Free Claim Construction Statement - District Court of California - California

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F.T. Alexandra Mahaney, State Bar No. 125984 WILSON SONSINI GOODRICH & ROSATI Professional Corporation 12235 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: (858) 350-2300 Facsimile: (858) 350-2399 Email: [email protected] Bruce R. Genderson (admitted pro hac vice) Aaron P. Maurer (admitted pro hac vice) Rachel Shanahan Rodman (admitted pro hac vice) Adam D. Harber (admitted pro hac vice) WILLIAMS & CONNOLLY LLP 725 Twelfth St. NW Washington, DC 20005 Telephone: (202) 434-5000 Facsimile: (202) 434-5029 Attorneys for Defendant and Counterclaimant SENORX, INC. IN THE UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA SAN JOSE DIVISION HOLOGIC, INC., CYTYC CORP., and HOLOGIC L.P., Plaintiffs, v. SENORX, INC., Defendant. ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) CASE NO.: 08-CV-0133 RMW DEFENDANT SENORX, INC.'S OPENING CLAIM CONSTRUCTION BRIEF

SENORX, INC., Counterclaimant, v. HOLOGIC, INC., CYTYC CORP., and HOLOGIC L.P., Counterdefendants.

Date: June 25, 2008 Time: 2:00 p.m. Courtroom: 6, 4th Floor Judge: Hon. Ronald M. Whyte

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1 2 3 TABLE OF AUTHORITIES .........................................................................................................iii 4 THE PATENTS IN SUIT ...............................................................................................................1 5 THE LAW OF CLAIM CONSTRUCTION ...................................................................................2 6 CONSTRUCTION OF THE DISPUTED TERMS ........................................................................3 7 I. 8 II. 9 A. 10 1. 11 2. 12 B. 13 14 15 2. 16 17 18 19 2. 20 21 22 23 24 III. 25 A. 26 1. 27 28 2. The Claims of the '142 Patent Define the "Apparatus Volume" as a Volume, Not a Surface. .............................................................................19 Other Intrinsic Evidence Shows the "Apparatus Volume" To Be a Volume, Not a Surface. .............................................................................21 i
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TABLE OF CONTENTS

The Person of Ordinary Skill in the Art. .............................................................................3 The '813 and '204 Patents...................................................................................................4 Predetermined Spacing ('813 Patent Claim 1, '204 Patent Claim 3)......................4 "Predetermined Constant Spacing" ('813 Patent Claim 1). ........................4 "Predetermined Spacing" ('204 Patent Claim 3). .......................................7

Substantially Similar "Three-Dimensional Isodose Profile" ('204 Patent Claims 1, 17). ..........................................................................................................8 1. "Isodose Profile" Means the Final Absorbed Dose Profile in the Tissue. .........................................................................................................9 The "Isodose Profile" Must Be Concentric with the Expandable Outer Surface...............................................................................................9

C.

"Inner Spatial Volume" ('813 Patent Claim 1; '204 Patent Claim 1). ..................11 1. The "Distensible Polymeric Film Wall" Defining the Inner Spatial Volume. .....................................................................................................12 The "Outside Surface of a Solid Radionuclide Sphere" Defining the Inner Spatial Volume. ...............................................................................13

D. E. F.

"Means . . . For Rendering Uniform" ('813 Patent Claim 1). ...............................14 "Inner Closed Chamber" ('813 Patent Claim 2). ..................................................17 Providing a "Controlled Dose . . . to Reduce or Prevent Necrosis" ('204 Patent Claim 2)......................................................................................................18

The '142 Patent .................................................................................................................18 "Apparatus Volume" ('142 Patent Claims 1, 6)....................................................18

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1 2

B. C.

"Located So As To Be Spaced Apart from the Apparatus Volume" ('142 Patent Claim 1)......................................................................................................23 "Predetermined Asymmetric Isodose Curves" ('142 Patent, Claims 1, 6, 8). ......23 "Asymmetrically Located and Arranged Within the Expandable Surface" ('142 Patent Claim 1). ...........................................................................................25

3 D. 4 5 6 7 8 9 C. 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28
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IV.

"Plurality"..........................................................................................................................26 A. "Plurality of Radioactive Solid Particles" / "Plurality of Solid Radiation Sources" ('813 Patent Claim 12; '204 Patent Claim 17; '142 Patent Claim 6)............................................................................................................................26 "Plurality of Radioactive Solid Particles Placed At Predetermined Locations" (`813 patent, Claim 12).......................................................................29 "Being Provided on At Least Two Elongate Members" ('142 Patent Claim 6)............................................................................................................................29

B.

CONCLUSION .............................................................................................................................30

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TABLE OF AUTHORITIES FEDERAL CASES Bilstad v. Wakalopulos, 386 F.3d 1116 (Fed. Cir. 2004) ............................................................................................... 26 Burke, Inc. v. Bruno Indep. Living Aids, Inc., 183 F.3d 1334 (Fed. Cir. 1999) ............................................................................................... 25 Chimie v. PPG Indus., Inc., 402 F.3d 1371 (Fed. Cir. 2005) ............................................................................................... 11 Computer Docking Station Corp. v. Dell, Inc., 519 F.3d 1366 (Fed. Cir. 2008) ............................................................................................... 11 CVI/Beta Ventures, Inc. v. Tura LP, 112 F.3d 1146 (Fed. Cir. 1997) ......................................................................................... 21, 22 Dayco Prods., Inc. v. Total Containment, Inc., 258 F.3d 1317 (Fed. Cir. 2001) ............................................................................................... 26 MSM Invs. Co., LLC v. Carolwood Corp., 259 F.3d 1335 (Fed. Cir. 2001) ............................................................................................... 19 Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc) ........................................................... 2, 3, 14, 22, 26 Texas Instruments Inc. v. United States Int'l Trade Comm'n, 988 F.2d 1165 (Fed. Cir. 1993) ............................................................................................... 20 Unique Concepts, Inc. v. Brown, 939 F.2d 1558 (Fed. Cir. 1991) ............................................................................................... 20 York Prods., Inc. v. Central Tractor Farm & Family Ctr., 99 F.3d 1568 (Fed. Cir. 1996) ................................................................................................. 26

