Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-cand-5_05-cv-05312/USCOURTS-cand-5_05-cv-05312-4/pdf.json

Nature of Suit Code: 830
Nature of Suit: Patent
Cause of Action: 28:2201 Declaratory Judgement

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United States District Court

For the Northern District of California

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1

 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 . 

CLAIM CONSTRUCTION ORDER—No. C-05-05312 RMW

JAH

United States District Court

For the Northern District of California

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.,

Defendants.

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

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2

 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 36 19 32 34

 / | \ / / \ \ |

 2 16 17 20 21 23 24 35

 / | \ . / \

 4 8 18 . 25 30

 / 

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CLAIM CONSTRUCTION ORDER—No. C-05-05312 RMW

JAH 2

Distance from source

Radiation strength

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. 10-

11. 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.

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3

 Presumably all occurrences of "spacial" in the '813 patent should be read as "spatial."

CLAIM CONSTRUCTION ORDER—No. C-05-05312 RMW

JAH 3 Radiation strength

Distance from source

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:

II. ANALYSIS

A. Terms of the '813 patent

"Inner spatial volume"

Cytyc's proposed construction Xoft's proposed construction

A region of space surrounded by an outer

spatial volume that is defined by a closed

inflatable chamber

Inner balloon in two-balloon device or

spherical solid radionuclide in one-balloon

device

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

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4

 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).

CLAIM CONSTRUCTION ORDER—No. C-05-05312 RMW

JAH 4

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:

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. 

'813 patent, col. 4, ll. 32-54. Since all claims of this patent other than claim 1 depend from claim 1,

construction of "inner spatial volume" is critical.

In most embodiments of the invention disclosed in the patent specification, the inner spatial

volume is a region of space surrrounded by an outer spatial volume that is defined by a closed

inflatable chamber. See '813 patent, col. 2, ll. 44-63; col. 3, ll. 9-16, 42-48; col. 4, ll. 16-20; figs. 1,

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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. 

Although somewhat awkwardly worded, the language of the patent allows for the inner

volume to be defined by something other than a region enclosed by a polymeric wall. As Cytyc

points out, Xoft's construction conflates the boundary of the volume with the volume itself. Cytyc's

proposed construction, however, is a paraphrasing of the language of claim 1 that only clarifies a

little the language of the patent. Furthermore, Cytyc's proposed construction would exclude an inner

volume defined by a solid sphere, and thus cannot be correct. 

Xoft objects that an abstract concept like a region of space cannot be part of an apparatus. 

Xoft is correct. However, the language of the patent does not imply that the inner volume is ever

defined by something other than a physical object. In all embodiments of the invention disclosed in

the '813 patent, the boundary of the inner volume is either a polymeric film wall or the edge of a

solid sphere. Furthermore, it would seem difficult to fill one volume with radioactive liquid and the

other with another fluid if the two volumes were not separated by some structure (which would

necessarily be the outer boundary of the inner spatial volume.) See '813 patent, col. 1, ll. 57-62. The

patent is even entitled "Double-Wall Balloon Catheter for Treatment of Proliferative Tissue." Xoft's

expert, Dr. Lovoi, acknowledged that an "inner spatial volume" is a volume that is inside another

volume. Lovoi Dep. at 101:25-102:7. The court defines "inner spatial volume" as "a region of

space surrounded by an outer spatial volume and either enclosed by a polymeric film wall or defined

by the edge of a solid radionuclide sphere."

Claim Language Court's Construction

"inner spatial volume" 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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CLAIM CONSTRUCTION ORDER—No. C-05-05312 RMW

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"Outer, closed, inflatable chamber"

Cytyc's proposed construction Xoft's proposed construction

(no construction required) 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 Court's Construction

 "outer, closed, inflatable chamber" outer, closed, inflatable chamber 

"Predetermined constant spacing" 

Cytyc's proposed construction Xoft's proposed construction

(no construction required) (indefinite)

"Predetermined constant spacing between said inner spatial volume and radiation

transparent wall"

Cytyc's proposed construction Xoft'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

(indefinite)

Xoft argues that the '813 patent is indefinite because it does not disclose how one

"predetermines" the amount of spacing. Xoft points out that the spacing between the edges of the

inner and outer volumes may change as parts of the apparatus are inflated or deflated, so the spacing

is not constant. Cytyc's expert explained that "predetermined constant spacing" means that "the

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5

 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.

