bases for asserting irreparable harm during the Preliminary Injunction phase of this case was that the Contura was directly targeted at the MammoSite's market because the two devices used the same afterloaders. See Pls.' Reply Br. in Support of Motion for Preliminary Injunction (Dkt. No. 74), at 13. These afterloaders are only capable of delivering one radionuclide at a time. In addition, Plaintiffs' Preliminary Infringement Contentions recognize the use of a single radionuclide when discussing literal infringement. This is not a case where amended infringement contentions are justified by facts that have actually changed during the course of litigation and a plaintiff acts promptly upon learning them. See, e.g., ZiLOG v. Quicklogic Corp., No. C03-03725 JW, 2006 WL 563057 (N.D. Cal. Mar. 6, 2006) (granting leave to amend where the USPTO invalidated certain claims of the patents-in-suit after plaintiff filed preliminary infringement contentions); Stanford Univ., 2008 WL 624771, at *3 (finding that the late assertion of infringement against an additional product was not improper because "upon discovering that TaqMan products were approved for sale in the United States, [plaintiff] immediately served amended contentions"). Nothing has changed here other than the legal theory Plaintiffs wish to assert. 2. SenoRx Would Be Prejudiced If Plaintiffs Were Allowed To Amend Their Infringement Contentions.

Even if Plaintiffs had been diligent in seeking to amend their infringement contentions to assert infringement under the doctrine of equivalents, SenoRx would be unfairly prejudiced if 28
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Plaintiffs were allowed to add new theories at this late date. See Berger I, 2006 WL 1095914, at *4 (finding prejudice because "[b]ased on [the preliminary] contentions, defendant incurred substantial costs in creating its preliminary invalidity contentions and [incurred] the costs associated with preparing their motion for summary judgment"). Since receiving Plaintiffs' contentions, SenoRx has deposed all six inventors of the patents-in-suit, filed summary judgment motions, submitted expert reports, and served its final written discovery requests. The schedule of this case would not allow SenoRx the time necessary to take discovery and adequately defend itself against Plaintiffs' newly asserted claims. SenoRx would need to re-depose Plaintiffs' inventors and serve additional written discovery only weeks before trial, to say nothing of additional expert discovery.3 See MEMC, 2004 WL 5363616, at *5 ("Granting [plaintiff] leave to amend its infringement contentions would require reopening discovery so that [the defendant] could develop its evidence to prepare its defenses to [the additional infringement] theory. This prejudice . . . supplies an additional reason for denying the motion [to amend]."). MEMC, 2004 WL 5363616, at *5. Accordingly, even absent the other factors which militate against allowing Plaintiffs to amend their infringement contentions, such an amendment would unfairly prejudice SenoRx at this stage of the case.

That Plaintiffs discussed the use of a single radionuclide at multiple locations in their assertion of literal infringement does not reduce the effect of, or prejudice from, their failure to assert the doctrine of equivalents. The two are distinct legal issues that require a different defense. The issues raised by the assertion that a claim requiring a plurality of radioactive sources is not literally infringed by a single source are very different from the factual issues relevant to whether a single source performs the same function in the same way with the same result as a device that contains multiple sources present at the same time. SenoRx had no notion it had to explore these issues, which would require fact and expert discovery regarding differences between use of the Contura and a device that contains many high energy radionuclides inserted at the same time, such as, for instance, whether constructing and using the latter device were practical, whether there are radiation risks or engineering problems with such devices, and how radiation attenuation would affect dose delivery. Some of these issues would require an additional expert who has not been retained at this point.
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SENORX, INC.'S MOTION TO STRIKE IMPROPER DOCTRINE OF EQUIVALENTS ARGUMENT

CONCLUSION Because Plaintiffs have not asserted infringement under the doctrine of equivalents for the claim elements in claims 12 of the `813 patent and 17 of the `204 patent, and have no basis to assert new theories of infringement at this late date, SenoRx objections to and respectfully requests that the Court strike argument regarding that theory from their Opposition to SenoRx's Motion for Partial Summary Judgment of Non-Infringement (pages 18-21).

Dated: June 11, 2008 Respectfully submitted,

By:

s/F.T. Alexandra Mahaney

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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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

Plaintiffs' Disclosure of Asserted Claims and Preliminary Infringement Contentions Case No. C08 00133 RMW (RS)

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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.
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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. They function in substantially the same way (controlled positioning of a radiation source within the outer spatial volume) to provide substantially the same result (delivery of a prescribed radiation dose to target tissue). This claim element is thus infringed under the doctrine of equivalents. SUPPORT: Ref. No. 24 at 28. "Five radiation source wire lumens are provided; one central lumen located along the long axis of the applicator and four curved lumens symmetrically offset from the central lumen." Ref. No. 1 at Device description. "Five radiation source wire lumens are provided; one central lumen located along the long axis of the applicator and four curved lumens symmetrically offset from the central lumen." Ref. No. 2 at page 2. An illustration of the ConturaTM applicator shows the five treatment lumens within Ref. No. 3.

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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.

12. The apparatus as in claim 1 wherein the material containing a radionuclide comprises a plurality of radioactive solid particles placed at predetermined locations within the inner spatial volume to provide a desired composite radiation profile.

