month at last the federalcircuit...an audience including cereal chemists and took no measures to...

Last month at

EDITED BY VINCE KOVALICK

This publication brings you a synopsis of patent cases decided last month by the United States Court of Appeals for the Federal Circuit based on slip opinions received from the court. You can review anddownload the full text of each opinion by visiting our website at www.finnegan.com

POSTER PRESENTATION CONSTITUTES A“PRINTED PUBLICATION”Distribution and indexing are not the only fac-tors to consider for printed publication; the keyinquiry is whether the reference has been made publicly accessible. In re Klopfenstein,No. 03-1583 (Fed. Cir. Aug. 18, 2004) . . . .1

“DYING” PLANT APPLICATIONS RESUSCITATEDNonenabling publication disclosing a plantvariety plus foreign sales of the plant creates abar under 35 U.S.C. § 102(b). In re Elsner, No. 03-1569 (Fed. Cir. Aug. 16, 2004) . . . .1

COURT REINSTATES JURY VERDICTOF VALIDITY, MODIFIES CLAIM CONSTRUCTION, AND REMANDS FOR NEW TRIALRecognition of a need does not render obvious the achievement that meets that need. Cardiac Pacemakers, Inc. v. St. Jude Med. Inc., No. 02-1532 (Fed. Cir. Aug. 31,2004) . . . . . . . . . . . . . . . . . . . . . . . . . . . .3

ELEVENTH AMENDMENT BARS CLAIM AGAINST STATE TO CORRECT INVENTORSHIPState University’s entrance into commercialarrangements and application for patent doesnot waive state’s Eleventh Amendment immu-nity from federal suit for correction of inventor-ship. Xechem Int’l, Inc. v. Univ. of Tex., No. 03-1406 (Fed. Cir. Aug. 31, 2004) . . . .4

PARTIAL PROTEIN SEQUENCE DOES NOT PROVIDE SUFFICIENT WRITTENDESCRIPTIONAppellants provided no evidence that the fullamino acid sequence of a protein can bededuced from a partial sequence and the limit-ed additional physical characteristics that theyidentified. In re Wallach, No. 03-1327 (Fed. Cir. Aug. 11, 2004) . . . . . . . . . . . . . .5

HAIRBRUSH PRIOR ART INCLUDES TOOTHBRUSHESCommon sense must be considered in deter-mining what prior art may be “analogous.” In re Bigio, No. 03-1358 (Fed. Cir. Aug. 24,2004) . . . . . . . . . . . . . . . . . . . . . . . . . . . .6

CLAIM BROADER THAN PREFERRED EMBODIMENTApplicant’s choice to disclose only a singleembodiment does not mean that the patentclearly and unambiguously disavowed otherembodiments. Home Diagnostics, Inc. v.LifeScan, Inc., No. 03-1370 (Fed. Cir. Aug. 31, 2004) . . . . . . . . . . . . . . . . . . . . . .7

“OPERATIVELY CONNECTED” CONSTRUEDTOO NARROWLYContrasting nature of the axioms that (a) aclaim must be read in view of the specificationand (b) a court may not read a limitation into aclaim from the specification presents the long-standing difficulty in claim construction.Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., No. 04-1097 (Fed. Cir. Aug. 11, 2004) . . . . . . . . . . . . . . . . . . . . . .8

GENERAL AND CONCLUSORY TESTIMONYDOES NOT SUFFICE AS SUBSTANTIAL EVIDENCE OF INVALIDITYExpert did not mention specific prior art refer-ence after introducing it into evidence; there-fore, jury’s verdict of invalidity cannot beupheld. Koito Mfg. Co. v. Turn-Key-Tech, LLC,No. 03-1565 (Fed. Cir. Aug. 23, 2004) . . . .9

NOTHING PRECLUDES A DISTRICT COURTFROM MAKING ADJUSTMENTS TO A CLAIMCONSTRUCTION AS A TRIAL PROCEEDSParty’s failure to address ambiguity left in district court’s claim construction during trialleads to affirmance of noninfringement. Power Mosfet Techs., L.L.C. v. Siemens AG, No. 03-1083 (Fed. Cir. Aug. 17, 2004) . . .10

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Poster Presentation Constitutesa “Printed Publication”

Jeffrey C. Totten

[Judges: Prost (author), Michel, andSchall]

In In re Klopfenstein, No. 03-1583 (Fed.Cir. Aug. 18, 2004), the Federal Circuitaffirmed a decision of the Board, whichupheld the PTO’s denial of PatentApplication Serial No. 09/699,950 (“the‘950 application”) because the applicantshad described the invention in a printedpublication more than one year prior toapplying for a patent.

