Free Reply Memorandum - 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

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 IN SUPPORT OF ITS MOTION FOR PARTIAL SUMMARY JUDGMENT OF INVALIDITY ('142 PATENT, CLAIMS 1 AND 8) Date: June 25, 2008 Time: 2:00 p.m. Courtroom: 6, 4th Floor Judge: Hon. Ronald M. Whyte

DEFENDANT SENORX, INC.'S REPLY IN SUPPORT OF ITS MOTION FOR PARTIAL SUMMARY JUDGMENT OF INVALIDITY

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ARGUMENT IN REPLY At issue here is the critical public notice function of patent claims. Claims 1 and 8 of the '142 patent, as they are actually drafted, lead to an inoperable invention. Plaintiffs insist this Court should fix their error in drafting an inoperable claim, but to do so the Court would have to selectively ignore, contort and rewrite the language of the claim. This the Court cannot do. What Plaintiffs seek is contrary to the "`bedrock principle' of patent law that `the claims of a patent define the invention.'" Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc) (citation omitted). It is contrary to the statutory requirement that the claims "particularly point[] out" and "distinctly claim[] the subject matter" regarded as their invention. 35 U.S.C. § 112. And it is "unjust to the public," White v. Dunbar, 119 U.S. 47, 52 (1886), particularly competitors such as SenoRx who are entitled to rely on claims as written. Patent claims serve the critical public policy 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)). If patent claims can be construed to mean virtually anything, as Plaintiffs maintain, this public notice function will fail. 1. Public Notice. SenoRx construes the claimed "apparatus volume" as a "volume," i.e., a region of space. This is based on the language of the claim and the plain and ordinary meaning of the term, and is consistent with the use of the disputed term "apparatus volume" in the specification. Plaintiffs criticize SenoRx for its "literal interpretation of the claim language." Pls. Br. at 5. SenoRx does indeed base its construction on the notion that the language of the claim means what it says, but this is not grounds for criticism. Instead, it is exactly what is required by the patent laws and over a century of established case law, and ensures the public notice function of the patent is met. White v. Dunbar, 119 U.S. 47, 52 (1886). Plaintiffs argue that SenoRx's "literal interpretation of the claim language" (i.e., that the claim means what it says) is erroneous because it is a "rigid" interpretation "divorced from the context of the specification." Pls. Br. at 5. Not so. To the contrary, the specification clearly indicates that the definition of "apparatus volume" set forth in the claim itself, i.e., the "threeSENORX, INC.'S REPLY IN SUPPORT OF ITS MOTION FOR PARTIAL SUMMARY JUDGMENT OF INVALIDITY

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dimensional" volume "defin[ed]" by the expandable outer surface that "fill[s]" the surgical cavity, is the correct one. The specification teaches that the "present invention" of the '142 patent has "an expandable outer surface element defining an apparatus spatial volume." Ex. 11 ('142 patent), col. 2:55-64. This language tracks the language of the claim, and by its use of the adjective "spatial," shows that the plain reading of "apparatus volume" as a region of space is correct. So too the portion of the specification reciting an "outer spatial volume defined by an outer polymeric film barrier," cited by Plaintiffs in support of their position. Pls. Br. at 8 (emphasis added). But this does not support Plaintiffs; instead, it again makes clear that when the patent refers to a "volume," it is referring to a "spatial volume," i.e., a region of space defined by a surface. This is precisely the issue that arose in the Xoft case, where Plaintiffs took the opposite position of the one they argue here: The "outer spatial volume" is a region of space that is defined by an "expandable surface element" but it is not the "expandable surface element" itself. . . . [T]he term should be construed as "a region of space defined by an expandable surface element . . . ." This is consistent with the ordinary meaning of the claim term in view of the specification. Ex. 22 (Cytyc Br.) at 19:21-28 (emphasis added). The specification supports the language of the claim (and SenoRx's construction of the claim as meaning what it says) ­ the apparatus volume

17 is a region of space defined by an expandable outer surface. 18 Plaintiffs reverse the importance of the claims and specification in their approach to 19 construing "apparatus volume." Plaintiffs do not start with the claim language, and interpret it in 20 light of the specification. Phillips, 415 F.3d at 1312-13. Instead, Plaintiffs realize that the claim 21 as written is nonsensical and turn to the specification as though it were a substitute for the claim 22 language. But while the specification is an important guide for understanding the claim language, 23 it does not supplant the definitional function of the claims. Phillips, 415 F.3d at 1312-13. The 24 25 26 27 28
SENORX, INC.'S REPLY IN SUPPORT OF ITS MOTION FOR PARTIAL SUMMARY JUDGMENT OF INVALIDITY
1

