Baniel 2017 (Ali 2014 Update) Patent Law - Prosecution (Seymore) I. Introduction to Patent Law ..........................................................................................................2 Historical and Theoretical Background ....................................................................................................................................... 2 Patent Procedures ................................................................................................................................................................................ 3 II. Disclosing and Claiming the Invention .........................................................................................4 Introductions to Claim Interpretation ......................................................................................................................................... 4 Substantive Aspects of Claim Interpretation............................................................................................................................. 5 Canons of Claim Construction ............................................................................................................................................................... 6 Enablement, 35 U.S.C. §112 ¶1 ........................................................................................................................................................ 6 Claim Scope and Commensurability ................................................................................................................................................... 7 Undue Experimentation ........................................................................................................................................................................... 7 Written Description, 35 U.S.C. §112 ¶1 ....................................................................................................................................... 8 Best Mode, 35 U.S.C. §112 ¶1 ........................................................................................................................................................... 9 Definiteness, 35 U.S.C.§112 ¶2 ..................................................................................................................................................... 10 Markush Claiming .............................................................................................................................................................................. 10 III. Novelty, 35 U.S.C. §102 ............................................................................................................ 11 Introduction ......................................................................................................................................................................................... 11 Anticipation Standard ...................................................................................................................................................................... 12 “Known or Used” by Others ...................................................................................................................................................................13 Accidental Anticipations and Inherency .........................................................................................................................................13 Prior Disclosure in a Patent Document, 35 U.S.C. §102(e) ............................................................................................... 14 Third-Party Inventive Activity, 35 U.S.C. §102(g)(2) .......................................................................................................... 15 Foreign Activity, 35 U.S.C. §119, Hilmer Rule ........................................................................................................................ 16 Printed Publication, 35 U.S.C. §102(a) and (b) ...................................................................................................................... 16 IV. Priority, 35 U.S.C. §102............................................................................................................. 17 Rule 131 [Swearing Behind a Reference], 37 C.F.R. §1.131 ............................................................................................. 18 V. Statutory Bars, 35 U.S.C. §102(b)............................................................................................... 19 On Sale Bar............................................................................................................................................................................................ 19 Public Use Bar ..................................................................................................................................................................................... 21 Third Party Activity........................................................................................................................................................................... 22 Experimental Use Exception ......................................................................................................................................................... 22 VI. Provisional Patent Applications, 35 U.S.C. §111(b) .................................................................... 23 VII. Nonobviousness, 35 U.S.C. §103(a) ......................................................................................... 24 Modern Analysis................................................................................................................................................................................. 25 Constructing the PHOSITA ............................................................................................................................................................. 27 Available Prior Art and the Analogous Art Doctrine ........................................................................................................... 27 Secondary Considerations.............................................................................................................................................................. 28 Notable Cases ...................................................................................................................................................................................... 28 VIII. Eligible/Patentable Subject Matter, 35 U.S.C. §101 ................................................................. 29 Biomedical-Related Inventions .................................................................................................................................................... 29 Business Methods and Software-Related Inventions ......................................................................................................... 30 IX. Utility, 35 U.S.C. §101 ............................................................................................................... 30 I. Introduction to Patent Law Historical and Theoretical Background COTUS Art. I, §8, cl. 8: Congress shall have the power “to promote the Progress of Science and useful Arts by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.” Patent: government issued grant, conferring upon the Patent Owner the right to exclude others from making, using, offering for sale, or selling the invention throughout the US or importing the invention into the US for a period of 20 years ending from the filing date of the patent application. o Patent rights do not include a positive right to make, use, or sell the invention—it’s the right to exclude others to do those things—“A patent does not furnish the owner with the right to practice the invention” o Three types: utility (90%), design, plant Inventors can: (1) give to the public w/o protection; (2) keep as trade secret (invention, w/o tech details); (3) patents (invention + tech details) o Law prefers patents because information is guaranteed to enter the public knowledge domain Basic characteristics attributed to patents o (1) Quid-Pro-Quo Inventor gets temporary exclusive rights and the public (throughout the “public store house of knowledge” gets the technical details and invention after 20 years that will benefit society o (2) Property (patent rights can be transferred, by license/assignment, in whole or in part) Patent claims set the “metes and bounds” of the right to exclude o (3) Monopoly a/k/a limited right to exclude, but limited temporally by Constitution (Bonita Boats) Patent clause reflects balance between need to encourage innovation and the avoidance of monopolies which stifle competition without any advance in the progress of science and useful arts (Bonito Boats) You cannot remove existing knowledge from the public, b/c that’s an ex post facto law obstructing others from what they already had (Jefferson, cited in Bonito Boats) Economic Theory o (1) Reward Theory (incentive to invent) Premise: without expectation of patent, certain inventions wouldn’t be produced (patent inducement theory) Criticisms: (1) if everyone is trying to be 1st and only the 1st gets rewarded, the others are wasted resources; (2) doesn’t address inventions that would’ve come w/o patent o (2) Incentive to Disclose Theory Premise: without patents, inventors would chose trade secrets (sub optima), but a property right induces inventors to seek prosecution and disclose Criticism: Ignores trade secrecy as sometimes viable, preferable option o (3) Prospect Theory (Incentive to innovate) Premise: Give patentee broad rights and they can control how it goes downstream; patents as a coordination tool reducing transaction costs; improvements can fall under original patent Criticisms: (1) Theory assumes technical predictability which doesn’t work in some fields (e.g., biotech); (2) often patentees neither commercialize nor license their patented technology Sources of Patent Law o Patent Statute, Title 35 of U.S.C. (Patent Act of 1952; AIA of 2011 (3/16/2013) o Title 37 of C.F.R. (rules for conducting business at PTO o Judicial opinions ((1) appeals from PTO denial of patent application; (2) infringement suits) o MPEP o Federal Circuit (est. 1982) Adopted CCPA’s precedent as binding precedent (Ct. of Claims, too, sort of) 12 judges; Art. III Jurisdiction: appeals from PTO, appeals from D.C.sfederal claims, internal claims, trademarks, patents o Guidance—Manual of Patent Examining Procedure (represents the PTO’s official interpretation of Patent Act) Benefits of Patents o Right to exclude o Blocking competitors o Exclusivity in the marketplace o Commercialization – licensing of patents o Positive Marketing Benefits – increase portfolio values o Freedom to operate o Bargaining Power (mutually assured destruction) 2 Patent Procedures Patent Requirements: (1) Eligible subject matter, §101; (2) utility, §101; (3) Novelty, §102; (4) Nonobviousnessness, §103; (4) adequate disclosure and claim definiteness, §112 Mechanics of Patent Prosecution: (1) Filing, (2) Office Action, (3) Applicant’s response, (4) Examiner’s Reconsideration, (5) Issuance and/or after-final practice on average, takes about 39 mos. o Filing: Written description (disclosure of claimed invention; teaching device) + One or more claims (metes and bounds of the PO’s property rights) Examination Protocol o Application may only disclose one invention; if discloses more, PO has to “elect” one and prosecute others later (Restriction Requirement—unappealable acc. to Fed. Cir.) o Substantive examination to ensure compliance with patent building requirements o Examiner can allow or reject a claim (examiner must give reason for rejection) o If rejection, Patentee can: (1) Continuation Application – Resets application process, but allows original priority date (2) Request for Continuing Examination (RCE) – Resets the process (3) Divisional - Prosecutes in response to a restriction requirement; same WD but new claims (4) Amend the claim (change the language) (5) Cancel the claim (take it out) (6) Argue respectfully with the examiner (7) Continuation in Part (CIP) - Amend the written description, but cannot add new subject matter, 35 U.S.C. §132(a) (“NO amendment shall introduce new matter into the disclosure of the invention.”). o Examiner can reconsider and allow some or all of the claims, or point out another issue After patent prosecution, (1) issuance; (2) give up; (3) PTAB appeal o If PTAB affirms examiner’s rejection, PO can appeal directly to the Federal Circuit or have it tried in District Court (usually, EDVa Rocket Docket) by suing the PTO Fed. Cir: record is closed, no new evidence E.D. Va.: new evidence permitted, more expensive o Judicial Presumption of Validity of Patent (In Re Oetiker) Burden is on the PTO to establish unpatentability (and other requirements) by POE—PFC If PTO meets PFC, burden shifts to applicant to rebut it, but if not, claim remains rejected Continuance/Continuation Practice, Rule 53(b) (37 CFR §1.53(b)) (1st patent: parent; the rest are children) o If an applicant receives from the examiner a final rejection of some of the claims in her application but an allowance of other claims, she might want to obtain a patent, as soon as possible, on the allowed claims, perhaps bc of a potential infringer in the marketplace, while at the same time continue prosecuting the rejected claims, rather than appealing their rejection. o Continuation application—way of prolonging the application process—extends the patenting transaction that began with the applicant’s earlier-filed application Generic term for a later-filed patent application that contains some or all of the disclosure of that applicant’s earlier-filed application (parent application) and that names at least one inventor also named in the parent application o CON (simple continuation application): starts rejected or cancelled claims all over again (same WD; original filing date) o DIV (divisional): prosecution of claims that weren’t elected in restriction requirement (same WD; diff. claims; original filing date) o CIP (continuation in part): add new matter to the WD (original WD gets original filing date, but new matter gets later filing date) o ***You must file a continuation application before the parent patent issues—must be filed while parent application is still pending (i.e., has not been abandoned or issued as a patent) o Policy: Patentee might file continuation app just prior to issuance to leave time to amend to force out competitor’s similar claims (as seen in Hamilton Beach) o §120: to the extent the claims of the continuing application are supported by the disclosure set forth in the parent application in accordance with the requirements of §112¶1 (enablement + WD) [commonly disclosure subject matter], those claims are entitled to the benefit of the filing date of the earlier-filed parent application; effective filing date = parent application’s filing date PA of others effective between parent filing and continuing app’s filing will not be considered PA against claims entitled to earlier date Claims in continuing application not adequately supported by disclosure, not entitled to benefit of parent’s filing date o §154(a)(2): all the claims in a designated continuing application will be deemed to expire 20 years after the parent application’s filing date, regardless of whether particular claims are supported in the §112 sense by the parent application’s disclosure 3 Reissuance (withdraw, return to prosecution): usually done to correct an error (broaden or narrow claim) o No new matter is allowed o Doctrine of intervening act: if an act was noninfringing before the issue, it will not be after Derivation Proceeding – plaintiff claims first filer stole the patent idea – proceeding focuses on first to invent; reduction to practice. ITC Hearings – Three month proceeding to obtain an injunction against the importation of products into the United States if they infringe US patents – no actual damages available. Post Grant Review – Can review any aspect of patentability before the PTAB; used in parallel to litigation Inter Partes Review – Can review 102/103 challenges to patentability; used in parallel to litigation Interference proceedings to establish priority (only under Patent Act (1952)) o Published application is out there and other inventor tries to file application claiming the same thing—can invoke interference—must be done within a year of the patent o Can also sue for correction of inventorship, asserting that one should be on the patent (litigation matter) §256 No double patenting allowed—patent applicant may obtain only one Us patent on a given invention (often charged against pharmaceutical firms allegedly engaged in evergreening—obtaining a series of patents on closely related drug inventions in an attempt to improperly prolong patent life of products) Publications o Historically, all pending patent applications were maintained in secrecy throughout their pendency by the PTO and the public did not see the content of applications until they issued as patents, if at all—submarine patents (competitors would be suddenly liable as potential infringers at issuance with no prior notice) o Current law: a nonprovisional US utility patent application will be automatically published 18 mos after its effective filing date (added in the 1999 amendments) Publication can be avoided by abandoning and certifying to the PTO that applicant has not and will not file any other applications on the same invention in foreign countries. II. Disclosing and Claiming the Invention 35 U.S.C. §112¶2: Each patent must conclude with “one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.” Introductions to Claim Interpretation 35 U.S.C. §112(b): Claims must “particularly [point] out and distinctly [claim] the subject matter which the applicant regards as his invention.”