Appellants filed the ‘950 application onOctober 30, 2000, claiming methods ofpreparing foods containing extruded soycotyledon fiber (“SCF”), which lowersserum cholesterol levels while raising HDLcholesterol levels. In particular, the ‘950application disclosed a double-extrusionprocess, which enhanced SCF’s previouslyknown lowering effect on cholesterol lev-els.

In October 1998, two years beforeapplying for a patent, Appellants presentedthe process subsequently claimed in the‘950 application to a meeting of theAmerican Association of Cereal Chemists.During the meeting, Appellants displayed a copy of the presentation—which disclosed every limitation claimed in the application—on poster boards for two andone-half days. Later that same year, theydisplayed the same presentation, for lessthan a day, at an Agriculture ExperimentStation at Kansas State University.

The presentation consisted of fourteenslides, including a cover page, an acknowl-edgement slide, and four slides presentingexperimental data in graphical form. Ofthe eight substantive slides in the presenta-tion, most contained information alreadyknown by persons of skill in the art. Thepresentation did not contain a confidential-

ity notice, or otherwise alert viewers thatthey could not copy or disseminate theinformation it contained. Appellants didnot disseminate copies of the slides.

On appeal, Appellants argued thatprecedent required (1) distribution ofcopies or (2) indexing in a library or data-base for a reference to constitute a “print-ed publication.” The Federal Circuit reject-ed this assertion, noting that the keyinquiry is whether a reference has beenmade “publicly accessible.” To make thisassessment, the Court analyzed (1) thelength of time Appellants displayed thepresentation, (2) the expertise of the targetaudience, (3) the lack of reasonable expec-tation that the audience would not copythe displayed material, and (4) the relativeease of copying the displayed material.The Court stressed that Appellants dis-played their presentation for three days toan audience including cereal chemists andtook no measures to protect the informa-tion it contained. Moreover, the slidescontained easily understood bullet points,which a person of skill in the art could easi-ly copy or remember. Given these factors,the Court affirmed the Board’s decision.

“Dying” Plant ApplicationsResuscitated

Robert F. Shaffer

[Judges: Lourie (author), Clevenger, andBryson]

In In re Elsner, No. 03-1569 (Fed. Cir.Aug. 16, 2004), the Federal Circuit vacatedand remanded the Board’s decision reject-ing applicants’ plant applications under35 U.S.C. § 102(b). The Board determinedthat Appellants’ published Plant Breeder’sRights (“PBR”) applications anticipatedtheir claims in view of the foreign sales ofthe claimed plants. The issue of firstimpression was whether evidence of the

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foreign sale of a claimed reproducible plantvariety may enable an otherwise nonen-abled printed publication disclosing thatplant, thereby creating a § 102(b) bar.While the Court held that the publicationof the applications coupled with foreignsales of the plants may constitute a §102(b) bar to patentability, it vacated andremanded the case because (1) the recordwas silent on the extent to which the for-eign sales were known to the public, and(2) the Board did not adequately addressthe degree to which availability of theplants through foreign sales enabled thepreparation of the claimed plants.

Wilhelm Elsner, a plant breeder inGermany, filed an application for aCommunity Plant Variety Rights (“CPVR”)Certificate, or PBR, at the Community PlantVariety Office (“CPVO”) in Europe for atype of geranium named “Pendec.”Elsner’s application was listed in the CPVOOfficial Gazette that was published inDecember 1997. That listing only dis-closed the names and addresses of thebreeder and its representative, a statementof botanical classification, and a provisionaldenomination for the plant. In July 1998, asale of the Pendec geranium occurred inGermany. Elsner withdrew the applicationin May 1999, and it did not thereforemature into a CPVR certificate. InSeptember 2000, Elsner filed a plant patentapplication claiming the Pendec geranium.

The Board affirmed the Examiner’srejection of the only claim in the applica-tion as anticipated under § 102(b) on theground that the CPVO listing disclosed theinvention and that the sales placed theskilled artisan in possession of the inventionmore than one year before the effective fil-ing date.

On appeal, Elsner argued that foreignactivity cannot cause a nonenabled publi-cation to constitute a statutory bar under§ 102(b). Appellants further asserted that,

because foreign sales are not prior artunder the patent statute, they may not beconsidered within the knowledge of one ofskill in the art and cannot be used toenable an otherwise nonenabling publica-tion. Accordingly, Appellants claimed thatthe published PBR applications are notenabled because it is impossible to recreatethe claimed plants from the textual descrip-tions alone and, thus, are not effective asreferences.

