Document 84
Filed 04/08/2008
Page 1 of 3
Exhibit JJ
Case 5:08-cv-00133-RMW
Document 84
Filed 04/08/2008
Page 2 of 3
The ConturaTM MLB Applicator consists of a multi-lumen ~atheter inflatable spherical balloon (Figure I). Lumens are provided fo commercially available HDR (High Dose Rate) remote afldrloader equipment for passage of the radiation source delivery wire. Five radiation source 1ire lumens are provided; one central lumen located along the long axis of the APptcator and four curved lumens symmetrically offset from the central lumen. A remo able stiffening stylet is positioned in the central lumen. Two proximal portslare als provided with Luer-type connectors for balloon inflation/deflation and for app'ication fintracavitary
DESCRIPTION
· ·
Contrast media concentrations of less than 10% are recommended to prevent dose
attenuation.
Non-ionic contrast media is recommended for patients who are allergic to iodinebased agents.
I
3. 4.
PRECAUTIONS · · The Applicator must be used only by physicians trained in catheter implantation, radiation treatment planning and delivery. Metal vascular and marking clips should not be used during the lumpectomy procedure to prevent potential abrasion or puncture of the ConturaTM balloon. Care should also be taken to direct suture knots and tails away from the cavity and whenever possible position tissue between the potential balloon surface and the tails. Store the SenoRx Applicator at room temperature (20 to 25"C). Care must be taken when handling and manipulating the ConturaTM balloon to prevent damage and foreign material contamination ofthe balloon surface. A scalpel should be used to incise the skin prior to inserting the trocar tip. Do not inject fluids into the Vacuum Port. Replace Luer caps and radiation lumen caps after use. Only clinical personnel trained in the operation ofHDR afterloaders should deliver radiation using the Applicator.
vacuum.
I
The ConturaTM MLB accessories provided for introduction arid deplrent include: trocar with split sheath, drainage catheter, three, 30 ml and one, 0 ml inflation syringes, nil scalpel, contrast media tray, radiation lumen caps rd lab Is (Figure 2). Aflerloader compatibility: I Model BOOI-45- VariSource 200, VariSource ID and Nucletron HDR rloaders. Model BOII-45 - GammaMedPlus afterloader (Cannot be used Mth G$maMed 12i)
5.
· · · · · ·
6.
7. 8.
I
Warning: The safety and effectiveness of the SenoRx Applicator as a ~placement for whole breast irradiation in the treatment of breast cancer has not been established, INDICATIONS FOR USE
!
I
9.
The Contura"O>\ MLB Applicator is intended to provide biachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following I lumpectomy for breast cancer. CONTRAINDlCATlONS · The Applicator is not intended for use in cavities that are to'; small, large andlor of shapes unable to conform to an approximately spheric~l, 4 to 5 cm diameter SenoRx balloon. I
,
inject 58 ml of sterile saline into the Applicator and inspcct for leaks and spherical symmetry. Discard Applicator if defective. Holding the Applicator by the connectors, with the halloon hanging vertically, completely withdraw the saline from balloon. Prepare a maximum 5% contrast media/sterile saline solution in the Tray (D) provided. Determine the desired point on the breast surface for the insertion of the Applicator. Inject appropriate anesthetic to the skin and pathway to the lumpectomy cavity. Make a skin incision with the scalpel at the insertion point of sufficient length to fully insert the Trocar (F) tip. Dilate the skin incision, if desired. Advance the Trocar with Split Sheath (G) into the cavity. Remove the Trocar. Attach a 30 mI syringe to the Drainage Catheter (H) and drain any fluids within the cavity by inserting the Drainage Catheter through the Split Sheath and suctioning. Remove the Drainage Catheter. Insert the Applicator through the Split Sheath into the cavity. Remove the Sheath. Align the Radiopaque Line (I) on the catheter shaft with the skin incision. Removc the stiffi:ning Stylet (J) from the Central Source Lumen (K). Attach a red radiation source lumen Cap (L). Using the syringes provided, inflate the Applicator balloon with the contrast media solution to the desired fill volume. Purge any air from the fill syringes before attaching them to the Applicator. Desired balloon diameter 4cm 5 em
I I I
Approximate balloon fill volume 33ml 58ml
100
·
· ·
Verify that the appropriate aflerloader connectors are available and function with .
