Free Claim Construction Statement - District Court of California - California

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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) Andrew R. Sommer (Admitted Pro Hac Vice) 7 HOWREY LLP 1299 Pennsylvania Avenue, NW 8 Washington, DC 20004 Telephone: (202) 783-0800 9 Facsimile: (202) 383-6610 10 Attorneys for Plaintiffs HOLOGIC, INC., CYTYC CORPORATION and HOLOGIC L.P. 11 UNITED STATES DISTRICT COURT 12 NORTHERN DISTRICT OF CALIFORNIA 13 SAN JOSE DIVISION 14 HOLOGIC, INC., CYTYC CORPORATION, Case No. C08 00133 RMW (RS) 15 and HOLOGIC L.P., PLAINTIFFS' REPLY CLAIM Plaintiffs, 16 CONSTRUCTION BRIEF (PATENT L.R. 45(c)) vs. 17 Markman Hearing 18 SENORX, INC., Date: June 25, 2008 Time: 2:00 p.m. Defendant. 19 Room: Courtroom 6, 4th Floor Judge: Hon. Ronald M. Whyte 20 21 AND RELATED COUNTERCLAIMS. 22 23 24 25 26 27 28
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1

TABLE OF CONTENTS

2 PRELIMINARY STATEMENT ......................................................................................................... 1 3 ARGUMENT...................................................................................................................................... 2 4 I. 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 II. 26 27 28 E. F. D. C. B. 2. THE '813 AND '204 PATENTS ............................................................................................. 2 A. "Predetermined Constant Spacing" and "Predetermined Spacing" SenoRx's Proposed Constructions Ignore Clear Differences in the Claim Language and Usage in the Specification ........................................................... 2 1. "Predetermined Constant Spacing Between Said Inner Spatial Volume and the Radiation Transparent Wall" SenoRx's Construction Adds Limitations That Are Not Supported (Claim 1, '813 Patent)...................................................................... 3 "Predetermined Spacing . . . Between Said Inner Spatial Volume and the Expandable Surface Element" ­ SenoRx Ignores Clear Differences in Claim Language (Claim 3, '204 Patent) ...................................................................................................... 4

"Three-Dimensional Isodose Profile" - SenoRx Improperly Reads "Concentricity" and "Finality" into the Claims (Claim 1, 17, '204 Patent).......................................................................................................................... 5 "Inner Spatial Volume" - SenoRx Would Improperly Limit the Claim To Only the Preferred Embodiments.................................................................. 7 1. 2. There Is No Justification for Importing "Distensible" into the Claim.......................................................................................................... 7 Limiting the "Inner Spatial Volume" to a Radionuclide "Sphere" Improperly Limits the Claim to Preferred Embodiments.................................................................................................... 9

"Means . . . For Rendering Uniform" - SenoRx's Proposed Construction Impermissibly Adds An Unclaimed Function ('813 Patent, Claim 1) ......................................................................................................... 11 "Inner Closed Chamber" ­ SenoRx Adds a Limitation Without Support in the Specification (`813 Patent, Claim 11) .................................................. 14 "Providing a Controlled Dose at the Outer Spatial Volume Expandable Surface to Reduce or Prevent Necrosis in Healthy Tissue Proximate to the Expandable Surface" (`204 Patent, Claim 4) ............................................................................................................................... 15

SENORX'S PROPOSED CONSTRUCTIONS OF THE TERMS FROM THE '142 PATENT IMPROPERLY DIVORCE INDIVIDUAL TERMS FROM THE REMAINDER OF THE INTRINSIC EVIDENCE ............................................ 16 A. "Apparatus Volume" and "Located So As To Be Spaced Apart From the Apparatus Volume" ('142 Patent, Claim 1) ................................................. 16
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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 III. C. B.

1.

An "Apparatus Volume," in the Context of the Claimed Invention, Is a Structure Composed of an Expandable Outer Surface ........................................................................................................... 17 "Located So As To Be Spaced Apart From the Apparatus Volume" ­ Once the Term "Apparatus Volume" Is Properly Construed, the Term "Spaced Apart" Is Clear................................... 19

2.

"Asymmetrically Located and Arranged Within the Expandable Surface" - Means Not on the Longitudinal Axis ('142 Patent, Claim 1) ..................................................................................................................... 20 "Predetermined Asymmetric Isodose Curves" ('142 Patent, Claims 1 & 8) ........................................................................................................................ 21

SENORX'S CONSTRUES THE "PLURALITY" TERMS TOO NARROWLY ­ DIVORCED FROM THE ACCOMPANYING CLAIM LANGUAGE AND SPECIFICATIONS................................................................................ 22 A. "Plurality of Radioactive Solid Particles Placed At Predetermined Locations" (`813 Patent, Claim 12) and "Plurality of Solid Radiation Sources" ('204 Patent, Claim 17) ............................................................... 23

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1 2 CASES

TABLE OF AUTHORITIES

3 ACTV, Inc. v. Walt Disney Co., 346 F.3d 1082 (Fed. Cir. 2003).............................................................................................. 19 4 Afga Corp. v. Creo Prods. Inc., 451 F.3d 1366 (Fed. Cir. 2006).............................................................................................. 23 5 6 Anchor Wall Sys., Inc. v. Rockwood Retaining Walls, Inc., 340 F.3d 1298 (Fed. Cir. 2003)................................................................................................ 8 7 Applied Med. Res. Corp. v. U.S. Surgical Corp., 448 F.3d 1324 (Fed. Cir. 2006).............................................................................................. 12 8 9 BBA Nonwovens Simpsonville, Inc. v. Superior Nonwovens, L.C.C., 303 F.3d 1332 (Fed. Cir. 2002) ............................................................................................. 11 10 CollegeNet, Inc. v. ApplyYourself, Inc., 418 F.3d 1225 (Fed. Cir. 2005).............................................................................................. 11 11 12 Computer Docking Station Corp. v. Dell, 519 F.3d 1366 (Fed. Cir. 2008)................................................................................................ 6 13 Elbex Video, Ltd. v. Sensormatic Elecs. Corp., 508 F.3d 1366 (Fed. Cir. 2007).......................................................................................... 6, 13 14 15 Elkay Mfg. Co. v. Ebco Mfg. Co., 192 F.3d 973 (Fed. Cir. 1999)................................................................................................ 18 16 Forest Labs, Inc. v. Abbott Labs., 239 F.3d 1305 (Fed. Cir. 2001)................................................................................................ 4 17 18 Hill-Rom Co., Inc. v. Kinetic Concepts, Inc., 209 F.3d 1337 (Fed. Cir. 2000).............................................................................................. 21 19 Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363 (Fed. Cir. 2008).............................................................................................. 10 20 21 Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111 (Fed. Cir. 2004).............................................................................................. 17 22 Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d 1374 (Fed. Cir. 2005).............................................................................................. 17 23 24 Jonsson v. The Stanley Works, 903 F.2d 812, (Fed.Cir.1990)................................................................................................ 18 25 LG Elecs., Inc. v. Bizcom Elecs., Inc., 453 F.3d 1364 (Fed. Cir. 2006).........................................................................................12, 13 26 27 Libel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898 (Fed. Cir. 2004).................................................................................................. 8 28
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1 Medtronic, Inc. v. Advanced Cardiovascular Sys., Inc., 248 F.3d 1303 (Fed. Cir. 2001).............................................................................................. 18 2 Merck & Co. v. Teva Pharms USA, Inc., 395 F.3d 1364 (Fed. Cir. 2005).............................................................................................. 19 3 4 Micro Chemical, Inc. v. Great Plains Chemical Co., Inc., 194 F.3d 1250 (Fed. Cir. 1999)................................................................................................ 5 5 NeoMagic Corp. v. Trident Microsystems, Inc., 287 F.3d 1062 (Fed. Cir. 2002).........................................................................................16, 19 6 7 Omega Eng'g, Inc. v. Raytek Corp., 334 F.3d 1314 (Fed. Cir. 2003).............................................................................................. 13 8 Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 F.3d 1358 (Fed. Cir. 2008).............................................................................................. 19 9 10 Pfizer, Inc. v. Teva Pharms., USA, Inc., 429 F.3d 1364 (Fed. Cir. 2005).............................................................................................. 10 11 Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc) ........................................................................passim 12 13 Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d at 1243 (Fed. Cir. 1998) ...................................................................................... 7, 10 14 Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576 (Fed. Cir. 1996)................................................................................................ 16 15 16 Wenger Mfg., Inc. v. Coating Mach. Sys., Inc., 239 F.3d 1225 (Fed. Cir. 2001).............................................................................................. 12 17 STATUTES 18 35 U.S.C. § 112............................................................................................................................11, 16 19 35 U.S.C. § 282 (2006)...................................................................................................................... 17 20 21 22 23 24 25 26 27 28
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1

