#14152 - Patent Law Attack - Patent Law

Patent Law Attack Outline

Fall 2015

University of Virginia – Prof. John Duffy

Formalities

• Claims

  • Preamble

  • Transition: open, closed, or in between

  • The Body

    • Three Formal Requirements for Claim Drafting

      • (1) Single Sentence

      • (2) No Freestanding Elements

      • (3) Antecedent Basis

    • Independent & Dependent Claims (multiple-dependent claims, combination claims)

    • Means-Plus-Function Elements (112(f))

    • Jepson Claims

    • Negative Limitations: must have adequate support w/reason to exclude (Sontarus)

• Specification

• Drawings

Patent Eligible Subject Matter

• 35 U.S.C. § 101: Inventions patentable. Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.

  • Broadly interpreted (includes “anything under the sun that is made by man” Chakrabarty quoting S. Rep., dicta), but subject to two types of exclusions

    • General Exclusions: principles of nature, natural products, physical phenomena, abstract ideas

    • Field Restrictions: specific legislative exclusions from patentability (e.g. some nations exclude surgical methods or business methods)

• Naturally Occurring Things: Living Things & Natural Phenomena

  • There is no per se rule against patenting living things (Chakrabarty)

  • Current Two Step Process: (From Alice, applied in Ariosa Diagnostics)

    • (1) Are the claims directed to a patent-ineligible subject matter? (but isn’t everything abstract or natural to some degree?)

      • Natural: DNA and blood samples (Ariosa)

      • Natural: Naturally occurring plasmids (Chakrabarty)

      • Natural: Level of compound in blood (Mayo)

      • Natural: Isolated DNA (Myriad)

      • Natural: Non-modified bacteria

      • Y/N Natural: Electrical signals (O’Reilly v. Morse & Telephone Cases)

      • N Natural: Synthetic non-naturally occurring cDNA (Myriad)

    • (2) If yes, do the claims recite additional elements that “transform the nature of the claim” into a patent eligible application

      • Two Parts:

        • (a) Look at each element alone - is it beyond the abstract idea and was it in the prior art?

        • (b) Look at the combination - does it add more over prior art? (Duffy thinks Ariosa missed this step)

      • N: Describe the natural relation (Mayo)

      • N: Simple Application of Discovered Phenom. !patentable (Funk Bros.)

      • N: Isolated natural thing (Myriad)

      • Maybe: Measurement method or actual dosage adjustment (see Mayo)

      • Y/N: Limited to structure beyond overly broad new principle (compare O’Reilly v. Morse to Telephone Cases)

      • Y: Genetic modification (Chakrabarty)

  • Case Overview:

    • Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015, supplement) two step process for claims directed to ineligible SM (paternally inherited DNA from maternal blood)

    • Diamond v. Chakrabarty (1980) no formalistic or per se rule against living things (genetically modified microorganisms)

    • Mayo v. Prometheus (2012) - something more than describe natural relation (testing to indicate to change dose)

    • O’Reilly v. Morse (1853, p. 107) - Overly Broad New Principle (sending characters w/EM)

    • Telephone Cases (1888, p. 116) - Limitation to Contribution (electrical undulations carrying sounds)

    • Funk Bros. Seed Co. v. Kalo Inoculant Co. (1948) - Can’t Patent Conventional Application of Natural Phenomenon (combination of bacteria inoculant strains that found not to inhibit each other)

    • AMP v. Myriad (2013, supplement) naturally vs. randomly occurring (isolated DNA & cDNA to find breast cancer)

• Abstract Ideas:

  • Two step test (Alice v. CLS Bank)

    • Step 1: identify the abstract idea

      • If there is a combination of abstract idea, you may be able to stop the analysis as no case says this is unpatentable

      • See stuff above for natural phenom.

      • Abstract: Binary to decimal conversion (Benson)

      • Abstract: hedging process (Bilski)

      • Abstract: third party intermediary exchange (Alice)

      • Abstract: digitally implementation of method (Alice, Diehr, Bilski)

      • Abstract: electrical signals (Morse but see Benson)

    • Step 2: Go through the claim and look for “an element or combination of elements that is ‘sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself.”

      • Two Parts:

        • (a) Look at each element alone - is it beyond the abstract idea and was it in the prior art?

        • (b) Look at the combination - does it add more over prior art?