the Applicator prior to treatment. Be snre that the Applicator is as straight as possible and free of sharp bends and kinks prior to connecting to the HDR afterloader. Inspect package before use. damaged. Discard if seal is compromised or packaging is
·
The Applicator is not intended for use in patients with unusual anatomy including a highly curved rib structure andlor unequal amounts oftis sud surrounding the cavity that may cause the SenoRx balloon to be asymmetrical. I
WARNINGS · · ·
i
COMPUCATlONS Complications that may be associated with the use of the ConturaT>I MLB Applicator are the same as those associated with the use of similar devices. These may include: erythema, catheter site drainage, breast pain, ecchymosis, breast fibrosis, telangiectasia, breast induration, breast serorna, breast edema, dry desquamation, dry skin, skin discoloration, parasthesia, axilllary pain, fatigue, pruritis, breast retraction, nausea, skin irritation, moist desquamation, hematoma, rash, asymptomatic fat necrosis, breast infection, breast blister and lymphedema.
Use caution when positioning the trocar tip near the chestlwall orlskin margin to avoid unintended tissue damage. I Do not fill the Applicator with more than 58 ml of fluid as overffiliqg may result in I ballonn rupture andlor device fuilure.
i
I
10. Replace the Luer Cap on to the Inflation Port (M). I I. Use ultrasound to confirm appropriate placement, volume and cavity conformance. Fluid and air surrounding the Applicator balloon may be aspirated with a 30 ml Syringe attached to the white Vacuum Port (N). The volume of the balloon may be adjusted through the blue Inflation Port (M). Replace Luer Caps when finished. 12. Confirm that the radiopaque line is aligned with the skin incision. 13. Apply a surgical dressing to the exit site with the catheter positioned to minimize bending. 14. Record the final balloon fill volume on the Labels provided and attach to the patient's chart.
RADIATION DELIVERY - Refer 10 Figure 3
I.
The Applicator must be pre-tested before implantation. Do inot use lbe balloon ifit is not approximately spherical andlor any leakage is detected. The breast cavity must be imaged before implantation ro insure thelApplicator will fit appropriately. Do not usc if the cavity is too small or if,j skin sulface to balloon surface distance of less than 5 mm will result I
How SUPPLIED
The ContumTM MLB Applicator and accessories are provided sterile and are intended for single patient use only. DIRECTIONS FOR USE
PLACEMENT - Refer to Figures I
2.
·
To insure appropriate treatment dose distribution, the Applicator must be imaged prior to delivering each fraction of radiation to confirm correct P9sition, balloon volume, skin spacing and conformance. I If excessive resistance is encountered when attempting to Iremovelthe Applicator from the patient, surgical removal is recommended. I
I
3.
&2
·
I. 2.
Use ultrasound to identify the lumpectomy cavity. Open the ConturaTM MLB Applicator sterile package and remove the Applicator (A) and one 30 ml Syringe (B). Remove the Inflation Port Luer Cap (C) and Page3
CT imaging should be used in conjunction with commereially available treatment planning soflware to determine the appropriate source lumens, source dwell positions and dwell times for optimized radiation delivery ofa prescribed dose to the targeted treatment volume. Note the orientation of the ContumTM MLB Applicator with respect to the radiopaque line on the catheter shaft. Verify correct Applicator orientation, balloon position, balloon volume, skin spacing and conformance using imaging prior to delivery ofeach fraction of radiation. Adjust if necessary. The Applicator red-capped, radiation source wire lumens are numbered 'I', '2', '3" '4' and '5' and positioned as shown in Figure 3. Lumen number 'I' corresponds to the offset lumen closest and parallel to the longitudinal radiopaque line (M) along the outside of the catheter. Lumen number '5' corresponds to the ceniral lumen. Remove the red caps and use commercially available connectors to attach the source lumens to the aflerloader. Page 4