—definiteness requirement Claim: precision-drafted, single-sentence definition of the patent owner’s right to exclude others. Every US patent must conclude with one or more claims that particularly point out and distinctly claim the subject matter which the applicant regards as his invention. Peripheral claim system—patent claims describes the outer boundaries of the invention; claim recites a precise boundary or periphery of the patentee’s property right Central claiming (Disfavored) —reciting the preferred embodiment of the invention, but understood to encompass all equivalents Purpose of claims—notice (so the world knows what infringes a patent) Purpose of adequate disclosure req’t: to put public in possession of invention once patent expires and to spur more creative activity Independent Claim – Exists on their own; does not rely on other claims Dependent Claim - (read in conjx with claim on which it depends) and independent claims, §112(c)–(d) o Purpose of dependent claims: (1) examiners love them; (2) charge is less for dependent claims; (3) if ind. claim is valid, dependent claims are valid b/c they are more limited and doesn’t read on PA; (4) provide fall back if ind. Claim is invalid (will be rewritten) o Cannot infringe on a dependent claim unless you infringe on corresponding independent claim as well. o If the independent claim is enabled, the dependent claim must also be enabled o Invalid independent claims do not invalidate corresponding dependent claims [Claim Syntax] o Preamble: general introduction words which set forth the nature of the invention (e.g., a compound, method, pharmaceutical composition, method of treating cancer)—short and plain expression of what the invention is Does not need to expressly reference one of the statutory classifications of patentable subject matter under §101 (process, machine, manufacture, or composition of matter) so long as it is clear from the entirety of the claim that the invention fits within one or more of those classifications Preamble language is considered a limitation of the claim if the language is necessary to give “life, meaning and vitality” to the claim or if it recites essential structure or steps (as in In Re Paulsen— computer) 4 E.g., limiting—preamble terminology is repeated and referenced in body E.g., not limiting—body of the claim recites a structurally complete invention and preamble language only states an intended purpose or use for that invention o Transition phrase/term: defines the scope of the claim elements-look at transition term to (1) determine the scope or (2) potentially broaden or narrow the claim in an amendment (1) Comprising (open term) Includes/contains everything in the claim and open to additional elements E.g., lotion comprising A+B+C (but also covers A+B+C+…+Z) Does not render a claim anticipated by a device that contains less (rather than more) than what is claimed (2) Consisting of (closed term) Closed to additional elements—infringement only occurs when invention has exactly what’s in claim, nothing more or less E.g., lotion comprising A+B+C (must be exact) Useful for avoiding prior art, since it cannot include other stuff (3) Consisting essentially of (hybrid term) Claim covers additional elements that do not affect the basic and novel characteristics of the invention a/k/a does it materially alter a/k/a does not change the essential function or properties of the composition E.g., lotion comprising essentially of A, B, and C (A+B+C+D may be covered if D does not materially alter the invention) o Body: claim elements or limitations (e.g., A + B + C …) Lists all the elements of the invention and should specify how the elements are related to or interact with each other The more elements added to a claim, the progressively more difficult to prove infringement of that claim because of the all-elements rule Claim that is relatively broader in that it is enforceable against a greater number of accused devices is correspondingly easier to invalidate for lack of novelty or nonobviousness o Claims written in “funnel” from broad to narrow, with last as “preferred embodiment” (what you’ll sell) Three types of claims patent owner can claim o Composition of Matter (COM): claim of the thing; offers the broadest protection E.g., a composition comprising X o Method of Making (MOM) E.g., a method of making x, comprising Y o Method of Using (MOU) E.g., a method of treating [disease], comprising administering X o Should use all three to make sure some claims survive and make patent as robust as possible (questionable whether examiner will impose restriction req’t) Types of Claims o Genus – Group of species all sharing a similar functional/structural trait relevant to the invention OK to claim a genus as long as disclosure is sufficient (demonstrated connection between each member or enough information so PHOSITA can identify connection) # of species to claim a genus varies (more in chem/pharm/bio) If prior art discloses a species, one cannot claim a genus (102 novelty issue) If prior art discloses a genus, one may still be able to claim a future species (must avoid 103 nonobviousness issue) o Subgenus o Species – A specific member of a group. “Reading On” o A claim must not read on prior art or it is invalid for novelty, §102 o Claim can read on an object or the description of an object o If a claim reads on something that is NOT prior art, then that something infringes the patent o E.g., lotion comprising A+B; claims reads on anything that has A+B+…Z (if it’s PA—invalid; if it’s competitor, then competitor is infringing) Substantive Aspects of Claim Interpretation Claim construction is to determine the scope of the right to exclude Claim Interpretation occurs three times: (1) at PTO to assess patentability; (2) in litigation to assess infringement or invalidity (did infringement actually occur?); (3) opinions/advisory on early state patents or risks of infringement (is there freedom to operate?) 5 Claim clarity reflects patentee’s incentives: broad as possible to cover more for infringement; narrowly construed to avoid PA and meet req’ts (“Exploit the inherent indeterminacy of language,” SCt) Requirements – 1) Clarity and 2) Sufficient to disclose the invention to PHOSITAs Evidentiary Sources o Intrinsic: claim lang., specification, prosecution historypublicly available so notice to potential infringers; not susceptible to litigation influence o Extrinsic: experts, dictionaries, treatises, inventor testimony Phillips v. AWH Corp. (FC 2005) o Words of a claim are “generally given their ordinary and customary meaning” attributed by a PHOSITA at the time of invention o (1) Intrinsic evidence first “bedrock principle [of patent law] that the claims of a patent define the invention to which the patentee is entitled the right to exclude” Claims do not stand alone; they are part of a written, fully-integrated document and claims must be read in light of the specification Claims are the starting point but the spec is “always highly relevant to the claim construction analysis” and is “usually dispositive” as the single best guide Prosecution history: helpful, but is a result of negotiation and is not final, so lacks clarity When a patentee actually defines a term, acting as his own lexicographer, that def. governs o (2) Extrinsic evidence second less significant; tech. dictionaries maybe helpful to understanding underlying technology; but conclusory, unsupported assertions by experts are not helpful Canons of Claim Construction Claim terms are interpreted from the perspective of a PHOSITA As a general rule, claim terms are assigned their ordinary and customary meaning to the PHOSITA It is function and purpose of claims, not the WD part of the spec itself, to delimit the right to exclude (improper to import limitation from spec’s general discussion, embodiments, and examples) (Alloc 2003) o Limitations from the preferred embodiment or written description should not be read into claims Claims are not to be construed by reference to the accused device, but knowledge of accused product is relevant Claim Differentiation: each claim in a patent is presumptively different in scope; the existence of a dependent claim shows that the independent claim from which it depends is not so thus limited o “The presence of a dependent claim that adds a particular limitation gives rise to a presumption that the limitation in question is not present in the independent claim.” (Phillips) o The existence of a narrower dependent claim shows that the broader claim from which it depends is not so limited Courts should generally not adopt a claim interpretation that would exclude a preferred embodiment Claims should be construed to preserve their validity (goes along with presumption of validity) When there is an equipoise between narrow and broad interpretation, chose the narrow interpretation (as punishment to app. for being ambiguous) Preamble is only a limitation when it brings “life and meaning” to a claim—the preamble is analyzed to ascertain whether it states a necessary and defining aspect of the invention, or is simply an introduction to the general field of the claim Enablement, 35 U.S.C. §112 ¶1 “The spec shall contain a WD of the invention. . . in such full, clear concise, and exact terms as to enable any person skilled in the art”…to make and use…” Thus, the enablement requirement specifies that an inventor must disclose both “how to make” the invention as well as “how to use” it. [Enablement is a question of law (de novo), but there are underlying factual findings (substantial evidence standard); Burden is on PTO to establish why scope of protection is not adequately enabled by WD] Written Description must teach what is claimed. Patentee’s specification must enable a PHOSITA to practice the full scope of the claimed invention without UNDUE EXPERIMENTATION Enablement is measured at the time of filing o Tech. info that arose post-filing cannot be used to satisfy enablement req’t but can be used as evidence of the level of ordinary skill in the art at the time of app and as evidence that disclosed device would’ve been operative (Qigg); (In Re Wright—looked at article 5 years after filing date to show level of knowledge in the field) o Problem of hindsight bias (b/c it’s assessed retroactively) Two Functions: (1) information dissemination [teach a PHOSITA how to make and use invention without undue experimentation]; (2) constrain claim scope [set outer boundaries of exclusionary rights and how broad claims can be] PHOSITA’s Level of Skill (Environmental Designs) o (1) education level of inventor; (2) types of problems encountered in art; (3) prior art solution to those problems; (4) rapidity with which innovations are made; (5) nature/sophistication of the technology; (6) education level of active workers in field Policy: must balance reward pioneering inventor v. incentivize future inventors to make improvements 6 o Puts the public in effective possession of the invention, by providing the PHOSITA a detailed description of how to make and use the invention o Once patent expires and with it patentee’s right to exclude others, the public should be in position to make and use invention without undue experimentation o Disclosure provides a blueprint that the public may follow once the patent expires and they are free to make and use the invention without liability Closely tied to utility requirement of §101 because if inventor doesn’t know the utility of her invention, then logically she cannot describe how to use the invention (SBS disagrees, fwiw) Claim Scope and Commensurability Language: the claim is “not supported by an enabling disclosure reasonably commensurate with the scope of the claim” Scope of Enablement o Ensure the public gets the information o Claim scope must be ≤ the scope of enablement a/k/a app. cannot claim more than he enables o Scope of enablement: [PHOSITA’s knowledge and skill] + [Teaching provided by applicant] must be commensurate with claim scope sought PHOSITA knowledge and teaching are inversely related (e.g., smart PHOSITA fills more gaps) O’Reilly v. Morse [The Telegraph Patent Case] (SCt 1854): Morse claims that he did not limit himself to specific machinery or parts, but that invention is use of electro-magnetism for making or printing intelligible characters at any distances). o Holding: claims are invalid because “he claimed an exclusive right to use a manner and process which he has not described and indeed had not invented, and therefore could not describe when he obtained his patent” (claim would give him his invention and improvements, incl. things he didn’t invent or contemplate) o Policy concerns: can award patent for something he didn’t event; claim would read on future improvements he never thought of o You cannot claim what you have not taught the PHOSITA, but you definitely not claim more than what you invented o Dissent (Grier): statutory authority for improvement patents and they can cross-license Consolidated Elec. Light Co. v. McKeesport Light Co. (SCt 1895): Consolidated argues that bamboo used by Edison patent is encompassed by “carbonized fibrous material” and therefore infringes. o Holding: The amount of experimentation by Edison shows there is no common trait between all fibrous materials that permits Sawyer & Man to claim the genus. o An entire genus of materials can only be claimed if there is a common use or trait between them that is common or naturally related to the patent by one skilled in the art. o Policy: Permitting such a broad claim would inhibit experimentation/advancement of the incandescent light industry. Analyzing Morse o Majority - Ex post incentives are more important than ex ante (encourage future development). Worried about blocking patents. o Dissent – Ex ante incentives better – encourages cross licensing and development. Doesn’t care about blocking patents Patent Holdups - 1) patent owner is (2) able to exploit its bargaining power vis-a-vis downstream users (3) due to the possibility that the patent owner will be able to enjoin the manufacture, use or sale of and end product that incorporates the patented invention (4) in such a way as to threaten static deadweight loss or dynamic efficiency losses Problems with Overly Broad Enablement o Goal is to prevent underfishing, AND overfishing if claim is too broad, no one will innovate after first inventor If claim is too narrow, no incentive for future inventors Undue Experimentation A disclosure is sufficient if it enables a PHOSITA to make and use the claimed invention without undue experimentation o Some experimentation, trial and error, is permitted and not fatal (Cedarapids) as long as it is “merely routine” or the spec “provides a reas. amt of guidance” o PHOSITA’s knowledge of PA and routine experimentation can often fill gaps, interpolate between embodiments, and extrapolate beyond disclosed embodiments, depending upon predictability of art Need not disclosed what is well known in the art E.g., single embodiment enablement (one working ex. disclosed to claim multiple embodiment) sufficient for predictable arts (mech, elec), but not for unpredictable (chem, bio) Wands Factors test for determining whether undue experimentation is needed (totality of the circumstances and one factor is not determinative; factors are not necessarily exhaustive) o (1) breadth of the claims; (2) nature of the invention; (3) state of the prior art; (4) the level of one of ordinary skill; (5) the level of predictability in the art; (6) the amount of direction provided by the inventor; (7) the existence of 7 working examples; and (8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure o Scope of the claims—degree of enabling disclosure must bear a reasonable correlation to the scope of the claims Cedarapids v. Nordberg (FC 1997): Method patent for increasing efficiency and output of rock crusher w/o increasing size of crusher chamber by simultaneously increasing speed and throw, but did not provide values of increasing for crushers of various sizes. o Holding: Single embodiment was sufficient to enable the claim because art is predictable and the PHOSITA can extrapolate and determine values for any size conical crusher o Mechanical & Electrical art is predictable—at this time predictable fields only req’d a single embodiment (Auto Tech changed law) o Some required experimentation does not preclude enablement. Must determine if its unduly exclusive Auto Tech. Int’l v. BMW of N.Am. (FC 2007): Side Impact Sensors for airbag deployment. WD discusses mechanical sensors (in detail) and electrical sensors (minimally, just an overview without details on how it works—“conceptional view”). o