Free Declaration in Support - District Court of California - California

Case 5:08-cv-00133-RMW

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1 Henry C. Su (SBN 211202; [email protected]) Katharine L. Altemus (SBN 227080; [email protected]) 2 HOWREY LLP 1950 University Avenue, 4th Floor 3 East Palo Alto, California 94303 Telephone: (650) 798-3500 4 Facsimile: (650) 798-3600 5 Robert Ruyak Matthew Wolf (Admitted Pro Hac Vice) 6 Marc Cohn (Admitted Pro Hac Vice) HOWREY LLP 7 1299 Pennsylvania Avenue, NW Washington, DC 20004 8 Telephone: (202) 783-0800 Facsimile: (202) 383-6610 9 Attorneys for Plaintiffs 10 HOLOGIC, INC., CYTYC CORPORATION and HOLOGIC L.P. 11 12 13 UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA SAN JOSE DIVISION Case No. C08 00133 RMW (RS) DECLARATION OF HENRY C. SU IN SUPPORT OF PLAINTIFFS' OPPOSITION TO SENORX, INC.'S MOTION FOR PARTIAL SUMMARY JUDGMENT OF NON-INFRINGEMENT (`813 PATENT, CLAIMS 11 & 12; `204 PATENT, CLAIMS 4 & 17; AND `142 PATENT, CLAIM 6) Date: Time: Ctrm: Judge: June 25, 2008 2:00 p.m. 6, 4th Floor Hon. Ronald M. Whyte

14 HOLOGIC, INC., CYTYC CORPORATION, and HOLOGIC L.P., 15 Plaintiffs, 16 vs. 17 SENORX, INC., 18 Defendant. 19 20 21 22 AND RELATED COUNTERCLAIMS. 23 24 25 26 27 28
Su Decl. ISO Opposition to Non-Infringement MSJ Case No. C08 00133 RMW (RS)

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I, Henry C. Su, declare that I am a partner at the law firm Howrey LLP and a member of the bar

2 of this Court, and I serve as outside counsel for Plaintiffs Hologic, Inc., Cytyc Corporation and 3 Hologic LP ("Hologic"). The following declaration is based on my personal knowledge, and if called 4 to testify, I could and would competently testify as to the matters set forth below. 5 1. Attached hereto as Exhibit A is a true and correct copy of excerpts from SenoRx's April

6 20, 2007 510(k) Notification regarding the SenoRad Multi-Lumen Balloon Source Applicator for 7 Brachytherapy, produced by SenoRx with Bates numbers SRX-HOL00000413-495 (only relevant 8 pages attached), marked Confidential ­ Outside Counsel Only, and filed under seal. 9 2. Attached hereto as Exhibit B is a true and correct copy of the Court's April 27, 2007

10 Claim Construction Order in Xoft, Inc. v. Cytyc Corporation, et al., Case No. C-01-05312 RMW. 11 3. Attached hereto as Exhibit C is a true and correct copy of the Contura Multi-Lumen

12 Balloon Source Applicator for Brachytherapy's Instructions for Use, produced by SenoRx with Bates 13 numbers SRX-HOL00002232-3. 14 4. Attached hereto as Exhibit D is a true and correct copy of SenoRx slides pertaining to

15 the accused device, produced by SenoRx with Bates number SRX-HOL00006665, marked 16 Confidential ­ Outside Counsel Only, and filed under seal. 17 5. Attached hereto as Exhibit E is a true and correct copy of a document entitled "Contura

18 - Frequently Asked Questions," produced by SenoRx with Bates numbers SRX-HOL00006684-86, 19 marked Confidential ­ Outside Counsel Only, and filed under seal. 20 6. Attached hereto as Exhibit F is a true and correct copy of a SenoRx slide pertaining to

21 the accused device, produced by SenoRx with Bates number SRX-HOL00001685, marked 22 Confidential ­ Outside Counsel Only, and filed under seal. 23 7. Attached hereto as Exhibit G is a true and correct copy of excerpts from the April 4,

24 2008 deposition of Douglas W. Arthur, M.D., designated Highly Confidential, and filed under seal. 25 8. Attached hereto as Exhibit H is a true and correct copy of excerpts from the April 2,

26 2008 deposition of Philip Z. Israel, M.D., filed under seal. 27 28
Su Decl. ISO Opposition to Non-Infringement MSJ Case No. C08 00133 RMW (RS) -1-

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9.

Attached hereto as Exhibit I is a true and correct copy of excerpts from the April 2,

2 2008 deposition of William F. Gearhart, designated Confidential, and filed under seal. 3 10. Attached hereto as Exhibit J is a true and correct copy of a document entitled: "Contura

4 - Frequently Asked Questions," produced by SenoRx with Bates numbers SRX-HOL00006598-6601, 5 marked Confidential ­ Outside Counsel Only, and filed under seal. 6 11. Attached hereto as Exhibit K is a true and correct copy of SenoRx slides pertaining to

7 the accused device, produced by SenoRx with Bates number SRX-HOL00006492, marked 8 Confidential ­ Outside Counsel Only, and filed under seal. 9 12. Attached hereto as Exhibit L is a true and correct copy of SenoRx slides pertaining to

10 the accused device, produced by SenoRx with Bates number SRX-HOL00006493, marked 11 Confidential ­ Outside Counsel Only, and filed under seal. 12 13. Attached hereto as Exhibit M is a true and correct copy of SenoRx slides pertaining to

13 billing and payment information for the accused product, produced by SenoRx with Bates numbers 14 SRX-HOL00006624-6631 (only relevant pages attached), marked Confidential ­ Outside Counsel 15 Only, and filed under seal. 16 15. Attached hereto as Exhibit N is a true and correct copy of excerpts from the May 20,

17 2008 deposition of James B. Stubbs, Ph. D., marked Confidential ­ Outside Counsel Only, and filed 18 under seal. 19 16. Attached hereto as Exhibit O is a true and correct copy of a document entitled "510(k)

20 Summary," dated May 18, 2007, produced by SenoRx with Bates numbers SRX-HOL00006605-6, 21 marked Confidential ­ Outside Counsel Only, and filed under seal. 22 17. Attached hereto as Exhibit P is a true and correct copy of an excerpt from SenoRx's

23 Contura MLB Source Applicator for Brachytherapy ­ Special 510(k), entitled "Device Description," 24 produced by SenoRx with Bates numbers SRX-HOL00005563-65, marked Confidential ­ Outside 25 Counsel Only, and filed under seal. 26 27 28
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18.

