AUTHORITY

must take into account not only the benefits generated by additional investment in innovation but the related costs of preventing use by others of those inventions

distinguishes between applied ideas (functional ideas) and expression of ideas○

point where the incentive benefits most greatly exceed the related costs thus producing the greatest possible net social gain

"limited Times" constraint - calibrate the patent right to obtain the maximum net benefit to society at large○

RULE: more "foundational" - that is, can be the basis for a wide variety of additional applications - less patentable○

Intellectual Property Clause - US CONSTITUTION Article 1, Section 8, Clause 8 - authorizes Congress to promulgate both federal patent (useful arts) and copyright (sciences) legislation

A.

Statutory -- Title 35 of US Code (101 - patentable, 102 - novelty, 103 - obviousness, 112 - spec)B.Rules Title 37 of Code of Federal Regulations (CFR)C.MPEP (Manual of Patent Examination Procedure)D.Federal Circuit -- subject matter ct only; high volume of patent opinionsE.

CLAIMS

Interpretation of claims is a legal issue (judge) not fact issuea.

Entire claim must be stated in one sentencei.Must set forth how each element interacts with at least one other element (no list of elements)ii.Internal references must be cleariii.

Formal requirements include:b.

Can't claim prior art (anything w/i the mass of publicly available information)i.Can't claim anything beyond actual discoveries of inventorii.

Broad as possible, but two restrictionsc.

REQUIREMENTSMERRILL V. YEOMANS (deodorized heavy carbon oils) Claims have the primary importance in determining the extent of the patent rights and therefore have primary, though not exclusive, role in determining infringement questions. The specification may also be used in construing the claims.

A.

Preamble (identifies what kind -- basic nature -- of invention is being claimed; tries not to limit)a.

Ex. An invention comprising elements A, B, and C1)Any embodiment of the invention having elements A, B, and C and any additional elements2)Selling a product with elements A, B, C, and D would infringe3)

OPEN CLAIM - "Comprising" i.

Ex. An invention consisting of elements A, B, and C1)Selling a variant of the product that also incorporates element D does NOT infringe2)Narrower than open type -- used lots of earlier inventions and prior art ("crowded art")3)

CLOSED CLAIM - "Consisting of"ii.

Covers a variant on the invention having element D only if element D did not make the variant essentially different from the claimed invention

1)

Variants having basic and fundamental additions fall outside scope2)Variants with less significant additions fall within3)

IN BETWEEN - "Consisting Essentially of"iii.

Transition (formally defines claim breadth)b.

List all elements of the invention (i.e. parts and features)i.Describe how they interactii.

Body (all the rest of the claim)c.

STRUCTUREB.

Dep. claims are narrower than independent claims ; andi.Must be valid under USPTO examination if the claims to which they refer are valid; and ii.Their validity in court is determined separately from the claim(s) it refers to; thus theyiii.act as insurance against invalidity of broad indep. claimiv.

Independent (stand alone) / Dependent Claims (specifies some feature of invention claimed in any other claim or claims)

a.

35 USC § 112 ¶ 6 - authorizes use of "means for doing X", where "doing X" is functioni.Means-Plus-Function Elementsb.

CLAIM TYPESC.

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35 USC § 112 ¶ 6 - authorizes use of "means for doing X", where "doing X" is functioni.35 USC 112, 6th paragraph – “An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents

thereof.”

TEST: Is supporting structure given in specification?ii.No "single -means" claim (claim w/ only one element in means plus format) as format must be used in combination with at least one other element

iii.

Covers glue, tape, nails, rivets, screws, and any other "means for" attaching one thing to another1)Limited by 112 to cover corresponding structure, material, or acts described in the specification and equivalents thereof

2)

Ex. "means for fastening together A and B" (the function is fastening)iv.

Means-Plus-Function Elementsb.

Long preamble set forth all elements of known invention (device or product)i.Transition phrase typically says "wherein the improvement comprises" or similarii.Body describes the improvementiii.

Jepson Claims (Ex Parte Jepson case not Read)- specially designed for claiming improvementsc.

PATENTABLE SUBJECT MATTER35 USC 101 - Inventions patentable. A.

SECTION 100 Definitionsa.Invention = invention or discovery-Process = process, art, or method (includes new use of known process, machine, manufacture, composition of matter, or material)

-

Machine = apparatus, generally has moving parts-Comp of matter = mixtures of substances like chemical compositions or metallic alloys (see Chakrabarty)-Manufacture = catch all category for human-made items without moving parts (i.e, hot drink sleeve)-

Markedly different characteristics from any found in nature andi.Having potential for significant utilityii.Composition of matter = all compositions of two or more substances and… all composite articles, whether they be results of chemical union, or mechanical mixture, or whether they be gases, fluids, powders or solids (common usage)

iii.

DIAMOND v. CHAKRABARTY (host bacterium w/ plasmids to breakdown oil)TEST: Anything under the sun that is made by man is patentable subject matter

b.

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.

ISSUE OF LAW - Judge decidesB.

LAWS OF NATURE, a.

PARK - DAVIS - If it doesn't appear in nature that way then it is patentable. (Purified is ok) District court case -- judge Learned Hand -- Pre Myriad

1)

MYRIAD CASE - After purification, the matter must be "markedly different than before." District court case -- up for appeal

2)

"DNA, in particular the ordering of its nucleotides, therefore serves as the physical embodiment of laws of nature - those that define the construction of the human body…the preservation of this defining characteristic of DNA in its native and isolated forms mandates the conclusion that the challenged composition claims are to unpatentable products of nature."

Compositions of Matter / Purified forms of natural products - no precedenti.

Compositions of Matter / Life Forms -- not nature's handiwork but man'sii.see Charkrabarty case above

PRODUCTS OF NATURE - newly discovered mineral or plant found in wild are not patentableb.

PHYSICAL PHENOMENAc.MATHd.MEDICAL PROCEDURES - patentable as process, but sometimes unenforceable see notes at tail of infringment (more of a remedy to patentable subject matter)

e.

GOTTSCHALK v. BENSON (algorithm to convert binary code decimals to binary numbers) - sole application was to program a general purpose digital computer… algorithm = procedure for solving mathematical problem… such is like a law of nature and not patentable

1)

PARKER v. FLOOK (method for computing an alarm limit) - court concluded an alarm limit was merely a number and all that was provided was a formula… once the formula was found to be in the prior art,

2)

Processes -- must be applied in a useful application (i.e. is it the right type of transformation as physical preferred) Utility must be substantial. Usefulness is not patentable.

i.ABSTRACT IDEAS - Machine and or transformation test plusf.

ExclusionsC.

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number and all that was provided was a formula… once the formula was found to be in the prior art, there was nothing left to patent since everything in prior art and abstract algorithm is only invention… insignificant post activity or limiting use to field not enough to make patentableDIAMOND v. DIEHR (computer-controlled process for curing synthetic rubber) - claims must be analyzed as a whole, not dissected into their component parts…while a well known mathematical equation was used, it was not the sole basis of the patent application… the application, curing synthetic rubber, involved other claimed steps of which the equation was a required part (held patentable)

3)

STATE STREET - OLD1)

obviousness of automating something on computeri)Prevalence of computers in everyday life, is exclusivity to broadii)

Tied to a machine / process - does it say computer specifically? Considera)

Transformation - does it transform article to different state? Physical change is favoredb)Next step unclear, wait for case law (m/t test not only test, as tech changes so should test) Back to must be applied (see processes)

c)

BILSKI v. KAPPOS (method for hedging risk in energy commodities) - if satisfies the machine-or-transformation test, then likely patentable. Not the sole test.

2)

Business Methodsii.

INFRINGEMENT ANALYSISBURDEN OF PROOF for INFRINGEMENT - preponderance of the evidence (51% convincing)A.TWO Questions to ask 1) Does the patent cover the accused activity?B.

HOW - Limitation by limitation, @ TIME= Filing date, time of invention, follow cannonsa.

MARKMAN v. WESTVIEW INSTRUMENTS (system for tracking clothing for dry cleaning)1)Jury found infringement based on expert testimony of meaning of "inventory". District Ct. ruled JMOL for non-infringement and made clear "inventory" in the patent meant "clothing" not "invoices". On appeal, Supremes concluded a)judges not juries better equipped to interpret legal documents and thus construe patent claims AND gave b) policy reasons for needing uniform interpretation case to case . No 7th Amendment right to jury trial for patent claims.CYBOR CORP v. FAS TECHNOLOGIES, INC. (appeal to infringement of patent on Cybor's pump)2)

Heard en banc to resolve the fact v. law issue as to if dist. Ct. needs to find factsa)Decided entirely legal, no findings of fact are made by dist. Ct. construction of claimsb)

Example one dist. Ct. decides one way and another a different way on same claimi)to review w/ deference to dist ct. as finding of fact, inconsistency would resultii)

De novo on appeal - consider anew as if not previously heard, no deference to trial ct. findingc)

Standard of Review: Appellate review of claim interpretation by Federal Circuit

ISSUE of LAW - Judge decides, construes claimsb.

PHILLIPS v. AWH Corp. (modular, vandalism-resistant wall panels for prison walls including "baffles")Patents' specification, intrinsic evidence, is primary basis for construing the claims ; prosecution history (less clear than spec. but ) informs meaning of claim: (1) how inventor understood invention; (2) whether in course of prosecution claim scope made narrower than otherwise would be.UNIQUE CONCEPTS, INC. v. BROWN (fabric wall cover assembly with linear border & corner border pieces) Fine line: proper interpretation of claims in light of written description v. improperly narrowing claims by reading in limitations from written description.

CORNING GLASS WORKS v. SUMITOMO ELEC. USA, INC. (optical wave guide for long-distance communications) Preamble in claim stated "An optical wave guide…". Def argued preamble not limitation when merely states an intended use. On review of the entire patent (specification in particular) to understand that inventor meant not any fiber but those for optical wave guide, Ct. held claim preamble gave "life and meaning" and provided further positive limitations to the invention claimed.

