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1 !! WEST/CR$ No ,-1512,-1513,-1514, n t_e _[nteb State_ Court 0( _[ppea_ Jot _e.1f'el_era[cr_t THERASENSE, NC. (now known as Abbott Dabetes Care, nc.) and ABBOTT LABORATORES, V. Plantffs BECTON, DCKNSON AND COMPANY, -Appellants, [= _ K. : _d NOVA BOMEDCAL CORPORATON, OFAFPEAL_ - U.S_ERAt c=_ct,_ Defendants-Appellees, 'FEB.= JAN HORBALY CLEEK and BAYER HEALTHCARE LLC, Defendant-Appellee. Appeal from the Unted States Dstrct Court for the Northern Dstrct of Calforna n consoldated case nos. 04-CV-2123, 04-CV-3327, 04-CV-3732, and 05-CV-3117, Judge Wllam H. Alsup. REPLY BREF OF PLANTFF-APPELLANTS ABBOTT LABORATORES AND ABBOTT DABETES CARE, NC. Roht K. Sngla, Esq. (SBN ) Jason A. Rantanen, Esq. (SBN ) MUNGER, TOLLES & OLSON LLP 560 Msson Street, 27 t_lfloor San Francsco, CA Telephone: (415) Facsmle: (415) Attorneys for Plantff-Appellants Abbott Dabetes Care, nc. and Abbott Laboratores Bll Ward, Esq. (SBN ) MUNGER, TOLLES & OLSON LLP 355 South Grand Avenue, 35th Floor Los Angeles, CA Telephone: (213) Facsmle: (213)

2 UNTED STATES COURT OF APPEALS FOR THE FEDERAL CRCUT Therasense v. Becton No ,-1512,-1513,-1514,-1595 CERTFCATE OF NTEREST Counsel for the (pettoner) _ (respondent) (appellee) (amcus) (name of party) Abbot Dabtqes Care nc. _^_,out_,,o,_ certfes the followng (use "None" f applcable; use extra sheets f necessary):. The full name of every party or amcus represented by me s: Therasense, nc. (now known as Abbott Dabetes Care, nc.) and Abbott Laboratores 2. The name of the real party n nterest (f the party named n the capton s not the real party n nterest) represented by me s: None 3. All parent corporatons and any publcly held companes that own ]0 9ercent or more.of the stock or" the party or am cus curae represented by me are: None. 4. The names of all law frms and the partners or assocates that appeared tbr the party or amcus now represented by me n the tral court or agency or are expected to appear n ths court are: See attachment Please Note: All questons must be answered cc: Bradford Badke, Esq. and Morton Amster, Esq. ^ ) Prnted name of counsel

3 CERTFCATE OF NTEREST ATTACHMENT 4. The names of all law frms and the partners or assocates that appeared for the party or amcus now represented by me n the tral court or agency or are expected to appear n ths court are: MUNGER, TOLLES & OLSON LLP BAKER BOTTS LLP BNGHAM McCUTCHEN LLP Jason Jeffrey Rantanen. Wenberger Roht K. Sngla John Peck (no longer at MTO) Ted G. Dane Bll Davd Ward Wlle James W. Cannon, Jr. Mara W.. Boyce Matthew A. Hayenga Shannon Steven H. Hutcheson Mtby Wllam P. Johnson (no longer at BB) Davd Arlngton JeffBaxter Scott Danel Joshua Powers Goldberg Dalton ABBOTT LABORATORES Jose E. Rvera Karen L. Hale

4 !! l!!! * TABLE OF CONTENTS Page REPLY... 1 A. '551 Obvousness Dsclosure... :... _... :... 1 a. The phrase "optonally, but preferably" must be read n the context of the techncal teachngs b. The techncal dsclosures of the '382 teach away Reasonable Expectaton of Success a. There was no evdence of reasonable expectaton of success... 4 b. Even the nventors dd not know how to make a membraneless sensor for blood Enablement a. There was no evdence of enablement... 8 b. The only evdence was that tle pror art dd not enable the '551 nventon The '551 s not a new use for an old product or the deleton of a functon B. '551 nequtable Conduct Defendants' clam of nconsstency s spurous a. MedSense never argued that a membrane was optonal for blood b. MedSense's only argument to the EPO related to the dfference between the D1 and '382 membranes c. The onlyscentfc testmony supported Abbott d. nequtable conduct cannot be based on close nterpretaton of ambguous language..:... _._ Characterzatons of pror art are not materal There was no bass to fnd an ntent to deceve

5 !. TABLE OF CONTENTS (contnued) a. Credblty determnatons cannot substtute for Page evdence of ntent b. ntent to deceve could not be nferred There s no evdence that Dr. Sanghera's declaraton was false... _ Dr. Sanghera Was Enttled to Rely on Secton 1.56(d) C. " '164/'745 nfrngement... _ "Non-flowng manner" cannot exclude convectve moton Defendants msrepresent the prosecuton hstory D. '745 Antcpaton... : The '225 does not dsclose a dffusble medator wth the nventon Dr. Turner's testmony creates a trable ssue of fact Abbott's clam constructon postons were consstent There was a dspute of fact regardng whether the '745 "background sgnal" lmtaton s found n the ' _ CONCLUSON

6 TABLE OF AUTHORTES Page. FEDERAL CASES Akzo N. V. v. U.S. nt'l Trade Comm 'n, 808 F.2d 1471 (Fed. Cr. 1986)... _... 17, 18 Amgen nc. v. Hoechst Maron Roussel, nc., 314 F.3d 1313 (Fed. Cr. 2003) Anderson v. Bessemer Cty, 470 U.S. 564 (1985) B. V.D. Lcensn_ Corp. V. Body Acton Desgn, nc., 846 F.2d 727(Fed. Cr. 1988)... : Brstol-Myers Squbb Co. v. Ben Venue Labs., nc., 246 F.3d 1368 (Fed. Cr. 2001) Cargll, nc. v. Cambra Foods, Ltd., 476 F.3d 1359 (Fed. Cr. 2007)... 16, 20 Celertas Techs., Ltd. v. Rockwell nt!l Corp., 150 F.3d 1354 (Fed. Cr. 1998)... _._ Cords Corp. v. medtronc Ave, nc., 511 F.3a (Fed. Cr. 2008) , 27 Dayco Prods., nc. v. Total Contanment, nc., 329 F_3d 1358 (Fed. Cr. 2003) Hallburton Co. v. Schlumber_er Tech. Corp., 925 F.2d 1435 (Fed. Cr. 1991) mpax Labs., nc. v. Avents Pharms. nc., 545 F.3d 1312 (Fed. Cr. 2008) n re Benno. 768 F.2d 1340 (Fed. Cr. 1985)... 4, 29 n re Deutsch, 75 F.2d 994 (C.C.P.A. 1935) n re nland Steel Co., 265 F.3d 1354 (Fed. Cr. 2001) ;... 3 Kngsdown Med. Consultants, Ltd. v. Holster nc., 863 F.2d 867 (Fed. Cr. 1988) Net MoneylN v. VerS_n, nc., 545 F.3d 1359 (Fea. Cr. 2008) Newman v. Qu_, 877 F.2dl575 (Fed. Cr. 1989) , 10 Pfzer, nc. v. Teva Pharms. USA, nc., 518 F.3d 1353 (Fed. Cr. 2008) , 20 Rchards v. Chase Elevator Co., 159 U.S. 477 (1895)