Attached hereto as Exhibit Q is a true and correct copy of SenoRx CTO Paul Lubock's

2 November 6, 2002 patent application entitled "Vacuum Device and Method for Treating Tissue 3 Adjacent a Body Cavity." 4 19. Attached hereto as Exhibit R is a true and correct copy of a July 22, 2004 Information

5 Disclosure Statement submitted in support of SenoRx CTO Paul Lubock's patent application. 6 20. Attached hereto as Exhibit S is a true and correct copy of a Contura MLB

7 Brachytherapy Applicator Clinical Data Report, produced by SenoRx with Bates numbers SRX8 HOL00005395-5405, marked Confidential ­ Outside Counsel Only, and filed under seal. 9 21. Attached hereto as Exhibit T is a true and correct copy of a document entitled "Multi-

10 Lumen Radiation Balloon (MLB) Background Information, produced by SenoRx with Bates numbers 11 SRX-HOL00001535-37, marked Confidential ­ Outside Counsel Only, and filed under seal. 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28
Su Decl. ISO Opposition to Non-Infringement MSJ Case No. C08 00133 RMW (RS) -3-

I declare under penalty of perjury that the foregoing is true and correct. Dated: HOWREY LLP

By:

/s/ Henry C. Su

HOWREY LLP Attorneys for Plaintiffs Hologic, Inc., Cytyc Corporation, and Hologic L.P.

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Exhibit B

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1 2 3 4 5 6 7 8 9 10 United States District Court For the Northern District of California 11 12 13 14 15 Defendants. 16 17 18 19 20 21 22 23 24
1

E-FILED on

4/27/07

IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF CALIFORNIA SAN JOSE DIVISION

XOFT, INC., Plaintiff, v. CYTYC CORPORATION; and PROXIMA THERAPEUTICS, INC.,

No. C-05-05312 RMW CLAIM CONSTRUCTION ORDER [Re Docket Nos. 48, 50, 53]

Xoft, Inc. sued Cytyc Corporation and one of its subsidiaries, Cytyc Surgical Products II, Inc., (collectively "Cytyc") for a declaratory judgment of non-infringement and invalidity of U.S. Patent Nos. 5,913,813 and 6,413,204. Cytyc responded by filing counterclaims for infringement of the same patents and currently asserts that Xoft infringes six claims of the '813 patent1 and twenty

25 26 27 28

Cytyc asserts claims 1, 2, 3, 4, 8, and 12. Claim 1 is an apparatus claim and the only independent claim of the '813 patent. Claims 2, 3, and 12 depend directly from claim 1. Claim 4 depends from claim 3, and claim 8 depends from claim 2. The following is a graphic representation of the relationship of the asserted claims: 1 /|\ 2 3 12 / | . 8 4 .
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claims of the '204 patent2. The application for the '204 patent was filed as a continuation-in-part of the '813 patent; the former purports to incorporate by reference the latter. '204 patent, col. 1, ll. 1011. The parties seek construction of eight terms or phrases from the '813 patent and twenty-one terms or phrases from the '204 patent. I. BACKGROUND The patents-in-suit are directed to methods and apparatus for treatment of proliferative tissue diseases. The prior art discloses that a radiation source can be implanted at a tumor site to irradiate any remaining diseased tissue; this process is known as interstitial brachytherapy. The parties agree that for the purposes of this suit, the strength of radiation may be assumed to decrease with the square of the distance from the radiation source. The graph of the equation y = 1 / x2 thus can be used as an approximation of the relationship between the radiation strength and distance. The graph, shown below, illustrates that the radiation strength close to the radiation source is disproportionately higher than that at a relatively small distance away from the radiation source. Radiation strength
Distance from source
2

22 23 24 25 26 27 28

Cytyc asserts claims 1, 2, 3, 4, 8, 16, 17, 18, 19, 20, 21, 23, 24, 25, 26, 30, 32, 34, 35, and 36 of the '204 patent. Claims 1 and 36 are the only independent apparatus claims. From claim 1 depend claims 2, 16, and 17. From claim 2 depend claims 4, 8, and 18. Claims 19, 32, and 34 are independent method claims. Claims 20, 21, 23, and 24 all depend from claim 19. Claim 25 depends from claim 24, and claim 26 depends from claim 25. Claim 30 also depends from claim 24. Claim 35 depends from claim 34. The following is a graphic representation of the relationship of the asserted claims: 1 /|\ 2 16 17 /|\ . 4 8 18 . 36 19 / / \ \ 20 21 23 24 / \ 25 30 / 26 2 32 34 | 35

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This shows one of the problems encountered in radiation therapy, namely, that tissue close to the radiation source may get more radiation than a physician would prefer. When using interstitial therapy, a physician may wish to give all tissue within a certain distance--say, for example, 3 centimeters--from the tumor site a certain dose of radiation. However, tissue closer to the tumor site--say, 1 centimeter--will receive a much higher dose of radiation because of the inverse-square relationship. This means that healthy tissue near the tumor site may be killed by the radiation, which is an undesirable result. Following the teachings of the patents-in-suit, the very high levels of radiation near the source can be avoided by simple mechanical means. Surrounding the radiation source on all sides with empty space (or some material other than living tissue) prevents the highest levels of radiation from affecting living tissue, giving the tissue a radiation dose profile that looks something like this:

Radiation strength
Distance from source

II. ANALYSIS A. Terms of the '813 patent "Inner spatial volume" Cytyc's proposed construction A region of space surrounded by an outer spatial volume that is defined by a closed inflatable chamber The summary of the invention provides that it is possible to deliver a desired radiation dose at a predetermined radial distance from a source of radioactivity by providing a first spacial[3] volume at the distal end of a catheter and a second spacial volume defined by a surrounding of the first spatial Presumably all occurrences of "spacial" in the '813 patent should be read as "spatial." 3 Xoft's proposed construction Inner balloon in two-balloon device or spherical solid radionuclide in one-balloon device