CLAIM CONSTRUCTION ORDER—No. C-05-05312 RMW

JAH 7

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 Court's Construction

"predetermined constant spacing" (no construction necessary)

"predetermined constant spacing between said

inner spatial volume and radiation transparent

wall" 

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

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 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.

CLAIM CONSTRUCTION ORDER—No. C-05-05312 RMW

JAH 8

"Rendering uniform"

Cytyc's proposed construction Xoft's proposed construction

(no construction required) 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 Xoft'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.

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

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CLAIM CONSTRUCTION ORDER—No. C-05-05312 RMW

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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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CLAIM CONSTRUCTION ORDER—No. C-05-05312 RMW

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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 Court's Construction

"rendering uniform" 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

"Means . . . for rendering uniform the radial

absorbed dose profile of the emissions"

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.

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 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.

CLAIM CONSTRUCTION ORDER—No. C-05-05312 RMW

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"The radioactive material"

Cytyc's proposed construction Xoft's proposed construction

The material of claim 1 containing a

radionuclide.

(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 Court's Construction

"The radioactive material" 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 Xoft'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.

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

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 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.

CLAIM CONSTRUCTION ORDER—No. C-05-05312 RMW

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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 Court's Construction

"A plurality of radioactive solid particles

placed at predetermined locations within the

inner spatial volume to provide a desired

composite radiation profile"

(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.

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 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.

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"Interstitial"

Cytyc's proposed construction Xoft's proposed construction

(no construction required) Site in natural or surgically created

cavity in body.

"Brachytherapy"

Cytyc's proposed construction Xoft's proposed construction

Radiation therapy delivered by a

spatially confined radiation source

at or near the site of the diseased

tissue.

Radiation therapy delivered by a

spatially confined radionuclide at or

near a tumor or other proliferative

tissue disease site.

"Interstitial brachytherapy"

Cytyc's proposed construction Xoft's proposed construction

Brachytherapy applied directly to

the interspaces of a body tissue,

where the interspaces are not

naturally occurring.

Radiation therapy delivered by a

spatially confined radionuclide at or

near a tumor site in a natural or

surgically created cavity in a 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

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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

the background section of the patent, which mentions surgical cavities several times but not natural

ones. '204 patent, col. 1, ll. 19, 23, 25, 63, col. 2, l. 1. Also, although the summary section does not

specify what type of cavities the apparatus claims are directed to, the summary makes clear that the

method claims are directed to a method that "includes surgically creating access to the proliferating

tissue within a patient and surgically resecting at least a portion of the proliferating tissue to create a

resection cavity within body tissue." Id., col. 3, ll. 3-6.

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10 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).

CLAIM CONSTRUCTION ORDER—No. C-05-05312 RMW

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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

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11 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. 

CLAIM CONSTRUCTION ORDER—No. C-05-05312 RMW

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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 Court's Construction

"interstitial" involving a surgically-created cavity in a body

"brachytherapy" radiation therapy delivered by a spatiallyconfined radioactive material inserted into the

body at or near a tumor or other proliferative

tissue disease site

"interstitial brachytherapy" (no construction necessary)

"Inner spatial volume"

Cytyc's proposed construction Xoft's proposed construction

A region of space surrounded by an outer

spatial volume that is defined by an

expandable surface element

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 Court's Construction

"inner spatial volume" 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 spatial volume"

Cytyc's proposed construction Xoft's proposed construction

(no construction required)

 or

A region of space defined by an

expandable surface element and

surrounding an inner spatial volume.

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 Court's Construction

"outer spatial volume" a region of space defined by an expandable

surface element and surrounding an inner

spatial volume

"Expandable surface element"

Cytyc's proposed construction Xoft's proposed construction

(no construction required)

 or

A device that can be expanded or inflated,

such as an expandable cage or an inflatable

balloon.