Page2
SRX-HOL00002232
Case 5:08-cv-00133-RMW
Document 84
Filed 04/08/2008
Page 3 of 3
4. I.
Note: When using the GnmmaMedPlus Afterioaderlthe radiation source lumens of the B0l1-45 Applicatormust first be trimmedto length u~ing the GammaMed length cuttinggauge. After each treatment replace the Tedcaps.
REMOVAL
Remove the ConlUIaTM MLB Applicator by first attaehiog Asyringe to the blue
Inflation Port and deflatingthe balloon,
I
2.
Note: If difficultyis encountereddeflatingballoon'fth syri ~e: I) Re-attachsyringe and securelyrotate clockwise to activate the valve. If the balloon,still does not deflate,the? 2) Cat the blue Inflation Port tubing. The saline/con t contents of the balloonwill now drain from the end of the cut'tubing Rotateand withdraw(unscrew)the Applicatorfrom the cavh
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MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY
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Sli!(ening stylet
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Vacuum Pon{Nl(Whlte)
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Figure 3: SOURCE WIRE LUMEN ORIENTATION
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© 2001 by SenoRx Inc. All rights reserved.
This product is covered by one or more ofthe following U.S. Patents: 6,923,154; 6,955,641; 1,241,118. Other domestic and foreign patents pending.
INSTRUCTIONS FOR USE
EXPLANATION OF SVMBOLS ON THE PACKAGE
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CatalogueNumber Use by Date Lot Number Contents Sterile(Gamma radiation) Attention,See Instructionsfor Usc Do Not Reuse UpperTemperatureLimit Keep away from sunlight Keepdry
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Page 6 Page I
SRX-HOL00002233
Case 5:08-cv-00133-RMW
Document 84-2
Filed 04/08/2008
Page 1 of 4
Exhibit MM
Case 5:08-cv-00133-RMW
Document 84-2
Filed 04/08/2008
Page 2 of 4
UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA
---------------------- x
XOFT MICROTUBE, INC.,
a Delaware corporation, Plaintiff, vs. CYTYC CORPORATION, a Delaware corporation, and PROXIMA THERAPEUTICS, INC., a Delaware corporation, Defendants. Civil Action No. CV 05-05312 RMW
---------------------- x
VIDEOTAPED DEPOSITION OF RONALD E. Wednesday, April 18, 2007, Proskauer Rose One International Place
CAHILL
9:00 a.m.
--- --- ----------- ----------- -------- -- ------ - B()s-t-()n-,~Ma-s-s-a-e-h-'tl:se-t;-t-s-------------------------------H------~--I
Reporter:
Dana Welch,
CSR,
RPR
Certified LiveNote Trainer
MERRILL LEGAL SOLUTIONS 800-826-0277 818-593-2300 Fax 818-593-2301 www.merrillcorp.com
Case 5:08-cv-00133-RMW
Document 84-2
Page 126
Filed 04/08/2008
Page 3 of 4
Page 128
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
balloon, appears to be the balloon. On the right-hand side that 200 curve appears to be right on it, and on the left-hand side it appears to be spaced apart; so it doesn't appear to have the same shape. Q. Does it have -A. And-Q. I'm sorry. Please continue. A. And it says right above the figure that the goal was to produce an isodose curve that matches the shape of the cavity. Q. Okay. A. And not the shape of the balloon. Q. Okay. Be that as it may, you still don't believe that the device shown in Figure 3 illustrates a configuration wherein the isodose profile is the same shape as the expandible surface element; is that correct? MS. ALTEMUS: Objection to the extent it's calling for a legal conclusion, especially with respect to the expandible surface . element. A. Looking at Figure 3 and looking at the text relating to Figure 3, I believe that this does
Page 127
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
generate an isodose curve that matches the shape of the cavity. Q. Yeah. I understand. A. And it is also my understanding, I think it says so in the response that we were discussing earlier, that generally when dealing with cavities ofthe brain, the balloon is chosen and inflated in a way so that it doesn't contact the tissue all the way around or push on the tissue. Q. Okay. Well, let's --let's leave aside the goal of the paper and -- and the other matters for a second and return to the question of whether or not this figures shows an isodose profile that's substantially the same in shape -MR. ALTEMUS: Objection. Q. -- as the expandible outer expandible surface element. MS. ALTEMUS: Objection, asked and answered; calls for a legal conclusion; and other form objections. BY MR. MULVILLE: Q. You have in front of you -- I'm sorry. Please go ahead and answer the question. If you need me to read it back, I'll be happy to.
