Therasense, Inc. v. Becton, Dickinson and Co.

history. prosecution rely on view, construc majority’s claim my

In that disclaimer artificially eliminates

tion after taken limiting it to actions recognition range

transmitter

device.3 (now

THERASENSE, known as INC. Inc.) Care, and Ab

Abbott Diabetes Laboratories, Plaintiffs-Appel

bott

lants,

BECTON, AND COMPA DICKINSON Corpora

NY, and Biomedical Nova

tion, Defendants-Appellees, LLC,

Bayer Defendant- Healthcare

Appellee. 2008-1511, 2008-1512, 2008-

Nos. 2008-1514, 2008-1595. Appeals, Court of

United States

Federal Circuit.

Jan. 2010. scope anything regarding the rely suggests majority opinion appears to also particular, embodi- the unclaimed "individual features” were retained. claims that print recognition. See finger relating to ment have prosecution history cannot disclaimer Majority Op. that this embod- at 1283. Given claims. been addressed the abandoned abandoned, I not think that iment was do Singla, Munger, K. Tolies & Olson

Rohit CA, LLP, Francisco, argued for of San him on the With plaintiffs-appellants. Rantanen; A. and Donald brief Jason were Ward, Angeles, of Los CA. W. LLP, Badke, Gray& Ropes J. Bradford NY, York, for argued defendants- of New Becton, Company, and appellees Dickinson al. counsel Gabrielle M. Ci- et Of were Sona De. uffreda and Krevans, & Foerster Morrison Rachel CA, LLP, Francisco, argued for of San Bayer Healthcare defendant-appellee R. brief were Jason LLC. her With Jorjani; Kenneth Parisa Bartlett and Casino, M. Amster Joseph P. George York, LLP, of New & Ebenstein Rothstein Overson, Wesley E. body NY. Of counsel drate metabolism which the either LLP, Foerster produce Morrison & San Francis- enough prop- does not or does not co, insulin, CA. erly produced utilize a hormone pancreas. Insulin regulates sug- LINN, DYK, FRIEDMAN, Before by facilitating absorption ar levels Judges. Circuit diabetics, into glucose cells. In this failure body to produce or utilize insulin Opinion the court filed by Circuit causes to build up Judge Opinion DYK. concurring-in-part leading to potentially complica- serious and filed dissenting-in-part by Circuit tions, blindness, comas, as kidney such Judge LINN. disease, damage, cardiovascular and lower- DYK, Judge. Circuit amputations. limb today rely Diabetics on inexpensive glu- and accurate home blood (now Therasense, Inc. Abbott Diabetes meters help manage cose to Inc.) them their Care, ap and Abbott Laboratories condition. peal judgment from a final of the United States District Court for the Northern patents-in-suit claim technology in Following District of a bench California. of disposable glucose area blood test trial, the district determined that strips. single-use strips These work in 5,820,551 claims 1-4 U.S. of Patent No. conjunction glucose meters and em- (“the '551 patent”) were invalid due to ploy electrochemical biosensors to measure obviousness and the entire '551 of glucose sample level in a of was unenforceable due to con inequitable usually single drop. When blood is in- Therasense, Becton, duct. See Inc. v. to a strip, glucose troduced test in the Co., Dickinson F.Supp.2d & 1088 blood reacts with an enzyme present on (“Trial (N.D.Cal.2008) ”). Opinion The dis strip, transferring electrons to the en- trict granted summary judg court also zyme. mediator, A incorporated also noninfringement ment of of all asserted strip, transfers the electrons from the (“the 6,143,164 claims Patent U.S. Nos. enzyme to the sensor’s “active electrode.” (“the patent”) 6,592,745 '164 pat and The electrons then strip flow from the into ent”). Therasense, Becton, See Inc. v. meter, which glucose calculates the Co., Dickinson & F.Supp.2d concentration based on the current flow. (N.D.Cal.2008) (“Summary Judgment Or der”). While common test strips measure Finally, nearly found all (blood in samples levels of whole blood asserted claims of the '745 invalid that contains all of anticipation. components, due to its Id. We affirm. includ- cells),

ing red blood electrochemical sen- sors also capable measuring glucose are BACKGROUND variety in a sample levels types, other I (blood plasma such blood as without red (fluid cells), interstitial fluid between The Centers for Disease Control and cells in the skin organs), and and Prevention buffer estimates that 23.6 million (test solutions solutions that Americans have simulate diabetes. Ctrs. for Dis- blood). They Prevention, ease are capable Control & also of measur- National Dia- Sheet, 2007, (2008). ing betes Fact samples body—such at 5 Diabe- vivo—inside mellitus, tes generally as simply referred to live blood. We below the vari- describe diabetes, carbohy- disorder of patents ous involved here. any infringe of the asserted ucts did

II patents. It also of the '164 or '745 claims Care, Inc., the succes- Diabetes Abbott 21-23, 31, 1-5, 8, and 34 found claims Therasense, subsidiary and Inc. sor anticipated. Summary the '745 Laboratories, the owner Abbott Order, at Judgment F.Supp.2d we will For convenience patents-in-suit. relating '551 patent were Issues “Abbott” re- single designation use the May in a trial from 27- bench considered foregoing. all any fer trial district court June 2008. After Becton, Dickinson Co. March 1-4 of the '551 determined that claims (“BD”) States United sued patent were invalid due obviousness of Massa- for the District District Court unenforcea- that the entire '551 declaratory judgment of seeking a chusetts Trial inequitable ble conduct. due pat- of the '164 and noninfringement 1127.2 The dis- were products involved The two ents. 54(b) judgments, trict court entered Rule Sys- Management BD Diabetes Latitude jurisdiction appeal and have over this we Blood Mon- Logic the BD Glucose tem and 1295(a)(1). § to 28 pursuant U.S.C. BD’s featured products itor. Both strip, Strip. BD Test Two test glucose DISCUSSION later, BD in countersued months Abbott Patent I of the '551 Obviousness alleging District of California the Northern '164, '745, and '551 infringement first address the district court’s We of Mas- The action District patents. patent 1-4 of '551 holding that claims subsequently transferred sachusetts light been would have obvious U.S. District California. to the Northern (“the 4,545,382 patent”) '382 Patent Nos. thereafter, Shortly Abbott also initiated an (“the 4,225,410 patent”). '410 Obvi and Biomedi- infringement against action Nova a of law based on question ousness is (“Nova”), alleging supplier, BD’s Corp. cal questions of fact. Daiichi underlying '164, '745, and infringement of '551 Co., Inc., 501 Apotex, v. F.3d Sankyo Ltd. against asserted in Abbott’s suit patents (Fed.Cir.2007) 1254, (citing Winner 1256 2005, Bayer August In Abbott sued BD.1 202 Royalty Corp. Wang, Int’l (“Bayer”) alleging LLC its Healthcare (Fed.Cir.2000)). 1340, We therefore strips glucose and Autodisc blood Microfill of obvi the ultimate determination review infringed patents. '551 '745 and by a novo and the ousness district de inquiries for clear error. underlying factual consolidated, with All cases were Id. prod- asserting that their the defendants infringe patents Abbott’s ucts did A Membraneless Sensor 3, April On patents were invalid.

that the patent a describe summary judg- The claims the court issued with an electrochemical sensor prod- strip test finding that ment order BD/Nova’s patent, Strip infringe BD did Nova Test Abbott accuses BD and 1. Because products, BD infringement based on the same patent entry of was invalid. After be referred to BD and Nova will hereinafter appealed, judg- judgment, collectively as “BD/Nova.” appeal subject separate is the ment Therasense, Becton, Co., Inc. v. Dickinson & alleging that sued 2. Abbott also BD/Nova - -1035, Nos.2009-1008, -1009, -1010,-1034, Strip infringes Patent U.S. No. BD Test -1037, 2010 WL 254904 5,628,890. subject patent was of a That 25, 2010). (Fed.Cir. jury Jan. separate jury which the found trial any blood without mem '382 disclosed testing whole electrochemical sen- e.3 brane over the electrod Some sensors protective sors in “a which membrane was prior employed art had diffusion- optional in except all cases the case of live limiting membranes to control the flow of blood, in which case protective mem- glucose to the electrode because the slower preferred—but brane not required.” the time could deal with a mediators of Trial Opinion, at 1103. rapid Other art sensors em influx. Whether the disclosed a mem- ployed prevent protective membranes question braneless sensor is a of fact which “fouling”—when red blood cells stick to we review for clear error. See Graham v. the active electrode and interfere with Co., 1, 17, John Deere U.S. S.Ct. electrode, electron transfer to the resulting 684,15 (1966). L.Ed.2d 545 in an inaccurate measurement. addi Initially filed in one of Abbott’s tion, injected body into the human sensors predecessors, patent represented the '382 for in used vivo measurements an early achievement in the field of elec- safety to prevent membranes as measure measuring trochemical sensors for chemistry dissolving from into the levels. The '382 disclosed faster- body fouling particular was a because acting ferrocene chemistry mediator problem respect long-term with in vivo response allowed for better times and implants. quicker test results. The first two named question respect The central to ob- inventors on are also the prior viousness whether art is dis- first patent. two named on the '551 closed a glucose sensor without a mem- outset, important brane for use whole blood. The At district is to after trial the prior found art the scope understand context and of the 3. patent representative. Claim 1 '551 is configured wherein said active is electrode to provides: It exposed be to said sample whole blood with- single disposable strip intervening A use electrode out an membrane or other whole signal circuitry for attachment to the readout filtering by blood member and is formed representative of a to sensor detect a current coating portion a of the first conductor with compound drop a concentration of in a layers enzyme a mixture of or of an which a sample comprising: of whole blood catalyzes a redox with reaction said com- a) elongated support having an a substan- pound in whole blood a and mediator com- flat, surface, planar tially adapted for pound which transfers electrons from said releasable attachment said readout redox reaction to said first conductor to circuitiy; representative create a current of the con- b) extending along a first conductor said compound centration said in said whole comprising surface and a conductive ele- sample; blood and wherein said active elec- ment for connection to said readout cir- portion trode which formed on a of said cuitry; is not conductor in electrical contact with c) strip an active electrode on said in elec- said reference but counterelectrode these trical contact with said first conductor posi- electrodes are so dimensioned and positioned and to contact said whole they simultaneously tioned that can be com- sample; blood pletely by single drop covered a of whole d) extending along second conductor said drop provides blood such an elec- comprising surface a conductive element path sup- trical between these electrodes to circuitry; for connection to out said read port representative said current of the con- and e) compound of said centration said whole a reference counterelectrode electrical sample. blood contact with said second conductor and positioned (emphasis col. 13 1.17 contact said whole blood 1.29-col. 14 added). sample,

1295 art test fluids such as blood after sensors claims In re the body. of its disclosure. have been extracted from part are (Fed.Cir.1985) Benno, 1-17 of the '382 cover both Claims (“[I]t part sensors; ... ‘a claim is is true in vivo and in vitro additional Smolak, ”); re sensors, disclosure’.... limited in vivo claims 18-19 are (1937) 1132, 88 F.2d C.C.P.A. again though those claims do distin- (“[T]he [prior specifica- art] disclosures blood and guish between sensors for other claims, the tions ... include the written fluids. drawings.” (quotation specification, and the Thus, found, district court omitted)); Prince see also Gabrielidis difficulty that mem- position with Abbott’s Inc., 99-1490, 99-1469, Group, Nos.