Noting the difference between plantsand statutorily distinct inventions, theCourt disagreed. It reasoned that in thecase of plant patents, the touchstone of thestatutory subject matter is asexual repro-duction of a unique biological organism.Thus, a statutory bar arises when a publica-tion, which only identifies the plant that isinvented, is combined with a foreign salethat puts one of ordinary skill in the art inpossession of the plant itself. In coming toits conclusion, the Court cautioned that theprecise focus of the analysis is not whetherthe foreign sales are themselves § 102(b)prior art, but whether the publication hasplaced the claimed invention in the posses-sion of the public before the critical date.Thus, foreign sales of the claimed plantsmay be within the knowledge of the skilledartisan and may be considered to providethe public with access to Appellants’ inven-tions.

Even though the Court ultimatelyagreed with the PTO that foreign sales mayenable an otherwise nonenabling publica-tion, it found that factual issues remained.For example, with respect to the accessibili-ty of the foreign sales of the claimed inven-tion, the Court found that it was unclearwhether a skilled artisan would have knownof the sales. In comparing it to a printedpublication under § 102(b), the Court stat-ed that the sale must have been known tothe public and not merely an obscure orsolitary occurrence that would go unno-

ticed to those skilled in the art. Therefore,the Court remanded for further factualfindings relating to the accessibility of theforeign sales and the reproducibility of theclaimed plants from the plants that weresold.

Court Reinstates Jury Verdict ofValidity, Modifies ClaimConstruction, and Remands forNew Trial

Steven L. Park

[Judges: Newman (author), Friedman,and Rader]

In Cardiac Pacemakers, Inc. v. St. JudeMedical, Inc., No. 02-1532 (Fed. Cir. Aug.31, 2004), the Federal Circuit reinstated ajury verdict of no invalidity of U.S. PatentNo. 4,407,288 (“the ‘288 patent”) andremanded for a new trial based on theCourt’s partially modified claim construc-tion.

At trial, Cardiac Pacemakers, Inc.(“CPI”) charged St. Jude Medical, Inc. (“St.Jude”) of infringing U.S. Patent No.4,316,472 (“the ‘472 patent”) and the‘288 patent, both of which relate toimproved implantable cardiac defibrillators(“ICD”) for treating abnormal cardiac activ-ity. The jury found both patents valid andfound that St. Jude infringed the ‘472patent, awarding damages of $140 million.On post-trial motions, the district courtgranted JMOL in favor of St. Jude, findingboth the patents invalid and not infringed.CPI only appealed the district court’s judg-ment of invalidity and noninfringement asto the ‘288 patent.

The ‘288 patent relates to an improvedmultimode ICD that treats multiple typesof abnormal cardiac activity by deliveringelectrical shocks to the heart muscle inappropriate strengths, including a treat-ment known as cardioversion. Despite the

jury’s finding to the contrary, the districtcourt found that the ‘288 patent wasinvalid based on obviousness and best-mode grounds.

In determining invalidity based onobviousness, the district court had foundthat cardioversion therapy was known, andthat there was a known need to treat mix-tures of arrhythmias. Thus, the courtdetermined that it would have been obvi-ous to combine known methods of sepa-rate treatment within a single ICD. TheFederal Circuit disagreed, opining that themere recognition of the problem of treat-ing complex heart arrhythmias does notrender obvious the eventual solution.Indeed, it was undisputed that the solutionof this problem had not previously beenachieved.

The Federal Circuit explained thatwhether the prior art provides the sugges-tion or motivation to combine prior knowl-edge in a way to produce the invention atissue is a question of fact. And these issueswere extensively explored at trial, includingevidence of commercial success and licens-ing interest. The Court concluded that thetrial record contained substantial evidence,whereby a reasonable jury could havereached the verdict that it would not havebeen obvious to provide an ICD thatincludes cardioversion therapy.

In determining invalidity based on bestmode, the district court had found that theinventors requested a third party to devel-op an improved battery for use in CPI’sICDs. Approximately four months beforethe ‘288 patent application was filed, thethird party published an article describingthe battery that it developed. The districtcourt held that failure to include the third-party battery in the specification invalidat-ed the patent on best-mode grounds,because it was the best battery then knownto them.

The Federal Circuit disagreed for tworeasons. First, the Court noted that thebattery for use in battery-powered ICDs

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was not part of the claimed invention.Second, even if the battery was part of theclaimed invention, a best-mode violationrequires that the inventor knew of and con-cealed a better mode than was disclosedfor making and using the claimed inven-tion. The Federal Circuit held that therewas no evidence of such concealment.Accordingly, there was substantial evi-dence, whereby a reasonable jury couldhave found that the best-mode require-ment had not been violated.