Page 129
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
not disclose the generation of isodose curves of substantially the same shape as the balloon. Q. It's not substantially the same shape. A. I think that's the claim language. Q. Okay. And the reason for that, if I understood you correctly, is because the difference between this black line that says 200, and it sort of -- I'll characterize it sort of at the 4:00 position, and as we work back towards the 12:00 position, you've noted that it's right on the outer balloon; is that correct? A. It looks that way. Q. And then if we take it sort of at the 11:00 position and we go back down toward let's say the 7:00 position, that's -- you've noticed that
1 A. That would be helpful if I could hear it 2 again. 3 Q. Okay. So the question is whether or not 4 Figure 3 of the Ashpole reference shows a device 5 generating an isodose profile that's substantially 6 the same shape as the expandible outer balloon. 7 MS. ALTEMUS: Objection. That's not 8 really the same question you asked before. 9 And objection as to form. l O A . I'm afraid I haven't been able to follow 11 you. Could you either ask the question again or 12 just read it back, either way. 13 Q. Absolutely. 14 A. I promise to pay close attention. 15 Q. No problem at all. I'm asking you a
1 --I1-1c6-theI:e-appear-S-tQ-be-an-add.itiG.na1-gI:a¥-ar-ea-in-that-- -l-6-question-and..you!r.e-ttying-to-under.stand-the-thiI.li~ M fT ~-1~_-----j
17 portion; is that correct? 17 So I don't want to interrupt your looking at the .--- -18----1\-.--Thatappears-toheso;·· ~--------18---reference: -----Il----1 19 Q. And in your understanding, that renders 19 A. Okay. 20 the difference not substantially similar in shape? 20 Q. Do you need to look at it more? 21 MS. ALTEMUS: Objection that it calls for 21 (Simultaneous speaking.) 22 a legal conclusion. 22 A. Could I have the question again? 23 Q. Absolutely. 23 A. Well, I combine what I see in the figure 24 with what it says in the text, that the goal was to 24 The question is whether or not Figure 3 of
33 (Pages 126 to 129) MERRILL LEGAL SOLUTIONS 800-826-0277 818-593-2300 Fax 818-593-2301 www.merrillcorp.com
Case 5:08-cv-00133-RMW
Document 84-2
Page 162
Filed 04/08/2008
Page 4 of 4
Page 164
Q. Yeah, sure. Have you read any cases where the content of a 51O(k) application bears on the validity of a patent where the 51O(k) application covers a device that's substantially similar to what's disclosed in the patent at issue? MS. ALTEMUS: Same objections. A. I don't think I have. Q. Okay. If you'd known that the MammoSite 9 device was characterized as an intercavital device lOon a vast number of occasions, would it have 11 affected your tendency to argue that the 12 distinction between an intercavital device and an 13 interstitial device is important in explaining 14 differences between the prior art and the claims at 15 issue? 16 MS. ALTEMUS: Objection. Form. 17 A. No. 18 Q. Okay. That's all I have for this witness. 19 MS. ALTEMUS: Okay. That's all I have. 20 THE VIDEOGRAPHER: This concludes the 21 deposition of Ronald E. Cahill. The number of 22 tapes used today was three. Going offthe 23 record. The time is 2:33. 24 (Deposition concluded at 2:33 p.m.)