Patent itself (including spec and preamble) - disclosed embodiments; advantages/ purposesa)

Prosecution historyb)Prior art cited in patentc)

Intrinsic - part of public record of patent - considered not "litigation influenced" - usually sufficient to resolve and claim interpretation issues

1)

Expert testimony - not used to vary or contradict claim language; used to understand (Cybor Ct.)a)

Extrinsic - evidence outside official administrative record of patent's procurement -relied on only when claim terminology still ambiguous following review of public record

2)

EVIDENCE -Evidentiary sources used to interpret claimsc.

Interpret the claims (a.k.a. claim construction, construing claims) -- what do the claims mean?(1)TWO STEP ANANLYSIS

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Expert testimony - not used to vary or contradict claim language; used to understand (Cybor Ct.)a)Dictionaries, encyclopedias, and treatises - merely useful in claim construction (Phillips Ct.)b)

Interpreted from PHOSITA (Perspective of Hypothetical person of Ordinary Skill In The Art)1)

Exception: Patentee as on lexicographer -- patentee redefines a term, usually explicitlyGeneral Rule: PHOSITA meaning given to claims. Heavy presumption of ordinary meaning by Fed Cir.2)

Exception: unless prosecution history shows patentee amended to exclude preferred embodiment

Ct should not adopt claim interpretation that excludes preferred embodiment 3)

Existence of narrower dependent claim shows broader claim is not limited (claim differentiation)4)

CANONS - rules of claim interpretationd.

ISSUE OF FACT - juries decide infringementa.

limitation-by- limitation, each limitation of properly construed claim be met in accused device□If claimed invention is combination of elements, accused device must be fully assembled and ready for use to constitute a making under § 271 (a)

□

LITERAL infringement - found where accused subject matter falls precisely w/i express boundaries of claim. See if each interpreted limitation is there. If not, try equivalents to see if it is close enough.

1)

EQUIVALENT Infringement - Doctrine of Equivalents (DOE)2)

INSUBSTANTIAL DIFFERENCE /FWR RULE (function/way/result, triple identity, tripartite test) - 1) Is the element in accused doing substantially the same function, 2) in substantially same way, 3) and producing substantially same result? Look to the degree of substantiality of the differences.

a)

QUESTION OF FACT (jury) at TIME OF INFRINGEMENT - applies to unforeseeable equivalents to prevent unscrupulous copyist from making insubstantial changes and avoiding infringement

b)

economic/fairness - if patent avoided by making minor insubstantial change when copying invention, right to exclude by patenting not worth much.

i)

Linguistic safety when words not always optimal medium to convey inventive concepts, particularly pioneer, stat-of- the art technology where well-recognized vocabulary does not exist

ii)

POLICY Rationalesc)

TENSION - Claims intended to provide clear advanced notice to competitors of the scope of patentees right to exclude v. DOE extends the right to exclude beyond that denoted by literal boundaries of claim;

d)

RESOLUTION - application of DOE as equivalency of an element or part of the invention (All -elements rule) with one that is substituted in the accused -- the scope is not enlarged if do not go beyond substitution of equivalent elements. -- Warner-Jenkinson citing Grover Tank;

Presumed PTO had substantial reason related to patentabilityFirst.Burden on patent owner to give reason for amendment,Second.Unrebutted presumption of PHE results in complete bar to DOE for that element

Third.

WARNER-JENKINSON (silent/ unexplained record)A)

Rebuttable presumption that any equivalents to a narrowed claim limitation have been surrendered.

First.

QUESTION OF LAW - district ct to make factual findings, not jurySecond.

Objective inquiry - unforeeseable to PHOSITA @ time of amendment

1.

Depends on factual issues: State of art and understanding of 2.

UNFORESEEABLE - patentee demonstrates alleged equivalent would be unforeseeable at time of narrowing amendment

1.METHODS for overcoming presumption of complete estoppelThird.

FESTO III (amendments made infringer's two way sealing ring inferior and unforeseeable equivalent magnetic and one-way sealing ring)

B)

PROSECUTION HISTORY ESTOPPEL - patentee estopped from using DOE on subj. matter patentee surrendered in order to obtain the patent from USPTO; Common Form: narrowing amendments made to claims during prosecution; Judge-made law, TEST: Is there estoppel? If so, what is the scope? Scope:

i)LIMITATIONS on patentees ability to rely on DOE to establish infringemente)

WARNER-JENKINSON Co. v. HILTON DAVIS CHEMICAL CO. ( originally no PH limits; prior art PH>9.0; amended as PH 6.0-9.0; infringer PH=5.0)

RULE / INSTRUCTION: Use All - elements / All - limitations RULE -- met literally or by equivalentsb.

Compare properly interpret claims with the accused device (a.k.a. reading the claims onto the accused device) Take plain claim language and look at each below

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Depends on factual issues: State of art and understanding of PHOSITA @ time

2.

Expert testimony in district ct may be used & other relevant extrinsic evidence

3.

Essential (not tangential) if narrowing made to avoid prior art1.Focus: Patentees objectively apparent reason for narrowing claim2.Limited to intrinsic evidence (prosecution history record)3.

TANGENTIAL RELATION - rationale underlying the narrowing amendment bears no more than a tangential relation to equivalent in question

2.

May include short comings of language1.Although not limited, intrinsic evidence should be used2.

OTHER REASON - patentee could not reasonably be expected to have described the insubstantial substitute in question

3.

CORNING (optical waveguide -- positive dopant to core v. negative dopant to cladding layer to achieve RI differential) Def. argued it did not meet the language literally or by equivalents b/c it did not add any dopant or equivalent to the core. Ct. distinguished btwn "components" (what is used) & "limitations" and that DOE required equivalence in the latter. F/W/R - both methods created RI differential necessary for fiber to function as optical wave guide.

ALL-LIMITATIONS RULE-Every limitation of a claim is considered material and must be met in accused device to find infringement; DOE applied on a claim limitation-by limitation basis rather than to invention as a whole

ii)

Some recent Fed Cir. Decisions seem to equate patentee's reliance on DOE with an attempt to completely nullify or erase claim limitations of numerical specificity (i.e., when accused dimension is 47.8 % and infringement found under DOE when claimed dimension is a majority 50% or more as this would "vitiate" claimed requirement.)

VITIATION - DOE must not be applied so broadly as to effectively eliminate a particular claim limitation (Think Corning Case - totally deprive claim element of meaning then don't want that level of equivalents - totally vitiating or not?

iii)

WILSON (jury found Dunlop balls to infringe & no principle difference btwn Dunlop balls and prior art Uniroyal balls) Patentee has burden to show its expanded right to exclude does not encompass prior art. No infringement if the asserted scope of equivalency of what is literally claimed would encompass prior art.

A)

Begin w/ properly interpreted language of patent claim that is allegedly infringed under DOE

First.

Amend claim so just broad enough to literally read on accused deviceSecond.Analyze validity of hypo claim for novelty 102 and non-obviousness 103Third.

3 step TEST:B)

PRIOR ART (Hypothetical Claim Analysis)- One who merely "practices the prior art" does not infringe under DOE (i.e., making a device already in public domain.) Policy: Patentee should not be able to use DOE to encompass equivalents to claimed invention that could not have obtained from USPTO by applying for patent protection of that scope.

iv)

JOHNSON & JOHNSON (claimed a device with “a sheet of aluminum”; spec said "other metals" including stainless steel; accused: stainless steel) Rule: In spec but not claimed, then devoted to public; Can't extend thru DOE to cover. Bar applies to amendments too. Foreseeability -- it was foreseeable and should have put in.

DEDICATION TO THE PUBLIC - patentee may not attempt to cover through DOE any subject matter disclosed but not claimed in its patent app, thereby avoiding USPTO examination

v)

FORESEEABILITY - patentee may not encompass through DOE reasonably foreseeable alterations to claimed structure, when it had an opportunity to negotiate broader claim but did not.

vi)

presumption it is means + function / Rebutted if gives specific structure to meet the function

1.

Is same function performed? 1.If so, is done by same means or equivalent (insubstantial change) structure? Similar: F/W/R/ EXCEPT w/o function because to have

2.

Infringe TEST: 2.

If "Means / Means for" used, First.Test: Is it 112(6)?A)

MEANS PLUS FUNCTION- statutory limitation in 35 USC 112(6) - "…may be expressed as means or step for performing a specific function w/o recital of structure… and… shall be construed to cover the corresponding structure… described in spec and equivalents thereof."

vii)

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structure? Similar: F/W/R/ EXCEPT w/o function because to have literal infringement of means plus function claim, the function must be identical (not merely insubstantially different).

If "Means" not used / rebutted by recitation of function w/ no supporting structure

Second.

DON'T FORGET TO DO DOCTRINE OF EQUIVALENTS ON THIS NEXT !!!B)

Later developed technologyFirst.AL-SITE CORP v. VSI INT'L, INC. (fastening means for holding eyeglasses to stand using either rivet or button/hole vs. glue) Statutory equivalents of means element must be in existence at time patent is granted to be considered w/i literal scope of the claim, and therefore a literal infringement thereof. POLICY: Claims must "particularly point out and distinctly claim" the subject matter, so difficult to see how claim could literally encompass technology not yet in existence.SoftwareSecond.ARISTOCRAT TECH's AU PTY LMTD v. INT'L GAME TECH (Claimed "game control means" or "control means"; spec: any microprocessor… appropriate programming) Ct. held spec did not link asserted structure to any of the claimed functions b/c general purpose computers can be programmed in variety of ways to perform various tasks -- corresponding structure, the algorithm (not necessarily detailed) used with the computer, should have been disclosed.

