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EXHIBIT A
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CONFIDENTIAL CONTAINS INFORMATION SUBJECT TO PROTECTIVE ORDER
IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF CALIFORNIA SAN JOSE DIVISION
HOLOGIC, INC., CYTYC CORPORATION, and HOLOGIC L.P., Plaintiffs, vs. SENORX, INC., Defendant. AND RELATED COUNTERCLAIMS.
Case No. C08 00133 RMW (RS)
EXPERT REPORT OF LYNN J. VERHEY, Ph.D.
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Ashpole therefore teaches "over-treatment of body tissue at or close to the outer wall of the instrument," which the claimed device must prevent according to the Court's prior construction of "render uniform." For this reason, Ashpole does not teach the device in claim 11 and, therefore, does not anticipate claim 11, expressly or inherently. Moreover, I must note that Ashpole expressly describes that the tolerance of brain tissue to radiation is 55-60 Gy the provision of 70 Gy or more is therefore "over treatment" of tissue as defined by Ashpole. In addition, Ashpole does not disclose that the balloon is expanded to conform the shape of the cavity to the outer surface of the balloon, or that the balloon comes into contact with the tumor bed at all points, or that the distance from the tumor bed to the radiation source can be adjusted through expansion of the balloon. Indeed, it is critical to the claimed invention that the tissue and the balloon conform to each other this is the primary way to achieve a "uniform" dose. During prosecution, when the terms "uniform" and "render uniform" were added to the claims to overcome prior art, the applicant stated that, in order to have dose "uniformity," there must be constant distance between the radiation source and the tissue being treated: Applicants invention is specifically designed to provide a uniform radial absorbed dose profile of the emissions from the particular chamber containing the radionuclide material so that occurrences of "hot spots" and/or "cold spots" are substantially eliminated. Hot spots can result in necrosis of healthy tissue, a condition to be avoided, while cold spots may mean that cancerous cells are not irradiated and killed. In one embodiment, uniformity of the radial absorbed profile is achieved by providing a spherical outer chamber which when inflated to contact the cavity margins resulting from surgical removal of the tumor, a desired constant spacing will be maintained between the radiation source and the adjacent tissue structures. (Amendment dated 9-1-98 at 6 (emphasis added).) One cannot have a "constant spacing . . . maintained between the radiation source and the adjacent tissue structures" unless the tissue contacts the balloon at all points. If the tissue did not so contact the balloon, then - 39 Report of Lynn J. Verhey, Ph.D.
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6.5.2.1.1. Ashpole Ashpole does not anticipate claim 8 of the `142 patent. I disagree with SenoRx's contention that Ashpole anticipates claim 8. In my opinion, Ashpole does not disclose the following claim elements: (A) an expandable outer surface defining a three-dimensional apparatus volume configured to fill an interstitial void created by the surgical extraction of diseased tissue and define an inner boundary of the target tissue being treated (B) the radiation source further being asymmetrically located and arranged within the expandable surface to provide predetermined asymmetric isodose curves with respect to the apparatus volume. (C) wherein the expandable outer surface is sufficiently rigid to deform the target tissue into the shape of the expandable outer surface, causing the predetermined asymmetric isodose curves to penetrate into the target tissue to a prescribed depth (A) See my analysis under 6.5.1.1.1(A). Thus, there is no express or inherent disclosure of this claim element in Ashpole and Ashpole, therefore, does not anticipate claim 8 of the `142 patent. (B) See my analysis under 6.5.1.1.1(B). Accordingly, Ashpole does not disclose this claim element, expressly or inherently and it therefore cannot anticipate claim 8. (C) Ashpole does not describe "wherein the expandable outer surface is sufficiently rigid to deform the target tissue into the shape of the expandable outer surface, causing the predetermined asymmetric isodose curves to penetrate into the target tissue to a prescribed depth." SenoRx has cited only pages 334-36 and Figure 3 of Ashpole in contending that Ashpole describes this claim element. There are no specific citations to any language in these passages nor is any language quoted by SenoRx in its contentions. I see nothing in the cited passages that shows the element above. The claim language provides that the expandable outer surface must "deform the target tissue into the shape of the expandable surface." This means more than that the - 79 Report of Lynn J. Verhey, Ph.D.
