Patent Law – Spring 2010 – Ossorio

OVERVIEW

Bundle of Rightso Wholly negative; only the right to exclude (as opposed to broader

ownership/possession/sale/manufacture rights for other types of property)o Not a monopoly – often reasonable substitutes compete in the same marketo Valid only in the issuing jurisdiction

Need for Patentso Problem

Ideas themselves are “non-rival Inexhaustible and non-excludable

Need incentive and way to recoup costs of inventiono Many Solutions

Patents Trade Secret First-mover advantages (fast-moving industries, network/infrastructure)

Purpose o Purpose is to promote public good

Maximizing production of things (inventions) Disclosure/dissemination of ideas

o Side-effect is extraneous quid-pro-quo to inventors Governing Law

o Constitution – Art I § 8 cl. 8 (empowers Congress to make patent laws) “Useful art” = patent “Science” = philosophical writings/copyright

o Federal law – 35 USC o MPEP – 37 CFR

Governing Bodieso PTOo Federal courts

Two components o Invention = new/useful…. [machine/manufacture/method/composition]..etc

Plays large role in pharma, where research costs to invent are higho Innovation = bringing invention to market

Plays large role in biotech, where useful application of invention is sometimes unclear

History

Aristotle (4th Century B.C.)o Community called for a reward system for inventiono Aristotle was against patents – there should be no exclusionary right; thought that giving things

to society built good character of citizenry Middle Ages

o Guilds kept techniques, similar to trade secreto Community sought dissemination of this information

Venice (15th Century)

o Administrative scheme for granting exclusionary rights to inventors England

o Adopted patent system to draw inventors England (17th Century )

o King James had been manipulating England’s patent law to grant his friends monopolieso In response, House of Lords passed Statute of Monopolies (basis for U.S. patent law)

Famous Section 6 – “new and useful” inventions get exclusionary rights U.S. (1790)

o First patent statute

1/26/09 – Structure Of the patent document- INID Codes – Internationally agreed Numbers for the Identification of bibliographic Data- Look like [1], [45], etc.- Helps w/ international patents- Patents usually referred to by last 3 numbers of the patent- Also contains:

o Serial # (issued upon filing)o Domestic and international classificationso Fields of search, references cited and other informationo Abstracto Drawings

If necessary to understand the inventiono Specification

Written description of the invention and of the manner and process of making and using it

Must disclose the “best mode” known to the inventor of carrying out the invention

Generally known as the written description, enablement, and best mode requirements

No new matter can be amended after filing o Claims

Most important part

Basics of Claim Drafting- 3 parts: preamble, transition and body- Preamble

o Introduces and identifies the basic parts of the inventiono E.g. “device for attaching pages together”

- Transitiono Open: “claims comprising” – includes claims

Most commono “Closed” claims: “consisting of”

Used for o “Consisting essentially of”

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

- Bodyo Must perform two functions: (a) list all the elementsof the invention and o (b) describe how they interact.

- Many attorneys rely on previously-blessed phrases, such as Richard C. Faborer, Landis on Mechanics of Patent Claim Drafting

Requirements for Claim Drafting- The claim must be written as one sentence.- Claim must set forth how each element interacts with at least one other element- Internal references must be clear- Claims are either dependent or independent – they rely on previous claims or they stand alone- Claims may depend on multiple claims (they are multiple dependant)- Multiple dependent claims may not depend on other multiple dependent claims- Patent claims most often begin with a broad independent claim followed by subsequent

narrower dependent claimso These narrower dependent claims afford protection in case the PTO invalidates one of

the broad claimsMeans-Plus-Function Elements

- Claims specifically authorized in the form “means for doing X” where X is the function- Must be used in combination with at least one other element

Improvements – Jepson claims- Used for patenting improvements to an existing invention- Typically have long preambles followed by the transitional phrase “wherein the improvement

comprises”- Improvements can also be drafted in the standard format

For 2/3/2010:- read Bilski 545 F.3d 943 (2008) Federal Circuit In re Bilski

o Read up to the end of the majority opinion, skip or skim Deek’s concurrenceo And read the dissents