Sports are required testing branes (Fed.Cir. 1648134, at *7 Nov. 2000 WL covering claims membraneless 2000). the '382 are The claims of do not exclude blood that oth- sensors part without to sensors plainly directed being by fluids described as tested er are membrane, de- as is made clear Most signifi- sensors without membranes. include a specifically claims that pendent cantly, specification addresses blood an feature of the membrane as additional directly, stating that: claim claims a example, device. For Optionally, preferably being when and a utilizing enzyme sensor electrode protective used live mem- an elec- generating mediator for ferrocene enzyme both the brane surrounds level of representative trical current layers, permeable mediator water liquid, sample in a see '382 a substance glucose molecules. 11.52-63, dependent while patent col. face, its specifica col.4 On Id. 11.63-66. “an claim 12 adds outermost appears posi to contradict Abbott’s tion water and permeable membrane testing tion. states when molecules, covering membrane said said (i.e., in body blood—blood in the vivo test upon layer,” enzyme located said ferrocene ing)—a protective preferred. membrane is embodiment de- id. col.ll 11.29-32. One “preferably” implies involves a The use of the term patent scribed in the membrane- fluid, necessary. for interstitial see not testing less sensor that such a membrane is 1.53-eol.41.2, See, Example id. col.3 and e.g., Callaway Co. v. Acushnet Golf strips (Fed.Cir.2009) Co., describes tests on specifically 1346-47 with using a solution both and with- buffer (holding despite stating that that the outer membranes, see col.9 out id. 11.22-30. layers golf “preferably” of a ball were resins, made of ionomer the also the appears not to contest that Abbott of disclosed the use other materials such patent broadly claims membraneless '382 polyurethane); Energy as Halliburton the strips specification and that discloses Servs., LLC, Inc. M-I 514 F.3d contends, strips. such membraneless (Fed.Cir.2008) (“[T]he specification however, in case of that the blood—as clays that ‘preferably’ states none these is opposed to other fluids—a membrane added; strongly suggests that are ab it is required. respect significant In this clays simply preferred is em sence in the of the claims none bodiment.”); Corp. v. Medtronic Cordis distinguishes between blood explicitly (Fed.Cir. AVE, Inc., 1352, 1357 is Also the differ- pertinent other fluids. 2003) (“[U]se ‘preferably’ of the term in in vitro ence vivo sensors and between the language or makes clear that describes In vivo sensors test live blood sensors. embodiment, not the invention body, preferred while in vitro other fluids inside the whole.”). Furthermore, testing escaping when the risk of as a chemicals the sensor sample types—which body, include whole entering other and to eliminate body, as well blood blood outside the as problem fouling occur would fluid, and solu- plasma, interstitial buffer for body sensor remained weeks “option- tions—the membrane is or months. He that with testified vitro al,” that it strongly confirming even more testing a necessary membrane was not required lan- is not for whole blood. The because there was no risk of chemicals thus that a guage of confirms entering body period and the time necessary testing membrane is not when short, testing very involved whole live blood vivo or blood in vitro. particularly respect with to the faster chemistry Abbott, however, claimed in the '382 person contends that a plainly district court found ordinary in the art the Abbott tes- having skill would timony not way. Bayer credible credited specification have read testimony, stating: Abbott asserts that the conventional wis- dom of those skilled in the art was that a Skilled artisans would have known that necessary testing membrane was when deleting the simply membrane would and that skilled would artisans have deleted their mechanical advan- patent’s not have read the disclosure liter- known, tages. They would have howev- ally it said that a when membrane was er,- that electrochemistry would still necessary with blood. They have worked. would have known may degree of fouling well be correct that for would have testing—-where depended long vivo blood sensor how the sensor was implanted body up for year—a exposed They to a to blood. would have might required membrane sometimes be known fouling the risk of would safety for and for accurate measurement have been faster-acting reduced fouling long because the risk of over the chemistry and reduced even more for period time that only once, i.e., disposable opera the sensor must sensors used however, question, te.4 The whether sensors with no accumulation of residue. required membrane was for in vitro test They would known omitting have ing stays of whole blood where the filter would have had the further most, for, on the sensor matter advantage of speeding up the test time Johnson, expert, minutes. Dr. Abbott’s even more. that ordinary testified one of in skill the Opinion, Trial at F.Supp.2d 565 1101. art in thought 1983 would have a that clearly district The court did not err in required

membrane was with with blood crediting Bayer’s expert testimony. patent the '382 because of risk of Abbott also contends that fouling. specifically por- He did not another address tion patent’s specification in of '382 be- differences between vivo and in vitro witness, yond “[ojptionally, testing Bayer’s expert preferably” of blood. but sen- hand, specifically the other tence demonstrates that a addressed membrane is types testing, recognizing required testing both of for when that whole blood. Ab- in testing might particular vivo of a Example blood membrane bott in to points 8 of necessary patient be to safety ensure from Abbott theorizes that the fail- However, 4. "you proba- one of the inventors of the '382 on live blood" meant that would membrane, patents, Higgins, bly and '551 definitely.” Dr. testified need a but not phrase "preferably being even the when used J.A. 3104.

1297 Ina, (Fed.Cir.2003); a 1357 (listing test results for Example 8 ure Techs., Symbol Opticon, a mem- Inc. v. with and without see also buffer solution membrane) Inc., (Fed.Cir.1991); a men- F.2d 1578 with brane and blood Instruments, a testing without mem- 892 F.2d at 1551. whole blood Beckman tion that whole demonstrates somehow brane patent contends that the '382 in We testing required a membrane. blood patent with the '410 not combination could single example A reject argument. enable sensor of the the membraneless membrane does testing with a whole blood oxygen '551 invention because the sensitiv- required. are imply not that membranes ity patent it the '382 renders ineffective fact, from Dr. Tur- testimony was there without a mem- testing when whole blood the buffer Example 8’s tests with ner an Oxygen sensitivity brane. is indicator that the membrane- demonstrated solution oxygen-rich sample of the effect that an have worked with blood less sensor would ability will on the of a sensor to have so, do suggestion a be- provided and reading. accurate provide Example an appar- level of the buffer pH cause example, patent, Roussel, clearly Although erroneous. there was Amgen, v. Hoechst Marion Inc. example whole attempts rely U.S. tained an in which blood was 5. to on Patent Abbott also 4,897,173 ("the including using a a to tested sensor membrane patent”) No. '173 show hardly suggests that univer- a membrane was a patent did not disclose mem- '382 sally required. sensor for whole blood braneless ordinary wisdom of those of skill conventional sensitivity, necessary oxygen a in the art was that membrane The '551 invention's “minimal,” only slightly testing after the as when whole blood even '382 characterized patent col.7 patent better at See '551 11.18-20. patent. fact that the '173 con- 4%. issue, conflicting testimony on the dis- disposable strip-type cartridge electrode Bayer’s properly trict court could credit that attaches readout To- circuitry. Turner, expert, Dr. that Ex- who testified gether, every these disclose element ample 8 of the showed that patent '382 patent’s '551 Ab- strip. test oxygen would be no 5% greater there than argues bott there was no motivation sensitivity when whole testing with blood to these combine references per- because only 5% because buffer test showed sons of skill the art would not have oxygen sensitivity and blood would whole a sensor “combined be- did not necessarily oxygen sensitivity have a lower lieve would work in whole blood with the light than the buffer solution. components produce ‘seemingly other patent district court’s that the '382 inoperative’ strip test testing for whole “very oxygen sensitivity” low exhibits com- Pls.-Appellants’ blood.” Br. 37-38. parable patent, to that of the '551 we Abbott’s characterization of pat- the '382 reject oxygen Abbott’s contention that the sensitivity of a patent does not en- ent’s disclosure membraneless sensor a membraneless sensor. “seemingly inoperative” able simply repeats arguments its related to enablement Abbott if argues also that even the '382 expectation light reasonable of success. In patent disclosed membraneless sensor of our conclusions that the district court whole for the '551 would not clearly did not err in finding that the '382 have been obvious pat- because the '382 patent disclosed a membraneless sensor ent’s disclosure did not provide reason- and that those with ordinary skill in the Here, expectation able of success. Abbott expected art would have such a mem- essentially recycles regard- its contentions work, braneless sensor to we conclude that ing the conventional wisdom those the district court did clearly err in the art concerning skilled the need for a finding that those with ordinary skill would oxygen sensitivity membrane is- have been motivated to sue.7 For the combine reasons discussed above this sen- (the contentions, rejecting disposable those sor in a Abbott’s form contribution claims that expec- patent). there was no reasonable the '410 Dr. Turner testified tation of similarly success fail. the field of early biosensors in the “sophisticated

1980s awas field.” J.A. C Motivation to Combine time, 2523. He also testified that at the

Prior Art References persons ordinary skill in the rec- art ognized advantages to the strip-type The district court found that one skilled format for home testing, which have would in the art “readily thought would have person put motivated a the membrane- combine” the and the '410 strip. less sensor failed patent to create the membraneless sensor present any expert whole evidence to Trial blood of rebut that the '551 expert testimony. Therefore, 565 F.Supp.2d at 1123. While district the '382 clearly discloses a membraneless court did not err in finding that a sensor, the '410 the use of a teaches motivation to combine existed. alleged 7. Abbott also relies patent's on two other dif- nonoxidized electrodes. How- ever, patents: ferences between the '382 and '551 any these distinctions do not relate to (1) the use of printing screen the patent, to make '551 claimed elements the '551 and electrode, (2) and the hardly upon use of oxidized elec- be can relied to show '551 the opposed trodes on the '382 patent’s to the nonobviousness. patent. '551 Abbott’s ex- patent and the Secondary Considerations: D Johnson, that the Exac- pert, Dr. admitted Success Commercial all of limitations of strips tech met the if the that even district Abbott contends Furthermore, patent. claim of the '382 prima facie finding were correct court years product the that the was for fifteen obviousness, finding is over- of case market—during pat- the which the '382 on commercial success. by evidence of come was and in for the entire ent valid force that Abbott court concluded The district the final months— period save for three a sufficient nexus failed to demonstrate the '382 product Abbott marked the with the '551 the claims of between pat- patent, both before and after the '551 product. Exactech of Abbott’s the success such, presump- ent As there is no issued. 1124. F.Supp.2d at Trial product’s tion that the success was due finding clearly is not erroneous. This only patent. to '551 the a finding In of order to overcome presented The defendants uncontrovert- by demonstrating commercial obviousness Exac- demonstrating ed evidence that the success, between commercial “[a] nexus was product’s tech success due to features and the features is re claimed success already prior the present art such as Brown, Tobacco quired.” & Williamson on primary Abbott’s witness Inc., Philip 229 F.3d Corp. v. Morris that the Ex- commercial success conceded (Fed.Cir.2000). asserted com “[T]he product actech was because it successful product of must be due success mercial disposal offered “fast whole blood that invention be the merits the claimed to onto directly put strip, [pro- could be available in the readily what was yond reading, basically and then vided] the v. Atl. J.T. Eaton & Co. Paste strip disposable.” art.” J.A. 2640. [was] (Fed.Cir. Co., addition, presented the defendants numer- & Glue 1997). ous declarations that Abbott had filed during prosecution the PTO argues appeal Abbott district patent describing the of the Exac- success Abbott to show requiring court erred tech all of which attested to the strips, Exac- the commercial success use, product’s training short user “ease attributable the '551 product tech ability consistently obtain period, and and that Abbott was entitled to patent, results,” J.A. and “[t]he accurate test commercial success presumption (allowing a small configuration electrode claimed in the due to the invention size), strips, sample the size the test that “if the patent. Abbott claims stored, they can be the ease with which product embodies claimed marketed of,” J.A. Abbott disposed used and 6985. them, features, and is coextensive with nothing to contradict this evidence offered presumed nexus is burden then a success of and show that commercial party asserting obviousness shifts lack product was due to the Exactech presumed evidence rebut present of a membrane over the sensor Williamson, Brown nexus.” & circumstances, these electrode. Under rejecting Ab- district did not err in contending is incorrect that commercial success bott’s assertion a nexus. presumption supported was entitled nonobviousness. not a situation where success of This is single can to a product be attributed above, no Exactech For stated we find

patent, product because Abbott’s the reasons error with the district court’s conclusion patents: at least two the '382 embodied 1300 1-4 patent Co.,

that claims would Reynolds 1357, R.J. Tobacco 537 F.3d (Fed.Cir.2008). in light have been obvious art. 1365 penalty inequitable for II Inequitable Conduct severe, conduct is as entire is the Prosecution of the rendered unenforceable. Therefore it is '551 Patent important that courts maintain a high trial, Following the bench the district standard. “Just inequitable also held the '551 unenforcea- permit patentee who obtained his ble inequitable conduct based on a through misrepresentations deliberate or failure to disclose statements made to the omissions of material information to en (“EPO”) European Patent Office during patent against others, force the it is also revocation proceeding of the European inequitable to strike down an entire patent counterpart to the '382 Trial patentee where the only committed minor 565 at 1127. missteps or acted with minimal culpability in good faith.” Scientific, Star 537 F.3d “[Unequitable conduct includes at 1366. This is one of those rare cases in affirmative misrepresentation of a material which a finding inequitable conduct fact, failure to disclose material informa appropriate, particularly in light of tion, or submission of false material infor critical nature of the representations to mation, coupled with an intent to deceive.” in securing PTO allowance of the '551 Innogenetics, Labs., v. N.V. 512 patent and the district court’s careful and 1363, (Fed.Cir.2008) F.3d 1378 (quoting thorough findings materiality as to and Pharm., Corp. Inc., Pharmacia v. Par intent. 1369, (Fed.Cir.2005)) F.3d (quotation omitted).