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THE PATENTS IN SUIT Plaintiffs have asserted infringement of claims from three patents relating to radioactive devices placed in the body to treat diseases such as cancer: U.S. Patent Nos. 5,913,813 (the "'813 patent"), 6,413,204 (the "'204 patent"), and 6,482,142 (the "'142 patent"). The '813 and '204 patents are closely related. They share substantially overlapping descriptions of the claimed devices and common priority and expiration dates. The '813 and '204 patents purport to solve "unresolved problems" with prior art devices that occur because the prior art devices place radiation sources "directly adjacent" the tissue. Declaration of Adam D. Harber in Support of SenoRx's Opening Claim Construction Brief ("Harber Decl.")1, Ex. 1 ('813 patent), col. 1:28-31, Ex. 2 ('204 patent), col. 2:14-18. This results in the tissue being "overly `hot' to the point where healthy tissue necrosis may result." Id. The '813 and '204 patents claim to solve the problems with the prior devices by using an outer volume, or balloon, that when inflated completely surrounds an inner volume containing radioactive material. This design accomplishes the goal of limiting overexposure of body tissue through two key features incorporated into the claims of both the '813 and '204 patents. First, because the intensity of radiation decreases dramatically as the distance from the radiation source increases,2 overexposure of tissue close to the device is controlled by placing the radiation source in the inner of the two volumes, which is spaced away from the surrounding tissue by the outer volume. This thereby avoids exposure of the surrounding tissue to extremely high doses of radiation directly adjacent the radiation source. See Ex. 4 (Xoft Cl. Constr. Order) at 2-3; Ex. 1 ('813 patent), Fig. 4, col. 3:14-38; Ex. 2 ('204 patent), Fig. 7D, col. 5:66-7:28. Second, radiation hot spots are avoided by ensuring that the radiation is delivered uniformly to the tissue surrounding the outer balloon. See Ex. 1 ('813 patent), col. 3:27-32; Ex. 2 ('204 patent), Claim 1(d). This uniform dosing is accomplished by providing as an essential feature of the devices claimed in the
1

All exhibits ("Ex.") referenced herein are exhibits to the Declaration of Adam D. Harber in Support of SenoRx's Opening Claim Construction Brief, unless otherwise specified. The decrease in radiation occurs as a function of the inverse square of the distance from the source.
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'813 and '204 patents that "the distance from the [inner] spatial volume and the wall [of the outer balloon] is maintained substantially constant over their entire surfaces." Ex. 1 ('813 patent), col. 1:55-57; see also Ex. 2 ('204 patent), col. 5:13-26 (same). As discussed below, this necessarily means that the two volumes must be concentric (i.e., sharing a common center and orientation) and substantially the same shape. These structural requirements ­ symmetry of shape and constant spacing between the inner and outer volumes ­ are used to produce the symmetrical isodose curves that are at the core of the '813 and '204 patents, and are required by the asserted claims, as discussed below. The '142 patent, on the other hand, is directed to a device that produces predetermined asymmetric isodose curves. Ex. 3 ('142 patent), col. 2:62-64. Instead of the uniform profile provided by the '813 and '204 patents, the devices of the '142 patent "specifically alter[] the isodose profile for applications where particularly sensitive tissue or other concerns result in a desire to limit the dosage on one or more sides of the device." Id. at col. 6:25-29. This is accomplished by using a radiation source that is asymmetrically placed with respect to the apparatus, or with shielding. Id. at col. 2:65-3:36. Again, specific structural requirements are found in the limitations in the claims of the '142 patent, as described below. THE LAW OF CLAIM CONSTRUCTION In construing patent claims, a court should first examine the words of the claims, as "the claims themselves provide substantial guidance as to the meaning of particular claim terms." Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005) (en banc). "Claims `must be read in view of the specification, of which they are a part.'" Id. at 1315. Other claims of the patent in question "can also be valuable sources of enlightenment as to the meaning of a claim term." Id. at 1314. Because claim terms are normally used consistently throughout the patent, "the usage of a term in one claim can often illuminate the meaning of the same term in other claims." Id. A patent's prosecution history may also be relevant when construing a patent's claims, as the prosecution history is "the complete record of the proceedings before the PTO" when the patentee was applying for the patent. Id. at 1317. However, where the prosecution history lacks clarity, it is less reliable and "less useful for claim construction purposes" as compared to the
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other intrinsic evidence. Id. The Federal Circuit also has "authorized district courts to rely on extrinsic evidence," including expert and inventor testimony, dictionaries, and learned treatises. Id. While such evidence may "shed useful light on the relevant art," it is "less significant" and "less reliable" than the intrinsic record for claim construction. Id. at 1317-18. CONSTRUCTION OF THE DISPUTED TERMS3 I. THE PERSON OF ORDINARY SKILL IN THE ART. The person of ordinary skill in the art has the skills of both a radiation oncologist and a medical radiation physicist. Such a person would have a Ph.D. in Physics or Medical Physics with two or more years of clinical experience, or equivalent training and experience, and/or an M.D. degree with further training and Board Certification in radiation oncology and at least two years experience practicing as a radiation oncologist, or equivalent training and experience. Such a person would have knowledge of and experience in various forms of irradiation, including external beam radiation therapy and brachytherapy, the history and use of brachytherapy devices, including balloon brachytherapy devices, to treat tumors and tissue remaining after the surgical extraction of all or a portion of a tumor in and around both naturally occurring and surgically created cavities, the physics of brachytherapy procedures, the principles of radioactivity and an understanding of the effect of radiation on cells. Such a person would have experience inserting and using brachytherapy devices in a variety of cavities, including the brain, breast, bladder, rectum and vagina. In addition, such a person would be familiar with remote afterloader technology and available radiation sources. Declaration of Colin G. Orton ("Orton Decl.") ¶ 9.
3

Given the substantial differences between the subject matter claimed in the '813 and '204 patents versus that claimed in the '142 patent, SenoRx has addressed the disputed terms of the '142 patent in a separate section of this brief than that addressing the terms of the '813 and '204 patents. SenoRx also has included an additional section on the construction of "plurality," a key term common to at least one asserted claim in each of the patents, and the subject of a copending motion for summary judgment of non-infringement. Pursuant to the Court's direction at the Case Management Conference, SenoRx has ordered the subsections within each of the primary sections by priority. (Although the '813 and '204 patents are addressed before the '142 patent and plurality claim elements, that was done for purposes of clarity, and SenoRx does not mean to imply that the '142 patent or the plurality elements are of any lesser importance.)
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II.