- For next week: p. 175 n.8 – 194; p. 207-221

Patentable Subject Matter- Patent Co-operation Treaty (PCT)

o Enables a shared prior art searching to occur so that a party wanting to patent in a jurisdiction ( > 100 countries)

o There can be filing that can be used in any country during the ‘national phase’ of the patent prosecution

o Referenced in U.S. statutteso There is also a EU patent convention (European Patent Convention – EPC)o You can do more than just a prior art search. Afterward, you do have to register in

individual countrieso So the EPC, you can have the entire prosecution done in the countries and then file to

activate in those countries- General agreements on tariffs and trade – most countries participate

o ’93 : first time international patent harmonization tied to international treaty talkso Patent law agreement called TRIPS – Trade Related Intellectual Property o Lots of change in the U.S. as a result, lots in other countries as wello For U.S. companies, under TRIPS, there can’t be any field restrictions as to what is

patentable Directed toward India, Brazil, who had laws that excluded patent law on

pharmaceuticals and chemicals Under TRIPS there can only be exclusions for public health or environmental

emergencies- Although there is a clause in EU law about patent law regarding public law or morality, it isn’t

used much by the courts or the EU patent- Medical process patents in EU can be excluded from patentability

o Even in the U.S. process patents aren’t enforceable against medical personnel- Treaty has language which sounds like a positive right

o Really it’s the ability to exclude others from importing things covered by the patento It doesn’t confer a positive right to import

- Remember, the patent privilege is to exclude others- After GATT trips the length changed

o Used to be 17 years from date of issueo Now it’s 20 years from date of filing (+ any applicable extensions)o Changed the strategy for prosecution – used to be niggling back and forth until you were

really sure you wanted to get the patent- Benefits of a patent

o Exclusionary rule means you can prohibit someone from researching your inventiono Not usually done b/c if there’s new use and it’s covered by your patent, any inventor

would have to license from youo Also most biotech companies research using competitors’ products

And this reduces transaction costso If you’ve chosen not to enforce your patent, you will have trouble getting a preliminary

injunctiono Patent system: 20 years term good for longer product cycles, shorter more ideal for

industries with short product cycles

- PTA’s – patent term adjustmento Granted to patentees whose applications sat in the USPTO too long and it was their faulto Indicated on the face page of the patent

- Provisional Patentso You file an applications w/o claims. It’s not examined – it just holds your place in line.o |--------------|------------------------------|-------------------------------------------------|o DO file provisional file app w/ claims - 20 yrs. o Invention (w/in 1 yr., have to add on claims)o Also remember, you can have up to 2 continuationso If you file the provisional, then any art that would be obvious subsequent to the

provisional would not be considered

Patentable Subject Matter- Infringement or D/J action- If you are the defendant or accused infringer, you argue that the other party’s claims are not

valid- Or argue the patent is not enforceable because inequitable conduct or patent use- Only then do you argue “we didn’t do it”- Patents are born valid!!

o Once the patent has been issued, the courts should presume it is valido Means party opposing has to prove by clear and convincingo And once a patent issues, it’s gone through scrutiny by USPTO, so we defer with this

higher standard- Claim validity

o Is it patentable subject matter? Is it useful (utility requirement)? Is it new (novelty requirement)? Is it enough of a contribution to knowledge

(non-obvious)o Drafting concerns

Is the claimed invention properly disclosed? (§ 112)- Whoever invents or discovers

o Any new and useful Well-defined in § 102 what is “new” Useful isn’t well-defined

o process, machine, manufacture, or composition of matter, or any new and useful improvement thereof

- 35 USC § 100 Definitionso When used in [the patent act] unless the context otherwise indicates –o (a) the term ‘invention’ means invention or discoveryo (b) the term ‘process’ means process, art or method, and includes a new use of a known

process, machine, manufacture, composition of matter or material.

o So if there’s a new use for a product, - Product vs. Process Patents

o Product patent = patent claims cover physical embodiments Covers all uses of the product

o Process patents Method of making Method of using Method of doing

Funk Brothers- People knew there was a bacteria that would help the plants grow better- But each bacterium only infected a specific type of plant, and when they were put together,

they would cancel each other out- One Bond discovered two strains of bacteria that wouldn’t mutually inhibit one another- I: is this patentable? - H: No. The bacteria’s character hadn’t changed – it was just as though the bacteria were in

nature- The Court says this is nothing more than an advance in packaging- It’s not modified according to a human thought process- Pronouncements

o Laws of nature are not patentable – and that’s what the Court thought he’d done.- Frankfurter dissent

o He basically argues that there wasn’t enablement or that the invention wasn’t adequately described

o He would’ve invalidated on other grounds

Why do we have this product of nature doctrine?- The idea that certain knowledge is so fundamental to the advancement of so many fields that it

would not advance, but inhibit progress in science and the useful arts- Courts are highly deferential to “high tech.” inventions

Diamond v. Chakrabarty- The Products of nature doctrine

o Cannot patent product of nature and because it’s a living thing- Defines what section 101 prevents patenting of something that occurs in nature- Ossorio argues that Product of nature subsumes Living thing- Patent Office & Lower Ct. – problem is: it’s a living thing?