The Federal Circuit also overturned thedistrict court’s claim construction that“determining a condition of the heart fromamong a plurality of conditions of theheart” is in the step-plus-function form of35 U.S.C. § 112, ¶ 6. Method claims, theCourt explained, necessarily recite the stepsof the method, and the preamble words,“the method comprises the steps of,” donot automatically convert each ensuingstep into the form of § 112, ¶ 6. To thecontrary, the absence of the signal “stepfor” creates a presumption that each ensu-ing step is not in step-plus-function form. The Court clarified, however, that removalof a clause from § 112, ¶ 6 does not auto-matically convert it into an open-endedstep without limits. A claim limitation isalways construed in light of the specifica-tion, regardless of the form of the claim.Accordingly, the Federal Circuit remandedthe case in order to construe the “deter-mining” step in light of the specificationand the prosecution history.

Eleventh Amendment BarsClaim Against State to CorrectInventorship

Paul C. Goulet

[Judges: Newman (author), Gajarsa, andLinn]

In Xechem International, Inc. v. Universityof Texas, No. 03-1406 (Fed. Cir. Aug. 31,2004), the Federal Circuit affirmed the trial

court’s conclusion that the University ofTexas, an arm of the state of Texas (“theUniversity”), is immune from federal suitfor the correction of inventorship and thatthe University had not waived that immu-nity by entering into commercial arrange-ments with Xechem International, Inc.(“Xechem”) and by applying for andreceiving patents.

Xechem and the University entered intocollaborative research agreements for thepurpose of developing a pharmaceuticalformulation that would enhance the solu-bility and effectiveness of the cancer drugpaclitaxel. Upon the successful develop-ment of that formulation, Xechem pre-pared a draft patent application namingXechem’s Dr. Pandey and the University’sDr. Andersson as joint inventors. TheUniversity objected to the designation ofinventorship and filed the patent applica-tion naming the University’s Dr. Anderssonas the sole inventor. Xechem and theUniversity subsequently entered into apatent and technology license agreement,and Xechem agreed to pay certain contin-uing sums and a royalty to the University.The patent application subsequently result-ed in the issuance of U.S. Patent Nos.5,877,205 (“the ‘205 patent”) and6,107,333 (“the ‘333 patent”). Dr.Andersson assigned the patents to theUniversity.

Eventually, Xechem brought suit, seek-ing correction of inventorship of the ’205and ’333 patents to include Xechem’s Dr.Pandey. The University claimed immunityfrom suit under the Eleventh Amendment.Xechem argued that the University hadwaived immunity by: (1) entering into var-ious commercial agreements with Xechemfor the purpose of financial gain; (2) caus-ing its employee, Dr. Andersson, to applyfor a United States patent; and (3) accept-ing “gifts” from the federal government inthe form of United States patents. Finally,Xechem argued that Eleventh Amendmentimmunity does not apply to actions for cor-rection of inventorship. The Federal Circuitrejected each of these arguments in turn,acknowledging that Supreme Court prece-

dent controlled each of Xechem’s argu-ments.

The Federal Circuit rejected the notionthat a state’s entrance into commercialarrangements can waive EleventhAmendment immunity. Specifically, theFederal Circuit rejected Xechem’s argumentthat by entering into a collaborativeresearch agreement and then a licenseagreement with Xechem for purposes offinancial gain, the University waived objec-tion to federal court jurisdiction to secureconstitutionally protected property rights(patents), and for issues that can be decid-ed only in federal court under preemptivefederal statutes (the Patent Act). TheFederal Circuit highlighted Supreme Courtprecedent that a waiver of a state’s immuni-ty cannot be imposed or implied based ona state’s entry into commerce; rather, thewaiver must be founded on a clear declara-tion of the state’s intent to submit to federaljurisdiction. The Federal Circuit found nosuch “clear declaration” of waiver by theUniversity in entering into its various rela-tionships and contracts with Xechem.

The Federal Circuit further rejectedXechem’s argument that the University con-structively waived immunity when it averredthat Dr. Andersson was the sole inventor inits application for a United States patentand, thus, consented to correction of thaterroneous averral in a federal court. TheFederal Circuit noted that the SupremeCourt had already rejected the argumentthat a state’s voluntary participation inactivities controlled by federal statuteimposes a consent to suit arising from thoseactivities.