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

2 respectfully submit this Reply Brief addressing SenoRx, Inc.'s ("SenoRx") proposed construction of 3 disputed terms, phrases, and clauses in the asserted claims of U.S. Patent Nos. 5,913,813 (the "'813 4 patent"), 6,413,204 (the "'204 patent"), and 6,482,142 (the "'142 patent") (collectively, "the patents5 in-suit"). 6 7 PRELIMINARY STATEMENT SenoRx's proposed constructions of the disputed claim terms should be rejected. Even a

8 cursory review of SenoRx's proposed constructions reveals a tactic repeated time and time again ­ the 9 attempt to add limitations where none exist, thereby narrowing the inventions that the patentee sought 10 and was granted by the PTO. For the most part, SenoRx's claim construction methodology is contrary 11 to applicable Federal Circuit precedent. For example, by reading the words "concentric" and 12 "spherical" into certain claim terms, SenoRx seeks to impose on the claimed inventions a degree of 13 geometrical precision that is neither required by the plain language of the claim, nor counseled by the 14 specification. Indeed, the relevant portions of the specifications teach that geometric precision is 15 unnecessary, evidenced by the use of terms such as "generally" and "substantially." Further, SenoRx 16 attempts to construe the claims to exclude embodiments that the plain meaning of the claims would 17 otherwise cover. In some instances, SenoRx attempts to read the claims to exclude all of the disclosed 18 embodiments. This, of course, is in all but the rarest cases impermissible. 19 SenoRx's proposed constructions run afoul of other fundamental claim construction principles.

20 For example, in another effort to narrow the claimed inventions, SenoRx contends that "predetermined 21 constant spacing" means the same thing as "predetermined spacing." In so arguing, SenoRx disregards 22 the glaring difference between these terms on their face, ignores language from the specification 23 confirming that they mean different things, discounts the Court's own prior ruling that these two terms 24 have different meanings, and overlooks clear Federal Circuit precedent that where a patentee uses 25 different terms, those differences are presumed to reflect a difference in claim scope. 26 Finally, in some instances, SenoRx simply misunderstands the import of the intrinsic record

27 and how that record applies to the claims. In these cases, SenoRx again defaults to the narrowest 28
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1 interpretation of the claim terms that it can conceive, notwithstanding the broad language actually used 2 in the claims. Claim construction is not an exercise of juxtaposing the accused product and the 3 disputed terms and concocting a construction that removes the accused device from the scope of the 4 invention. Hologic respectfully requests that its proposed constructions, which (with one exception) 5 are consistent with the Court's prior construction of many of these same terms, more accurately reflect 6 the plain meaning and the teachings of the intrinsic evidence. Thus, SenoRx's proposed constructions 7 should be rejected.1 8 9 I. 10 11 12 THE '813 AND '204 PATENTS A. "Predetermined Constant Spacing" and "Predetermined Spacing" - SenoRx's Proposed Constructions Ignore Clear Differences in the Claim Language and Usage in the Specification ARGUMENT

The term "predetermined constant spacing" appears in claim 1 of the '813 patent, whereas the

13 facially broader term "predetermined spacing" appears in claim 3 of the '204 patent.2 SenoRx 14 suggests that "predetermined constant spacing" and "predetermined spacing" should be construed as 15 meaning exactly the same thing, despite apparent differences in the phrases themselves. In so doing, 16 SenoRx ignores the general rule that different claim terms are presumed to reflect a different scope. 17 As described in further detail below, Hologic's proposed construction stays true to the express 18 language of the claim and is consistent with the intrinsic evidence. 19 \\ 20 21 22 23 Many of the claim terms at issue here have already been disputed, briefed, argued by litigants, and construed by this Court in a prior infringement action involving two of the three patents asserted here. 24 Xoft, Inc. v. Cytyc Corp. et. al., Case No. C-05-05312 RMW (the "Xoft litigation") (involving both the `813 and `204 patents). With one exception (discussed below), Hologic agrees with all of the Court's 25 prior constructions. Conversely, with one exception, SenoRx disagrees with all of the Court's prior constructions but it fails to offer any persuasive reason why the prior constructions are wrong. 26 2 The '813 patent and the '204 patents are related and share common subject matter between their 27 respective specifications. The '204 patent is a continuation-in-part of the '813 patent due in part to the disclosure of additional subject matter. 28
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1.