THE '813 AND '204 PATENTS. A. Predetermined Spacing ('813 Patent Claim 1, '204 Patent Claim 3).

An essential requirement of the alleged inventions of the '813 and '204 patents ­ and the asserted claims of those patents ­ is the delivery of a uniform dose to the tissue. In other words, it is critical to the claimed inventions that "the absorbed dose within the target tissue at points equidistant from the surface of the outer spatial volume should be substantially uniform in substantially every direction." Ex. 2 ('204 patent), col. 5:16-19. The asserted claims of the '813 and '204 patents thus require a structure that obtains that uniform dose ­ two concentric volumes with a predetermined spacing between the wall of the inner volume and the wall of the outer volume. This structure is required by the '813 patent in claim 1's requirement of "a predetermined constant spacing" between the surfaces of the inner volume and outer balloon. Similarly, it is required by the '204 patent in claim 3's requirement of "a predetermined spacing" between the surfaces of the inner volume and outer balloon, and also (as discussed in section B below) by the limitation of claims 1 and 17 to "a three-dimensional isodose profile that is substantially similar in shape" to the outer surface. 1.
Claim Term predetermined constant spacing between said inner spatial volume and the radiation transparent wall

"Predetermined Constant Spacing" ('813 Patent Claim 1).
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). Plaintiffs' 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 requires that there be a predetermined fixed distance between the surfaces of the inner and outer volumes. This occurs only when the volumes have the same shape and are concentric (i.e., sharing a common center and orientation), and holds true
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for any shape of outer balloon. Orton Decl. ¶¶ 25-32. As discussed below, SenoRx's construction is consistent with all the intrinsic evidence relating to this claim limitation. Plaintiffs' proposed construction, on the other hand, incorrectly construes "predetermined constant spacing" in the '813 patent to require different things for differently shaped outer balloons.4 For spherical balloons, Plaintiffs state the spacing must be "constant in all directions." While the parties may agree in concept, Plaintiffs' definition does not precisely capture the claim language. SenoRx's proposed construction accurately describes what must be held constant: the distance from any point on the outside surface of the inner spatial volume to the closest point on the wall of the outer surface. For the non-spherical balloons, Plaintiffs' construction is that the spacing need be "constant only along a radial plane." That construction is inconsistent with the intrinsic evidence, which shows the term "constant spacing" means that the walls of the two volumes are spaced equidistant over their entire surfaces. Orton Decl. ¶¶ 26, 30. First, claim element 1(c) of the '813 patent requires "constant spacing" between the inner spatial volume and the radiation transparent wall. It does not say the spacing need be constant only along a single plane, or that it varies depending on the shape of the outer balloon. Second, in the specification, the patentees clearly and repeatedly state that it is important for the spacing of the volumes of their claimed devices to be constant over the entire surfaces of the volumes, not just along a single plane. The abstract for the '813 patent concisely describes the requirement: An instrument for use in brachytherapy comprises a concentric arrangement of inner and outer distensible, spherical chambers disposed near the proximal end of a catheter body . . . . An alternative embodiment includes non-spherical inner and outer chambers whose respective walls are spaced equidistant over the entire surfaces thereof. Ex. 1 ('813 patent), Abstract (emphases added). With respect to the only non-spherical

24 embodiment (Figure 3), the specification repeats that it is critical that "the spacing between the 25 26 27 28
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In Xoft, Cytyc proposed essentially the same construction. Xoft claimed indefiniteness and proposed no construction of its own. The Court rejected the indefiniteness argument and, accordingly, accepted the definition proposed by Cytyc. Ex. 4 (Xoft Cl. Constr. Order) at 6-7.

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wall of the inner chamber and the wall of the outer chamber remain generally constant." Id. at col. 3:10-14. Again, the constant spacing is not limited to a single plane. See also id. at col. 1:55-57 ("[T]he distance from the [inner] spatial volume and the wall [of the outer balloon] is maintained substantially constant over their entire surfaces."); id. at 4:12-15 ("the spacing between the inner and outer chambers needs to be held somewhat constant to avoid `hot spots.'"). The embodiments illustrated by the inventors further demonstrate the accuracy of SenoRx's proposed construction. Figure 1 of the '813 patent depicts concentric spheres. See also id. at col. 2:56-63 (the device "may have a solid spherical radiation emitting material in which event that solid sphere would be surrounded with the outer spherical wall"). Figure 3 is non-spherical, but clearly depicts two chambers that are the same shape and concentric, thus allowing "the spacing between the wall of the inner chamber and the wall of the outer chamber [to] remain generally constant[.]" Id. at col. 3:10-13. Third, the prosecution history of the '813 patent also establishes that the inner and outer volumes must be concentric and the same shape, with a fixed spacing between them. In the prosecution of the '813 patent, Plaintiffs distinguished the prior art Ishiwara patent on the basis that, unlike Ishiwara, the spacing between "the inner and outer radiation transparent walls" of the claimed invention "is constant over the entire surfaces of the two chambers," not simply constant along a radial plane. Ex. 5 (Sep. 1, 1998 Am., `813 Prosecution History) at 6 (emphasis added). Ishiwara, Plaintiffs explained, "teaches away from applicants' invention given the elongate, cylindrical shape of the radiation source employed and the oblong-shaped outer balloon surrounding it." Id. at 7 (emphasis added). By distinguishing Ishiwara, the inventors made clear that "constant spacing" was required between the entire surfaces of the volumes ­ not just in the radial plane ­ and that this holds true even for non-spherical outer surfaces. The inventors also accordingly reemphasized that the shapes of the inner and outer chambers must be the same. Finally, Plaintiffs did not disagree in the Xoft case that the two volumes must be concentric and the same shape. There, Plaintiffs described the device of the '813 patent as "an instrument comprising a concentric arrangement of an inner spatial volume and an outer spatial volume," and the outer spatial volume of the device of the '204 patent as "surrounding and
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concentric with the inner spatial volume." Ex. 6 (Cytyc Cl. Constr. Br.) at 7, 15 (emphases added). And at the Markman hearing in Xoft, Plaintiffs agreed that constant spacing results in the volumes having the same shape: "if it's not constantly spaced, if it's, for example, an oblong figure in a spherical balloon, then you don't have a constant distance." Ex. 7 (Xoft Markman Tr.) at 71:3-5. 2.
Claim Term Predetermined spacing . . . between said inner spatial volume and the expandable surface element