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volume by a polymeric film wall where the distance from the spatial volume[4] and the wall is maintained substantially constant over their entire surfaces. One of the inner and outer volumes is filled with either a fluid or a solid containing a radionuclide(s) while the other of the two volumes is made to contain either a low radiation absorbing material, e.g., air or even a more absorptive material, such as an x-ray contrast fluid. Where the radioactive material comprises the core, the surrounding radiation absorbing material serves to control the radial profile of the radioactive emissions from the particular one of the inner and outer volumes containing the radionuclide(s) so as to provide a more radially uniform radiation dosage in a predetermined volume surrounding the outer chamber. Where the core contains the absorbent material, the radial depth of penetration of the radiation can be tailored by controlling the core size. '813 patent, col. 1, l. 50-col. 2, l. 3. The first two claims of the '813 patent read:

8 9 10 United States District Court For the Northern District of California 11 12 13 14 15 16 17 18 19 20 '813 patent, col. 4, ll. 32-54. Since all claims of this patent other than claim 1 depend from claim 1, 21 construction of "inner spatial volume" is critical. 22 In most embodiments of the invention disclosed in the patent specification, the inner spatial 23 volume is a region of space surrrounded by an outer spatial volume that is defined by a closed 24 inflatable chamber. See '813 patent, col. 2, ll. 44-63; col. 3, ll. 9-16, 42-48; col. 4, ll. 16-20; figs. 1, 25 26 27 28
4

1. Apparatus for delivering radioactive emissions to a body location with a uniform radiation profile, comprising: (a) a catheter body member having a proximal end and distal end; (b) an inner spatial volume disposed proximate the distal end of the catheter body member; (c) an outer, closed, inflatable, chamber defined by a radiation transparent wall affixed to the body member proximate the distal end thereof in surrounding relation to the inner spatial volume with a predetermined constant spacing between said inner spatial volume and the radiation transparent wall; (d) a material containing a radionuclide(s) disposed in one of the inner spatial volume and outer chamber; and (e) means disposed in the other of the inner spatial volume and outer chamber 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. 2. The apparatus as in claim 1 wherein said inner spatial volume is an inner closed, chamber defined by a further radiation transparent wall.

Presumably this "spatial volume" should be taken to be the first spatial volume, which would mean that the polymeric film wall forms the outer boundary of the second spatial volume and that the second spatial volume is of a uniform thickness on all sides of the first spatial volume. Such a reading would comport with claim 1(c).
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3-5. However, the patentee drafted the claims in such a way as to make clear that the inner spatial volume was not necessarily so limited: Those skilled in the art will appreciate that instead of having the inner spatial volume 30 defined by a generally spherical polymeric film wall as at 32, the catheter body member 12 may have a solid spherical radiation emitting material in which event that solid sphere would be surrounded with the outer spherical wall 36 with the spatial volume therebetween occupied by a radioactive ray absorbent material, such as air, water or a contrast material. '813 patent, col. 2, ll. 55-63.

7 Although somewhat awkwardly worded, the language of the patent allows for the inner 8 volume to be defined by something other than a region enclosed by a polymeric wall. As Cytyc 9 points out, Xoft's construction conflates the boundary of the volume with the volume itself. Cytyc's 10 United States District Court For the Northern District of California proposed construction, however, is a paraphrasing of the language of claim 1 that only clarifies a 11 little the language of the patent. Furthermore, Cytyc's proposed construction would exclude an inner 12 volume defined by a solid sphere, and thus cannot be correct. 13 Xoft objects that an abstract concept like a region of space cannot be part of an apparatus. 14 Xoft is correct. However, the language of the patent does not imply that the inner volume is ever 15 defined by something other than a physical object. In all embodiments of the invention disclosed in 16 the '813 patent, the boundary of the inner volume is either a polymeric film wall or the edge of a 17 solid sphere. Furthermore, it would seem difficult to fill one volume with radioactive liquid and the 18 other with another fluid if the two volumes were not separated by some structure (which would 19 necessarily be the outer boundary of the inner spatial volume.) See '813 patent, col. 1, ll. 57-62. The 20 patent is even entitled "Double-Wall Balloon Catheter for Treatment of Proliferative Tissue." Xoft's 21 expert, Dr. Lovoi, acknowledged that an "inner spatial volume" is a volume that is inside another 22 volume. Lovoi Dep. at 101:25-102:7. The court defines "inner spatial volume" as "a region of 23 space surrounded by an outer spatial volume and either enclosed by a polymeric film wall or defined 24 by the edge of a solid radionuclide sphere." 25 26 27 28
CLAIM CONSTRUCTION ORDER--No. C-05-05312 RMW JAH

Claim Language "inner spatial volume"

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

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"Outer, closed, inflatable chamber" Cytyc's proposed construction (no construction required) Xoft's proposed construction Inflatable balloon, i.e., deflated balloon

Part (c) of claim 1 explains that the "outer, closed, inflatable chamber" is "defined by a radiation transparent wall affixed to the body member proximate the distal end thereof in surrounding relation to the inner spatial volume with a predetermined constant spacing between said inner spatial volume and the radiation transparent wall." '813 patent, col. 4, ll. 40-45. The preferred embodiment recites a similar structure: "Surrounding the spatial volume 30 is an outer chamber 34 defined by an outer polymeric film wall 36 that is appropriately spaced from the wall 32 of the inner chamber 30 when the two chambers are inflated or otherwise filled and supported." '813 patent, col. 2, ll. 37-41. There is no support in the patent for Xoft's argument that "outer, closed, inflatable chamber" should be limited to only a balloon in a deflated state. The court will therefore adopt Cytyc's proposal and not otherwise define this term. Claim Language "outer, closed, inflatable chamber" Court's Construction outer, closed, inflatable chamber

"Predetermined constant spacing" Cytyc's proposed construction (no construction required) Xoft's proposed construction (indefinite)

"Predetermined constant spacing between said inner spatial volume and radiation transparent wall" Cytyc's proposed construction The spacing between the inner spatial volume and the radiation transparent wall of the outer, closed, inflatable chamber, when inflated, can be made constant in all directions if the outer chamber is spherical, or constant along a radial plane if the outer chamber is not spherical Xoft's proposed construction (indefinite)