          • E.g. Ariosa decided wrongly - each step was known but many think the combination itself was enough

      • Enough:

        • Digital implementation of method connected to machine for process (Diehr)

          • Best case for software patents

        • Bell telephone

      • Not Enough:

        • Digitally implementation of method (Alice, Bilski)

        • Convert binary to decimal (shift register or not) (Benson)

  • Case Overview:

    • Alice v. CLS Bank (2014) - Two Step Test (computer implemented third party intermediary for exchange of obligations)

    • Bilsky v. Kappos (2010) - no per se bar on bus. methods, MOT doesn’t control (market hedging process)

    • Gottschalk v. Benson (1972, p. 123) cannot essentially cover idea/formula (method of converting binary into decimals)

    • Diamond v. Diehr (1981, p. 133) - best case for software eligibility (operating rubber press with computer)

    • See also Telephone Case and Morse

• Field Restrictions: TRIPS (fields of tech.), comparison with other countries, Medical Procedures

Utility: § 101 and § 112

• Operability: generally only made for incredible inventions

  • Concerned with as of filing

  • Presumptively operable

  • See also enablement: speculation and prophecy

• Beneficial Utility: (see also patent eligible SM)

  • Thing of the past (Lowell v. Lewis)

  • Deception is likely OK (Juicy Whip)

  • Illegal things are not per se non-beneficial - we must be against them as a nation

• Practical/Specific Utility: must be substantial and identified in the patent

  • Concerned with as of date of invention (can’t discover it later), see Brenner, Fisher

    • Concern = Blocking Patents for things that we do not have a use for yet!

  • Not enough: in vitro usually (Brana); subject of research (Fisher, Brenner)

  • Enough: for use in research (e.g., microscope, not like Fisher, Brenner)

Disclosure & Enablement

• (Best Mode)

• Enablement

  • Concerned with time of invention, question of law

  • Standard is what PHOSITA would understand

  • Allows for post-filing evidence

  • Two Issues:

    • (1) Is the disclosed invention operative for some use? (see credible utility)

    • (2) Did the applicant enable all that is being claimed?

  • Cases:

    • Must have a Common Distinguishing Principle enabling the invention for a broad class claimed (The Incandescent Lamp Patent - carbonized fibrous or textile material)

      • Pioneering patents okay if enabled

    • Entire Scope (e.g. ranges) must be enabled for a PHOSITA (In re Fisher - at least 1 mg when enabled for only 1.11-2.3, prior art <1)

    • Cannot have undue experimentation for field - look to Wands Factors (In re Wands - process for using antibodies only worked 1-2% of the time)

      • Also must enable starting materials (Wands)

    • Repository - (1) final product, or (2) initial materials (Duffy thinks illegal)

  • Speculation & Prophecy

    • Prophetic: it’s ok to be prophetic if a PHOSITA would understand this to be true (Strahilevitzi - combination of existing tech to cure blood impurities)

    • Speculative: not okay when PHOSITA wouldn’t understand it to be true (Jansen - helped memory in animal studies-->claim treat Alzheimers/humans)

    • See also Operability

• Written Description

  • See reading of § 112(a) for differing views on the scope of the WD requirement

  • Does not allow for post-filing evidence

  • Limitations on Amendments:

    • New Matter: cannot bring in new matter (§ 132) w/ amendments, method of enforcing Written Description

      • Procedural: not defense to infringement (instead raise enablement or claim breadth)

    • Called Written Description if raised during infringement/etc. trial

    • Compare Gentry Gallery (sofa recliner control) with VasCath (vein catheter design patent)

  • Claim Breadth: must precisely define product (Eli Lilly 1997 - cDNA for rat insulin but claimed for all mammals) and method (Ariad - no disclosed structure for reducing binding site)

    • Difference from enablement: this requires possession, not just allowing PHOSITA to understand (contribution - enablement), this is more restrictive

• Definiteness

  • Standard: “invalid for indefiniteness if its claims, read in light of the specification delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention” (Nautilus - “spaced relationship”)

    • Old test: “insolubly ambiguous” (Standard Oil v. American Cyanamid)

  • Breadth Indefiniteness, breadth is Enablement or Written Description

  • Means-Plus-Function Claims: Law limits means-plus-function to that which is in the spec and equivalents, but it might be able to be called indefinite if there isn’t sufficient structure in the specification (Duffy says no)

Novelty

• See main outline regarding classification under Pre-AIA or AIA statutory categories

• Anticipation: must be all elements

  • Look for separate elements (Robertson - first and third fastening elements)

  • Inherent capabilities (Schreiber - oil can cap inherently capable of use as popcorn lid)

  • No Backsliding Principle: Only requires enabling, not actual creation or reduction to practice (Schering v. Geneva - patenting metabolite of Claritin; but see Seaborg - element 95, Tilghman - glcerine in steam engines, Edison - wires joined in glass bulb, these cases are all still good law...