Ex. 1 is an exhibit to the Declaration of Adam D. Harber in Support of SenoRx, Inc.'s Motion for Partial Summary Judgment of Invalidity.
Exs. 2-4 are exhibits to the Declaration of Adam D. Harber in Support of SenoRx, Inc.'s Reply in Support of its Motion for Partial Summary Judgment of Invalidity.
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notice function of claims does not permit this: "The written description, however, is not a substitute for, nor can it be used to rewrite, the chosen claim language. Specifications teach. Claims claim." Superguide Corp. v. DirecTV Enters., 358 F.3d 870, 875 (Fed. Cir. 2004) (citation and quotations omitted); see also Aro Mfg. v. Convertible Top Replacement Co., 365 U.S. 336, 339 (1961) ("The claims made in the patent are the sole measure of the grant . . . ."). Indeed, Plaintiffs' objections to SenoRx's construction do not derive from the claim language actually defining the disputed "apparatus volume" limitation in the first clause of the claim 1. Rather, it is because the second clause of claim 1 requires that the radiation source is "spaced apart from the apparatus volume" at the same time it is "completely within" the surface defining that volume ­ an impossibility ­ that Plaintiffs seek to rewrite the meaning of "apparatus volume" in the first clause. That is plainly improper. Neither Plaintiffs nor the Court is empowered to redraft the claim to give a different meaning to "apparatus volume" in order to resolve the problem that arises from the plain meaning of the second clause of the claim, even to avoid a nonsensical result. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1356-57 (Fed. Cir. 1999). Doing so completely undermines the bedrock purpose of claim language in providing the public with notice of the scope of the claims and "unduly burden[s] competitors who must determine the scope of the claimed invention based on an erroneously drafted claim." Id. at 1357. "Courts do not rewrite claims; instead, we give effect to the terms chosen by the patentee." K-2 Corp. v. Salomon S.A., 191 F.3d 1356, 1364 (Fed. Cir. 1999); see also Process Control, 190 F.3d at 1357 ("[W]e do not permit courts to redraft claims."); Quantum Corp. v. Rodime, PLC, 65 F.3d 1577, 1584 (Fed. Cir. 1995) ("[I]t is well settled that no matter how great the temptations of fairness or policy making, courts do not redraft claims."). For authority to ignore this precept, Plaintiffs rely on the Federal Circuit's statement that "a claim interpretation that would exclude the inventor's device is rarely the correct interpretation." Modine Mfg. Co. v. United States Int'y Trade Comm'n, 75 F.3d 1545, 1550 (Fed. Cir. 1996). But this is just such a rare case. It is a rare case that the prosecuting attorney claims an impossibility, a rare case that it is so clear that the claim is nonsensical as written, and a rare case that patentees would struggle like Plaintiffs here to ignore the plain meaning of the language
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of their claim.

If Plaintiffs had wanted to redraft the claims to be consistent with the constructions it favors in this litigation, they should have done so in prosecuting the patent before the Patent Office. But they took no such action.3 2. Ortho-McNeil Pharmacuticals v. Mylan Laboratories, Inc. Plaintiffs suggest that Ortho-McNeil Pharmaceuticals v. Mylan Laboratories, Inc., 520 F.3d 1358 (Fed. Cir. 2008), distinguishes the cases cited by SenoRx in its opening brief (Process Control, Chef America, Allen Engineering), and mandates this Court rewrite the claims to preserve their validity. Pls. Br. at 6. Not so. Although Ortho-McNeil determined that the claim at issue in that particular case was not nonsensical, it also reaffirmed (just like Process Control and the other cases relied on by SenoRx) that claims cannot be rewritten to preserve their validity if, as here, the only reasonable construction is one that is nonsensical. The limitation in question in Ortho-McNeil stated that the claimed drug encompassed two possible formulas, one where