Considerations: C)

112/6 v. DOE - Unlike DOE which compares patent claim limitation w/ accused product, section 112/6 entails a comparison of one structure material or act (that in specification) to another structure, material, or act (that in a product or process alleged to be covered by the patent claim) AT TIME OF INVENTION/FILING.

D)

RULE: Requires "control or direction" of 3rd parties' conducti)BMC RESOURCES INC. V. PAYMENTTECH L.P. (method processing debit trxns w/o personal code) Ct. looked for contractual relationship btwn parties as evidence of "control." Held no evidence of control. Policy: Though accused may contract steps out to 3rd party to avoid direct infringement under all limitations rule, law doesn't extend/reach to independent activity of parties b/c direct infringement is strict liability defense (limited to those who practice every limitation of claim) and to expansion of rules subverts indirect infringement statutes which require some form of intent.

ii)

Joint and Divided (vicarious liability)a)

MAKE (generally) - must be made (fully assembled) to infringe under 271(a)Ex. Chair with legs not put on. No infringing use.

1)

USE - must be employed for its functional purposeEx 1: flying object sits on table at trade show. No infringing use.

2)

Ex. 2: All parts tested, not used together. Yes, surprisingly!OFFER TO SELL - must be potential for acceptance (as required under UCC)3)Ex. Catalog = soliciting offers to buy, not offer to sell. No infringing use.IN U.S.(sells or imports) - companies must be located in U.S. or control of system in U.S. or each step performed in U.S.Ex. 1: Sale btwn two companies in U.S. for goods made/delivered overseas? Yes.

4)

Ex. 2: F.O.B. (free on board - title transfers b4 ships) in Germany, is it offer to sell in U.S.? Yes.

Use of system- place where control of system is exercised and beneficial use obtaineda)Use of method - each step must be performed in U.S. Some steps in Canada? Not met.b)

NTP v. RIM (cell towers in Canada, not in reading)

DURING THE TERM - from issuance to expiration5)Ex. 1: pre-patent sale / b4 issuance - not infringement

Send out catalogs. No (not offer to sell)a)Manufacture (not assemble) components outside U.S.b)Contact to acquire components. No. (no make use offer to sell)c)

Ex. 2: preparation to conduct activity after expiration

§ 271 (a) Except as otherwise provided in this title, whoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States, or imports into the United States any patented invention during the term of the patent therefor, infringes the patent.

a.

§ 271 (f) Covers loophole of making components in U.S. (no infringement under 271 (a) b/c ct. interprets b.

DIRECT - Use, Make, Sell - Vicarious liability(1)TWO questions to ask: 2) Is this the type of activity that infringes?C.

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Contact to acquire components. No. (no make use offer to sell)c)

271 (f) (1) Makes infringing the act of supplying "in or from U.S. all or substantial portion of… components… in… manner… to actively induce… combination…" overseas. (echo 271b)

1)

Abstract software is idea w/o physical embodiments (does not extend to instructions must be physically supplied)

a)

Master disk supplied was not installed on the foreign components (the copies were)b)POLICY: Since 271(f) created to address shrimp deveining problem, obtaining and enforcing foreign patents is best ay to prevent copying abroad & Congress better than courts to address "loophole" in favor of software makers

c)

MICROSOFT CORP. v. AT&T CORP (computer software sent from US to foreign manufacturers on a master disk to be copied for installation on computers made and sold abroad) Held no infringement under 271(f). Reasoning:

271 (f) (2) - specially made - Makes infringing the act of supplying "in or from U.S." a nonstaple component of patented invention" intending… combination… overseas. (echos 271 c)

2)

§ 271 (f) Covers loophole of making components in U.S. (no infringement under 271 (a) b/c ct. interprets make as complete assembly) and shipping over seas to assemble (No direct infringement, so no inducement or contribution)

b.

Materially changed by subsequent process b4 imported; or1)Trivial & nonessential component of another product2)Note from review: Method of writing book using MS Word does that get you all books?

§ 271 (g) "imports into U.S. , offers to sell, sells or uses w/I U.S. a product… made by process patented in the U.S… during the term" EXCEPT:

c.

ISSUE OF FACT (jury decides)a.EVIDENTIARY STANDARD : Preponderance of the evidence, 51%, civil standardb.

Deliberate resistance, indifference, actively disregard known risk, willful disregarda)Direct evidence not required, circumstantial okb)Affirmative acts required (beyond the sale?)c)

SPECIFIC INTENT (actively and knowingly) aiding and abetting another's infringement (ex. Instructions / info about how to make or use accused device/process);

1)

Actual or constructive KNOWLEDGE of the patent by inducer (necessarily imposed by specific intent)2)Case of DIRECT INFRINGEMENT in U.S. for each instance of indirect infringement (burden on patentee)3)

infringer knowingly(knew or should have known) induced infringement and possessed specific intent to encourage another's infringement

a)

Mere knowledge of other's possible infringement not enough (must prove a)b)

DSU MEDICAL CORP v. JMS CO., LTD. (guarded winged-needle assembly) Patentee burden to show

INDUCED - § 271 (b) - Whoever actively induces infringement of a patent shall be liable as an infringer. Requires:

c.

CONTRIBUTORY - §271 (c) - offers to sell, sells, imports into the US a component...for use in practicing a patented process, constituting a material part of the invention, knowing… especially made or especially adapted for use in an infringement of such patent...and not a staple article..."

d.

Good for nothing else besides infringementa)No legitimate public interest in it s unlicensed availabilityb)

Substantial non-infringing use (must be non-commodity / nonstaple component)1)

Awareness of patent (can be passive) and of relevant acts (not whether they infringe or not) a)If only adapted to be used in patented combination then presumed accused intended they should be used in combination of the patent

b)

Specific intent to infringe not requiredc)

Intent requires:2)

Case of direct infringement for each instance of indirect infringement (burden on patentee)3)

REPAIR/RECONSTRUCTIONa)ARO MFG v. CONVERTIBLE TOP REPLACEMENT CO. (fabric top assembly for convertible cars) Fabric top wore more rapidly (~3 yr.) than the rest of assembly and its replacement deemed repair not reconstruction (i.e., new making) of entire claimed assembly. Replacement of unpatented parts, having shorter life than available from the combination of as whole is characteristic of repair. No infringement on behalf of supplier b/c no direct infringement due to consumer's implied right to repair (sale of patent article carries with it an 'implied' license to use).COMPLIANCE w/STANDARD AS PROOFb)FUJITSU et al v. NETGEAR (recent Fed cir. Decision) If a patent covers a standard, and the product complies with the standard, then the patent covers the product and direct infringement can be

Considerations:4)

REQUIRES:

INDIRECT - direct infringer and indirect infringer both considered jointly and severally liable for the infringement under theory of joint torfeasance

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complies with the standard, then the patent covers the product and direct infringement can be inferred for purposes of contributory patent infringement, even without showing that anyone actually committed direct patent infringement.

Common law; Narrowly construed, rarely a success as defense1)Requires: absolutely no activity viewed as commercialization or based on profit motiveMADEY v. DUKE UNIVERSITY (Duke U. scientist used lab laser equipment patented by Dr. John Madey) Such use not exempt and university's non-profit status not dispositive, b/c university engaged in "legitimate biz… not solely for amusement, curiosity, or philosophical inquiry" of attracting top scholars, students, and funding.

2)

EXPERIMENTAL USE - defense asserted against infringement claima.

Purpose: delay to get FDA aproval; w/o generic drug manufacturers would have to wait to begin testing of equivalent drug until patent expired and patentee gets de facto extension of patent term

1)

Broad Interpretation: "reasonably related" to development and submission of info under Federal Law. Limited to intent to develop particular drug or effect -- not for use on basic scientific research.

2)

MERCK KgaA v. INTEGRA LIFESCIENCES I, LTD. (testing of patented peptides with potential cancer fighting activity) held 271e(1) allows clinical (human) trials as well as pre -clinical (test tube and animal) testing associated with development of new (or "pioneer") drugs. Properly construed 271(e) allows for experimentation at least where drug maker has reasonable basis to believe that the compound tested could be subject of FDA submission and experiments will produce info relevant to submission.Not limited to drugs; can be for medical device (regulated by same laws), if getting FDA approval for it3)PROVERIS v. INNOVASYSTEMS (system & apparatus for characterizing aerosol sprays in drug delivery) FDA approval was required with the aerosol drug delivery product whose spray plume characteristics the accused device measured. Because accused device itself was not subject to FDA pre-market approval, and therefore faced no regulatory barriers to market entry upon patent expiration, defendant was not privy to safe harbor relief under 271(e)(1).

FDA USE - 271(e)(1) - Not infringement if use of patented invention solely for purposes reasonably related to gathering data in support of an application seeking FDA approval for manufacture and sale of a generic version of a previously FDA-approved drug

b.

REPAIR - Intent of patentee for use of patented item does not matter c.JAZZ PHOTO CORP. v. INTERNATIONAL TRADE COMMISSION (refurbishing single use cameras bought overseas resold in US) Pl. argued camera intended for single use. Def. argued patent exhaustion - patented articles after sell no longer protected by patent laws & are property of owners for use, disposition, and preservation of utility (repair). Repair is affirmative defense. The right to make a substantially new article (deemed reconstruction) is retained by patentee. First sale doctrine under US patent right applies and patent is exhausted upon fist sale in the US.

Use of patented machine, manufacture or comp of matter in violation of such patenta)Practice of patented use of comp of matter in violation of such patentb)Or practice of a process in violation of a biotech patentc)

Narrowly defined - "medical activity" as "the performance of a medical or surgical procedure on a body, but… not…

1)

281 civil action for infringementa)283 injunctionb)284 damagesc)285 attorney's feesd)

Deprives the patent owner of any remedy for infringement (Direct or inducing as no remedy for2)

MEDICAL PROCEDURES - 287(c)(1)- see page 235 in study guide - Medical and surgical procedures are patentable subject matter under process, but a lobbied congress made some of these patents null and void under 35 U.S.C. 287(c). A "REMEDIES EXCLUSION"...

d.