7 !!!! TABLE OF AUTHORTES (contnued) Rchards v. Chase Elevator Co., 159 U.S. 477 (1895) _ Salazar v. Procter & Gamble, 414 F.3d 1342 (Fed. Cr. 2005)... 25, 26 Scanner Techs. Corp. v. COS Vson Sys. Corp. N. V,, 528 F.3d 1365 (Fed. Cr. 2008)... :... _ SR nt'l v. Matsushta Elec. Corp. of Am., 775 F.2d 1107 (Fed. Cr. 1985) :... 4 Star Scentfc, nc." v. R.J. Reynolds Tobacco Co., 537 F.3d 1357 (Fed. Cr. 2008).: U.S. v. Ktsap Physcans Serv F.3d 995 (9th Cr. 2002) Upsher-Smth Labs., nc. v. Pamlab, L.L. C:, 412 F.3d 1319 (Fed. Cr. 2005) FEDERAL RULES AND STATUTES Fed. R. Cv. P. 9(b) U.S.C. 102, , FEDERALREGULATONS 37 C.F.R. 1.56(d)... : OTHER Merram-Webster's Collegate Dctonary (10th ed. 1999) Robert Faber, Lands on Mechancs of Patent Clam Draftng, Secton 3.7C (5t hed. 2008)... :...! 4, 15 -v- Page

8 . REPLY A. '551 Obvousness The queston before ths Court s whether the '551 patent s obvous based on the "optonally but preferably" sentence alone, (1) despte the fact that the rest of the '382 actually teaches away from a membraneless sensor for blood; (2) wthout proof that a PHOSTA would have had a reasonable expectaton of success (whch even the '382/'551 nventors dd not have); and'(3) wthout proof that the '382, together wth the pror art, enabled the practce of the '551 nventon. s 1. Dsclosure a. The phrase "optonally, but preferably" must be read n the context of the techncal teachngs. Despte ther clam to "consder the entre dsclosure of the '382 patent," all of the testmony defendants rely upon (lke the dstrct court) bols down to the '!optonally, but preferably" language.l (Bayer Opp. 6-7.) But the "broad teachng" now beng ascrbed to that language (Tral Order 16) conflcts wth the techncal detals of the '382. (See Openng Br ) t s error to nterpret such solated phrases beyond a patent's specfc techncal teaohngs, because that s so 1 Bayer ctes, for example, to JA2531 at 239:13-22 (Turner on "optonally" sentence); JA at 534:3-537:5 (Johnson on same); JA at 333:18-338:3 (Turner testmony about "optonally" and "preferably"); JA3076 (Davs on "optonally" sentence); and JA (same for Hggns)

9 easly subject to hndsght analyss,.e., readng the pror art +vth the nventon at ssue already n mnd: 2 t s mpermssble to frst' ascertan factually what appellants dd and then vew the pror art n such a manner as to select from the random facts of that art only those whch may be modfed and then utlzed to reconstruct appellants' nventon. Applcaton of Shuman, 361 F.2d 1008, 1012 (C.C.P.A. 1966). n Shuman, the Court rejected a smlarly broad readng of a general suggeston n a pror art patent because that readng was "a departure from the more specfc teachngs" of the pror art and from the embodments "dscussed n detal." d. b. The techncal dsclosures of the '382 teach away. Defendants do not dspute that despte thrteen workng examples, descrptons of numerous addtonal sensor desgns, and the undsputed advantages of membraneless sensors, the '382 descrbes no membraneless sensor tested n blood. Ths slence speaks volumes. ndeed, the only membraneless sensors descrbed n the '382 are expressly not used n blood. The frst s descrbed as "projectng only nto the derms,".e., 2 Even defense expert Dr. Turner admtted, when dscussng the '164 patent, that words lke "preferably" are "patent tease [sc]" and have to be "read... n context." (JA9738:3-19.) Bayer clams Abbott's wtnesses testfed that the words "optonally" and "preferably" had ther "ordnary meanng" n the '382. (Bayer Opp. 7.) But Dr. Sanghera specfcally sad the opposte, that "[]n the context of' of the '382, "optonally" and "preferably" "deems that t's requred" for blood. (JA3009 at 748:6-12.) So dd Mr. Scott. (JA3542.)

10 for ntersttal flud. (JA6508 col. 3:57-4:2. (emphass added).) The second s n Example 8, whch defendants try to explan by suggestng that buffer was used to "smulate testng n blood." (Bayer Opp. 8.) But the Example 8 sensor was n fact tested n blood -- after t was "modfed" by addng "a cellulose acetate membrane." Nether defendants nor the dstrct court can reconcle ths wth ther readng of the patent. The obvous mplcaton s that a membrane was needed for blood. Bayer clams that Abbott's expert Dr. Johnson testfed that the Example 8 membraneless sensor was a "prototype" that could have been used n blood. (Bayer Opp. 9, ) But Johnson actually testfed that the "prototype... wasn't a fnshed sensor" and that although t could be tested n blood, "makng t work s a dfferent story." (JA2756 at 565:19-21; JA2751 at 546:1.) Johnson merely stated the obvous: the membraneless sensor could have been tested n blood but was not. That would be tellng to any reader of the patent. Bayer ctes n re nland Steel Co., 265 F.3d 1354, 1361 (Fed. Cr. 2001) for the proposton that "non-preferred embodments" cannot be gnored. (Bayer Opp. 31.) However, none of the '382 embodments -- whether preferred or not -- dsclose membraneless sensors for blood. BD/Nova repeatedly reles on the fact that the '382 clams cover sensors wthout membranes and that the ExacTech s marked wth the '382 patent. (See,