Furthermore, it is not true that every claim need cover the preferred embodiments. On June 4, 2008, the Federal Circuit in Helmsderfer et al. v. Bobrick Washroom Equipment, Inc., et al., ___ F.3d ___ (Fed. Cir. 2008), upheld a construction in which claims "[did] not cover the preferred embodiment or the other illustrated embodiments." Id., slip op. at 7. In so doing, the Court distinguished Vitronics, and other cases cautioning against construing claims to exclude preferred embodiments, as limited to situations where a claim term "has multiple ordinary meanings consistent with the intrinsic record." Id. at 6. The Court further reasoned that, where some claims cover the disclosed embodiments, the fact others do not is not a barrier to construing the claims according to the language "the patentee chooses . . . ." Id. at 7. Here, as in Helmsderfer, claim 1 should be construed according to the language the patentee chose. There is no "ordinary meaning[]" of apparatus volume other than as a "volume." And furthermore, the other claims of the patent plainly cover the disclosed embodiments. E.g., compare Ex. 1, '142 patent, claim 2 with Figure 1. Accordingly, the inventors here are not being denied their invention by SenoRx's construction; instead, the public notice function of the claims is being upheld.

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certain molecules were "independent[]" and one where those same molecules formed a "group."4 Id. at 1361. Because those two variations were claimed with an "and" between them, the accused infringer argued that a drug had to meet both variations to infringe, which is impossible. The Federal Circuit held instead that there was a reasonable reading of "and" ­ that it was disjunctive ­ and that such a reading was consistent with the claim's recitation of "independently" and "together." The Federal Circuit then looked to the "larger context of the patent," id. at 1362, to confirm this understanding of how "and" was used, starting with the language of the other claims and then turned to the specification. The Court concluded that "and" consistently was used to be disjunctive. As described in detail in SenoRx's claim construction briefing, following that same process here dooms claim 1 of the '142 patent. "Apparatus volume" is defined in the claim itself as the region of space within the expandable outer surface that fills the surgical cavity. This definition is the only one that makes sense of the use of "apparatus volume" in the other claims of the patent. E.g., Claim 3 ("a catheter in communication with the apparatus volume"); Claim 4 (an "elongate member . . . taking on a substantially straight shape while being inserted through the catheter to the apparatus volume, and resuming an asymmetric shape when extended into the apparatus volume"); Claim 6 ("two elongate members extending into the apparatus volume"); cf. Claim 9 ("a radiation source disposed completely within and spaced apart from the expandable outer surface"). And, as discussed above, the specification consistently refers to the apparatus volume as a "spatial volume," i.e., a region of space, defined by the expandable outer surface. There is but one reasonable construction of apparatus volume that is consistent with claim 1, the other claims and the specification ­ the "apparatus volume" is the region of space defined by the expandable outer surface that fills the void. Accordingly, claim 1 (and dependent claim 8) require an impossibility and should be held to be invalid.

"R2, R3, R4, and R5 are independently hydrogen or lower alkyl and R2 and R3 and/or R4 and R5 together may be a group of formula (II) (emphasis added)." Ortho-McNeil, 520 F.3d at 1361.

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3. Plaintiffs' Construction of "Apparatus Volume" Means that Claims 1 and 8 are Inoperable and Not Enabled. Even should this Court adopt Plaintiffs' construction of "apparatus volume," claims 1 and 8 still are invalid for inoperability and lack of enablement. In his report on claim construction, Plaintiffs' expert, Dr. Verhey opines that the "apparatus volume" of claim 1 "is a threedimensional geometric solid (e.g., a sphere) having both volume that fills an interstitial void created by the surgical extraction of diseased tissue and a surface area that defines an inner boundary of the target tissue being treated." Ex. 4 (Verhey Decl. (May 21, 2008)) at 5:4-10 (emphases added). Plaintiffs explain, "by way of analogy," that the expandable outer surface of the claimed device defines an "apparatus volume" the same way "the skin of a basketball defines a three-dimensional basketball." Pls. Cl. Constr. Br. at 22, n.14. If the "apparatus volume" encompasses "both volume . . . and a surface area," the claim limitation that the radiation source is "located so as to be spaced apart from the apparatus volume" must be understood to require that the radiation source is "located so as to be spaced apart" from both the volume and the surface area. To further Plaintiffs' basketball analogy, a radiation source that is "located so as to be spaced apart from the basketball" must mean that the radiation source is outside of the basketball. Accordingly, not even Plaintiffs' construction of "apparatus volume," as contorted as it may be, saves claim 1. Plaintiffs tacitly acknowledge this by attempting to rewrite their own construction of "apparatus volume" as used in the "spaced apart" limitation. There, instead of staying true to their own construction that "apparatus volume" is "both" the expandable outer surface of the device and the volume within it, Plaintiffs assert instead that it means only the surface: A radiation source can thus be "disposed completely within" the volume that fills the interstitial void and "spaced apart from" the surface that defines the inner boundary. Pls. Br. at 8. But this is precisely the opposite of what claim 1 says: a radiation source disposed completely within the expandable outer surface and located so as to be spaced apart from the apparatus volume