Was acting in good faith anda)Reduced to practice at least 1 yr prior to effective filing date andb)B4 effective filing date, used commercially (use of a method in U.S. so long as connected with internal commercial use or arms length sale or other commercial transfer of use end result, whether or not subject matter accessible or otherwise known to public)

c)

Defense limited to cases involving method claims where accused infringer / defendant 1)

BUSINESS METHOD PRIOR USE RIGHTS - 273 - see p. 333 in guide - personal defense to charge of infringement, raised by non-patentee who used invention in business, typically under trade secret, prior to the patent owner's filing on the same invention.

e.

EXCEPTIONS to infringement(3)

VALIDITYBURDEN OF PROOF for VALIDITY - clear and convincing evidence (much greater than 51% -- matter is highly probable)Although issued patent entitled to rebuttable presumption of validity, it may be invalidated by litigation if the challenger

A.

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Although issued patent entitled to rebuttable presumption of validity, it may be invalidated by litigation if the challenger (who has the burden to rebut the assumption of validity) can establish, by clear and convincing evidence, that any of those statutory requirements were not complied with.

TWO STEP GENERAL TEST FOR VALIDITY: 1)construe claim; 2) Apply - decide if it is valid.B.

QUESTION OF FACT for UTILITY (jury decides)(1)

utility asserted contravenes generally accepted scientific principlesa.Ex. Mistake, A+B=A, where B <> 0 - applicant did not intend to patent fantastic invention but made mistakeIt is Inherently unbelievable undertaking b.NEWMAN v. QUIGG (perpetual motion machine - more energy output than input) Violated laws of thermodynamics and evidence produced that it operated at best 70% efficiency. It did not produce what is claimed to produce and inventions must operate in manner claimed.

inoperable species w/i genus - a general claim that includes one or more species w/I it that are inoperable. Fed cir. held presence of some inoperative embodiments does not necessarily render claim invalid as lacking utility as patent claims need not exclude all possibly inoperative embodiments. However, this may give rise to embodiment issue… see part d below and enablement.

1)

Utility v. 112 ¶ 1 - PTO will reject under 101 (no utility) and 112 ¶ 1 (failure to enable) b/c if invention has no utility then applicant could not have disclosed the manner and process of using the invention as required by 112. In litigation, usually treated as enablement.

2)

Other considerationsc.

OPERABILITY / INOPERABILITY - (patenting impossible or uproven, not useful b/c doesn't work) it does not work as claimed, then it is not considered useful in patent law sense. Invention rejected as inoperable subject matter if:

(2)

BENEFICIAL UTILITY - (patenting evil, not useful in right way) historically, must be moral and non-injurious. Now Ct. moves away from morals.

(3)

LOWELL v. LEWIS (construction of pumps) No need to prove invention is better than what is already out there, just that it is not frivolous or injurious to well being, good policy, or sound morals of society.JUICY WHIP INC. v. ORANGE BANG, INC. (slurpee-like beverage dispenser machine w/ transparent display chamber) Fed Cir. reversed trial cts. finding of deceptive and held invention benefitted consumers b/c decreased risk of contamination. The Utility standard only requires some minimal real world value and USPTO not proper arbitrar of morality.PRACTICAL UTILITY - (patenting useless, it works but no use for it) must have some real world practical use; not necessarily significant or extensive. TEST: 1) Is there specific utility (stated)? 2) Does it work (do what is claimed)?

(4)

PROCEDURAL BURDEN - USPTO bears burden of challenging applicants presumptively correct assertion of utility by showing PHOSITA would reasonably doubt asserted utility.

a.

BUREN SHIFTS - Applicant then must prove utility often w/ test data, experimental results, affidavits of experts, etc.

b.

IN RE BRANA (compounds intended for use in chemotherapy) Held may posses patentable utility though not ready for sales approval by FDA. Pl. used in vivo(test tube) evidence which is ok b/c stage in which useful often is way b4 ready to be given to humans. It is useful for further R+D. Policy: Requiring FDA approval would deter further research + patenting.

Specific utility - must show invention can provide a well-defined and particularbenefit to the public. a.Substantial utility - must show invention has significant and presently availablebenefit to the public.b.

IN RE FISHER (ESTs, expressed sequence tags, encoding protein and fragments in maize plants) Ct. characterized ESTs as intermediates that provided no information on structure and function of gene. POLICY: Patents not hunting licenses and hewed to specific and substantial utility requirement. If what is claimed is of no use to public why should monopoly be granted. For:

UTILITY - 101 "Useful" - invention is "useful" if it is capable of providing some identifiable benefit. (Juicy Whip Case) Policy: If invention is not very useful to society the cost temporarily borne by the public due to the patent is not excessiv e. Marketplace decides degree of utility not courts.

C.

112 P1 - Written Description, Best Mode, EnablementDisclosure is Quid Pro Quo for government to give the public the disclosure in exchange for granting a time -limited monopoly on the invention to the patentee. Patents provided greater rights than trade secrets which ultimately may be lost for failure to maintain secrecy of the information.

D.

QUESTION OF LAW (judge decides, fed cir. reviews de novo - no deference); Except for undue experimentation which is question of fact and where jury makes all underlying factual determinations and judge decides (even at trial ct. level). Fed Cir. review of factual findings is for clear error.

a.ENABLEMENT - enable to make and to use commensurate w/ scope of claim(1)

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judge decides (even at trial ct. level). Fed Cir. review of factual findings is for clear error.Assessed AT TIME OF FILINGb.

Must be able to make and use w/o undue experimentation1)

Should be commensurate w/ scope of the claim (Wands factors) meaning scope of claims must bear "reasonable correlation" to the scope of enablement described in the spec to PHOSITA. (In RE FISHER)

a)

POLICY: Goal is to put public in "possession" of the invention by providing PHOTISTA with how to make/use it. Only fair that applicant must seek right to exclude commensurate with inventive contribution as disclosed. BALANCE: Too much exclusion, and resulting disincline to conduct follow-on research in this area; Patent so narrow (pertains only to specific embodiments mentioned) it encourages imitation w/ only minor change and patent of no economic value.

b)

Quantity of experimentation necessaryi)Amount of direction or guidance presentedii)

Working - results of experiments / tests actually performedOne.Prophetic - written in future tense and suggest how to go about test in future; based on notion that some applications of known techniques so predictable that they can be "prophesied" by PHOSITA.

Two.

Presence or absence of working examples - simple specific, illustrative instruction for how to make/use

iii)

Nature of the inventioniv)State of the prior artv)Relative skill of those in artvi)

Predictable = mechanical / electrical; based on well understood laws of physics, etc.; adequate description of 1 embodiment, easy to predict how others made/used

One.

Unpredictable = chemistry /biotech ; minor change in physical structure makes major change in function/property; thus must provide greater degree of info on make/use

Two.

Predictability or unpredictability of the art - look at elements of invention rather than whole and decide...

vii)

Breadth of the claimsviii)

WANDS FACTORS - analyzed by USPTO during ex parte (for only one party) prosecution of patent app and during litigation challenging validity. In latter, decided by jury as underlying facts for judge to make legal decision.

c)

How much experimentation to enable is undue? 2)

TEST - PHOSITA….c.

Different than enablement for anticipation for prior art (see that section). If you can't enable, the public doesn't have it.

d.

Doesn't work (inoperable, undue experimentation) - did not experiment enough to get breadth1)JANSSEN v. TEVA(method for treating Alzheimer's disease with galanthamine) Held results from patent's proposed animal tests (Prophetic example) could not be used to establish enablement b/c they were not available at the time of the application. Further, if patent claim fails to meet the utility requirement because is not useful or operative, then it also fails to meet the how-to-use aspect of the enablement requirement. Rare for a patent to be invalidated on grounds of utility during litigation.Unbound limits - undue breadth or too broad for what was achieved2)

Potency v. Purity - if 75% pure okay to treat humans - should be able to get 75-100% b/c natural upper (upper bound) limit. Potency is different in this regard.

a)

IN RE FISHER (ACTH w/ potency 1.11 to 2.3 for treating arthritis and pathological conditions in humans) held the preparation of ACTH having potencies much greater than 2.3 not enabled, and the claimed recitations of potency of "at least 1" render the claims insufficiently supported. POLICY: Okay to dominate the future patentable inventions of others where based in some way on inventor's teachings (i.e., any improvements are made possible by his work); however, not okay to achieve dominance by claims that are insufficiently supported b/c includes all such compositions w/ potency greater than 1.0 including future compositions having potencies far in excess of those obtainable from his teachings plus ordinary skill.

Genus/ species issue - find 2 acids, do you get all acids or just the two found. How many species must be disclosed to get the genus / generic claim?

3)

IN RE WANDS (methods for the immunoassay of HBsAg by using high-affinity IgM monoclonal antibodies) held no undue experimentation because experiments carried out three times and were successful each time in making at least one antibody that satisfied all of the claim limitations. Boils down to is it "fairly in play" meaning is it fair and should one be expected to teach that (see In re Fisher Policy argument). Common argument for patentee: once you found one , routine to find the others.Too many inoperable embodiments (some work, but not enough work)4)

Common Attacks against enablement:e.

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Too many inoperable embodiments (some work, but not enough work)4)AMGEN v. CHUGAI PHARMACEUTICAL CO. (broad claims covered all possible DNA sequences that would encode w/ amino acid sequence possessing property to increase production of red blood cells) held invalid b/c number of claimed DNA encoding sequences could be enormous and it is insufficient to support broad claim by having made the gene and handful of analogs whose activity is not clearly ascertained. Decision based heavily on the unpredictability of the art and the court noted that after five years of experimentation, Amgen was still unable to specify which analogs have the biological properties set forth in the broad claim. Nascent and After-Arising Technology - claims later asserted to cover embodiments of invention that were not in existence when patent application was filed (ex. Invention of LCD monitor should it extend to holographic displays). Enabling disclosure must provide a specific and useful teaching b/c PHOSITA has little to no knowledge independent from the patentee's instruction. Runs into undue experimentation and inventor possession at time of filing (written description) issues if not. Also see 112 P 2 for definiteness below.