Page 163
1 2 3 4 5 6 7 8
1
2
3 4
CERTIFICATE Commonwealth of Massachusetts Suffolk, ss.
I, DanaWelch, Registered Professional Reporter andNotary Public in andforthe Commonwealth of Massachusetts, do hereby certify thatRONALD E. CAHILL, the witness whose deposition is hereinbefore set forth, wasduly sworn bymeand thatsuchdeposition is a true record of the testimony given bythe witness. I further certify that I am neither related 13 to nor employed by anyof the parties in or counsel 14 to this action, nor am I fmancially interested in 15 the outcome of this action. 16 In witness whereof, I have hereunto set my 17 hand andsealthis 27thdayof April, 2007. 18 19 DanaWelch Notary Public 20 My commission expires: 21 October 22, 2010 22 23 24
5 6 7 8 9 10 11 12
1
CER TIFICA TE I, RONALD E. CAHILL, do hereby certify that I have read the foregoing transcriptof my testimony, and furthercertifythat it is a true and accurate recordof my testimony (with the exception of the corrections listed below): Page Line Correction
2
3
4
5 6 7 8
9
10 11 12 13 14 15 16
--\-'l-'=J,--------------------!----------------------!'i-------j
18 ""- T9---Signea unaerthepainsanapenalties-of " " " " " " - - - - - 1 - - - - - - - - " " -""-"---"-"-"-""-20 perjury this __ day ,2007. 21
22
RONALD E. CAHILL 23 24 42 (Pages 162 to 164) MERRILL LEGAL SOLUTIONS 800-826-0277 818-593-2300 Fax 818-593-2301 www.merrillcorp.com
Case 5:08-cv-00133-RMW
Document 84-3
Filed 04/08/2008
Page 1 of 32
Exhibit OO
Case 5:08-cv-00133-RMW Case 5:05-cv-05312-RMW
Document 84-3 Document 109
Filed 04/27/2007 Filed 04/08/2008
Page 1 of 31 Page 2 of 32
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 .
CLAIM CONSTRUCTION ORDER--No. C-05-05312 RMW JAH
Case 5:08-cv-00133-RMW Case 5:05-cv-05312-RMW
Document 84-3 Document 109
Filed 04/27/2007 Filed 04/08/2008
Page 2 of 31 Page 3 of 32
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 16 17 18 19 20 21
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
CLAIM CONSTRUCTION ORDER--No. C-05-05312 RMW JAH
Case 5:08-cv-00133-RMW Case 5:05-cv-05312-RMW
Document 84-3 Document 109
Filed 04/27/2007 Filed 04/08/2008
Page 3 of 31 Page 4 of 32
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 16 17 18 19 20 21 22 23 24 25 26 27 28
3
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
CLAIM CONSTRUCTION ORDER--No. C-05-05312 RMW JAH
Case 5:08-cv-00133-RMW Case 5:05-cv-05312-RMW
Document 84-3 Document 109
Filed 04/27/2007 Filed 04/08/2008
Page 4 of 31 Page 5 of 32
1 2 3 4 5 6 7
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).
CLAIM CONSTRUCTION ORDER--No. C-05-05312 RMW JAH
4
Case 5:08-cv-00133-RMW Case 5:05-cv-05312-RMW
Document 84-3 Document 109
Filed 04/27/2007 Filed 04/08/2008
Page 5 of 31 Page 6 of 32
1 2 3 4 5 6
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
5
Case 5:08-cv-00133-RMW Case 5:05-cv-05312-RMW
Document 84-3 Document 109
Filed 04/27/2007 Filed 04/08/2008
Page 6 of 31 Page 7 of 32
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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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6
"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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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 radioactivit
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