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Ex. 1, claim 1. The claim does not say that the radiation source is "disposed completely within" the volume ­ it says "disposed completely within the expandable outer surface." And the claim does not say that the radiation source is "spaced apart from" the surface ­ it is "spaced apart from the apparatus volume." If Plaintiffs are contending that "apparatus volume" means solely the "expandable outer surface" in the "spaced apart" limitation, why did they not simply say that the apparatus volume is equivalent to the surface (as they did in the hearing for a preliminary injunction)? Because, as SenoRx pointed out at the hearing, such a reading renders the first element of claim 1 equally nonsensical, as it would read "an expandable outer surface defining an expandable outer surface" under that definition.5 But that is precisely the result Plaintiffs urge by their argument that the "apparatus volume" in the "spaced apart" limitation is only the surface. This should be rejected. Plaintiffs' current position can be summarized as follows: · In the first half of the claim, the apparatus volume "is a three-dimensional geometric solid (e.g., a sphere) having both volume . . . and a surface area." Id. at 5:4-10. · But in the second half of the claim, the "apparatus volume" refers to only the surface of the apparatus volume.6 This construction is more than "somewhat unusual," which is how even Plaintiffs' own expert described the construction in his own expert report. Ex. 4 (Verhey Decl. (May 21, 2008)), at 5:11-12 (emphasis added). It is an unreasonable construction.

In the preliminary injunction proceedings, the Court noted its "concern that Hologic does not [seem] to be able to propose an alternate construction of this limitation." PI Order at 16. It is not surprising that when Plaintiffs finally do supply a definition of "apparatus volume," the definition changes depending on where (and when) it is used by Plaintiffs; the definition makes no sense and is completely contrary to the claim language. Plaintiffs seek here a ruling that the second half of the claim requires a radiation source disposed within and spaced apart from the expandable outer surface. This is not what claim 1 states. It is, however, what is plainly spelled out in claim 9, which states that the radiation source is "disposed completely within and spaced apart from the expandable outer surface." If Plaintiffs had wanted claim 1 to read this way, they should have drafted it to read that way during the prosecution of the patent, as was done with claim 9. Instead they chose different language, apparently seeking a different result. They should not be able to divorce themselves from that which they sought now, in contravention of the public notice function of what they claimed.
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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 Under any reasonable construction (and SenoRx submits that there is only one), the claim is inoperable and invalid. 4. There Is No Factual Dispute. Plaintiffs suggest that SenoRx's motion is deficient because it is not accompanied by any "supporting affidavits from an expert or otherwise." Pls. Br. at 3. That is a complete red herring. There is no dispute as to the relevant facts; indeed, Plaintiffs concede as much, agreeing that reading the claims as SenoRx contends leads to a "nonsensical" result. Pls. Br. at 2. The basis for SenoRx's motion, as plainly set forth in SenoRx's opening brief, is that it is impossible for a radiation source to be "disposed completely within" the outer surface of the device and also at the same time to be located outside that same outer surface. E.g., SenoRx Op. Br. at 1 ("SenoRx requests the Court hold claims 1 and 8 of the '142 invalid on the grounds that, as a matter of law, they are inoperable and not enabled since the radiation source recited in claim 1 cannot simultaneously be `within' the claimed outer surface and `spaced apart' from the claimed volume defined by that surface. As claim 8 depends from claim 1, it incorporates all of claim 1's limitations (and flaws as to operability and enablement) as a matter of law."); see also id. at 4, 9. Plaintiffs cannot and do not dispute this. It is absurd to suggest that an affidavit from an expert is required to reach this conclusion, which is not only self-evident, but as to which all parties agree. What claims 1 and 8 mean is a matter of claim construction, i.e., a matter of law. If the Court construes the claims according to SenoRx's construction, the claims recite a factual impossibility and thus are not enabled and inoperable as a matter of law. That a radiation source cannot simultaneously be both within a surface and outside the surface is plainly true, and Plaintiffs have not identified any evidence or argument to the contrary. As the controlling rule clearly states, and the Supreme Court squarely has held, SenoRx was not required to put in an affidavit as to this undisputed fact. See Fed. R. Civ. P. Rule 56(b) (explaining that party may move for summary judgment "with or without supporting affidavits") (emphasis added); Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986) ("[W]e find no express or implied requirement in Rule 56 that the moving party support its motion with affidavits or other similar materials negating the
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opponent's claim."). CONCLUSION Since the radiation source of claim 1 cannot simultaneously be "within" the outer surface and "spaced apart" from the volume defined by that surface, claim 1 is inoperable and invalid. As claim 8 depends from claim 1, it too should be declared invalid for the same reasons.