marks “The party in asserting equitable conduct prove must a threshold A Materiality level of materiality and by intent clear and question rules, There is no that the PTO convincing evidence. The court must then 56, in particular require Rule the submis- determine questioned whether the conduct sion any known information that contra- amounts to inequitable conduct balanc dicts information submitted to the PTO: ing the levels materiality intent, Each individual associated with fil- greater “with a showing of one factor al ” ing prosecution of a applica- lowing a lesser showing of the other.’ duty tion has a of candor good faith Control, Digital Inc. v. Charles Mach. in dealing [PTO], with the which in- Works, (Fed.Cir.2006) duty cludes a to disclose to the all [PTO] (quoting Union Pac. Res. Co. v. Chesa information known to that individual to peake Energy Corp., 236 F.3d be patentability.... material to (Fed.Cir.2001)) (citations omitted). (b) section, Under this information is The ultimate finding of inequitable material to patentability when it is not conduct is reviewed under an abuse of cumulative to already information of rec- discretion Kingsdown standard. Med. ord or being made of appli- record Consultants, Inc., Ltd. v. Hollister cation, and (Fed.Cir.1988) (en banc). We review the underlying factual determi

nations of materiality (2) and intent for refutes, clear with, or is inconsistent error, however. Star Scientific, Inc. position applicant takes in:

(i) a unpa- require protective of that did not mem- argument an Opposing [PTO], tentability by or testing relied Pope brane when whole blood. (ii) Asserting patenta- specifically of and the examiner discussed the argument an bility. “[ojptionally, preferably” language Pope’s summary In patent. the '382 own 1.56(a)-(b). § These rules are 37 C.F.R. interview, he stated “pointed that he materiality compo- directly relevant to the that patent] [to [the out '382 inequitable examiner] conduct because “if a nent of or un- designed omission material teaches that active electrodes for misstatement standard, Rule it is the ... material require der protective use whole blood a inequitable purposes conduct].” [for 7644. membrane.” J.A. The examiner Control, 1316; F.3d at see also Digital agreed that if “an produced then Abbott Pharmacia, (affirming at 1373 a showing affidavit evidentiary or other inequitable where a finding pri- conduct at the of the invention a mem- time such by a declarant contradicted his or article [for brane was considered essential whole PTO). The district declaration pat- overcome it] would [the by made Ab- court found statements teaching.” J.A. ent’s] highly the EPO were predecessor to bott’s In with that Dr. agreement, accordance prosecution to the the '551 material Sanghera a declaration to the submitted repre- contradicted because urging PTO language Abbott made to the PTO re- sentations patent concerning membraneless sen- sensor dis- garding membraneless taken sor should not be at face value. in the '382 Trial patent. closed part: stated relevant 1112-13. This erroneous, clearly indeed is clearly not knowledge [B]ased on his historical he is correct. that on filing confiednt date of [sic] application leading earlist to the [sic] 1 PTO Representations present application on 1983 and June led original application The a time for considerable thereafter one in 1984. filed Over skilled art would that an have felt years, pursued next thirteen comprising enzyme active electrode an through half-a-dozen continuation protec- a require and mediator would a rejected applications repeatedly were tive it were be used with membrane if obviousness, anticipation including for Therefore, sample. a he is whole blood repeated rejections over the '382 sure would that one skilled in the art a new argu- Abbott formulated lines 68 to 65 column read J a patentability during for brain- ment J, 5^5,882 No. U.S. Patent to teach storming session attended Lawrence the use membrane with (“Pope”), patent attorney, Pope Abbott’s sample is optionally whole blood Sanghera, and Dr. Abbott’s Director of merely Thereafter, preferred. Development. Research including claims were drafted electro- new added). Pope, in sub- (emphases J.A. 7637 lacking sensors a membrane. chemical affidavit,- mitting represented: further examiner, with the During interview art continued believe [follow- Pope presented the new claims with the ing patent] layer barrier the '882 application argument that claims of sample necessary whole blood anticipated or obvious because were for period .... taught considerable the claims a new sensor argued in the not have Dl. to the the One skilled art would Abbott8 EPO that distinguishable. Dl was Higgins pat- reference On read the disclosure the of 12, 1994, (U.S. January patent Abbott’s Jp,5J¡,5,382) counsel teaching ent as submitted the EPO a brief distinguish- protective use membrane with of reference, ing patent from Dl the '636 the optional. He samples whole blood stating: not, especially would in view the Contrary semipermeable mem- the working examples, “op- have read ” Dl, protective the brane of membrane tionally, preferably language at but optionally glucose utilized with the sen- line 63 a technical [f] column as patent sor suit [sic] teaching patent phrase- but rather mere controlling the permeability of sub- the ology. Decla- supported This is the (as IV.2., strate set forth above in under ration under 37 C.F.R. 1.132 Gordon the membrane of Dl permeability the Sanghera accompanies pres- which the kept for the substrate must be low on a ent amendment. achieve a relationship value to linear the between measures and currency [sic] ... applicants have established the substrate concentration in test that a supported by new claim limitation solution). Rather, with accordance present application provides pat- column lines 30 to patent 33 of the entable distinction over Patent No. U.S. suit: 4,545,382, key pros- reference “Optionally, preferably but be- when present ecution of the application and its blood, ing used on live a protective predecessors. teaching There is no enzyme membrane surrounds both the suggestion unprotected active elec- layers, permeable and the mediator trodes speci- use with whole blood for glucose water molecules.” mens in patent this or the other claim patent See also 10 of the suit art of record in application. granted according to which the sensor added). (emphases Shortly J.A. 7645-46 has an protective electrode outermost thereafter, pat- PTO allowed the '551 (11) permeable membrane water with newly ent claims added for a Finally, molecules. see Exam- membraneless sensor. ple 7 in column lines report- 19 to 26 ing by using such a protective mem- Representations EPO response brane the time did not increase The district court found that Abbott had (without 24 to from 60 sec. mem- directly contradictory representa- made brane) (with membrane). to 36-76 sec. tions to the concerning teaching EPO Accordingly, purpose protec- patent in European Patent EP suit, tive membrane (“the patent”)—a 0 078 counter- preferably to be used with in meas- vivo part virtually to the '382 iden- urements, safety is a measurement specifications—and tical had prevent any particles course com- [sic] contradictory represen- not disclosed those ing during use but not a permeabili- off tations to the ty PTO. control substrate. for added). (emphases J.A. 6530-31 was revoked as obvious. One of the 23, 1995, references the EPO May On Abbott’s coun- relied on was a German reference sel labeled submitted another brief to the EPO time, party operating 8. At this before the Therasense Abbott. We use the term Medisense, EPO predecessor to both “Abbott” to include Medisense. ing the that these position problems and the '636 did the D1 reference regarding testing not exist in vitro of whole blood “[o]ptional- for again discussed necessary and that a membrane was not preferably” language: ly, but testing whole blood vitro. See id. at preferably when be- “Optionally, but findings clearly are These erro- on live ing used neous, manifestly are and indeed correct. enzyme both the membrane surrounds layers, permeable to and the mediator Arguments 3 Abbott’s glucose molecules.” water Abbott that the district court asserts It is submitted that this disclosure is in the it erred statements protective The unequivocally clear. made to the EPO were inconsistent however, optional, membrane is it is PTO It in the statements. contends that live in when used on blood preferred EPO, distinguishing the focus was on the larger prevent order to the constituents semipermeable the membrane of the D1 blood, erythrocytes particular of the in protective, the permeable reference from interfering from with the electrode sen- the '636 is membrane of said, it is that said sor. Furthermore correct that such a made in distinction was not prevent should protective membrane However, EPO the submissions. is penetration, from glucose the molecules only point not the Abbott made in the “permeable” glucose membrane the is distinguish EPO two references. molecules. correctly The district court found that Ab- added). (emphases J.A. 6585 also argued bott before the EPO that the The district court found the EPO protective membrane of the '636 the PTO repre- contradicted statements optional. optional was The nature of the significant ways. in at sentations least two not dis- membrane was irrelevant to the First, that by the district court found de- semipermea- tinction D1 of the reference’s preferably” but scribing “[optionally, ble because the nature optional membrane clear,” language “unequivocally Abbott’s proved of the that it not membrane was representations contradicted Abbott’s D1 type required by EPO membrane reference, PTO that a representations person appears recognize.9 as Abbott ordinary in the art having representation particularly skill would have Abbott’s in In “patent May as mere clear 1995 submission. phrase understood convey labeling “[o]ptionally, preferably” not a clear but phraseology” that did clear,” language “unequivocally See Abbott em- meaning. Trial Second, phasized alleged plain meaning at 1110. district language specification quoted noted that EPO clear- in the documents merely immediately preceding were sentence and rein- ly explained that membranes meaning following forced sen- for live blood. Id. 1109-10. preferred tence, stated, protective reasons it “The specifi- The documents identified where however, optional, pre- blood is it is cally explaining directed toward live membrane necessary, live support- ferred when used on blood order why a membrane was blood, Thus, by showing describing fluid. distinction made before or interstitial that the did not a membrane for and the D1 use the EPO between the '382/'636 reference, brief, reply liquids, proved it at least [Abbott] in its “If some Abbott states glucose-controlling mem- [semipermeable] did use the Dl's that kind membrane needed, (citation Pl.-Appellants' Reply whenever brane.” Br. 13 is needed measured, omitted). liquid—buffer, regardless of the larger prevent constituents of the and other fluids. The three sentences blood, question read: particular erythrocytes from in- terfering with the electrode sensor.” J.A. “Optionally, preferably but when be- ing used on clearly protective 6585. This sentence live di- membrane enzyme surrounds both the permeability. rected to There can be no and the layers, permeable mediator making doubt that Abbott was two asser- water and glucose molecules.” tions in this submission. explained first It is submitted that this disclosure is protective optional membrane is unequivocally clear. preferred when used on live blood and optional, however, membrane is pre- it is language the '382 was “un- ferred when used on live order Then, equivocally point. clear” on this to prevent larger the constituents of the “furthermore,” using the transition it ex- blood, particular in erythrocytes from pressed point its second about permea- interfering with the electrode sensor. bility of the membrane. face, J.A. 6585. On its the description of suggests The dissent a somewhat differ- the membrane’s function was ent theory explain to Abbott’s representa- designed itself why establish the mem- theory tions to the PTO—a signifi- optional brane was with whole blood and cantly by was not addressed Abbott itself. fluids, other preferred but with live blood. theory Abbott’s is that the “unequivocally preferred It was with live blood because it clear” statement of protected against the second fouling. EPO sub- Both with re- spect mission to whole blood permeability was directed to the and live it “unequivocally clear” that membrane glucose. membrane water and As (whole was optional blood and above, other discussed theory ignores this fluids) (live blood). preferred Neces- context of “unequivocally clear” state- sarily, it was “unequivocally clear” that ment and particularly the sentence imme- the membrane was required for either diately following “unequivocally clear” Thus, whole blood or live blood. this is statement, which says nothing about not a situation such as that referred to in permeability. The dissent attempts to fill Scanner Technologies Corp. v. ICOS Vi- gaping hole argument by Abbott’s sion Systems Corp. in which “multiple suggesting that it would be reasonable to reasonable inferences” meaning as to the interpret the sentence following the “un- representations could be drawn from equivocally clear” statement as also direct- the evidence and there “equally existed an ed to functioned, i.e., how the membrane reasonable inference” favorable to Abbott. it was “unequivocally clear” that (Fed.Cir.2008). 1365, See 528 F.3d protected against fouling, rather than that Indeed, argument Abbott oral it was “unequivocally clear” that it was agreed that the EPO statements were a optional. respect, With Abbott’s EPO “recharacterization of the sentence that possibly statements cannot be read in this already before the [PTO] examiner.” manner. Oral Argument at 40:40. Pope in his testi The “unequivocally clear” statement is mony agreed plain English read directly tied optional nature of the ing of what told the EPO was membrane when used with whole blood contrary to what Abbott told the PTO.10To Pope agreed that "as a matter of normal clear” '[ojptionally, statement "refers [the construction," English "unequivocally preferably’ language] and refers to all of (Fed.Cir.2000); deprive examiner the EPO state Akzo N.V. U.S. Int’l (Fed. directly contrary Comm’n, ments—statements Trade 808 F.2d Cir.1986). representations Abbott’s to the PTO—on None of these cases involved were not material grounds contradictory arguments situation which duty to eviscerate the would be disclo made another forum were withheld Moreover, if regarded sure. this could be They speak from the PTO. do not case, not, it is have close which we applicant’s obligation to advise PTO of repeatedly emphasized duty contrary representations made in another requires disclosure the material EPO, forum. Before the Abbott made question be submitted to the examiner statements that represen contradicted the rather than withheld See applicant. regarding tations Abbott made to the PTO Plastics, Eng’g LNP Inc. v. Miller Waste applicant’s the '382 An earlier (Fed.Cir. Mills, Inc., 275 F.3d art, prior statements about especially one’s 2001) (“[W]hen a question materiality is art, own are material to the PTO close, a patent applicant should err on the directly when those statements contradict disclosure.”); LaBounty Mfg., side of Inc. applicant’s position regarding that pri- Comm’n, v. U.S. Int’l Trade or art in the PTO. See 37 C.F.R. (“[A (Fed.Cir.1992) 1076 close makes case] 1.56(b)(2). event, § In any represen necessary it all the more that the [refer merely tations to the PTO were not lawyer should to the ence] [be] disclosed examin argument; they were factual assertions as er. Close cases should be resolved dis art, to the views those skilled in the closure, unilaterally by applicant.”). provided in affidavit form. Abbott nonetheless contends that finding district court’s that the EPO lawyer argument prior about art is not highly statements were material because patentability information material to and they position contradicted the taken before that since both EPO and the PTO the PTO was not clearly erroneous and representations merely argument, were strongly supported by the uncontra- any inconsistency between the two could dicted record. not be material. This court has held that