5)

QUESTION OF FACT (jury decides) - deferential standard of review by Fed Cir.a.Assessed as of FILING DATEfrom prospective of PHOSITAb.

Does it show that an invention is there? "possession of the invention at the time of filing"1)Claim by claim - what is defined as invention in the claims? Note: patents issue w/ claims of different filing dates. Later app gests 1st app filing date if it meets 112(1) otherwise claim gets later date.

2)

obviously art - recognized equivalents are not prohibited + considered w/I scope of inventor's possession

a)

Need not be in words VAS-CATH v. MAHURKAR (Catheter w/ double tubes of diameters w/I specified range of ratios) held drawings in earlier filed design patent app provided adequate written description despite showing only one particular ratio cited in utility patent claims. Expert testimony showed PHOSITA viewing drawings know on2ly certain diameter ratios would work.

b)

CONSIDERATIONS: 3)

TEST: To PHOSITA..c.

amendment of old application, new claims added to pending app1)priority claim in new application (see VAS-CATH above)2)Interference - where issue is support for a count in spec of one of more parties3)Un- amended originally filed claims (new development)THE GENTRY GALLERY, INC v. THE BERKLINE CORP. (dual reclining chairs facing same direction in sectional w/ console for controls) Held broad claims not supported by written description b/c inventor was not in possession of "other locations of controls" at filing. Provided for only minor variation in location (top, side, front) and only discernible purpose for console was to house controls.

4)

UNIVERSITY OF ROCHESTER v. G.D. Searle & Co. (inhibition of PGHS-2 in humans) Held failed to describe compounds or molecules that would inhibit, pathway only identified. POLICY: writ description teaches as "quid pro quo" for excluding public from practice of invention for limited time.GENUS / SPECIES - how many representative # do they need to meet requirement? Ex. Could one get mammalian if not in possession of human (they have monkey, giraffe, etc?)

5)

REGENTS OF UNIVERSITY OF CALIFORNIA v. ELI LILY CO. (claimed microorganism containing cDNA sequence for rat insulin and gave example stating generally how to obtain human cDNA sequence which(differs from rat version by 12 out of 300+ DNA base pairs) Held PHOSITA can not visualize or recognize the identity of members of the genus and a sufficient description of a genus requires disclosure of either a representative number of species falling within scope of the genus or structural features common to the members of the genus so that PHOSITA can recognize members of the genus. (Sounds like enablement!!) Note: Could get genus if can show not product of nature/isolation cDNA species; if can't get CDNA then can't claim species.ARIAD PHARMACEUTICALS, INC. v. ELI LILY & CO. (regulation of gene expression) held level of detail required in written description varies depending on nature and scope of the claims and complexity and predictability of the relevant technology. When a patent claims a genus by its function or result the spec must recite sufficient materials to accomplish that function.

ARISES in d.

WRITTEN DESCRIPTION - ensures claims amended or added after filing date have adequate support (explicit or implicit) in written description of originally filed application. (traditional view) POLICY: guards against overreaching of inventors (see Univ. of Rochester below).

(2)

BEST MODE - enablement plus requirement is an obligation to disclose the best way known to inventor as of filing date of "carrying out the invention."

(3)

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QUESTION OF FACT (jury decides - clear and convincing evidence needed)a.Assessed a TIME OF FILINGb.

Subjective: Did inventor have best mode (preferred embodiment) at time of filing? (inventor state of mind)

1)

GLAXO INC. v. NOVOPHARM LTD. (specific crystalline form of ranitidine hydrochloride useful for ulcers) ct held best mode requirement satisfied b/c inventor could not be held for responsible for best mode contemplated by assignee company. The best mode belongs to inventor; if congress wanted it differently then the they would change the statute to broaden from inventor. Beware of inequitable conduct.Objective: Assuming best mode exists, does the disclosure enable PHOSITA to practice the best mode? (same as enablement… make and use the best mode of invention w/o undue experimentation)

2)

CHEMCAST CORP. v. ARCO INDUS. (grommet for sealing openings in sheet metal panels) held b/c patent never disclosed how to make and use claimed grommet with proprietary R-477 inventor preferred and instead broadly stated materials w/ hardness of 70 shore plus as suitable then best mode not enabled. Inventor did not know proprietary formula for R-477 (material essential not just production detail) so obligated to disclose specific supplier and trade name of material.SPECTRA-PHYSICS, INC. v. COHERENT, INC. (improved laser in which the discharge tube had copper cups to help conduct heat) invalidated patents b/c described soldering or brazing as way to attach cups to discharge tube, but did not describe best mode for doing so as brazing with copper-silver composition in tightly-controlled braze cycle. Coherent argued braze cycle unique to its ovens and meaningless to others with different ovens, but this did not overcome ct's finding .

TEST (2 parts):c.

POLICY: restrains inventors from applying for patents while concealing from public preferred embodiments of their inventions. Disclosure of best mode puts PHOSITA in commercially competitive position with holder of expired patent. Most foreign countries do not have best mode requirement.

d.

How to disclose - sometimes referred to as "preferred embodiment" but not required to point it out 1)RANDOMEX, INC. v. SCOPUS CORP. (portable apparatus for cleaning disk packs; no claim on cleaning solution) indiscriminate listing of best mode along with other modes okay and did not violate best mode requirement b/c invention neither added nor claimed to add anything to the prior art respecting cleaning fluid. DISSENT: May run afoul of best mode obligation if best mode is listed indiscriminately among so many other possibilities as to result in "burial" or effective concealment. POLICY: Concealment problematic whether intentional or not.Scope of enablement in comparison to scope of the claims - runs foul when failure to disclose aspects of making and using the claimed invention where the undisclosed matter "materially affected" properties of claimed invention.

2)

CHRISTIANSON v. COLT CORP. (parts and mechanics of certain M16 rifles) best mode known to inventor is mass production but held one does not have to enable trade secrets to comply with disclosure of best mode b/c mass production is not invention; only disclosure of claimed invention is required. Accuser argued that Colt's non-disclosure of its trade secrets in patent app amounted to extension of its exclusionary rights. In this case, mass production is merely a production detail and therefore its disclosure is not needed for carrying out the invention. APPLIED MEDICAL RESOURCES v. U.S. SURGICAL CORP. (trocar seal technology with seal limitations and preference for certain type of material for seal) Asserted failure to disclose preferred lubricant for seal, but here lubricant plays no role in functioning of the invention claimed. Obligation to disclose nonclaimed elements only when necessary to the operation or to carry out the invention to which the patent is directed. Where invention relates only to a part of a device applicant is not required to disclose a nonclaimed element necessary to operation of the overall device, but not necessary to operation of invention to which patent is directed.

Considerations:e.

date of "carrying out the invention."(3)

QUESTION OF LAW (often decided in Markman hearings during claim construction)(1)POLICY: Need to know what patent covers to not infringe it(2)

Claims read in light of written description, would reasonably give notice to PHOSITS of the scope of the patentee's right to exclude others

a.

After patent issues, statements by inventor about what she intended or understood claimed language to be are irrelevant

b.

TEST: Would PHOSITA understand what is claimed?(3)

How definite should it be to PHOSITA? - as accurate as subject matter permits and satisfies policya.Considerations:(4)

112 P 2 - Definiteness - a claim must "particularly point out and distinctly claim" the subject matter of inventionE.

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How definite should it be to PHOSITA? - as accurate as subject matter permits and satisfies policya.ORTHOKINETICS, INC. v. TRAVEL SAFETY CHAIRS, INC. (portable folding wheelchair for kids easily installed and removed from car seat) dimensions of chair to be altered to make of car so applicant claim recited "...is so dimensioned as to…." and accused alleged invariability dimensions as indefinite under 112(2). Held so long as "accurate as the subject matter permits" and PHOSITSA could reasonably determine if particular chair infringed claim, then sufficiently definite. No requirement to list dimensions to fit into all automobiles in the patent or its claims (patent not production spec).Adjectives like "substantially" and "about" -- not uncommon in usageb.STANDARD OIL CO. v. AMERICAN CYANAMID CO. (catalytic process for acrylamide, a precursor for compounds used in environmental apps and industry) term "partially soluble" not so clear in spec but established in industry, but expert testimony showed difference between "slightly soluble" and "partially soluble" as not interchangeable. Ct. held indefinite b/c term to vague to past muster. Ct. noted own lexicographer rule that applicant can make up and define new words to describe invention, but here the words were not defined in patent which would have made all the difference.Errors in claims - sometimes obvious typo renders indefinite when (think specific DNA sequence)c.Antecedent Basisd.Difficult to see how a claim that literally encompassed technology not yet in existence could satisfy the statutory requirement for claims in 112 (2)

e.

Considerations:(4)

Burden of Proof - USPTO must negate a presumption of novelty / party attacking validity of patent has burden of persuasion to overcome statutory novelty presumption

(1)

POLICY - We do not permit withdrawal by a patent applicant of technology already in public's possession.(2)

Anticipation - when one or more novelty provisions under 102 is triggered, the invention is anticipateda.Novelty v. loss of right - Loss of right means patent may be lost even though the invention is technically, novel. Subsections b, c & d are loss of right.

b.

Invention date - USPTO: presumed filing date = invention date by constructive RTP, unless applicant atedates (swears behind) a 102 (a) or (e) reference / Litigation: must connect conception w/ RTP by reasonable diligence

c.

Critical date - one year prior to the applicant's filing date for the purposes of 102(b) and (d)d.Actual v. constructive RTP - Construction of physical embodiment that works for intended purpose v. patent app claiming invention has been filed with USPTO

e.