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outer surface of the device must touch (or very nearly touch) the entire surface of the target tissue it means that the balloon must apply force to the target tissue to deform it to the balloon's shape. Ashpole does not teach that the outer surface of the balloon even touches all points of the tissue (to define an inner boundary of the target tissue) much less that it presses against the tissue to deform it to the balloon's shape. Ashpole only mentions "filling" the cavity with the balloon, which one skilled in the art would understand to mean that the balloon is inflated until it contacts surrounding brain tissue it is not an express teaching that the tissue conforms to the balloon (or even that the balloon conforms to the tissue). There is also no inherent description of the balloon conforming tissue to the balloon because the balloon is capable of filling the cavity without conforming the tissue to its shape. Moreover, while SenoRx contends that figure 3 shows the tissue conformed to the balloon, this is not necessarily the case. The lateral radiographic image is merely a twodimensional slice of a three-dimensional cavity. It is quite possible indeed, likely that there is some space between the cavity and the balloon in the parts of the cavity that lie outside the figure, i.e., in front of or behind it. Thus, there is no express or inherent disclosure of this claim element in Ashpole and Ashpole, therefore, does not anticipate claim 8 of the `142 patent. 6.5.2.1.2. Williams `774 Williams `774 does not anticipate claim 8 of the `142 patent. I disagree with SenoRx's contention that Williams `774 anticipates claim 8. In my opinion, Williams `774 does not disclose the following claim elements: (A) the radiation source further being asymmetrically located and arranged within the expandable surface to provide predetermined asymmetric isodose curves with respect to the apparatus volume.
- 80 Report of Lynn J. Verhey, Ph.D.
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IN THE UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA SAN JOSE DIVISION
HOLOGIC, INC., CYTYC CORPORATION and ) HOLOGIC L.P., ) ) Plaintiffs, ) ) v. ) ) SENORX, INC., ) ) Defendant. ) ) SENORX, INC., ) ) Counterclaimant, ) ) v. ) ) HOLOGIC, INC., CYTYC CORP., and ) HOLOGIC L.P., ) ) Counterdefendants. )
Case No. 08-CV-0133 RMW
EXPERT REPORT OF COLIN G. ORTON, Ph.D.
EXPERT REPORT OF COLIN G. ORTON, PH.D.
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'142 Patent, Claim 1 a radiation source disposed completely within the expandable outer surface and located so as to be spaced apart from the apparatus volume,
Ashpole Disclosure If Plaintiffs' interpretation is adopted, the radiation bead(s) described in Ashpole is disposed within the expandable outer surface and spaced apart from the outer surface because it is inside the catheter body. pp. 333-34; Figs. 1 & 3. The authors make clear that if matching the shape of the cavity does not produce a satisfactory dose curve for an individual tumor bed, "[a] certain measure of dosimetrical versatility is possible in that the positions of the active beads can be changed to produce an isodose distribution specific to the geometry of the individual tumour beds." See p. 336. The person of ordinary skill would understand from Ashpole that one circumstance in which this was desirable is discussed at page 334 where only "as much [of the] tumour was removed as deemed safe." Such a person would understand that when the remaining tumor tissue was located, for example, near the distal end of the device, the radiation source should be arranged and predetermined to deliver more radiation nearer the remaining "tumour beds" at the distal end of the device (i.e., locating the radiation sources off center in the balloon).
The radiation source further being asymmetrically located and arranged within the expandable surface to provide predetermined asymmetric isodose curves with respect to the apparatus volume.
'142 Patent, Claim 8 The apparatus of claim 1, wherein the expandable outer surface is sufficiently rigid to deform the target tissue into the shape of the expandable outer surface, causing the predetermined asymmetric isodose curves to penetrate into the target tissue to a prescribed depth.