"Predetermined Spacing" ('204 Patent Claim 3).
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). Plaintiffs' Proposed Construction the distance between the inner spatial volume and the expandable surface element is determined in advance

Although claim 3 of the '204 patent uses slightly different language than claim 1 of the '813 patent ("a predetermined spacing" versus "a predetermined constant spacing"), a person of ordinary skill in the art would understand the terms identically based on the specification of the '204 patent, including the explicit incorporation of the '813 patent therein. Ex. 2 ('204 patent), col. 1:10-11; Orton Decl. ¶¶ 25-32. Because the specification of the '204 patent makes clear that "predetermined spacing" means the same thing as the closely related term in the parent '813 patent, SenoRx proposes the same construction for both terms. The '204 patent teaches that the claimed device should "ensur[e] that the spacing between the wall of the inner volume and the wall of the outer volume remain[s] generally constant." Ex. 2 ('204 patent), col. 5:22-27. The '204 patent incorporates the embodiments pictured in the '813 patent, and the specification of the '204 patent (like the '813 patent) repeatedly emphasizes the constant spacing of the volumes and, consequently, the arrangement of inner and outer volumes to be the same shape and concentric. See, e.g., id. at col. 3:61-65 (the
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wall of the volumes are "appropriately spaced" when inflated); 4:61-67 (describing Figure 3 of the '204 patent as a "solid spherical inner spatial volume" surrounded by an "outer spherical wall"); 5:27-28 (referring to the "concentric spherical embodiment of FIG. 1"). Plaintiffs' construction is silent as to what the spacing must be, and only addresses the "predetermined" term.5 However, when Plaintiffs addressed the meaning of "predetermined spacing" in the context of the '204 patent in Xoft, Plaintiffs' expert Dr. Verhey defined it to mean that the "spacing between the inner and outer spatial volumes can be set to a predetermined and constant value." Ex. 8 (Verhey Decl.) at 10 (emphasis added). Similarly, in addressing claim 4 in Xoft (the same claim asserted here), Dr. Verhey opined "the desired shape of the expandable surface element is that shape which provides the predetermined constant spacing between the inner spatial volume and the conformed surface of the resection cavity (see patent 204 5:47-61)." Id. at 9 (emphasis added). Thus, the experts on both sides agree the person of ordinary skill in the art would understand the claim term to require constant spacing. See Orton Decl. ¶ 25. Because both claim 1 of the '813 patent and claim 3 of the '204 patent require a predetermined constant spacing, SenoRx's proposed construction should be adopted. B. Substantially Similar "Three-Dimensional Isodose Profile" ('204 Patent Claims 1, 17).
SenoRx's Proposed Construction A final three-dimensional isodose profile that is substantially the same shape as the outer spatial volume expandable surface and is concentric with the outer spatial volume expandable surface. Plaintiffs' Proposed Construction No construction necessary.

Claim Term three-dimensional isodose profile that is substantially similar in shape to the expandable surface element ('204 patent, claim 1); isodose profile having a shape substantially similar to the shape of the outer spatial volume ('204 patent, claim 17)

Again, in the Xoft case, the Court adopted Plaintiffs' proposed construction where Xoft argued that the claim term was indefinite and proposed no construction of its own. Ex. 4 (Xoft Cl. Constr. Order) at 24-25.

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Plaintiffs have not proposed any construction for this claim element. SenoRx submits it is proper to instruct the jury as set forth above based on the intrinsic evidence, which compels the conclusion that the claimed "three-dimensional isodose profile" refers to the final isodose profile delivered to the tissue. This isodose profile must be substantially the same shape as, and concentric with (i.e., sharing a common center and orientation), the outer surface. This result follows from the goal of avoiding the hot spots and radiation overexposure caused by prior art devices, as illustrated by the specification and prosecution history. See Orton Decl. ¶¶ 49-53. 1. "Isodose Profile" Means the Final Absorbed Dose Profile in the Tissue.

The "three-dimensional isodose profile" recited by the claim reflects the final, cumulative dose of radiation administered by the apparatus to the tissue. Orton Decl. ¶ 50. The stated purpose of the '204 patent is to provide an "absorbed dose within the target tissue" that is "substantially uniform in substantially every direction." Ex. 2 ('204 patent), col. 5:13-19. The dose to be delivered is consistently described as the "absorbed dose," i.e., the final, total resulting dose from the delivery of radiation absorbed by the tissue at the end of radiation therapy with the apparatus. Indeed, the focus of the invention is on achieving a "predetermined dose range" in the target tissue, defined as the dose "between a minimum prescribed absorbed dose for delivering therapeutic effects to tissue that may include cancer cells, and a maximum prescribed absorbed dose above which healthy tissue necrosis may result." Ex. 2 ('204 patent), col. 2:46-55; see also, e.g., id. at col. 2:21-26 ("It is desirable to keep the radiation that is delivered to the tissue in the target treatment region within a narrow absorbed dose range . . . ."). This clearly is referring to the final, cumulative absorbed dose delivered by the device to the tissue, and the "isodose profile" of claim 1 should be construed accordingly. Orton Decl. ¶ 50. 2. The "Isodose Profile" Must Be Concentric with the Expandable Outer Surface.

