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) HOWREY LLP 7 1299 Pennsylvania Avenue, NW Washington, DC 20004 8 Telephone: (202) 783-0800 Facsimile: (202) 383-6610 9 Attorneys for Plaintiffs 10 HOLOGIC, INC., CYTYC CORPORATION and HOLOGIC L.P. 11 12 13 UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA SAN JOSE DIVISION Case No. C08 00133 RMW (RS) PLAINTIFFS' OPENING CLAIM CONSTRUCTION BRIEF (PATENT L.R. 45(a)) Markman Hearing Date: June 25, 2008 Time: To Be Set Room: Courtroom 6, 4th Floor Judge: Hon. Ronald M. Whyte

14 HOLOGIC, INC., CYTYC CORPORATION, and HOLOGIC L.P., 15 Plaintiffs, 16 vs. 17 SENORX, INC., 18 Defendant. 19 20 21 22 23 24 25 26 27 28
Pls.' Opening Claim Construction Brief Case No. C08 00133 RMW (RS)

AND RELATED COUNTERCLAIMS.

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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 V. D. E. F. G. III. IV. I. II.

TABLE OF CONTENTS
Page(s) PRELIMINARY STATEMENT.............................................................................................. 1 BACKGROUND..................................................................................................................... 1 A. B. THE TECHNOLOGY.................................................................................................. 1 THE EXPERTS ........................................................................................................... 2

APPLICABLE LAW ............................................................................................................... 2 CONSTRUCTION OF `813 PATENT TERMS ....................................................................... 4 A. B. C. "inner spatial volume" (All Asserted Claims) ............................................................... 5 "predetermined constant spacing between said inner spatial volume and the radiation transparent wall" (All Asserted Claims)............................................. 7 "means...for rendering uniform the radial absorbed dose profile of the emissions from the one of the inner spatial volume and outer chamber containing the radionuclides" (All Asserted Claims) ...................................... 9 "inner, closed chamber" (Asserted Claim 11) ............................................................. 10 "plurality of radioactive solid particles" (Asserted Claim 12) ..................................... 12 "predetermined locations" (Asserted Claim 12) .......................................................... 12 "plurality of radioactive solid particles placed at predetermined locations" (Asserted Claim 12)................................................................................... 12

CONSTRUCTION OF `204 PATENT TERMS ..................................................................... 13 A. B. C. "inner spatial volume" (All Asserted Claims) ............................................................. 14 "outer spatial volume" (All Asserted Claims) ............................................................. 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" (Asserted Claim 4)........................................... 15 "predetermined spacing...between said inner spatial volume and the expandable surface element" (Asserted Claim 4 ................................................... 16 "plurality of solid radiation sources" (Asserted Claim 17) .......................................... 16 "three-dimensional isodose profile that is substantially similar in shape to the expandable surface element" (All Asserted Claims) ................................ 17 "isodose profile having a shape substantially similar to the shape of the outer spatial volume" (Claim 17) .......................................................................... 18

D. F. F. G.

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1 VI. 2 3 4 5 6 7 8 9 10 11 12 13 VII. 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28

CONSTRUCTION OF `142 PATENT TERMS ..................................................................... 19 A. B. C. "located so as to be spaced apart from the apparatus volume" (Claim 1).................................................................................................................... 19 "being provided on at least two elongate members extending into the apparatus volume" (Claim 6) ................................................................................ 20 "at least one of the elongate members being shaped to provide asymmetric placement of the radiation source with respect to a longitudinal axis through the apparatus volume" (Claim 6) ........................................ 21 "apparatus volume" (Claims 1 & 6)............................................................................ 22 "three-dimensional apparatus volume configured to fill an interstitial void" (Claims 1 & 8) ................................................................................. 22 "asymmetrically located and arranged within the expandable surface" (Claim 1) ...................................................................................................... 23 "predetermined asymmetric isodose curves (All Asserted Claims) ............................. 24 "plurality of solid radiation sources" (Claim 6) .......................................................... 25

D. E. F. G. H.

CONCLUSION ..................................................................................................................... 25

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1 2 3 CASES

TABLE OF AUTHORITIES
Page(s)

4 Accord Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc), cert. denied, 126 S. Ct. 1332 (2006)..............................................................................................................................passim 5 6 Acumed LLC v. Stryker Corp., 483 F.3d 800 (Fed. Cir. 2007).................................................................................................. 6 7 8 Applied Med. Res. Corp. v. U.S. Surgical Corp., 448 F.3d 1324 (Fed. Cir. 2006).............................................................................................. 10 9 10 Bausch & Lomb, Inc. v. Barnes-Hind/Hydrocurve, Inc., 796 F.2d 443 (Fed. Cir. 1986)................................................................................................ 10 11 Biagro W. Sales, Inc. v. Grow More, Inc.¸ 423 F.3d 1296 (Fed. Cir. 2005)................................................................................................ 4 12 13 CollegeNet, Inc. v. ApplyYourself, Inc., 418 F.3d 1225 (Fed. Cir. 2005)................................................................................................ 3 14 Comark Commc'ns, Inc. v. Harris Corp., 156 F.3d 1182 (Fed. Cir. 1998)................................................................................................ 3 15 16 Elkay Mfg. Co. v. Ebco Mfg. Co., 192 F.3d 973 (Fed. Cir. 1999)................................................................................................ 20 17 Epcon Gas Sys., Inc. v. Bauer Compressors, Inc., 279 F.3d 1022 (Fed. Cir. 2002)................................................................................................ 4 18 19 Hockerson-Halberstadt, inc. v. Converse Inc., 183 F.3d 1369 (Fed. Cir. 1999)................................................................................................ 2 20 In re Nelson, 280 F.2d 172 (C.C.P.A. 1960).................................................................................................. 3 21 22 Jonsson v. The Stanley Works, 903 F.2d 812 (Fed.Cir.1990),................................................................................................. 20 23 JVW Enters., Inc. v. Interact Accessories, Inc., 424 F.3d 1324 (Fed. Cir. 2005).................................................................................3, 9, 10, 18 24 25 Kahn v. Gen. Motors Corp., 136 F.3d 1472 (Fed. Cir. 1998)................................................................................................ 4 26 Key Pharms. v. Hercon Labs. Corp., 161 F.3d 709 (Fed. Cir. 1998).................................................................................................. 4 27 28
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1 Libel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898 (Fed. Cir. 2004).................................................................................................. 6 2 MBO Labs., Inc. v. Becton Dickinson, 474 F.3d 1323 (Fed. Cir. 2007)............................................................................... 3, 18, 21, 24 3 4 MedRad, Inc. v. MRI Devices Corp., 401 F.3d 1313 (Fed. Cir. 2005)................................................................................................ 2 5 Medtronic, Inc. v. Advanced Cardiovascular Systems, Inc., 248 F.3d 1303 (Fed. Cir. 2001).............................................................................................. 20 6 7 Minnesota Mining & Mfg. Co. v. Johnson & Johnson Orthopaedics, Inc., 976 F.2d 1559 (Fed. Cir. 1992).............................................................................................. 10 8 NeoMagic Corp. v. Trident Microsystems, Inc., 287 F.3d 1062 (Fed. Cir. 2002).......................................................................................... 3, 23 9 10 Oatey Co. v. IPS Corp., 514 F.3d 1271 (Fed. Cir. 2008).....................................................................................8, 11, 23 11 Omega Eng'g, Inc. v. Raytek Corp., 334 F.3d 1314 (Fed. Cir. 2003).........................................................................................14, 17 12 13 PCTEL, Inc. v. Agere Sys., Inc., 2005 WL 2206683, at *3 (N.D. Cal., Sept. 8 2005)...........................................................14, 17 14 U.S. Surgical Corp. v. Ethicon, Inc., 103 F.3d 1554 (Fed. Cir. 1997)........................................................................................passim 15 16 Varco, L.P. v. Pason Sysytems USA Corp., 436 F.3d 1368 (Fed. Cir. 2006) ............................................................................................... 6 17 Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576 (Fed. Cir. 1996)............................................................................................ 3, 20 18 19 Wright Flow Control Corp. v. Velan, Inc., 438 F.3d 1374 (Fed. Cir. 2006).............................................................................................. 14 20 STATUTES 21 35 U.S.C. § 112, ¶ 6 (2006) ........................................................................................................... 4, 10 22 23 24 25 26 27 28
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1