Ashpole Disclosure See '204 Patent, claim 4. A person of ordinary skill in the art would understand that, the outer balloon of the Ashpole device, which was made with a Portex, Blue Line endotracheal tube, i.d. 8.0 with a Profile cuff, see p. 334, is sufficiently rigid when inflated to deform brain tissue into the shape of the expandable outer surface, which would cause the predetermined asymmetric isodose curves to penetrate into the target tissue to the prescribed depth. By filling the postsurgical -36CASE NO. 08-CV-0133 RMW
EXPERT REPORT OF COLIN G. ORTON, PH.D.
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'142 Patent, Claim 8
Ashpole Disclosure cavity and deforming the target tissue into the shape of the balloon, the Ashpole device makes it possible to deliver the prescription dose to the prescribed depth of 0.5 cm. See p. 335 & Fig. 3.
In addition to my opinion that Ashpole, both alone and in combination with the
general knowledge of a person of ordinary skill in the art, anticipates the asserted claims of the patents-in-suit, it is my opinion that Ashpole combined with Friedman 1958 renders the asserted claims of the '813 and '204 patents obvious. A person skilled in the art, starting with Ashpole, would be motivated to combine these references because such a person interested in interstitial use would start with Ashpole, and Friedman 1958 teaches a very similar device that would be of interest to someone attempting to make an Ashpole-like balloon brachytherapy device with a single radioactive source. For example, Johannesen utilized a single-source Ashpole device during the 1990s after reviewing the Ashpole disclosure. For the reasons discussed in paragraphs 87 to 116 regarding Ashpole and in paragraphs 122 to 136 regarding Friedman 1958, including the tables, these references render the claimed inventions of the '813 and '204 patents obvious. 110. For the same reasons, a person of ordinary skill would be motivated to combine
Ashpole with Johannesen. Indeed, I understand that Johannesen's use and public description of the apparatus and method described in his article was motivated by the Ashpole article and method. For the reasons discussed in paragraphs 87 to 116 regarding Ashpole and paragraphs 154 to 164 regarding Johannesen, including the tables, these references render the claimed inventions of the '813 and '204 patents obvious. 111. In addition, Ashpole combined with either Low-Beer 1950 or Low-Beer 1954
renders the asserted claims of the '813 and '204 patents obvious. A person skilled in the art, starting with Ashpole, would be motivated to combine these references because such a person interested in interstitial use would start with Ashpole, and both Low-Beer 1950 and Low-Beer 1954 teach a very similar device that would be of interest to someone attempting to make an
EXPERT REPORT OF COLIN G. ORTON, PH.D.
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F.T. Alexandra Mahaney, State Bar No. 125984 WILSON SONSINI GOODRICH & ROSATI Professional Corporation 12235 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: (858) 350-2300 Facsimile: (858) 350-2399 Email: [email protected] Bruce R. Genderson (admitted pro hac vice) Aaron P. Maurer (admitted pro hac vice) Rachel Shanahan Rodman (admitted pro hac vice) Adam D. Harber (admitted pro hac vice) WILLIAMS & CONNOLLY LLP 725 Twelfth St. NW Washington, DC 20005 Telephone: (202) 434-5000 Facsimile: (202) 434-5029 Attorneys for Defendant SENORX, INC. IN THE UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA SAN JOSE DIVISION HOLOGIC, INC., CYTYC CORP., and HOLOGIC L.P., Plaintiffs, v. SENORX, INC., Defendant. ) ) ) ) ) ) ) ) ) ) ) ) ) CASE NO.: 08-CV-0133 RMW DEFENDANT SENORX, INC.'S SUPPLEMENTAL CLAIM CONSTRUCTION BRIEF REDACTED VERSION Date: June 25, 2008 Time: 2:00 p.m. Courtroom: 6, 4th Floor Judge: Hon. Ronald M. Whyte
DEFENDANT SENORX, INC.'S SUPPLEMENTAL CLAIM CONSTRUCTION BRIEF
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1 2 3 PRELIMINARY STATEMENT.....................................................................................................1 4 CONSTRUCTION OF THE DISPUTED TERMS ........................................................................2 5 A. 6 B. 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28
DEFENDANT SENORX, INC.'S SUPPLEMENTAL CLAIM CONSTRUCTION BRIEF
TABLE OF CONTENTS
Uniform Radial Absorbed Dose Profile ('813 Patent Claim 1). .............................2 "Adapted To Conform" and "Sufficiently Rigid To Deform" ('204 patent, Claim 4; '142 patent, Claim 8)................................................................................6 "Predetermined Asymmetric Isodose Curves" ('142 Patent Claims 1, 8). .............9
C.