CONTENTION: During treatment using the Contura, the radiation source wire lumens to which the radionuclide(s) is/are attached are inserted into predetermined locations (dwell positions) within the treatment lumens at the distal end of the device. The multiple treatment lumens of the ConturaTM allow multiple solid radiation sources (e.g., single radionuclide sources on multiple separate source wires) to be arrayed simultaneously within separate lumens to provide a desired composite radiation profile within the targeted tissue. Alternatively, a single solid radionuclide on a source wire can be inserted sequentially into one or more predetermined locations within multiple treatment lumens to provide a desired composite radiation profile within the targeted tissue. This claim element is thus literally infringed. 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 12 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

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Asserted Claim1

ConturaTM Multi-Lumen Balloon Source Applicator 2
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 SRXHOL00006734, 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 radiation balloon uses vacuum to remove excess air and fluid and to adhere closely to often irregularly shaped lumpectomy cavities in order to deliver precise radiation dosing through multiple seed lumens." Ref. No. 17 at SRX-HOL00006639. "Each lumen can accommodate 8 dwell positions." Ref. No. 17 at SRX-HOL00006642. 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 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,

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ConturaTM Multi-Lumen Balloon Source Applicator 2
1692-1702; Ref. No. 41 at SRX-HOL00001784-1788, 1792-1794; Ref. No. 42 at SRXHOL00002016-2019, 2030. See also Ref. No. 21.

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APPENDIX B INFRINGED CLAIMS OF U.S. Patent No. 6,413,204 Asserted Claim1,2
1. An interstitial brachytherapy apparatus for delivering radioactive emissions to an internal body location comprising:

ConturaTMMulti-Lumen Balloon Source Applicator3
CONTENTION: The Contura Multi-Lumen Balloon Source Applicator ("ConturaTM") 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

1

Each asserted claim is entitled to a priority date of July 24, 1997.
Asserted Claims 4 and 17 depend from unasserted claims 1, 2, and 3 (for which, therefore, the elements are matched to features of the accused instrumentality).

2

3

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 on at least the identified evidence to show that the element is present under the doctrine of equivalents.
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Asserted Claim1,2

ConturaTMMulti-Lumen Balloon Source Applicator3
HOL00005564. "The radiation balloon uses vacuum to remove excess air and fluid and to adhere closely to often irregularly shaped lumpectomy cavities in order to deliver precise radiation dosing through multiple seed lumens." Ref. No.17 at SRX-HOL00006639. "Use ultrasound to confirm good tissue to balloon conformance and document skin spacing." Ref. No. 17 at SRX-HOL00006650. "Contour anatomy and target." Ref. No. 17 at SRX-HOL00006654. 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 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.

17. The apparatus of claim 1, wherein the radiation source is a plurality of solid radiation sources arranged to provide an isodose profile having a shape substantially similar to the shape of the outer spatial volume.

CONTENTION: The multiple treatment lumens of the Contura allow multiple solid radiation sources to be arrayed simultaneously within two or more separate treatment lumens to provide an isodose profile having a shape substantially similar to the shape of the balloon within the targeted tissue. Alternatively, the multiple treatment lumens of the Contura allow one or more solid radiation sources to be arrayed at different points in time within one or more separate treatment lumens to provide an isodose profile having a shape

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Asserted Claim1,2

ConturaTMMulti-Lumen Balloon Source Applicator3
substantially similar to the shape of the balloon within the targeted tissue. Appropriate pre-treatment dosimetry planning (with multiple dwell locations, multiple dwell times and/or use of multiple lumens) allows the isodose profile to be contoured to be substantially similar to the shape to the outer spatial volume defined by circumference of the expandable balloon. This claim element is thus literally infringed. 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 17 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 SRXHOL00006734, 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.

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Asserted Claim1,2
SUPPORT:

ConturaTMMulti-Lumen Balloon Source Applicator3

Ref. No. 9 at SRX-HOL00006494; Ref. No. 17 at 6655-6656; Ref. No. 22 at 10, 16. 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 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.

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1299 Pennsylvania Avenue, NW Washington, DC 20004-2402 T 202.783.0800 F 202.383.6610 www.howrey.com

. Marc A. Cohn
[email protected] Direct Dial 202.383.6858 TK#6142.File 01990.0009.000000

May 28, 2008

VIA EMAIL

Mr. Aaron Maurer, Esq. Williams & Connolly LLP 725 Twelfth Street N.W. Washington, DC 20005-5901 Re: Hologic et al. v. SenoRx, Inc., C.A. No. C08-00133 RMW

Dear Mr. Maurer: Please note that, per footnote 2 to Hologic's preliminary infringement contentions, to the extent that any of the elements of any of the asserted claims is determined not to be literally present in SenoRx's Contura MLB, Hologic will be asserting infringement under the doctrine of equivalents. Hologic's proof will consist of demonstrating that (should any element not be present literally) element(s) are present in the Contura MLB that perform the same function, in the same, way, to achieve the same result as the claimed element and/or that the element(s) present in the Contura MLB are otherwise insubstantially different. Sincerely,

FOR: Marc A. Cohn

AMSTERDAM BRUSSELS CHICAGO EAST PALO ALTO HOUSTON IRVINE LONDON LOS ANGELES MUNICH NEW YORK NORTHERN VIRGINIA PARIS SALT LAKE CITY SAN FRANCISCO TAIPEI WASHINGTON, DC

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