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

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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 Court's Construction

"expandable surface element" (no construction needed)

"Radiation source"

Cytyc's proposed construction Xoft's proposed construction

(no construction required) 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

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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).

CLAIM CONSTRUCTION ORDER—No. C-05-05312 RMW

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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 Court's Construction

"radiation source" radionuclide

"Minimum prescribed dose"

Cytyc's proposed construction Xoft's proposed construction

Minimum prescribed dose received within

a target tissue for delivering therapeutic

effects.

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'

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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 Court's Construction

"minimum prescribed dose" (no construction necessary)

"Delivering a prescribed absorbed dose"

Cytyc's proposed construction Xoft's proposed construction

(no construction required) (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 Court's Construction

"delivering a prescribed absorbed dose" (no construction necessary)

"The inner and outer spatial volumes are configured to provide a minimum prescribed

absorbed dose"

Cytyc's proposed construction Xoft's proposed construction

The inner and outer spatial volumes are

configured to provide a minimum

prescribed absorbed dose for delivering

(indefinite)

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14 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.

CLAIM CONSTRUCTION ORDER—No. C-05-05312 RMW

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"The inner and outer spatial volumes are configured to provide a minimum prescribed

absorbed dose"

Cytyc's proposed construction Xoft'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.

(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 Court's Construction

"the inner and outer spatial volumes are

configured to provide a minimum prescribed

absorbed dose"

(no construction necessary)

"the inner and outer spatial volumes are

configured to provide a minimum prescribed

absorbed dose"

(no construction necessary)

"A minimum distance outward from the outer spatial volume expandable surface"

Cytyc's proposed construction Xoft's proposed construction

(no construction required) (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. 

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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

brachytherapy apparatus . . . such as those employed in U.S. Pat. No. 5,429,582, having a single

spatial volume 50 filled with a radioactive material in solution." '204 patent, col. 6, ll. 3-7. In any

case, this discussion does not use the phrases "target tissue" or "a minimum distance outward." 

Nevertheless, Xoft has presented no evidence that one skilled in the art would not understand 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." Xoft has not met its

burden of proving by clear and convincing evidence that this language is indefinite, and the court

finds that no construction is necessary. 

Claim Language Court's Construction

"a minimum distance outward from the outer

spatial volume expandable surface"

(no construction necessary)

"Controlled dose"

Cytyc's proposed construction Xoft's proposed construction

(no construction required) (indefinite)

"To reduce or prevent necrosis in healthy tissue proximate to the expandable surface"

Cytyc's proposed construction Xoft's proposed construction

(no construction required) (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 Xoft'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

(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 expandable surface is not so high that it lethally damages cells in

healthy tissue in contact with the expandable surface." 

Claim Language Court's Construction

"controlled dose" (no separate construction necessary)

"to reduce or prevent necrosis in healthy tissue

proximate to the expandable surface"

(no separate construction necessary)

"providing a controlled dose at the outer spatial

volume expandable surface to reduce or prevent

necrosis in healthy tissue"

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

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 "Adapting the expandable surface to contact tissue surrounding the resection cavity to

conform the tissue"

Cytyc's proposed construction Xoft's proposed construction

(no construction required) (indefinite)

Xoft's contention that this phrase is indefinite springs from its argument that "expandable

surface element" means "deflated balloon or cage." As the court has rejected Xoft's interpretation of

"expandable surface element," no construction of "adapting the expandable surface to contact tissue

surrounding the resection cavity to conform the tissue" is necessary.

Claim Language Court's Construction

"adapting the expandable surface to contact

tissue surrounding the resection cavity to

conform the tissue" 

(no construction necessary)

"Desired shape of the expandable surface element"

Cytyc's proposed construction Xoft's proposed construction

(no construction required) (indefinite)

Xoft has again presented no evidence to back up an argument that the phrase is indefinite and

therefore again fails to carry its burden of proof. No construction of "desired shape of the

expandable surface element" is necessary.