CONCLUSION .............................................................................................................................10
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TABLE OF AUTHORITIES FEDERAL CASES Bicon, Inc. v. Straumann Co., 441 F.3d 945 (Fed. Cir. 2006) ................................................................................................... 5 Catalina Mktg. Int'l v. Coolsavings.com, Inc., 289 F.3d 801 (Fed. Cir. 2002) ................................................................................................... 5 Degeorge v. Bernier, 768 F.2d 1318 (Fed. Cir. 1985) ................................................................................................. 5 IMS Tech., Inc. v. Haas Automation, Inc., 206 F.3d 1422 (Fed. Cir. 2000) ................................................................................................. 5 In re Venezia, 530 F.2d 956.............................................................................................................................. 8 O2 Micro Int'l Ltd. v. Beyond Innovation Tech. Co., Ltd., 521 F.3d 1351 (Fed. Cir. 2008) ................................................................................................. 1 Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298 (Fed. Cir. 1999) ................................................................................................. 5 South Corp. v. United States, 690 F.2d 1368 (Fed. Cir. 1982) (en banc) ................................................................................. 8
DEFENDANT SENORX, INC.'S SUPPLEMENTAL CLAIM CONSTRUCTION BRIEF
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1
PRELIMINARY STATEMENT In their Markman briefs, Plaintiffs made plain they intend to argue claim construction to the jury in support of their infringement case against SenoRx. With the submission of Dr. Lynn Verhey's expert report, Plaintiffs again make plain their intent to argue claim construction to the jury this time to avoid invalidity of the patents-in-suit over the prior art. Dr. Verhey's expert report, submitted on June 4, 2008, disclosed that Dr. Verhey plans to present at trial new claim construction arguments to distinguish the prior art and rebut SenoRx's invalidity case. These new claim constructions were neither disclosed by Plaintiffs, briefed by the parties, nor presented to the Court as required by the Patent Local Rules. And substantively, they are wrong. Dr. Verhey's proffered opinions regarding the meaning of the claims are inconsistent with the claim language and unsupported by the teachings of the patents-in-suit. Not surprisingly, Plaintiffs seek to avoid a ruling on the meaning of the terms at issue, arguing, just as in their Markman briefs, that the claim terms should be given their "plain meaning," or that they require no further construction beyond what Plaintiffs first proposed in their Markman briefs. The Court should not accept Plaintiffs' invitation to decline to construe these terms, as the parties dispute their meaning. As SenoRx previously noted, the law provides that "[w]hen the parties raise an actual dispute regarding the proper scope of these claims, the court, not the jury, must resolve that dispute." O2 Micro Int'l Ltd. v. Beyond Innovation Tech. Co., Ltd., 521 F.3d 1351, 1360 (Fed. Cir. 2008). Accordingly, the Court should construe the claim terms at issue consistent with SenoRx's proposed constructions, thereby preventing Plaintiffs' expert from presenting to the jury invalidity positions based on erroneous constructions. See id.1
Alternatively, SenoRx requests that the Court treat this supplemental Markman brief as a motion in limine to exclude Dr. Verhey's testimony on the new claim construction arguments identified herein.
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CONSTRUCTION OF THE DISPUTED TERMS Uniform Radial Absorbed Dose Profile ('813 Patent Claim 1).
SenoRx's Proposed Construction The "radial absorbed dose profile" means the absorbed dose as a function of distance in a radial direction from the outer surface of the radiation transparent wall. "Uniform" does not require that the tissue and the balloon conform to each other or relate to the shape of the isodose curve; instead, it refers to the slope of the dose profile as discussed in SenoRx's previous briefing. [If the preamble is a claim limitation] The "radiation profile" means the absorbed dose as a function of distance in a radial direction from the outer surface of the radiation transparent wall. "Uniform" does not require that the tissue and the balloon conform to each other or relate to the shape of the isodose curve; instead, it refers to the slope of the dose profile as discussed in SenoRx's previous briefing.