"Predetermined Constant Spacing Between Said Inner Spatial Volume and the Radiation Transparent Wall" - SenoRx's Construction Adds Limitations That Are Not Supported (Claim 1, '813 Patent)

Hologic urges that the Court adopt its previous construction of this term, i.e., "spacing

4 determined by one skilled in the art between the wall or edge of the inner spatial volume and the 5 radiation transparent wall of the outer, closed, inflatable chamber, when inflated, which is constant in 6 all directions if the outer chamber is spherical, or constant along a radial plane if the outer chamber is 7 not spherical." Dkt. No. 135-6 at 6-7, 28 (Claim Construction Order from the Xoft litigation). SenoRx 8 offers no principled basis for altering the Court's prior construction. SenoRx's proposed requirement 9 of a "fixed" spacing ­ such that, "for each point on the wall or edge of the inner spatial volume, the 10 distance to the closest point on the outer chamber is the same" ­ is contradicted by the specification, 11 which counsels against reading the claim term "constant" too narrowly. For example, the specification 12 states that one objective is to keep the distance between the inner spatial volume and the radiation 13 transparent wall "substantially constant," '813 patent, 1:50-57, "generally constant," id. at 3:10-13, 14 "somewhat constant," id. at 4:13-16. These words confirm that the spacing is not "fixed" or "the 15 same." The specification's less restrictive description of the claim element is consistent with its 16 description of the radiation transparent wall as conforming tissue to the surface of the balloon; such a 17 wall inherently would not be "fixed" or at the same distance from the wall of the inner spatial volume 18 "for each point on the wall or edge of the inner spatial volume," as SenoRx incorrectly contends. 19 Moreover, SenoRx's proposed construction ignores the practical limitations of radiotherapy

20 that existed in 1997 and today. Verhey Decl. ¶¶ 4-5. Brachytherapy balloons and the lumpectomy 21 margins against which they are expanded are generally spherical in shape but cannot be perfect 22 spheres. Id. The patent's specification expressly recognizes this limitation by avoiding words of 23 exactitude. Id. SenoRx's narrow reading of this claim term to require a "fixed" spacing is divorced 24 from the specification and the understanding of one skilled in the art, and should be rejected. 25 SenoRx also insists that the inner spatial volume and the outer wall must be "concentric" and

26 "the same shape." The Court has already construed this term and concluded that no such limitations 27 are required or supported by the specification. While the patentee clearly contemplated configurations 28
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1 having concentricity and similarly shaped surfaces, it specifically chose not to limit claim 1 to such 2 configurations or embodiments. SenoRx's repeated references to the patent figures are unavailing 3 because the claimed invention is not limited to specific examples or embodiments set forth in the 4 specification. Id. If the patentee had intended to so limit the invention's scope, then he would have 5 said so. SenoRx's proposed additional limitations should be rejected. 6 7 8 2. "Predetermined Spacing . . . Between Said Inner Spatial Volume and the Expandable Surface Element" ­ SenoRx Ignores Clear Differences in Claim Language (Claim 3,3 '204 Patent)

SenoRx ignores the fact that the phrase "predetermined spacing" in the `204 patent is facially

9 broader than the term "predetermined constant spacing" used in the `813 patent. When read in light of 10 the specification and file history of the '204 patent, "predetermined spacing" must be given a broader 11 meaning than "predetermined constant spacing." Indeed, that is exactly what the Court did in the Xoft 12 litigation when it broadly defined this term to mean that "the distance between the inner spatial volume 13 and the expandable surface element is determined in advance." Dkt. No. 135-6 at 24-25 (Claim 14 Construction Order from Xoft litigation). The Federal Circuit has held that "[w]here claims use 15 different terms, those differences are presumed to reflect a difference in the scope of the claims." 16 Forest Labs, Inc. v. Abbott Labs., 239 F.3d 1305, 1310 (Fed. Cir. 2001); cf. Phillips v. AWH Corp., 17 415 F.3d 1303, 1314 (Fed. Cir. 2005) (en banc) ("Differences among claims can also be a useful guide 18 in understanding the meaning of particular claim terms.") 19 SenoRx is unable to point to any intrinsic evidence suggesting that "predetermined spacing" is

20 the same as "predetermined constant spacing." As Hologic demonstrated in its initial claim 21 construction brief, the plain meaning of "predetermined spacing" ­ i.e. "the distance between the inner 22 spatial volume and the expandable surface element," which is "determined in advance" ­ should be 23 adopted. Dkt. No. 134 at 16. SenoRx's reference to Dr. Verhey's prior declaration misses the point. 24 Dkt. No. 130 at 8. The fact that the spacing can be predetermined or made substantially constant does 25 not mean the claim requires a "constant" spacing. Verhey Decl. ¶¶ 6-7. 26 27 28
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This term appears in claim 3, on which asserted claim 4 depends.

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B.

"Three-Dimensional Isodose Profile" - SenoRx Improperly Reads "Concentricity" and "Finality" into the Claims (Claim 1, 17, '204 Patent)

The term "three-dimensional isodose profile that is substantially similar in shape to the

4 expandable surface element" means just that; the plain meaning is apparent without altering the 5 language used by the patentee. Again, SenoRx attempts to add limitations, this time suggesting that 6 the term requires (1) that the isodose profile be "concentric with the outer spatial volume expandable 7 surface," and (2) that the isodose profile be "final." Dkt. No. 130 at 8-11 (SenoRx's Opening Claim 8 Construction Brief). These additional limitations are not supported by the intrinsic evidence. 9 First, SenoRx improperly conflates specification and prosecution statements regarding the

10 claim language "substantially similar in shape" with the notion of "concentricity." In the specification, 11 when the patentee described an embodiment requiring concentricity, it expressly stated so. See '204 12 patent, col. 5:28-29 ("In either the concentric spherical embodiment or the non-spherical configuration 13 of FIG. 5 . . . .").4 Moreover, contrary to SenoRx's contention, "concentricity" was not the basis upon 14 which the inventors distinguished their inventions from the prior art during prosecution before the 15 PTO. The prosecution statements describing "a three-dimensional isodose profile that is substantially 16 similar in shape to the expandable surface element" do not mean that the "three-dimensional isodose 17 profile" must be "concentric," as SenoRx suggests. The mere fact that the balloons in the Williams 18 prior art discussed by the application were not concentric does not provide a basis for limiting the 19 claims to concentric embodiments. Importantly, the arguments accompanying the addition of the 20 "substantially similar in shape" element do not point out or distinguish the Williams balloons as being 21 non-concentric. Cf. Micro Chemical, Inc. v. Great Plains Chemical Co., Inc., 194 F.3d 1250, 1260-61 22 (Fed. Cir. 1999) (finding statements used during prosecution describing differences between the claim 23 and prior art were only relevant to the extent that the difference was recited in the claim--and were not 24 relevant to unclaimed features). It would be inappropriate to limit the claimed invention based on 25 distinctions the inventors did not draw during prosecution. Cf. Computer Docking Station Corp. v. 26 27 28
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In fact, the word "concentric" appears only once in the entire specification.