Likewise, the Federal Circuit rejectedXechem’s argument that the grant of apatent is a “gift” from the government,whereby acceptance of that gift is a con-structive waiver of immunity. The FederalCircuit reasoned that the grant of a patentis not a disbursement of governmentlargesse. Rather, it is the result of a careful-ly crafted bargain that encourages both the

creation and the public disclosure of newand useful advances in technology, in returnfor an exclusive monopoly for a limitedperiod of time.

Finally, the Federal Circuit rejectedXechem’s argument that because theUniversity is not a necessary party to theaction to correct inventorship, it need notconsent to or participate in the hearingand, thus, the Eleventh Amendment doesnot bar federal suit to correct inventorship.The Federal Circuit noted, however, thatwithout any defendant, there is no suit.The Federal Circuit further argued that,while inventorship is determined under fed-eral law, state courts can apply federal lawto issues properly before the state court.And, federal preemption of causes arisingunder the Patent Act does not include mat-ters of ownership. Therefore, becauseXechem is not left without a possible reme-dy under state law, the due-process con-cerns of the Fourteenth Amendment are notimplicated and there is no reason to abro-gate the state’s Eleventh Amendmentimmunity.

Partial Protein Sequence DoesNot Provide Sufficient WrittenDescription

Michael V. O’Shaughnessy

[Judges: Lourie (author), Mayer, andGajarsa]

In In re Wallach, No. 03-1327 (Fed. Cir.Aug. 11, 2004), the Federal Circuit affirmeda decision of the Board that upheld a rejec-tion of several claims of U.S. PatentApplication No. 08/485,129 (“the ‘129application”) by David Wallach et al. (col-lectively “Wallach”) for failure to provide anadequate written description.

The ‘129 application is directed to twospecific tumor necrosis binding proteins(“TBP-I” and “TBP-II”) that inhibit the cyto-

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toxic effect of tumor necrosis factor(“TNF”). Among other aspects of theinvention, Wallach claimed proteins havinga partial sequence, a particular molecularweight, and the ability to inhibit the cyto-toxic effect of TNF. The disclosed sequenceincluded only the partial amino acidsequence for the N-terminal portion ofTBP-II. The complete DNA sequenceencoding the proteins was claimed in divi-sional application 07/930,443 (“the ‘443application”), which had been allowed sub-ject to an interference proceeding.

The patent Examiner rejected theclaims of the ‘129 application under35 U.S.C. § 112 because the specificationdid not provide an adequate writtendescription of the claimed invention. TheBoard affirmed the rejections becauseWallach did not describe the invention withsufficient specificity.

Wallach appealed, contending thatbecause the ‘443 application had beenallowed, the identical specification of the‘129 application could not be viewed asinadequate. Wallach argued that the twoapplications differed substantively onlybecause the ‘129 application claimed thepartial protein sequence, whereas the ‘443application claimed the DNA sequenceencoding the protein. Citing the corre-spondence between the amino acidsequence and encoding DNA codons,Wallach argued that the distinction was notmeaningful and, in fact, the amino acidsequence of a protein automatically putsone of ordinary skill in the art in possessionof all DNA sequences encoding that pro-tein. Moreover, Wallach argued that thecomplete amino acid sequence is an inher-ent property of an isolated protein that hasbeen fully characterized by a partial aminoacid sequence and other characteristics,such as molecular weight. Therefore,according to Wallach, the ‘129 applicationprovided sufficient description for theentire claimed genus of DNA sequences.As a final point, Wallach also argued that

the ‘129 application satisfied the written-description requirement by providing afunctional description of the identified pro-tein, namely, the ability to selectively inhib-it TNF.

The Federal Circuit recognized that acomplete amino acid sequence of a proteinmay put one in possession of the genusDNA sequence that encodes it and, there-fore, may satisfy the written-descriptionrequirement. Wallach, however, did notclaim the nucleic acid sequence for theprotein they disclosed. Rather, Wallachclaimed only a partial sequence (approxi-mately 5%) of the disclosed protein. TheCourt stated that mere possession of theprotein does not amount to knowledge ofthat protein’s sequence absent any evi-dence that the sequence of the full proteincan be deduced from a partial sequence.

Finally, the Court rejected Wallach’sfunctional-description argument.Acknowledging that the written-descriptionrequirement may be met by a functionaldescription of the genetic material, theCourt explained that there must be a rela-tionship between the chemical structureand the biological function. Finding thatno correlation existed between a protein’spartial structure, biological activity, andmolecular weight on the one hand and thecomplete structure of the DNA encodingthe protein on the other, the FederalCircuit affirmed the Board’s rejection of theclaims.