In order to obtain their patent in the face of a prior art rejection, the inventors of the '204 patent added the "substantially similar in shape" limitation to claim 1. Ex. 9 (Dec. 20, 2000 Am., '204 Prosecution History) at 2, 10-16. In doing so, they described how this limitation differentiated their invention from the prior art, and clearly defined what isodose profile meets
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the "substantially similar in shape" limitation: one that is both substantially similar in shape and positioned so as to be concentric with (i.e., sharing the same center and orientation) the outer volume. Id. There is no dispute that "substantially similar in shape" is an element of the claim. The dispute is whether the "similarly shaped" isodose profile also must be concentric. This result is plainly mandated by the patent specification, which discusses the exact relationship between the dose profile and the outer surface: As illustrated in FIG. 5, it is not essential to the invention that the volumes 30 and 34 have spherical walls, so long as the resultant dosing profile is consistent with the shape of the outer volume 34. That is, the absorbed dose within the target tissue at points equidistant from the surface 36 of the outer spatial volume 34 should be substantially uniform in substantially every direction. Ex. 2 ('204 patent), col. 5:13-19 (emphasis added). By definition, if the absorbed dose in the

12 target tissue equidistant from the surface of the outer spatial volume is substantially the same in 13 substantially every direction, then the dose profile and the surface must be concentric. Orton 14 Decl. ¶ 51. The applicants in the prosecution history acknowledged this requirement in 15 distinguishing the '204 patent over the prior art (in particular, Figure 7 of the Williams patent, 16 U.S. Patent No. 5,429,582 (reproduced below)): 17 18 19 20 21 22 23 24 25 26 27 28
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As seen in Figure 7 of Williams ['582 patent], outer lumen 28B is not evenly spaced apart from inner lumen 28A that contains the radiation source. In this system, where the radiation source is provided as a liquid within the inner balloon, the shape of the threedimensional isodose profile will correspond to the shape of the inner balloon. For this reason, Williams does not provide an apparatus that can generate a three-dimensional isodose profile that is substantially similar in shape to the expandable surface element, as is recited in the claims. That is, because the balloons are not equally spaced apart, Williams' apparatus cannot create an isodose profile that has substantially the same shape as the outer element. Hence, Williams fails to disclose each and every limitation of the claimed invention. Ex. 9 (Dec. 20, 2000 Am., `204 Prosecution History) at 15-16 (emphases added). Figure 7 of the prior art Williams '582 patent, which the applicants distinguished as non-concentric, appears below:

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Claim Term 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. Plaintiffs' Proposed Construction A region of space surrounded by an outer spatial volume that is either enclosed by a polymeric film wall or defined by the outside surface of a solid radionuclide.

Ex. 10 (Williams '582 patent), Fig. 7. Plainly, the two balloons in Williams (28A and 28B) are the same shape, but not concentric (i.e., sharing a common center and orientation) as the inner balloon is positioned off center from the outer balloon. As a result, the isodose profile generated by this configuration also would not be concentric with the expandable outer surface. Orton Decl. ¶ 52. Because the applicants clearly made the argument that "substantially the same shape" requires concentricity in order to gain allowance of claim 1, the claim limitation must be construed to include concentricity. See, e.g., Computer Docking Station Corp. v. Dell, Inc., 519 F.3d 1366, 1374-75 (Fed. Cir. 2008); Chimie v. PPG Indus., Inc., 402 F.3d 1371, 1384 (Fed. Cir. 2005). C. "Inner Spatial Volume" ('813 Patent Claim 1; '204 Patent Claim 1).

19 20 21 22 23 24 25 26 27 28

inner spatial volume

The parties' dispute here centers on the physical structure of the inner spatial volume ­ whether the polymeric film wall must be "distensible" and whether the solid radionuclide must be a "sphere." In the Xoft case, the Court rejected Cytyc's proposed construction, and adopted the construction SenoRx proposes here, with the exception that the Court did not include the word "distensible" (and in Xoft, neither party addressed the concept). Ex. 4 (Xoft Cl. Constr.

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Order) at 3-5, 16. Plaintiffs seek to remove the word "sphere" which was part of the Court's construction in Xoft. 1. The "Distensible Polymeric Film Wall" Defining the Inner Spatial Volume.

In the Xoft case, this Court concluded that the "inner spatial volume" must be defined by a physical object. See Ex. 4 (Xoft Cl. Constr. Order) at 5 ("Xoft objects that an abstract concept like a region of space cannot be part of an apparatus. Xoft is correct. However, the language of the patent does not imply that the inner volume is ever defined by something other than a physical object."). Because "inner spatial volume" does not specify any structure to one of skill in the art, the Court looked to the specifications of the '813 and '204 patents for a definition and concluded that "[i]n all embodiments . . . the boundary of the inner volume is either a polymeric film wall or the edge of a solid sphere." Ex. 4 (Xoft Cl. Constr. Order) at 5; see also id. at 16.6 Accordingly, the Court construed "inner spatial volume" as an inner volume that is "either enclosed by a polymeric film wall or defined by the outside surface of a solid radionuclide sphere." Id. at 5, 16. SenoRx requests that the polymeric film wall be further construed ­ consistent with the specification and reasoning of the Court's prior opinion ­ to be "distensible" (i.e., able to stretch or expand). The patents consistently describe the polymeric film wall used to define the "inner spatial volume" to be distensible. Orton Decl. ¶ 22. For example, in the general discussion of the overall invention, the '204 patent states: "In different embodiments, the inner spatial volume can be defined by a distensible polymeric wall containing radioactive source material . . . ." Ex. 2 ('204 patent), col. 2:56-60 ("Summary of the Invention") (emphasis added). Similarly, in discussing specific embodiments, the patent specifications make clear that the polymeric film walls must be distensible:

Neither party here disagrees with the Court's prior holding in Xoft that "inner spatial volume" should be construed consistently across the '813 and '204 patents.

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· "With no limitation intended, the distensible polymeric film walls may comprise a biocompatible, radiation resistant polymer . . . ." Ex. 2 ('204 patent), col. 3:66-4:3 (emphasis added); · "Where the inner and outer spatial volumes are created by inflatable membranes . . . ." Ex. 2 ('204 patent), col. 5:22-23 (emphasis added); · "where the radiation source is provided as a fluid within an inner balloon . . . ." Ex. 2 ('204 patent), col. 5:64-65 (emphasis added); · "wherein the inner spatial volume is an inner closed, distensible chamber defined by a further radiation transparent wall . . . ." Ex. 2 ('204 patent), claim 9 (emphasis added); · "inner and outer distensible, spherical chambers" Ex. 1 ('813 patent), Abstract (emphasis added); and · "With no limitation intended, the distensible polymeric chambers may comprise a biocompatible, radiation resistant polymer . . . ." Ex. 1 ('813 patent), col. 3:39-41 (emphasis added).7 Non-distensible polymeric walls are described nowhere in the patents, and were plainly

13 not conceived of or claimed by the inventors as part of their invention. Accordingly, the 14 "polymeric film wall" embodiment of the "inner spatial volume" should be construed to require 15 "distensible" polymeric film walls. Orton Decl. ¶ 22. 16 2. 17 18 19 20 21 22 23 24 25 26 27 28
7

The "Outside Surface of a Solid Radionuclide Sphere" Defining the Inner Spatial Volume.