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1 Dell, 519 F.3d 1366, 1376 (Fed. Cir. 2008) ("Prosecution disclaimer does not apply, for example, if the 2 applicant simply describes features of the prior art and does not distinguish the claimed invention 3 based on those features."). The implicit limitations that SenoRx strains to see in the prosecution 4 history do not exist and cannot "prevail over the plain language of the claim." Elbex Video, Ltd. v. 5 Sensormatic Elecs. Corp., 508 F.3d 1366, 1373 (Fed. Cir. 2007). The prosecution statements in this 6 instance are far from being the requisite "clear and unmistakable" statements necessary to require the 7 importation of concentricity into the phrase "substantially similar in shape," SenoRx's arguments 8 notwithstanding. See Verhey Decl. ¶¶ 8-9. 9 Second, by adding the word "final" to its proposed construction (which is not found in either

10 the claim language or anywhere the specification), SenoRx improperly attempts to import a temporal 11 limitation into the term "three-dimensional isodose profile that is substantially similar in shape to the 12 expandable surface element." To support its construction, SenoRx mischaracterizes the purposes of 13 the invention and proffers unhelpful, conclusory expert testimony. The `204 patent describes two 14 primary purposes of the invention: one purpose is to provide a radiation dose delivered to the target 15 tissue that is "substantially uniform in substantially every direction" ('204 patent, 5:13-19) and another 16 is to provide a "predetermined dose range" such that cancerous tissue is destroyed and healthy or 17 "normal" tissue is not destroyed, i.e. by necrosis. See, e.g. id. at 2:51-55; 6:48-60. Neither of these 18 objectives imposes any requirement of finality; to the contrary, the whole point of the invention is that 19 it will be used flexibly in conjunction with treatment planning software to achieve the desired 20 therapeutic result. One skilled in the art would understand and expect that the desired therapeutic 21 result may call for the dose profile to be modified or adjusted. Accordingly, there is no such thing as a 22 "final" isodose profile. Moreover, as stated previously (dkt. no. 134 at 17), inserting the word "final" 23 into the claim would render the claim vague rather than provide clarification (how would a jury 24 determine when an isodose profile is to be considered "final"). Verhey Decl. ¶ 9. Accordingly, this 25 term should be construed to mean what it says, namely a "three-dimensional isodose profile that is 26 substantially similar in shape to the expandable surface element," and nothing more. 27 28
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C.

"Inner Spatial Volume" - SenoRx Would Improperly Limit the Claim To Only the Preferred Embodiments

The claim term "inner spatial volume" appears in claim 1 of the '813 patent and claim 3 of the

4 '204 patent.5 Again, the meaning of this term was briefed and argued in the prior Xoft litigation and it 5 should mean what the Court construed it to mean, with one modification ­ "a region of space 6 surrounded by an outer spatial volume and either enclosed by a polymeric film wall or defined by the 7 outside surface of a solid radionuclide []." Dkt. No. 135-6 at 3-5 (Claim Construction Order in Xoft 8 litigation.) SenoRx's proposed changes to the Court's prior construction are overly narrow and 9 impermissibly import aspects of certain embodiments from the disclosure into the claims. Specifically, 10 the parties disagree on whether the term "distensible" should be read into the claim and whether, when 11 the inner spatial volume is a radionuclide, it must be "spherical." In both cases, SenoRx's attempt to 12 import these limitations from the specification is improper. Hologic's proposed construction should be 13 adopted because it "stays true to the claim language and most naturally aligns with the patent's 14 description of the invention." Phillips, 415 F.3d at 1316 (quoting Renishaw PLC v. Marposs Societa' 15 per Azioni, 158 F.3d at 1243, 1250 (Fed. Cir. 1998)). 16 17 1. There Is No Justification for Importing "Distensible" into the Claim

SenoRx contends that the specification of the '813 and '204 patents "consistently describe" the

18 "inner spatial volume" as being distensible, thus "mak[ing] clear that the polymeric film walls must be 19 distensible." Dkt. No. 130 at 12 (SenoRx's Opening Claim Construction Brief). To the contrary, the 20 specification never says that an "inner spatial volume" has to be distensible if it is a polymeric film 21 wall: 22 23 24 25 26 27 28
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"Affixed to the tubular body 12 proximate to the distal end 28 thereof is an inner spatial volume 30 which may be defined by a generally spherical polymeric film wall 32." '813 patent, 2:33-36; '204 patent, 3:57-59; "Those skilled in the art will appreciate that instead of having the inner spatial volume 30 defined by a generally spherical polymeric film wall as at 32 . . . ." '813 patent, 2:56-58;

·

SenoRx and Hologic agree that this term should have the same meaning in both the '813 and '204 patents.

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· · · ·

"[I]nstead of having the inner spatial volume 30 defined by a generally spherical polymeric film wall as at 32 . . . ." '204 patent, 4:44-46; "It is not essential to the invention that the chambers 30 and 34 have spherical walls . . . ." '813 patent, 3:10-11; "[W]herein said inner spatial volume is an inner closed, chamber defined by a further radiation transparent wall." '813 patent, 4:53-55 (claim 2); "[R]adioactive source material . . . may be coated on, chemically bonded to, or copolymerized with the material forming inner spherical wall 32." '204 patent, 4:24-27.

8 These passages from the '813 and '204 patents describe embodiments in which the inner spatial 9 volume is a "polymeric wall" and nowhere is there a requirement that it be "distensible." As the 10 Federal Circuit has held, "varied use of a disputed term in the written description attests to the breadth 11 of the claim term rather than providing a limiting definition." Anchor Wall Sys., Inc. v. Rockwood 12 Retaining Walls, Inc., 340 F.3d 1298, 1308 (Fed. Cir. 2003). Thus, the proper construction of "inner 13 spatial volume" does not import the limitation "distensible" because doing so would be inconsistent 14 with the varied use of that term in the specification. Id. 15 In addition, the prosecution history of the '813 patent demonstrates that the inventors did not

16 limit their claims to an "inner spatial volume" with a "distensible" polymeric film wall. For example, 17 the original claims filed in connection with the application that became the '813 patent, original claim 18 2, recited that the "inner spatial volume is an inner closed, distensible chamber." Dkt. No. 135-10 at 119 2. That claim was amended to broaden the language by deleting the term "distensible" so that the 20 claim called for an "inner spatial volume" that "is an inner closed chamber." Id.; see also '813 patent, 21 4:53-55. By this amendment, the inventors clearly expressed their intent--consistent with the scope of 22 the specification--that the "inner spatial volume" need not be "distensible." It would be improper to 23 ignore "the effect of [this amendment] on the scope of the claims." See Libel-Flarsheim Co. v. 24 Medrad, Inc., 358 F.3d 898, 911 (Fed. Cir. 2004). 25 Other claims of the '813 and '204 patents "provide substantial guidance as to the meaning of"

26 the "inner spatial volume" claim term. Phillips, 415 F.3d at 1314. Comparing claim 2 of the '813 27 patent and claim 9 of the '204 patent demonstrates that the "inner spatial volume" may or may not be 28
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1 distensible. Compare '813 patent, 4:53-55 ("wherein said inner spatial volume is an inner closed, 2 chamber defined by a further radiation transparent wall") with '204 patent, 8:59-61 ("wherein the inner 3 spatial volume is an inner closed distensible chamber defined by a further radiation transparent wall" 4 (emphasis added)). Again, if the inventors wanted to claim an invention more narrowly, they knew 5 how to do so by adding the word "distensible" to an "inner closed chamber." See Verhey Decl. ¶¶ 106 11. This is no different from the situation in Phillips, in which the selective use of the term "steel" 7 makes clear that the term "baffles" does "not inherently mean objects made of steel." 415 F.3d at 8 1314. Thus, there is no reason to limit the even broader term "inner spatial volume" to structures that 9 are "distensible." 10 11 12 2. Limiting the "Inner Spatial Volume" to a Radionuclide "Sphere" Improperly Limits the Claim to Preferred Embodiments