Respectfully Submitted,

Dated: June 11, 2008

WILSON SONSINI GOODRICH & ROSATI Professional Corporation

By: 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28
SENORX, INC.'S REPLY IN SUPPORT OF ITS MOTION FOR PARTIAL SUMMARY JUDGMENT OF INVALIDITY

/s/ F.T. Alexandra Mahaney F.T. Alexandra Mahaney [email protected]

Attorneys for Defendant 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) DECLARATION OF LYNN J. VERHEY, Ph.D. IN SUPPORT OF PLAINTIFFS' PROPOSED CONSTRUCTION OF CLAIM TERMS, PHRASES AND CLAUSES

14 HOLOGIC, INC., CYTYC CORPORATION, and HOLOGIC L.P., 15 Plaintiffs, 16 vs. 17 SENORX, INC., 18 Defendant. 19 20 AND RELATED COUNTERCLAIMS. 21 22 23 24 25 26 27 28
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I, Lynn J. Verhey, Ph.D., declare and state as follows: I have been retained in this case as an expert witness by Plaintiffs Hologic, Inc., Cytyc

3 Corporation, and Hologic L.P ("Hologic"). I make this declaration based on my personal knowledge, 4 training and experience, and if I were to be called to testify, I could and would testify competently 5 about the subject matter set forth below. 6 I understand that the parties propose different constructions of various terms, phrases and

7 clauses in the patents-in-suit. I submit this declaration to provide my opinion on the meaning of the 8 disputed claim terms. 9 I. 10 INTRODUCTION AND MY EXPERT QUALIFICATIONS On April 3, 2008, in support of Hologic's Motion for Preliminary Injunction, I submitted a

11 declaration describing my current employment and summarizing my background and education. Ex. A 12 (¶¶ 3-7) (Dkt. No. 77). I have also submitted a current curriculum vitae to the Court. Ex. B. In the 13 April 3, 2008 declaration, I explained that I previously served as an expert witness for Cytyc 14 Corporation (Cytyc has since been acquired by Hologic) in the case of Xoft, Inc. v. Cytyc Corporation 15 and Proxima Therapeutics, Inc., Case No. C05-05312 RMW (¶ 8) (the "Xoft litigation"). The Xoft 16 litigation involved United States Patent Nos. 5,913,813 (the "'813 patent") and 6,413,204 (the "'204 17 patent"), both of which are at issue in this case.1 In that declaration, I also briefly described the subject 18 matter of the three patents-in-suit. Ex. A at ¶ 9. Rather than repeating those statements again, I 19 incorporate the contents of my April 3, 2008 declaration by reference. 20 II. 21 TOPICS THAT I HAVE BEEN ASKED TO ADDRESS I have been asked to provide opinions regarding how a person of ordinary skill in the art would

22 interpret the meaning of certain claim terms and phrases from the `813, `204 and `142 patents. 23 III. 24 INFORMATION CONSIDERED IN FORMING MY OPINIONS On October 12, 2006, I submitted a declaration in the prior Xoft litigation relating to claim