The only radionuclide described as an "inner spatial volume" in the '813 and '204 patents is a spherical radionuclide, and the claim term should be construed to require that the radionuclide be spherical. Orton Decl. ¶¶ 23-24. The '204 patent describes using "a solid spherical radiation emitting material 44 as the inner spatial volume 30. For example, radioactive micro spheres of the type available from the 3M Company of St. Paul, Minn., may be used." Ex. 2 ('204 patent), col. 4:44-50 (emphasis added). Likewise, the '813 patent states that "a solid spherical radiation emitting material" can be the "inner spatial volume" instead of an inner balloon. Ex. 1 ('813 patent), col. 2:56-63 (emphasis added); see also id. at 2:64-65 ("inner spatial volume comprising a single solid sphere") (emphasis added). In the Xoft case, the Court

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quoted this portion of the specification in concluding that the inner spatial volume should be "defined by the outside surface of a solid radionuclide sphere." Ex. 4 (Xoft Cl. Constr. Order) at 5.8 The description of the radionuclide as spherical was not accidental. As discussed above, the claimed invention of the '813 and '204 patents requires constant spacing between the inner volume and outer volumes in order to achieve a radiation profile that is "uniform" (Ex. 1 ('813 patent), claim 1) and "substantially similar in shape to the expandable surface element" (Ex. 2 ('204 patent), claim 1). A non-spherical radionuclide will not achieve this result, but instead will generate a non-uniform dose because of the greater self-absorption of a solid non-spherical radionuclide in a longitudinal direction than a radial direction. Orton Decl. ¶¶ 23-24. In sum, "inner spatial volume" should be construed to cover that which was described: the region of space defined by a distensible polymeric film wall or the outside surface of a solid radionuclide sphere. See Phillips, 415 F.3d at 1321 (describing the specification as "the single best guide to the meaning of a disputed term" because it "acts as a dictionary" when it defines terms expressly or by implication). D. "Means . . . For Rendering Uniform" ('813 Patent Claim 1).
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. Plaintiffs' Proposed Construction Function: making the absorbed dose of radiation more uniform to prevent over-treatment 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

Claim Term 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

In Xoft, Xoft proposed a definition that included "spherical." The Court rejected Cytyc's proposed construction and construed the claim to require that the solid embodiment be a "sphere." Ex. 4 (Xoft Cl. Constr. Order) at 3-5.

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Claim element 1(e) of the '813 patent requires "means . . . for rendering uniform the radial absorbed dose profile." The parties agree this is a means-plus-function claim element, and that the structure is "a radiation absorbing or attenuating material." The primary dispute between the parties is whether the "radiation absorbing or attenuating material" must perform the claimed function by absorbing or attenuating radiation (SenoRx's position), or whether the limitation is satisfied so long as a "radiation absorbing or attenuating" material is present, even if it does not render the dose uniform by absorbing or attenuating radiation (Plaintiffs' position). Both parties in the Xoft case agreed that uniformity of the dose curve was affected solely by the distance from the radiation source to the tissue, and not by the radiation absorbing or attenuating material that occupied the space between the radiation source and the outer balloon. Accordingly, the Court determined that the material that provided the necessary distance satisfied the claim element, irrespective of whether it did so as a result of its absorptive properties. Ex. 4 (Xoft Cl. Constr. Order) at 10. SenoRx respectfully disagrees on this key point. The evidence shows that radiation absorbing or attenuating material in the spatial volumes can, and was meant to, affect the dose curve. See Orton Decl. ¶¶ 37-38. The specification describes the structure that performs the function of making the absorbed dose of radiation substantially uniform as "radiation absorbing fluid," "radioactive ray absorbent material," "radiation absorbing material," and "radiation attenuation fluid." Ex. 1 ('813 patent), col. 2:50; 2:62-3; 3:27; 1:63; 3:62. The consistent description of the structure as having this property makes no sense if the structure does not perform the claimed function as a result of absorbing or attenuating radiation. That the radiation absorbing material must perform the function by absorbing or attenuating radiation is made clear from the embodiment described at column 3, lines 51-65 of the '813 patent. In this embodiment, the radioactive material is in the outer balloon, and the radiation absorbing material is in the inner balloon.9 See Ex. 1 ('813 patent), col. 3:51-65.

This embodiment is within the scope of claim 1. Although asserted claim 11 requires that the source be in the inner chamber (see claim 8 on which claim 11 depends), claim 1 is not so limited. Element (d) of claim 1 states that the radioactive material can be disposed in either the (continued...)
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Because of this configuration, the radiation-absorbing material clearly is not performing any function of spacing the radiation source from the tissue. Nonetheless, the patent describes how the use of "radiation absorptive material" in the inner chamber can be used to obtain a "uniform profile" and how "radiation attenuation fluid" in the inner chamber can affect the slope of the "radial absorbed source gradient." Ex. 1 (`813 patent), col. 3:51-65. Thus, in order to have a construction of the claim that applies to all embodiments, the radiation absorbing or attenuating material identified by the specification as the "structure" for performing the claimed function must perform that function by absorbing or attenuating radiation. Orton Decl. ¶ 38. The conclusion that radiation absorbing material may render the dose more uniform, as the patent states, is scientifically sound. As Dr. Orton explains in detail in paragraphs 37-38 of his declaration, some of the radiation sources identified in the '813 patent at col. 2:51-55 and col. 3:42-8 are relatively low energy sources. The radiation dose delivered from low energy sources such as those described in the patent can be substantially affected by radiation absorbing materials. Therefore, the patent contemplated that the radiation absorbing material performed its function by absorbing radiation, Orton Decl. ¶¶ 37-38, and to satisfy this claim element, the structure must perform the function by absorbing or attenuating radiation. This reading is further supported by the prosecution history. As in the specification, Plaintiffs stated the device of their invention used "a radiation attenuating material" to render uniform the radial absorbed dose profile. Ex. 5 (Sep. 1, 1998 Am., `803 Prosecution History) at 4; see also id. at 5 (discussing the use of "a substance for rendering uniform the radial absorbed dose profile") (emphasis in original). And the Plaintiffs also distinguished the prior art Ishiwara patent on the grounds that there was "no teaching or suggestion in the patent of how to provide a uniform radial absorbed dose profile . . . ." Id. (emphasis in original). If providing such a profile was a simple matter of spacing the source apart from the tissue (a configuration shown in Ishiwara), then the distinction made by Plaintiffs would not hold true. In sum, the "radiation