Hairbrush Prior Art IncludesToothbrushes

Elizabeth M. Burke

[Judges: Rader (author), Schall, andNewman (dissenting)]

In In re Bigio, No. 03-1358 (Fed. Cir.Aug. 24, 2004), the Federal Circuitaffirmed the Board’s claim construction and

determination that the prior art applied ina rejection of claims of U.S. PatentApplication No. 09/145,747 (“the ‘747application”) was analogous art.

The ‘747 application claims a hair-brush having an hourglass configurationfor a bristle substrate and the overall bristlearray. During prosecution of Alberto LeeBigio’s ‘747 application, the Examinerrejected certain claims as being obvious inview of three toothbrush patents.

Before the Board, Bigio argued that theterm “hair brush” should be narrowly con-strued to encompass only brushes for scalphair. The Board rejected this interpretation,instead construing the term “hair brush” toencompass brushes that may be used forhuman hair on a scalp and other parts ofanimal bodies, e.g., human facial hair,human eyebrow hair, or pet hair.

Bigio also argued that the toothbrushpatents were nonanalogous art. Under itsclaim construction, the Board found thatthe toothbrush patents relate to the samefield of invention as the claimed invention,specifically to the field of hand-held brush-es having a handle segment and a bristle-substrate segment. The Board thereforeaffirmed the Examiner’s rejection.

On appeal, the Federal Circuit first con-strued the term “hair brush” and then,based on that construction, determinedwhether the toothbrush references wereanalogous art. In construing the term“hair brush,” the Court reviewed the rea-sonableness of the Board’s construction ofthe disputed term. First, the Court notedthat the modifier “hair” before the word“brush” was not in itself sufficient to limitthe claim to brushes for scalp hair, as it didnot limit the claim to any particular type ofhair. The Court also noted that the Boardcorrectly refused to import from the specifi-cation a limitation that would apply theclaim only to hairbrushes for the scalp.The Court concluded that the term “hair

brush” does not in itself specify the type ofhair to be groomed, and, therefore, theBoard’s interpretation of the term was rea-sonable.

After affirming the Board’s claim con-struction, the Court reviewed the use ofthe toothbrush references as analogous art.The Court set forth the two separate teststhat define the scope of analogous priorart: (1) regardless of the problemaddressed by the inventor, whether the artis from the same field of endeavor, and(2) if not within the same field of endeavor,whether the reference still is reasonablypertinent to the particular problem to besolved. The Board based its determinationon the first test, finding that the tooth-brush patent(s) related to the same field ofendeavor as Bigio’s claimed invention. TheCourt also stated that the reality of the cir-cumstances, or common sense, must beconsidered in determining where one ofordinary skill in the art could reasonably beexpected to look for a solution to the givenproblem. Bigio had agreed that if the priorart was analogous, then his invention wasobvious.

Judge Newman dissented, arguing thatthe toothbrush art is about as analogous tothe hairbrush art as teeth are to hair.

Claim Broader than PreferredEmbodiment

Robert Pollock

[Judges: Rader (author), Dyk, and Prost]

In Home Diagnostics, Inc. v. LifeScan,Inc., No. 03-1370 (Fed. Cir. Aug. 31,2004), the Federal Circuit reversed the dis-trict court’s claim-construction order, vacat-ed the order entering judgment in favor ofHome Diagnostics, Inc. (“Home

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Diagnostics”), and remanded the case for adetermination of validity and infringement.

Home Diagnostics initiated the suitbelow by seeking a DJ that its Prestigeblood-glucose meters do not infringeLifeScan, Inc.’s (“LifeScan”) U.S. Patent No.6,268,162 (“the ‘162 patent”). LifeScanfiled a counterclaim for infringement.Following a Markman hearing, LifeScanstipulated that it could not prove infringe-ment given the district court’s claim con-struction. The district court dismissedLifeScan’s counterclaim and entered a finaljudgment of noninfringement in favor ofHome Diagnostics.

The sole claim at issue, claim 4 of the‘162 patent, recites a method of measuringblood glucose with a reflectance-readingdevice. In particular, a sample of wholeblood applied to a test strip reacts with areagent, whereupon reflectance readingsare taken “at specified time intervals upondetecting a predetermined drop inreflectance.” The glucose concentration inthe sample is calculated from one of thereflectance readings “upon detection of asuitably stable endpoint.”

The central dispute in this case focusedon the meaning of “upon detection of asuitably stable endpoint.” The districtcourt construed this language as limitingthe claim to detection at the expiration of apredetermined time period—a constructionthat effectively precluded a finding ofinfringement against Home Diagnosticsbecause its device did not detectreflectance readings at a predeterminedtime.

