TheBasicsandRecentDevelopmentsinUSPatentPracticeAlanS.Nadel,Esq.,PartnerWeihongHsing,Ph.D.,Esq.IntellectualProperty(IP)EverythingyoudevelopcanbeyourIPThreewaysto“handle”IPPublish:makeitfreelyavailabletothepublicTradeSecret:“hide”fromthepublic,butprotectbyagreements,risklossofexclusivityifmadepublicPatent:agovernmentgrantedexclusiverightgivenforalimitedamountoftimeinexchangeforcompletedisclosureoftheinvention

ExclusiveRightInventorshaverighttoexcludeothersfrommaking,selling,offeringtosell,using,orimportingtheinventionintheU.S.Righttoexclude

righttopracticeWaystouseapatentAssignmentinexchangeforincome:completelytransferstherighttoexcludeLicenseinexchangeforincome:partiallytransferstherighttoexcludePatentlitigationMaintainrighttoexclude:seekinjunctionCompensation:seeklostprofitsandreasonableroyaltyPatenttermillustrationJune8,1995Filed3/18/942NDfiled3/10/961STfiled3/18/94Filed3/18/96Filed3/18/94Issued3/30/00Issued3/30/98Issued6/7/95Expires3/30/15,thelongertermof17yfromissuanceor20yfromfiling

Expires3/18/14,thelongertermof17yfromissuanceor20yfromfiling

Expires3/18/16,20yfromfiling

Issued3/25/00Expires3/18/14,20yfrom1stfilingCompletedisclosure(35U.S.C.§112)

Enablement

mustteachoneskilledinthearthowtomakeandusetheclaimedinventionwithoutundueexperimentationChemicalorbiotechinventionisconsideredunpredictable,it’softennotsufficientby,e.g.,propheticexamplesonlywithoutdataoractualexamples;1or2speciesforagenusclaim.

Sufficientwrittendescription

suchthatoneskilledintheartreadingthedescriptionwouldrecognizethattheinventorhadinventedtheclaimedsubjectmatterandhadpossessionoftheinventionatthetimetheapplicationwasfiledClaim

definiteness

mustparticularlypointoutanddistinctlyclaimthesubjectmatterwhichtheinventorregardsasherinventionDefinesthemetesandboundsoftheinventionMustincludeallessentialelementsoftheinventionBest

Mode

knowntotheinventorattimeatthetimetheapplicationwas

filed.

Whatcanbepatented?

“Anythingunderthesunthatismadeby[hu]man”Designpatent:new,originalandornamentaldesignPlantpatent:asexuallyreproduced,nottuber-propagating,cultivatedplantUtilitypatent:machine,manufacture,process,compositionorimprovement,e.g.,Isolatednucleicacids,proteins,cells,antibodiesTransgeniccells,animals,plantsBiomarker,crystalstructure,deviceMethodsoftreatment,diagnosis,synthesis,storageCompoundsandnovelintermediatesProcessincludesnewuseofoldmaterial Whatcannotbepatented?(35U.S.C.§101)

NaturallyoccurringUnlesspurifiedorgeneticallyengineeredScientificprincipleUnlessusedinprocessorapparatusLackutilityforutilitypatentFraudulentutility,i.e.,transgenicanimalassnakefood;acandlelightforburglarInoperative,i.e.,perpetualmotionNot“realworld”use,i.e.,useESTasaprobeSubjecttoU.S.DeptofDefensereviewi.e.,AtomicBombsNonobviousRequirement

(35U.S.C.§103)

Iftwoormorepublicationscanbecombinedtodiscloseallelementsofaclaimedinvention,theymayrendertheclaimedinventionobvious

RecentU.S.SupremeCourtcasemaymakeiteasiertofindaclaimedinventionobvious,KSRv.Teleflex

Inordertorenderaclaimobvious,thepriorartpublicationsneednotexplicitlycontainteaching/suggestion/motivationthatwouldleadoneofordinaryskillinthearttocombinethepriorartinthemannerasclaimed;obvioustotrymaysuggestobvious.USPTOKSRMemo:itremainsnecessarytoidentifythereasonwhyapersonofordinaryskillintheartwouldhavecombinedthepriorartelementsinthemannerclaimedKSRreaffirmedthefourfactortestunderGrahamv.JohnDeere