(...continued from previous page) inner or outer chamber, and element (e) states that the "means . . . for rendering uniform" is disposed in the other chamber.
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absorbing or attenuating material" that the specification clearly links to performing the claimed function must do so by absorbing or attenuating radiation. The other disputes relating to this element are: 1) whether the dose must be made "substantially more uniform"; and 2) whether the claimed function includes the limitation of preventing over-treatment of body tissue at or close to the balloon wall. As to the first question, SenoRx agrees with the Court that "rendering uniform" the dose in a literal, absolute sense probably is impossible. Ex. 4 (Xoft Cl. Constr. Order) at 8-10. That does not mean, however, that "rendering uniform" should be construed to cover rendering the dose "slightly more uniform." "Substantially more uniform" is consistent the Court's rationale in the Xoft case but is closer to the claim language and the use of the term in the prosecution history. Orton Decl. ¶ 37 n.2. As to the second question, Plaintiffs' proposed construction provides that the function of making the absorbed dose more uniform is "to prevent over-treatment of body tissue at or close to the outer wall of the instrument." While "prevent[ing] over-treatment" may in some cases be the result of performing the claimed function, that result is not a part of the claimed function and unnecessary to add.10 E. "Inner Closed Chamber" ('813 Patent Claim 2).
SenoRx's Proposed Construction A compartment located completely inside of the outer chamber and closed off within the outer chamber. Plaintiffs' Proposed Construction No construction necessary.

Claim Term inner closed chamber

Claim 2 of the '813 patent defines the inner spatial volume of claim 1 as an "inner, closed chamber." Ex. 1 ('813 patent), claim 2. By its plain meaning, this claim further limits the inner spatial volume to a "closed chamber" or compartment located inside of the outer chamber. Because it is undisputed that the inner spatial volume must be surrounded by the outer spatial

If the Court is inclined to add language concerning the purpose of the function, SenoRx suggests that "to reduce or prevent necrosis in healthy tissue at or close to the outer wall of the instrument" would be more accurate. See discussion at Section F infra concerning claim 2 of the '204 patent.

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volume, when the inner spatial volume is an inner closed chamber, it must be completely inside of the outer chamber and closed off within the outer chamber. See Orton Decl. ¶ 39. F. Providing a "Controlled Dose . . . to Reduce or Prevent Necrosis" ('204 Patent Claim 2).
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. Plaintiffs' 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.

Claim Term providing a controlled dose at the outer spatial volume expandable surface to reduce or prevent necrosis in healthy tissue proximate to the expandable surface

SenoRx's proposed construction of this term is more consistent with the plain language of the claim term and the specification than Plaintiffs' proposed construction.11 The claim specifically refers to "reduc[ing] or prevent[ing] necrosis," as does the specification. See Ex. 2 ('204 patent, col. 7:26-28) (the device allows physicians "to reduce or eliminate the risk of healthy tissue necrosis"). Plaintiffs' proposed construction, on the other hand, requires avoiding "lethally damag[ing] cells in healthy tissue in contact" with the balloon, a standard found nowhere in the claims or specification, Orton Decl. ¶ 54, and virtually impossible to meet. III. THE '142 PATENT A. "Apparatus Volume" ('142 Patent Claims 1, 6).
SenoRx's Proposed Construction The three-dimensional region of space within the expandable outer surface. Plaintiffs' Proposed Construction A three-dimensional geometric solid composed of an expandable outer surface.

Claim Term

21 22 23

apparatus volume

The meaning of "apparatus volume" was debated at length during the preliminary 24 injunction proceedings in this case. SenoRx stated then, and contends here as well, that the 25 26 27 28 Although the Court construed the term in the manner proposed by Cytyc in the Xoft case, again Xoft argued that the claim was indefinite and did not propose its own definition. Ex. 4 (Xoft Cl. Constr. Order) at 23.
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ordinary and customary meaning of "volume" should apply, and thus the "three-dimensional apparatus volume" is the three-dimensional region of space within the expandable outer surface. In the course of the preliminary injunction proceedings, Plaintiffs initially took the position that the plain meaning of the claim phrase should apply. See Pls' Resp. to SenoRx Interrs. at 9 (Ex. 7 to Docket No. 53) (stating that the term should be given its "Plain meaning (no construction necessary)"). However, Plaintiffs later changed their mind and asserted at the hearing that the terms "apparatus volume" and "expandable outer surface" should be used interchangeably. This construction is repeated here, where Plaintiffs define the apparatus volume as being "composed of an expandable outer surface."12 But such a construction is clearly contrary to the language of the claim, the other intrinsic evidence, and the prior position Plaintiffs took regarding the meaning of "volume" in the Xoft litigation. Orton Decl. ¶¶ 55-57. SenoRx respectfully suggests that the claim is not reasonably amenable to the interpretation that the volume is used interchangeably with the surface. Cf. Order Denying Plaintiffs' Motion for Preliminary Injunction ("PI Order") at 16. 1. The Claims of the '142 Patent Define the "Apparatus Volume" as a Volume, Not a Surface.