Antedating (swearing behind) - applicant can submit affidavit or declaration of prior invention to establish that she invented subject matter of a rejected claim prior to the effective date of the 102 (a) or (e) prior art reference. Must establish either by (1) showing actual RTP prior to effective date or (2) conception prior to effect date coupled with due diligence up to actual RTP or filing date of patent app.

f.

Definitions:(3)

NOVELTY / LOSS OF RIGHT TEST (2 part):(4)

STEP ONE: to evidence anticipation of claimed invention under 102, either... 1)

Interpret limitationi)Apply and see if it is thereii)

TEST: single prior art reference must disclose (explicitly or inherently) every element of that invention, arranged as in the claim

a)

Example: widget comprising A attached to B by C. Claim not anticipated by two prior art references A attached to by D and second showing D is equivalent to C. This may be obvious (103) but it is novel.

b)

STRICT IDENTITY RULE: explicit disclosure of elements in reference

OR

TEST: Must be certain that missing descriptive matter is necessarily present in thing described in reference AND that it would be so recognized by PHOSITA

a)

EXAMPLE: claimed container structure with plurality of plastic ribs that are hollow compared to prior art reference of container with plastic ribs made by conventional blow molding techniques. no explicit disclosure of hollowness of ribs in prior art. Anticipates if extrinsic evidence can show that ribs made by this method would necessarily be hollow.IN RE ROBERTSON (diaper w/ fastening mechanism for disposal) reasoning one of the fastening means in the prior art could also operate as a third fastening means to close the diaper for

ANTICIPATE BY INHERENCY: If disclosure of individual elements not explicit, it can be inherent and gap in reference may be filled with recourse to evidence extrinsic to the reference.

PART 1 OF TEST: Does it anticipate? (another 2 step test)a.

NOVELTY AND LOSS OF RIGHT - 35 U.S.C. 102 - Novelty = a,e,g; Statutory bar= b,c,d; Sui Generis = fF.

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means in the prior art could also operate as a third fastening means to close the diaper for disposal as claimed in app in question is insufficient for inherency b/c inherency requires that the prior art disclosed or extrinsic evidence make clear the third fastening means was "necessarily" present, and would be so recognized by PHOSITA .IN RE SCHREIBER (conical popcorn container that dispensed only a few kernels at shake of package) anticipated by Swiss patent (prior art) on conical dispensing top for dispensing oil from a can b/c prior art did not inherently lack the functionality defined limitations recited in the claim and nothing in the prior art suggested oil was the only use.

ACCIDENTAL ANTICIPATION - Single, appreciated prior uses and prior uses that were a consistent result of that which was intended, regardless of appreciation so long as the involved product in issue is known…, are anticipatory.

One.

NOTE: Could argue claim doesn't cover trace amounts in transient form - not "necessarily present", but (forget inherency) can't remove running of reactor from prior art.

IN RE SEABORG (new transuranic element Americium) although trace amountsproduced in Fermi reactor (prior art), it was not detected or identified as such , and thus the prior art does not anticipate.

TILGHAM v. PROCTOR (new process for breaking down animal fat into glycerin and free fat acids for candles and soaps) no anticipation from lubrication of steam engine lubricated with fat b/c breakdown of acid accidental and not realized (what was made or how it was made) by PHOSITA.NO RECOGNITION REQUIRED of the inherent disclosure by PHOSITA in the prior art at the time prior art is created - Fed. Cir.

Two.

NOTE: Distinguish Tilghman by did not show conclusively that claimed process occurred in prior art. Prof. Lowrie: Tilgham bad law; can't remove from prior art

SCHERING CORP. v. GENEVA PHARMACEUTICALS, INC. (DCL as metabolite in patient's body) Description of method that if done then inherently produces claimed material

CONSIDERATIONS:b)

ISSUE OF FACTa)TEST: Whether PHOSITSA can take prior art description and combine with own knowledge in the art so as to possess the invention?

b)

Example 1: If Star Trek teleporter patented, did the movie anticipate. Not enabled, so did not remove from public's hands.Example 2: Inventor files claiming new chemical compound X and prior art reference describes only chemical formula for X but does not describe how to make X, the reference does not anticipate because it is not enabling.

Need not be actually made to satisfy the enablement requirement i)Example: For public use or things being sold (like Aspirin) in public's hands so anticipates even if public doesn't know how to make it. For printed publication, does not anticipate unless enabled.USE OR UTILITY NOT REQUIREDii)IN RE HAFNER (new chemical compositions) for which applicant could not claim the benefit of an earlier German filing date b/c a disclosure lacking specific, substantial utility or how to use is adequate to anticipate a claim to either the product or the process, but is not sufficient to support the allowance of such claim under 112.

112 102

Patent can fail if not enabled Description alone w/o utility will anticipate

Must be commensurate w/ claim scope Printed pub w/I range will anticipate

Law Fact

Wands factors Wand factors w/ scope of claim don't apply

Differences between 112 enablementiii)

CONSIDERATIONSc)

STEP TWO: ENABLEMENT STANDARD - quality of description - Prior art must provide an enabling description of current claimed invention to anticipate.

2)

NEW USE OF OLD PRODUCT RULE - cannot patent old products b/c discover new usei)IN RE CRUCIFEROUS SPROUT PATENT LITIGATION (johns Hopkins researches discovered cruciferous sprouts rich in glucosinolates to fight cancer and try to patent new use of old product) anticipated b/c describe a process for germinating sprouts from certain seeds and

CONSIDERATIONS3)

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NOTE: new process patents sometimes granted for old products, but process patents subservient to product patents b/c product patents cover all uses (even unforeseen uses). User of process will need to obtain license from product patent holder.

harvesting sprouts as a food product which as a process was done long b4 patentapplication. POLICY: Broccoli farmers should not wake up and find that new patent bars them from what they've done for years.

Non-informing Productsii)Markush Groups - list of things not of same class (chemicals by structural formula) but where swapping things from list results in same asserted utility; members of group can be so unrelated and diverse that a prior art reference anticipating the claim w/ respect to one of the members would not render the claim obvious under 103.

iii)

GENUS / SPECIES RULE: species anticipates genus, but genus does not necessarily anticipate species. Why? b/c the genus as a whole cannot be new if one or more of its species are is old.

iv)

Note: latter may be grounds for obviousness rejection which can be overcome if applicant can show some difference in structure/function of nail v. other species in the genus or unexpected result that flows from selection of nail species.

Ex. the prior art reference (say a nail for fastening) is considered anticipatory and prevents applicant from obtaining the generic claim (a fastening mechanism) ; Conversely, if the prior art reference is the fastening mechanism, unless it expressly or inherently includes a nail, there is no anticipation b/c strict identity rule not met.

PART 2 OF TEST: Is it prior art?b.

Anywhere - patented or described in printed pub (both). i)US - knowledge or use (102 a), public use or on sale (102 b).ii)POLICY: Personal activities (knowledge/use/sale) in foreign country harder to disseminate to US public then printed materials like pubs and patents. Search costs too great for US citizens to find knowledge /use abroad.

iii)

WHERE? a)

Under 102 a must involve act by someone other than applicant; i)102(b) can be by anyone. An inventor's own work can only be use against him as prior art if it constitutes a 102(b) bar.

ii)

WHO? b)

B4 invention for 102 (a) and i)over 1 year prior to filing for 102 b (critical date)ii)

WHEN? c)

JOCKMUS v. LEVITON (issued patent alleged anticipated by picture of lamp in shape of candle w/o words in a commercial catalogue)found anticipated b/c catalogue distributed generally to a trade is a publication and likely to go direct to those whose interests make them likely to observe and remember whatever it may contain that is new and useful. Also no rule that figures can't be anticipation of mechanical inventions.

i)

IN RE BAYER (Masters thesis submitted to university library but not yet indexed and placed in the public catalogue) not pub b/c could only be found by one having been informed of its existence by the faculty committee and not by means of the customary research aids available in the library and probability of public knowledge of content virtually nil.

a)

IN RE CRONYN (three undergraduate theses describing invention made available in main library of college and library of chemistry department but not indexed or cataloged)such "availability" not sufficient to make them accessible to the public b/c listing titles of thesis on index cards (and not theses themselves) by author in a shoebox is not indexed or cataloged in a meaningful way since only research aid was the student's name which bears no relationship to title of paper.

b)

NORTHERN TELECOM, INC. v. DATAPOINT CORP. (four reports about military computer system housed in a corporate library) not pub b/c although not under security classification, access to the library was restricted to authorized persons of the

c)

IN RE HALL (Single copy of doctoral thesis properly cataloged in the collection of German University library open to public) thesis was sufficiently accessible at least to the public interested in the art ("public accessibility")

ii)

CONSIDERATIONS for 102 a and 102 b -What is printed publication for prior art purposes? - sufficiently accessible to the public interested in this particular technology (interested public could obtain info if they wanted to)

d)

Is it 102 a or 102 b?1)

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security classification, access to the library was restricted to authorized persons of the company.