representations made to the PTO concern B Intent ing the prior content of art “amount[] In attorney determining whether a argument prece mere and our failure dent has made that an to disclose material applicant clear information was inten tional, conduct, interpretation free to advocate its “the involved its viewed evidence, teachings prior light claims and the art.” of all including evidence However, Innogenetics, faith, 512 F.3d at 1379. good indicative of must indicate suffi all of the paten culpability cases Abbott cites involve cient to require simply tees who representations made to intent to deceive.” Kingsdown, 863 F.2d prior the PTO art in about order to secure at 876. Because decep direct evidence of id., available, the allowance patents. rarely of their See tive intent is such intent Lumenis, Inc., Young v. can be inferred from indirect and circum Techs., (Fed.Cir.2007); 1344 Inc. Scientific, stantial evidence. Star Life Labs., Inc., Clontech 1326 F.3d at 1366. Thus, according Pope, it.” J.A. 2990. "if the use of a membrane was ‘[ojptionally, preferably'] language [the optional preferable.” J.A. 2988. alone, definitely stood ... it would indicate judge oppor- had the The district court representa- that Abbott’s concluding In Sanghera—intended tunity Pope’s Dr. and Dr. observe both tives—Pope by -withholding the the PTO testimony during to deceive the bench tri- Sanghera’s documents, court made the district EPO explanations al and found their neither (1) the statements made findings: five fact, nor In the court plausible credible. concerning prior art '382 to the PTO “Attorney explicitly Pope noted that did absolutely critical overcom- were trial prove convincing to be a witness.” rejections of the earlier ing the examiner’s F.Supp.2d at 1113. Trial (2) that the EPO patent; claims of the '551 similarly found Dr. The district court very impor- have been statements would credible, testimony Sanghera’s not to be because contra- tant to an examiner opinion in its that his expressing twice made to the representations dicted unconvincing. See id. at demeanor was (3) PTO; Sanghera and Dr. both Pope (“As witness, a trial it must be said and con- the EPO statements knew of Sanghera impeached that Dr. on sub- (4) PTO; from the sciously withheld them points stantive with his inconsistent Sanghera pro- nor Dr. Pope that neither unconvincing statements and exhibited failing for explanation vided a credible (citation omitted)); demeanor.” id. at 1116 PTO; submit the EPO documents (“His unconvincing trial demeanor has (5) Pope’s Sanghera’s and Dr. determination.”). been a factor withholding the EPO doc- explanations they sug- uments were so incredible amply supported. findings These are gested Opin- intent to deceive. See Trial example attempting One will suffice. ion, at 1113-16. The first merely statements as dismiss EPO undisputed. of these is The second is not cumulative, Pope was confronted with the clearly erroneous as discussed above. The May explain need to 1995 statement Dr. undisputed; Pope third is also “[ojptionally, preferably” but lan- the docu- Sanghera together evaluated Pope guage “unequivocally was clear.” during proceedings ments from the EPO my understanding that “it was at testified prosecution unequivocally the time that what was clear made a conscious decision to withhold membrane, was that that them from the PTO. required by the which was sometimes '636 The district court’s fourth and fifth find permeable glu- was to water and ings regarding intent are based on the contrary to cose.” J.A. 2983. This is district court’s assessment of witness cred May explicit meaning of the 1995 state- “[Djetermination ibility. credibility of the ment, as the district court found. When of the witnesses is within the discretion of Pope the district court asked to further presiding official who heard their testi sentence, “It is submitted that explain demeanor,” mony and saw their Griesse clear,” unequivocally this disclosure is 361, Dep’t Energy, nauer v. Pope responded: (Fed.Cir.1985), judge’s that a such agree I Your Honor that would “virtually credibility determinations are English as a matter of normal construc- unreviewable,” Dep’t Hambsch v. tion, sentence, “it is submitted” re- (Fed.Cir. Treasury, 796 F.2d immediately 1986). fers to what comes before such, may As not reas “[t]his it, to all of but as a sess, and refers incapable and indeed is reassess attorney reading this document and ing, credibility and motive witness issues call, making judgment making I was Eng’g, on review.” LNP 275 F.3d at 1361. opinion language what was as to the my judgment being call on impor- patent. Higgins, was Dr. inventor on conveyed, what information both tant, being the '382 and the position patents, what taken. testified that context, phrase even the “preferably being And in that I didn’t believe that when convey “you used on live meant that trying anything were blood” would membrane, preferably probably lan- need a but not optional about the defi- nitely.” J.A. 3104. He felt that guage. Dr. Sanghera’s declaration statements con- 2990. The district court did not err in J.A. cerning simply whole “wrong.” blood were Pope’s explanation that “trial Sanghera] J.A. 3708. “Had been [Dr. withholding EPO [the submissions] his field, working around in the in the field in plausible not credible” and and he was our specifica- and he had seen specific intent Pope “acted with tion, he, I person believe as a skilled in the PTO,” and the Tri- [the examiner] deceive art, would have concluded that the mem- partic- al may necessary.” brane not be J.A. 3707- ularly Pope’s in view of admission that the OS. English “normal con- EPO statement’s directly repre- contradicted his

struction” Finally, argues Dr. Sangh- on a critical issue. sentations PTO era demonstrated a lack of intent to de- Sanghera too Dr. testified that So he by duty ceive satisfying his to disclose from appropriate considered withhold providing Pope. the EPO documents to See knowledge, the PTO his own reflected 1.56(d) (“Individuals § 37 C.F.R. other submission, “general English EPO than attorney, agent may or inventor representations usage” contradicted the comply by disclosing with this section in- He he had made to the PTO. testified attorney, agent formation to the or inven- “in general English usage, would [he] tor.”). However, the district court was ‘optional’ ‘preferable’ use the terms by submitting correct to note that a decla- required,” something to describe PTO, Sanghera ration to the Dr. was still “any instance dur- and he could not recall obligated deception. to avoid intentional scientific ing the course of career in [his] See Trial at 1115. ‘optional’ terms or [he] use[d] which involving “Cases affidavits declarations something that ‘preferable’ to refer to was higher Innogen- are held to a standard.” required.” Pope, Yet like J.A. 3009. Dr. etics, 512 at This court has Sanghera representations testified that to past expected more of declarants be- confirming language the EPO was fore v. Ferring the PTO. In B.V. Barr could be withheld. “unequivocally clear” Laboratories, Inc., held that we the failure in finding district court not err did possible to disclose biases of the declarants faith. bad constituted a material omission where the The district conclusion of intent declarations were submitted overcome a court’s 1181, prior rejection. the fact that art 437 F.3d support Pope finds also (Fed.Cir.2006). International, Sanghera, on Dr. who was not a Ltd. relied Refac Corp. Development skill the art at Lotus involved simi- person having ordinary lar which provide circumstances in declarations patent, the time of the '382 enablement regarding PTO submitted to establish failed to declaration to the possible disclose biases. 81 F.3d teachings rather than (Fed.Cir.1996). case, appear who patent, the inventors contrary Sanghera’s duty Dr. avoid intentional quite have had a view to Abbott’s by withholding the PTO those sub- before the deceive in his declaration deception erroneous, clearly docu- not PTO, disclosing the EPO missions were merely and duty. not obviate that discretion in Pope did district court did not abuse its ments to unenforceable due holding various straw men up The dissent sets inequitable conduct. to the district court’s irrelevant that are majority’s affir- and the of intent Noninfringement Ill Thus, the dis- intent issue. mance of the '164 and '745 Patents Sanghera Dr. Pope and urges sent 4,388,- Patent No. aware of U.S. were not summary the dis judgment, On art reference al.—a 166 to Suzuki et there was no trict court concluded disadvantages of advantages disclosing BD of material fact as to whether the issue whole sensors with using membraneless pat and '745 Strip infringes Test the '164 Hig- of Dr. were not aware blood—and Strip ents because the BD Test does “[o]p- gins’s contrary interpretation “non-flowing manner” limitation satisfy the language. This is tionally, preferably” present patents. in both Abbott contends court did not base undisputed; the district is based that the district court’s decision the existence of finding on intent on its claim on an erroneous construction. We Nor did the district knowledge. such grant district court’s review both the misrepresented Dr. find that Abbott summary judgment and claim construc its qualifications before the PTO. Sanghera’s Indus., Inc. v. AquaTex tion de novo. point urging is the dissent’s More Solutions, Techniche 479 F.3d Pope’s Sanghera’s and Dr. testimonies (Fed.Cir.2007); Cybor Corp. v. FAS plausible conclusion the EPO reflect (Fed.Cir. Techs., Inc., not material. For the submissions were 1998) (en banc). above, district court reasons described The '164 describes sen- clearly concluding correct in than samples sor for blood smaller one Dr. by Pope offered explanations microliter. The '745 describes Sanghera plausible. were not The dis- samples smaller glucose sensor for blood up sent’s efforts to come with new theories than diffusible employs one microliter (discussed plausibility above connec- A limitation in each of Ab- mediators. materiality) tion with are both unconvinc- in the '164 and '745 bott’s asserted claims Dr. ing point. Pope’s and beside the requires sample that the blood be- patents judged by their Sanghera’s intent must be analyzed strip within the in a ing be held time, asserted beliefs some manner.” Claim 16 of the “non-flowing theory that itself not imputed Abbott does re- representative is appeal. even offer on spect: Accordingly, the district court did not determining A method for a con- 16. Dr. clearly Pope err and analyte glu- of an [such centration Sanghera both intended to deceive the body patient, in a fluid of a com- cose] by withholding PTO the EPO documents. prising steps the of: body of a