Pursuant to the Stipulated Scheduling Order, Plaintiffs Hologic, Inc., Cytyc Corporation, and

2 Hologic L.P. (collectively, "Hologic") respectfully submit this Brief addressing the 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") (attached hereto as Exhibits 5 A, B, and C, respectively, to the Declaration of Katharine L. Altemus In Support of Plaintiffs' Opening 6 Claim Construction Brief, "Altemus Decl.")1. Hologic currently asserts claims 11 and 12 of the `813 7 patent, claims 4 and 17 of the `204 patent, and claims 1, 6, and 8 of the `142 patent against Defendant 8 SenoRx, Inc. ("SenoRx"). 9 I. 10 PRELIMINARY STATEMENT Dramatic differences mark the parties' approach to claim construction. Hologic proposes

11 constructions that are straightforward. In many cases, Hologic simply applies the plain meaning of the 12 claim terms as apparent to one of ordinary skill in the art informed by the intrinsic evidence (i.e., the 13 specification and prosecution history). Accord Phillips v. AWH Corp., 415 F.3d 1303, 1313-15 (Fed. 14 Cir. 2005) (en banc), cert. denied, 126 S. Ct. 1332 (2006). In contrast, SenoRx urges this Court, 15 without support from or contrary to intrinsic evidence, to restrict the plain meaning of the patent 16 claims. In most cases, SenoRx asks this Court to rewrite the claims to narrow their scope to less than 17 what the inventors actually invented and claimed. SenoRx also requests that the Court limit the claim 18 terms to exemplary embodiments in the specification--or, in some cases--urges constructions that 19 would exclude preferred embodiments. Each of these approaches is erroneous under modern claim 20 construction jurisprudence. SenoRx's strained interpretations of the disputed terms should be rejected. 21 II. 22 23 BACKGROUND A. THE TECHNOLOGY

All three patents-in-suit are related. The `813 patent is the parent. The `204 and `142 patents

24 are continuations-in-part of the `813 patent. Rather than repeat an explanation of the technology of the 25 patents-in-suit with which the Court is well familiar, and in the interest of brevity, Hologic refers the 26 27 28
1

Unless otherwise noted, all cited exhibits are exhibits attached to the Altemus Decl.
1

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1 Court to synopses of the technology at issue contained within multiple previous filings with, and orders 2 from this Court, as well as to specific discussions of each patent-in-suit, infra. Ex. D at 2-3; Ex. E at 2; 3 Ex. F at 2-3; Ex. G at 4, 6-7. 4 5 B. THE EXPERTS

To demonstrate how one skilled in the art2 would construe the disputed claim terms, Hologic

6 provides the testimony of Dr. Lynn J. Verhey. Dr. Verhey is a well-recognized and independent expert 7 in methods of delivering radiation to cancer patients, and unquestionably qualified to provide opinions 8 as one skilled in the relevant art. He has provided testimony to this Court in the past. His credentials 9 are summarized within the Declaration of Lynn J. Verhey, Ph.D. ("Verhey Decl."), attached as Exhibit 10 H. 11 III. 12 APPLICABLE LAW Claim construction begins with the words of the claims themselves, which define the subject

13 matter that the inventors intended to claim. See Phillips, 415 F.3d at 1313 ("The inquiry into how a 14 person of ordinary skill in the art understands a claim term provides an objective baseline from which 15 to begin claim interpretation."). The words of the claims are not interpreted in a vacuum: they must 16 be read in light of other words in the claim, the patent specification, and the prosecution history (i.e., 17 the intrinsic evidence). See MedRad, Inc. v. MRI Devices Corp., 401 F.3d 1313, 1319 (Fed. Cir. 2005). 18 Importantly, "[a]bsent some particular reason to do otherwise, the claim terms must be interpreted as 19 would one of ordinary skill in the art . . . and in light of the particular patent in suit." Id.; see also 20 Phillips, 415 F.3d at 1313. 21 Contextual language--either in the same claim, or in other claims--may be a key to

22 determining what the inventors intended in their use of certain claim terms; and, in any event, should 23 not be ignored. See Hockerson-Halberstadt, inc. v. Converse Inc., 183 F.3d 1369, 1374 (Fed. Cir. 24 1999) ("Proper claim construction...demands interpretation of the entire claim in context, not a single 25 element in isolation."). At least as important, the specification--of which the claims are a part--"is 26 27 28
Pls.' Opening Claim Construction Brief Case No. C08 00133 RMW (RS) 2 2 i.e., the objective person from whose perspective the intrinsic evidence must be viewed. Phillips, 415 F.3d at 1313.