SenoRx requests that the Court read the term "spherical" into the meaning of "inner spatial

13 volume." SenoRx places substantial weight on this Court's construction of "inner spatial volume" 14 from the Xoft litigation as limiting the claim to a polymeric film wall or a "radionuclide sphere." Dkt. 15 No. 130 at 11-13 (SenoRx's Opening Claim Construction Brief). It must be noted that the question of 16 whether a "radionuclide" must be spherical when the "inner spatial volume" is a radionuclide was not 17 briefed by either party in the Xoft case, nor was it relevant to the resolution of any issues raised in that 18 case. See Dkt. No. 134 at 6 n.5 (Hologic's Opening Claim Construction Brief). With the Court and 19 the parties now focused on this issue, it becomes apparent from the intrinsic evidence that 20 radionuclides comprising the "inner spatial volume" do not need to be (but can be) spherical. 21 Requiring that radionuclide inner spatial volumes be spherical imports features of a preferred

22 embodiment from the specification into the claims, in derogation of the general disclosure in the 23 specification, which provides that "[i]t is not essential to the invention that the chambers 30 and 34 [i.e. 24 the inner and outer volumes] have spherical walls . . . ." '813 patent, 3:9-10; '204 patent, 5:13-16. 25 The specifications of both the '813 and '204 patents include a number of exemplary embodiments. 26 Among these are two principal embodiments (each of which has numerous variations): (1) an 27 embodiment in which the inner and outer spatial volumes are "generally spherical," (e.g. `813 patent, 28
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1 1:35; Fig. 1), and (2) one in which the inner and outer spatial volumes are non-spherical. (e.g. `813 2 patent, 3:9-14; Fig. 3). Nothing in the specification--or elsewhere in the intrinsic record--limits solid 3 radionuclides to embodiments where they are "generally spherical." Rather, it describes "radioactive 4 particles," '813 patent, 2:66, "radioactive beads," '813 patent, 3:3, "solid radioactive core[s]," '813 5 patent, 4:6-7, '204 patent, 4:56, "solid radionuclides," '813 patent, 4:9; '204 patent, "radiation 6 emitting particles," '204 patent, 5:3-4, or "radioactive particle sources," '204 patent, 5:35. None of 7 these passages requires the radionuclide to be "spherical." To the contrary, the specification makes the 8 point that "[s]olid radionuclides that could be used with the delivery device of the present invention are 9 currently generally available as brachytherapy radiation sources," '813 patent, 4:10-12; '204 patent, 10 4:58-61, and "radioactive micro spheres" are merely one example that was then available from a 11 particular vendor, '813 patent, 4:1-3; '204 patent, 4:48-50. See also Verhey Decl. ¶¶ 12-13 (explaining 12 that the invention's objectives can be achieved whether or not the radionuclide is spherical, and noting 13 that both spherical and non-spherical radionuclides in this context are effectively point sources); see 14 also Dkt. No. 135-7 at 3-4 (Verhey Decl., noting that in 1997, radionuclides used in brachytherapy 15 were often not spherical). Thus, the claim term "inner spatial volume" should not be limited to 16 "spherical" radionuclides because the intrinsic record read as a whole supports a broader construction. 17 See Pfizer, Inc. v. Teva Pharms., USA, Inc., 429 F.3d 1364, 1373-76 (Fed. Cir. 2005) (refusing to 18 construe term "saccharides" as being limited to sugars despite a reference in the specification to 19 "saccharides" (i.e., sugars)). 20 It is improper to "add a narrowing modifier [i.e., "spherical"] before an otherwise general term

21 [radionuclide] that stands unmodified in a claim . . . ." [citations omitted]. For example, if an 22 apparatus claim recites a general structure e.g., a noun [inner spatial volume] without limiting that 23 structure to a specific subset of structures (e.g., with an adjective [e.g., "spherical"]), we will generally 24 construe the claim to cover all known types of that structure that are supported by the patent disclosure. 25 Reinshaw PLC, 158 F.3d at 1249-50. To do otherwise improperly imports aspects of preferred 26 embodiments into the claims--thereby violating fundamental Federal Circuit precedent. See, e.g., 27 Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1370 (Fed. Cir. 2008) (quoting CollegeNet, Inc. v. 28
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1 ApplyYourself, Inc., 418 F.3d 1225, 1231 (Fed. Cir. 2005) for the proposition that "[i]n examining the 2 specification for proper context, however, this court will not at any time import limitations from the 3 specification into the claims"). 4 5 6 D. "Means . . . For Rendering Uniform" - SenoRx's Proposed Construction Impermissibly Adds An Unclaimed Function ('813 Patent, Claim 1)

The parties agree that this term is a means-plus-function element and is subject to 35 U.S.C. §

7 112, ¶ 6, requiring the identification of the claimed function and corresponding structure.6 Hologic 8 requests that the Court construe this term as it did the first time. SenoRx seeks to add limitations to the 9 Court's previous construction of both function and structure.7 SenoRx first argues that the absorbed 10 dose profile must be rendered "substantially" more uniform (rather than simply "more uniform" ­ as 11 the Court previously concluded). SenoRx further contends that the structure must perform the stated 12 function (i.e. rendering the dose more uniform) "by absorbing or attenuating radiation"--despite the 13 claim making no reference to this additional requirement. 14 First, SenoRx identifies no justification for requiring that the absorbed dose profile be rendered

15 "substantially" more uniform, rather than simply "more uniform" ­ as the Court previously decided. 16 This proposed change adds nothing but ambiguity to the claim term. Verhey Decl. ¶ 15. Dr. Orton's 17 assertion that some radiation absorbing or attenuating materials, in conjunction with a low energy 18 source, can "significantly affect the dose versus distance curve" (dkt. no. 132 at 11) provides no basis 19 for narrowing the claim term by requiring that the absorbed dose profile be rendered "substantially" 20 more uniform. Id. 21 22
6 BBA Nonwovens Simpsonville, Inc. v. Superior Nonwovens, L.C.C., 303 F.3d 1332, 1343 (Fed. Cir. 23 2002) (construction of means-plus-function claims requires identification of claimed function and corresponding structure). 24 7 The parties agree that the corresponding structure is "a radiation absorbing or attenuating material." 25 Dkt. No. 130 at 14 (SenoRx's Opening Claim Construction Brief). Moreover, both parties agree that the specification discloses certain materials that, if they or their equivalents are present in the accused 26 device, are encompassed within the literal scope of the claim (e.g., air, x-ray attenuating material, contrast fluid, contrast media used in angiography, water, a gas, or barium sulfate, and their 27 equivalents). Id. SenoRx, however, believes that these materials must perform a function other than that recited in the claim. 28

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1

Second, it is well settled that the addition of an unstated functional limitation to a claim, as