Rejecting the district judge’s narrowconstruction, the Federal Circuit found thatthe claim language does not explicitlyrequire a predetermined time for the reac-tion, but instead measures the endpointwith reference to the stability of thereflectance. The Court pointed to theteaching of the specification as simply one

means of determining when a “suitably sta-ble endpoint” has been reached. The ‘162patent describes a preferred embodimentusing predetermined time periods, butdescribes no other embodiments in detail.Nevertheless, the Court found no disavowalof alternative methodology, because anapplicant’s choice to describe only a singleembodiment does not mean that thepatent clearly and unambiguously disavowsother embodiments. Rather, the preferredembodiment is just one way of using theinvention.

In addition, the Court noted that priorart identified by the ‘162 patent recites var-ious methods of monitoring a reaction andcited these teachings as further evidencethat one of ordinary skill would understandthe claims as not limited to predeterminedtiming methods. Finally, the Court notedthat during the prosecution of the family ofpatents including the ‘162 patent, LifeScansought progressively broader claim lan-guage culminating in the limitation at issuein this case. The Court found that thiscourse of prosecution showed that LifeScanpurposefully sought claim scope in the ‘162patent broader than the predeterminedtiming method disclosed. Thus, finding nodisavowal, the Federal Circuit found thatLifeScan was entitled to the full scope of itsclaim language and remanded for determi-nations on the liability issues.

“Operatively Connected”Construed Too Narrowly

Eric P. Raciti

[Judges: Clevenger (author), Rader, andLinn]

In Innova/Pure Water, Inc. v. Safari WaterFiltration Systems, Inc., No. 04-1097 (Fed.Cir. Aug. 11, 2004), the Federal Circuit

ruled that the term “operatively connect-ed,” describing the relationship betweentwo recited claim elements, could not beconstrued to require “tenacious engage-ment” as required by the district court ingranting SJ of noninfringement, andreversed that decision.

Innova/Pure Water, Inc. (”Innova”) isthe owner of U.S. Patent No. 5,609,759(“the ’759 patent”), which claims a filterand cap combination for water bottles.Innova’s claimed filter and cap combina-tion includes a filter for radial filtration ofwater exiting a bottle that is “operativelyconnected” to the cap of the bottle. SafariWater Filtration Systems, Inc. (“Safari”)argued, and the district court agreed, thatbecause the specification only discussedpreferred embodiments in which the capand filter were integral, the term “opera-tively connected” must be construed torequire the filter and cap to be integral, orto be in “tenacious engagement.” Safari’sfilter was held in the mouth of the bottleby the cap when threaded onto the bottleneck. Because the cap and filter were notintegral, or in “tenacious engagement,”the district court ruled for Safari.

Innova’s appeal focused on the properinterpretation of the disputed claim term“operatively connected.” Specifically,Innova challenged that the district courtimproperly read the “tenacious engage-ment” limitation into the claims, where theliteral claim language required no suchthing. The Federal Circuit agreed. First,the Court pointed out that the assertedclaims do not literally require that the filterand cap form a unitary structure. TheCourt noted that the phrase is a frequentlyused functional term used across variousarts. Absent any special meaning, as is thecase here, the Court found that the generaldescriptive meaning of the term was con-trolling. Accordingly, the Court found thatthe term “operatively connected,” as used

in the claims, required only that the capand the filter be connected in a way toperform their designated function.

Accordingly, the Court vacated the dis-trict court’s grant of SJ and remanded thecase for further proceedings.

General and ConclusoryTestimony Does Not Suffice asSubstantial Evidence ofInvalidity

Vince Kovalick

[Judges: Gajarsa (author), Bryson, andDyk]

In Koito Manufacturing Co. v. Turn-Key-Tech, LLC, No. 03-1565 (Fed. Cir. Aug. 23,2004), the Federal Circuit reversed a juryfinding of invalidity based on prior art butaffirmed findings that the patent is notinvalid for lack of embodiment, failure ofwritten description, and the addition ofnew matter. In addition, the FederalCircuit affirmed the district court’s deci-sions reflecting a jury’s verdict of nonin-fringement.

Turn-Key-Tech, LLC and Jens OleSorensen (collectively “Turn-Key”) own U.S.Patent No. 5,045,268 (“the ‘268 patent”),which teaches a method of strengtheninginjection-molded plastic. After Turn-Keyasserted the ‘268 patent against severalcustomers of Koito ManufacturingCompany, Ltd. (“Koito”), Koito filed a DJaction against Turn-Key requesting that the‘268 patent be declared invalid and notinfringed.