creating an unassisted flow patient; fluid from the findings court’s Because the district body the highly transporting portion material the EPO submissions were analyte config- patent and fluid into an sensor prosecution the arranged Dr. ured and to determine Pope Sanghera intended analyte proper of the from that the construction of the concentration “non- fluid; flowing manner” limitation should body be that 500nL or less sample moving not through is the sam- non-flowing holding sample in a ple during chamber measurement. Abbott sample manner within a chamber analogizes to a river or stream that stops sensor; analyte However, flowing when dammed. of the determining the concentration plain meaning of “flow” not is so limited. analyte body in the fluid from the A river may longer dammed or stream no portion body transport- of the fluid did, along path flow the same as it once analyte ed into the sensor. but the water will continue to flow within (emphasis col.25 1.11 1.66-col.26 lake behind the dam—a flow that is added). court construed the The district more than mere convective flow. The “holding sample in a non- claim term sample BD Strip chamber Test is sample manner within the flowing chamber no different. Blood can flow through the analyte sensor” to mean that “the sample chamber or can flow within the moving sample not cham- sample is sample chamber. In either case the blood Summary the measurement.” during ber flowing. is still construe a We “non-flow- Order, at Judgment 854. ing manner” to mean that a sample “is very at a sample “flowing Even a slow moving in sample during chamber “directly plain rate” is at odds with the measurement,” other than motion attribut- ” ordinary meaning ‘non-flowing,’ flow, motion, able to convective Brownian the court stated. Id. other qualities inherent to all liquids. summary judgment, At the dis Under the correct claim construc construction, applied trict court its con tion, summary judgment noninfringe cluding that the limitation is not satisfied ment appropriate. ap was still Abbott on only if present even motion peal does not contend that the BD Test sample convective flow. See id. Strip does evidence flow under the argues expansive such claim construction that we adopted, have reading liquids is unwarranted because all expert and indeed Abbott’s admitted that have at least a minor amount of convective “slight swirling there is a in the chamber.” flow, pointing uncontroverted testi presented J.A. 12258. uncontra BD/Nova mony expert always of its “[t]here BD Strip dicted evidence that Test ... at a minor least amount convection infringe does not Abbott’s '164 and '745 occurring any liquid.” within J.A. 10553. patents because the sample blood flows agree any We Abbott. Here reason strip’s within the measurement zone dur able construction allow for certain must ing the entire Ex period. measurement types of motion that are inherent within pert testimony and numerous video re liquids, including convective flow and cordings samples showed on the Brownian motion.11 BD Strip swirling Test exhibit a motion. reject though Even we the district swirling The evidence also showed that the “non-flowing reading court’s broad of the persists during motion the entire five-sec limitation, reject manner” we also Abbott’s measuring Strip. ond time of the BD Test Therefore, record, summary alternative construction. Abbott contends judg on this noninfringement that “flow” means to move in a stream and ment of of the '164 and Summary Judgment 11. The district court did not decide whether claim construction. Or- der, by F.Supp.2d at Brownian motion would be covered 560 856. to contain a volume of Strip was is sized the BD Test by patents '745 jxL than about 1 no more proper. sample; '745 Patent Claims Anticipation IV (iii) enzyme analyte-responsive an district judgment, summary On and a redox mediator diffusible there was no concluded court also disposed in the measurement anticipation as to the of fact material issue zone; 21-28, 28, 31, 1-5, 8, and 34 of of claims (b) holding sample within the application because PCT the '745 zone in a non-flow- measurement reference”) (“the1 al- WO 98/35225 manner; ing mediators. ready diffusible disclosed (c) Order, generating signal a sensor at the F.Supp.2d Summary Judgment within a meas- working electrode ruling reviews a “This court 875. period greater urement of no than Although novo. an- summary judgment de minutes, wherein a back- ques- § 102 is a about 5 under 35 U.S.C. ticipation fact, summary generated by may ground signal be decided on that is tion of genuine reveals no judgment if the record the redox mediator is no more Bridge fact.” Golden dispute signal generated of material than times a five Inc., Tech., Nokia, 527 F.3d Inc. v. mM oxidation or reduction 5of (Fed.Cir.2008) (citation omitted). glucose-, reference contains the same The '225 (d) determining the concentration of Summary as the '164 disclosure glucose using sig- the sensor Order, F.Supp.2d at Judgment 874. nal. glucose a sensor for blood sam- describes (emphases col.61 11.39-63 add- pri- than one microliter. The ples smaller ed). mary improvement over challenges only appeal, On Abbott and the '164 the '225 reference reference disclosed the whether the '225 of diffusible or leachable mediators the use redox limitation and “diffusible mediator” 1 of the '745

with such sensors. Claim “background signal” limitation. How- patent reads: ever, argue Abbott did not the “back- determining A a con- method ground signal” issue to the district court sample, centration of in a com- opposition summary judgment. its See prising steps of: Order, Summary Judgment (a) contacting sample a with an elec- Therefore, can at 871-72. not do comprising: trochemical sensor has waived the appeal so now issue. (i) pair comprising an electrode Int’l, Fresenius Inc. v. Baxter See USA working and a counter electrode (Fed.Cir.2009) Inc., electrode, working wherein (“If party argument fails to raise electrode and counter electrode court, presents only or before the trial separated by are a closest dis- undeveloped argument to the skeletal range tance of 200 to 1000 court, may argument trial we deem that ixm; ”). appeal.... waived on (ii) positioned a measurement zone Thus, adjacent working only remaining elec- issue is electrode, redox mediator” element. trode and the counter “diffusible concluded that there was wherein the measurement zone The district court present independent fact on is not claim.” genuine issue of material wheth- the no 1303, Phillips Corp., the “diffusi- the '225 reference disclosed AWH er (en banc). (Fed.Cir.2005) Here, of the redox mediator” element '745 1315 ble '225 reference “ac- the dependent only because where the claim adds the knowledge[s] possibility using (non-diffusible) a non-leachable mediator mediator, although leaching diffusing or limitation, of claim principle construc- those that clearly preferred the drafters tion compels the conclusion the '225 Summary Judg- not leach or did diffuse.” reference claims diffusible well as non- Order, at 873. Abbott ment claim diffusible mediators in 127. As dis- argues that court focused on a the district above, cussed the claims here must be However, context. single passage out of part considered of the disclosure. the '225 plain language of reference Moreover, single expert not a in the case diffusible or leachable media- does disclose challenged the fact that '225 reference tors. mediators, disclosed diffusible either ex The '225 reference states: plicitly implicitly. While the witnesses little or no Preferably, leaching there is argued that the '225 reference at least to away from of the redox mediator use, taught away some extent from their into working sample electrode 22 if, anticipatory “[a] reference is no less during period, the measurement which is invention, disclosing after the refer typically less than about 5 minutes. ence then it.... disparages question [T]he preferably, More redox mediators of away’ whether a ‘teaches reference from are bound or oth- present invention inapplicable anticipa invention is the working erwise immobilized on elec- Techs., analysis.” tion Celeritas Ltd. v. prevent leaching trode undesirable 1354, Corp., Rockwell Int’l sample. A mediator into dif- (Fed. Cir.1998). Therefore, there was no releasable) (i.e., fusing or re- leachable fact left jury triable issue of material for a dox mediator is not desirable when the consider on the issue whether the electrodes are working and counter close '225 reference disclosed diffusible media together.... such, summary judgment tors. As on an plain meaning '225 reference at 9. The ticipation proper. of the '745 diffusible media- passage implies though they contemplated, tors are are not CONCLUSION is reinforced preferred. This conclusion reference. the claims of the '225 Claim reasons, For the aforementioned af-we describes a the reference method firm judgment the district court’s calling for a “redox does not mediator.” 1-4 are claims invalid is a specify whether this mediator leacha- due to obviousness and entire is, or a mediator—that ble non-leachable inequitable unenforceable because con- Claim or non-diffusible. diffusible duct. We also affirm district court’s however, method encompasses “[t]he of grant summary judgment of nonin- wherein the redox mediator is claim fringement patents of the '164 and '745 mediator,” i.e., a non- non-leachable redox 1-5, 8, 21-23, 28, invalidity of claims '225 reference at mediator. diffusible patent due and 34 of the '745 to antici- presence dependent of a claim that “[T]he pation. gives rise to a particular adds limitation AFFIRMED question that the limitation presumption withheld informa- tively believed COSTS during prosecution. immaterial tion was costs. No charge will defeat a of explanation an Such “plausible.” if it conduct is inequitable LINN, Judge, concurring-in-part Circuit thus, is not whether it is question, The dissenting-in-part. and that the information is immateri- plausible III of the join Part pleased I am objective asked under the question al—a judgment affirming majority opinion rather, it materiality prong—but whether respectfully I dissent noninfringement, but subjective- that the individuals plausible court’s affirming the district Part II from immate- ly believed that the reference was ruling. regard conduct With inequitable question it-a they at the time withheld rial IV, I in the result I and concur to Parts subjective intent presented under reasoning majority’s with much of prong. of obviousness judgments affirming in turn. questions I address these I separately write anticipation, majori- with the my disagreement express Materiality A. my unnecessary, improp- view ty’s Corp. v. Technologies In Scanner ICOS er, in this case to the claims of reference (Fed. Systems Corp., 528 F.3d 1365 Vision a measure of what the prior art as Cir.2008), we stated: art discloses. proffered to show

Whenever evidence Inequitable I. Conduct materiality susceptible or intent is either inferences, a multiple reasonable dis- attorney arguments involves This case overlooking clearly trict court errs the EPO in the '636 submitted to equally one inference favor of another (the counterpart pat- European in- reasonable inference. All reasonable ent) interpretation, allegedly which over its must be drawn from the evi- ferences with, refute, arguments or are inconsistent dence, judgment and a then rendered to the PTO in the '551 submitted range of the evidence as informed lan- interpretation of the same over inferences. Where the rule reasonable question purposes of ma- guage. breached, may inequitable no conduct argu- teriality here is not whether Abbott’s necessary, for found. The rule is be (i.e., to the PTO were meritorious ments findings inequitable con- without “preferably” that the word '382/'636 duct, punishment of unenforce- actually interpret- have been patent would ability patent, wrong- of the entire could by a skilled artisan to mean “re- ed ly stand. rather, quired”); question is whether (footnote omitted). In that “re- Id. at 1376 anything Abbott’s EPO submissions futes, with,” case, expe- argu- applicant an asked the PTO or is inconsistent its 1.56(b)(2) handling application § of its in view to the PTO. 37 C.F.R. dite the ments (2009). allegedly infringing device on the Even if this information were ma- terial, however, applicant the individuals who owed a market. The told PTO “rigid comparison” it had made a duty produced disclosure to the PTO why application, with the claims of the good explanation faith as to with- device “open display” Far from a and that the device was on held the EPO submissions. intent, The district at a trade show. Id. deceptive mere blanket denial materially these statements explanation specif- includes court found the individuals’ ic, subjec- misleading. It inferred from these state- why they reasons as to detailed actually instance, applicant ments that the had rial. each the district seen when, fact, the accused device the device meaning inferred one from the EPO sub- inspection missions, in a black sealed box and an material, was rendering them when (if not have revealed how the of it would an equally reasonable not more reason- able) meets the limitations of claims. device inference them renders immaterial. Although acknowledged we the dis- The district court found that Abbott’s interpretation language of this trict court’s “submissions made to the EPO were incon- unreasonable,” ultimately was “not we re- sistent with the submissions made to the that, versed, holding equally under an rea- in at important ways.” PTO least two Tri- interpretation, “rigid favorable sonable Opinion, F.Supp.2d First, al at 1109.1 comparison” require physical would not in- words, in the district court’s “The EPO “open and that the device was on spection, was told under the a protective display” sense the black box merely preferred membrane was and not public, located in a as opposed required when dealing with live blood and at private, setting. Id. 1376-77. specifically quoted ‘optionally, but Accordingly, a district court “overlooks” preferably’ sentence in support.” Id. at inference, meaning a favorable within the (emphases 1109-10 in original). Second, Technologies, simply of Scanner when “The EPO was told that the critical sen- ignores possibility it or fails to mention the tence was ‘unequivocally clear’ taught inference, actually of such an but when it skilled artisans that ‘the protective mem- “adopt[s] an inference ... unfavorable optional, brane [was] however it is pre- equally over an reasonable favorable infer- ” blood____’ ferred when used on live Id. rule, Citing ence.” Id. at 1377. this we (alteration at 1110 origi- omission in have that an stated unfavorable inference nal). only “must not be based on sufficient evi- view, In my the district court arrived at light dence and be reasonable in of that findings these two in error. I address evidence, it single but must also be the findings these turn. most reasonable able to be inference from drawn the evidence to meet the clear “merely preferred 1. required” and not convincing Scientific, standard.” Star Co.,