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1 the single best guide to the meaning of the disputed term." Phillips, 415 F.3d at 1315. Within the 2 specification, the inventors may "use a term in a manner either more or less expansive than its general 3 usage in the relevant community, and thus expand or limit the scope of the term in the context of the 4 patent claims." CollegeNet, Inc. v. ApplyYourself, Inc., 418 F.3d 1225, 1231 (Fed. Cir. 2005). 5 While the specification is critical to understanding what the inventors claimed as their

6 invention, several principles guide its use in understanding the scope of the claims. First, the Federal 7 Circuit has repeatedly warned against improperly importing limitations into the claim. See, e.g., MBO 8 Labs., Inc. v. Becton Dickinson, 474 F.3d 1323, 1333 (Fed. Cir. 2007) (stating that importation of 9 limitations into claims is "fraught with `danger'" (quoting Phillips, 415 F.3d at 1323)); JVW Enters., 10 Inc. v. Interact Accessories, Inc., 424 F.3d 1324, 1335 (Fed. Cir. 2005) ("We do not import limitations 11 into claims from examples or embodiments appearing only in a patent's written description, even when 12 a specification describes very specific embodiments of the invention or even describes only a single 13 embodiment . . . ."). Second, a claim construction that excludes preferred embodiments "is rarely, if 14 ever correct and . . . require[s] highly persuasive evidentiary support." NeoMagic Corp. v. Trident 15 Microsystems, Inc., 287 F.3d 1062, 1074 (Fed. Cir. 2002) (quoting Vitronics Corp. v. Conceptronic, 16 Inc., 90 F.3d 1576, 1583 (Fed. Cir. 1996)). These two principles require this Court to walk a "fine line 17 between reading a claim in light of the specification, and reading a limitation into the claim from the 18 specification." Comark Commc'ns, Inc. v. Harris Corp., 156 F.3d 1182, 1186 (Fed. Cir. 1998). 19 Third, the prosecution history, though "often lack[ing] the clarity of the specification," may

20 also be considered. See Phillips, 415 F.3d at 1317. This exchange between the patent examiner and 21 the inventors was "created by the patentee in attempting to explain and obtain the patent," and may 22 "demonstrat[e] how the inventor understood the invention." Id. 23 Lastly, this Court may also consider extrinsic evidence, such as expert testimony. This is

24 because the patent claims and the specification are directed to those skilled in the relevant art--and 25 therefore, a skilled artisan's view on the meaning of certain claim terms is relevant to what the claims 26 mean. See, e.g., Phillips, 415 F.3d at 1313 (quoting In re Nelson, 280 F.2d 172 (C.C.P.A. 1960), for 27 the proposition that "[t]he descriptions in patents are not addressed to the public generally, to lawyers 28
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1 or to judges, but, as section 112 says, to those skilled in the art to which the invention pertains or to 2 which it was most nearly connected"). Thus, expert testimony may be considered in construing the 3 claims so long as it stays true to the intrinsic evidence. Biagro W. Sales, Inc. v. Grow More, Inc.¸ 423 4 F.3d 1296, 1302 (Fed. Cir. 2005) ("Extrinsic evidence, such as expert testimony, may be useful in 5 claim construction, but it should be considered in the context of the intrinsic evidence."); Key Pharms. 6 v. Hercon Labs. Corp., 161 F.3d 709, 716 (Fed. Cir. 1998). 7 One claim term at issue in this litigation is in "means-plus-function" format. See 35 U.S.C. §

8 112, ¶ 6 (2006). By statute, this claim term covers both any structure(s) in the specification and 9 equivalents of that/those structures. Id. Construction of a "means-plus-function" term "requires 10 identification of the function recited in the claim and a determination of what structures have been 11 disclosed in the specification that correspond to the means for performing" the claimed function. 12 Epcon Gas Sys., Inc. v. Bauer Compressors, Inc., 279 F.3d 1022, 1032 (Fed. Cir. 2002). Those 13 structures that are clearly linked by the specification to the function are the structures that are literally 14 within the scope of the claim--as are their equivalents. Kahn v. Gen. Motors Corp., 136 F.3d 1472, 15 1476 (Fed. Cir. 1998). 16 IV. 17 CONSTRUCTION OF `813 PATENT TERMS3 The `813 patent relates to an instrument comprising a concentric arrangement of an inner

18 spatial volume and an outer spatial volume defined by an inflatable chamber, disposed near the distal 19 end of a catheter body. One of the volumes contains a source of radiation, while the other volume may 20 contain a radiation absorptive material. In one preferred embodiment, shown in Figure 1 of the patent, 21 the inner volume is defined by an enclosed chamber surrounding the catheter body and containing a 22 radioactive source. The outer chamber, surrounding the inner volume, is then inflated with air or other 23 radiation absorbing material so that its wall contacts the wall of the surgical cavity substantially at all 24 points. The distance between the radiation source and the wall of the outer chamber can be made 25 26 3 Hologic addresses herein only those terms about which the parties disagree and which Hologic believes to be material to
the resolution of this suit. As to terms not addressed, Hologic's position is as set forth in the parties' Joint Claim 27 Construction Statement (to be filed on May 30, 2008, concurrently with parties' Reply Briefs), which Hologic incorporates by reference herein.

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1 substantially constant. This embodiment permits the controlled delivery of radiation to a layer of 2 tissue surrounding the surgical cavity. 4 By manipulating the volume and type of material in the outer 3 chamber, the ratio of the absorbed dose at the surface of the wall of tissue to the dose at the tissue 4 depth where the minimum dose is prescribed to be received can be controlled so as to maximize the 5 efficacy of the treatment and minimize adverse side effects, namely, unwanted necrosis of healthy 6 tissue. 7 The `813 patent teaches that other embodiments can be used to deliver therapeutic radiation to

8 the layer of tissue surrounding a surgical cavity. Col 2:64 ­ 4:20; FIGS. 3-5. These other 9 embodiments include the use of: (1) a radioactive liquid within an inner inflatable chamber; (2) a 10 number of radioactive solid particles; (3) a slurry containing particles of a radioactive isotope; or (4) a 11 solid radioactive source. Alternatively, these same radiation sources can be placed in the volume of 12 space between the inner chamber and the outer inflatable chamber. Any of these embodiments might 13 be used as a means of delivering radiation to tissue within the wall of a surgical cavity. 14 15 16 17 18 19 There are two substantive differences between the proposed constructions. First, where the A. "inner spatial volume" (All Asserted Claims) SenoRx's Proposed Construction A region of space surrounded by an outer spatial volume that is either enclosed by a distensible polymeric film wall or defined by the outside surface of a solid radionuclide sphere

Hologic's Proposed Construction a region of space surrounded by an outer spatial volume and either enclosed by a polymeric film wall or defined by the outside surface of a solid radionuclide

20 inner region of space is surrounded by a polymeric film wall, SenoRx seeks to add a requirement that 21 the wall be "distensible." Secondly, SenoRx seeks to require that if the inner spatial volume is a 22 radionuclide, that radionuclide must be a sphere. Both of SenoRx's additions to the claim language 23 should be rejected. 24 25 26 4 The tissue to be treated and the resected cavity can be thought of as an orange peel with the fruit (i.e., the tumor) 27 corresponds to the thickness of the tissue to be treated ­ in most procedures the "orange peel" of tissue to be treated is about 28
2 centimeters thick. See, e.g., `813 patent at FIG. 4. Pls.' Opening Claim Construction Brief Case No. C08 00133 RMW (RS) 5 removed. A radiation source is placed within the space previously occupied by the fruit. The thickness of the "orange peel"

SenoRx's argument that the claim should be limited to a "distensible polymeric film wall" is