After a trial, a jury found the ‘268patent not infringed and invalid for lack ofenablement, lack of written description,and addition of new matter through a cer-tificate of correction. The jury also found acertain number of claims anticipated and

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obvious based on prior art. The districtcourt upheld the finding of invalidity basedon prior art but granted JMOL as for theother invalidity grounds.

On appeal, Turn-Key took issue withthe district court’s claim construction ofcertain claim terms. The Federal Circuitconcluded, however, that Turn-Key did notpreserve its claim-construction argument attrial and did not object to the jury instruc-tions on this claim term. If Turn-Key hadwanted a different construction of that lim-itation, the Federal Circuit commented, itshould have objected at trial. After resolv-ing this claim-construction issue, theFederal Circuit quickly concluded that suffi-cient evidence supported the ruling of non-infringement.

Concerning anticipation and obvious-ness, the district court had focused exclu-sively on a Japanese UnexaminedApplication No. 148,082 (“JP ‘082”). Turn-Key argued that Koito merely submittedthat reference into evidence and made nospecific mention of it at trial. The FederalCircuit agreed that the evidence based onthe JP ‘082 reference was insufficient tosupport the determination of anticipationand obviousness. Koito had entered theJP ‘082 reference into evidence but other-wise failed to provide any testimony todemonstrate how it met the limitations ofthe claims. Instead, Koito’s expert simplymade conclusory statements about JP ‘082together with several other pieces of priorart. However, given that Koito had pre-sented an array of other evidence of antici-pation and obviousness at trial, the FederalCircuit vacated the district court’s ruling ofinvalidity based on prior art and remandedfor further proceedings to determinewhether sufficient evidence supported thejury’s findings of invalidity based on theother prior art evidence.

Koito argued that the ‘268 patent isinvalid because a certificate of correctionaltered the definition of the thickness of a

flow channel described in the specification.According to Koito, this change was notsupported by the specification and broad-ened the scope of the claims. The FederalCircuit found that the amended materialwas inherently contained in the originalapplication and, therefore, was not newmatter. The Court also found that certainfigures demonstrated that the inventor wasin possession of the patent claims at thetime of filing, and, therefore, the written-description requirement was satisfied.

Nothing Precludes a DistrictCourt from MakingAdjustments to a ClaimConstruction as a TrialProceeds

Vince Kovalick

[Judges: Gajarsa (author), Michel, andProst]

In Power Mosfet Technologies, L.L.C. v.Siemens AG, No. 03-1083 (Fed. Cir. Aug.17, 2004), the Federal Circuit affirmed afinding of noninfringement. Power MosfetTechnologies, L.L.C. (“PMT”) owns U.S.Patent No. 5,216,275 (“the ‘275 patent”),which is directed to a specific type ofMOSFET semiconductor power device.PMT sued Infineon TechnologiesCorporation and related companies (collec-tively “Infineon”), STMicroelectronics, N.V.and related companies (collectively “ST”),and International Rectifier Corporation andrelated companies (collectively “IR”).

An SM construed the claims, and thedistrict court found no infringement. Thedistrict court also found that the ‘275patent was not invalid.

The Federal Circuit engaged in adetailed analysis of specific claim limita-tions, only to conclude that the record

revealed both an incomplete claim con-struction containing a significant ambiguityand an awareness by the parties that thelimited constructions that did exist weresubject to further modification by the dis-trict court. In the end, the Federal Circuitaffirmed the district court’s claim construc-tions and its judgment of noninfringement.

The Federal Circuit also deniedInfineon’s request for attorney fees,because, according to the district court, allof the parties had conducted themselveswithout the decorum required when prac-ticing before a federal court. The Federal

Circuit characterized Infineon’s request forattorney fees in view of the district court’sadmonition as “quite bold.”


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In Last month at The Federal Circuit, certain terms, titles, and names of fed-eral agencies that are frequently referred to in text, appear in abbreviatedforms or as acronyms. These abbreviated forms and acronyms are listed below.

ALJ Administrative Law Judge ANDA Abbreviated New Drug ApplicationAPA Administrative Procedures ActAPJ Administrative Patent Judge Board Board of Patent Appeals and InterferencesCommissioner Commissioner of Patents and Trademarks CIP Continuation-in-PartDJ Declaratory Judgment DOE Doctrine of EquivalentsFDA Food & Drug AdministrationIDS Information Disclosure StatementIP Intellectual PropertyITC International Trade CommissionJMOL Judgment as a Matter of Law MPEP Manual of Patent Examining ProcedurePCT Patent Cooperation TreatyPTO United States Patent and Trademark Office SEC Securities and Exchange CommissionSJ Summary JudgmentSM Special Master

month at last the federalcircuit...an audience including cereal chemists and took no measures to...

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