2 urged by SenoRx, is impermissible. See, e.g., Applied Med. Res. Corp. v. U.S. Surgical Corp., 448 3 F.3d 1324, 1334 (Fed. Cir. 2006) (stating that it is improper to "import[] unclaimed functions into a 4 means-plus-function claim" by "defining a claimed function to require more than is actually claimed"); 5 Wenger Mfg., Inc. v. Coating Mach. Sys., Inc., 239 F.3d 1225, 1233 (Fed. Cir. 2001) ("In construing a 6 means-plus-function limitation, a court must identify both the claimed function and the corresponding 7 structure in the written description for performing that function."). The Federal Circuit has cautioned 8 that where "the recited function is clear on its face, it [is] improper to incorporate . . . additional 9 functional limitation[s]" into the claim." LG Elecs., Inc. v. Bizcom Elecs., Inc., 453 F.3d 1364, 1379 10 (Fed. Cir. 2006), cert. granted on other grounds, 128 S. Ct. 28 (2007). Therefore, SenoRx's proposed 11 construction, which seeks to import an additional function to be performed by the disclosed structure 12 (i.e., the radiation absorbing or attenuating material), should be rejected. 13 The intrinsic record does not dictate the construction urged by SenoRx. SenoRx contends "the

14 radiation absorbing material must perform the function by absorbing or attenuating the radiation" (dkt. 15 no. 130 at 14) - based on a single embodiment disclosed at column 3, lines 51-65 of the '813 patent. 16 This passage is merely illustrative of how one embodiment performs the recited function. Moreover, 17 that discussion pertains to an embodiment where the attenuating material is in the inner spatial volume 18 and the radionuclide is in the outer spatial volume. Id. SenoRx admits that claim 1 also encompasses 19 an embodiment in which the attenuating material is in the outer spatial volume and the radionuclide is 20 in the inner spatial volume. Dkt. No. 130 at 16 (SenoRx's Opening Claim Construction Brief). 21 SenoRx's conclusion from this ­ i.e., that the material "for performing the claimed function must 22 perform that function by absorbing or attenuating radiation" flies in the face of the claim language, 23 which does not recite a specific mechanism by which the function of "rendering uniform . . ." is 24 performed. Thus, it is impermissible to limit the recited function to a particular scientific mechanism 25 26 27 28
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1 of "attenuation," as SenoRx proposes.8 SenoRx's construction improperly imports an unclaimed 2 function into the claim. See, e.g., LG Elecs., 453 F.3d 1364, 1379 (Fed. Cir. 2006). 3 SenoRx's reliance on the prosecution history also fails to justify the importation of an

4 additional functional limitation. SenoRx ignores the rule that "[f]or a prosecution statement to prevail 5 over the plain language of the claim, the statement must be clear and unmistakable such that the public 6 should be entitled to rely on any `definitive statements made during prosecution.'" Elbex Video, Ltd. v. 7 Sensormatic Elecs. Corp., 508 F.3d at 1373 (quoting Omega Eng'g, Inc. v. Raytek Corp., 334 F.3d 8 1314, 1323 (Fed. Cir. 2003)). Here, the prosecution history does not clearly state that the "means . . . 9 for rendering uniform" must include the function of attenuating or absorbing radiation. Indeed, the 10 prosecution history does not refer to any particular mechanism (such as absorption or attenuation) by 11 which the claimed function is performed--nor did it distinguish the prior art on that basis.9 See, e.g., 12 Dkt. No. 135-10 at 5 ("There is then provided a means disposed in the chamber, not having the 13 radiation source, for rendering uniform the radial absorbed dose profile of emissions from the chamber 14 that contains the radiation source." (emphasis in original).) Far from constituting a "clear and 15 unmistakable" statement sufficient to overcome the plain language of the claimed function, the 16 prosecution history does not require the function of "rendering uniform" to be performed in any 17 particular way. Therefore, SenoRx's proposed construction should be rejected. See also Verhey Decl. 18 ¶ 16 (explaining that SenoRx's proposed language would improperly limit the claim by adding a 19 requirement that is not always true). 20 21 22 The fact that the specification discloses as corresponding structures materials in the outer spatial volume that attenuate or absorb the radiation of no moment; one cannot conflate the recited function in 24 the claim with the behavior of the corresponding structures disclosed in the specification. All that is required is that the corresponding structures disclosed in the specification perform the claimed 25 function. 9 Rather, the distinction over the Ishiwara et al. '360 patent was that the chamber "cannot provide a 26 uniform radiation profile" or how it could be modified to provide a uniform radial absorbed dose profile. Dkt. No. 135-10 at 5. 27 23 28
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1 2 3

E.

"Inner Closed Chamber" ­ SenoRx Adds a Limitation Without Support in the Specification (`813 Patent, Claim 11)10

This claim term should be entitled to its plain and ordinary meaning. Verhey Decl. ¶ 17.

4 SenoRx appears to agree that "[b]y its plain meaning, this claim further limits the inner spatial volume 5 to a `closed chamber' or compartment located inside of the outer chamber." Dkt. No. 130 at 17 6 (SenoRx's Opening Claim Construction Brief). Instead of stopping there, however, SenoRx seeks to 7 add a limitation requiring that the "inner closed chamber" also be "completely inside . . . and closed off 8 within the outer chamber." To support this proposed addition, SenoRx relies only on the conclusory 9 statement of its expert, Dr. Orton. Id. This "conclusory, unsupported assertion[]"is "not useful to [the] 10 [C]ourt." Phillips, 415 F.3d at 1318.11 Nor does it make sense as a matter of logic; since the claimed 11 function of the inner closed chamber is to contain the radioactive material (see claim 8, from which 12 claim 11 depends), the chamber cannot be "completely inside and closed off within the outer chamber" 13 because then there would be no way of getting the radioactive material into or out of it. 14 In the absence of any support in the intrinsic evidence for narrowing this claim term, SenoRx's

15 acknowledgement that the plain meaning of "inner closed chamber" is "a `closed chamber' or 16 compartment located inside of the outer chamber" supports Hologic's construction. Moreover, as set 17 forth in Hologic's Opening Claim Construction Brief (Dkt. No. 134 at 11), the specification and other 18 intrinsic evidence describe embodiments of the invention that would be excluded by SenoRx's unduly 19 narrow claim interpretation. Therefore, SenoRx's interpretation should be rejected.12 20 21 22 This term is found in claim 2 of the '813 patent, on which asserted claim 11 depends. 11 Indeed, Dr. Orton's testimony as to this claim term consists of one conclusory statement: that "[a] 24 person of ordinary skill in the art would understand the term `inner closed chamber' to mean an inner chamber completely closed off within the outer, closed, inflatable chamber." Dkt. No. 132 at 11, ¶ 37 25 (Orton Declaration). 23
12 The Court previously found that the closed, inflatable chamber" means exactly 26 and requires no construction. Dkt. No. term "outer, (Claim Construction Order in Xoft v. Cytycthat ­ 135-6 at 28 Corp.) The same should be true for "inner, closed chamber." 27 10

28
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1 2 3

F.