Claim Term uniform radial absorbed dose profile ('813 patent, claim 1(e))
6 7
uniform radiation profile
8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28
('813 patent, preamble)
Prior to the submission of Dr. Verhey's expert report on June 4, 2008, the parties agreed that "uniform radial absorbed dose profile" and "uniform radiation profile" in claim 1 of the '813 patent referred to the strength of the dose in the tissue at various distances from the radiation source. Dr. Verhey's report now asserts that these terms address a different subject: whether the surface of the outer balloon contacts the tissue at all points so that there is conformance between the tissue and the balloon. Plaintiffs' newly-minted construction is simply wrong. As SenoRx explained in its Markman brief, the '813 patent teaches that "radial absorbed dose profile" refers to the radiation dose absorbed in the tissue measured as a function of distance in a radial (i.e., outward) direction from the outer balloon. See SenoRx Opening Brief ("Op. Br.") at 9-10. Put another way, a "radial absorbed dose profile" plots the strength of the radiation dose within the target tissue as the radiation progresses outward from the radiation source and into the tissue. See generally Ex. 1 ('813 patent), col. 3:13-37; fig. 5.2 The '813 patent represents the dose profile in Figure 4, which depicts a line plotting the radiation dose
Exs. 1-14 are exhibits to the Declaration of Adam D. Harber in Support of SenoRx's Opening Claim Construction Brief, Exs. 15-17 are exhibits to the Declaration of Adam D. Harber in Support of SenoRx's Responsive Claim Construction Brief, and Exs. 18-21 are exhibits to the Declaration of Adam D. Harber in Support of SenoRx's Supplemental Claim Construction Brief. 2
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absorbed in the tissue on the y axis, and the distance from the outer balloon to the target depth in the tissue on the x axis. See id. Rendering the "absorbed dose profile" more "uniform" means to reduce the slope of this line, which indicates there is less variation in the strength of the radiation dose at various distances outward from the surface of the balloon to the edge of the target depth in the tissue. This is exactly how the Court described the dose profile in its construction of claim element 1(e) in the Xoft case. See Ex. 4 (Xoft Cl. Constr. Order) at 8-9 (reproducing Figure 4 of the '813 patent and discussing reducing the slope of the dose profile). And, it is exactly how Plaintiffs described the claim element in their Markman briefs. Plaintiffs argued the "uniformity" of a radiation profile is measured over a "distance from the center of the cavity along a direction of interest" and is characterized by the "flatter" line 42 shown in Figure 4 of the '813 patent. See Pls' Cl. Constr. Br. at 9 (emphasis added). Plaintiffs even reproduced Figure 4 of the '813 patent in their brief and argued that the "written description explains the objective of flattening line 40 to achieve an absorbed dose profile depicted by line 42," thus making the point that a "uniform" radiation profile was achieved over the span of distance from radiation source, as represented by the "flatter" slope of line 42. See Pls' Cl. Constr. Br. at 9 (citing '813 patent, col. 4:14-38) (emphasis added).
By contrast, claim 4 of the '204 patent requires that the "expandable surface element is adapted to contact tissue surrounding a resected cavity and adapted to conform the tissue to the desired shape of the expandable surface element." Ex. 2 ('204 patent), claim 4. While this element does not require actual conformance, see discussion infra Section B, Dr. Verhey is attempting to import this element from an interstitial device into a claim that is not limited to interstitial cavities. 3
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For the reasons discussed supra, Dr. Verhey's construction of "uniform" in claim element 1(e) of the '813 patent should be rejected. Plaintiffs' new position is flatly inconsistent with the Court's and their own prior construction, and it is contradicted by the teachings of the '813 patent. There is simply no basis anywhere in the patent for a conformance requirement. The patent requires only that the inner and outer volumes are "filled" with radioactive material or radiation attenuating material. It says nothing about filling the balloon to match the size of the cavity, let alone filling it to "conform" the cavity. In addition, Plaintiffs' attempt to read a conformance limitation into claim element 1(e) does not square with Dr. Verhey's own testimony on the subject. As far back as November 2006 in the Xoft case, Dr. Verhey stated that the "radial dose profile is defined as the absorbed dose to tissue as a function of distance from the center of the cavity along a particular direction of interest." See Ex. H to Altemus Decl. (Verhey Decl. (Nov. 9, 2006) Appx. C at 6:21-28), cited in Pls' Cl. Constr. Br. at 9. He reiterated the same position in his declaration in support of Plaintiffs' Reply Claim Construction Brief in this case. See Verhey Decl. (May 30, 2008) at 3 (discussing a "more or less uniform" dose profile and explaining that "dose fall-off will be primarily a function of distance").