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1 incorrect. None of the claims refers to a distensible wall. In fact, during prosecution, claims directed 2 to an embodiment including "an inner closed distensible chamber" were broadened--by deleting the 3 word "distensible." Ex. I at 1, 2. "[I]t would be improper to disregard the effect of that action on the 4 scope of those claims." Libel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 911 (Fed. Cir. 2004). Nor 5 does the specification require that the wall be distensible. Indeed, the "Summary of the Invention" 6 section of the '813 patent, while referring to the "polymeric film wall" does not describe it as 7 "distensible;" a pattern that is repeated elsewhere in the specification. See col. 1:50-55; col. 2:34-36, 8 56-58. Although established law prohibits a court from limiting the claimed invention to "preferred 9 embodiments or specific examples in the specification," SenoRx attempts to do exactly that. See 10 Varco, L.P. v. Pason Sysytems USA Corp., 436 F.3d 1368, 1375 (Fed. Cir. 2006). There is no 11 justification for reading the claims so narrowly, as this Court has already recognized. Ex. F at 3-5, 28 12 (April 27, 2007 Claim Construction Order in Xoft, Inc. v. Cytyc Corp. et al., Case No. C-05-05312 13 RMW [Dkt. No. 109].) 14 SenoRx's second attempt to limit the "inner spatial volume," by requiring a "spherical"

15 radionuclide, is not supported by the intrinsic evidence.5 The specification provides that "it is not 16 essential that the chambers 30 and 34 have spherical walls . . . ." Col. 3:9-10; see also. col. 4:25-30 17 ("the invention can be carried out by . . . different equipment and devices . . . various modifications . . . 18 can be accomplished without departing from the scope of the invention."). Claim 13 further shows that 19 the applicants knew how to insert a spherical limitation when desired, but specifically chose not to do 20 so with respect to claim 1. 6 See Acumed LLC v. Stryker Corp., 483 F.3d 800, 807 (Fed. Cir. 2007) 21 ("The intrinsic evidence . . . suggests that the patentees knew how to restrict their claim coverage . . . . 22 23 24 sphere, adopting the sphericity language suggested in Xoft's proposed construction without analysis or comment. The
5 The Court previously construed "inner spatial volume" to include either a polymeric film wall or a solid radionuclide main issue in the Xoft litigation was not the shape of the radionuclide, but whether Xoft's brachytherapy device used any for this limitation, Hologic respectfully advocates that such a limitation is unmerited despite being subsumed within the

25 radionuclide. Thus, the shape of the radionuclide was a tangential, non-briefed issue. Given the lack of intrinsic evidence 26 Court's prior construction of "inner spatial volume."
concentric."

27 6 Claim 13 reads "The apparatus as in claim 2 wherein the inner and outer chambers are spherical in shape and are 28
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1 They could have used the word "[spherical]," as they did [elsewhere]. Instead, they chose a different 2 term that implies a broader scope."). Moreover, one of ordinary skill in the art would appreciate that 3 claiming a "spherical" radionuclide would not reflect the realities of standard brachytherapy practice, 4 as solid radionuclides "generally available as brachytherapy radiation sources" at the time of the 5 invention were and are not necessarily spherical. Col. 4:9-11; Verhey Decl. at 3-4. 6 7 8 9 10 11 12 13 14 B. "predetermined constant spacing between said inner spatial volume and the radiation transparent wall" (All Asserted Claims) Hologic's Proposed Construction spacing predetermined by one skilled in the art between the wall or edge of the inner spatial volume and the radiation transparent wall of the outer, closed, inflatable chamber, when inflated, which is constant in all directions if the outer chamber is spherical, or constant along a radial plane if the outer chamber is not spherical SenoRx's Proposed Construction Fixed spacing, predetermined by one skilled in the art before administering radiation, between the wall or edge of the inner spatial volume and the radiation transparent wall of the outer, closed inflatable chamber, when inflated, which for each point on the wall or edge of the inner spatial volume, the distance to the closest point on the outer chamber is the same (i.e., the inner spatial volume and outer chamber are concentric and the same shape)

The Court has already considered this claim term and agreed with Hologic's proposed

15 construction. Ex. F at 6-7. In attempting to add "fixed spacing" and "each point on the wall or edge" 16 limitations, among others, SenoRx offers no justification to modify the previous construction and lacks 17 the intrinsic evidence to support its unduly restrictive interpretation. This claim term means that the 18 spacing between the inner spatial volume and the radiation transparent wall of the outer, closed 19 inflatable chamber, when inflated, can be made constant. Ex. H at Ex. C (at 7:2-5). If the outer 20 chamber is spherical, then the distance is constant in all directions. Id. If cylindrical, however, then 21 the distance is constant around a radial plane that is perpendicular to the axis of the catheter. Id. 22 Figures 1 and 3 (below, left and right, respectively) show the constant spacing between the inner 23 spatial volume and the radiation transparent wall in both the spherical and ellipsoidal configurations. 24 \\ 25 26 27 28
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1 2 3 4 5 6 7 Rather than elucidate, SenoRx's addition of a "fixed spacing" limitation renders the claim more

8 ambiguous. The word "fixed" has been cut by SenoRx from whole cloth; it does not appear anywhere 9 in the intrinsic record. SenoRx's attempt to limit "constant" to "fixed" conflicts with the 10 specification's explanation that "constant" should not be construed too literally--i.e., the objective is 11 to keep the spacing between the inner and outer chambers "somewhat," "substantially" or "generally" 12 constant to avoid hot spots. Col. 4:15-16; 1:55-57; 3:11-13. Moreover, it is well understood that one 13 skilled in the art may want to change the spacing during treatment, but as long as the spacing is 14 "constant," this limitation is satisfied. 15 SenoRx also improperly seeks to require that "each point on the wall or edge of the inner

16 spatial volume" be equidistant to "the closest point on the outer chamber." This construction 17 improperly excludes a preferred embodiment of the invention (see, e.g., FIG. 3 above7). The claims 18 generically cover both spherical and non-spherical embodiments. And the written description further 19 supports this conclusion by referring to both the spherical and non-spherical embodiments as including 20 the claimed "constant spacing." See col. 3:10-13 (describing shape as secondary to a "generally 21 constant spacing"). The claims should be construed accordingly. Oatey Co. v. IPS Corp., 514 F.3d 22 1271, 1277 (Fed. Cir. 2008) ("At least where claims can reasonably to interpreted to include a specific 23 embodiment, it is incorrect to construe the claims to exclude that embodiment, absent probative 24 evidence on the contrary."). SenoRx's proposed additions to the Court's prior construction of this term 25 should be rejected. 26 27 7 In which the distance from the "wall or edge" of the inner spatial volume to the "closing point on the outer chamber" may
not be the same at each end of the inner spatial volume. Pls.' Opening Claim Construction Brief Case No. C08 00133 RMW (RS)