Thescopeandcontentofthepriorart;Thedifferencebetweentheclaimsatissueandpriorart;Thelevelofordinaryskillinpertinentart;andEvidenceofsecondaryconsiderations(objectivecriteria):commercialsuccess;longfeltbutunsolvedneeds;failureofothers;recognitionofproblem;unexpectedresults;copyingbyothers,etc.ProvisionalapplicationEffectivesinceJune8,1995byU.S.PTOSimplifyfiling,lowcost,1extrayearof“patentpending”.NoStartingpatentterm,examination,amendment,publication,claim,oath/declaration,andIDS.YesPrioritydate,completewrittendisclosure,namingatleast1inventor,filingfee,identificationasaprovisionalfiling.Toclaimthebenefitofearlierprioritydatefromaprovisionalapplication,thenon-provisionalmustbefiledwithin1yfromprovisionalfilingdate(F.D.)musthavesupportinprovisionalmayclaimbenefitofmorethan1provisionalmayaddnewmatter(withoutthebenefitofpriority)Automaticallybecomesabandoned1yafteritsF.D.InterferenceAlegalprocessbyUSPTOtodeterminewhoisthefirsttoinventtheinventionattheclaimedscope.Canbedeclaredbetweentwopatentapplicationsorapatentapplicationandapatentissuedlessthanoneyearfromthefilingdateofthepatentapplication.U.S.firsttoinvent,mostothersfirsttofile.(MaychangeinproposedlawpendinginCongress)Proofoffirsttoinvent:notebookNotebookentriessufficientlydemonstratethattheinventorhasformedadefiniteandpermanentideaofthecompleteandoperableinventionWhattoinclude: -Ideasandspeculationsasdocumentationofconception

-FACTS

-Conditionsinwhichinventionistestedandisshowntowork

WhatNOTtoinclude:

Speculationsorconclusionsincludingnotesoropinionson:

-Patentability

-Priorart

-Whetheracomponentiscriticaloressentialtothe inventionShouldbehardcopy(orinatangiblemedium),signed,dated,andwitnessedbyathirdpartyRecordkeeping:Emails,Drafts,NotebooksEverythingyouwrotecanbeusedagainstyouinacourtNoDiscussionofpatentabilityinemailCommentsonpriorartUse“extreme”terms,e.g.,key,critical,essential,required,alwaysKeepingmanyversionsofolddraftsNotebookentriesinpencil(usepen)LooseslipsofpapertorecorddataErasures,blankorpartialblankpagesinnotebookNotsignanddateandwitnesseachpageofthenotebookUsepasttensetodescribeexperimentsthathavenotbeendoneDescriptioninnotebooknotsufficienttoenableanotherpersontoduplicatetheprocedureandresultsHideornotinformpatentattorneyofrelevantpriorartreferencesWhocanbeaninventor?Apersonwhocontributesto

theconceptof

issued

claimsfortheinventionContributiontotheconceptmustbecomplete,operableNottheonewhohadthemereideaw/ospecificplansonhowtorealizetheidea

Contributionmustbe>exerciseofordinaryskilloftheartNottheonewhomerelyfollowedinstructionsandmadetheinventionInventorshipmayvaryfromclaimtoclaimInventorshipmaychangeduringprosecutionTheorderhasnolegalsignificanceInventorship≠authorshipWronginventorshiprenderspatentunenforceableCanbecorrectedifoccurredwithoutdeceptiveintentThecorrectnessofinventorshipisonlyexaminedduringinterferenceorlitigationNotebook,writtendocumentationWhathappenstoapatentapplication?PrioritydateUSnon-prov’lPCTapp’n(Havenewdataready2mbefore)1YearUSprov’lorOtherforeignfilingforprioritydate30(or31)MonthFileNat’lorRegionalapp’nsbasedonPCTapp’nBegin20Year-termPublicationUSnon-prov’lPCTapp’n1Year0.5YearIssuanceorabandonedPatentExaminationIttakesabout3-5yearsfromthefirstF.D.totheissuanceofabiotechpatent.OfficeActionsfromapatentexamineroftheUSPTORestrictionrequirementrequiringanelectionbetweentwoormoreindependentorpatentablydistinctinventionsToensurethatthefeespaidforexaminationarecommensuratewiththescopeoftheexaminationRejections101:lackutility102:notnoveltyinviewofonepriorartreference103:obviousinviewofthecombinationofmultiplepriorart112:notenabled,lackwrittendescription,indefiniteObjectionsformality,spellingerrors,etc.ResponsestoanOfficeActionfromtheinventorMustelectaninventionforexaminationinresponsetoarestrictionrequirement,evenifdisagreewiththerestrictionrequirementMustaddresseachrejectionandobjectionandbeabonafideattempttoadvanceexaminationCanamendclaimsandspecification,butcannotaddnewmatterMustbefiledwithinlimitedtimeperiod,6monthmax.withextensionfeesMaysubmitnewdatatosupportenablementbydeclarationHowtoreadapatent/publication?