o Well, can’t they just patent the process of making it?o Are these little guys machines?o Ethical issues – cloning human beings

- USPTO said it was not in the subject matter- SCOTUS said Sup. Ct. said it intended patents to be all encompassing- I: can a living thing fit into patentable subject matter?

o Useful arts is interesting: - “Anything under the sun made by man” may be patentable

o Has to show the effects of human manipulation- Here the product of nature doctrine wasn’t implicated b/c - What did Chakrabarty do?

o He put bacteria together, and had them “bacteria sex” and then they transfer their plasmids

- If you were the patent office, what would you argue?o That this is just advancement in packaging?o The court says these bacteria aren’t found in nature, but we have no idea whether they

do exist in nature or not- So, living v. non-living – both patentable- Dissent argues that the Plant Patent Act specifically mentioned certain items and wasn’t meant

to have such broad applicability.- Chakrabarty not very well argued – they never advanced the Funk Brothers argument and

instead argued there would be a “parade of horribles.”- The court announced that the distinction is not living vs. non-living

o It’s human created or constructed vs. “product of nature” Manufactured v. Natural Unnatural v. natural Artificial v. Natural

- They say it’s Congress’s or another agency’s job to limit what can receive protection- Chakrabarty had a number of claims

o The only ones the USPTO didn’t allow were the product claims themselves (the composition of matter)

o Why?o There are other ways to get to the same result

- The thing about process patents is that if there’s > 1 way to get to the final product, then your process patent gives you almost not protection

- A product patent gives you the right to exclude doing anything with the product- Product patents are viewed as being much more powerful in terms of their exclusion

What about patenting a dog breed, like a Labradoodle?- J.E.M. Ag Supply Inc. v. Pioneer Hi-Bred Int’l – newly eveloped plant breeds may be protected

under the general patent statute.- They cite Chakrabarty- Invention that was a brewing process and the yeast – again it wasn’t just the patenting of yeast.- There was a widespread view that bacteria weren’t going to meet the requirement for

patentability, and so weren’t even trying-

Parke-Davis . H.K. Mulford – opinion by Learned Hand

- Purified adrenaline – even though naturally occurring, as long as it’s useful – and is purified is patentable

o It becomes a new thing for all practical purposes- Mr. Takamine isolated and purified adrenaline

o Prior to this, a slurry of ground up adrenal glands were usedo Transformed a salt into a baseo He had another application in which he claimed the salt variety, but this was already in

nature- He obtained a patent on the compound w/ the salt as well- Hand says that as long as the product has new uses, that’s what we should care about- Also he says it’s stunning that judges have to deal with patent law- And he uses the market share after the product was released to see if it should be patented

o And this is questionable jurisprudenceo But the federal circuit is fond of that evidence in determining non-obviousness evidence

- One patent for the patent, and another for adrenaline + salt- Learned Hand says that purification of an animalian substance is patentable- Even though different chemicals were used to get the end product, it was a product patent, so if

there were different methods used, it doesn’t matter- Now, was Takamine’s product anticipated from prior art?

o All the prior arts were a salt, so no prior art- Nor does another patent in Germany that used Zinc constitute – - “it became for every practical purpose a new thing commercially and therapeutically That was a

good ground for a patent.”

55-64, 67-78, 98-117Patent Process Consolidation

- Patent co-operation treaty (PCT) - And EPC – European Patent Convention- Inventors may file a single “PCT app in any patent office of a jursidcition bound by the

agreemento 2 phases “international phase” and “national phase” – applicant must prosecute the

application through the patent office of each country where the prosecution is sought.- EPC establishes centralized office for prosecution – the European Patent Office

o Only applies to 20 nations, compared to PCT’s 20- GATT – Global agreement on tariffs and Trade –

o Gatt Trips – Trade Related Aspects of Intellectual Propertyo Made almost everything patentable subject matter (pharma. For developing nations)o Tested them for an inventive step and application (equal to our non-obviousness and

utility)o Gave patentees the exclusive right to import invention

- Changed the patent term to 20 years from 17 from filing date

o Can get term extensions for PTO and FDA delays, though- Provisional apps give you up to 1 year longer of a term. They act as a placeholder

o Meant to even out foreigners’ advantages- We also began publishing some applications after 18 months of being in the patent law

o But an application will be kept confidential unless the applicant also filed a patent on the same invention in another country that has the 18 month publishing policy

o You can never get that anonymity back – so it’s a tradeoff

Lab Corp. v. Metabolite- Metabolite sued Labcorp for methodof detecting a vitamin b12 / b9 deficiency- Detects the deficiency by detecting elevated levels of homocysteine

o Comprising the steps of: testing the body for a level of a hormone, and then correlating it with the level of