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1 2 3 4 5 6 7 8 9 10

C. "means...for rendering uniform the radial absorbed dose profile of the emissions from the one of the inner spatial volume and outer chamber containing the radionuclides" (All Asserted Claims) Hologic's Proposed Construction function: making the absorbed dose of radiation more uniform to prevent overtreatment of body tissue at or close to the outer wall of the instrument structure: a radiation absorbing or attenuating material, e.g., air, x-ray contrast fluid, contrast media used in angiography, water, a gas, or barium sulfate or their equivalents SenoRx's Proposed Construction Function: Making the absorbed dose of radiation substantially more uniform between the surface of the outer chamber and a predetermined depth in the target tissue. Structure: A radiation absorbing or attenuating material, e.g., air, x-ray contrast fluid, contrast media used in angiography, water, a gas, barium sulfate, or their equivalents, that performs this function by absorbing or attenuating radiation

The Court has already considered this limitation and agreed with Hologic's proposed

11 construction. Ex. F at 8-10. For the same reasons set forth in the Court's Claim Construction Order, 12 the Court should adopt Hologic's construction. 13 The first step in the construction of this means-plus-function element is a determination of the

14 claimed function. JVW Enters., 424 F.3d at 1330. Here, the function identified by the limitation is 15 "rendering uniform the radial absorbed dose profile of the emissions . . . ." Col. 4:49-50. As Dr. 16 Verhey explains, the radial absorbed dose profile is the absorbed dose in tissue, which varies as a 17 function of distance from the center of the cavity along a direction of interest. Ex. H at Ex. C (at 6:2118 28). In the `813 patent, the direction of interest would be from the cavity wall to a specific depth in the 19 20 21 22 23 24 25 target tissue at which a prescribed therapeutic dose is defined. Id. The specification explains that one goal of the invention was to render the absorbed dose profile in the target tissue more uniform than it would otherwise be thereby "preventing over-treatment of body tissue at or close to the outer wall 36 of the instrument." Col. 3:2833. Describing Figure 4 (shown left), the written

26 description explains the objective of flattening line 40 to achieve an absorbed dose profile depicted by 27 line 42. See Col. 4:14-38. 28
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1

The specification does not provide any basis for requiring a "substantial" change in the

2 absorbed dose profiles. Rather, it describes a more "uniform" profile. See Abstract ("the apparatus 3 functioning to provide a more uniform absorbed dose profile . . ."); Col. 1:63-67 ("so as to provide a 4 more radially uniform radiation dosage"); Col. 1, line 36 ("as uniform as possible"); see also Ex. F at 9 5 ("[T]he inventor's purpose was to deliver radiation more uniformly than had previously been done, 6 thus preventing over-treatment of body tissue at or close to the outer wall . . . of the instrument.") In 7 this context, "uniform" means uniform enough to serve the objects of the invention. See Minnesota 8 Mining & Mfg. Co. v. Johnson & Johnson Orthopaedics, Inc., 976 F.2d 1559, 1565-67 (Fed. Cir. 1992) 9 ("lubricated" means sufficient lubricant to serve the invention's purpose); Bausch & Lomb, Inc. v. 10 Barnes-Hind/Hydrocurve, Inc. 796 F.2d 443 (Fed. Cir. 1986) (same). No intrinsic evidence champions 11 a requirement that the radial absorbed dose be "substantially" more uniform. 12 The second step in construing this means-plus-function element is an identification of the

13 corresponding structure in the written description. JVW Enters., 424 F.3d at 1330; 35 U.S.C. § 112, ¶ 14 6. The parties agree that the corresponding structure disclosed in the specification is "a radiation 15 absorbing or attenuating material," but SenoRx attempts to add the words "that performs this function 16 by absorbing or attenuating radiation." SenoRx seeks to interject additional function to the claim 17 under the guise of calling it "structure." This, of course, is impermissible. See, e.g., Applied Med. Res. 18 Corp. v. U.S. Surgical Corp., 448 F.3d 1324, 1334 (Fed. Cir. 2006) ("A court errs when it improperly 19 imports unclaimed functions into a means-plus-function claim limitation."). Because this language 20 does not describe any structure at all, but rather seeks to impose additional, unclaimed function into the 21 claim, it should be rejected. 22 23 24 25 26 27 28
Pls.' Opening Claim Construction Brief Case No. C08 00133 RMW (RS) 10 8 This element is contained within Claim 2 on which asserted Claim 11 depends (via Claim 8).

D.

"inner, closed chamber" (Asserted Claim 11)8 SenoRx's Proposed Construction A compartment located completely inside of the outer chamber and closed off within the outer chamber

Hologic's Proposed Construction inner, closed chamber

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1

The term "inner, closed chamber" should be construed to mean exactly that, an "inner, closed

2 chamber." See U.S. Surgical Corp. v. Ethicon, Inc. 103 F.3d 1554, 1568 (Fed. Cir. 1997) (holding that 3 courts are not required to construe every disputed term unless necessary). This term has an ordinary 4 and customary meaning to one of skill in the art without reference to intrinsic or extrinsic evidence, 5 and there is no evidence of any intent by the inventors to impart a novel or special meaning to the term. 6 Thus, "inner, closed chamber" should be construed to mean "inner, closed chamber." 7 SenoRx's proposed construction cannot be correct because it would exclude a preferred

8 embodiment. See `813 patent, FIG. 1 & Col. 2:35-37 (describing and depicting an inner "chamber 30 9 [that] is in fluid communication with the inflation port 26," thus the inner spatial volume is not 10 "completely" inside the outer chamber and not "closed off within the outer chamber."); Oatey, 514 11 F.3d at 1276-77 (a claim interpretation excluding a preferred embodiment is "rarely, if ever, correct"). 12 Indeed, SenoRx's agreement that "outer, closed, inflatable chamber" (in asserted claim 1 of the `813 13 patent) is unambiguous and requires no additional construction belies its contention that the similar 14 term "inner, closed chamber" is unclear and requires construction. 15 Further, the Court already considered and rejected an analogous argument (made with respect

16 to the related '204 patent) in the context of Hologic's Motion for Preliminary Injunction. Ex. F at 17 7:15-8:10. SenoRx argued that the lumens in its Contura device protrude into the catheter shaft and 18 therefore cannot constitute an "inner spatial volume" because they are not completely surrounded by 19 the outer spatial volume. Id. The Court disagreed, reasoning that if SenoRx were correct, that 20 construction would impermissibly exclude the embodiments wherein the portion of the device holding 21 the radioactive material in the inner spatial volume was in contact with the outer spatial volume. Id. at 22 7:22-8:10. The same reasoning applies to the term "inner, closed chamber" in the related `813 patent, 23 which has essentially the same disclosure as the '204 patent. See Ex. A at FIGs. 1, 3 and 5, col. 2:3524 42. Thus, to adopt SenoRx's proposed construction of "inner, closed chamber" would impermissibly 25 exclude a preferred embodiment from the claims. 26 \\ 27 28
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1 2 3 4 5

E.