11 e.g., BD/Nova Opp. 5.) BD/Nova s confusng clams and specfcatons. "[S]pecfcatons teach. Clams clam." SR nt'l v. Matsushta Elec. Corp. of Am., 775 F.2d 1.107, 1121 n.14 (Fed. Cr. 1985). The nventon clamed n the '382 patent s a faster medated chemstry. Just because the ExacTech uses that chemstry, and so falls wthn the '382 clams, cannot mean that the '382 specfcaton teaches and renders obvous every feature of the ExacTech. See n re Benno, 768 F.2d 1340, 1346 (Fed. Cr. 1985) ("The scope of a patent's clams determnes what nfrnges the patent; t s no measure of what t dscloses."). 2. Reasonable Expectaton of Success a. There was no evdence of reasonable expectaton of success. The dstrct court conceded that before the '382, PHOSTAs would have expected a blood sensor to requre a membrane because of foulng. 3 (Tral Order 14.) Defendants are unable to cte any evdence that the '382 changed the conventonal wsdom and gave a reasonable expectaton of success for a membraneless blood sensor. Tellngly, defense expert Turner dd not testfy on ths ssue. 3 Bayer's reference to the '166 Suzuk reference s another red herrng. Turner offered no testmony about Suzuk, and the dstrct court dd not rely on t. (Tral Order 14.) Suzuk n fact refers to an electrode "free of a sempermeable membrane" -- the knd of glucose lmtng membrane used n the D 1 reference dscussed at the EPO -- not the protectve membrane at ssue here. (d.) And Suzuk acknowledges that a sensor wthout a sempermeable membrane does not Work; t s subject to "notceable varaton[]." (d.)

12 Bayer Ctes only seven pages of ts own bref, n whch no evdence of that supposed fact s cted. (Bayer Opp. 35, 4-11.) BD/Novajust echoes the dstrct court's own "expert" opnon that a PHOSTA would have understood the '382 faster chemstry to elmnate the rsk Of foulng and render a membrane "no longer necessary." (BD/Nova Opp. 25). But agan, there s no evdence to support that concluson. Turner ne_er so testfed -- and defendants pontedly never asked hm that.. Turner sad only that foulng was somewhat less of a concern. Crtcally, however, he testfed that, "[f]oulng s stll a desgn feature n these devces because you're stll dealng wth blood." (JA2531 at 241 : (emphass added).) Hs testmony thus corroborates that a PHOSTA would have stll thought foulng was a problem. Moreover, Johnson ponted out that Example 8's addton of a membrane before testng n blood ndcated to a PHOSTA that the membraneless sensor would not work n blood. (JA2739 at 498:3-21.) ndeed, Example 8 of the '382 reports a 5% oxygen dscrepancy n buffer for the membraneless sensor, ndcatng that ths sensor would not work n blood, whch has a much greater oxygen concentraton. (Openng Br. 15; JA6511 col. 9:19-21.) Dr. Sanghera testfed to ths based on hs personal experence workng wth the Example 8 devces. 4 (JA at 715:5-717:23.) Lke the dstrct 4 BD/Nova's asserton that ths ssue s beng rased for the frst tme s nexplcable. Dr. Sanghera testfed to ths at tral and t s dscussed n Abbott's proposed fndngs. (JA14578.)

13 court, Bayer responds by notng the '551 reports a smlar 4% oxygen senstvty. (Bayer Opp. 10.) Ths s hghly msleadng. The 5% fgure n the '382 relates to buffer. The 4% fgure n the '551 s for "anaerobc and fully aerobc samples,".e., blood samples. (JA3861 col. 7:18-22.) Unlke the '382 sensors, the '551 sensors are drected entrely to blood samples. Tumer's own research, whle employed at MedSense, demonstrated that the older electrodes exhbted an oxygen senstvty n blood of 23% not 5%. (JA6367.) Thus, the evdence demonstrates that a PHOSTA would not have had a reasonable expectaton of success n makng a membraneless sensor for blood based on the '382 specfcaton. b. Even the nventors dd not know how to make a membraneless sensor for blood. Reasonable expectaton of success s contradcted also by the testmony of the nventors -- worldwde leaders n the feld wth no nterest n the patent or the ltgaton.-- that they were themselves not confdent they could make a membraneless sensor for blood n (See Openng Br ) Bayer grossly mscharacterzes ths nventor testmony. t clams Dr. Hll testfed that they had known "protectve membranes were not necessary for n vtro devces tested wth blood." (Bayer Opp. 13.) But Bayer crtcally omts the tmng. Hll sad they conceved of a membraneless sensor for blood durng the research for the '551 nventon, n 1982 or after the '382 specfcaton

14 (JA ; JA3210.) Hll testfed, n fact, that even n "'82, '83, as far as remember tl_ere were no electrodes that could be ntroduced nto blood wthout a membrane." (JA3209.)! Bayer ctes nventor Davs' testmony that the,'optonally, but preferably' sentence contemplated embodments wthout a membrane." (Bayer Opp. 13.) But that s not n dspute. The queston s whether a membraneless embodment s taught for blood. Davs never sad that. ndeed, Davs expressed surprse n hs lab notebooks well after the '382 when they learned to test n blood. (JA6437.) Fnally, Bayer clams Dr. Hggns testfed that "membranes were not necessary" for blood and a PHOSTA "would have understood" that from the '382. (Bayer Opp. 13.) n truth, Hggns (a wtness pad by Bayer) sad only that the nventors had speculated a membrane "mght well not be necessary." (JA3105 (emphass added).) They merely thought further research mght produce a membraneless sensor for blood: that t was "qute concevable that t would be possble to get that system to work n blood wthout a membrane." (JA3746 (emphass added).) Wth respect to PHOSTAs, Hggns added speculaton on top. of speculaton: that PHOSTAs "mght well have concluded: maybe ths wll work wthout a membrane." (JA (emphass added).)