Xoft argues that the '813 patent is indefinite because it does not disclose how one 26 "predetermines" the amount of spacing. Xoft points out that the spacing between the edges of the 27 inner and outer volumes may change as parts of the apparatus are inflated or deflated, so the spacing 28 is not constant. Cytyc's expert explained that "predetermined constant spacing" means that "the
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spacing between the inner spatial volume and the wall of the outer inflatable chamber can be made constant in all directions if the outer chamber is spherical, or constant along a radial direction if nonspherical, whenever the outer chamber is inflated." Su Decl. (dkt. # 49), Ex. D (Verhey Decl.) at 7 (citations omitted). Cytyc also argues that "[o]ne skilled in the art knows how to determine an appropriate 'predetermined constant spacing' and Xoft provides no evidence, testimony, or case law to the contrary. Xoft cannot possibly show that the term is indefinite by clear and convincing evidence." Reply Br. (dkt. # 53) at 15. Because 35 U.S.C. § 282 gives a patent "a statutory presumption of validity," a challenger bears the burden of proving "by clear and convincing evidence" that a patent is invalid. Monsanto Co. v. Scruggs, 459 F.3d 1328, 1336-37 (Fed. Cir. 2006). "[P]atent documents need not include subject matter that is known in the field of the invention." S3 Inc. v. NVIDIA Corp., 259 F.3d 1364, 1371 (Fed. Cir. 2001). From the testimony of Dr. Verhey, it appears that one skilled in the art would know how to "predetermine" the amount of spacing.5 See Tr. at 56-61, 85-89. Xoft offered no evidence suggesting otherwise. As the burden of proof is Xoft's, its indefiniteness argument necessarily fails given the absence of supporting evidence. The court will therefore adopt Cytyc's proposed construction of "predetermined constant spacing between said inner spatial volume and radiation transparent wall" modified only to make the definition easier to understand. A separate construction for "predetermined constant spacing" is not necessary. Claim Language "predetermined constant spacing" "predetermined constant spacing between said inner spatial volume and radiation transparent wall" Court's Construction (no construction necessary) 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

5

28

Xoft argues that the size of the cavity determines the size of the apparatus when fully inflated, but this alone does not determine the spacing between the inner spatial volume and the wall of the outer chamber. 7

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"Rendering uniform" Cytyc's proposed construction (no construction required) Xoft's proposed construction Making the same, i.e., causing to have the same value or characteristic at all points.

"Means . . . for rendering uniform the radial absorbed dose profile of the emissions" Cytyc's proposed construction Function: Modifying the ratio of the absorbed dose at a depth of interest in the target tissue to the absorbed dose at the surface of the tissue. 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. Xoft's proposed construction Function: Making the dose along a radius extending from the radionuclide outwardly from the outer chamber wall the same at every point on the radius. Structure: No such means disclosed in '813 patent, means for making more uniform disclosed as substance within outer chamber.

Xoft's argument is that "uniform" must be taken literally, and the apparatus must produce radiation that does not decrease in strength with increasing distance from the source.6 The parties do not dispute that Xoft's construction would require a physical impossibility; the strength of radiation necessarily decreases with distance from its source. Xoft, however, seeks to interpret "uniform" in a vacuum. The meaning of a particular word in a claim must be interpreted in light of the rest of the patent. Ekchian v. Home Depot, Inc., 104 F.3d 1299, 1303 (Fed. Cir. 1997). While the patent could have been drafted with more clarity, it is readily apparent that the patentee did not contemplate absolute uniformity. Figure 4 of the patent (reproduced below) is a comparison between the distance versus radiation dose plots of two scenarios. Line 40 shows the radiation dose that would result if chamber 36 were filled with a radioactive fluid. '813 patent, col. 3, ll. 20-24. Line 42 shows the radiation dose that would result if, following the teachings of the patent, the same radioactive fluid were contained only in chamber 32. '813 patent, col. 3, ll. 24-28. As explained in the patent, "Comparing the plots 40 and 42, by providing the concentric arrangement depicted, the absorbed dose profile in the space between the 2 cm site and the wall of the outer balloon is maintained much more uniform, thus preventing over-treatment of body tissue at

Xoft also stated that it would "submit a Motion for Summary Judgment on this issue prior to the conduct of the Markman hearing," Responsive Br. (dkt. # 50) at 14, but did not do so. 8

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or close to the outer wall 36 of the instrument." '813 patent, col. 3, ll. 28-33. The patentee obviously did not expect absolute uniformity of radiation dosing. To interpret "uniform" in the manner urged by Xoft would go against the clear intent of the patentee. In Bausch & Lomb, Inc. v. BarnesHind/Hydrocurve, Inc., 796 F.2d 443 (Fed. Cir. 1986), the defendant made a similar argument regarding the patentee's use of the term "smooth" with respect to the edges of contact lenses. The Federal Circuit looked to the intrinsic evidence and found that "smooth" did not mean absolutely ridge free but rather that it meant "smooth enough to serve the inventor's purposes, i.e., not to inflame or irritate the eyelid of the wearer or be perceived by him at all when in place." Id. at 450. In this case, the inventor's purpose was to deliver radiation more uniformly than had previously been done, "thus preventing overtreatment of body tissue at or close to the outer wall . . . of the instrument." '813 patent, col. 3, ll. 28-32. The court will therefore define "rendering uniform" to mean to make the absorbed dose of radiation more uniform in order to prevent over-treatment of body tissue at or close to the outer wall of the instrument. Since limitation language "means . . . for rendering uniform the radial absorbed dose profile of the emissions" is in means-plus-function format, the function must be construed and the corresponding structure or its equivalent identified in the specification. BBA Nonwovens Simpsonville, Inc. v. Superior Nonwovens, L.C.C., 303 F.3d 1332, 1343 (Fed. Cir. 2002). As discussed, Xoft's definition of the function requires absolute uniformity which is not possible and which is not what the patent requires or the inventor intended. Cytyc's proposed definition construes the function as "modifying the ratio of the absorbed dose at a depth of interest in the target tissue to
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the absorbed dose at the surface tissue." Although this appears to be a function of the invention, Cytyc's definition is too broad because it encompasses absorbed doses at the surface tissue that are not substantially uniform to absorbed doses at the target tissue. In other words, Cytyc's definition would not only encompass the radiation dose profile of line 42 above, but would also encompass the radiation doese profile of line 40. Furthermore, all radiation dose profiles between line 40 and line 42 that result in over-treatment of the surface tissue would also be included under Cytyc's definition. A more accurate construction of the function would require the absorbed dose at the target tissue and the absorbed dose at the surface tissue to be more uniform to prevent over-treatment of the surface tissue. Thus, the court defines the function of the "means . . . for rendering uniform the radial absorbed dose profile of the emissions" as 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. Cytyc also identifies a radiation-absorbing or -attentuating material as the corresponding structure. At the claim construction hearing, Xoft argued that the uniformity of the radiation dose curve is solely affected by distance from the radiation source; the parties agree that this is true. See Tr. at 60-61. Although the composition of the material is not critical to the function, the radiationabsorbing or -attenuating material provides the distance necessary for achieving the uniformity in radiation dose curve. Thus, the court construes the language consistently with Cytyc's position. Claim Language "rendering uniform" Court's Construction to make the absorbed dose of radiation more uniform to prevent over-treatment of body tissue at or close to the outer wall of the instrument Function: Making the absorbed dose of radiation more uniform to prevent overtreatment of body tissue at or close to the outer wall of the instrument. Structure: A radiation absorbing or attenuating material, e.g., air, x-ray contrast fluid, contrast media used in angiography, water, a gas, or barium sulfate or their equivalents.