25 construction issues in that case. Ex. C. A substantial part of that declaration is relevant to the present 26 27 28
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1 case. Rather than repeating those statements again, I incorporate the contents of my October 12, 2006 2 declaration by reference. Ex. C. Therein, I identified the information I considered in forming my 3 claim construction opinions. Id. at 2-3. I have considered the same information here, with the 4 following additions: (1) I have reviewed and considered the text of the `142 patent and the file history 5 associated with its issuance; (2) I have reviewed and followed the claim constructions that the Court 6 issued in the Xoft case for the `813 and `204 patents; and (3) I have reviewed and considered the claim 7 constructions proposed by the parties in this case. I have not reviewed any written or oral opinions 8 from any expert whom SenoRx has retained or may retain in connection with this case. I reserve the 9 right to modify my opinions stated in this declaration after having reviewed any such opinion offered 10 by any such expert. I also reserve the right to modify my opinions based on any rulings that the Court 11 might issue in the future relating to these patents. 12 IV. 13 14 APPROACH I HAVE USED IN READING THE `813, `204, AND `142 PATENTS AND INTERPRETING THEIR CLAIMS In my October 12, 2006 declaration (Ex. C), I explained my methodology for interpreting claim

15 terms and phrases from the `813 and `204 patents. The statements made in that declaration with regard 16 to my approach to claim construction apply equally to the present case. 17 This case involves one additional patent and different asserted claims. I understand that the

18 claims of the `813 patent at issue in this lawsuit are claims 11 and 12, found in columns 5 and 6 of the 19 patent. I understand that the claims of the `204 patent at issue here are claims 4 and 17, found in 20 columns 8 and 9 of the patent. I understand that the claims of the `142 patent at issue here are claims 21 1, 6 and 8, found in columns 8, 9, and 10 of the patent. I understand that all three patents are related to 22 one another by lineage, with the `813 patent being the parent. The `204 and `142 patents are 23 continuations-in-part of the `813 patent. 24 V. 25 LEVEL OF SKILL OF ONE OF ORDINARY SKILL IN THE ART In my October 12, 2006 declaration (Ex. C), I identified the skill level of one of ordinary skill

26 in the art for purposes of interpreting the claims of the `813 and `204 patents. Id. at 4. The same skill 27 level would apply to construing the `142 patent claims. 28
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1 VI. 2 3

THE MEANING OF THE DISPUTED CLAIM TERMS IN THE `813, `204, AND `142 PATENTS I have reviewed and relied upon the material identified in Section III above. Based on these

4 materials, my knowledge and experience in the technical field to which the patented inventions relate, 5 and my familiarity with the level of ordinary skill in the art at the times the applications for the `813, 6 `204, and `142 patents were filed, I have formed opinions as to how one of ordinary skill in the art 7 would have interpreted certain claim terms at the time of their invention. My opinion regarding the 8 meaning of each of the disputed claim terms is set forth below. Where the disputed term is present in 9 more than one of the asserted patents, my interpretation is given only once. The list of disputed terms 10 includes those identified by either party. For a few of the terms, I provide an explanation of why I 11 disagree with SenoRx's proposed construction. 12 VII. 13 TERMS ALREADY CONSTRUED IN THE PRIOR XOFT LITIGATION I notice that SenoRx disputes a number of claim terms that the Court already construed in the

14 prior Xoft litigation. I will not address those terms already construed by the Court. I reserve the right 15 to address them at a later point in time if appropriate. 16 17 The `813 Patent "inner spatial volume" (claims 1, 2, and 12) - The Court previously construed this term to

18 mean "a region of space surrounded by an outer spatial volume and either enclosed by a polymeric 19 film wall or defined by the outside surface of a solid radionuclide." Col. 1:50-2:3; 2:33-63; 3:9-16, 4220 48; 3:64-4:12; 4:16-30, 32-52; 6:6-7; Figs. 1, 3-5; Decl. of Katharine Altemus in Support of Plaintiffs' 21 Opening Claim Construction Brief ("Altemus Decl.") at 3-5, 28 (Claim Construction Order from Xoft, 22 Inc. v. Cytyc Corp. et al.) I address this term again only to respond to a particular problem I see with 23 SenoRx's proposed construction. 24 SenoRx proposes to modify the Court's construction to limit, for embodiments where the

25 "inner spatial volume" is defined by the outside surface of a solid radionuclide, the radionuclide to a 26 "sphere." This is an artificially narrow construction, which does not accurately reflect standard 27 brachytherapy treatment. One skilled in the art of brachytherapy would know that in a typical 28 brachytherapy procedure using a solid radionuclide, the radionuclide is not necessarily spherical in
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1 shape and does not need to be. This was also true in 1997, when the application for the `813 patent 2 was filed. Therefore, to so limit the definition of the term "inner spatial volume" does not accurately 3 reflect standard practice. Nor does it comport with the claim language, which does not include or 4 imply such limiting language. 5 "inner, closed chamber" (claim 2) ­ One of ordinary skill in the art would understand this term