Inc. Reynolds v. R.J. Tobacco clearly The first finding inap- erroneous (Fed.Cir.2008) (emphasis propriately attributes to Abbott state- added) Techs., (citing Scanner at that it ments did not make. Abbott never 1376). said that the membrane “merely pre- ferred” or required” I “not when dealing believe the “rule” of Scanner Technologies has with blood. Such a statement been breached would be devastating by clearly case. The submissions made to Abbott and would be Instead, susceptible multiple the EPO are rea- material. Abbott’s EPO submis- and, depending sonable inferences sions simply quoted “[o]ptionally, drawn, may may inference preferably” be mate- sentence from the '382/'636 only ways 1. These were the two in which EPO "highly submissions would have been examiner, Abbott’s submissions were found to be "in- material” to such an the district consistent” and thus material under 37 C.F.R. finding only court made this to the extent that Thus, 1.56(b)(2). § findings these two "contradictory” the submissions were or in- that must be reviewed for clear Al- error. consistent. Trial though the district court cited the "reasonable examiner” standard and found that Abbott's fouling from protects the electrodes and, closely just-quot- brane tracking found in language, larger stated constituents ed caused to be used with “preferably membrane is itself, re- upon The EPO Board blood.3 “preferred is in measurements” vivo submissions, recognized Abbott’s viewing 6531, 6585. J.A. live blood.” when used on “The Board can much when it held: as very is the same “preferably” The word Appellant by the agree therefore patent. Abbott used in the word '382/'636 exercising meant protective membrane is it “merely preferred,” and cer- never said function, preventing grosser filtering required.” Nor did “not tainly never said reaching from components of blood any synonym might use Abbott ever J.A. 6570-71. Given electrode....” meaning light on have shed some recognized pro- that the the Board itself Instead, patent. in the as used the word important “fil- tective membrane serves very (prefera- same word used the Abbott blood, in it cannot be said tering function” (blood) as very in same context bly) submissions somehow that Abbott’s EPO in the appears the word '382/'636 mem- denigrated protective the role of to the EPO Abbott’s submissions Because when used on blood.4 brane of the very language tracked '382/'636 nothing meaning they add patent, that, important appreciate It is aside beyond what was “preferably” the word “blood,” the sensor recited testing from on the examiner already before '382/ in is also claimed claim of the '636 patent.2 testing on “interstitial fluid.” Intersti- bol- the EPO submissions anything, If larger tial not contain those fluid does refute, ster, argu- Abbott’s rather than fouling constituents cause protective that a mem- ment to the PTO larg- the sensor’s electrodes. Because the ordinary thought persons of brane was are absent in interstitial er constituents required be for use blood. One skill to fluid, protective that a parties agree all explains that the submissions the EPO optional is when the sensor is membrane “prevent protective membrane serves interstitial fluid.5 It is there- used test blood, in of the larger constituents interpret “op- the word fore reasonable to interfering erythrocytes, from particular “[o]ptionally, tionally,” phrase 6585. with the electrode sensor.” J.A. blood,” preferably when used on live as Indeed, very function that makes it is this governing those situations which the membrane: the mem- “protective” it a why says ‘preferably being (Attorney reason when 2. Tr. Jun. See Trial blood,' whereas, used on live when we look Pope testifying that the EPO submissions down to the sentence the EPO submis- already [in be- "redundant of information were sion], why you they give a want the reason quote ap- "[t]hat because fore the examiner” membrane.”). pears precisely patent”), 653 in the '382 use, they ("[T]hey paraphrased quote that they picked up language (Attorney Pope testifying doing, 4. Trial and in so See Tr. was, mind, my simply at the Technical 'preferable.' [EPO] That decision "[t]he .”); Appeals entirely they tracking quote... Board of consistent with because were ("I "prefera- they 'pre- my understanding at the time” that used the word understand they bly” "required”). argumentation because meant ferred' in their simply tracking paraphrasing the were discussing.”). quote that were testifying: (Attorney Pope 5. See Trial Tr. 674 definitely op- protective membrane was "The option depended (Attorney Pope testifying depended—the Tr. 676 tional. See Trial analyzed.”). give any being what was “doesn’t '382/'636 blood, than being something respectively, tested is other district fluid such interstitial fluid.6 negative by extending drew a inference “optionally” govern the word in- both do not submissions to the EPO Abbott’s blood, collectively. terstitial fluid and Abbott nev- interpretation. this contradict way, the district court from inferred all optional that the membrane er said EPO Abbott’s submissions that a mem- time, fluids, in all all condi- or under required brane “not dealing when Rather, the mem- Abbott said that tions. blood”—language with live it- glu- “optionally utilized with brane suit,” self used in its J.A. never submissions. Trial cose sensor in added), (emphasis specifical- Opinion, F.Supp.2d more (emphasis 6530-31 suit,” 1 of the in J.A. ly, “claim original). By adopting in one inference added). (emphasis 1 of Claim (i.e., governs “optionally” both and blood recites, disjunctive, in fluid) the “blood or over an equally interstitial reason- fluid.” No claim is directed to interstitial (i.e., able inference “optionally” favorable alone.7 Abbott’s EPO blood submissions fluid, governs interstitial “preferably” and be consistent interpreted, can therefore blood), governs court, the my district in quoted prefera- “[ojptionally, with the but view, erred. clearly sentence, protective bly” to mean that a blood, “preferably” is used on

membrane “unequivocally 2. clear” blood, “optionally” fluids other than again, such interstitial And the clearly as The second erroneous fluid. in is not defined “preferably” word concerns Abbott’s submission to EPO explained, EPO submissions otherwise that submitted that is this disclosure “[i]t say serves to except membrane is clear.” unequivocally J.A. 6585. The of the “prevent larger constituents district court found this statement to be blood, in- particular erythrocytes, in from argument inconsistent Abbott’s terfering with the electrode sensor”—a “preferably,” PTO that the word in as used support, that tends to rather statement patent’s “[ojptionally, preferably” but refute, argument than Abbott’s sentence, not being colloqui- used in a PTO. J.A. 6585. (to express preference) al sense a mere “patent phraseolo- but rather constituted giving

But instead of Abbott the benefit (to gy” express requirement). Because favorable interpretation, of a reasonable told the that dis- “optionally” “prefer- the words Abbott had EPO “this which clear,”8 ably” unequivocally are directed to interstitial fluid and close is the district testifying: (Attorney Pope Tr. 6. See Trial of whether membraneless sensor could be blood). understanding optional "My was it used in blood.”); any other than fluid Trial (Abbott's Proposed at 1100 paragraph 8. The full EPO submission Finding language 'preferably' No. 90: “the May 1995 reads: dated optional that when means the membrane is It is submitted that this disclosure is un- vivo an in sensor does not contact whole equivocally protective clear. The mem- required but that membrane is however, optional, preferred brane is it is [i.e., the sensor contacts red blood cells when on live prevent when used blood in order to blood.”). erythrocytes] in whole blood, larger par- constituents of testify- erythrocytes (Attorney Pope interfering with 7. See Trial Tr. 661-62 ticular from ing encompassed "the claims sensor the electrode sensor. Furthermore is said, analytes. variety be said membrane that could used on should glucose scope speak prevent claim issue” from th[e] So the didn't molecules being “protective,” the membrane from this submission inferred “to that its membrane serves told the EPO “[option- of the every word that each and larger constituents of the carry prevent must sentence ally, preferably” but in- erythrocytes from particular ordinary meaning. plain its the electrode sensor.” J.A. terfering with in- court’s the district plausible, While in Abbott’s words Second—or that can only inference not the ference is membrane “[furthermore”10—the Abbott’s sub- drawn from reasonably be molecules glucose because “permeable” say any spe- did mission. Abbott mole- prevent it “should not Rather, clear. unequivocally cific word J.A. 6585. penetration.” cules from clear is unambiguously was said be what articulated in Ab- concepts, These two disclosure”—i.e., quoted full sen- “this submission, directly from the flow bott’s which patent, tence from the '382/'636 patent, quoted sentence '382/'636 reads: they appear the same order being when preferably Optionally, It is reasonable to read Ab- sentence. protective a mem- on live used more than argument saying no bott’s enzyme both the brane surrounds clear,” “unambiguously quot- in the what is layers, permeable to water the mediator sentence, is that the membrane serves ed molecules. glucose preventing larger constit- the dual roles of functional sets forth two This sentence interfering with the uents blood from (1) it of the membrane: is characteristics sensor, allowing while also electrode (2) “permeable “protective,” and is molecules to glucose smaller water and glucose molecules.” is these water pass through. Abbott, that functional characteristics two only this imme- The district court believed argument, in its went on describe function, glucose permeability, “un- second was diately calling this disclosure after First, Dl reference necessary distinguish the equivocally regard clear.”9 with Repro- "permeable” considerable trial and error work. penetration, the membrane is glucose molecules. This teaches the ducability is al- [sic] of such membranes that, whereas the semi- skilled artisan ways a factor. critical permeable Dl be con- membrane of must (emphases original). J.A. 6585-86 structed, by crosslinking, example for way that the membrane will in fact such (Attorney Pope testifying 9. See Trial Tr. glucose permeability of the at control the "unequivocally that the clear” statement value, purpose required low the of the the ”; to "the nature the membrane directed patent protective in suit is membrane understanding, my I believed that the "And permeation the of the not to control appears quote entire the EPO [in reason the very reason the sensor molecules. For only the clear disclosure submission] is (and as claimed does not have electrode patent patent or the '636 in the '382 have) semipermeable must not membrane regard protective mem- to the nature of that the in the sense of Dl. The fact same sentence, anoth- brane "There isn’t another (cellulose acetate) may material be used patent in the '636 er clear disclosure semipermeable for the membrane of both protective mem- talks about the nature of Dl and the membrane added)). (emphases brane." patent The decisive in suit is not relevant. (crosslinking) feature is modification (Attorney Pope testifying: 10. See Trial Tr. 658 to an extent so as to control said material disagree that the mere "I would with the fact permeation glucose. of the substrate that it’s of the word 'furthermore' means use semipermeable Finding sat- membranes argument,” "simply be- rather than second isfying requirements page set forth on word.”). ing Dl involves a transitional lines 24 to 56 of is tedious and unnecessary and that Abbott’s be if a diffusion proceeding, controlling in the EPO “plainly to the EPO went be- argument membrane present.” J.A. 6571. point of distinction and submit- yond this words, presence other of a protective ‘unequivocally that it clear’ ted membrane, performs erythro- which at all needed no membrane '382/'636 cyte-filtering function of a diffusion-limit- with blood.” Trial use membrane, ing implies the absence of a F.Supp.2d at 1116. But Abbott never told diffusion-limiting membrane. The EPO the EPO that the “needed '382/'636 agreed Board therefore with Abbott that for use no membrane all with blood.” possess did not a dif- '382/'636 words, court’s Those are district fusion-limiting membrane like the one in Moreover, Abbott’s. the fact reference, the D1 precisely which was optionally can be used '382/'636 point was trying to make. “protective” membrane with or without (i.e., By adopting one inference what is fluids, glucose-containing in some like in- “unambiguously clear” is the meaning of fluid, important terstitial was indeed an word) each individual over an equally rea- ultimately con- point of distinction (i.e., sonable favorable inference what is vinced the EPO Board '382/'636 “unambiguously clear” is the functional a “diffusion-limit- possess did membrane), role of the the district court ing” membrane like that of the D1 refer- view, again, my clearly erred. requires ence.11 The D1 reference a diffu- sion-limiting membrane because its sensor rapid glucose

cannot handle a influx of pores molecules. The of this membrane foregoing The interpretation of the am- enough partially are small reduce the biguous language in Abbott’s EPO submis- glucose complete- flow of molecules and is, view, my sion in at least as reasonable ly larger block the much blood constitu- as the district majority’s. court’s and the ents, erythrocytes. pat- like The '382/'636 This interpretation, favorable unlike the ent, by contrast, problem has no with a contrary interpretation, rely does not on molecules, rapid influx of so it does isolation, individual words or in phrases membrane, not need a diffusion-limiting but properly views them in context: look- only a protective protect membrane to ing surrounding to the text in which those against fouling by larger blood constitu- phrases appear, eye words and with an ents. But the fact that the pat- '382/'636 purpose argu- towards the for which the protective ent even discloses the use of a during ments were submitted prosecution, diffusion-limiting membrane shows that no ultimately and is way consistent with the present membrane was in the '382/'636 arguments the interpreted by were the If it present, were then the diffu- EPO Board. As shown with regard to sion-limiting membrane itself would block each point foregoing substantive in the constituents, larger rendering blood thus materiality analysis, and with all due re- protective entirely membrane redundant spect my colleagues majority, in the unnecessary. this The EPO Board under- interpretation favorable point, stating: stood this exact “Common invented appeal; sense each optional point argued dictates moreover presence protective of a membrane would district court. (“Thus, Pl.-Appellants’ Reply by proved glucose-