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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 Equally unpersuasive is Plaintiffs' attempt to read a balloon-tissue conformance limitation into the "uniform" language of the preamble. Language in a claim preamble generally does not serve to limit claims. Bicon, Inc. v. Straumann Co., 441 F.3d 945, 952 (Fed. Cir. 2006); Degeorge v. Bernier, 768 F.2d 1318, 1322 n.3 (Fed. Cir. 1985). In particular, a preamble "is not limiting `where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention.'" Catalina Mktg. Int'l v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (quoting Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997)). "If the preamble adds no limitations to those in the body of the claim, the preamble is not itself a claim limitation and is irrelevant to proper construction of the claim." IMS Tech., Inc. v. Haas Automation, Inc., 206 F.3d 1422, 1435 (Fed. Cir. 2000); see also Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999). As the preamble here adds no structure to the claim, it is "not limiting." Catalina, 289 F.3d at 808. In any event, there is no basis to distinguish the meaning of "uniform" in the preamble from the means-plus-function limitation (e) in the body of the claim. The invention after the preamble is structurally complete, and the "uniform" language in the preamble simply states a "purpose or intended use" for the invention as defined in the claim body. The prosecution history supports this reading. During prosecution, the applicants changed the word "controlled" to "uniform" in the preamble of claim 1 at the same time they amended the means-plus-function claim limitation (e) to change "controlling the radial absorbed dose profile" to "rendering uniform the radial absorbed dose profile." Ex. 5 (Sep. 1, 1998 Am., '813 Prosecution History) at 1-2. Thus, it is clear the preamble merely refers to the claim limitation in (e), and does not state 5 DEFENDANT SENORX, INC.'S CASE NO. 08-CV-0133 RMW
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a new claim limitation,
Finally, Plaintiffs' infringement position is further proof that Dr. Verhey's newlyproposed "conformance" requirement is driven by the need to avoid invalidity, and not by any actual limitation of claim 1 of the '813 patent. Plaintiffs first staked out a position on the requirements of claim element 1(e) in their preliminary infringement contentions. They made no mention that the Contura balloon "conformed" the tissue as Dr. Verhey now requires. See Ex. 11 (Pls' Infr. Cont.) at Appx. A, 1-3, 7-9. Plaintiffs also failed to cite any claim limitation based on "uniform" in the preamble. See Ex. 11 (Pls' Infr. Cont.) at Appx. A, 1-3; Ex. 13 (Pls' Prel. Cl. Constr.) at Ex. A, 3. If, as Dr. Verhey asserts, the preamble and claim element 1(e) require "conformance," then Plaintiffs would have asserted the Contura meets that limitation in order to make their infringement case. Their failure to do so speaks for itself. B. "Adapted To Conform" and "Sufficiently Rigid To Deform" ('204 patent, Claim 4; '142 patent, Claim 8)
SenoRx's Proposed Construction the expandable outer surface element is capable of contacting the tissue and capable of conforming the tissue. This does not require that the expandable outer surface actually contacts or conforms the tissue.
Claim Term the expandable outer surface element is . . . adapted to contact / adapted to conform ('204 patent, claim 4) the expandable outer surface is sufficiently rigid to deform the target tissue ('142 patent, claim 8)
the expandable outer surface element is sufficiently rigid so as to be capable of deforming tissue. This does not require that the expandable outer surface actually deforms the target tissue.