Claim Language Court's Construction

"desired shape of the expandable surface

element" 

(no construction necessary)

"Predetermined spacing"

Cytyc's proposed construction Xoft's proposed construction

(no construction required) (indefinite)

 "A predetermined spacing is provided between said inner spatial volume and the

expandable surface element" / "A predetermined spacing between said inner spatial

volume and the expandable surface element"

Cytyc's proposed construction Xoft's proposed construction

The distance between the inner spatial

volume and the expandable surface element

is determined in advance

(indefinite)

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United States District Court

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Xoft's contention that these phrases are indefinite is based on its argument that "expandable

surface element" means "deflated balloon or cage," and Xoft has again presented no evidence to

back up arguments that the phrases are indefinite. No construction of "predetermined spacing" is

necessary. The court will adopt Cytyc's proposals and define both of the long phrases ("a

predetermined spacing is provided between said inner spatial volume and the expandable surface

element" and "a predetermined spacing between said inner spatial volume and the expandable

surface element") as "the distance between the inner spatial volume and the expandable surface

element is determined in advance."

Claim Language Court's Construction

"predetermined spacing" (no construction necessary)

"a predetermined spacing is provided between

said inner spatial volume and the expandable

surface element" / "a predetermined spacing

between said inner spatial volume and the

expandable surface element"

the distance between the inner spatial volume

and the expandable surface element is

determined in advance

"Intraoperatively"

Cytyc's proposed construction Xoft's proposed construction

(no construction required)

 or

During the surgical operation to remove

proliferative tissue.

After surgical removal of tumor but prior

to closing the surgical site

At the claim construction hearing, the parties appeared to agree on the definition of

"interoperatively." See Tr. at 140. The previous apparent disagreement revolved around whether

the surgical site could be closed before insertion of the catheter apparatus. The court understands

that the parties agree that the catheter must be inserted before the surgical site is closed. The '204

patent at column 7, lines 55-64, specifically refers to the catheter being inserted "[f]ollowing tumor

resection, but prior to closing the surgical site."

Claim Language Court's Construction

"intraoperatively" following tumor resection, but prior to closing

the surgical site

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"Solid radiation source"

Cytyc's proposed construction Xoft's proposed construction

A radiation source that has a fixed shape

and volume, and is not deformable

Solid radionuclide

The parties' primary dispute here is whether "radiation source" encompasses more than

radionuclides, which the court addressed above to limit "radiation source" to radionuclides. Cytyc

presents a dictionary definition of "solid," namely, "of definite shape and volume; not liquid or

gaseous," from the AMERICAN HERITAGE COLLEGE DICTIONARY, 1295 (3d ed. 1997). The court will

therefore define "solid radiation source" as "a radionuclide of definite shape and volume; not liquid

or gaseous." 

Claim Language Court's Construction

"solid radiation source" a radionuclide of definite shape and volume;

not liquid or gaseous

"The prescribed absorbed dose is delivered to the target tissue in substantially three

dimensions"

Cytyc's proposed construction Xoft's proposed construction

The prescribed absorbed dose is delivered

to the target tissue such that all points at a

given outward distance from the tissue wall

will receive the same dose.

(indefinite)

Xoft contends that "prescribed absorbed dose" and "in substantially three dimensions" render

"the prescribed absorbed dose is delivered to the target tissue in substantially three dimensions"

fatally indefinite. The court has already rejected Xoft's argument regarding "prescribed absorbed

dose." 

Xoft points to Cytyc's expert's testimony that "there's no such thing as substantially three

dimensions" because something is either three dimensional or not. Mulville Decl. (dkt. # 51), Ex. L

(Verhey Decl.) at 153. Cytyc points to Xoft's expert's testimony that he could envision a

brachytherapy apparatus that delivered 99 percent of its radiation in a plane; Cytyc claims such a flat

radiation field would not be in substantially three dimensions. Though a closer question than some

of Xoft's other indefiniteness contentions, the court nonetheless finds that Xoft has not shown by

clear and convincing evidence that one skilled in the art would not understand "in substantially three

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dimensions" in the manner put forth by Cytyc. The court therefore adopts Cytyc's proposed

construction for "the prescribed absorbed dose is delivered to the target tissue in substantially three

dimensions," namely, "the prescribed absorbed dose is delivered to the target tissue such that all

points at a given outward distance from the tissue wall will receive the same dose."