IN RE KLOPFENSTEIN (Academic conference poster presentation on display three days but not reproduced or distributed)distribution or indexing not required in this case to be sufficiently accessible to public b/c presentation had been made publicly accessible to large numbers of viewers experienced in the art with no stated expectation that information would not be copied or reproduced.

iii)

Length of time of displaya)Expertise of target audienceb)Existence (or lack thereof) of reasonable expectation of no copyingc)Simplicity or ease to copyd)

FACTORS: (QUESTION OF FACT)

NOTE: entirely oral presentation w/ no slides or handouts, probably not; transient display of slides accompanying oral presentation, maybe not; slides with six copies handed out, yes -MIT v. AB Fortia

KNOWNi)NATIONAL TRACTOR PULLERS ASS'N v. WATKINS (Weighting device for tractor pulling sleds) alleged earlier drawings of the device on the underside of a kitchen tablecloth that were never printed or otherwise published and never reduced to practice are not prior art b/c "to be known" under 102(a) constitutes prior public knowledge which is reasonable accessible to publicand is not satisfied by knowledge of a single person or a few persons working together.USEDii)ROSAIRE v. BAROID SALES DIVISION, NATIONAL LEAD CO. (prospecting for oil or other hydrocarbons) whether invention used extensively in the field (drilling holes, etc.) without any deliberate attempt at concealment or effort to exclude the public or instructions of secrecy to employees performing work and suspended to examine data for further testing in different geological area is failed experiment. prior art b/c the program was not suspended to test worth of method but to examine data produced by use of method involved and work was done openly in ordinary course of activity for company.W.L. GORE & ASSOCIATES v. GARLOCK INC. (prior use by another of a machine conforming to elements of Gore's claim) the nonsecret use of a claimed process in the usual course of producing articles for commercial purposes is a public use. POLICY: if not then patent could issue and stop the first inventor from continuing to practice her invention. Note: Here use was kept secret -- see on sale bar under 102b.

KNOWN or USED BY OTHERS - to anticipate, prior knowledge or use of an invention by others in this country must have been knowledge or use that was accessible (not done secretly) to the public

a)

PATENTED ANYWHEREb)REEVES BROS. v. U.S. LAMINCHING CORP. (lamination of polyurethane foam to fabric by use of flame heat and improvement to method and apparatus for doing so) Gebrauchsmuster (GM) issued in Germany alleged to anticipate but it is patent not a publication. Where a foreign utility model qualifies only as "patented" prior art, then it may be used only for what it claims not for what is disclosed in their specifications.

102 a - Novelty - B4 invention: known or used by others in US; patented or printed publication in US or abroad

2)

Must not remove from public inventions freely available through prolonged public use or sales activity

i)

Prompt, widespread disclosure desirable so inventor must file promptly or loose rightii)Prevent commercially exploiting invention substantially beyond statutory period (17-18 years)

iii)

To give inventor grace period to evaluate invention for marketabilityiv)

POLICY:a)

Grace period or safe harbor - one year time period between critical date and filing date during which invention may be patented, described in printed pub, in public use, on sale, without triggering 102 b and a loss of right to patent.

b)

TEST: Did inventor keep control (no intent to abandon or dedicate to public) of invention?i)

PUBLIC USE - any use by a person other than the inventor who is under no limitation, restriction or obligation of secrecy to the inventor. Note: inventors own acts can trigger bar too

c)

102 b - Statutory Bars - over 1 year prior to filing: patented or printed publication in US or abroad; in public use / on sale in US

3)

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TEST: Did inventor keep control (no intent to abandon or dedicate to public) of invention?i)EGBERT v. LIPPMANN (improved women's corset worn by inventor's intimate friend) held b/c inventor gave (or sold) to another to be used w/o restriction or injunction of secrecyand it was so use, then that use is public even though the use and knowledge may be confined to one person.MOLECULON RESEARCH CORP. v. CBS, INC. (inventor of Rubik's cube puzzle showed paper mock-up to friends at graduate school and wooden mock-up to employer) held not given over to free and unrestricted use by others b/c inventor at all times retained control over puzzle's use, used it privately for own enjoyment, and never allowed others to use it in a place or time when no legitimate expectation of privacy and confidentiality.

Secret use that is commercial in nature is also barred.a)EXPERIMENTAL USE NEGATION -use of an invention "only by way of experiment" that is pursued with bona fide intent of testing the qualities of the invention. doctrine negation of, rather than as exception to 102(b) bar.

b)

Distinguish w/ Egbert (corset) - not under hi control, getting benefit and not trying to improve/test, no experimental use after reduction to practice

CITY OF ELIZABETH v. AMERICAN NICHOLSON PAVEMENT CO. (tested method of paving streets using wooden blocks in a checkerboard arrangement by paving well-traveled road in Boston) Despite fact inventor did not file a patent application claiming the invention for six years after starting the test, held valid b/c invention was of the type that could not be satisfactorily tested anywhere besides a public place like a road and evidence showed bona fide intention to test invention and that inventionkept under inventor's control at all times.

BAXTER INTERNATIONAL v. COBE LABORATORIES, INC. (sealess centrifuge for separating blood into its components designed by fellow scientist was used by another scientist in experiments in lab) public use and not experimental b/c lack of effort to maintain invention as confidential coupled with free flow of visitors to lab who observed invention in use and who were under not duty of confidentiality.

Considerationsii)

QUESTION OF LAW with underlying factsi)

Must be subject of a "commercial offer" for sale --- one which could be made into binding contract by simple acceptance (assuming consideration)

a)

Already RTP ori)At least reduced to drawings (or written description that would enable PHOSITA to practice the invention) Note: application must be in

ii)

Must be ready for patentingb)

TEST (2 part):ii)

PFAFF v. WELLS ELECTRONICS, INC. (computer chip socket idea marketed commercially before reducing to practice) on sale bar applies when two conditions are met b4 the critical date: 1) must be subject of commercial offer for sale (here purchase order suffices) AND2) invention must be ready for patenting either by proof of RTP b4 critical date or by proof that prior to critical date, inventor had prepared drawing or descriptions sufficient to enable PHOSITS to practice invention (here drawings given to manufacturer suffice). POLICY: Inventor must not exploit invention commercially after ready for patenting; he must be content with secrecy (trade secret) or legal monopoly not both.CONSIDERATIONS - Ambigous offer/ patented item not for saleiii)W.L. GORE & ASSOCIATES v. GARLOCK INC. (process patent for rapidly stretching teflon allegedly infringed and defendant raises activity of thirdparty as defense) third party built unpatented machine which stretched teflon into tape. Machine was sold to another company under orders to keep machine workings and know-how secret; said Company sold tape produced by secret machine. Held tape for sell not whatever process was used in producing it and no evidence that public could learned claimed process by examining tape.MAHURKAR c. IMPRA, INC. (improved double lumen catheter licensed prior to critical date to company) held no on sale bar despite company's prototype being a RTP b/c licensee company completed sham sale to satisfy terms of license agreement which did not result in commericialization or place invention in public domain.

ON SALE BAR - sold or offered for sale in U.S. more than one year prior to filingd)

102 c - Abandonment - rarely seen today b/c an affirmative action of the inventor (the only way to trigger this bar) also triggers a 102 b bar. …. More… see guide

4)

102 d - Foreign Patenting - first patented or caused to be patented in foreign country prior to U.S filing 5)

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Inventor files app in foreign countryi)Files app in US more than one year laterii)Foreign patent issues before US filing (claims are directed to same invention in US app)iii)

Bar triggered when:a)

POLICY: promotes prompt entry into US patent system once inventor has filed in foreign countryb)Rarely see today, but may arise in Geschmauchmusters (GM) and other foreign patent-like rights granted if inventor delays in seeking US patent protection. See

c)

102 d - Foreign Patenting - first patented or caused to be patented in foreign country prior to U.S filing date more than one year prior...

5)

TEST - Whether previous disclosure made it impossible for later applicant to claim invention at a later date?

a)

ALEXANDER MILBORN CO. v. DAVIS-BOURNOVILEE CO. (improvement in welding and cutting apparatus) Not first inventor b/c another earlier patent disclosed but did not claim invention. Rationale: the patentee must be the first inventor, why treat published patent different then if disclosed in periodical? Obviously one in not first inventor if somebody else has made a complete and adequate description of thing claimed b4 earliest moment which alleged inventor can carry his invention back. CONSIDERATION for FOREIGN PRIORITY - in cases where previously filed foreign application on same invention establishes priority date of U.S. app, the real not established US filing date is used for 102e purposes

b)

102 e - Anticipation by Description in another's patent or published App -described in patent filed in US by another b4 invention thereof by applicant

6)

Corroboration of witness testimony to invalidate a patent - clear and convincingi)Patent not yet issued - derivation proved by preponderance of evidence and corroboration needed

ii)

STANDARD OF PROOF - charge of derivation requires proof of prior conception by another; allegations of conception require corroboration

a)

TEST: No one is entitled to a patent if the invention was derived from someone else's work done anywhere

b)

102 f - Derivation and Inventorship (p. 437) - did not herself invent the subject matter7)

QUESTION OF LAW predicated on factual findings (priority, conception, and RTP); Appellate ct reviews w/o deference.

a)

In interference w/ app filed after date of the patent; jr. party must show priority by clear and convincing evidence

i)

In interference w/ app antedates (prior to date of) patent issuance date, jr. party must show priority by preponderance of evidence

ii)

BURDENS OF PROOF b)

Conceptioni)Diligence (fact question)ii)RTPiii)Corroborationiv)Abandoned, suppressed, concealed v)

DEFINITIONSc)

the other party can show it was the first to conceive the invention AND a)that it exercised reasonable diligence in later RTP.b)

TEST: Priority of invention goes to the first party to RTP unless ...i)

SUPPRESSION OR CONCEALMENT - must be deliberate or intentional, but a lengthy delay btwn making invention and filing can be inferred as concealment

a)

PEELER v. MILLER (improved hydraulic fluid designed to reduce cavitation) discovered during interference that despite earlier reduction to practice inventor's assignee company was not diligent to file a ready to file application. ct. deemed invention suppressed under 102g b/c proof of specific intent to suppress is not necessary where time between actual RTP and filing is unreasonable and company's lack of justification for delay is inadequate to overcome inference of suppression.Note: inference of suppression or concealment can be over come with evidence that the reason for delay was to perfect the invention. If delay is caused by working on improvements not reflected in final app, then delay will not be excused.