Plaintiffs did not identify claim 4 of the '204 patent or claim 8 of the '142 patent as claims requiring construction in their preliminary claim construction disclosure, Joint Claim Construction Statement, or Markman briefs. Ex. 13 (Pls' Prel. Cl. Constr.) at Exs. B, C.
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CASE NO. 08-CV-0133 RMW
Case 5:08-cv-00133-RMW
Document 175-6
Filed 06/20/2008
Page 11 of 15
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DEFENDANT SENORX, INC.'S SUPPLEMENTAL CLAIM CONSTRUCTION BRIEF
Plaintiffs' proposed constructions of these claim terms should be rejected as inconsistent with their plain and ordinary meaning, as well as with the intrinsic evidence. The "adapted to" claim language in claim 4 resulted from a rejection by the PTO of the exact claim construction Plaintiffs now assert is correct. In the prosecution of the '204 patent, the application was rejected for claiming that "the expandable surface element contacts . . . and conforms the tissue." Ex. 20 (June 20, 2000 Office Action, '204 Prosecution History) at 2. The examiner explained that this claim language impermissibly recited "a positive connection to the body." Id. The examiner suggested the claim instead be amended to read "adapted to," to eliminate this problem. Id. As a result, the applicants so amended claim 4, changing the claim language from "the expandable surface element contacts tissue . . . and conforms the tissue" to "the expandable surface element is adapted to contact tissue . . . and adapted to conform the tissue." Ex. 8 (Dec. 20, 2000 Am., '204 Prosecution History) at 2, 9 (emphases added). By amending the claim language, the applicants made clear the claim does not require the expandable surface element actually to contact and conform the tissue. Rather, the expandable surface element must be "adapted to" capable of contacting and conforming the tissue. This is entirely consistent with the plain meaning of the claim language. "Adapted to" means capable of. See, e.g., In re Venezia, 530 F.2d 956, 959 (CCPA 1976)4 (holding that a sleeve "adapted to be fitted over the insulated jacket of one of the cables" meant that each sleeve was so structured
Decisions of the CCPA are binding on the Federal Circuit. South Corp. v. United States, 690 F.2d 1368, 1370-71 (Fed. Cir. 1982) (en banc). 7
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CASE NO. 08-CV-0133 RMW
Case 5:08-cv-00133-RMW
Document 175-6
Filed 06/20/2008
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or dimensioned that it could be fitted over the insulated jacket of a cable); 1 The Oxford English Dictionary 130 (Clarendon Press) (2d ed. 2001) (defining "adapted" as "suitable") (attached hereto as Ex. 21). The same is true for the "sufficiently rigid" language of claim 8 of the '142 patent. Claim 8 does not require that the expandable outer surface actually deform the target tissue. Rather, the language of claim 8 requires that the "expandable outer surface is sufficiently rigid to deform the target tissue." Ex. 3 ('142 patent), claim 8. The claim language requires that the apparatus have the property of being sufficiently rigid to deform. Put another way, the apparatus must be sufficiently rigid so as to be capable of or suitable for deforming tissue. The plain claim language does not require that the expandable outer surface actually deforms the tissue.
DEFENDANT SENORX, INC.'S SUPPLEMENTAL CLAIM CONSTRUCTION BRIEF
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CASE NO. 08-CV-0133 RMW
Case 5:08-cv-00133-RMW
Document 175-6
Filed 06/20/2008
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('142 patent, claim 1)
When the very same expert who put forth the construction disagrees with it, it is clear Plaintiffs' new limitations are entirely without support. C. "Predetermined Asymmetric Isodose Curves" ('142 Patent Claims 1, 8).
SenoRx's Proposed Construction SenoRx already has proposed a construction of "predetermined asymmetric isodose curves." "Predetermined" requires that the asymmetric isodose curves that will be created by the radiation source are determined prior to treatment. It does not require the ability to change the location and arrangement of radiation sources to provide any specific asymmetric isodose curves, but rather determining prior to treatment the isodose curves resulting from the actual asymmetric arrangement and location of the radiation source.