15 l: The nventor testmony s unambguous: at the tme of the '382 (and for perhaps a year or two afterwards), the '382/'551 nventors dd not have a reasonable expectaton of success, even wth ther superor Sklls n the art. 3. Enablement a. There was no evdence of enablement. Defendants cte no evdence that a membraneless sensor bult wth the '382 technology (or anythng else n the pror art) would work n blood. Nether defendants' expert, nor any of the nventors, nor any other wtness, testfed that the '382 dsclosures elmnated the central problem of foulng. BD/Nova (but notceably not Bayer) clams that Turner testfed to that effect (BD/Nova Opp. 30, 32), but all he actually sad was that Example 8 does not expressly say the membraneless sensor would not work n blood. (JA2533 at 248:25-249:6.) That s hardly clear and convncng evdence of enablement. Moreover, Turner (and the dstrct court) gnored the smple fact that the nventors added a membrane n Example 8 before testng n blood. b. The only evdence was that the pror art dd not enable the '551 nventon. l Oxygen Effect. The '382 reports a 5% oxygen effect n buffer, ndcatng a severe problem f used n blood. (See supra 5-6.) Dr. Sanghera's Testmony. Sanghera testfed that when he workedat MedSense, he ' replcated what was n the '382 patent" and expermented wth

16 those devces. (JA3007 at 741:2-13.) Based on hs personal know!edge, Sanghera testfed that the membraneless sensor of Example 8 would not work n blood: There would be a very large reducton n the true value of the glucose sgnal because of the nhbton effect of the oxygen... The system would gve a falsely low readng for a fxed glucose concentraton. (JA3001 at 717:14-23.) That s the only testmony n the record regardng whether '382 technology worked n blood wthout a membrane. Oxdaton. Defendants do not dspute that after the '382 nventon, the nventors dscovered that oxdzed electrodes exhbt greater foulng, or "adsorpton." (JA ) Nor do they dspute that the '551 teaches sensors that are not oxdzed. Bayer's only response s that the '382 mentons non-oxdzed electrodes. (Bayer Opp. 18.) But a non-oxdzed sensor desgned for non-blood applcatons and constructed wth a membrane s besde the pont, because foulng would not be a concern there. What Bayer gnores s that the membraneless sensor for blood supposedly taught n Example 8 s conspcuously oxdzed: "heat [ ]n an oven for 40h at 200 C to gve a[n] oxd[z]ed surface." (JA6511 Col. 9:1-3.) Bayer also complans that the '551 does not explan how t avods the foulng problem. (Bayer Opp. 15, 18.) But that cannot render the patent nvald: "t s not a requrement of patentablty that the nventor correctly set forth, or evenknow,

17 how or why the nventon works." Newman v. Qugg, 877 F.2d 1575, 1581 (Fed. Cr. 1989). Defendants' ntpckng at Abbott'S evdence gnores that defendants bore the burden of proof. 5 Even wthout any of Abbott's evdence, the absence of clear and convncng evdence that the pror art enabled the '551 nventon requres reversal. 4. The '551 s not a new use for an old product or the deleton of a functon. Bayer's "new use" argument s specous. (Bayer Opp. 40) There s no "old product" analogous to the '551 nventon -- whch clams not just a membraneless sensor for blood, but other features such as an elongated, dsposable test strp wthout the separate reference electrode taught n the '382. (JA 128 at 13:29-14:17.) There s no dspute that the '382 sensors dd not have these elements; the dstrct court reled on other references for these elements. (Tral Order ) The dstrct court's alternatve holdng -- that the '551 patent s nvald as "the mere deleton of the membrane wth a correspondng loss of ts functons" (Tral Order 21) _ s just a varaton of the same argument. As noted, the '551 5 n passng, Bayer ctes mpax Labs., nc. v. Avents Pharms. nc., 545 F.3d 1312, 1312 (Fed. Cr. 2008) suggestng that case swtched the burden of proof. But mpax s an antcpaton case and the ssue here s obvousness. Obvousness requres the challenger to prove the pror art made the entre "subject matter" of the nventon obvous (ncludng how to practce t), not jus t that the nventon s "descrbed n a prnted publcaton." 35 U.S.C. 102 (emphass added), 103. mpax followed Amgen nc. v. Hoechst Maron Roussel, nc., 314 F.3d 1313, (Fed. Cr. 2003), whch dd not extend ts holdng to obvousness

18 ! nventon s not just the '382 sensor wth the membrane removed. And n any case, the Rehards case tself recognzed that t s nventve to remove a functonal element and reach the same result: "the omsson of an element n a combnaton may consttute nventon f the result of the new combnaton be the same as before." Rehards v. Chase Elevator Co., 159 U.S. 477, 486 (1895). The nventve "result" here s the ablty to Jest n blood wthout a membrane. See n re Deutsch, 75 F.2d 994, (C.C.P.A. 1935) (omsson of element s a "patentable change" where omsson n the pror art devce would have rendered t noperable). B. '551 nequtable Conduct 1. Defendants' clam of nconsstency s spurous. a. MedSense never argued that a membrane was optonal of blood. Lke the dstrct court, defendants focus on MedSense's lawyers' statements to the EPO that a membrane was "optonal" n the 636/38_ devce. (See, e.g., Bayer at 23, 44-45; BD/Nova at 39.) But that snot n dspute: everyone agrees that a membrane s optonal n some embodments of the '382. Pope and Sanghera never suggested to the PTO that the '382 requred a membrane for all applcatons, just for blood. As for whether the '382 requred a membrane for blood, MedSense's lawyers told the EPO that: For use on human blood the sensor of Example 7 was provded wth a protectve membrane

19 !! (JA6586; JA6531.) (Example 7 of the '636 s the same as Example 8 of the '382, dscussed above.) n a slence that speaks volumes, nether the defendants nor the dstrct court even address ths statement to the EPO that a membrane was used for blood. BD/Nova baldly asserts, wthout ctaton or support, that MedSense told the EPO a membrane was "optonal" n "all cases." (BD/Nova Opp. 40 (emphass n orgnal).) But the EPO brefs say nothng of the sort. n a smlar ven, Bayer argues that MedSense was mplctly tellng the EPO that a membrane was optonal for blood, because "Clam 1 of the ' specfcally clamed measurements of glucose n 'blood' or ntersttal flud." (Bayer Opp. 45.) That accusaton answers tself, as the '636 clam expressly calls out "ntersttal flud,", for whch all agree a membrane was not necessary. (JA2740 at 499:18-23; JA2745 at 521:12-522:2.). More mportantly, basng nequtable conduct on supposed mplct assertons would be a radcal and dangerous expanson of the law. b. MedSense's only argument to the EPO related to the dfference between the D1 and '382 membranes. TO dstngush the D1 reference, t would have been pontless for MedSense to argue that a membrane was always optonal n the '636/'382 devces, because the '636 clams explctly called out sensors wth membranes. (JA6589, clam 9; JA2985 at 654:5-17; JA at 655:20-656:9.) MedSense needed to dstngush the type of membranes Used