"Means . . . for rendering uniform the radial absorbed dose profile of the emissions"

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7

"The radioactive material" Cytyc's proposed construction The material of claim 1 containing a radionuclide. Xoft's proposed construction (indefinite)

Claim 8 of the patent covers "[t]he apparatus as in claim 2 wherein the inner chamber contains the radioactive material." Claim 2 depends from claim 1. The parties dispute whether "a material containing a radionuclide(s)" suffices as an antecedent basis for "the radioactive material." It is readily apparent that the "radioactive material" in claim 8 refers back to "a material containing a radionuclide" described in claim 1, since "radionuclide" is the only radioactive material mentioned in claim 1. Anyone skilled in the art would so conclude. Xoft's contention that the term "radioactive material" is indefinite because it contains no antecedent basis is without merit. Xoft offers no authority suggesting that the antecedent basis of a term used in a dependent claim must be stated in identical words.7 The court, therefore construes "the radioactive material" in claim 8 to be the "radionuclide(s)" referred to in claim 1. Claim Language "The radioactive material" Court's Construction The material of claim 1 containing a radionuclide.

"A plurality of radioactive solid particles placed at predetermined locations within the inner spatial volume to provide a desired composite radiation profile" Cytyc's proposed construction A plurality of radioactive solid particles placed at pre-determined locations within the inner spatial volume to provide a desired dose profile that is the sum of the radiation profiles of the plurality of particles. Xoft's proposed construction Static array of solid radioactive particles each placed in a single location and mounted on distal ends of separate wires. Desired composite radiation profile" is indefinite.

Claim 12 of the patent is directed to "[t]he apparatus as in claim 1 wherein the material containing a radionuclide comprises a plurality of radioactive solid particles placed at predetermined locations within the inner spatial volume to provide a desired composite radiation profile." Xoft argues claim 12 is indefinite on two grounds: first, that "desired composite radiation profile" is not At the Markman hearing, Xoft stated that it would provide a citation to such supporting authority. Tr. at 64. Xoft, however, has not done so. 11

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defined, and second, that "inner spatial volume" is indefinite because no physical structure bounds it. The court rejects Xoft's second argument for the reasons given when construing "inner spatial volume" above. The court rejects Xoft's first argument because it presents no evidence that one skilled in the art would not understand "desired composite radiation profile."8 Cytyc's proposed construction does not clarify the meaning of claim 12. However, since the language is understandable as is, no construction of "a plurality of radioactive solid particles placed at predetermined locations within the inner spatial volume to provide a desired composite radiation profile" is necessary or appropriate. Claim Language "A plurality of radioactive solid particles placed at predetermined locations within the inner spatial volume to provide a desired composite radiation profile" Court's Construction (no construction needed)

B. Terms of the '204 patent Claim 1 of the '204 patent is similar to claim 1 of the '813 patent. Claim 1 of the '204 patent describes: An interstitial brachytherapy apparatus for delivering radioactive emissions to an internal body location comprising: (a) a catheter body member having a proximal end and distal end; (b) an inner spatial volume disposed proximate to the distal end of the catheter body member; (c) an outer spatial volume defined by an expandable surface element disposed proximate to the distal end of the body member in a surrounding relation to the inner spatial volume; and (d) a radiation source disposed in the inner spatial volume and generating a three-dimensional isodose profile that is substantially similar in shape to the expandable surface element.

8

It would seem that for one skilled in the art, it would be a relatively simple matter to add up the individual radiation profiles of individual particles. See Tr. at 75-76. 12

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9

"Interstitial" Cytyc's proposed construction (no construction required) "Brachytherapy" Cytyc's proposed construction Radiation therapy delivered by a spatially confined radiation source at or near the site of the diseased tissue. "Interstitial brachytherapy" Cytyc's proposed construction Brachytherapy applied directly to the interspaces of a body tissue, where the interspaces are not naturally occurring. Xoft's proposed construction Radiation therapy delivered by a spatially confined radionuclide at or near a tumor site in a natural or surgically created cavity in a body. Xoft's proposed construction Radiation therapy delivered by a spatially confined radionuclide at or near a tumor or other proliferative tissue disease site. Xoft's proposed construction Site in natural or surgically created cavity in body.

Cytyc argues that "interstitial" and "brachytherapy" should be constructed together; Xoft seeks a separate construction for each word. Cytyc also complains that Xoft seeks to limit "brachytherapy" to radionuclides, arguing that the definition should encompass any radiation source. However, the patent provides a clear definition of "brachytherapy": "The term 'brachytherapy,' as used herein, refers to radiation therapy delivered by a spatially confined radioactive material inserted into the body at or near a tumor or other proliferative tissue disease site." '204 patent, col. 1, ll. 30-33. Here, the patentee clearly acted as his own lexicographer, and Cytyc's arguments for a broader definition do not acknowledge this clear definition. The court construes "brachytherapy" to mean "radiation therapy delivered by a spatially-confined radioactive material inserted into the body at or near a tumor or other proliferative tissue disease site."9 Xoft argues that "interstitial" means any body cavity, while Cytyc argues that "interstitial" should be limited to only non-naturally-occurring cavities. As Xoft points out, one medical dictionary defines "interstitial" as "1. Placed or lying between. 2. Pert. to

This definition does not resolve the parties' dispute over whether "radioactive material" should be read to encompass only "radionuclides" (as Xoft wishes) or any "radiation source" (as Cytyc urges). As the parties have separately sought construction of "radioactive material," the court will address construction of that phrase below. 13