Holding: Spec does not enable electronic side impact sensor. Mech and elec sensors are distinct and there must be enablement of the scope of the range. o Predictable art, like in Cedarapids, but if embodiments are different, PO must enable bothdemise of the single embodiment enablement [Full Scope Enablement req’d in all arts] o PHOSITA knowledge is relevant, but novel aspect of invention must be enabled in patent. Claims can be less sufficiently disclosed if the tech is known/skill is common. Court can use prior art/nature of technology/experts to make this determination Pharm. Res. V. Roxane Labs (FC 2007): Flocculated suspension of acetate/glycol group/surfactant does not permit all surfactant combinations described in the patent. o The patent specification describes the technology as novel and unpredictable this requires more information for the PHOSITA to use the invention without undue experimentation. o Based on the uncertainty of results during prosecution history, there is no reasonable expectation of success here. Written Description, 35 U.S.C. §112 ¶1 “Specification shall contain a written description of the invention” [Question of fact] [Language: “inadequate support in the patent doc for x” or “the applicant didn’t posses x”] ***measured at time of filing—new matter can’t be introduced to show compliance nor can applicant rely on information provided by others after the filing date to fill gaps Refers to (1) physical part of the patent doc that comes before the claims and (2) legal requirement: WD must convey with reasonable clarity to the PHOSITA as of the filing date that he or she was in possession of the claimed subject matter o The description must be capable of conveying to readers of the patent that the inventor had actually invented the claimed subject matter as of the filing date, notwithstanding any precise manner I which the claimed invention is described (i.e., drawings alone could suffice) – 4 CORNERS TEST Technically you could use broadening language in the WD to try and capture later elements, but it will depend on whether a PHOSITA would’ve understood with reasonable clarity that the newly claimed subject matter was included within the description at time of filing. Purpose: o Limitations on claim amendments (“priority policing”): serves as check on applicants who want to amend claims, add new claims, for file continuation application o Adequate support for originally-filed claims – show possession to PHOSITAs o Hand-in-hand with 35 U.S.C. §132(a) no new matter—do new claims have support in original document (If not, lack of WD) Functions: o Fulfill prior disclosure requirements o Serve as potential prior art Ariad Pharms. V. Eli Lilly & Co. (FC 2010) [Lilly Written Description]: Ariad discovered that reduced levels of a transcription factor could control gene expression in response to extracellular stimuli, hypothesizing 3 diff. inhibiting mechanisms to reduce the binding, but does not say how that blocking is occurring or name specific inhibitor molecules. The requirement to describe the invention is different from the requirement to teach the invention (description of manner and process of making and using invention); You can enable something but not describe it (e.g., spec discusses A with no broadening language, which may enable PHOSITA to make and use compound B and C, but the class of A, B, C has not been described) Possession test: the description must “clearly allow PHOSITA to recognize that the inventor invented what is claimed” from the four corners of the patent document a/k/a whether the disclosure of the app. relied upon reas. conveys to PHOSITA that the inventor had “possession” of the claimed subject matter as of the filing date 8 But court also says that the level of detail required varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant tech—i.e., factors external to the disclosure of the patent Factors: existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, and the predictability of the aspect at issue o Highlights issue with functional claims—describes only desired effect and not method of getting there SCt: “A patent is not a reward for research, but compensation for a successful conclusion” More lab work needed before patenting (effects universities) o Genus claims (big group) encompass use of all types, but not example; needs to be more than a research plan An adequate written description of a claimed genus requires more than a generic statement of an invention’s boundaries—requires a precise definition of a representative number of species (varies by the art) falling within genus (either a representative group of species themselves or the common structural features so that a PHOSITA would recognize them as a species) Claims recite method encompassing a genus of materials achieving stated result (reducing binding) but spec does not disclose a variety of species that accomplish the result Species (individual group members which share some characteristics) always anticipates genus (grouping or category) o Policy: may lead to delayed filing for upstream research; invalidates early stage patents Part of the quid pro quo – allows for efficient processing/understanding of patents by PTO & public o Some believe that enablement can handle the Ariad type written description, especially considering the overlap in the factors with those under enablement, but Judge Lourie is hold out o SBS: seems to suggest that there is a difference between standard priority policing and the Lilly Written Descriptions Starting with Eli Lilly, the Fed. Cir. has expanded WD of invention analysis to consider the validity of unamended, originally filed claims (i.e. claims in the original application, instead of just claims that were later added or amended) Potential policy against this Originally filed claims constitute their own disclosure and by their inclusion in the originally filed application, so they signal that the applicant considered herself to be in possession of the claimed subject matter as of the filing date The applicant could not have obtained an advantage in terms of extent of prior art that would be legally available for citation against her originally filed claim Enablement is different Difference between WD and Enablement Requirements o Enabled subject matter: everything the inventor TEACHES a PHOSITA how to make and use without undue experimentation o Adequate described subject matter (priority policing type): everything the inventor conveys to a PHOSITA that he or she possessed at the time of filing This is broader than enablement concerned with certainty Rivera v. Int’l Trade Comm’n (FC 2017): Patent describing a coffee pod as "broad term given its ordinary meaning and shall include, but not be limited to, a package formed of water permeable material and containing an amount of ground coffee or other beverage herein” is not enabled such to show patentee was in possession of the invention. o Possession does not require examples or actual RTP, but cannot look outside the four corners of the document EXCEPT to PHOSITA’s knowledge. Constructive reduction to practice can suffice. o Here, patented claims are all broader than disclosed embodiments. Best Mode, 35 U.S.C. §112 ¶1 “The specification…shall set forth the best mode contemplated by the inventor of carrying out his invention.” [Mixed question of law and fact] ***measured at time of filing—new matter can’t be introduced to show compliance nor can applicant rely on information provided by others after the filing date to fill gaps (and no duty to update best mode after filing) PTO still requires it but AIA eviscerates best mode requirement as a defense to patentability in litigation o Difficult to prove subjective inquiry Policy: want competitors on equal footing once the patent expires; foster improvement b/c it’s already at its peak o Prevents double dipping (patenting some invention, but retaining Best Mode as trade secret) o Sets boundaries so future inventors know what to avoid Two-Part Test o Subjective: did the inventor know of a mode of practicing an invention that she knew was superior to another o Objective: does the WD disclose sufficient info to enable the PHOSITA to practice the best mode or did she conceal it? 9 Does not need to be labeled as the best mode, just present in the WD—okay to be buried o Inventors often bury the best mode in the patent document Issue rarely comes up in prosecution (b/c examiner has no way of knowing), but often in litigation Definiteness, 35 U.S.C.§112 ¶2 “The spec shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as the invention” [Question of law] Purpose: (1) give people notice of what infringes the patent and (2) to distinguish the claimed invention over the prior art Determined from perspective of PHOSITA; assessed as of filing date; claims should be read in light of WD and prosecution history Problematic claim terms: words of degree (e.g., about, approx., closely approx. to, substantially equal to, essentially)—need an objective anchor o But not fatal—look at whether a PHOSITA would understand the vague work in the context of the invention, e.g., to accommodate the minor variations that may be appropriate to secure to the inventor the benefit of her invention Nautilus v. Biosig Instruments (SCt 2014, Ginsburg): heart-rate monitor used with exercise equip using two pairs of electrodes “mounted . . . in spaced relationship with each other.” o Rule: Reasonable certainty [objective] standard—“Patent is invalid for indefiniteness if its claims, read in light of the spec delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention.” o Rejects Fed. Cir. standard of “insolubly ambiguous” (low standard; looks to intrinsic evidence; no guidance to lower courts) o Policy: balance between inherent limitations of language v. patent must be precise enough to accord clear notice of what is claimed (thereby apprising public of what is still open to them) Ginsburg: some modicum is unavoidable & is price of ensuring appropriate incentives for innovation Ex Parte Breed (PTAB 2014) “[T]he spec teaches an invention, whereas the claims define the right to exclude.” If the claims of the patent, read in light of the written description, would reasonably give notice to the PHOSITA of the scope of the patentee’s right to exclude others, this is all that the definiteness rule of §112¶2 requires—statements by the inventor, etc… are largely irrelevant in this inquiry Also look at antecedents (e.g., using A the first time and THE or SAID for references following) Patent claims are not product specifications—as long as PHOSITA could reasonably determine if a particular product infringed the claim, the claims are sufficiently definite For means-plus-function claims, in order to interpret the scope of a MPF element in a claim, reference to the WD must be made o WD must disclose the “corresponding structure” (or materials or acts) for the means recited in the claim. Failure to do so renders the claim indefinite under §112(2) Markush Claiming Claims are used to claim a class of chemical compounds in terms of a structural formula, where a given substituent of the compound can be selected from among a customized list (i.e., an artificial genus) of alternatives, each of which will result in a compound having the same asserted utility Format o …comprising X, wherein X is selected from the group consisting of A, B, and C OR o …comprising X, wherein X is A, B, or C o A, B, and C are “members of the Markush group” Example o A brake pad comprising a nonasbestos material, wherein said nonasbestos material is selected from the group of carbon, alumnia, glass, or Kevlar (rubber) Purpose/Use o All members of Markush group must have at least 1 thing in common [“the sesame street rule”] Usually, belong to a physical or chemical class or an art-recognized class If one thing is not like the other, examiner will reject the claim and issue restriction requirement (not appealable) o One group member’s problem is fatal in litigation, but in prosecution, examiner will usually allow you to amend claim A species always anticipates a genus, so remove specific members to avoid prior art AVOID THIS: Claim matrix (start with broadest, go to most narrow, so remaining members of genus survive litigation) 10 o o o o Esp. used in unpredictable fields, chem and biotech Allows one to claim a genus of certain specified members (and several species in one claim) Allows patent holder to be intentionally vague about most effective structural formula The bigger the Markush group, the broader the claim TEST: Are the members so unrelated and diverse that the prior art reference anticipating the claim with respect to one member would not render the claim obvious with respect to other members? III. Novelty, 35 U.S.C. §102 Introduction ***Remember, an inventor’s own work can only be used against him as prior art if it constitutes a §102(b) bar (because it has to occur before invention date so the applicant shouldn’t be able to know, use, or patent, or describe invention before inventing it), essentially giving the inventor a one-year grace period [Considerations: (1) where the PA reference takes place; (2) who is behind the PA reference—inventor or rando?; (3) whether it meets the requirements for prior art—strict identity and anticipatory enablement] Prior art must anticipate the claim, not the use. Finding a new use for an already claimed invention is NOT ok Reference date is filing date (presumed by court, unless patentee can show entitlement to an earlier priority date. A patent must issue or publish to be considered prior art. Abandoned applications are not prior art Under AIA (2011): defines novelty from the filing date (first-inventor-to-file regime)—applies on or after 3/16/2013 o §102(a)(1): absolute novelty—the claimed invention was patented, described in a publication, or in public use or on sale, or otherwise available to the public before filing date No grace period or geographical limitations Otherwise available to the public: (1) catch all, capturing other unspecified publications to the public OR (2) distinct, new form of PA (majority) Public disclosure is req’d—confidential sales or non-informing uses are not fatal o §102(a)(2): prior art can be an issued U.S. patent or a published patent application naming another inventor Geographic limitation implied because the patent must be issued under §151 or published under §112(b), but because the AIA repealed the Hilmer rule, the earliest effective filing date for the defeating patent prior art may very well be a foreign filing date Corrollary to §102(e) of 1952 Act Eliminated the notion of invention date, because novelty is now assessed as of a claimed invention’s effective filing date Art under §102(a)(2) will be assigned an effective date that is its actual US filing date, the earlier US filing date of a parent or provisional application, or the earlier foreign priority date o Exception, §102(b): a disclosure is not prior art if w/n 1 year of filing application (only applies to disclosures by the same inventor; everyone else is completely barred) Disclosure was made by inventor (related, obtainer), §102(b)(1)(A) Disclosure by another was after public disclosure by inventor (related, obtainer), §102(b)(1)(B) (1) Inventor publicly discloses his invention, (2) another individual thereafter discloses the same invention, and (3) the inventor/first discloser thereafter files his patent application within one year of his (the inventor’s) public disclosure, the inventor will not be prevented by 3d party’s disclosure *obtained the subject matter disclosed directly or indirectly—misappropriation, stealing, etc… all included o Derivative: someone who derived the invention from another cannot be an inventor under §100(f) (even if it was an earlier filed application) o Under the AIA , the statute requires the PTO or the challenger to establish that before the effective filing date of the claimed invention, the invention was already (1) patented, (2) described in a printed publication, (#) in public use, (4) on sale, (5) otherwise available to the public, or (6) described in a U.S. patent or published patent application naming another inventor o ***Novelty is assessed as of the invention’s effective filing date, not the invention date o OTHERWISE AVAILABLE TO THE PUBLIC DEBATE (1) Catch-all language to cover activity not already falling within the first four §102(a)(1) categories—new category E.g., purely oral disclosure of an invention at a scientific conference of non-restrictive attendance might qualify as prior art (although Klopfenstein said in dicta that purely oral divulgations do not qualify) Probably better because enactment of AIA not likely to sub silentio overrule the well-established case law interpretations of public use and on sale as encompassing certain secret activity—to 11 conclude otherwise would be to reverse centuries of U.S. patent law ; dramatic shift in US patent policy o Reenactment of statutory language with a known legal meaning constitutes the known meaning o Nothing else suggested that Cognress wanted to undo a fundamental principle of patent law o Elephants in mouseholes—overturning two centuries of consistent law would be as much o Legislative history is not the democratically elected text (2) Language modifies