20 The reason MedSense's lawyers noted the membrane was "optonal" n some stuatons wa s precsely to demonstrate the dfference n the D1 and '636/'382 membranes. The sempermeable membrane used n the D1 reference controls the dffuson of glucose. (Openng Br. 8.) f that knd of membrane s needed, t s needed whenever glucose s measured, regardless of the lqud -- buffer, blood, or ntersttal flud. (JA2745 at 520:16-25.) Thus, by showng that the '382/'636 dd not use a membrane for at least some lquds, MedSense proved that t dd not use the Dl's glucose-controllng membrane. That s all MedSense needed to or dd tell the EPO. " The dstrct court and the defendants ultmately pont to just two sentences -- out of 25 pages of EPO brefs -- n whch the "optonally, but preferably" sentence s descrbed as "unequvocally clear." (JA6585.) The nequtable conduct judgment bols down to the assumpton that MedSense's lawyers sad t was "unequvocally clear" that a membrane was optonal for blood. But defendants and the dstrct court gnore the surroundng context, whch makes clear that what was descrbed as "unequvocally clear" was that the '382/'636 membrane s "permeable to water and glucose," unlke the D1 membrane -- not that the membrane was optonal for blood. (Openng Br ; JA6585.) The surroundng text s all about the permeablty of the membrane, not ts optonalty

21 The EPO Board tself understood that MedSense cted the "optonall but preferably" sentence for ts descrpton of the type of membrane used.- (Openng Br (ctng JA ).) The only statement about the membrane beng "optonal" s the quotaton, and subsequent paraphrase, of the "optonally, but preferably, sentence tself. But the '382 specfcaton and the "optonally, but preferably" sentence were already before the Examner, and nothng n the EPO bref s nconsstent wth what Pope and Sanghera told the PTO,.e., that whle the membrane can be optonal (e.g., for ntersttal flud), the "optonally, but preferably" language cannot be read as a techncal teachng that the membrane s optonal for whole blood. Bayer takes a crtcal lberty wth the facts n argung that Pope told the PTO the "'optonally, but preferably' sentence s... 'mere patent phraseology.'" (Bayer Opp ; ) Pope acknowledged, after all, that the sentence has content; t contans the clearest statement n the patent of the type of membrane Used. (JA2990 at 672:13-23.) What Pope actually addressed, and what the Examner cared about, was the "'optonally, but preferably' language," the ntroductory phrase, not the whole sentence. (JA7645.) Gven the teachngs of

22 Example 8 and the rest of the '382, Pope concluded that phrase dd not teach that a membrane was optonal for blood. 6 (JA2986 at 658:19-659:20.) c. The only scentfc testmony supported Abbott. Even though the dstrct court and defendants nsst that these few sentences of the EPO brefs were a materal techncal admsson, the dstrct court based ts nequtable rulng solely on ts own nterpretaton of those sentences, unaded by any supportng scentfc testmony. Defendants pontedly never had Turner testfy on how a PHOSTA would have read the EPO brefs, whether they were materal, or whether they were nconsstent.wth Abbott's PTO submssons. Ths s especally surprsng as Turner revewed the EPO submssons and testfed about other aspects of them at length. (JA at ) Defendants had several scentfc experts (JA7; JA23), yet none came forward to opne about the EPO submssons. Turner dd not rely on the EPO brefs even to support hs obvousness opnon that the '382 patent.;) dsclosed a membraneless sensor for blood. f defendants were correct that 6 The dstrct court's Vew of whether patent phraseology s good publc polcy s rrelevant. The queston s whether Pope's readng of the '382 was reasonable gven that rpatent prosecutors n fact utlze such terms of art. See Robert Faber, Lands on Mechancs of Patent Clam Draftng, Secton 3.7C (5th ed. 2008) ("the specfcaton wrter should avod words lke 'crtcal,' 'requred,' 'necessary,'... as the clams wll ahnost assuredly be construed to requre a feature so characterzed")

23 ! MedSense admtted that fact n the EPO brefs, defendants' expert would presumably have reled on that admsson. The only scentsts to testfy on the nterpretaton of the EPO brefs were Dr. Sanghera (JA ) and Dr. Johnson. Johnson, an emnent scentst n the feld, testfed at length and wthout mpeachment that the EPO brefs should not be read as nconsstent wth the PTO submssons. (JA at ) The dstrct court acknowledged that t was approprate for Johnson to testfy on the nterpretaton of the EPO brefs (JA2747 at 528:9-21), but then gnored hs testmony. (d. 529:7.) d. nequtable conduct cannot be based on close nterpretaton of ambguous language. The queston s not whether Pope's readng of the "unequvocally clear" sentence and the rest of the EPO brefs was "correct." The queston s only whether Pope's nterpretaton was reasonable. Close and conflctng nterpretatons of ambguous legal arguments should not be the bass for renderng a patent unenforceable and jeopardzng a lawyer's career. (See Openng Br. 41, 46.) Patentees subject to an nequtable conduct charge are enttled, after all, to all reasonable nferences from the evdence: "Whenever evdence proffered to show ether materalty or ntent s susceptble of multple reasonable nferences, a dstrct court clearly errs n overlookng one nference n favor of another equally 71o7357.s 16

24 reasonable nference." Scanner Techs. Corp. v. COS Vson Sys. Corp. N.V., 528 " F.3d 1365, 1376 (Fed. Cr. 2008); see also Star Scentfc, nc. v. R.J. Reynolds Tobacco Co., 537 F.3d 1357, (Fed. Cr. 2008). BD/Nova (though not Bayer) argues to the contrary, but n both cases BD/Nova ctes (Cargll and Brasseler) the evdence ofmateralty was n fact overwhelmng. 2. Characterzatons of pror art are not materal. As Bayer notes, "[d]efendants presented a sngle nequtable conduct argument": 7 that Pope faled to dsclose the "pror characterzaton of the '382 dsclosure" n legal brefs submtted to the EPO durng the prosecuton of the foregn counterpart to the '382, n an effort to dstngush yet another patent, the D1 reference. (Bayer Opp. 42, 47.) Defendants cte no precedent for such an attenuated clam. Nor do defendants respond to the concern that expandng materalty so broadly -- to nclude any statement, from any proceedng n any / forum, that someone mght nterpret as nconsstent wth an argument to the PTO -- creates an unbearable burden on nventors, patent counsel, and even patent examners. (Openng Br ) 7 BD/Nova rases a new theory of nequtable conduct, that the PTO was not told the ExacTech was marked wth the '382 patent. (BD/Nova Opp. 43.) Defendants rased ths theory post-tral and never ped t wth partcularty, as requred by Rule 9(b). (JA ; JA ) n any event, as noted supra 3-4, that the ExacTech practces the '382 chemstry s rrelevant