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interstices or spaces within an organ or tissue." TABER'S CYCLOPEDIC MEDICAL DICTIONARY, 1007 (Clayton M. Thomas, ed., 17th ed. 1993). Although not cited by the parties, a British oncology text indicates that "interstitial" has a particular meaning in the field of the invention: Two main techniques are used for the delivery of radiation which is given either as an external beam or as short range radiation from an implanted radioactive source. External beam radiation usually involves megavoltage produced by linear accelerator as photons or electrons or from cobalt sources in the form of relative low energy X-rays or gamma rays. The latter are often used to treat relatively superficial lesions such as basal cell carcinoma or recurrences within the skin. High energy radiation can be used to treat deeply located lesions such as prostatic carcinomas without delivering an excessive dose to adjacent normal tissue. . . . Interstitial implant irradiation gives a high local dose to the tumour and usually employes sources such as radium, iridium, or caesium used in the form of needles or wires implanted in the tumour. This technique is widely used in the treatment of head and neck cancers to deliver a high tumour dose without irradiation to sensitive organs such as the lens of the eye or the spinal cord. I.S. Fentiman, The local Treatment of Cancer, INTRODUCTION TO THE CELLULAR & MOLECULAR BIOLOGY OF CANCER, 434, 446 (L.M. Franks & N.M. Teich, eds., 2d ed. 1991). However, Cytyc points out that regardless of any generally-accepted meaning of "interstitial" in the field of the invention, the patentee limited "interstitial" during prosecution to refer to only surgically-created cavities (and similarly defined "intercavital" to refer to natural body cavities): Turning to the cited prior art, the Ishiwara device comprises a thermotherapeutic apparatus having a catheter body member, an inner lumen surrounded by an outer lumen, and a radiation source contained within the inner lumen. . . . Ishiwara's apparatus is inserted into a body cavity. Hence, the apparatus does not provide interstitial radiation treatment, as Applicant's invention requires, but rather intercavital radiation treatment. Su Decl. (dkt. # 49), Ex. C (Amendment & Resp.) at 11 (citations omitted). This is consistent with

21 the background section of the patent, which mentions surgical cavities several times but not natural 22 ones. '204 patent, col. 1, ll. 19, 23, 25, 63, col. 2, l. 1. Also, although the summary section does not 23 specify what type of cavities the apparatus claims are directed to, the summary makes clear that the 24 method claims are directed to a method that "includes surgically creating access to the proliferating 25 tissue within a patient and surgically resecting at least a portion of the proliferating tissue to create a 26 resection cavity within body tissue." Id., col. 3, ll. 3-6. 27 28
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10

The parties did not brief the issue of how much weight the court should afford the prosecution history in this instance.10 The Federal Circuit has instructed that "[a]lthough prosecution history can be a useful tool for interpreting claim terms, it cannot be used to limit the scope of a claim unless the applicant took a position before the PTO that would lead a competitor to believe that the applicant had disavowed coverage of the relevant subject matter." Schwing GmbH v. Putzmeister Aktiengesellschaft, 305 F.3d 1318, 1324 (Fed. Cir. 2002). Here, the patentee clearly disavowed coverage of intercavitary radiation treatment when arguing to the PTO. Given the

In its recent en banc explanation of the evidence to be used in construing claims, the Federal Circuit devoted a paragraph to prosecution history: In addition to consulting the specification, we have held that a court "should also consider the patent's prosecution history, if it is in evidence." Markman, 52 F.3d at 980; see also Graham v. John Deere Co., 383 U.S. 1, 33, 86 S.Ct. 684, 15 L.Ed.2d 545 (1966) ("[A]n invention is construed not only in the light of the claims, but also with reference to the file wrapper or prosecution history in the Patent Office."). The prosecution history, which we have designated as part of the "intrinsic evidence," consists of the complete record of the proceedings before the PTO and includes the prior art cited during the examination of the patent. Autogiro, 384 F.2d at 399. Like the specification, the prosecution history provides evidence of how the PTO and the inventor understood the patent. See Lemelson v. Gen. Mills, Inc., 968 F.2d 1202, 1206 (Fed. Cir. 1992). Furthermore, like the specification, the prosecution history was created by the patentee in attempting to explain and obtain the patent. Yet because the prosecution history represents an ongoing negotiation between the PTO and the applicant, rather than the final product of that negotiation, it often lacks the clarity of the specification and thus is less useful for claim construction purposes. See Inverness Med. Switz. GmbH v. Warner Lambert Co., 309 F.3d 1373, 1380-82 (Fed. Cir. 2002) (the ambiguity of the prosecution history made it less relevant to claim construction); Athletic Alternatives, Inc. v. Prince Mfg., Inc., 73 F.3d 1573, 1580 (Fed. Cir. 1996) (the ambiguity of the prosecution history made it "unhelpful as an interpretive resource" for claim construction). Nonetheless, the prosecution history can often inform the meaning of the claim language by demonstrating how the inventor understood the invention and whether the inventor limited the invention in the course of prosecution, making the claim scope narrower than it would otherwise be. Vitronics, 90 F.3d at 1582-83; see also Chimie v. PPG Indus., Inc., 402 F.3d 1371, 1384 (Fed. Cir. 2005) ("The purpose of consulting the prosecution history in construing a claim is to 'exclude any interpretation that was disclaimed during prosecution.'"), quoting ZMI Corp. v. Cardiac Resuscitator Corp., 844 F.2d 1576, 1580 (Fed. Cir. 1988); Southwall Techs., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1576 (Fed. Cir. 1995). Phillips v. AWH Corp., 415 F.3d 1303, 1317 (Fed. Cir. 2005) (en banc). 15

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intrinsic evidence is of primary importance11 and all supports Cytyc's position, the court construes "interstitial" to mean "involving a surgically-created cavity in a body." In light of the constructions of "interstitial" and "brachytherapy" above, no further construction of "interstitial brachytherapy" is necessary. Claim Language "interstitial" "brachytherapy" Court's Construction involving a surgically-created cavity in a body radiation therapy delivered by a spatiallyconfined radioactive material inserted into the body at or near a tumor or other proliferative tissue disease site (no construction necessary)

"interstitial brachytherapy"

"Inner spatial volume" 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 The extrinsic evidence that Cytyc used "intercavitary" in literature and advertising in a manner that encompases the definitions of "interstitial" and "intercavitary" it advances now, see Tr. at 93, is of little weight in this situation. Similarly, evidence presented by Cytyc that Xoft represented to the FDA that the term "interstitial" "is a more appropriate word for a cavity that is surgically created as compared to a natural body cavity," (see Decl. of Henry Su Supp. Cytyc's Scupplemental Claim Construction Br., Ex. A, is not entitled to significant weight although it does suggest that one skilled in the art construes the term as Cytyc proposes.
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11

Cytyc's proposed construction A region of space surrounded by an outer spatial volume that is defined by an expandable surface element

Xoft's proposed construction Inner balloon in two-balloon device or spherical solid radionuclide in one-balloon device.