the other five categories, meaning that they all must be available to the public—so excludes any type of secret prior art that is not available to the public Inventor’s own secret commercial exploitation will not bar that inventor from later seeking a patent Patent Act (1952): defines novelty from the date of invention; date of invention is presumed to be the first filing date unless proven otherwise (first-to-invent regime)—applies before 3/16/2013 o §§102(a), (e), (g) are true novelty provisions, but §§102(b), (c) (abandonment), (d) are loss-of-right situations in which the right to a paten may be lost even though the invention is, technically, novel o §§102(a), (e), (g) are triggered by events “before the invention by the application for patent”—before the invention date (so either before filing date, or before earlier invention date if proven under Rule 131) o §§102(b), (d) critical date—one year prior to the applicant’s filing date o §102(a): true novelty provision—invention/patent claim must not read on the prior art; also see §§102(e) and –(g) Prior art: preexisting knowledge and technology already known to the public NO NOVELTY: No patent if, before the date of invention, [the invention was (a) patented or (b) described in a printed publication (c) anywhere] OR [the invention was (a) known or (b) used (c) by others (d) in the US] o §102(b): statutory bar…bar to patentability based on taking too long before filing a patent application after a prior art event a/k/a “loss of right” provision applies to everyone ***START HERE*** Has a 1 year grace period from triggering event to file an application Critical date: one year before the application was filed NOT TIMELY FILED: No patent if, more than 1 year prior to application, [the invention was (a) patented or (b) described in a printed publication (c) anywhere] OR [the invention was (a) in public use or (b) on sale (c) in the US] o §102(e): focus is on 3rd party disclosures filed prior to applicant’s date of invention; PA if Published patent app filed by another in the US Patent issued by another o §102(g): focus is on 3rd party inventive activity prior to applicant’s date of invention; PA if Invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it Seymore is never seen a §102(g) rejection o An inventor’s own work cannot destroy novelty, but it can create a statutory bar Anticipation Standard [Question of fact] A patent is invalid for anticipation if a single prior art reference discloses, expressly or inherently, each and every limitation of the claimed invention. Appreciation is not required. (Schering) ***Presumption of novelty—“A person shall be entitled to a patent unless…,” indicating that the initial burden of disproving novelty during examination of a patent application rests with the PTO ****To reject applicant’s claim under §102, the agency must show that at least one of the statue’s novelty-destroying subsections has been triggered §102 is like the catalog or universe of prior art that can be cited in rejecting the claims—any defeating prior art must be eligible under the statute Anticipation Inquiry: o (1) Assess the universe of PA (individual references (incl. activity like an offer to sale) and effective date of prior art event Extrinsic evidence is allowed to say what the state of the art was in the past (In Re Wright), but hindsight bias The one asserting lack of novelty can presume that PA is enabled; applicant must prove otherwise o (2) Whether invention claimed reads on a single prior art reference, identically (all elements of claimed invention must read on for it to be PA—strict identity rule—a single prior art reference must disclose every element of that invention, arranged as in the claim) o (3) Whether prior art reference meets anticipatory enablement standard (Paulsen) 12 In re Paulsen (FC 1994): Patent claimed a portable computer and Japanese reference allegedly anticipated the portable computer b/c it was a calculator. “Computer” is within the preamble of the claims at issue. Patentee challenges whether Jap. computer was enabled. o Holding: calculator is a type of computer, so PA ref was sufficiently enabling. Presumption that PA is enabled; applicant must prove otherwise. o Two requirements of anticipation (1) Each and every claim must appear expressly or implicitly (inherently) in a single, prior art reference— strict identity rule (four corners rule) (2) Asserted prior art reference must be enabling—anticipatory enablement (invalid prior art does not count) o Strict Identity rule: Preamble of claim does not limit the scope of the claim when it merely states a purpose or intended use of the invention, but term may be deemed limitation of a claim when it “gives meaning to the claim and properly define the invention” a/k/a “breathes life and meaning into the claim” o Anticipatory enablement: narrower than §112(b) enablement requirement; judicially created Uses Wands factors, but only “make” not “use” required Question of law—de novo standard of review Must sufficiently describe the claimed invention so that a PHOSITA could have combined the description and her own knowledge to make invention a/k/a to have put the public in possession of it PHOSITA’s skill level taken into account Does not require reduction to practice or actual creation of prior art “A generic claim cannot be allowed to an application if PA disclosed a species falling within the claimed genus.” (In re Slayter)—SPECIES ALWAYS ANTICIPATES THE GENUS o Test is “whether a PHOSITA could [envision] the claimed species within the disclosed genus” (In re Petering) E.g., if PA is “wooden widgets” and claim is “widget comprising mahogany,” claim reads on PA if the PHOSITA could envision mahogany at the time of the PA A genus claim can read on some inoperative species, and not be invalid. If it reads on too many inoperative species, it is invalid. FEDERAL CIRCUIT has not said how many species is too many. o What about other way (claims a species, prior art is a genus) Depends! Would PHOSITA envision this when they look at prior art? The genus as a whole cannot be new if one or more of its constituent species is old “Known or Used” by Others Majority rule—contemplates that knowledge and use under §102(a) must be that which is available to the public (Gayler v. Wilder) This cannot be the inventor himself (OTHERS); knowledge of the activity by the inventor can defeat novelty Gayler v. Wilder (SCt 1850, Taney): fireproof chests constructed with plaster. Alleged PA was made for personal use in home and passed onto others with no description or knowledge of its whereabouts. o Holding: “known or used” by others means in a manner accessible to the public§102(a) has a publicity requirement o Inaccessible to the public or private use of the invention is not enough—does not foster innovation or public dissemination; similar to policy on foreign inventions and “lost arts” pre-AIA. o Policy: Improve the public knowledge. o Note: actual knowledge of the prior art by the inventor is fatal o Learned Hand: “what had not in fact enriched art, should not count as prior art” Rosaire v. Baroid Sales Division (5th Cir. 1955): Methods of prospecting for oil. PA by Gulf Oil which had developed the method (not gotten patent) and used method in remote location to test it o Holding: Work is publicly accessible even w/o publication if done openly and in the ordinary course of business and they were not actively concealing it; no affirmative act of publicity req’d. (Still publicity req’t but really low standard)—Publicity requirement may be met by a lack of concealment o Work here was successful b/c they used method in business; it doesn’t matter why their earlier applications were unsatisfactory or why they abandoned it—enough to show practicability Novelty is ascribed to new things, w/o regard to successful & continued use of old things If the experiments were unsuccessful, it may not have been enabling so can’t be PA Accidental Anticipations and Inherency Inherency Doctrine: PA ref may anticipate without disclosing a feature of the claimed invention if that missing characteristic is necessarily present, or inherent, in the single anticipating reference (Schering) o Limitation or entire invention is inherent and in the public domain if it is the “natural result flowing from” the explicit disclosure of the prior art (Schering) 13 o Infers lack of novelty if a comparable process for making the product is found to exist in the prior art o Inherency must be certain—it’s insufficient that there are probabilities or possibilities In re Seaborg (1963): Patent discloses new element and methods for producing compositions. PTO says Fermi reactor inherently produces element 95, but Seaborg says it’s small, undetectable, inaccessible amounts o Holding: Not invalid for anticipation because claimed product was produced in such miniscule amounts that presence was undetectable (J. Learned Hand: if the teaching does not inform how to practice new invention or enrich the store of common knowledge, then it is not anticipation) – Not anticipatory if: it is no more than a starting point for further experimentation. Its teaching will only sometimes succeed. It does not inform on the production of a product It does not increase the public knowledge FORK (SBS): But, doesn’t a Fermi patent user now infringe: (mirror function truism: “that which infringes if later would anticipate if earlier”) NO! No anticipation, no infringement! o Two interpretations of holding Anticipation requires that the prior art appreciates the invention—argument rejected in Schering Anticipation requires accessibility to invention in the prior art Schering Corp v. Geneva Pharms (FC 2003): Drug co. tried to patent a metabolite of the drug right before its patent for the drug itself expired (loratadine [Claritin]) metabolite). o Holding: A patent is invalid for anticipation if a single PA reference discloses, expressly or inherently, each and every limitation of claimed invention. This is not necessary at the time of filing (what distinguishes inherent novelty from standard novelty). Unlike Seaborg, there are detectable amounts; DCL necessarily forms from loratadine under normal conditions Appreciation, understanding, not required – A PHOSITA need not be able to anticipate the result o If new patent excludes the public from making prior art, then it should be invalid for lack of novelty (anyone who took Claritin would be infringing) o A reference is not inherently anticipatory IF Record does not show conclusively the product is produced when practicing prior art Product is produced through unusual conditions, unwitting or accidental circumstances Prior Disclosure in a Patent Document, 35 U.S.C. §102(e) “A person shall be entitled to a patent unless…the invention was described in (1) an application for patent…by another filed in the US before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in US before the invention by the applicant for patent.” *Involves anticipation through the description, not claiming, of the applicant’s invention in a patent or published patent application of another, where that “other” filed her application in the U.S. before the applicant’s invention date—codifies the Milburn Rule * **Requires that we treat a prior art U.S. Patent as constructively published as soon as it is filed—so effective date of the written description portion of a U.S. patent being used as §102(e) prior art is its filing date Alexander Milburn Co. v. Davis-Bournoville Co. (SCt 1962, Holmes): Improvement patent in welding and cutting apparatus, one of the inventors was not the first to invent o Milburn Rule: when a patent document itself, serves as evidence that the inventor was not the first to invent, novelty is destroyed—issued patents, published patent application, and published PTC applications can serve as PA o Here, patent couldn’t be PA until issuing bc PTO used to review patents in secret o The invention does not need to be claimed in prior art to be anticipatory; it just needs to enable a PHOSITA to sufficiently practice the claimed invention. §102(e) codifies Milburn Rule (1952 Patent Act) o Prior art effective date: patents are not available as PA until patent issues, but once it issues, effective date is prior art’s filing date 1999 Amend: most app. publish 18 mos. after effective filing date, even if it’s abandoned after publication Exception: if you swear not to file abroad, patent remains secret until patent issues, §122 o Patent application is prior art for what it discloses, not what it claims o Policy: “secret prior art” because 2nd patentee has no way of knowing it was coming b/c application not available for 18 mos. (prior art that is used at an effective date when the applicant against whom it is being asserted cannot have known anything about its contents); no actual public knowledge until app publishes But, application must be on trajectory toward public disclosure—must publish or issue (not prior art if it’s destined to remain secret) Secrecy was DEFINITELY a problem before the 1999 Amendments to the Patent Act because those applications were not published! So you really didn’t know until patent issued…a o Note: defeating patent prior art need not issue, if it’s already published (i.e., abandoned after publication) Purpose: the presence of a description of the invention that the applicant is claiming in someone else’s earlier-filed patent application evidences that the applicant was not in fact the first to invent that subject matter 14 Non-informing Products- If the product is actually in public use, some case law suggests that no enablement standard applies. EVEN IF the knowledge needed to produce the product is not available. Lockwood v. Am. Airlines (FC 1997) - Reservation system used for decades before filing for application (SABRE) o AA --> Asserted prior art is not enabling. Doesn't matter. Known or used by others, this IS prior art even though an enabling description is not available for a PHOSITA to practice the invention. (trade secret or patent, not both) Third-Party Inventive Activity, 35 U.S.C. §102(g)(2) “A person shall be entitled to a patent unless…before such person’s invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it. In determining priority of invention…, there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to practice, from a time prior to conception by the other.” Only one patent can be granted on a particular claimed invention. Secret Prior Art: not widely publicized and very difficult to find ***Remember: must not be abandoned, suppressed, or concealed and limited to the U.S. ***SEE PRIORITY SECTION Elements: o (a) made (conception w/ appreciation) o (b) reduced to practice o (c) in the US o (d) by another inventor o (e) before the date of the applicant’s invention o (f) continuously used (not abandoned, suppressed, or concealed) Purpose: o (1) codify the law on determining priority (102g2) o (2) preserve a basis for interferences (who actually invented) (102g1) No publicity requirement—trade secrets can serve as PA under this provision Has continuous use req’t, unlike §102(a) §102(g)(2) rejections are not often because they are discrete Trigger: 1st inventor opted not to patent but is making the invention Prior inventor must have possessed “contemporaneous recognition and appreciation of the invention” But, doesn’t have to have filed a patent application on her invention Nor does inventor have to understand its workings o Generally, the first to reduce to practice (who thereafter does not ASC) is the first to invent, unless the last to reduce to practice is also the first to conceive and sufficiently diligent. (See IV. Priority, infra) Thomson v. Quixote (FC 1999): Patents directed to information-storage devices that read or play CDs. Ds make CDs, claiming that Thomson’s claims anticipated by unpatented laser videodisc developed by MCA (non-party) (testimony of MCA EEs who worked on it, MCA internal dox, and expert testimony). o Holding: Claims are invalidated because of PA by 3rd party. No corroboration needed for expert witnesses—only required when there expert is the inventor and/or stands to benefit from outcome Other safeguards: high standard of proof (clear and convincing evidence); cross-examination o Policy: §102(g)(2) doesn’t have a publicity requirement like §102(a)—fair?? Public doesn’t get quid pro quo since first guy didn’t patent it; so why does he get protection 15 Judge Rich: preserve basis for interference; codify priority law; if not invalid, first inventor is infringing and that’s unfair to penalize for not filing; it’s being made and use so public is receiving benefit Secret uses are not prior art, but noninforming public uses are prior art o “Just as a secret use is not a public use, so a secret inventor is not a first inventor” (Gillman) Gillman (1940, Learned Hand): machine was kept secret from outside word. Process invention, but the product was commercialized. Machine could not be prior art. Concealment is different from §102(g) activity—not prior art if it’s destined to remain secret, like under §102(e) o Golf balls made with synthetic material “Surlyn,” where formula is secret but golf balls sold serves as PA because the public had benefit of the invention. Dunlop Holdings (7th Cir. 1975) Possibility of reverse