"Providing a Controlled Dose at the Outer Spatial Volume Expandable Surface to Reduce or Prevent Necrosis in Healthy Tissue Proximate to the Expandable Surface" (`204 Patent, Claim 4)13

The Court previously construed a near identical term in the Xoft litigation. Dkt. No. 135-6 at

4 23. The same construction should apply here. Verhey Decl. ¶¶ 18-20. SenoRx seeks to alter the 5 Court's construction by (1) replacing the language referring to "lethally damaging cells" with "reduce 6 or eliminate the risk of damage . . ."; and (2) adding the phrase "as compared to devices in which the 7 tissue is directly adjacent to the radiation source." Neither proposed addition is supported. As Hologic 8 has shown, those skilled in the art at the time the patent applications were filed understood the term 9 necrosis to mean the death of tissue.14 SenoRx's construction confuses the plain understanding of 10 reduce or prevent necrosis" by introducing a wholly new and undefined concept: reduce or eliminate 11 "risk of damage." Dkt. No. 130 at 18 (SenoRx's Opening Claim Construction Brief). SenoRx's 12 proposed construction is inconsistent with the specification's description of the process of "necrosis." 13 See '204 patent, 6:55-57 ("With increasing cell death comes increasing risk of necrosis or tissue death 14 in healthy tissue that is treated with a high dose of radiation." (emphasis added)); see Verhey Decl. ¶ 15 19 (it is impossible to "eliminate the risk of damage" to healthy tissue ­ as SenoRx suggests). The 16 intrinsic evidence shows that the reduction or prevention of necrosis is achieved by "keep[ing] the 17 maximum radiation dose delivered by the brachytherapy apparatus as low as possible while still 18 delivering the desired therapeutic dose to the desired range of tissue."15 '204 patent, 6:57-60. The 19 specification reveals no attempt by the inventors to depart from this common meaning of the term 20 "necrosis," as it was understood in the art. 21 22 This term is found in claim 2 of the '204 patent, on which claim 4 depends. 14 Dr. Orton opines that Hologic's proposed construction "would require avoiding any death to cells in 24 healthy tissue, which is inconsistent with how a person of ordinary skill would understand `reduce or prevent necrosis in healthy tissue' within the meaning of the claim." Dkt. No. 132 at 17, ¶ 54 (Orton 25 Declaration). That is not an accurate characterization of Hologic's claim construction. Verhey Decl. ¶ 19. 26 15 Moreover, the specification teaches that there is an "inherent difference in radiosensitivity between 27 the tumor and the adjacent normal tissues," which permits destruction of "cancerous tissue while causing minimal disruption to surrounding normal tissues." '204 patent, 6:48-52. 28 23
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1

SenoRx also seeks to add the requirement that the claimed "controlled dose . . ." must be

2 viewed in light of a single, specific prior art method of operation in which ". . . the tissue is directly 3 adjacent to the radiation source." Dkt. No. 130 at 18 (SenoRx's Opening Claim Construction Brief) 4 (. . . "as compared to devices in which the tissue is directly adjacent to the radiation source."). The 5 specification and claims fail to teach or suggest such a comparison, nor is one required by the intrinsic 6 record. Moreover, such a comparison is impractical--the degree of necrosis (or in SenoRx's terms: 7 "risk of damage") will depend on the amount of energy radiated by the radiation source, the patient's 8 physical profile, as well as its relative proximity to the tissue, as would be understood by those skilled 9 in the art. Verhey Decl. ¶ 20. Thus, Hologic's proposed definition, which stays true to the language of 10 the claim and the inventions described in the specification, is the proper one and should be adopted. 11 II. 12 13 14 15 SENORX'S PROPOSED CONSTRUCTIONS OF THE TERMS FROM THE '142 PATENT IMPROPERLY DIVORCE INDIVIDUAL TERMS FROM THE REMAINDER OF THE INTRINSIC EVIDENCE16 A. "Apparatus Volume" and "Located So As To Be Spaced Apart From the Apparatus Volume" ('142 Patent, Claim 1)

SenoRx's flawed construction of the terms "apparatus volume" and "located so as to be spaced

16 apart from the apparatus volume" forms the basis for its motion for summary judgment that the 17 claimed invention is inoperable, rendering the claims invalid under 35 U.S.C. § 112. Dkt. No. 133. 18 However, SenoRx's claim construction is divorced from the context of the patent, reads out every 19 embodiment described in the specification, and runs contrary to the understanding of one skilled in the 20 art - as well as common sense. SenoRx's position runs counter to the rule that "[a] claim construction 21 that excludes preferred embodiments "is rarely, if ever correct and . . . require[s] highly persuasive 22 evidentiary support." NeoMagic Corp. v. Trident Microsystems, Inc., 287 F.3d 1062, 1074 (Fed. Cir. 23 2002) (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1583 (Fed. Cir. 1996)). Moreover, 24 to the extent that SenoRx's construction would render the claims invalid, SenoRx fails to overcome the 25 26 Hologic originally asserted claims 1, 6, and 8 of the `142 patent. Based on representations made by SenoRx regarding the accused device after the parties filed their opening claim construction briefs, 27 Hologic has agreed not to assert claim 6. Accordingly, claim 6 is not discussed herein. 28
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1 statutory presumption of validity, see 35 U.S.C. § 282 (2006), which "requires a showing of facts 2 proved by clear and convincing evidence." Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d 1374, 3 1378 (Fed. Cir. 2005). Because the disputed claim terms are easily amenable to a construction that 4 encompasses the preferred embodiments, that stays true to the language of the claim, are consistent 5 with statements made during prosecution of the '142 patent, and are well understood by those skilled 6 in the art, SenoRx's strained constructions should be rejected. 7 8 9 1. An "Apparatus Volume," in the Context of the Claimed Invention, Is a Structure Composed of an Expandable Outer Surface

Hologic's construction of the term "apparatus volume"17 stays true to the language of the

10 claim, gives effect to what the inventors actually invented, is consistent with the specification, and is 11 reflected in the inventors' statements to the PTO during prosecution of the application that became the 12 '142 patent. Thus, this Court should reject SenoRx's attempt to impose an unduly literal reading on 13 the term "apparatus volume" and adopt Hologic's construction. Verhey Decl. ¶¶ 21-23. 14 SenoRx contends that Hologic's proposed construction is contrary to (1) Cytyc's position in the

15 Xoft litigation; (2) other intrinsic evidence; and (3) the claim language. Dkt. No. 130 at 19 (SenoRx's 16 Opening Claim Construction Brief). On all three points, SenoRx is wrong. 17 First, Cytyc's arguments in the Xoft case regarding the meaning of "inner spatial volume" do