The phrase "inner spatial volume" appears in both patents-in-suit. The parties' arguments regarding the meaning of "inner spatial volume" are similar for each patent. The relevant portions of the specification are the same, and, additionally, the '204 patent purports to incorporate by reference the '813 patent. '204 patent, col. 1, ll. 10-11. The court will therefore construe "inner spatial volume" in the '204 patent in the same manner as for the '813 patent. Claim Language "inner spatial volume" Court's Construction a region of space surrounded by an outer spatial volume and either enclosed by a polymeric film wall or defined by the outside surface of a solid radionuclide sphere.

16

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"Outer spatial volume" Cytyc's proposed construction (no construction required) or A region of space defined by an expandable surface element and surrounding an inner spatial volume. Xoft's proposed construction Balloon or cage.

The phrase "outer spatial volume" in the '204 patent is analogous to the "outer, closed, inflatable chamber" of the '813 patent. The "outer spatial volume" is also explained in a similar manner; it is "defined by an expandable surface element disposed proximate to the distal end of the body member in a surrounding relation to the inner spatial volume." '204 patent, col. 8, ll. 22-25. Xoft again confuses the concepts of a volume with the boundary of a volume. Cytyc's proposed construction is congruent with the language of claim 1 of the '204 patent, so the court will construe "outer spatial volume" as "a region of space defined by an expandable surface element and surrounding an inner spatial volume." Claim Language "outer spatial volume" Court's Construction a region of space defined by an expandable surface element and surrounding an inner spatial volume

"Expandable surface element" Cytyc's proposed construction (no construction required) or A device that can be expanded or inflated, such as an expandable cage or an inflatable balloon. Xoft's proposed construction Deflated balloon or collapsed cage.

Xoft's basic argument is that "expandable surface element" must be a deflated structure because once something is fully inflated, it is no longer expandable. Xoft also points out that part (d) of claim 1 refers to the "isodose profile" being "substantially similar in shape to the expandable surface element" without specifying whether the expandable surface element is fully expanded. It is apparent that the patentee intended "expandable surface element" to refer to a structure whether it was fully inflated or not. Xoft's proposed construction would have this element wink out of

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existence at full inflation, leaving the "outer spatial volume" unbounded and giving the "isodose profile" no shape. The court agrees with Cytyc that no construction of the term is necessary. Claim Language "expandable surface element" Court's Construction (no construction needed)

"Radiation source" Cytyc's proposed construction (no construction required) Xoft's proposed construction radionuclide

The patent provides a clear definition of "brachytherapy": "The term 'brachytherapy,' as used herein, refers to radiation therapy delivered by a spatially confined radioactive material inserted into the body at or near a tumor or other proliferative tissue disease site." All asserted independent claims of the '204 patent contain the phrase "interstitial brachytherapy," which the court has construed as "radiation therapy delivered by a spatially-confined radioactive material inserted into the body at or near a tumor or other proliferative tissue disease site." Cytyc's argument that "radiation source" should not be constructed to exclude any radiation sources must be rejected; the claims clearly do not contemplate a radiation source other than "radioactive material." There is still, however, the question of whether "radioactive material" means the same thing as Xoft's proposed construction of "radionuclide."12 In describing the preferred embodiment, the patent says: "[t]he inner volume 30 is then filled with a material containing a predetermined radionuclide, for example, I-125, I-131, Yb-169 or other source of radiation, such as radionuclides that emit photons, beta particles, gamma radiation, or other therapeutic rays." '204 patent, col. 4, ll. 9-13 (emphasis added). Since all the examples of sources of radiation given in the specification are radionuclides, the patentee appears to have intended to define "radioactive material" as "radionuclides." Cytyc argued at the Markman hearing that "or other therapeutic rays" could refer to other sources such as x-rays. The words "or other therapeutic rays," however, clearly refers to types

12

The parties have agreed that "radionuclide" means "an isotope that undergoes radioactive decay." 18

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of radionuclides. Cytyc's construction would require the patentee to have inserted the word "or" before "gamma radiation," indicating the end of the list of types of radionuclides.13 Dictionary definitions are consistent with construing "radiation source" as a "radionuclide." One definition of "radioactive" is "[a] descriptive term for a material made up of atoms in which radioactivity occurs." AMERICAN HERITAGE NEW DICTIONARY OF CULTURAL LITERACY (3d ed. 2006). A medical dictionary provided by Xoft defines "radioactive" as "giving off radiation as the result of the disintegration of the nucleus of an atom." MOSBY'S MEDICAL, NURSING, AND ALLIED HEALTH DICTIONARY, 1326 (Kenneth N. Anderson et al. eds., 4th ed. 1994). Cytyc has not presented evidence that one skilled in this art would understand "radioactive material" any differently. The court agrees with Xoft--the term "radioactive" in the context of the '204 patent does not encompass such radiation sources as x-ray tubes, and "radiation source" therefore should be taken to mean "radionuclide." Claim Language "radiation source" radionuclide Court's Construction

"Minimum prescribed dose" Cytyc's proposed construction Minimum prescribed dose received within a target tissue for delivering therapeutic effects. Xoft's proposed construction Minimum dose needed to treat cancer cells.