6 as written ­ i.e., it means "inner, closed chamber." No further elaboration or explanation is needed. 7 It does not make sense from a technical standpoint to say that the inner spatial volume must be

8 "completely" inside the outer chamber or "closed off within the outer chamber," as SenoRx suggests. 9 Clearly, as seen in the text of the `813 patent, Col. 2:36-38, and as commonly understood in the field, 10 an inner spatial volume that is an inner, closed chamber defined by a radiation transparent wall must 11 still permit a radiation source to be placed in there. If it were completely sealed or closed off, that 12 would not be possible. 13 14 The `204 Patent "three-dimensional isodose profile that is substantially similar in shape to the expandable

15 surface element" (claim 1) ­ means exactly that, "three-dimensional isodose profile that is substantially 16 similar in shape to the expandable surface element." One of ordinary skill in the art would understand 17 this term as written. No further elaboration or explanation is needed. 18 "plurality of solid radiation sources" (claim 17) ­ means exactly that, "plurality of solid

19 radiation sources." One of ordinary skill in the art would understand this term as written. No further 20 elaboration or explanation is needed. 21 "isodose profile having a shape substantially similar to the shape of the outer spatial volume"

22 (claim 17) ­ means exactly that, "isodose profile having a shape substantially similar to the shape of 23 the outer spatial volume." One of ordinary skill in the art would understand this term as written. No 24 further elaboration or explanation is needed. 25 26 The `142 Patent "three-dimensional apparatus volume configured to fill an interstitial void" (claims 1 and 8) ­

27 In my opinion, this claim phrase can only be understood in the context of the limitation in which it 28
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1 appears and is a part of. This limitation is "an expandable outer surface defining a three-dimensional 2 apparatus volume configured to fill an interstitial void created by the surgical extraction of diseased 3 tissue and define an inner boundary of the target tissue being treated." As the italicized language 4 makes clear, the "three-dimensional apparatus volume" is something that is defined by the "expandable 5 outer surface." What this expandable outer surface defines is a three-dimensional geometric solid 6 (e.g., a sphere) having both volume that fills an interstitial void created by the surgical extraction of 7 diseased tissue and a surface area that defines an inner boundary of the target tissue being treated. 8 Accordingly, in my opinion, the term "three-dimensional apparatus volume" means "a three9 dimensional geometric solid composed of an expandable outer surface." By "solid," I mean a 10 geometric shape, such as a sphere, having three dimensions and a surface area. 11 In my opinion, SenoRx construes this claim term divorced from its context. I agree that the

12 patentee's use of the word "volume" here is somewhat unusual. However, it is clear from the context 13 that the patentee uses the term "apparatus volume" to refer to a three-dimensional geometric solid or 14 shape defined by the expandable outer surface rather than "a region of space within the expandable 15 outer surface" ­ as SenoRx's suggests. Col. 2:20-53, 60-64; 3:20-36, 55-62, 66-67; 4:1-2, 27-42; 5:3616 65; 6:11-29; 8:1-32, 52-59, Figs. 1, 3-4. 17 "located so as to be spaced apart from the apparatus volume" (claim 1) ­ Like the preceding

18 claim phrase, this claim phrase can only be understood in the context of the limitation in which it 19 appears and is a part of. This limitation is "a radiation source disposed completely within the 20 expandable outer surface and located so as to be spaced apart from the apparatus volume." As noted 21 above, the three-dimensional apparatus volume is a geometric solid defined by the expandable outer 22 surface that has both volume and surface area. Understood in this context, the phrase "located so as to 23 be spaced apart from the apparatus volume" logically refers to the surface area of the apparatus volume 24 that defines the inner boundary of the target tissue being treated. Accordingly, in my opinion, this 25 claim phrase means "located so as to be not on or touching the apparatus volume." Col. 2:20-53; 3:2026 25, 55-62, 66-67; 4:1-2, 27-30, 35-57; 5:36-65; 6:11-29; 7:1-15, 49-55; 8:1-32, 52-59; Figs. 1, 3-4. 27 \\ 28
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