Claim Term the radiation source ... asymmetrically located and arranged within the expandable surface to provide predetermined asymmetric isodose curves with respect to the apparatus volume
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predetermined asymmetric isodose curves ('142 patent, claim 8)
SenoRx asserted in its Markman briefs that "predetermined asymmetric isodose curves" in claims 1 and 8 and the '142 patent should be construed to mean "isodose curves determined before radiation is administered which are not substantially the same shape as the apparatus volume and/or not concentric with the apparatus volume." See Op. Br. at 23-24; Resp. Br. at 2324. Dr. Verhey's expert report seeks to add new limitations to claims 1 and 8 of the '142 patent based on the term "predetermined" in an effort to argue against the invalidity of the claims over the prior art. The new limitations Dr. Verhey sets forth in his expert report are unsupported by the '142 patent and should be rejected. Claims 1 and 8 of the '142 patent require that the radiation sources are asymmetrically arranged within the balloon so that they provide asymmetric isodose curves, and that the asymmetric isodose curves are "predetermined" calculated before treatment based on the relative position of the source(s) and the balloon.5 In their Markman briefs, Plaintiffs seemed to
As discussed in SenoRx's Markman briefs and Motion for Partial Summary Judgment, the claim also requires that the source(s) be spaced apart from the apparatus volume, which is (continued...) 9 DEFENDANT SENORX, INC.'S CASE NO. 08-CV-0133 RMW
SUPPLEMENTAL CLAIM CONSTRUCTION BRIEF
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agree. Plaintiffs proposed no separate construction of "predetermined asymmetric isodose curves," and described the requirement consistent with SenoRx's proposed construction. See Pls' Resp. Cl. Constr. Br. at 21-22 ("As a direct consequence of this asymmetric location and arrangement of the radiation source, `predetermined asymmetric isodose profiles' are created.").
This construction is incorrect. The plain meaning of "predetermined" simply requires that the person administering radiation calculate prior to treatment the asymmetric isodose curves the device would generate. Indeed, "determine" means to ascertain what the curves will be. "Predetermined" is simply ascertaining what the curves will be before using the device. There is nothing in this concept that requires that the device have additional structure to give the user the flexibility to create any desired isodose curve. Rather, all the claim requires is that the radiation source is located asymmetrically so that it will provide asymmetric isodose curves which are determined before radiation is administered. CONCLUSION For the foregoing reasons, the Court should adopt SenoRx's proposed constructions of the disputed terms of the '813, '204, and '142 patents.
(...continued from previous page) impossible. See Op. Br. at 23; Resp. Br. at 21-23; Motion for Partial Summary Judgment of Invalidity. 10
DEFENDANT SENORX, INC.'S SUPPLEMENTAL CLAIM CONSTRUCTION BRIEF
CASE NO. 08-CV-0133 RMW
Case 5:08-cv-00133-RMW
Document 175-6
Filed 06/20/2008
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Dated: June 20, 2008
Respectfully submitted,
By:
/s/ F.T. Alexandra Mahaney__________
F.T. Alexandra Mahaney, State Bar No. 125984 WILSON SONSINI GOODRICH & ROSATI Professional Corporation 12235 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: (858) 350-2300 Facsimile: (858) 350-2399 Email: [email protected] Bruce R. Genderson (admitted pro hac vice) Aaron P. Maurer (admitted pro hac vice) Rachel Shanahan Rodman (admitted pro hac vice) Adam D. Harber (admitted pro hac vice) WILLIAMS & CONNOLLY LLP 725 Twelfth St. NW Washington, DC 20005 Telephone: (202) 434-5000 Facsimile: (202) 434-5029 Attorneys for Defendant SENORX, INC.
DEFENDANT SENORX, INC.'S SUPPLEMENTAL CLAIM CONSTRUCTION BRIEF
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CASE NO. 08-CV-0133 RMW
Case 5:08-cv-00133-RMW
Document 175-7
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Exhibit 20
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Exhibit 21
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Document 175-11
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Free Motion for Leave to File - District Court of California - California
| File Size: | 2,447.5 kB |
| Pages: | 62 |
| Date: | September 10, 2008 |
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| State: | California |
| Category: | District Court of California |
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