The claim construction analysis begins with, and must focus on, the language of the claims themselves. MSM Invs. Co., LLC v. Carolwood Corp., 259 F.3d 1335, 1338-39 (Fed. Cir. 2001). Here, the plain meaning of "apparatus volume," is defined by the claims as the region of space within the expandable outer surface. This region of space "fill[s] [the] interstitial void created by the created by the surgical extraction." Ex. 3 ('142 patent), claim 1. In filling the surgical cavity, it also necessarily "define[s] an inner boundary of the target tissue to be treated." Id; Orton Decl. ¶ 56. Plaintiffs' construction equates "apparatus volume" and "expandable outer surface" and impermissibly rewrites the claim. This results in the first element of the asserted claims being rendered nonsensical. That element requires "an expandable outer surface defining a three12

It is unclear what Plaintiffs mean by "a three-dimensional geometric solid," a phrase that is found nowhere in the claims, specification, or prosecution history of the '142 patent.
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dimensional apparatus volume . . . ." Plaintiffs' construction would have the claims instead read "an expandable outer surface defining an expandable outer surface." If the phrase "apparatus volume" was meant to be interchangeable with "expandable outer surface," there would be no need for the language "defining a three-dimensional apparatus volume," and the claim could simply refer to the "outer surface" throughout. Plaintiffs' redefinition of apparatus volume ­ which reads out the "apparatus volume" phrase and the requirement that it must fill the interstitial void ­ thus runs afoul of the principle that "[a]ll the limitations of a claim must be considered meaningful." Unique Concepts, Inc. v. Brown, 939 F.2d 1558, 1562 (Fed. Cir. 1991); see also Texas Instruments Inc. v. United States Int'l Trade Comm'n, 988 F.2d 1165, 1171 (Fed. Cir. 1993) (rejecting a patentee's proffered claim construction because it "would render the disputed claim language mere surplusage."). In its denial of Plaintiffs' Motion for a Preliminary Injunction, this Court raised a possible ambiguity in claim 1, in that it states that the "three-dimensional apparatus volume" could also be read to "define an inner boundary of the target tissue being treated." From this, the Court concluded that "apparatus volume" may also "refer to the surface of the apparatus, as it is the surface of the balloon that is [in] contact [with] the tissue to be treated and defines the inner margin of tissue to be irradiated." PI Order at 15. SenoRx respectfully disagrees that the claim language quoted by the Court transforms the "apparatus volume" into the outer surface. In context, there is no inconsistency between the apparatus volume defining an inner boundary of the target tissue and the apparatus volume being a distinct and separate structure from the outer surface (and defined by that surface). The first element of the claim 1 recites, on the Court's reading, that the apparatus volume (1) fills the void created by surgical extraction of diseased tissue and (2) defines an inner boundary of the target tissue being treated. When devices of this type are used, however, these two functions are two sides of the same coin. When the apparatus volume fills the void left by surgical removal of diseased tissue, the device's balloon is completely inflated and in contact with the inner boundary of the target tissue. As a result, for all practical purposes, the inner boundary of the target tissue is the same as the outer boundary of the void left after tissue has been removed ­ both are the edge of the cavity that has been filled by the
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volume. Accordingly, by filling the void left by the surgical extraction of tissue, the apparatus volume also necessarily defines an inner boundary of the target tissue to be treated ­ where the "filling" of the void stops, the "defining" of the boundary inevitably begins. See Orton Decl. ¶ 56. Alternatively, the claim can be read as Plaintiffs do in their infringement contentions, to the same end. Plaintiffs state: The outer surface of the inflatable spherical ConturaTM multi-lumen balloon (an "expandable surface element") defines the threedimensional apparatus volume that fills the interstitial void of the resection cavity. The expanded balloon conforms the cavity to the balloon shape and thereby defines the inner boundary of target tissue along the cavity wall that is being treated. Ex. 11 (Pls' Infr. Cont.) at 3. Plaintiffs thus construe claim 1 to mean that the "expandable outer

10 surface" defines two things: 1) the "three-dimensional apparatus volume that fills the interstitial 11 void of the resection cavity" and 2) "the inner boundary of the target tissue . . . that is being 12 treated." But either way, any ambiguity as to which structure defines the inner boundary of the 13 target tissue does not affect the plain definition of apparatus volume in the claim. Whether the 14 boundary of tissue to be treated is defined by the volume or by the surface, the claim plainly 15 states that the surface defines the volume, and that they are not the same thing. Orton Decl. ¶ 56. 16 2. 17 18 19 20 21 22 23 24 25 26 27 28
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Other Intrinsic Evidence Shows the "Apparatus Volume" To Be a Volume, Not a Surface.

Plaintiffs' attempt to define the apparatus volume as the surface also is contrary to the use of "apparatus volume" in other claims of the '142 patent (all of which include the limitation of "an expandable outer surface defining an apparatus volume"). For example, claim 3 requires a "catheter in communication with the apparatus volume," and an "elongate member extending through the catheter into the apparatus volume." Ex. 3 ('142 patent), claim 3. Under SenoRx's construction ­ that the "apparatus volume" is actually a "volume" ­ this makes perfect sense. The catheter is in communication with the volume and can be used to insert the radiation source into it. Plaintiffs' construction, on the other hand ­ that the "apparatus volume" is a "surface" ­ results in the catheter being in communication only with a surface and the elongate member extending "into" that surface, which makes no sense. See CVI/Beta Ventures, Inc. v. Tura LP,

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112 F.3d 1146, 1159 (Fed. Cir. 1997) (instructing that terms should be construed consistently throughout the claims).13 The specification likewise shows that the "apparatus volume" is different from the expandable surface. Thus, the "present invention" of the '142 patent is stated to have "an expandable outer surface element defining an apparatus spatial volume," just as in claims 1 and 6. Ex. 3 ('142 patent), col. 2:55-64. Specific embodiments describing the apparatus volume and expandable outer surface also do so in such a way that it is clear that the apparatus volume and outer surface are different. See, e.g., id. at 3:20-23 ("An interstitial brachytherapy apparatus of the invention may also be implemented in a device having an expandable outer surface defining an apparatus volume . . . ."); id. at 3:27-32 ("In one embodiment, radiopaque shielding is provided on a portion of the expandable outer surface. In another embodiment, the radiation source is encompassed within a second, inner surface within the apparatus volume . . . ."). The prosecution histo