CONSIDERATIONSii)

DETERMINING PRIORITYd)

102 g - Anticipation by prior invention in U.S.8)

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improvements not reflected in final app, then delay will not be excused.RESUMED EFFORTS AFTER LONG DELAY - No authority that would stop a jr. party from relying on resumed activities, following a long delay (during which suppression was inferred), to predate a sr. party's earliest date. Resumed activity must be considered as evidence of priority of invention and if combined with further diligence to file, then such evidence can be used to establish an earlier priority date to the sr. party's RTP. POLICY: Any "too long" delay would mean a loss of priority even if terminated by extensive and productive work done long before the newcomer entered the field. The concern is to establish and uphold first to invent policy.

b)

CONCEPTION - must encompass all limitations of the claimed invention AND is complete only when idea so clearly defined in inventor's mind that only ordinary skill, no experimentation need to RTP.

c)

BURROUGHS WELCOME?? (discussed with Baxter about conception)CORROBORATION - Inventor's testimony must be corroborated as inventive facts must not rest alone on testimonial evidence from inventor himself. Rule of reason test applied to and all pertinent evidence reviewed to determine credibility of inventor's story.

d)

BROWN v. BARBACID (Barbacid patent and Brown app both claim assay for identifying new anti-cancer compounds) Lab notebook and autoradiographs of first experiment of jr party did not include use of test substrate, an element of the count; thus, party did not satisfy every limitation of the count. Inventor testimony on second experiment was not corroborated to show actual RTP; however, physical evidence does not require corroboration and lab notebooks, autoradio-graphs) showed 2nd experiment contained all of the limitations of the count.

QUESTION OF LAW, w/ underlying facts(1)

USPTO - considerable deference is given for its factual findings on Graham factors and are overturned ONLY IF unsupported by substantial evidence of whether reasonable fact finder could have arrived at decision

a.

BENCH TRIAL - clearly erroneous - definite & firm conviction that mistake committed (given less deference than below)

1)

JURY - deferential substantial evidence - reasonable jury could make findings based on evidence on record

2)

DISTRICT CT b.

STANDARD OF REVIEW(2)

POLICY: No patent for invention created with no more ingenuity than that possessed by ordinary mechanic in field w/ nothing more

(3)

TEST: Whether invention as a whole would have been obvious to PHOSITA at time of invention?(4)GRAHAM v. JOHN DEERE (shock -absorber for plow shank) must be answered in any non-obvious determination whether in USPTO or court.

Proponent of validity, usually patentee, wants low level of skill (so non -obvious to a lot of people)1)Challenger of validity wants high level2)

Education level of typical worker in fielda)Type of problems encountered & previous solutionsb)How quickly new innovation occurs in technologyc)Sophistication of technologyd)

Factors3)

Level of ordinary skill in the art - established by both parties usually by expert testimonya.

Must qualify as prior art under 102 (doesn't have to anticipate)a)All types of 102 prior art available even though some 102 (e), (g), (F) could not have been known to PHOSITA at time of invention (temporarily secret prior art)

b)

Whether a reference may be considered prior art for 102 purposes?1)Scope & content of prior artb.

POLICY: must be identifiable difference or would anticipate under 1021)TEST: Whether differences would have been obvious to PHOSITA?2)

Differences between claimed invention and prior artc.

Secondary factors indicative of non-obviousness - focuses on impact of invention on marketplace rather than d.

GRAHAM FACTORS for analyzing non-obviousness:

103 (a) NON-OBVIOUSNESS - Not patentable if difference between prior art under 102 and subject matter of invention would be obvious to PHOSITA at time invention made. The way in which invention created (long painstaking toiling v. eureka moment) cannot negate patentability. 103 (b) biotech process, 103 (c) "in -house" prior art

G.

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Types of evidence showing: Failure of others to solve problem, commercial success of invention, existence of long felt need for invention, licensing & acquiescence of others to patent at issue, unexpected advantage, and copying of invention

1)

Nexus requirement - evidence presented only successful if a sufficient causal relationship exists between commercial success and features claimed

2)

ARKIE LURES INC. v. GENE LAROW TACKLE, INC. (salt onto plastic lure for fish) held non-obvious b/c scope & content of prior art cautioned away from invention (no motivation to combine salt & plastic) and years of not combining in field combined with secondary consideration (as important as other factors) showing strong commercial recognitionHYBRITECH, INC. v. MONOCLONAL ANTIBODIES INC. (Process that employed high affinity monoclonal antibodies in sandwich assay) held non-obvious where commercially successful and unexpected advantage that it worked b/c nexus (causal relationship) needed for evidence of commercial success inferred when patentee shows both commercial success and the product/method that is successful is the invention clamed and disclosed in patent.

Watch for dramatically reduced prices, licenses from litigation b/c less expensive, novelty feature - color, etc. as real reasons for commercial success

a)

IN RE WINSLOW (process / method using jet of air to open top plastic bag in stack of bags) held obvious despite need in market b/c PHOSITA is presumed to have available to her (to know) all pertinent prior art and the combination of them here is obvious.

Secondary factors indicative of non-obviousness - focuses on impact of invention on marketplace rather than on technical merits - where present must be considered (Fed. Cir.)

d.

POLICY: rigorous attention to TSM guards against improper use of hindsight in a non-obviosness analysis as such hindsight reasoning discounts value of combination in a new way to achieve new result -- often the very definition of invention

1)

Note: motivation can come from nature of problem itself especially w/ simpler mechanical technologies

TSM TEST - must be some motivation / suggestion / or teaching in prior art that would suggest making claimed combination

2)

KSR "Reason" Test - whether combination obvious to PHOSITA?KSR v. TELEFLEX (gas pedal & electronic sensor) taught rigid application of TSM test can lead to false outcome. Use Graham plus reason/motivation to combine and consider below elements.

3)

Can't COMBINE PRIOR ART unless PHOTISTA would see reason to do soa.

PREDICTABLE v. UNEXPECTED RESULTS - combination of familiar elements according to known methods obvious when yields only predictable results

b.

TEACHING AWAY - when prior art teaches away from combining certain known elements, successful combination more likely not obvious

c.

OBVIOUS TO TRY - design need or market pressure to try know options If it leads to anticipated success then obvious to try is obvious.

d.

CONSIDERATIONS(5)

INEQUITABLE CONDUCT

INEQUITABLE CONDUCT - failure to disclose material info w/ intent to deceive or mislead PTO (raised as defense)A.ISSUE OF LAW, except materiality and intent are factual issues subject to clearly erroneous (definite and firm conviction error has occurred) standard of review

B.

C. BURDEN OF PROOF - party asserting defense of unenforceability must establish each underlying factor of materiality and intent by clear and convincing evidence.POLICY: Patent system relies on conscientious disclosure, so it necessarily metes harsh punishment when duty is breached -- total unenforceability of the entire patent. Because applicants have obvious incentive to not disclose damaging information, thus anything less the unenforceability, would invite nondisclosure.

D.

MAY BE INFERRED from surrounding circumstances (e.g., patent applicant knew or should have know that withheld information would be material to PTO's prosecution) Why? b/c direct evidence of intent or proof of deliberate scheming is rarely available

a.

KINGSDOWN MEDICAL CONSULTANTS, LTD v. HOLLISTER INC. ( device for w/ waste) wrong claims issued b/c miscopied the claims. Such gross negligence not enough to intend to deceive. Actual intent must be shown.BRASSLER v. STRYKER SALES CORP. (medical instruments) Associate commits I.C. b/c did not verify critical date b4 filing date that was past and client company did not inform. All tried to sneak one by the patent office. Ct. said studied refusal to ascertain the precise on-sale bar date, even though client tipped them off to existence of the problem.

b. Good faith belief that claims should be narrowly construed to avoid uncited prior art will not necessarily or

INTENT - whether applicant had intent to mislead or deceive the PTO?(1)TEST:E.

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b. Good faith belief that claims should be narrowly construed to avoid uncited prior art will not necessarily or always preclude a finding of recklessness or gross negligence in failing to cite the art

1) Specific intent - yes2) Deliberate indifference / willful blindness - yes3) Reckless disregard - maybe4) Gross negligence - maybe depends see above5) Negligence - no

c. Gross negligence not always intent as it must be of such gravity as to warrant the inference of intent to deceive or mislead PTO

(2)

a. TEST: - Rule 1.56(b)(2)(ii)(1996) - material if "not cumulative to info already of record or being made of record in the application, and… *i+t refutes or is inconsistent with, a position the applicant takes in: …. *a+sserting an argument of patentability."J.P. STEVENS & CO. v. LEXTEX, LTD. (reprocessing "torque stretch" yarns) where none of the prior art cited during prosecution taught a key element of the claimed process invention, and where both the references at issue taught the key element; applicant should have know the references would be important to PTO, especially in light of (1) claim rejection based on one reference and (2) licenses taken under another reference and foreign app rejected based on it.

b. TREND: EXPANSION OF MATERIALITY - Duty to disclose is not limited to prior art; applicant must disclose any material info especially that which a reasonable examiner would likely consider to determine whether to allow an application to issue as a patentCRITIKON, INC. v. BECTON DICKINSON VASCUALR ACCESS, INC. (safety IV catheters designed to protect healthcare workers from needle pricks) Where patent for reissue involved in litigation in which defenses raised against validity of the patent , or charges of fraud or inequitable conduct, or violation of duty to disclose, such litigation must be brought before PTO's attention as such defenses would normally be material to patentability. Defendant knew or should have known reference and litigation was material. Given materiality and failure to offer good faith explanation of nondisclosure, an intent to mislead must be inferred.

MATERIALITY - Whether applicant should have known that prior art was material? information must be disclosed when it is material to patentability

a. High degree of materiality and high degree of intent -- compelling I.C. conclusion

BALANCING - Ct. must balance intent and materiality and determine as matter of law whether there was inequitable conduct.

(3)

(1) Failure to note acts that may constitute public use and on sale bars(2) False affidavits and declarations relating to dates of invention(3) Presentation of "doctored" data in affidavits and declarations relating to comparative testing and embodiment

examples(4) Knowingly taking advantage of examiner error

F. Examples:

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