"plurality of radioactive solid particles" (Asserted Claim 12) SenoRx's Proposed Construction two or more separate radioactive solid particles placed in the inner spatial volume at the same time

Hologic's Proposed Construction plurality of radioactive solid particles

This term means what it says - a "plurality of radioactive solid particles." See Ethicon, Inc. 103

6 F.3d at 1568. There was no attempt by the inventors to impart a novel or special meaning to this term 7 and there is no need to further refine the language they chose to define their invention. Furthermore, 8 this Court has already considered the meaning of this term within the context of the `813 patent and 9 found that no further clarification of the meaning is appropriate. Ex. F at 11-12, 28. Thus, "plurality 10 of radioactive solid particles" should be construed to mean "plurality of radioactive solid particles." 11 There is no need to clarify that "plurality" means "two or more" or that the particles have to be 12 "separate." 13 In any event, no intrinsic evidence supports SenoRx's contention that the "plurality of

14 radioactive solid particles" in claim 12 must be "placed in the inner spatial volume at the same time." 15 Claim 12 simply refers to the solid particles having pre-determined locations. Col. 6:1-5. Neither the 16 specification nor the prosecution history suggests that the particles must be placed in the inner volume 17 at the same time. Col. 2:69-3:9; Fig. 5. 18 19 20 21 F. "predetermined locations" (Asserted Claim 12) SenoRx's Proposed Construction more than one predetermined location

Hologic's Proposed Construction predetermined locations

Hologic agrees with SenoRx's proposed construction. Thus, "predetermined locations" should

22 be construed to mean "predetermined locations." No further construction of this term is necessary. 23 24 25 26 27 28
Pls.' Opening Claim Construction Brief Case No. C08 00133 RMW (RS) 12

G. "plurality of radioactive solid particles placed at predetermined locations" (Asserted Claim 12) Hologic's Proposed Construction SenoRx's Proposed Construction plurality of radioactive solid particles placed at predetermined locations two or more separate radioactive solid particles placed in the inner spatial volume at the same time at more than one predetermined location

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1

Again, the limitation means what it says, making further elaboration on its meaning

2 unnecessary. See Ethicon, 103 F.3d at 1568. This term has an ordinary and customary meaning to one 3 of skill in the art, and there is no evidence of any intent by the inventors to impart a novel or special 4 meaning to the term. Furthermore, this Court has already considered the meaning of this term within 5 the context of the `813 patent and found that no further clarification of the meaning is appropriate. Ex. 6 F at 11-12, 28 ("[S]ince the language is understandable as is, no construction of [this claim term] is 7 necessary or appropriate."). Thus, "plurality of radioactive solid particles placed at pre-determined 8 locations" should be construed to mean "plurality of radioactive solid particles placed at predetermined 9 locations." 10 In any event, there is no basis for SenoRx's narrow claim interpretation. Again, there is no

11 intrinsic basis for adding a restriction that multiple, separate, solid particles be placed in the inner 12 spatial volume at the same time. Neither the specification, the prosecution history, nor Claim 12 13 imposes such a limitation on the unambiguous language of the claim. Col. 6:1-5; Col. 2:69-3:9; Fig. 5. 14 V. 15 CONSTRUCTION OF `204 PATENT TERMS The `204 patent is a continuation-in-part of the `813 patent. The asserted claims are directed

16 toward an apparatus for brachytherapy used to irradiate interstitially diseased cells within the tissue 17 surrounding the cavity created by the surgical removal of proliferative (e.g., cancerous) tissue. The 18 apparatus includes a catheter body member having a proximal end and a distal end, an inner spatial 19 volume proximate to the distal end of the catheter body member, an outer spatial volume defined by an 20 expandable surface element proximate to the distal end of the body member, and surrounding and 21 concentric with the inner spatial volume. In a preferred embodiment, a radiation source is disposed 22 within the inner spatial volume. 23 The `204 patent describes a number of different sources of radioactivity that can be used to

24 deliver the therapeutic radiation to the excision cavity, including, without limitation, radioactive 25 microspheres (FIG. 4), concentric non-spherical chambers (FIG. 5), a single, solid radiation emitting 26 material surrounded by an expandable cage defining the shape of the tumor cavity (FIG. 6), a 27 radioactive fluid filling the inner chamber and the outer chamber filled with air or other radiation 28
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1 absorbing substance (FIG. 7b), and a single, solid source surrounded by an outer chamber filled with a 2 radiation absorbing substance (FIG. 7c). Figure 7d shows examples of radiation profiles which might 3 be obtained by the embodiments shown in Fig. 7a-7c where the depth of interest is shown as 2 cm from 4 the surface of the outer volume. As can be seen, different embodiments can be used to vary the ratio of 5 the dose at the prescribed depth to the dose at the wall of the cavity. 6 7 8 9 10 11 Constructions proposed by both parties consider the phrase "inner spatial volume" within the A. "inner spatial volume" (All Asserted Claims) SenoRx's Proposed Construction A region of space surrounded by an outer spatial volume that is either enclosed by a distensible polymeric film wall or defined by the outside surface of a solid radionuclide sphere

Hologic's Proposed Construction a region of space surrounded by an outer spatial volume and either enclosed by a polymeric film wall or defined by the outside surface of a solid radionuclide.

12 parent `813 to be the same within the child `204 patent. Because the `813 and `204 patents are related, 13 this claim term should carry the same construed meaning in both patents. See Omega Eng'g, Inc. v. 14 Raytek Corp., 334 F.3d 1314, 1334 (Fed. Cir. 2003) ("[W]e presume, unless otherwise compelled, that 15 the same claim term in the same patent or related patents carries the same construed meaning."); 16 PCTEL, Inc. v. Agere Sys., Inc., 2005 WL 2206683, at *3 (N.D. Cal., Sept. 8 2005) ( "[w]here patents17 in-suit share the same disclosures, common terms are construed consistently across all claims in both 18 patents"). Thus, as explained above in section IV.A, "inner spatial volume" should be construed to 19 mean "a region of space surrounded by an outer spatial volume and either enclosed by a polymeric 20 film wall or defined by the outside surface of a solid radionuclide."9 21 22 B. "outer spatial volume" (All Asserted Claims)

The parties have agreed to adopt the construction "a region of space defined by an expandable

23 surface element and surrounding an inner spatial volume." No further construction of this term is 24 25
9 In addition to the reasons already given for interpreting "inner spatial volume" as Hologic proposes, claim 9 of the `204 26 patent states that "the inner spatial volume is an inner closed, distensible chamber," suggesting that claims that do not include the "distensible" element are not so limited. See Curtiss-Wright Flow Control Corp. v. Velan, Inc., 438 F.3d 1374, 27 1380 (Fed. Cir. 2006) (claim differentiation creates a "presumption that an independent claim should not be construed as requiring a limitation added by a dependent claim.").