engineering, unlike machine in gillman Commercially-available product actually contained the secret material o Prior inventor must take affirmative steps to make invention publicly known, but only requires that public enjoy the benefits or use of prior invention, not details. Friction Divisions (Del. 1987) o Must be on trajectory toward public disclosure (not A+C+S) Cannot be actively concealing! AIA eliminates §102(g)—secret prior invention (like MCA’s) will not qualify as prior art when the patentee didn’t file an application (aka published application or issue), but secret inventor can commercially exploit invention under certain standards: Prior user rights (Safe haven defense): secret prior inventor can continue to commercially exploit the invention, §273 o To get prior user right, party must prove by clear and convincing evidence that (1) Invented at least one year prior to the a) effective filing date of the invention or b) date the invention was disclosed to the public in a manner that it would qualify as prior art. (2) Commercial use in the US o Notes – One year goal avoids races to the patent office Cannot transfer/license prior user rights Cannot assert the defense against a university (protect research rights) Does not apply to all claims of a patent Foreign Activity, 35 U.S.C. §119, Hilmer Rule The filing of foreign application shall have the “same force and effect” as the same application would have if filed in this country on the date on which the application for patent for the same invention was first filed in such foreign country, §119 Many inventors seek patents abroad. Common practice is to file at home then abroad. Treaties: o Paris Convention—creates int’l priority (if inventor files an app in a signatory state, any app for that invention filed w/n the year in another signatorty state will get same filing date) o Patent Corporation Treaty (PCT)—can file an int’l app in one language, one country and recognized in all member countries; publishes 18 mos. 102e date is earliest effective filing date Under 1952 Act, PCT apps 1) Designating the US, 2) publishes in English, can serve as 102e prior art EVEN IF NEVER FILED IN THE US. (Still available under 102a/b upon publication). Just changes the date. UNDER AIA - To serve as 102a prior art, a PCT need not publish in English. It just needs to designate the US Hilmer I & II (CCPA 1966): Whether US patent gets effect as §102(e) PA as of foreign filing date under §119 or only under US filing date o Holding: §119 does not modify the provision of §102(e) that a reference patent is effective as of the date the application for it was “filed in the United States” (literal reading)--§119 cannot be used for patent defeating purposes to enable a foreign filing date to serve as effective prior art date (limited to obtaining patent and priority) o Note: don’t get confused—this affects the patent that is to serve as defeating prior art, not the attempted patent application. This says that a patent serving as a prior art reference is not effective by its foreign filing date, but only by its US filing date. AIA overrules Hilmer: foreign filing date now serves as effective filing date for PA purposes (has patent-defeating effects), but only applies to patents issued after 3/16/2013 o §102(d): foreign date is effective filing date of foreign application Current Foreign Priority Rule: Any application in signatory state, any subsequent application filed in the next 12 months in another signatory state is afforded the same priority date Printed Publication, 35 U.S.C. §102(a) and (b) “A person shall be entitled to a patent unless . . . the invention was patented or described in a printed publication in this or a foreign country . . . more than one year prior to the date of application for patent in the United States.” 16 All elements must be disclosed—either expressly or inherently—such that a PHOSITA could make the claimed invention In re Klopfenstein (FC 2004): Alleged PA references included printed slide presentation at a meeting; poster displayed for 21/2 day at a conference; displayed at KSU for 1 day; disclosed every limitation of invention; no disclaimer to prohibit notetaking/copying; no copies were disseminated; never indexed o Holding: Ref was sufficiently publicly accessible to count as a “printed publication.” §102(b) rejection The poster was “prominently displayed for approximately three cumulative days” to PHOSITAs; it was displayed without expectation of confidentiality or no copying; inventor took no measurers to protected information; professional norms under which inventors displayed posters at academic conferences did not entitled them to reasonable expectation of copying; and poster display was relatively simple such that it was easy for an observer to copy down o Klopfenstein factors for determining “public accessibility” (1) Length of time display was exhibited (2) Expertise of targeted audience (3) Existence (or not) of reasonable expectation that the material will be copied (4) Simplicity/ease with which the material can be copied o Purely oral divulgations do not qualify as prior art under §102(b) o The court is not limited to finding something to be a printed publication only when there is distribution and/or indexing—key determination is public accessibility (case-by-case inquiry into the fats and circumstances surrounding references disclosure to members of the public) Examples (can be deemed available even if actual access if somewhat difficult) o Yes: public billboard targeted to PHOSITA; copies indexed in university library, open to public (Hall); paper delivered orally to group where 500+ PHOSITA’s heard presentation and at least 6 copies distributed (MIT); Australian patent app on microfilm at Australian Patent Office (Wyer) o No: college students’ presentations of theses to defense committee, later indexed in lib with only students’ name and title (Cronyn) Publicly accessible: if it was disseminated or otherwise made available to the extent that PHOSITA exercising reasonable diligence could locate it o No requirement that public ACTUALLY sees it; just that it is available. o Reasonably Diligence Factor: Is the topic searchable, or must it be found by mere chance? o Rationale: Policy concern of §102 that we not permit withdrawal by a patent applicant of technology already yin the public’s possession o “Public accessibility” is the touchstone in determining whether a reference constitutes a printed publication bar under the statute FORK: AIA: “or otherwise available to the public”—would this include oral presentations?? IV. Priority, 35 U.S.C. §102 A patent application “shall be made, or authorized to be made, by the inventor….” The validity of a patent requires that the inventors be correctly named. 35 U.S.C. §111(a). Patent Act (1952): first-to-invent principle system 17 o Governed by §102(g)(1): “a person shall be entitled to a patent unless during the course of an interference, another inventor involved therein establishes that before such person’s invention thereof the invention was made by such other inventor and not abandoned, suppressed, or concealed.” o Invention = Conception + RTP Conception: “a definite and permanent idea of the complete and operative invention…so clearly defined that a PHOSITA could reduce to practice without extensive research” (Mahurkar) Reduction to Practice: Constructive RTP: written description; filing date presumed to be RTP date (no requirement that invention actually be RTP before filing—SCt, Scalia) Actual RTP: physical reduction; actually making or performing the invention; an inventor must demonstrate that the invention is suitable for its intended purpose (Mahurkar) Reasonable diligence in working up until just before the PA reference date E.g., ongoing experimentation, preparing a patent app, seeking feedback, consulting with patent attorney AIA (2011): first-inventor-to-file system (harmonizing our patent system with rest of world) o Governed by §102: first inventor to submit an application to the patent office has priority of invention o Relevant question is who filed first, not who invented first; §102(g) eliminated; priority date is effective filing date (or 1st inventor to disclose to the public, assuming falls within 1 year) – Can no longer swear behind a reference Conception & Reduction to practice NO LONGER MATTER o §102(d) establishes derivative status, involving who invented the invention Patent application/patent will not serve as PA if the disclosed subject matter “was obtained directly or indirectly from the inventor” Derivation challenge must be filed w/n 1 year of issuance of patent or of publication of patent application containing the derived claim Conception + RTP matter in this determination, but conception won’t “save your place in line” o Rationale: AIA creates incentives for copyists to steal invention and file first. This permits others to challenge who actually invented the invention. PTO presumes that the filing date is the priority date unless otherwise proven (putative invention date) a/k/a PTO assumes that you wake up, invent, RTP, and file by 5pm o Priority date can be as early as the date of conception o Priority dates before application filing date in U.S.: Provisional Patent App. (PPA) Child (patent app continual or divisional) Foreign application PCT date filed in home country Mahurkar v. CR Bard (FC 1996): Patent disclosing simple double-lumen catheter to remove and restore fluids to the human body using two channels (entry/exit). o Sufficient evidence of conception: conceived and began work on catheters; constructed and tested catheters in his home; sought to locate companies capable of doing something to make it for human use Procedure when Challenger asserts that Patent is Anticipated under §102 o (1) Patent is presumed valid if issued o (2) Challenger must meet burden of production and persuasion of invalidity by clear and convincing evidence (show date of reference is before the putative date invention) o (3) Patentee has burden of production to show that he invented prior to the PA reference o (4) Challenger has burden of persuasion to challenge that date Basic Priority Rule: The first person who reduces to practice the invention is the prima facie first and true inventor. But, the person who first conceives and thus first invents may date his patentable invention back to the time of its conception, if he connects the conception with its RTP by reasonable diligence so that are substantially one continuous act. (Taft) Litigation Practice: o §102(b) prior art is permanent statutory bar—first strategy is to find §102(b) art o Oral testimony of an inventor requires corroboration where party seeks to show conception (courts apply a rule of reason analysis), Mahurkar o Smart to try and show conception + RTP, as well as reas. diligence like in Mahurkar Rule 131 [Swearing Behind a Reference], 37 C.F.R. §1.131 “When any claim of an application or a patent under reexamination is rejected, the inventor of the subject matter of the rejected claim, the owner of the patent, … may submit an appropriate oath and declaration to establish invention of the subject matter of the rejected claim prior to the effective date of the reference or activity on which the rejection is based.” A/k/a swearing behind; swearing back; antedating references 18 Rule 131 allows Patentee to rebut presumption (that filing date is invention/priority date) and declare an invention date earlier than the filing date (putative invention date), as early as conception date w/ declaration or affidavit o Usually includes oath, factual showings, exhibits, testimony, etc. Purpose: to avoid Prior Art : Comes up on ad hoc basis because you don’t have to prove invention date during prosecution Can only be used for §102(a) and §102(e)—cannot be used for §102(b) or §102(g) prior art o Allowing swearing behind for §102(b) would contradict policy of encouraging early/timely disclosure (statutory bar); interference proceeding is proper avenue for §102(g) o Only available under Patent Act (1952) Conception date < Rule 131 < 1 year before filing Must show Conception + RTP or Reas. diligence between Conception and CRTP V. Statutory Bars, 35 U.S.C. §102(b) “A person shall be entitled to a patent unless . . . the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.” More than one year before the applicant’s filing date, the invention was o (1) patented anywhere in the world; o (2) described in a printed publication anywhere in the world o (3) in public use in the United States; or o (4) on sale in the United States— o in order to trigger §102(b), a statutory bar event must have occurred prior to the critical date Focuses on the critical date, which is one year before the earliest effective filing date o Before the critical date, an invention amy be patented, described in a printed publication, in public use, or on sale, all without triggering a §102(b) loss of right, assuming that it is not also fatal under another subsection of §102(b) o Grace period gives inventor time to perfect invention & marketplace reaction (costliness of filing a patent application) Purpose o (1) Encourages diligence by penalizing inventors who are lazy or slow to file Encourages prompt dissemination, prompt and widespread disclosure of new inventions to the public; inventor is forced to file promptly or risk possible forfeiture of his patent rights due to prior sales or public uses o (2) Protects the public domain from being misled—because at some point, the public believes it has possession and it won’t be taken away Minimizing detrimental reliance, policy against removing inventions from the public o (3) Prevent Commercial Exploitation beyond statutory term o (4) BUT given inventor time to perfect, experiment, and test the market §102(b) is the preferred prior art to defeat a patent and is often fatal o Can be triggered by the applicant or by others (§102(b)) o 102(b) art cannot be sworn behind; the only defense is to argue it (that the critical date is incorrect or that the reference is not enabling) o Operates independently of novelty and can attach even if inventor satisfies novelty requirement AIA gets rid of statutory bar in stand alone provision, but language carries over to other parts of the text FORK: Other countries are generally “absolute novelty” systems that do not recognize any pre-filing date grace period, or it’s for limited time. So when clients want to obtain patent protection in foreign countries as well as in the U.S. they should not make any public disclosure of their inventions at any time prior to filing their priority patent application Statutory Bar v. Novelty o Bars focus on activity of both inventors & third parties o Bars focus on activity prior to critical date; novelty focuses on activity prior to invention On Sale Bar An inventor will be barred from obtaining patent rights if she or a third party sold or offered for sale the claimed invention more than 1 year before the patent application is filed [Question of Law based on underlying findings of fact] Offer for sale need not be enabling; offer to buy probably doesn’t count o Means “placement on sale”—which means offer to sell or completed sales (even one sale can be fatal if it meets the other requirements) Policy: prohibits the prolonged commercial exploitation of the invention outside of the statutorily authorized time period of exclusivity (patent statute already provides patentee with powerful right to exclude others in the patent term…will not give that to them before the patent is filed) 19 Pfaff v. Wells Electronics (SCt 1998, Stevens): Patent application directed to computer chip socket was challenged under on sale bar because it was commercially marketed, but at the time it was not yet reduced to practice (detailed drawings describing design, dimensions, and materials, and a written PO). Patent rendered invalid b/c there was a written confirmation for sale and the detailed engineering drawings sent was RTP o Rule: One sale bar applies when two conditions are satisfied before the critical date (1) The product must be the subject of a commercial offer for sale Use general contract rules (2) The invention must be ready for patenting Actual RTP (proof of this) OR Sufficient information for an inventor to file an application according to §112; sufficiently specific for PHOSITA to RTP (writings, drawings, descriptions…aka same enabling req’ts as §112(a)) o Policy consideration: balance motivating innovation and enlightenment by rewarding invention v. interest in avoiding monopolies that unnecessarily stifle competition; this creates a brightline rule for inventors Invention refers to inventor’s conception rather than to a physical embodiment of that idea; no express requirement that invention must be RTP before patented (The Telephone Cases) Space Systems/Loral, Inc. v. Lockheed Martin Corp. (Fed. Cir. 2001): Patent directed to attitude control system for maintaining position of satellite notwithstanding gravity or wind pressures. The inventor testified that he conceived of the method but was not sure he could make it work. No statutory bar applied. o Fed. Cir. rejects D.C. conclusion that the conception alone made it enabled and RTP o To be RTP, inventor must be able to provide an enabling disclosure as required by §112. Where the inventor was uncertain of whether it could be made to work, a bare conception has not been enabled and is not complete, ready for patenting. Important that there was a complicated process (rocket science literally) When development and verification are needed to prepare a patent application, it’s not RTP The fact that the concept is later shown to be workable does not retrospectively make the invention ready for patenting. o Note: unpredictable arts might be harder to show RTP E.g., Honeywell (Fed. Cir. 2007): terrain warning system still not RF despite design notes, comp stimulations, test aircraft, demonstrations to experts, videotape of invention of use The Medicines Co. v. Hospira (FC 2016): MedCo paied a third party to manufacture three batches of the patented product prior to the critical date. None of the batches were released for sale until after the critical date. This is OK o A transaction for mere manufacturing services to create embodiments of the invention does not trigger on the on sale bar. Commercial benefit alone does not trigger, there must be a commercial sale. o TEST: Commercial benefit on its own, is not enough to trigger the bar. The transaction must be on sale such that it is "commercially marketed" No transfer of title (but is not dispositive) Inventor maintained control of product Inventor could not sell on their own Sale did not represent full market value of the product. o Stockpiling, when not accompanied by a sale, is mere pre-commercial activity for future commercial sales, not commercial marketing. o Subject matter of the offer must "fully anticipate, or render obvious" what is eventually claimed No 102b bar if inventor offers to sell something that is different from what is eventually claimed Abbott Labs. V. Geneva Pharms (FC 1999) – Third party selling a drug that contains the patented compound before the critical date triggers the bar, even if the inventor is not aware the patented compound is in the drug o Held: Doesn’t matter if inventors knew the product was on sale or not o If product sold inherently possesses each of the limitations of the claims, the invention is on sale, even if the parties do not recognize the product possesses the claimed characteristics. The subject matter of the offer for sale must either fully anticipate or render obvious what is eventually claimed. E.g., Sparton (Fed. Cir. 2006) (holding invention was not subject of offer when offer was for multi-piece release plate for sonobuoy and claimed invention was single-piece released plate that was later developed) Timing of the Offer: o Commercial offer can occur at conception; even if not RTP! When the invention is conceived, this becomes a 102b offer AVOID THIS by rescinding offer prior to RTP. AIA, Secret Sales: an offer between two people that: (1) does not fully disclose invention and has (2) fiduciary duty of confidentiality should probably still trigger the bar because of extension of monopoly and commercial benefit, etc… o Pre-AIA: Can trigger on-sale bar (Hobbs – used under government secrecy triggers; Buildex – exclusive manufacturing agreement triggers; Caveney – selling agreement between third parties triggers) 20 o EXCEPTION: Sales of a unpatented product by a third party using a patented process by a third party that is noninforming does not trigger. FORK: AIA, §102(a)(1): “on sale or otherwise available to the public.” Some argue that last phrase modifies “on sale” and now all PA must be publicly available for on-sale events, which would exclude secret sales Public Use Bar Patent is invalid if the invention was in use with the consent and allowance of the inventor before the critical date. Low threshold. ***CONTROL is really the important factor here—probably does not need to be wholly locked away in secret, but patent rights are lost when an inventor acts in such a way as to indicate an intent to abandon or otherwise dedicate the invention to the public Public use must: o (1) include every limitation of the claimed invention or o (2) render the difference between the use and the claimed invention obvious to a PHOSITA Factors: o Evidence relevant to experimentation o Nature of the activity occurred in public – Was the public use the intended use of the product? o Public access to use -any one person can be the public Would public believe they could use invention? o Confidentiality obligations opposed on members of the public? – how much control does the inventor have? Testing handicap seats on city buses that are not in use is OK; private labs o Commercial exploitation (can be dispositive) Public use must be used for its intended purpose (Motionless) Purpose: o Incentivize patentees to disclose early o Protect public’s expectations that it won’t be patented o Avoid additional exploitation o Give time for development (grace period) Egbert v. Lippman (SCt 1882): corset springs case—Inventor made corset for girlfriend and let her wear it; inventor also told a friend about the steels and how they were made or used. o SCt concludes that it was public use because she wore the corset steels for several years, had no obligation of secrecy and not for purpose of experimentation. A single embodiment of the invention and “even if knowledge and use is confined to one person” can trigger fatal §102(b) bar; aka single person using it can be sufficient Not fatal that corset could not be seen by public (presumably under her clothing)—that the inventor used it as a part of something public is sufficient (e.g., motor for a machine) Test is control – is the invention given away without limitation or control? If she had made it herself, it would be under her control—bar would not apply o Dissent: private use w/ consent leaves public as ignorant as it was before and should not defeat claim Motionless Keyboard Co. v. Microsoft Corp. (Fed. Cir. 2007): ergonomic keyboard input device. Inventor demonstrated to potential investors and friend; investors signed NDAs. Inventor also disclosed to typing tester who used the device once and signed an NDA. o No public use because the device, although visually disclosed and used by typing tester, was never connected to be used in the normal course of business (actual intended use of the device). Visual disclosure by itself is not a use; must be the actual intended use. Typing tester did use it for its intended use (which is important), but it did not rise to level of public use: one-time, signed NDA, no record of use after, private use or experimentation Non-informing Uses (1952 Patent Act): o Non-informing public use that is commercial in nature: inventor uses inventive process in secret to make a product that he subsequently sells to public; product doesn’t reveal anything about process, but inventor commercially benefits from selltriggers §102(b) bar (Metallizing Engineering) o Private use under the inventor’s control, not for commercial purpose, does not trigger the §102(b) bar (Metallizing Engineering) Secret, commercial use by the patentee does trigger the §102(b) bar Fork: If the details of an inventive process are not ascertainable from the product sold or displayed and the third party has kept the invention secret, then that use is not a public use and the bar does not apply (Garlock) Secret, non-commerical use does not trigger the §102(b) bar Learned Hand: “It is a condition upon an inventor’s right to a patent that he shall not exploit his discovery competitively after it is ready for patenting; he must content himself with either secrecy, or legal monopoly.” 21 o E.g., Moleculon Reasearch Corp. (Fed. Cir. 1986) (no public use of Rubik’s cube invention despite displayed embodiments shown to roommates bc (1) implied confidentiality between frandz; (2) invention under control of inventor who did not allow unrestricted use; (3) non-commercial; (4) experimentation) AIA Patent Reform Perspective on Non-Informing Uses o §102(b)(1) Exception to novelty: not defeating prior art if disclosure made within 1 year by inventor/joint inventor/derivative individual OR subject matter had, before an otherwise defeating reference, been publicly disclosed by the inventor/joint inventor/derivative individual o Disclosure exceptions in §102(b)(1) only apply when the inventor publicly discloses before the 3 rd party disclosure; an inventor who makes a non-public disclosure (i.e., confidential sale activity or noninforming public use) is not entitled to protection under §102(b)(1)(B) o Whether secret commercialization by patentee is prior art under §102(a)(1)? (Corporate/PTO view): AIA overruled Metallizing and Caveney because “otherwise available to the public” modifies “on sale” and “public use” so that those events must be public (wholesale qualifier) Supported by legislative history Would dramatically shift patent policy and law (elephants in mouseholes?) (Academic): Use of term “public disclosure” later in §102(b)(1)(B) means that “disclosure” includes private disclosures – Any disclosure with no writing is prior art Creates distinct form of prior art Scholars prefer this view b/c otherwise it would let inventors keep trade secrets forever and patent at last minute Senator Lahey: §102(a) was drafted to do away with precedent about secret commercial activity Third Party Activity Third party actions can defeat patent rights, even in absence of legal relationship and even when invention was obtained through improper means. Lorenz v. Colgate-Palmolive-Peet Co. (3d Cir. 1948): P filed application and communicated invention to D’s chemist, who said he wasn’t interested, but later patented the invention after P abandoned his app. P tries to revive application and establish priority, but D’s patent serves as fatal prior art. o Pirating/fraud is no exception to public use statutory bar. The purpose of the statutory bar is to protect the innocent public, and there are no exceptions when the public could be deceived, even by third parties. It does not matter how it ends up to the public, but once public is in possession, cannot monopolize Purpose: incentivizes inventors to protect themselves (“master of the situation”(1) NDA + K not to appropriate; (2) wait until patent issues; refuse to let patent app go abandoned; (3) be more savvy in disclosing subject matter; (4) seek to be added as inventor Evans Cooling Sys., Inc. v. Gen. Motors Corp. (Fed. Cir. 1997): Reverse engineering cooling system. D requested that P demonstrate the system at a test facility and allegedly stole the invention during the demonstration (D even said that he was going to steal invention). D then placed it on sale to independent dealers in brochure disclosing invention before P filed patent application. o Court refuses to create exception to on sale bar for those instances in which a 3rd party misappropriates the invention and later places the invention on sale or causes an innocent 3rd party to place the invention on sale. Purpose is to protect the public—discourage removal of the invention from the public Also affects the innocent 3rd party—independent dealers merit protection b/c didn’t know about misappropriation o Here, P conceived and RTP’d invention at least 6 years before filing—should have filed earlier and before disclosure Helsinn Healthcare S.A. v. Teva Pharms. USA (FC 2017) Experimental Use Exception Patentee may rebut a finding of public use or on sale bar by asserting that he was engaged in experimental use—ongoing experimentation negates finding of public use bar. – Testing the invention is OK. Testing the market is NOT Purpose: want inventor to spend time to refine invention to give society the best invention possible and permits inventors to determine if the invention is worth the time and expense of preparing and prosecuting a patent application No alternations need to be made during testing to justify experimental use (Machine could be tested in a factory for 2 years and found to be "perfect" - no changes needed. Experimental use still applies for that period) Small businesses are typically given more leniency, but still must meet the basic factors necessary to meet experimental use. A test designed to determine if an invention suits a particular customer's purpose does not satisfy experimental use, particularly if the customer controls the test. (Cannot tailor experimentation to one person, but entire market) EXPERIMENTAL USE IS AN OBJECTIVE INQUIRY, NOT A SUBJECTIVE DISCUSSION TO WHAT INVENTOR THOUGHT Smith & Griggs Mfg. Co. v. Sprague - Profit from experimental use does not change its status if the profit is incidental to the experimental use. The test is the purpose: Is the main purpose for trade and profit? Or is it for experiment? 22 City of Elizabeth v. Am. Nicholson Pavement Co. (SCt 1879): Patent directed at improved wooden pavement. Inventor placed it on high-traffic road for several years and came daily to examine it. He purposely chose popular road to test durability w/r/t heavy loads. o Experimental use exception applies b/c Nicholson was engaged and exercising control over the invention Manner of machine also important—pavement had to be tested on public road and for long time to assess durability Inventor did not sell for general use; allowed others to make; or lost control of invention o Incidental public participation/ benefit is not fatal and does not defeat experimental use o Incidental payment not fatal (Nicholson was SH of the road and collected toll) Lisle Corp. v. AJ Mgf. Co. (Fed. Cir. 2005): Inner tie rod tool as a component of a rack and pinion steering control system. Lisle delivered prototype to 4 diff repair shops, received no payment, no req’t of formal confidentiality agreement. Filed patent app 30 mos. later. o Court affirmed that there was substantial evidence to support experimental use exception o Lack of confidentiality agreement was not dispositive; they had an informal working relationship o There was control: Lisle engineers got feedback and made reports on the progress o Mechanics knew it was for experimentation Experimental use ends when the invention is ready for patenting, acc. to Pfaff, or reduced to practice o RTP requires proof that inventor constructed an embodiment or performed a process that met all the limitations and determined that the invention would work for its intended purpose Judge Bryson Gatekeeping Test: (1) Control; (2) Record keeping and (3) inventor knowledge of testing must be present VI. Provisional Patent Applications, 35 U.S.C. §111(b) Created by statute in 1994, available for June 8, 1995 Minimal application with a small fee—no claims, not examined; good for one year (then required to file a regular, nonprovisional application) o Cover sheet; WD, “adequate” disclosure; drawings, if necessary, small fee o PPA is now effective filing date o No claims or oath by applicant required o Not substantively examined by PTO; nonprovisional application will be substantively examined and the applicant can claim for the later nonprovisional application the benefit of the earlier provisional application’s filing date, effectively “backdating” her application by up to 12 month, as long as the invention she claims in the nonprovisionsal patent application was adequately supported by the disclosure of the provisional application in accordance with 35 U.S.C. §112 Benefits of Provisionals o (1) Placeholder to secure your filing date and “set your place in line”; can say “patent pending” (shows conception earlier) o (2) Gives patentee cheap option to see if she actually wants to file a full-fledged app—helpful for startups, garage inventors, small companies in development of funding o (3) You can make pitches for investment and disclosures without fear of §102(b) because of early filing date o (4) PPA one-year pendency is not included in 20 year patent term—so it’s really 21 year patent term and 2 year grace period for §102(b) triggering event 23 If a savvy inventor files the PPA before public disclosure and timely files a nonprovisional application, §102(b) statutory bar cannot operate, even if provisional application is deficient because PPA falls within grace period If inventor files a nonprovisional application after a different disclosure, may lose all patent rights if he mistakenly believes that disclosure in the PPA adequately supports invention o (5) It freezes universe of prior art that can be used against you; when the examiner compares the claims of the nonprovisional application with the prior art for purposes of assessing novelty and nonobviousness, he will consider only that prior art that has an effective date earlier in time than the filing date of the provisional application o Priority date for the subsequent filing of foreign patent applications on the same invention in accordance with right of priority of the Paris Convention Limitations of Provisionals o (1) PPA must comply with §112, mainly WD & enablement—it must disclose what is claimed in nonprovisional application o (2) Potential loss of trade secrets—in trying to meet §112, a PE might say too much PE should, but is not req’d to, add claims to PPA o Feedback effect: ask if claims are adequately enable—if not, then edit WD to comply with §112 o How can you enable without drafting claims? Effect of inadequate disclosure o 1952 Patent Act: forgiving; interference proceeding permitted applicants to produce more information to