25 There s no dspute the pror art '382 patent was before the examner, and ths Court has consstently rejected nequtable conduct based on characterzatons of pror art already before the examner, even mscharacterzatons n affdavts. See, e.g., Akzo N. V. v. U.S. nt'l Trade Comm 'n, 808 F.2d 1471, 1482 (Fed. Cr. 1986). (see also Openng Br ) Defendants have not cted any authorty to the contrary. 8 Defendants try to dstngush Akzo and related cases by argung ths case nvolves characterzatons of pror art n foregn proceedngs rather than before the PTO. But a mscharacterzaton to the PTO s more lkely to mslead the Examner and should be more materal than a supposedly nconsstent characterzaton n a foregn proceedng. Defendants argue that ths case s dfferent also because Dr. Sanghera submtted a declaraton about the pror art. (Bayer Opp. 47.) But the ssue here s the falure to dsclose the EPO brefs, not Sanghera's declaraton. Moreover, under Akzo and related cases, the characterzatons of pror art n Sanghera's declaraton cannot be nequtable conduct. 3. There was no bass to fnd an ntent to deceve. Although defendants nsst that the dstrct court dd not merely nfer ntent from the supposed nconsstency between the EPO legal brefs and the PTO 8 The cases BD/Nova ctes nvolved a falure to dsclose pror art (McKesson and Pharmaca) or factual msrepresentatons about the dentty of affants (Paragon)

26 m,, submssons, they are unable to dentfy anythng else n the record to support an ntent to deceve. a. Credblty determnatons cannot substtute for evdence of ntent. Defendants prmarly rely on the dstrct court's credblty determnatons, but credblty determnatons are no substtute for evdence of ntent. Here the "credblty determnatons" were smply another way of sayng the dstrct judge dsagreed wth Pope and Dr. Sanghera's readng of the EPO legal brefs. That s the only bass the dstrct court gves for ts credblty determnatons. (Tral Order 33-34, 38.) Nether defendants nor the dstrct court ponted to any sgnfcant nconsstences n Pope or Sanghera's testmony. They were not contradcted by other wtnesses or by extrnsc evdence. As BD/Nova concedes, Pope was never mpeached. (BD/Nova Opp. 45.) Although BD/Nova clams Sanghera was mpeached, the supposed "mpeachment" was on entrely collateral ssues that reflect, at most, an ncomplete memory. (JA3012 at 763:25-JA3013 at 765:7; JA3013 at 766:13-767:9.) n short, as the Supreme Court has explaned, a tral judge may not "nsulate hs fndngs from revew by denomnatng them credblty determnatons." Anderson v. Bessemer Cty, 470 U.S. 564, 575 (1985)

27 b. lntent to deceve could not be nferred. ntent to deceve can be nferred from the omsson tself only when: (1) the wthheld nformaton s hghly materal; (2) the patentee knew of ts materalty; 9 and (3) there was no credble explanaton for wthholdng the nformaton. Pfzer, lnc. v. Teva Pharms. USA, lnc., 518 F.3d 1353, 1367 (Fed. Cr. 2008)_ The few sentences n dspute from the EPO brefs were not "hghly materal" nformaton -- whch means mportant pror art, crtcal techncal data, and the lke. There s no authorty cted, and we know ofnone, suggestng that characterzatons of pror art already before the Examner can ever be "hghly materal." The cases defendants cte (Monsato and Crtkon) nvolved crtcal pror art unavalable to the examner. Defendants cte Cargll, but Cargll holds that "repeated rejectons" on the same "pont of novelty" can make nformaton hghly materal. Cargll, lnc. v. Cambra Foods, Ltd., 476 F.3d 1359; (Fed. Cr. 2007). Here, the Examner had never prevously rejected the '551 on the same pont of novelty. 9 Although later cases menton a "should have known" standard, ths Court's semnal en banc decson n Kngsdown Medcal Consultants', Ltd: v. Hollster nc., 863 F.2d 867, 876 (Fed. Cr. 1988), explctly rejected a "gross neglgence" standard, whch s precsely what the "should have known" standard produces. See Hallburton Co. v. Schlumberger Tech. Corp., 925 F.2d 1435, (Fed. Cr. 1991) ("should have known of the materalty" was mproper gross neglgence standard for nequtable conduct)

28 Nor was there evdence that Pope or Sanghera knew of the materalty of the few sentences at ssue now and gave them the weght and nterpretaton that the dstrct court has now gven them. 1 Pope, for example, testfed that he had read the EPO submssons over a year before hs ntervew wth the examner and the PTO submssons at ssue. (JA2980 at 635:2-14; JA ) He explaned that he rememberedthe brefs as dscussng the types of membranes used, and not "whether or not the use of the membrane was optonal when testng wth blood." _JA2986 at 658:19-659:20). Fnally, "[]ntent to deceve cannot be nferred smply from the decson to wthhold the reference where the reasons gven for the wthholdng are plausble." Dayco Prods., nc. v. Total Contanment, nc., 329 F.3d 1358, 1367 (Fed. Cr. 2003). (See also Openng Br ) As dscussed above, Pope and Sanghera had a more than plausble nterpretaton of the EPO documents even f the dstrct court read the brefs dfferently. (See also JA2982 at 643:19-25; JA3003 at 724:13-16, 725:6-15.) Nether defendants nor the dstrct court pont to anythng that suggests otherwse. They do not dentfy, for example, any nternal nconsstency n Pope a0 BD/Nova alleges that Abbott had a motve for obtanng the '551 patent. (BD/Nova Opp ) Even f true, that provdes no bass to nfer that Pope would have rsked hs entre career for one patent. Nor s there evdence that Sangherg, who was not even an nventor, stood to gan personally for the ssuance of the patent. (JA '

29 and Sanghera's nterpretaton or conflct wth what MedSense was seekng to accomplsh or contradcton n the brefs themselves. 4. There s no evdence that Dr. Sanghera's declaraton was false. Despte admttng that defendants had advanced only one theory of nequtable conduct (Bayer Opp. 42), Bayer argues at one pont that Sanghera's declaraton was knowngly false. (Bayer Opp ) But there s no evdence of that. The declaraton says that (1) n 1983, PHOSTAs "would have felt that an actve electrode.., would requre a protectve membrane" for use n blood; and (2) "[t]herefore," a PHOSTA would not have read the "optonally, but preferably" sentence to teach that a membrane was optonal "or merely preferred" for blood. (JA7637.) The former opnon s entrely consstent Wth the dstrct court's own understandng of the conventonal wsdom at the tme. (Tral Order 14.) The latter s just Sanghera's opnon about how a PHOSTA would read that sentence. There s no evdence Sanghera dd not beleve what he wrote. Bayer ctes testmony from Hggns, but before t started payng hm, Hggns had specfcally revewed Sanghera's declaraton and the patents and concluded that Sanghera's conclusons "are perfectly reasonable. ''11 (JA3760:9-20.) _ Defendants also suggest that Sanghera msled the Examner nto thnkng that he was a PHOSTA n (Bayer Opp. 22; BD/Nova Opp. 9.) But the declaraton clearly lays Out Sanghera's educatonal hstory. JA7636.)