11. See Br. it did not use the Dl’s showing membranes.”). did not use controlling '382/'636 fluid, membrane for least some MediSense First, phrase protective Abbott’s mem- majority concludes that “[t]he The read possibly optional” says nothing statements “cannot be brane is of blood. EPO manner,” “unequivocal- moreover, statement, in general this because it is As directly to the ly statement is “tied clear” factually option- correct: the membrane is Maj. nature of the membrane.” optional fluids, fluid, al in certain like interstitial major- proposition, this Op. 1304. For As erythrocytes. which do contain the “three sentences ity focuses on discussed, pro- fact that the previously (1) the question” EPO submission: glu- is optional tective membrane some preferably” sentence “[ojptionally, fluid, cose-containing fluids, like interstitial (2) patent; quoted from '382/'636 shows that the does not '382/'636 para- of a nine-sentence first sentence membrane like possess diffusion-limiting reads, that this “It is submitted graph majority in the D1 the one reference. (3) clear”; and unequivocally disclosure is entirely point. misses this paragraph sentence this the second Second, live blood species is a whole reads, op- “The membrane blood; larger both contain all of the con- however, tional, when used preferred blood, erythrocytes. including stituents larger prevent on live order to Because both live blood contain and whole blood, particular er- constituents erythrocytes, the latter half of the second interfering from with the elec- ythrocytes describing filter- sentence the membrane’s are seven more sen- trode sensor.” There function—i.e., ing prevent “in order in this overlooked paragraph, tences larger partic- constituents of majority, to describ- are dedicated erythrocytes interfering ular from function of ing glucose-permeability equally the electrode sensor”—applies pre- See As supra the membrane. note 8. types majority, both of blood. The howev- discussed, it to read viously is reasonable er, distinguishes blood from live full whole paragraph saying that what is sentence) (first places “op- into the “unambiguously clear” is blood the former protective performs category retaining tional” the latter membrane while filtering erythrocytes the dual functions of “preferred” category. under But (second sentence) allowing in blood while nothing suggests any in this paragraph (third pass through through blood, between live distinction whole and sentences). ninth Moreover, erythrocytes. as both contain majority to the extent relies on reading paragraph Instead for purposes such distinction of material- whole, majority paragraph’s links the fatally ity, it undermines clear”) topic sentence (“unambiguously intent: deceptive Attorney Pope testified only to the first five of the second words (“The that he considered the terms “whole op- sentence is membrane ”). and “live synonymous. blood” blood” to be tional .... The majority then ascribes Trial Tr. 629. The court made no district “optional” the word to whole blood and the finding that did not actual- Attorney Pope “preferred” word It then to live blood. ly possess belief, this this or even concludes—“[njecessarily”—that “the Instead, belief was the dis- was either unreasonable. required membrane not Attorney Pope’s trict court dismissed mis- Maj. Op. whole blood or live blood.” three belief EPO submis- logical steps Each of these is based taken because “th[e] inference, represented and at I believe sions that a membrane step, each majority has blood.” inappropriately merely optional drawn when used with (em- against inference 1114 patentee. 565 Trial 1319 added). lumps LaBounty Mfg., to- disclosure.” Inc. U.S. This statement phases Comm’n, 1066, live and whole blood under F.2d 1076 gether both Int’l Trade (Fed.Cir.1992) added). majority, category. The “optional” (emphasis however, advice, and as- relies on this distinction practitioners take sage should blood “optional” cribes the word whole heart, they may it to so that avoid even “preferred” word to live blood. and the conduct, inequitable much being accused (“[Tjhe op- Maj. membrane Op. found to have committed it. being less fluids) (lohole or other tional adage But a legal rule. We (live added)). blood).” (emphases preferred recognized a stan have never “close case” majority relies on this distinc- Because materiality. majority, dard for The how Attorney purposes materiality, tion for case, ever, that if believes this is such a would honest but mistaken belief Pope’s duty then of disclosure “requires exculpatory additional evidence serve as question the material be submitted prong. the intent under Maj. Op. (emphasis the examiner.” added). that, Third, majority already irre- circuit concludes Our entertains five of whether the membrane was spective materiality. different standards for See Control, whole “preferable” or in either “optional” Inc. Digital v. Charles Mach. “[njecessarily” Works, (Fed.Cir. follows or live 1315-16 for either required 2006). the membrane was “not not think I do that we need a sixth. (emphases or live blood.” whole blood Id.

added). majority It is unclear how the B. Intent question at this arrives conclusion. The “preferably” not what the word here is in “[Ijnequitable requires conduct anything in isolation but means whether withhold, tent to but rather intent to de submissions, quotes EPO which Abbott’s Prods., Dayco ceive.” Inc. v. Total Con very language and tracks '382/ Inc., (Fed. tainment, 329 F.3d argument contradicts Abbott’s patent, Cir.2003). requisite level of intent is again, And never told to the PTO. “specific simple negligence, intent”—not “not re- the EPO membrane is Scientific, gross negligence. even Star blood; any for use in it use quired” nor did 1368; Kingsdown Con 537 F.3d at Med. “preferred.” for the word Be- synonym sultants, Inc., Ltd. v. Hollister explain cause the EPO submissions (Fed. Cir.1988) (en banc) (holding protect serves to the sensor the membrane negligence prove gross even insufficient to erythrocytes from found in whole deceive). by intent As recognized rather these submissions tend to bolster circuit, Supreme virtually every Court and arguments than refute Abbott’s “specific subjective denotes a rath intent” PTO. objective generally er than standard and is deliberately point A deserves comment. associated with actions final brief familiar majority adage consciously invokes the taken to achieve a res specific “[cjlose by cases should resolved ult.12 be 680, 686, Puckett, States, (10th Cir.2006); v. 1234 United States v. United 322 U.S. Hartzel 1233, (1944); 589, (7th Cir.2005); 88 L.Ed. 1534 United 64 S.Ct. United 405 F.3d 596 Inc., Philip v. Morris USA 566 F.3d States (2d 383, George, F.3d Cir. States v. 386 390 1095, (D.C.Cir.2009); Attorney Pierre v. 1118 Leon, 90, 2004); v. United States De 270 F.3d 180, Cir.2008); Gen., (3d United 528 F.3d 189 Cir.2001); (1st United 92 States v. Gracidas- 613, (5th Nguyen, Cir. v. 493 F.3d 624 States 1188, (9th Cir.2000). Ulibarry, 231 F.3d 1196 Zunie, 2007); United States v. 444 F.3d standard, subjective in manner contrary this EPO submissions a Consistent with “[ijntent But, Suzuki, prior cannot be inferred sim- all to deceive Suzuki. unlike art of to withhold the refer- ply prior Attorney from the decision record and all art of which given ence the reasons for the with- where Pope Sanghera Dr. were aware uni- Dayco, plausible.” are 329 F.3d holding formly showed that “those skilled in the added). at “reason” (emphases One typically employed art membrane on may legitimately that a reference be with- or whole sensor used with live blood.” Id. did “applicant held is that the not know entirely plausible at 1099. It is therefore materiality.” Corp. its FMC Manitowoc Attorney Sanghera and Dr. Pope sub- (Fed.Cir.1987) Co., F.2d jectively EPO believed that the discussion added). (emphasis It is this lack knowl- of the like all patent—just other '382/'636 edge, subjective belief that or one’s prior information known to not them—did immaterial, that a court reference was contradict the use of membranes for test- plausible implau- must assess as either ing on whole blood. Thus, purposes specific sible intent. for Attorney Nor did or Dr. Pope Sanghera assessing when for applicant’s reason any have knowledge that one of the inven- withholding a reference or she he tors, Dr. Higgins, contrary held a view of immaterial, the question believed was “[ojptionally, preferably” language. but not, that the plausible “Is it reference is Attorney Pope original did draft question belongs That under immaterial?” specification, and the two did not discuss the objective materiality prong, to be eval- language Higgins this with Dr. when uated the evidence as “on informed argument submitted their to the PTO. As range of reasonable inferences” both for clear, duty have we made “no inquire Techs., materiality. and against Scanner arises on notice Rather, unless counsel is at 1376. question relevant, likelihood is, specific, purposes intent material specific plausi- “Is it ble information exists and should be dis- applicant subjectively believed I, Brasseler, that the reference was immaterial?” This closed.” U.S.A. L.P. v. inquiry properly appli- Stryker focuses what the Corp., Sales added). (Fed.Cir.2001) cant believed to be knew or true about the (emphases “The at time that he or reference she decid- possibility mere that material information toed it. withhold may give exist will not suffice rise to a duty inquire.” Id. at 1382 (emphasis case, significant it is that Attor- added). Here, show, the record does not ney Pope Sanghera and Dr. were and no party argued, Attorney has aware what the district court called the notice, Pope Sanghera Dr. were on “one exception” Pat- art—U.S. withholding, the time of the of the likeli- (“Suzuki”)—of 4,388,166 ent No. mem- hood that Dr. Higgins held different view used on braneless sensor whole blood. of the “[ojptionally, preferably” lan- Trial Opinion, 565 at 1099 & n. guage. contrary, appears it 6, To the that they If had 1106 n. 12. known of Su- zuki, Higgins opinion Dr. formulated his of this significantly it have would undercut particular language for the first their to the PTO time argument persons that personal present litigation. Higgins’s Dr. ordinary skill believed membranes opinion entirely were for use on therefore irrelevant to required whole blood. Moreover, Suzuki, they Attorney Pope if had known what and Dr. Sanghera would it far more subjectively have made difficult for at the time of the believed they them explain why to interpreted withholding. (2) Sangh- gins’s contrary interpretation, any dispute

Nor is there Dr. qualified to submit an perfectly finding era was district court did not base its to the PTO as to the expert declaration knowledge, intent on the existence of such (3) meaning “[ojptionally, prefera- Sangh that it did not find that Dr. found, As the district court bly” language. unqualified misrepresented era or his ordinary in the art would person “a skill Maj. Op. calling credentials. 1308. While degree postgradu- had a doctoral or have “irrelevant,” ma these facts id. working toward a Ph.D” experience ate jority support” nevertheless “finds for the have had some level of and “would also district court’s of intent based on constructing in electro- experience actually facts, very namely, “Pope these relied at least fa- chemical sensors or would be on Dr. Sanghera, person who was not a Opinion, miliar with them.” Trial having ordinary skill the art at the time Sanghera n. Dr. had F.Supp.2d at 1100 8. ... patent, rather than the a Ph.D in Electrochemical Bio- earned patent, appear inventors of the who had worked in the research sensors and quite have had a contrary view to Ab for ten development of biosensors over bott’s,” Indeed, id. 1307. far from being years by the time he submitted his decla- “irrelevant,” any tending facts to show ration to the PTO 1997. J.A. 7636. Attorney Pope Sanghera what and Dr. did Although possess qualifi- he did not these during prosecution did not know are (the invention date of the cations critical to discerning their intent and the disqualify fact not patent), this would plausibility explanation. of their All avail giving competent opinion him from regarding able evidence an individual’s hypothetical person 1995 as to what a state, particularly mental “pointfing] facts ordinary skill would have known deceive,” away from an intent to must be Hauser, See Endress + Inc. v. Hawk weighed assessing culpable when intent. Ltd., 122 Sys. Pty. Measurement Polymer Corp. Akron Container v. Exxel (Fed.Cir.1997) (stating the Container, (Fed. Inc., ordinary skill in the art” in “person of Cir.1998) (stating “requisite weight § 103 is a “theoretical construct ... and is ... given” must be to evidence of good descriptive particular of some individu- faith). The fact these individuals al”). declaration, Sanghera his Dr. ful- any were unaware of information that ly qualifications disclosed his em- his argument would their contradict ployment assignee, with the Medisense PTO, despite having performed prior art (now Abbott). J.A. 7636. He also testi- (a search search that had no obli thoroughly fied that he had searched the gation perform) specific for the purpose art any might information that ensuring validity argument, of their contradict Trial his declaration. Tr. 709- good is evidence of faith. But the district 10. There is no much suggestion, any less expressly “found evidence of no[J” court, finding by the district that Dr. good any “possible faith and dismissed in Sanghera actually perform did not good ferences of faith.” Trial search or that it in good made F.Supp.2d. necessarily at 1114. faith. gave weight any no favorable inference. regard major- With foregoing, (1) ity correctly acknowledges: rejected Attorney that it The district court good Dr. “undisputed” Attorney Pope’s Sanghera’s Dr. faith ex- Pope and Sanghera planations plausible” as “not and “uncon- were unaware of the existence of Hig- vincing.” or Dr. deference either the Suzuki reference While considerable 1322 told examiner that such feature “must be credibility a trial court’s determi-