support o AIA (2011): no interference; no second chance; if it’s not disclosed in PPA, no benefit of earlier filing date for undisclosed claims Not sure if derivation proceeding will help PPA counts as §102(e) prior art (the §102(e) date reaches back to the PPA). See In re Giacomini, 2010, (holding that the §102(e) date should be the filing date of the provisional application and thus have patent defeating function) o Fundamental rule that the patentee must be the first inventor (Milburn), and a PPA shows that someone else was the first to invent. VII. Nonobviousness, 35 U.S.C. §103(a) “Conditions for patentability; non-obvious subject matter”; An invention must be nonobvious to be patentable—whether the difference between the claimed invention and the prior art would have been obvious to a PHOSITA at the time the invention was made (Patent Act of 1952) or at the time of filing (AIA 2011) [Question of law] [Remember: (1) Is PA available under §102? (2) Analogous Use] Should do the heavy-lifting in patent law – most frequently litigated, but big issues with hindsight bias! Even if patent survives prior art, an evaluation of the invention may reveal that a patent should not issue because the benefit obtained by society may not justify the cost of granting the patent. --> A trivial extension of what is already known o Is it already within the PHOSITA’s technical grasp? o Lack of nonobviousness: “If the difference between the new thing and what was known before is not considered sufficiently great to warrant a patent” (Graham) Patent-free zone around prior art—allows PHOSITA to tinker around without having to worry about patents (Former Chief Justice Rader) Novelty means new; obviousness means not new enough (Chisholm) o Novelty: rule; all elements from PA must be in one reference o Nonobviousness: standard (more flexible); biggest hurdle for a patentee to overcome; references can be combined to defeat patent; more aggressive protection of public domain Policy o Invention should be sufficiently removed from prior art o Encourage PHOSITAs to tinker with invention to improve science o Guard the public domain Hotchkiss v. Greenwood (SCt 1851): Door knobs; improvement consists of making knobs with clay/porcelain instead of metal or wood knobs, which was allegedly better and cheaper. o The knob is not new—combination invention but differences are trivial; would’ve been obvious to ordinary mechanic (grandpa of PHOSITA); simply changing or improving materials is not a sufficient advancement o “Improvement is the work of the skillful mechanic, not that of the inventor” Graham v. John Deere (SCt 1966, Clark): clamp for vibrating shank plows; devices were similar except for two elements— stirrup and bolted connection of shank to hinge plate are new and position of shank is reversed which patentee says effectively absorbs forces where PA arrangement failed. 24 o Creates nonobviousness standard: “He who seeks to build a better mousetrap today has a long path to tread before reaching the Patent Office” o Constitutional Limits on Congress’ patent power: (1) A patent may not remove existing knowledge from public domain or restrict free access to materials already available (2) Disclosure must actually add something to and enrich the public storehouse of knowledge o Five-Step Inquiry for Nonobviousness (Graham v. John Deere) (1) Determine the scope and content of the art PA reference must be available under some subject of §102 Together all of the P.A. must teach all elements of the claimed invention PA as a whole (combined) must be enabling, but one inoperative part is not fatal Probably includes some motivation to combine (2) Ascertain the differences between the claimed invention and the prior art Requires claim construction; prior art must still be enabling at this point (3) Ascertain the PHOSITA’s level of skill – factual; objective determination (4) Make the nonobviousness determination (5) Evaluate objective evidence (secondary considerations) of nonobviousness (rebuttal evidence) Unexpected results - lanolin v. coconut oil in lotion—may seem obvious to PHOSITA, but patentee context by showing that coconut oil has 24hr last v. 12 Teaching away - When a PHOSITA would be discouraged by prior art from following path set out in the reference or would be led in a different direction (In re Gurley) Skepticism or failure by others Commercial success: must be a nexus between the merits of invention and the commercial success (Iron Grip Barbell) - Because if it were obvious, someone else would have invented it to catch the profits o Mere existences of licenses are insufficient (need affirmative evidence) because it’s easier to license than litigate Long felt but unsolved needs: mere passage of time w/o claimed invention is not sufficient (Iron Grip Barbell) o If it were easy to do, someone would have invented to meet the need already Copying: must be the replication of specific product—every copy not okay because every infringement would confirm nonobviousness (Iron Grip Barbell) Graham factors (1)-(3) form the prima facie case of the lack of nonobviousness and then secondary considerations are the rebutall evidence the patentee can present if PFC is adverse Purposes of Nonobviousness Requirement o (1) To promote technological progress, allowing PHOSITA to tinker in the space of patent o (2) To coordinate the future development of technology, nonobviousness induces inventors to pursue more socially valuable and challenging projects than trivial ones o (3) To spur innovation, nonobviousness encourages inventors to be more creative; get those inventions that would not have been disclosed otherwise United States v. Adams (SCt 1966): Patent for battery electrode in water stuff something. Govt says invention lacked nonobviousness because of 6 P.A. references that PHOSITA could substitute and combine o Ct held nonobviousness for several reasons Uses claim construction canon that claim should be read in light of the WD and the principle of claim differentiation Secondary considerations: batteries worked better than PA designs, PA taught away from claimed batteries and govt experts had said that his invention (by combining the PA) would never work; long, practical need Modern Analysis TSM Test: To establish a lack of nonobviousness, some teaching, suggestion or motivation exists in the prior art that would’ve led PHOSITA to modify or combine its teachings to arrive at the claim o Purpose – guard against hindsight bias o Sources of motivation: (1) the references; (2) PHOSITA’s knowledge; (3) nature of the problem to be resolved; (4) other sources of info (KSR: market forces, design incentivized, interrelated teachings of multiple patents; problem known in field; background knowledge; creativity; common sense, predictability ) o Test triggered by the combination of old elements o Potential rebuttal: no reasonable expectation of success (usually because of unpredictability of the art) o Before KSR, the test was pro-patentee (rigidly applied), but it softened after KSR—it still alive and well, but not exclusive test 25 KSR v. Teleflex (SCt 2007, Kennedy): Patent for combining an electronic sensor with an adjustable automobile pedal so that the position can be transmitted to controlling computer. PA included adjustable pedals, electronic pedal sensors for computer-controlled throttles, placement of sensors on adjustable pedals, and self-contained modular sensors which could be used with diff types of pedals. o Ct. held that claim was invalid for lack of nonobviousness because P would have combined the PA references to achieve the same objective o Graham framework is broad, expansive, and flexible o “A [PHOSITA] is also a person of creativity, not an automaton.”—can be smart and put things together; question is whether combo was obvious to PHOSITA Hindsight bias should not overcome common sense—objects can be used for more than its intended purpose With simpler technologies, motivation to combine may be found in the nature of the problem to be solved—the PA references themselves need not provide an express, written motivation to combine (i.e., they might address a similar problem) o Flaws with TSM Test. Doesn’t account for: What problems are known in the field at the time of the invention by the PHOSITA (beyond the problem the inventor was trying to solve) that may lead an inventor to combine references Assuming a PHOSITA trying to solve a problem will only look at prior art related to that problem. A PHOSITA is creative, not an automaton It can be obvious to try a combination and that would lead to invalidity. If a finite number of combinations/solutions are available, trying them all may be obvious. Common sense should be permitted under any nonobvious analysis. o Takeaways after KSR Analysis should be flexible (Graham) Predictable results and “common sense”are generally unpatentable PHOSITA can be creative and combine insights from other fields Combination inventions should receive higher scrutiny Inferences are permissible Nonobviousness based on claims, not preferred embodiment “Obvious to try” might be useful in deciding nonobviousness (although Fed. Cir. tries to discount it) Weak patents can stifle rather than promote progress (policy) PTO Rationales for Lack of Nonobviousness Rejections [Manual of Patent Examining Procedure, §2141] o Combining elements according to known methods to yield predictable results o Simple substitution of one known element for another to get predictable results o Use of known technique to improve similar devices in same way o Applying a known technique to a known device ready for improvement to yield predictable results o “Obvious to try”—choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success o Known work in one field may prompt variations of it for use in the same or diff fields based on design incentives or other market forces if variations are predictable to PHOSITA o Some teaching, suggestion, or motivation in the PA that would’ve led one of ordinary skill to modify the PA reference or combine to arrive at claimed inventions Perfect Web Techs, Inc. v. InfoUSA, Inc. (Fed. Cir. 2009): Patent for managing bulk email distribution to groups of targeted customers by repeating the process of randomly selecting and emailing until desired quantity is reached. Repetition of send was only new part. o Court refers to common sense—to repeat the process until target # of emails sent o “Obvious to Try” Choosing from a finite number of identified, predictable solutions with reasonable expectation of success Rebutted by: showing there is an infinite # of identified, predictable solutions Proctor & Gamble Co. v. Teva Pharms, Inc. (Fed. Cir. 2009): Risedronate drug patent, which was not disclosed in the alleged PA, which is patent teaching intermittent dosing method for treating osteoporosis. Teva argues that structural similarities between risedronate and the claimed compounds render claims obvious. Nonobviousness because of lack of motivation, no reasonable expectation of success, and unexpected results. o Weak presumption: PHOSITA would expect compounds of similar structure to have similar properties, but can be overcome by unexpected results o In chemical arts, nonobviousness inquiry is based around chemical structure of the compound Party contesting nonobviousness must: (1) establish a lead compound from which a PHOSITA would start and (2) prove that PA gave PHOSITA motivation to modify the lead in a particular way and with a reasonable expectation of success in doing so Post-KSR, the motivation could come from a number of sources 26 o o No motivation and reference would not be a lead compound: unpredictable; properties of biphosimate couldn’t be anticipated Inferences between compounds are dangerous and potentially misleading Nonobvious to try scenario—no credible evidence that this structural modification was routine; unexpected results can rebut TSM Constructing the PHOSITA Six Factors Considered to Construct PHOSITA’s Identity (Non-exhaustive) (Envt’l Designs): o (1) Educational level of the inventor o (2) Types of problems encountered in the art o (3) Prior art solutions to those problems o (4) Rapidity with which innovations are made o (5) Sophistication of technology o (6) Educational level of active workers in the field Daiichi Sankyo Co., Ltd. v. Apotex, Inc. (Fed. Cir. 2007): Method patent for treating bacterial ear infections by topical administration of oflaxacin. Apotex sought approval to manufacture generic ear drop and Daiichi sued for infringement. o Level of ordinary skill in the art is that of a person engaged in developing pharmaceutical formulation Inventors are in the lab, not general practitioners of pediatrics Problem to be solved is a topical remedy without damage to ear (complex) Level of skill is higher—GPs and pediatricians wouldn’t be able to develop drug Reversible Error? o Judge Lourie: PHOSITA determination is only reversible error where it affects the ultimate conclusion under §103 Controversial—may be too simplistic? DC should be incentivized to put PHOSITA at correct level of skill Levels of skill aren’t necessarily linear, vertical—imputing info on more sophisticated PHOSITA o No reversal if there is a finding of obviousness and the reversal would result in a higher level of skill o No reversal if there is a finding of nonobviousness and the district court found the PHOSITA to have the highest level of skill PTO Manual of Patent Examining Procedure: The PHOSITA must “of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” This is a question of fact Stryker Corp. v. Hill-Rom Servs. (PTAB 2014): During IPR review; Stryker challenges the PHOSITA determination for a patent for hospitable beds with networking capabilities. o Holding: PHOSITAs can have multiple disciplines and wide range of knowledge – here an electrical engineer with experience in medical devices and communication networks” Available Prior Art and the Analogous Art Doctrine Only “analogous” prior art can be used for a §103 inquiry (stricter than §102 inquiry) [Question of Fact, Reviewed for substantial evidence] Rule: Art/reference for an nonobviousness inquiry must come from “the same field of endeavor” as the claimed invention or be “reasonably pertinent to the particular problem with which the inventor is involved” o Not as prevalently used after KSR o Purpose: limits the universe of prior art (helps patentee); need restriction b/c challengers can combine act references No analogous art under 102 In re Icon Health & Fitness, Inc. (Fed. Cir. 2007): Folding treadmill basis; challenged based on PA w/r/t springs that fold bed into a cabinet. Analogous art because pertinent field. o “Familiar items may have obvious uses beyond their primary purposes.” (KSR) o A reference is reasonably pertinent if, even though it may be in a different field from that of the inventor’s endeavor, it is one which, because of the matter with which it deals, logically would have commended itself to an inventor’s attention in considering his problem. o SIMPLE SUBSTITUTION OF ONE KNOWN ELEMENT FOR ANOTHER TO OBTAIN PREDICTABLE RESULTS SUPPORTS A FINDING OF OBVIOUSNESS (MPEP 2143) In re Klein (Fed. Cir. 2001): mixing device for use in prep of sugar-water nectar for butterfly feeders; device has divider allowing for creation of 2 compartments with proportionate volumes according to what’s needed for the nectar; then divider is removed and they are mixed. Spec says rations aren’t novel but adjustable dividers to match ratios are. PA included different containers with movable dividers. PHOSITA would not have thought to combine any of the 6 references (incl. account holders, drawer partitions, bottles, hair rinse containers—none would be sufficient for inventor to use). o Reasonably pertinent If a reference disclosure has the same purpose as the claimed invention, the reference relates to the same problem, then it supports use of that reference in an nonobviousness rejection o Note: statement by applicant in prosecution or examination is an admission and serves as prior art reference 27 o PHOSITA is important—judgment should be grounded on reality of circumstances (common sense) in deciding in which fields a PHOSITA would reasonably be expected to look for a solution to the problem facing the investor Optimization Through Routine Experimentation o If prior art is tweaked to improve/optimize a process; is this usually considered obvious (in re aller; in re Peterson) Overcome this: Show unexpected results (differences in kind v. difference in degree); show prior art teaches away from the optimizing method. Secondary Considerations What/how many/how severe must secondary considerations be to overcome a finding of obviousness. Transocean Deepwater Drilling v. Maersk Drilling USA (FC 2012): Dual activity apparatus for offshore drilling is nonobvious, despite combined prior art references, due to significant secondary considerations. o The fifth factor is applied as rebuttal evidence, and includes – Unexpected results – Not present Teaching away Skepticism/Failure by others – Fears by experts that this would not work Praise by others – 25% increase in efficiency Commercial success – 12% premium on market; licensing agreements Long-felt/unresolved need – Several unsuccessful attempts prior to this Copying – Defendant tried to copy An inventor must show a “nexus or causal relationship” to prove commercial success is due to the invention Unexpected Results must be more than conclusory statements (difference in degree v. difference in kind) Long Felt Need must be shown to be because of inability to invent; not other industry priorities. Iron Grip Barbell Co. v. USA Sports (FC 2004) – Rebuttal evidence is insufficient to survive a nonobviousness challenge. Unexpected results – Most doubted whether this would work Teaching away – No evidence present here Skepticism/Failure by others Praise by others Commercial success – License agreements alone are not sufficient; further some licensing agreements were taken in lieu of litigation Long-felt/unresolved need – No evidence of long-felt need; they were simply first to market Copying – No evidence o Note: FC states here they can make a decision on nonobviousness and secondary factors without having to issue a remand Notable Cases Millennium Pharms Inc. v Sandoz (FC 2017) – Millennium creates a compound which a different compound contained in the prior art; Sandoz challenges that it would have been obvious to create this new compound in light of prior art o Nonobvious: While the correct lead compound was identified for this analysis, there is no teaching/suggestion/modification to show this would occur – rather here the reference teach away from the obtained result to the PHOSITA o The mere fact that a thing may result from a given set of circumstances is not sufficient to render the result inherent. o Secondary factors show nonobviousness – this is an unexpected result based on the prior art and there was an unresolved need in the market for this o SBS: Inherency arguments rarely work in 103 cases In re Van Os (FC 2017) - Examination renders patent for Apple’s 3D Touch technology patent. On appeal, court finds that there was no common-sense reason for these references to be combined. o While KSR requires common sense and creativity/flexibility of the PHOSITA be recognized, this does not permit a factfinder to make an obviousness determination without well-reasoned analysis. Conclusory assertions are not permissible. o Ex poste reasoning is prohibited under KSR o Concur/Dissent: Appropriate result here is to grant the patent; not remand. PTO did not meet its burden so patent is valid Personal Web Techs. v. Apple Inc. (FC 2017) Apple’s patent for data storage and management is found obvious in light of available prior art. Court finds patent is nonobvious. o The amount of explanation needed will vary from case to case, depending on the complexity of the matter and the issues raised in the record. o Regardless, the PTAB must articulate logical and rational reasons for its decisions. Sure seems like the TSM test is dominating the in the FC again – will SCOTUS need to come in and reaffirm KSR? 28 VIII. Eligible/Patentable Subject Matter, 35 U.S.C. §101 “New and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent thereof” Should err on side of inclusiveness because “times change” and “technology . . . progress[es] in unexpected ways” (Bilski, Kennedy) Excluded from PSM: laws, products of nature, abstract ideas, physical phenomena o All lack human intervention/agency v. occurring in nature – they exist and just need to be found The claim on the thing (like the bacterium in Chakrabarty) is the most valuable—never acquiesce Huge policy question about whether §101 is appropriate venue to solve these issues or §102 & §103 Policy: Basic tools of scientific/technical work should be free to all; not monopolized Grant of a patent in these areas would tend to impede innovation more than promote it Biomedical-Related Inventions Diamond v. Chakrabarty (1980 SCt , Burger): patent disclosing invention of a bacterium. Inventor took bacterium and altered/engineered it so that it was particularly productive in breaking up crude oil and cleaning up oil spills. Court holds that living, genetically altered microorganism is PSM. o “Markedly different” from any characteristics found in nature—dispositive that there was human intervention 101 permits any non-natural occurring item that is created by man o Congress intended PSM to “include anything under the sun that is made by man”—broad scope Jefferson: “ingenuity should receive a liberal encouragement” o PTO/Dissent: Genetic materials were unforeseen; should wait for Cg. to ask (But see Marbury WE SAY LAWZ) Mayo v. Prometheus (2012 SCt, Breyer): method patent; whether claimed processes transform unpatentable natural laws into patent-eligible applications of those laws; claim here does not contain an inventive concept necessary for patentability o “To transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words ‘apply it’ “ o §101 should do real work where other sections cannot o TEST: To transform an unpatentable law of nature into a patent eligible application of such law, one must do more than simply state the law of nature and then add “apply it” STEP 1: Is the claim directed to a law of nature, natural phenomena, or abstract idea? STEP 2: Is any inventive concept, element, or combination thereof sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself? What is not enough: Well-understood, routine, conventional activity already engaged in by the scientific community Requires the patentee to set the law’s application in novel/nonobviousness manner Inventive concepts support a prohibition on a generic application of a law of nature o Claims that provide nothing more than instructions to the laws of nature are unlikely to succeed. “Determining” is a kiss of death in patent claims Association for Molecular Pathology v. Myriad Genetics (2013 SCt, Thomas): whether human genes are patentable. Myriad discovered precise location and sequence of BRCA genes for risks of breast and ovarian cancer. Claims involve an isolated DNA coding and a cDNA matching nucleotide sequence. If granted, patent would give it exclusive right to isolate an individuals BRCA genes by breaking covalent bonds that connect DNA to the rest of individual’s genome. o Holdings (really only dealt with composition of mater claim): Naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated. Synthetic cDNA is patent eligible because it is not naturally occurring. - “Myriad did not create anything.” Distinguished Chakrabaray, because inventor modified bacterium and in the end it had “markedly different characteristics” - Here, Myriad found something, but didn’t create it. Thomas criticizes Myriad method of claiming, they focused on genetic information, claiming anything that looked like BRCA Claims are not expressed in terms of chemical composition, nor do they rely on chemical changes that result from the isolation of a particular section of DNA PTO’s longstanding practice is not entitled to deference (it hasn’t been endorsed by Cg. like it was with the Plant Act and the US argued that it was not PSM) o Dicta: Patent protection strikes a delicate balancing between creating incentives that lead to creation, invention, and discovery, and impeding the flow of info that might permit, indeed spur invention Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry Court leaves open patent protection for: Innovative methods of manipulating genes New applications of knowledge about genes 29 o Inventions that alter the naturally occurring nucleotide sequence of genes Implications For method claims? Existing patent portfolios—will people shift to trade secrets or try to reissue? Claim drafting – need to show alterations to product from naturally occurring Includes anitbodies, hormones, etc. Business Methods and Software-Related Inventions Alice Corp. Pty. v. CLS Bank Int’l (2014 SCt , Thomas): 3 types of claims (media, systems, methods) all related to computer software acting as an intermediary to reduce settlement risk by creating real-time shadow accounts of each party and transferring simultaneously. Not PSM. o Claims are drawn to abstract idea of intermediated settlement and merely requiring generic computer implementation fails to transform that abstract idea into a patent-eligible invention. o Concern is preemption: whether patent would preempt use and research of approach in all fields and effectively grant monopoly over abstract idea o Must distinguish between patents that claim “the building blocks” of human ingenuity and those that integrate the “building blocks” into something more o SCt uses Mayo test, which previously only applied to laws of nature (1) Determine whether the claims at issue are directed towards an abstract idea, law of nature, or natural phenomenon Everything starts as one of the three exceptions to PSM Cg. have never defined abstract idea Compares to Bilski—abstract idea is not limited to “pre-existing fundamental truth”—can include a fundamental economic practice (2) Determine whether the claim “contains an inventive concept sufficient to transform the claimed abstract idea into a patent-eligible application” Distinguishes Diehr where balkanization process of computer was held to be PSM because (1) something was transformed and (2) end product is better, more inventive o Here, invention doesn’t improve anything; generic computer; function that usually happens in person put on computer—not enough After Alice, PTO Guidance about §101 (rejects a lot of patents based on new framework) o Mayo analysis applies to abstract ideas and to laws of nature o Mayo analysis applies to product and process claims, as well as method claims o Process (1) Determine whether claimed invention falls within four statutory categories of invention (process, machine, manufacture, or composition of matter) E.g. , fundamental economic practices, certain methods of organizing human activities, an idea of itself, mathematical relationships/formulas (1.1) Mayo Step 1 (2) Mayo Step 2 E.g., of enough: improvements to another technology or technical field; improvements to the functioning of the computer itself; meaningful limitations beyond generally linking the use of an abstract idea to a particular tech envt E.g., of not enough: adding the words “apply it” or mere instructions, requiring no more than generic comp to perform generic comp fx that are well-understood, routine, and conventional activities previously known to the industry o If there are no meaningful limitations in the claim that transform the exception into a patent eligible application such that the claim amounts to significantly more than the exception itself, the claim should be rejected under 35 U.S.C. §101 as being directed to non-statutory subject matter Bilski v. Kappos (2010 SCt) o Federal Circuit had previously established Machine or Transformation Test – Process claims are patent eligible under 101 if: It is implemented by a particular machine in a non-conventional and non-trivial manner Transforms an article from one state to another o SCOTUS: This is not the exclusive test. There is no categorical exclusion of business methods. IX. Utility, 35 U.S.C. §101 Inventions must be “useful” [Question of Fact] 30 [Presumption of utility; burden on PTO] Until 20th century, patent denials for lack of utility were rare Justice Story (1873): (1) some beneficial use to the public; (2) not injurious to the morals, the health, or good order of society; (3) operability: can the invention actually work to achieve the claimed result (capable of being used to effect the object proposed) o Operability is only remaining prong o Issues with this: (1) impossible inventions (cancer cures v. snake oils); (2) Morality (slot machines; (3) specific end use req’d at time of filing; (4) safety and efficacy before patenting When examiner rejects for §101 utility, it’s always paired with §112 enablement rejection (if invention lacks utility, the patent cannot teach the PHOSITA to use the invention) o Seymore disagrees because the req’ts are not coextensive and you can use something without utility Modern Standards – o Operability - Can operate crudely/not perfectly Seemingly impossible – is the invention incredible/would PHOSITA believe? Red Flags: Nascent technology, rapidly changing fields, primitive stage of development, technological renaissance, quests with poor track records of success Risk – Denying patents that are actually amazing! o Substantial Utility – A significant & immediate benefit to the public – useful in its current form o Specific Utility – Benefit must be so defined that there is a particular benefit to the public – cannot be so vague as to be meaningless. [No Morality Requirement] Juicy Whip v. Orange Bang (Fed. Cir. 1999): post-mix beverage dispenser that displays an identical-looking liquid like a pre-mix dispenser, but actually has a hidden juice—purpose of inducing customers into impulse buys. DC rejects under §101 because it’s designed for deception and it’s a limitation, only improving PA in salability o Bryson: PTO is not arbiter of deceptive trade practices—morality issues are not for patent law o Case killed morality requirement, if there were one [Operability] In Re Schwartz: Cold fusion claims rejected for not being reproducible. o The claimed invention must be “capable of being used to effect the object proposed” o Totally incapable of achieving objective results low bar for operability When properly claimed invention meets at least one stated objective, utility is clearly shown (Raytheon) Need not be the best or only way to accomplish stated objectives o Test for operability for “seemingly impossible” invention? Is the invention incredible in light of the knowledge in the art OR Would a PHOSITA believe the objective truth of the applicant’s assertions o In re Schwartz probably reflects bias from the public scientific community? What happens when something disbelieved in the past actually becomes possible (e.g., baldness treatment rejected for 59 yrs)? Burden is on PTO so why should patentee have to prove this? [Specific and Substantial Utility]-Modern Requirement (Brenner) o ***only needs one specific and substantial use—doesn’t matter if it’s useless in other settings o Substantial utility: practical significance, particularly as applied to chemical and biotech-related inventions (chemists sometimes make leaps between compounds, but hard to do if compound if unpredictable) o Brenner v. Manson (1966 SCt, Fortas): patent process/method for making known steroids. Few other inventors did the same, but Manson was denied interference proceeding because of §101 lack of utility. He could prove that he made the compound, but he could not prove that he discovered the utility at that time. Manson argues that because steroids of similar structure have utility, PTO should presume utility of similar structure (bootstrap argument). PTO rejects argument because steroid chemistry is unpredictable). Rule: Unless and until the process is refined/developed to the point where specific benefit exists in its currently available form Basic quid pro quo for granting a patent monopoly is the benefit derived by the public from an invention with “substantial utility” Court doesn’t define the terms though Until the process claim has been reduced to production of a product shown to be useful, the metes and bounds of that monopoly are not capable of precise delineation. The compound lacks utility if it merely serves as building block for other things or further research “A patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.” Effect: invention of a new process that is more efficient but can’t disclose it’s use—no patent Harlan’s Dissent: this will encourage secrecy; or incentivize inventors to concoct the trivial uses (poor expenditure of technical brain power and fills the WD with junk, acc. to Judge Rich) Delayed disclosure 31 o In re Fisher (Fed. Cir. 2005): patent for EST gene sequences, which are typically used to study an organism’s genome, that represent a fragment of cDNA which shows which gene was expressed at mRNA extraction. Fisher listed 7 things of utility but those 7 were common to all ESTs, nothing specific to these. Substantial Utility: Practical and real world utility Useful to the public NOW as disclosed in its current form, not that it’s useful in future research Must provide a significant and presently available benefit to the public Based on the PHOSITA Lacking substantial utility: basic research, method of treating unspecified disease or condition, method of making something where the something has no substantial utility) Specific Utility Not so vague as to be meaningless—nebulous expressions Well-defined and particular benefit to the public Policy—are these two prongs subjective?? Judge Rader dissent: use of obviousness req’t, not utility req’t for assessing sufficient contribution to the useful arts o Criticizes majority’s rejection of “general function” because general benefit is sufficient—research tools, advancing research, etc… o Cannot be the law that no further research is required Anti-commons prob: if these patents are allowed will it block off basic research and hinder development? (Seymore says no, research has not shown that) Question: why do amusement patents (pogo sticks) never raise §101 utility probs o Patent law started with mechanical and electric patents; chem is foreign and patent interpreters are uncomfortable o Less stake in games/puzzles than chemical arts 32