30 5. Dr. Sanghera Was Enttled to Rely on Secton 1.56(d). BD/Nova does not dspute Sanghera's rght to rely on Rule 1.56(d). But Bayer argues, wthout any support, that Rule 1.56(d) should be lmted to people who have "no further nvolvement n the prosecuton." (Bayer Opp. 54.) Rule 1.56(d) does not, however, read "attorney, agent, or nventor or anyone else who partcpates n the prosecuton," whch s how Bayer seeks to have the provson rewrtten. Such a lmtaton would effectvely evscerate Rule 1.56(d) by requrng anyone who partcpates n the prosecuton to second-guess ther counsel's judgments -- on pan of an nequtable conduct rulng. There s no justfcaton for rewrtng and narrowng Rule 1.56(d) n that way. C. '164/'745 nfrngement 1. "Non-flowng manner" cannot exclude convectve moton. t was error to fnd the BD/Nova strp dd not nfrnge the ' 164/'745 patents because t had convectve flow. Defendants do not dspute that convectve flow s present n all lquds. (JA ) Scence has a word for a substance wthout convectve flow: a sold. Defendants have never dsputed ths basc scentfc prncple. nstead, they confuse the ssue by dscussng Brownan moton and dffuson -- but those were not the bass for the dstrct court's summary judgment. The ssue on appeal s whether there was any bass for the dstrct court's

31 constructon of "non-flowng manner" to mean "not movng," and more specfcally to exclude even the convectve moton present n all lquds._2 "Flow," n general and as used n the '164/'745, refers to a specfc type of moton -- the bulk movement of lqud as "n a stream." Merram-Webster's Collegate Dctonary (10th ed. 1999).13 Ths nterpretaton conforms to both basc scence and common sense: fa stream s dammed the lqud stops "flowng" downstream, but t wll always have some nternal moton, ncludng the convectve flow necessarly present n all lquds. The patents themselves use the metaphor of a "stream." (JA col. 11:37-40; JA c01.23:7-10.) The specfcatons speak only of stoppng the "flow" of the "sample stream" or "flud stream," not all moton. (d. (emphass added).) There s no method descrbed n the patent specfcatons to stop all movement wthn the samples, much less to stop convectve moton. n other words, the court's constructon of non-flowng precludes even the embodments descrbed n the patents. 12BD/Nova ponts to the court's denal of summary judgment to Roche on the "non-flowng" lmtaton. (BD/Nova Opp. 53.) But Roche and ts expert had prevously conceded the "non-flowng manner" lmtaton. (JA ) Abbott dstngushed the Roche strps from the BD/Nova strps not based on convectve moton, but because Roche was mproperly relyng on BD/Nova's expert's opnon regardng the BD/Nova strp to overcome that concesson. (JA ) 13 See, e.g., B. V.D. Lcensng Corp. v. Body Acton Desgn, nc., 846 F.2d 727, 728 (Fed. Cr. 1988) ("Courts may take judcal notce of facts of unversal notorety," and "[t]o that end, dctonares.., may be consulted.")

32 l 2. Defendants msrepresent the prosecuton hstory. As defendants mplctly concede (BD/Nova Opp. 13, 49), the Examner's ntervew notes n the parent applcaton provde the only ndcaton of the ratonale for the "non-flowng manner" lmtaton: Takata and Nwa were stll applcable. [Applcants] wll consder ntroducng a lmtaton regardng non-flowthrough measurng. (JA13791 :) Non-flowlng was ntended to mean "not flowng through the chamber durng measurement" because n "flow-through-cell" pror art, a blood sample s measured as t contnuously flows through a small sample chamber. Defendants now argue, for the frst tme on appeal, that the "n0n-flowng" lmtaton was added also to dstngush the "Nakajma" reference. Ths newlyhatched argument has no support n the record. Nakajma requred a large sample sze. Because a small sample sze s a fundamental premse of the '164/'225 clams, the examner proposed to Combne Nakajma wth the flow-cell of"nwa," for ts small chamber sze. (JA13753.) n response, before the "non-flowng" manner lmtaton had even come up, Abbott dstngushed Nakajma because t could not work usng a small sample sze and the Nakajma/Nwa combnaton because nothng taught how to combne the two. (JA ) At no pont dd Abbott dstngush Nakajma based on ts havng sample flow or other movement. (BD/Nova Opp )

33 Defendants make an even more tortured new argument that Abbott ntroduced the "non-flowng" lmtaton to dstngush a supposed "stop-flow-cell" operaton of Nwa, even though Nwa does not operate as a stop-flow-cell. (BD/Nova Opp. 13, ) Rather than evdence, defendants present the followng proposed chan of nferences: Abbott never dsputed the Examner's suggeston that t would be obvous to operate Nwa as a stop-flow-cell; therefore Abbott accepted that Nwa dsclosed a stop-flow-cell; therefore, Abbott added the "non-flowng manner" lmtaton to dstngush Nwa not only as a flow-cell but also -- sub slento -- as a stop-flow-cell. Ths chan breaks down at each lnk. Frst, even f Abbott had not responded to the Examner's suggeston that Nwa could be operated as a stop-flow-cell, that would not have consttuted an acceptance of the Examner's vew. Salazar v. Procter & Gamble, 414 F.3d 1342, 1345 (Fe d. Cr. 2005) (non-response to Examner's statements s not dsavowal of clam scope). Second, Abbott dd dspute the Examner's suggeston n the very next sentence followng the one quoted by BD/Nova: The Examner suggests t would be obvous to operate the Nwa system n a stop-flow method so that coulometry could be performed. Applcants assert nothng n the Nwa publcaton teaches or suggests that a meanngful coulometrc method could be obtaned from,-the system descrbed nor at the volume clamed