28
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1 necessary. 2 3 4 5 6 7 8 9 10 C. "providing a controlled dose at the outer spatial volume expandable surface to reduce or prevent necrosis in healthy tissue proximate to the expandable surface" (Asserted Claim 4)10 Hologic's Proposed Construction controlling the ratio of the dose at the expandable surface of the outer spatial volume to the prescribed dose at the depth of interest in the target tissue so that the dose at the expandable surface is not so high that it lethally damages cells in healthy tissue in contact with the expandable surface SenoRx's Proposed Construction Controlling the ratio of the dose at the expandable surface of the outer spatial volume to the prescribed dose at the depth of interest in the target tissue so as to reduce or eliminate the risk of damage to healthy tissue in contact with the expandable surface as compared to devices in which the tissue is directly adjacent to the radiation source

The Court has already considered this limitation and agreed with Hologic's proposed

11 construction. Ex. F at 23. The `204 specification clearly explains that the various embodiments of the 12 apparatus work to control the ratio of the dose at the surface of the outer spatial volume to the dose at 13 the prescription depth, thereby reducing or preventing necrosis proximate the expandable surface. Col. 14 1:55-60, 2:7-18, 51-55.; 6:52-60. SenoRx's proposed language "so as to reduce or eliminate the risk of 15 damage" is inconsistent with one of the purposes of the invention. One of the inventor's express 16 objectives was to reduce or eliminate necrosis--not to reduce or eliminate "risk." Id. Similarly, the 17 applicant sought to prevent healthy cells from dying (i.e., "necrosis")--not merely from being sub18 lethally "damaged." Id. Hologic's proposed construction more accurately reflects the invention's 19 stated purpose--and the language of the claim. See Phillips, 415 F.3d at 1316 ("The construction that 20 stays true to the claim language and most naturally aligns with the patent's description of the invention 21 will be, in the end, the correct construction."). 22 There is also no basis for adding a limitation that the `204 patent invention provide a controlled

23 dose of radiation that improves upon "devices in which the tissue is directly adjacent to the radiation 24 source." The claimed invention discloses a better way to perform brachytherapy, but is not limited to 25 an improvement over unspecified prior art devices. SenoRx's argument lacks adequate support in the 26 27 28
Pls.' Opening Claim Construction Brief Case No. C08 00133 RMW (RS) 15 10 This element is contained within Claim 2 on which asserted Claim 4 depends.

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1 language of the claim - or, for that matter, elsewhere in the intrinsic record. This absence of support 2 undermines any justification for construing this term in a way that would limit the invention to an 3 improvement over a particular prior art technique. 4 5 6 7 8 9 10 11 12 D. "predetermined spacing...between said inner spatial volume and the expandable surface element" (Asserted Claim 4)11 SenoRx's Proposed Construction Fixed spacing, predetermined by one skilled in the art before administering radiation, between the wall or edge of the inner spatial volume and the wall of the expandable surface element, when inflated, which for each point on the wall or edge of the inner spatial volume, the distance to the closest point on the expandable surface element is the same (i.e., the inner spatial volume and expandable surface element are concentric and the same shape)

Hologic's Proposed Construction the distance between the inner spatial volume and the expandable surface element is determined in advance

This term is similar to the term "predetermined constant spacing between said inner spatial

13 volume and the radiation transparent wall," discussed above in Section IV.B. However, in some 14 respects, this term is broader. First, it does not require "constant" spacing. Second, rather than 15 claiming a "radiation transparent wall," the claim calls for an "expandable surface element." Hologic 16 contends that this "predetermined spacing" is "the distance between the inner spatial volume and the 17 expandable surface element" and that the spacing "is determined in advance." 18 As it did with respect to the '813 patent, SenoRx again attempts to read limitations into the

19 claim that are not supported by the claim language itself,the written description or the prosecution 20 history. Because the '204 and '813 patents share similar disclosures, Hologic incorporates its 21 arguments set forth in Section IV.B and requests that the Court reject SenoRx's unduly restrictive 22 reading of this term. 23 24 25 26 27 28
Pls.' Opening Claim Construction Brief Case No. C08 00133 RMW (RS) 16

F.

"plurality of solid radiation sources" (Asserted Claim 17) SenoRx's Proposed Construction Two or more separate radioactive solid sources placed in the inner spatial volume at the same time

Hologic's Proposed Construction plurality of solid radiation sources

11 This element is contained within claim 3 on which asserted claim 4 depends.

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1

The phrase "plurality of solid radiation sources" in the `204 patent mirrors the nearly identical

2 phrase "plurality of radioactive solid particles" in the parent `813 patent. SenoRx proffers an identical 3 construction for each, and no elaboration on the meaning of either term is necessary. Ethicon, 103 4 F.3d at 1568; Ex. H at 4. Because the `813 and `204 patents are related, this claim term should carry 5 the same construed meaning as the nearly identical terms in the `813 and `204 patents. See Omega 6 Eng'g, Inc., 334 F.3d at 1334; PCTEL, Inc., 2005 WL 2206683, at *3. Thus, "plurality of solid 7 radiation sources" should be construed to mean "plurality of solid radiation sources." 8 9 10 11 12 13 14 This claim term means what it says and that no further elaboration is necessary. Ethicon, 103 F. "three-dimensional isodose profile that is substantially similar in shape to the expandable surface element" (All Asserted Claims)12 Hologic's Proposed Construction three-dimensional isodose profile that is substantially similar in shape to the expandable surface element SenoRx's Proposed Construction a final three-dimensional isodose profile that is substantially similar in shape to the outer spatial volume expandable surface and is concentric with the outer spatial volume expandable surface

15 F.3d at 1568. This term has an ordinary and customary meaning to one of skill in the art. Moreover, 16 there is no evidence that the inventors intended to impart a novel or special meaning to the term. Thus, 17 "three-dimensional isodose profile that is substantially similar in shape to the expandable surface 18 element" should be construed to mean "three-dimensional isodose profile that is substantially similar 19 in shape to the expandable surface element." 20 SenoRx's proposed construction fabricates new restrictions on otherwise clear claim language

21 without any support in the intrinsic record. Because SenoRx's approach is contrary to established 22 claim construction principles, it should be rejected. First, SenoRx's proposes adding the word "final" 23 to describe the isodose profile, which serves only to create ambiguity where none exists. The claim 24 language makes no reference to any temporal standard, so there is no baseline against which to 25 evaluate "final." Second, referring to a "final" isodose profile suggests that use of the apparatus 26 27 28
Pls.' Opening Claim Construction Brief Case No. C08 00133 RMW (RS) 17 12 This element is contained within Claim 1 on which both asserted claims depend.

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1 generates multiple, "intermediate," isodose profiles, and that only the "final" one is substantially 2 similar in shape to the expandable surface element. No intrinsic evidence supports this conclusion or 3 provides justification for adding such a limitation. 4 Again, with the language "concentric with the outer spatial volume expandable surface,"

5 SenoRx manufactures a claim limitation where none exists. This is not an attempt to clarify the 6 "substantially similar" claim language--SenoRx retains that language, but then seeks to impose a 7 requirement that the profile be "concentric." The claims do not require this. Phillips, 415 F.3d at 1313 8 (the words of the claims define the subject matter that the inventors intended to claim). Likewise, 9 neither the written description nor the prosecution history suggests that the claim language be so 10 limited. SenoRx's proposed construction should be rejected. 11 12 13 14 15 16 17 G. "isodose profile having a shape substantially similar to the shape of the outer spatial volume" (Claim 17) Hologic's Proposed Construction isodose profile having a shape substantially similar to the shape of the outer spatial volume SenoRx's Proposed Construction a final three-dimensional isodose profile that is substantially similar to the shape of the outer spatial volume expandable surface and is concentric with the outer spatial volume expandable surface

This claim term means what it says and that further elaboration of that meaning is unnecessary.