The parties have requested construction of the phrase "minimum prescribed dose" and point out that the term appears in claims 2, 18, 24, 32, and 36 of the '204 patent. The parties do not argue that the term should be construed differently for different claims. However, claims 2, 24, 32, and 36 contain the phrase "minimum prescribed absorbed dose," and claim 18 contains the phrase "prescribed absorbed dose." These inconsistencies seem irrelevant, however, because the parties'

13

Cytyc also stated that this was an "Oxford comma" issue. Tr. at 137-38. However, in the sentence at issue, the Oxford comma is the one after "gamma radiation." Whether it is present does not alter the meaning of the sentence. Cytyc also argued that "we're in the land of eats, shoots and leaves." If Cytyc was referring to a book of such title, the court does not see how that would support Cytyc's argument; the theme of Eats, Shoots & Leaves is that punctuation should be used correctly. See Lynne Truss, Eats, Shoots & Leaves: The Zero Tolerance Approach to Punctuation (2004).
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dispute is whether any such doses should be limited to treatment of cancer cells or allowed to cover any potential therapeutic effects. The court's construction of "brachytherapy" limits the claims to treatments "at or near a tumor or other proliferative tissue disease site." Xoft's proposed construction is too narrow, and Cytyc's is too broad. However, in light of the construction of "brachytherapy," no construction of "minimum prescribed dose" or similar phrases is necessary. Claim Language "minimum prescribed dose" Court's Construction (no construction necessary)

"Delivering a prescribed absorbed dose" Cytyc's proposed construction (no construction required) Xoft's proposed construction (indefinite)

Xoft argues that the patent does not reveal how one goes about prescribing a dose using the device, and that the phrase "delivering a prescribed absorbed dose" is therefore fatally indefinite. The '204 patent, however, describes a tool for treating proliferative tissue disease. A patent could adequately describe and claim a new apparatus or method for making the corrective curves in contact lenses, but a description of the particular curves a patient might require would not be necessary. If those skilled in the art would know how to use the disclosed invention, describing how to use it is unnecessary--the patentee merely needs to adequately describe the invention. Since Xoft bears the burden of proving that those skilled in the art would not know how to use the tool or method described in the patent and has presented no evidence on the subject, the court rejects Xoft's contention that the phrase is indefinite. No construction is necessary. Claim Language "delivering a prescribed absorbed dose" Court's Construction (no construction necessary)

"The inner and outer spatial volumes are configured to provide a minimum prescribed absorbed dose" Cytyc's proposed construction The inner and outer spatial volumes are configured to provide a minimum prescribed absorbed dose for delivering
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Xoft's proposed construction (indefinite)

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14

"The inner and outer spatial volumes are configured to provide a minimum prescribed absorbed dose" Cytyc's proposed construction Configuring the inner and outer spatial volumes to provide a minimum prescribed absorbed dose for delivering therapeutic effects to a target tissue. Xoft's proposed construction (indefinite)

The phrases "the inner and outer spatial volumes are configured to provide a minimum prescribed absorbed dose" and "configuring the inner and outer spatial volumes to provide a minimum prescribed absorbed dose" are not indefinite for essentially the same reasons given in the previous section. As Cytyc again appears to be attempting to impermissibly broaden its claims to capture any therapeutic effect, despite the clear limitation provided by the patentee's definition of "brachytherapy," the court also cannot adopt Cytyc's proposed construction. No construction of the disputed language is necessary in light of the court's construction of other terms in the patent. Claim Language "the inner and outer spatial volumes are configured to provide a minimum prescribed absorbed dose" "the inner and outer spatial volumes are configured to provide a minimum prescribed absorbed dose" Court's Construction (no construction necessary)

(no construction necessary)

"A minimum distance outward from the outer spatial volume expandable surface" Cytyc's proposed construction (no construction required) Xoft's proposed construction (indefinite)

Claims 2, 24, 32, and 36 all include the phrase "the target tissue being defined between the outer spatial volume expandable surface and a minimum distance outward from the outer spatial volume expandable surface."14 Xoft asserts that "minimum distance" is indefinite in this context because the patent does not explain how the minimum distance is determined.

The court believes that one skilled in the art would understand that the patentee intended to define "target tissue" as the tissue "between the outer spatial volume expandable surface and a minimum distance outward from the outer spatial volume expandable surface." Taken literally, the patent explains the physical location where the act of defining "target tissue" takes place.
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Here, "minimum" does not appear to add anything to the patent. The "target tissue" is the tissue outside of the outer chamber for a fixed distance in all directions, but this fixed distance or how one determines it are not explained. It seems that one skilled in the art would know how to determine the distance. See Tr. at 85-89. But the patent may as well read "a short distance outward" or "a determined distance outward" or merely "a distance outward." Cytyc claims that specification provides some guidance and that the minimum distance may in some instances be between half and one centimeter. The specification does state that device A can readily be configured to provide a dose in a therapeutic range, say between 40 to 60 Gray, at a distance between 0.5 and 1.0 cm from the outer spatial volume for an outer spatial volume having a diameter of 4.0 cm and being in contact with the resection cavity wall. '204 patent, col. 6, ll. 31-35. However, Cytyc neglects to mention that "device A" is "an interstitial

11 brachytherapy apparatus . . . such as those employed in U.S. Pat. No. 5,429,582, having a single 12 spatial volume 50 filled with a radioactive material in solution." '204 patent, col. 6, ll. 3-7. In any 13 case, this discussion does not use the phrases "target tissue" or "a minimum distance outward." 14 Nevertheless, Xoft has presented no evidence that one skilled in the art would not understand the 15 phrase "the target tissue being defined between the outer spatial volume expandable surface and a 16 minimum distance outward from the outer spatial volume expandable surface." Xoft has not met its 17 burden of proving by clear and convincing evidence that this language is indefinite, and the court 18 finds that no construction is necessary. 19 20 21 22 23 24 25 26 27 28
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Claim Language "a minimum distance outward from the outer spatial volume expandable surface" "Controlled dose" Cytyc's proposed construction (no construction required)

Court's Construction (no construction necessary)

Xoft's proposed construction (indefinite)

"To reduce or prevent necrosis in healthy tissue proximate to the expandable surface" Cytyc's proposed construction (no construction required) Xoft's proposed construction (indefinite)

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"Providing a controlled dose at the outer spatial volume expandable surface to reduce or prevent necrosis in healthy tissue" Cytyc'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 issue 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 Xoft's proposed construction (indefinite)

Xoft argues that the patent does not reveal how one goes about controlling a dose using the device and that "reducing necrosis" is a hopelessly vague concept, making the '204 patent indefinite. Xoft, however, has presented no evidence that one skilled in the art would not be able to understand the patent and has again failed to meet its burden of proof. The court will therefore adopt Cytyc's construction proposals. "Providing a controlled dose at the outer spatial volume expandable surface to reduce or prevent necrosis in healthy tissue" means "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 issue so that the dose at the e