34 (JA13254 (emphass added).) The "volume clamed" refers to the sample sze n a stop-flow method beng the actual volume of the sample chamber, whch would not produce suffcent sgnal for the Nwa devce. Thus, there s no evdence that Abbott used "non-flowng manner" to dstngush Nwa as a stop-flow devce. Thrd, the Examner dd not conclude that Nwa dsclosed a stop-flow-cell. He stated n the parent applcaton's Notce of Allowablty that Nwa "s dstngushed from applcant's nstant nventon by dsclosng onlyflow-through embodments." (JA (emphass added).) n sum, wth respect to both Nakajma and Nwa, defendants ask ths Court not only to revew new arguments but also to magne that the "non-flowng manner" lmtaton was added n response to hypothetcal rejectons found nowhere n the actual record. Ths s hghly mproper. See Cords Corp. v. Medtronc Ave, ncl, 511 F.3d 1157, 1177 (Fed. Cr. 2008) (requrng "clear and unmstakable surrenders of subject matter"). D. '745 Antcpaton 1. The '225 does not dsclose a dffusble medator wth the nventon. Defendants argue the '225 patent dscloses the dffusble medator lmtaton, tbr antcpaton purposes, merely by mentonng dffusble medators wthn ts four corners. (BD/Nova Opp ; Bayer Opp. 56.) But to antcpate, the pror art "must not only dsclose all elements of the clam wthn the four

35 , corners of the document, but must also dsclose those elements 'arranged as n the clam.'" NetMoneyNv. VerSgn, nc., 545 F.3d 1359, 1369 (Fed. Cr (emphass added).) t sundsputed that the '225 reference'dscloses no devce wth a dffusble medator arranged as n the '745 clams. To the contrary, n the very language reled upon by defendants, the patent descrbes only embodments that do not use dffusble medators. (JA8787:21-32.) Defendants argue for the absurd poston that, by mentonng dffusble medators to nstruct PHOSTAs not to use them, the patent antcpates an embodment usng dffusble medators. That turns antcpaton on ts head: a reference antcpates what t dscloses, not the opposte of what t dscloses. 2. Dr. Turner's testmony creates a trable ssue of fact. Defendants attempt to re-frame Turner's testmony as descrbng the '225 reference as "dsclosng but teachng away" from dffusble medators. But that s not what he sad. When asked f the patent "teach[es] the use of dffusble medators," he dd not say yes. He testfed nstead that "[t]he ' 164 patent, accordng to my readng, tells you specfcally not to use dffusble medators2' (JA9736:8-16.) Later he explaned, "when you read ths secton of the patent n context, t's clearly tellng me that the nventors want to talk and are talkng about mmoblzed medators and not dffusble medators." (JA9741:20-24 (emphass added).)

36 Lke the dstrct court, defendants try to brng the facts wthn Upsher-Smth Laboratores, nc. v. Pamlab, L.L.C., 412 F.3d 1319 (Fed. Cr. 2005). But n Upsher, the pror art descrbed vtamn supplements wth and wthout antoxdants and, thus, the dsclosure expressly antcpated vtamn supplements "essentally free of antoxdants," even f such were dsparaged. See also Brstol-Myers Squb b Co. v. Ben Venue Labs., nc., 246 F.3d 1368, 1378 (Fed. Cr. 2001) (pror art "performed all the steps of the... clams at ssue," thus dsclosng the nventon); Celertas Techs., Ltd. v. Rockwell lnt'l Corp., 150 F.3d 1354 (Fed. Cr. 1998) (although t dsparaged the nventon, pror art clearly descrbed the nventon n detal). By contrast, here there was no dsclosure -- no embodment or example usng dffusble medators, as Bayer's own expert admtted. 3. Abbott's clam constructon postons were consstent. Defendants clam that Abbott argued durng clam constructon that the '164 patent dsclosed dffusble medators. Not true. At clam constructon, defendants sought to lmt the scope of the term "analyte sensor" to sensors employng mmoblzed medators. (JA ) (mmoblzed medators are a subset of nondffusble medators.) What Abbott successfully argued was that defendants' proposed constructon mproperly lmted the term to a preferred embodment, and would have excluded other analyte sensors explctly dsclosed n the patent whch do not use mmoblzed medators. (JA col. 24:20-35.)

37 Defendants suggest also that the '164/'225 specfcaton must dsclose a dffusble medator f the '164 s beng asserted aganst strps usng dffusble medators. (Bayer Opp. 27; BD/Nova Opp. 22, 58.) But a devce can nfrnge a patent wthout beng dsclosed theren, as often happens wth mprovement patents. "The scope of a patent's clams determnes what nfrnges the patent; t s no measure of what t dscloses." Benno, 768 F.2d at There was a dspute of fact regardng whether the '745 "background sgnal" lmtaton s found n the '225. There s no dspute that the '745 "background sgnal" lmtaton s not explctly dsclosed n the ' Bayer and BD/Nova rely on the report of another party's expert, Dr. Weber, who clamed ths element s nherently dsclosed n the '225. (JA ) But because Abbott's expert Dr. Bard credbly dsputed Dr. Weber's methodology and concluson, there was a trable ssue of materal fact. (JA , JA ) Notably, the dstrct court dened summary judgment of antcpaton for the "Gotoh reference" on ths exact bass: Bard rased suffcent questons regardng Weber's calculatons of the background sgnals. (JA45-46.) There was no reason for a dfferent outcome for the '225 reference. _4Defendants contend that Abbott waved ths ssue below. But Abbott preserved the ssue by rasng t at the summary judgment hearng. (JA at 142:24-145:15.) See, e.g., U.S.v. KtsapPhyscans Serv., 314 F.3d 995,999 (9th Cr. 2002) (argument waved f not presented n brefng or "at the summary judgment hearng")

38 Date: CONCLUSON For the foregong reasons, the judgments on appeal should be reversed. February 9, 2009 Roht K. Sngla _/ Munger, Tolles & Olson, LLP 31

39 CERTFCATE OF SERVCE BY FEDERAL EXPRESS am employed n the County of San Francsco, State of Calforna. am over the age of 18 and not a party to ths acton. My busness address s 560 Msson Street, 27th Floor, San Francsco, Calforna On February 9, 2009, served an orgnal and 12 copes by Federal Express overnght delvery to the Court and two copes by Federal Express overnght delvery to opposng counsel of the followng document, descrbed as: REPLY BREF OF PLANTFF-APPELLANTS ABBOTT LABORATORES AND ABBOTT DABETES CARE, NC. to the address(es) lsted below: Clerk of the Court Unted States Court of Appeals for the Federal Crcut 717 Madson Place, NW Washngton, DC Telephone: (202) Facsmle: (202) Counsel for Bayer Healthcare LLC: Rachel Krevans Jason R. Bartlett Parsa Jorjan Morrson Foerster LLP 425 Market St. San Francsco, CA Telephone: (415) Facsmle: (415) Counsel for Becton, Dcknson and Company, and Nova Bomedcal Corporaton: Bradford J. Badke Ropes & Gray LLP 1211 Avenue of the Amercas New York, NY Telephone: (212) Facsmle: Executed February 9, 2009, at San Francsco, Calforna. Steven Uhrg?