18 See Ethicon, Inc. 103 F.3d at 1568. One of ordinary skill in the art would understand the meaning of 19 this claim term without altering the claim language. Ex. H at 4. Thus, "isodose profile having a shape 20 substantially similar to the shape of the outer spatial volume" should be construed to mean "isodose 21 profile having a shape substantially similar to the shape of the outer spatial volume." 22 SenoRx's proposed construction is identical to its definition of the similar phrase within claim

23 1 ("three-dimensional isodose profile that is substantially similar in shape to the expandable surface 24 element") discussed immediately above. See, supra, at section V.F. As discussed in section V. F. 25 above, SenoRx's proposal, rather than clarifying the language at issue, creates ambiguity and adds 26 unsupported limitations to the claim term. SenoRx's proposed construction should be rejected. MBO 27 Labs., 474 F.3d 1323 at 1333; JVW Enters., 424 F.3d at 1335. 28
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1 VI. 2

CONSTRUCTION OF `142 PATENT TERMS The `142 patent, a continuation-in-part of both the `813 and `204 patents, describes an

3 apparatus that delivers localized radiation in an asymmetric fashion to target tissue surrounding a 4 surgical extraction site. The apparatus includes an expandable outer surface element defining an 5 apparatus spatial volume, a radiation source disposed within the apparatus volume, and a means for 6 providing a predetermined asymmetric isodose profile within the target tissue. Several embodiments 7 include a radiation source shaped or located so as to be asymmetrically placed with respect to the 8 longitudinal axis of the apparatus to create asymmetric isodose curves within the target tissue. See, 9 e.g., FIGS. 1, 3-7. In particular, FIG. 4 illustrates an embodiment in which three curved radiation 10 source wires, each including a number of solid radiation particles, are arranged asymmetrically with 11 respect to the longitudinal axis of the device to achieve the desired asymmetric isodose profiles. 12 13 14 15 16 The proper construction of the phrase "located so as to be spaced apart from the apparatus A. "located so as to be spaced apart from the apparatus volume" (Claim 1) SenoRx's Proposed Construction located outside (i.e., not within) the apparatus volume

Hologic's Proposed Construction located so as to be not on or touching the apparatus volume

17 volume" is one in which the claim term is not read in isolation, "but in the context of the entire patent, 18 including the specification." Phillips, 415 F.3d at 1313. Both within the specification and during 19 prosecution, the `142 inventors made clear that "spaced apart" referred to the positional relationship 20 between the radiation source and the wall of the expandable outer surface element, and hence the target 21 tissue. Col. 4:27-30 (an "outer spatial volume 30" is "affixed to the tubular body 12"). This outer 22 spatial volume is "defined by an outer polymeric film barrier 32 that is appropriately spaced from the 23 radioactive source." Col. 4:27-30. Indeed, the inventors distinguished the prior art on the basis that 24 25 26 [T]he radiation source is disposed completely within the expandable surface and spaced apart from the apparatus volume. (See Page 8, line 23 to page 9 line 13, noting the advantages of providing the radiation source within the interstitial volume and spaced apart from the target tissue . . .).

27 Ex. J at 6-7. The inventors further stated that "the radiation source is arranged within the device so 28
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1 that asymmetric dosing appears at the apparatus volume," indicating that the apparatus volume is 2 located adjacent to the band of tissue to be treated, and is not intended to be a geometric volume of 3 space encapsulated by the expandable outer surface. Id. at 7 (Response to Office Action); see also id. 4 at 8 (comparing the balloon disclosed in the Apple reference to the "apparatus volume" of claim 1). In 5 short, SenoRx's proposed construction would do what is virtually never proper: exclude all disclosed 6 embodiments of the patent. SenoRx cannot present the "highly persuasive evidentiary support" 7 necessary to do so.13 Vitronics, 90 F.3d at 1583. 8 As recognized by both this Court and Dr. Verhey, "a common sense reading indicates that one

9 of skill in the art could understand the claim to mean that the radiation source must be inside and 10 spaced apart from the surface of the expandable outer surface." Ex. E at 16; Ex. H at 5-6. SenoRx's 11 proposed construction should be rejected as contrary to the language of both the specification and 12 prosecution history. 13 14 15 16 17 18 19 B. "being provided on at least two elongate members extending into the apparatus volume" (Claim 6) Hologic's Proposed Construction being provided on at least two elongate members extending into the apparatus volume SenoRx's Proposed Construction radiation sources are attached to two or more elongate members (e.g., wires or rods) that extend into the three-dimensional region of space within the expandable outer surface at the same time

One of ordinary skill in the art would understand the meaning of this claim term. . Nothing in

20 the intrinsic record demonstrates that the inventors attempted to impart a novel interpretation to this 21 22 13 SenoRx has relied heavily on Cytyc's construction of "inner spatial volume" from the Xoft case. Although the '142 23 24 25 26 27 28
Pls.' Opening Claim Construction Brief Case No. C08 00133 RMW (RS) 20 patent is a continuation-in-part of the '813 patent at issue in Xoft, the terms "apparatus volume" and "inner spatial volume" are quite different and served different purposes. Moreover, the relevant specification and prosecution history are distinct with respect to the term "apparatus volume" and "spaced apart from the apparatus volume." The construction of "inner spatial volume" from the '813 patent is thus irrelevant to the construction of "apparatus volume" in the `142 patent. Indeed, the claims in a continuation-in-part may have different meanings than in their parent patents. See, e.g., Medtronic, Inc. v. Advanced Cardiovascular Systems, Inc., 248 F.3d 1303, 1315 (Fed. Cir. 2001) (refusing to use intrinsic evidence from parent application pertaining to a claim term different than the term under consideration); cf. Elkay Mfg. Co. v. Ebco Mfg. Co., 192 F.3d 973, 980 (Fed. Cir. 1999) (citing Jonsson v. The Stanley Works, 903 F.2d 812, 817-818 (Fed.Cir.1990), for the proposition that "[w]hen multiple patents derive from the same initial application, the prosecution history regarding a claim limitation in any patent that has issued applies with equal force to subsequently issued patents that contain the same claim limitation" (emphasis added)).

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1 language. Therefore, it should be construed to mean what it says. Thus, "being provided on at least 2 two elongate members extending into the apparatus volume" should be construed to mean "being 3 provided on at least two elongate members extending into the apparatus volume." 4 SenoRx's arguments should be rejected. SenoRx impermissibly adds the limitation that two or

5 more elongate members extend "at the same time." MBO La