Claim Language Court's Construction

"the prescribed absorbed dose is delivered to

the target tissue in substantially three

dimensions" 

the prescribed absorbed dose is delivered to the

target tissue such that all points at a given

outward distance from the tissue wall will

receive the same dose

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III. ORDER

1. For the reasons given above, the court adopts the following claim construction as detailed in

this order. 

Term or phrase Court's construction

"inner spatial volume" 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.

"outer, closed, inflatable chamber" outer, closed, inflatable chamber 

"predetermined constant spacing" (no construction necessary)

"predetermined constant spacing between said

inner spatial volume and radiation transparent

wall" 

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

"rendering uniform" 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

"Means . . . for rendering uniform the radial

absorbed dose profile of the emissions"

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.

"The radioactive material" 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"

(no construction needed)

"interstitial" involving a surgically-created cavity in a body

"brachytherapy" radiation therapy delivered by a spatiallyconfined radioactive material inserted into the

body at or near a tumor or other proliferative

tissue disease site

"interstitial brachytherapy" (no construction necessary)

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CLAIM CONSTRUCTION ORDER—No. C-05-05312 RMW

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"outer spatial volume" a region of space defined by an expandable

surface element and surrounding an inner

"expandable surface element"(no construction

needed)

"radiation source" radionuclide

"minimum prescribed dose" (no construction necessary)

"delivering a prescribed absorbed dose" (no construction necessary)

"the inner and outer spatial volumes are

configured to provide a minimum prescribed

absorbed dose"

(no construction necessary)

"the inner and outer spatial volumes are

configured to provide a minimum prescribed

absorbed dose"

(no construction necessary)

"a minimum distance outward from the outer

spatial volume expandable surface"

(no construction necessary)

"controlled dose" (no separate construction necessary)

"to reduce or prevent necrosis in healthy tissue

proximate to the expandable surface"

(no separate construction necessary)

"providing a controlled dose at the outer spatial

volume expandable surface to reduce or prevent

necrosis in healthy tissue"

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

"adapting the expandable surface to contact

tissue surrounding the resection cavity to

conform the tissue" 

(no construction necessary)

"desired shape of the expandable surface

element" 

(no construction necessary)

"predetermined spacing" (no construction necessary)

"a predetermined spacing is provided between

said inner spatial volume and the expandable

surface element" / "a predetermined spacing

between said inner spatial volume and the

expandable surface element"

the distance between the inner spatial volume

and the expandable surface element is

determined in advance

"intraoperatively" following tumor resection, but prior to closing

the surgical site

"solid radiation source" a radionuclide of definite shape and volume;

not liquid or gaseous

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"the prescribed absorbed dose is delivered to

the target tissue in substantially three

dimensions" 

the prescribed absorbed dose is delivered to the

target tissue such that all points at a given

outward distance from the tissue wall will

receive the same dose

2. The parties shall appear for a further case management conference on June 1, 2007 at 10:30

a.m. and shall file a further joint case management conference statement no later than four

days prior.

DATED: 4/27/07

RONALD M. WHYTE

United States District Judge

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Notice of this document has been electronically sent to:

Counsel for Plaintiff:

James W. Geriak jgeriak@orrick.com 

Kurt T. Mulville kmulville@orrick.com 

Mark Stirrat mstirrat@orrick.com 

Monte M.F. Cooper mcooper@orrick.com 

Counsel for Defendants:

Henry C. Bunsow bunsowh@howrey.com 

Henry C. Su suh@howrey.com 

Counsel are responsible for distributing copies of this document to co-counsel that have not

registered for e-filing under the court's CM/ECF program.

Dated: 4/27/07 SPT

Chambers of Judge Whyte

Case 5:05-cv-05312-RMW Document 109 Filed 04/27/07 Page 31 of 31