owed to nations, added)). view, this does not mean that a trial (emphasis used” his application can “cloak the of an erro- earlier EPO submissions did not contra legal guise neous standard of argument regarding dict his to the PTO determination, thereby credibility “preferably,” of meaning the word be review.” Andreu appellate shield it from cause those submissions themselves ex Sec’y Dep’t Health & Human v. (i.e., why a plain “preferred” membrane is (Fed.Cir.2009). Servs., 1367, 569 F.3d “required”) prevent in whole “to blood: Indeed, examination, closer becomes larger constituents of the apparent simply that the district court dis- particular erythrocytes interfering from Attorney and Dr. agreed Pope’s with with the electrode Trial Tr. 676- sensor.” interpretation of the EPO sub- Sanghera’s 23, May 1995 EPO submis (quoting opinion re- The district court’s missions. sion). Thus, Attorney Pope believed that “unconvincing” to proved flects that what the EPO submissions were not material not the truthfulness of the court was because were both cumulative of the beliefs, subjective rather the witnesses’ but patent and not inconsistent with '382/'636 notion that the submissions were not in the PTO submissions. fact material. Attorney Pope testified that he believed explanation conclusory. This is not the EPO submissions be cumulative of specific relies on statements and informa- because those sub references, '382/'636 it specifically tion quoted very missions and tracked the provides that this why, was the reason “[ojptionally, preferably” same lan time, the information was not disclosed guage patent, and that the '382/'636 to the an explanation PTO. Such is a far “preferably,” word read context of the cry from a “mere denial of intent to mis- patent, entire meant '382/'636 (which every lead would defeat effort to required membrane was conduct).” inequitable establish FMC 640-41, 643, whole blood. Trial Tr. 645- Corp., Compare F.2d at 1416. Prax- thirty over patent attorney 47. As a air, ATMI, Inc., 1306, Inc. v. 543 F.3d years Attorney professional experience, (Fed.Cir.2008) (affirming 1317-18 that, Pope testified when drafting and deceptive attorney’s expla- intent where prosecuting applications, practitioners of that, “suggest nation failed to at the time “preferred” ten use the word rather than prosecution patent, he “required” in order to avoid a disclaimer believed that disclosure of the RFO art scope. (testifying of claim Trial Tr. 632 cumulative; would have been he also does uust,’ specification says ‘y° that “[i]f the actually alleged state cumula- you’ve precluded yourself then now from tiveness was the reason he failed to dis- See, claiming broadly”). e.g., ever more PTO; art RFO devices to the prior close Composites, v. Corp. Andersen Fiber identify any specific and he was unable to (Fed.Cir.2007) LLC, 474 F.3d the RFOs cumula- rendered (construing product product-by- claim as reference added)), with In re Hari- (emphases tive” process specification claim because the (Fed.Cir.1988) ta, 806-07 “language requirement, pref used ” deceptive intent (reversing finding added)); (emphases erence Chimie Japanese patent agent explained Indus., Inc., where PPG (Fed.Cir.2005) time, believed, that he at the there was no (construing claim to re quire duty art dis- applicant unrecited feature where disclose PTO in in fact filing, practice after as was the for use blood”—a that Abbott sor[ ] covered fiercely disputes. Pl.-Appellant See Br. of Japan). Moreover, product 14-15. it relates to a “Intent to deceive should be determined specifically that is not claimed in the '382 patent practice, the realities of light in of (claiming cl.l See '382 “[a] liability what- and not as a matter of strict in liquid sensor electrode for use mix- the nature of the action before ever components specifically ture ”—not Telecom, Datapoint N. Inc. v. PTO.” added)). (emphasis The district (Fed.Cir.1990). 931, 939 Corp., 908 F.2d concluded, events, “At all ... Here, disagreement trial court’s ‘preferred’ fact remains that does not subjec- Attorney Pope centered not on his ‘required,’ point mean which was a made in understanding of the facts but rather tive appeal.” Opinion, EPO Trial the court’s normative view of the law. F.Supp.2d. at 1114. cir- This statement is First, dismissing explanation in his cular, again and it shows the district “preferably” in the context of the word Attorney court anchored its assessment “required,” means the dis- '382/'636 Pope’s subjective beliefs to the pre- court’s stated, supposed are trict court “Words finding objective materiality.13 vious Otherwise, they say. pat- our mean what system collapse.” majority deny does not ent-disclosure would F.Supp.2d. good at 1114. district court found the individuals’ Opinion, Trial long recognized “paten- explanations plausible” have faith “not and “not But we idiosyncratical- light prior finding use terms credible” of its frequently tees Moreover, ordinary objective materiality. skill the ma- ly,” why persons which is jority rejects good expla- must look to the full context which itself these faith Phillips Corp., very “plain term is used. 415 nations based on the same AWH banc). (Fed.Cir.2005) (en English” rationale on which it affirms the materiality finding. Compare Maj. court’s second reason for dis- Op. The district missing Attorney Pope’s explanation (affirming materiality 1304-05 based on that, words), “plain English reading” of the covered of isolated “since the claims (rejecting good as with id. 1306-07 faith ex- membraneless sensors used specification planation it contradicts “normal agree, both sides must because words).14 English” support meaning have been sufficient to the mem- of isolated Respectfully, sensors.” Trial this rationale misses the braneless original). point F.Supp.2d. (emphases question at 1114 as it relates to the of intent. reasoning presup- Attorney Pope I find this flawed. testified that he read the of the poses specification “[ojptionally, preferably” language, but isolation, “in patent enabled such “membraneless sen- the context of the Praxair, majority riality. (per- 13. The states that the district court See 543 F.3d at 1313-14 explanations “so in- found the individuals' mitting deceptive an inference of intent to be they suggested intent to de- credible (1) highly drawn “when material information Maj. Op. ceive.” 1306. A review of the dis- withheld; (2) applicant ‘the knew of the opinion finding. trict court’s reveals no such information ... knew or should have [and] information; materiality known of the By assessing “plausibility" or “credi- (3) applicant provided has not a credi- explana- bility” good faith of an individual's ” withholding.’ (quot- explanation ble for the light objectively tion in defined materi- Labs., Inc., ing Ferring B.V. v. Barr information, ality majority of the withheld (Fed.Cir.2006) has, not, (emphases add- wittingly either tied all three of ed))). Ferring of mate- factors to document,” nev- and that he “would entire something drawn attempt to understand

er I am left a definite and Because with standing alone.” Trial out of a document firm that a mistake has been conviction actually read Attorney Pope Tr. That respect materiality to both committed context, rather than iso- these words intent, I would reverse the district lation, disputed. not been The isolated has inequitable ruling. conduct court’s words, meaning of those “plain English” Invalidity II.

therefore, bearing plausi- little on the has agree majority prior I with the that the bility subjective regarding his of his belief patent art '382 the claims of the renders understanding of the EPO submissions. (Part I patent majority obvious view, Attorney Pope and Dr. my In art opinion) prior explanations faith are Sanghera’s good anticipates the claims of the '745 with the alternative entirely consistent (Part majority opinion). The de- IV interpretation of the EPO sub- reasonable portions prior patents of the art scriptive immaterial. missions that renders them alone sufficient to invalidate the are Indeed, by myriad demonstrated unnecessary, claims-in-suit. It is therefore record, footnote citations to the trial su- case, improper and I believe in this to look interpre- alternative reasonable pra, prior patents to the claims of the art as a tation is the one that the individuals’ art for prior measure of what the discloses presented to the district court. themselves purposes anticipation. of obviousness and Benno, Coupled with the fact that these individu- See re (Fed.Cir.1985) (“The (or scope patent’s of a als were unaware of the Suzuki infringes pat- claims determines what contrary any teachings), expla- other their ent; what it is no measure of dis- certainly plausible. nations are

closes.”). Here, although the claims of the repeating “plausi- It bears that what is patents art '382 and '225 are broad here, intent, purposes specific ble” enough to cover membraneless sensor subjectively the individuals believed mediator, respec- and a diffusible redox information was immate- withheld tively, specifically those structures are not rial when withheld it. This answers a instead are dis- recited claims but district question different than the one the descriptive portions closed in the of the ask, appeared which was whether specification. information plausible it is the withheld majority quotes Benno as follows: ap- in fact test more was not material—a ... part is true that ‘a claim is “[I]t objective under the propriately considered Maj. Op. disclosure’....” 1295. But the materiality extent that the prong. To the quotation internal is attributed PTO plausibility district court assessed the and overlooks the more relevant Solicitor subjective the individuals’ beliefs based on immediately statements made the court objective of those reasonableness be- full quota- before and after it. The court’s liefs, required or otherwise their mistake tion reads: to be reasonable order to defeat find- Morse, F.B. the inventor of the Samuel intent, ing specific it did so violation thereon, telegraph, had a issued (which Kingsdown, (holding 863 F.2d at 876 a claim containing invalid) gross negligence prove insufficient to held which was Supreme even Court deceive). enough to read on the modern intent to broad Smolak, 1132, 838, reasoning, re C.C.P.A. By the board’s Telex. (1937), appropriate it was to look therefore telegraph Morse’s of a for a Telex obvious. the claims reference made the would have “press disclosure of a molded” limitation patent’s of a claims deter- scope because, ‘press ap- it is no words molded’ infringes patent; “[t]he mines what pear only A in the claims of the reference.” it discloses. measure of what describes, Sports Group, v. Prince that which it Gabrielidis only discloses (Fed.Cir. terms, Inc., at *7 general or in WL specifically whether 2000) (non capa- precedential), to one Nov. we held convey intelligence as to so true, that certain elements were not disclosed understanding. While is ble of anywhere patent, in the reference either in suggested argu- at oral as the Solicitor ment, part speci- “a claim is of the disclo- the claims or the remainder of the fication, sure,” significance princi- and therefore affirmed the denial point summary judgment anticipation. pally the situation where a claim application as contains filed Thus, I agree majority’s while with the something specifically which discloses conclusion on obviousness and anticipation descriptive part in the disclosed reasoning much of the I with Parts (claims specification being technical- opinion, part company of the I IV ly part “specification,” of the 35 USC my colleagues unnecessary, their and in par.), applicant 2d which case the my improper, view reference to the claims be- may specification amend the without art prior patents. of the matter,” adding “new ing charged with §of But that meaning within the here. claim

is not the situation Danti’s any structure addi-

1 does not disclose specification to what the Danti

tional

discloses.

Benno, added; (emphases 768 F.2d at 1346 (now THERASENSE, known as INC. omitted). The court

internal citations Inc.) Care, Abbott Diabetes and Ab rejections on to the Board’s went reverse Laboratories, Plaintiffs-Appel bott art Danti prior over the lants, Here, the '382 and '225 the claims of

patents specifically do not disclose a redox

membraneless sensor or diffusible BECTON, AND DICKINSON COMPA mediator; those structures are instead NY, Corpora and Nova Biomedical descriptive parts disclosed in the tion, Appellants. Defendants-Cross also unclear whether specifications. 2009-1008, 2009-1009, 2009- Nos. majority relies the claims on which 1010, 2009-1034, 2009-1035, in the originally present applications were 2009-1036, 2009-1037. patents and '225 resulted during pros- added or whether were Appeals, United States Court ecution, may prior affect their art which Federal Circuit. date. 25, 2010. Jan. majority to The other cases cited justify its reference to the claims of the In In patents point. art are not on '382 for notes deliberately example in this ently chosen measuring oxy- tests levels an The district pH to match the blood. gen-saturated buffer solution returned “Example found that 8 in correctly court reading produced oxy- 95% that consistent with the patent [is] the '382 gen-depleted patent buffer. '382 col.9 meaning ‘[o]ptionally, [the plain patent displayed 11.19-21.The '382 thus Opinion, Trial preferably’] sentence.” 5% Both sides’ oxygen sensitivity. experts 1100. court thus did not F.Supp.2d at The agreed oxygen sensitivity that a 5% finding clearly err in that the '382 dispute The between Abbott’s tolerable.6 for whole disclosed a membraneless sensor expert experts wheth- defense testing.5 testing er with whole blood would lead to oxygen sensitivity of than greater 5%. B Enablement and Reasonable Expectation of Success explicit The court no find- district made ing the '382 would have en- ap In order render claimed art having ordinary abled one skill obvious, the cited paratus prior or method and use a sensor. make membraneless must one art as whole enable skilled find, however, district did apparatus art to make use “very Instruments, oxygen low exhibits method. Beckman Inc. AB, comparable sensitivity” disclosed LKB Produkter (Fed.Cir.1989). patent, therefore the '382 prior An individual art hand, any reference, other “need be would have issues on the enabled; art, oxygen sensitivity. regard as a See Trial qualifies less, is not therein.” This whatever disclosed

Case Details

Case Name: Therasense, Inc. v. Becton, Dickinson and Co.

Court Name: Court of Appeals for the Federal Circuit

Date Published: Jan 25, 2010

Citation: 593 F.3d 1289

Docket Number: 2008-1511, 2008-1512, 2008-1513, 2008-1514, 2008-1595

Court Abbreviation: Fed. Cir.