Claims:definewhatthepatentorapp’ncoversDetaileddescriptionInventors/Assignee(Assigneeneednotbelistedonpatentorpublishedpatentapp’n)PatenttermPrioritydateRelevantcitationsAnisolatedandpurifiedpolypeptidecomprisingthe

sequenceofaminoacids215to477ofSEQIDNO:2.

Theisolatedandpurifiedpolypeptideaccordingtoclaim1,consistingofthesequenceofaminoacids215to477ofSEQIDNO:2.

Whatisclaimedis:HowtoreadclaimsClaim1:anindependentclaimhavingbroadscopeClaim2:adependentclaimhavingnarrowerscopeTransitionalphrasesusedinclaimsOpen-ended:includingbutnotlimitedtoadditional,unrecitedelementsorsteps“Comprising”Closed:limitstheclaimtospecifiedelementsorsteps“Consistingof”Partiallyclosed:includesthosethatdonotmateriallyaffectthebasicandnovelcharacteristicsoftheclaim“consistingessentiallyof”RecentPatentCasesfromU.S.SupremeCourtSincetheFederalCircuit(CAFC)wascreatedin1982,theU.S.SupremeCourthastakenveryfewpatentcases,leavingtheFederalCircuittohavethefinalauthorityonpatentlawHowever,since1999,theSupremeCourthastaken9patentcases,andreversedtheFederalCircuitinmostofthemRecently,theSupremeCourthastakenfourpatentcases:EBay,Inc.v.MercExchangeInc.126S.Ct.1837(2006)MedImmuneInc.v.GenentechInc.127S.Ct.764(2007)KSRInternationalCo.v.TeleflexInc.etal.,April30,2007MicrosoftCorp.v.AT&TCorp.,April30,2007EBay,Inc.v.MercExchangeInc.

(permanentinjunctionsagainstpatentinfringement)TheFederalCircuit(CAFC)“generalrule”:courtswouldissuepermanentinjunctionsagainstpatentinfringementabsentexceptionalcircumstances.”U.S.SupremeCourtvacatedCAFC’sdecisionagainsteBayputtinganendtotheCAFC’s“generalrule”traditional“four-factortest”fordeterminingwhethertoissueapermanentinjunctionapplieswithequalforcetopatentdisputes.Apatentholdermustdemonstrate:(1)thatithassufferedanirreparableinjury;(2)thatremediesavailableatlaw,suchasmonetarydamages,areinadequatetocompensateforthatinjury;(3)that,consideringthebalanceofhardshipsbetweentheplaintiffanddefendant,aremedyinequityiswarranted;and(4)thatthepublicinterestwouldnotbedisservedbyapermanentinjunction.Thedecisionmayaffectpatentenforceabilitybymakinganinjunctionhardertoobtainforapatentholder.MedImmuneInc.v.GenentechInc

(jurisdictionforadeclaratoryjudgmentactionbyalicensee)

CAFCalicenseewhohadcompliedwiththetermsofitslicenseagreementcannotbringadeclaratoryjudgmentactiontochallengethevalidityofapatent,becausethereisnocauseofactualcontroversy,i.e.,possibilityofinfringementsuitorlicensecancellationbylicensorSupremeCourtapersonthathasbeenlicensedtouseapatentneednotbreakthatagreementbeforesuingtochallengethepatent'svalidityordefendagainstaclaimofinfringementMaymakeiteasiertobringasuittochallengethevalidityofapatentbyDeclaratoryJudgment.KSRInternationalCo.v.TeleflexInc.

(testforobviousness)CAFCrigidtest:requiredsometeaching/suggestion/motivation(TSM)inthepriorartpublicationsthatwouldleadoneofordinaryskillinthearttocombinethepriorartinthemannerasclaimedbeforeholdingtheclaimobviousSupremeCourtrejectedCAFC’srigidtestthemoreflexibletestunderKSR:thepriorartmaynotexplicitlycontainTSM;andobvioustotrymaysuggestobvious.reaffirmedthefourfactortestunderGrahamv.JohnDeere

Thescopeandcontentofthepriorart;Thedifferencebetweentheclaimsatissueandpriorart;Thelevelofordinaryskillinpertinentart;andEvidenceofsecondaryconsiderations:commercialsuccess;longfeltb