18 not contradict its proposed construction of the term "apparatus volume" in this case. As a threshold 19 matter, the "inner spatial volume" is not a claim element in the `142 patent, and the `142 patent was 20 not asserted in the Xoft litigation. As a result, differences in construction are permissible for wholly 21 different terms based upon a different disclosure. See Innova/Pure Water, Inc. v. Safari Water 22 Filtration Sys., Inc., 381 F.3d 1111, 1119 (Fed. Cir. 2004) ("[W]hen an applicant uses different terms 23 in a claim it is permissible to infer that he intended his choice of different terms to reflect a 24 It is inappropriate to construe the term "apparatus volume" without resort to the surrounding language "three-dimensional apparatus volume configured to fill an interstitial void . . . and define an 26 inner boundary of the target tissue being treated." See Phillips, 415 F.3d at 1314. Therefore, while Hologic may refer to the term "apparatus volume," Hologic does so merely by way of shorthand for 27 "three-dimensional apparatus volume configured to fill an interstitial void . . . and define an inner boundary of the target tissue being treated." 28 25
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1 differentiation in the meaning of those terms."). Although the '142 patent is a continuation-in-part of 2 the '813 and '204 patents at issue in Xoft, (1) the claim terms are different, and (2) the intrinsic 3 evidence for the `142 patent demonstrates that the term "apparatus volume" is not to be limited to a 4 geometric volume. Thus, SenoRx places undue and misguided reliance on the prior construction of the 5 '813 and '204 patents. See, e.g., Medtronic, Inc. v. Advanced Cardiovascular Sys., Inc., 248 F.3d 6 1303, 1315 (Fed. Cir. 2001) (refusing to use intrinsic evidence from parent application pertaining to a 7 claim term different than the term under consideration); cf. Elkay Mfg. Co. v. Ebco Mfg. Co., 192 F.3d 8 973, 980 (Fed. Cir. 1999) (citing Jonsson v. The Stanley Works, 903 F.2d 812, 817-818, (Fed.Cir.1990) 9 for the proposition that "[w]hen multiple patents derive from the same initial application, the 10 prosecution history regarding a claim limitation in any patent that has issued applies with equal force 11 to subsequently issued patents that contain the same claim limitation" (emphasis added)). 12 Moreover, there is in actuality no conflict between the position taken by Hologic in this case

13 for the term "apparatus volume" and the position taken by Cytyc in the Xoft case for the term "inner 14 spatial volume." Similar to the `142 patent, the `813 and `204 patents speak of an "inner spatial 15 volume" with reference to a structure that defines it. See, e.g., `813 patent, claim 2 ("wherein said 16 inner spatial is an inner closed, chamber defined by a further radiation transparent wall"); `204 patent, 17 claim 9 ("wherein the inner spatial volume is an inner closed, distensible chamber defined by a further 18 radiation transparent wall"). Thus, the "inner spatial volume" is not simply a volume of space but it 19 also has a surface or boundary such that there can be a "predetermined spacing" between it and the 20 structure that defines the "outer spatial volume." See, e.g., `813 patent, claim 1, element c; `204 21 patent, claim 3. 22 Second, as noted above, the intrinsic record demonstrates that the inventors did not intend for

23 the term "apparatus volume" to be interpreted strictly and literally as a "region of space," but rather, 24 with reference to a structure composed of the expandable outer surface. Thus, rather than requiring the 25 rigid, literal reading SenoRx seeks to impose on the term "apparatus volume," the claims "can and 26 should be interpreted as the patentees intended," Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 27 28
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1 F.3d 1358, 1363 (Fed. Cir. 2008), with the meaning of the term "apparatus volume" being "the three2 dimensional geometric solid composed of an expandable outer surface." 3 Third, the claim language shows that Hologic's interpretation is the correct one. The

4 expandable outer surface element, e.g., a balloon, "defines" (i.e., composes) the apparatus volume. 5 '142 Patent, 8:63-64. In other words, the phrase "expandable outer surface defining . . ." makes clear 6 that "three-dimensional apparatus volume" is to be understood with reference to the tangible structure 7 that creates or defines--hence the use of the modifiers "three-dimensional" and "apparatus" with the 8 word "volume." Thus, as the term "steel" modified the term "baffles" in the claim term "steel baffles" 9 in Phillips, 415 F.3d at 1314, the term "expandable outer surface" modifies the term "apparatus 10 volume" by conferring upon it structural features, i.e., three dimensions for filling an interstitial void 11 and surface area for defining the inner boundary of the target tissue. See ACTV, Inc. v. Walt Disney 12 Co., 346 F.3d 1082, 1088 (Fed. Cir. 2003) ("[T]he context of the surrounding words of the claim also 13 must be considered in determining the ordinary and customary meaning of those terms."). Hologic's 14 proposed construction gives effect to all of the claim language and does not render any portion of it 15 superfluous or nugatory. Cf. Merck & Co. v. Teva Pharms USA, Inc., 395 F.3d 1364, 1372 (Fed. Cir. 16 2005) (adopting construction that avoids rendering language superfluous). Moreover, Hologic's 17 interpretation includes certain disclosed embodiments, whereas, as SenoRx points out in its motion for 18 summary judgment of invalidity of claim 1, its interpretation would result in an inoperable device and 19 would exclude all of the embodiments disclosed in the '142 patent. SenoRx lacks the "highly 20 persuasive evidentiary support" for such a construction. NeoMagic Corp., 287 F.3d at 1074. 21 22 23 2. "Located So As To Be Spaced Apart From the Apparatus Volume" ­ Once the Term "Apparatus Volume" Is Properly Construed, the Term "Spaced Apart" Is Clear

When the term "apparatus volume" (in the phrase "three-dimensional apparatus volume

24 configured to fill an interstitial void . . . and define an inner boundary of the target tissue being 25 treated") is properly construed with reference to the "expandable outer surface" element that defines it, 26 the proper meaning of the term "located so as to be spaced apart from the apparatus volume" is clear. 27 Verhey Decl. ¶ 24. "Spaced apart" means "located so as to be not on or touching the apparatus 28
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1 volume," i.e., the surface area of the apparatus volume that defines the inner boundary of the target 2 tissue to be treated. Dkt. No. 134 at 19-20 (Hologic's Opening Claim Construction Brief). Aside from 3 the arguments it asserts with respect to the term "apparatus volume," SenoRx offers no justification for 4 its construction of "spaced apart"--which would exclude all preferred embodiments and potentially 5 render the claim invalid.18 Dkt. No. 130 at 23 (SenoRx's Opening Claim Construction Brief). As set 6 forth above, those arguments have no merit. Under the proper construction of the "apparatus volume" 7 terms, the "spaced apart" term "can and should be interpreted as the patentees intended," Ortho8 McNeil Pharm., 520 F.3d at 1363, to mean "located so as to be not on or touching the apparatus 9 volume." 10 11 12 B. "Asymmetrically Located and Arranged Within the Expandable Surface" - Means Not on the Longitudinal Axis ('142 Patent, Claim 1)

Every reference to "asymmetry" in the `142 refers to the longitudinal axis of the expandable

13 surface ­ i.e., if a radiation source is not on the longitudinal axis, the source is "asymmetric." 14 Hologic's proposed construction of the term "asymmetrically located and arranged within the 15 expandable surface" says exactly that: "located and arranged so as not to be on the longitudinal axis of 16 the expandable surface element." Dkt. No. 134 at 23-4 (Hologic's Opening Claim Construction Brief). 17 SenoRx's only comment with respect to this claim term is that its arguments "substantially track