o It’s a process patent – do an assay and think about it- So who’s the infringer? Well, a lab does the assay, and the doctor does the correlation

o Who are they suing? They’re suing a company does the assayso But they assays they’re doing aren’t covered in this claim!o The company (Labcorp) stopped paying royalties to Metabolite b/c they stopped using

their assay. But they came back and said it covers any assay for homocysteine- So, Labcorp got sued for inducement to infringe

o- Defendants argue that the patent is invalid- The court said it was improvident to grant cert. on this issue- Solicitor general said it’s probably unpatentable, but might be patentable if it entails the

transformation and reduction of an article to a different state or thing- Breyer, Stevens, and Souter

o Breyer has been sending lots of signals that he’s unhappy with the patentable subject matter doctrine

o Same thing with Souter- Breyer thinks that this isnt’ a process – and anything can be made a process- The correlation between homocysteine and vitamin deficiency is a natural phenomenon

The courts for patents- The CCPAs didn’t have subject matter jurisdiction – heard all patent cases that came up from the

patent office and a lot of FTC (the regulator who regulated importation of patent goods)- But it di

In Re Bilski – 545 F.3d 943- Background

o Rader = law & economics

o Gottschalk v. Benson – 1972 - for a “naked computer program” – converted BCD to binary

Court held it to be unpatentable subject matter Was a process claim No new apparatus claimed, no new machinery necessary to carry out the

invention If the patent were valid, it would wholly preempt the mathematical formula,

and would be a patent on a mathematical formula Did not say whether or not software could be patentable, however

- Paker v. Flook o Another method patent on updating alarm limits –

An alarm limits is just a threshold # after which something happens Might be a measure of temperature or pressure and when it gets too high, the

machine shuts down What was claimed was a more complicated algorithm (a pretty simple

algorithm) implemented through software If you wrote it down on paper, most people thought it wouldn’t be patentable The court held again that this was an abstract idea or mathematical formula,

and so not patentableo

- Diamond v. Diehr o One of the few cases where a supreme court upheld the patento Process for curing synthetic rubbero Method of operating rubber mold press, using a computero Court said this case is different because they weren’t claiming the algorithm was a new

thing – Also they were transforming unmolded rubber into molded rubber

o AN otherwise patentable industrial process is not rendered unpatentable by the fact that some steps refer to software, computers or algorithms

o So now you claim an algorithm as a machine- State Street Bank – Federal Circuit test – not ever followed by the Supreme Court

o Business method patent for transferring $$ between various accounts and investorso Opinion written by judge Richo Held that the algorithm can be patented to the extent that it produces a “useful,

concrete and tangible result.”o The supreme court had never upheld the test used in this caseo There are some cases that say business methods are unpatentable subject matter, but

these cases could be decided on other grounds, so: There is no business method exception Business methods may be patentable subject matter

o As for this particular claim, the issue is not whether or not there is some transformation of something physical. The issue is whether the math and the computer calculations are used to produce a “useful, concrete and tangible result.”

- Utility Requiremento 35 U.S.C. § 101 Whoever invents any new and useful process, machine, manufactureo 35 USC § 112 & 1 spec shall contain a written description of the invention and of the

manner and process of making and using it … to enable POSA to make and use the same and shall set for the best mode

- At&t v. Excelo A claim for a new field in a record of data

Purely method claimo Claim for a new field in a data record about a phone caller that would help phone

companies keep track of who was calledo Tipped the scale to saying that software is just plain patentable

- In order to understand if something is patentable, you have to look at the claim as a whole, so how can you say the algorithm is the real part inside the claim – that’s not examining the claim as a whole!

-- Tried to patent a method for managing consumption of risk costs of a commodity sold bya

commodity provider at a fixed price comprising the steps of:o (a) initiating transactions between commodity provider and consumers at a fixed rateo (b) identifying market participants for said commodity having a counter-risk position to

said consumers ando (c) initiating a series of transactions between said commodity provider and said market

participants at a second fixed rate such that said series of market participant transactions balances the risk position of said series of consumer transactions

- Essentially method for hedging risk by using an intermediary commodity provider- It was rejected by the patent office as not directed to patent eligible subject matter

o Why? Wasn’t directed to the technological artso Appealed to the board of patent appeals and interferences

They said it’s an abstract idea, but also by the way it doesn’t produce a useful, concrete and tangible result test

- H: Not patentable subject matter – forget utility, non-obviousness, or enablement- Clarified Comiskey – “physical steps” are not required (a previous clarification)

o There could actually be physical steps, but if it doesn’t meet the machine-or-transformation test, forget it

- Useful Concrete and tangible result test in State Street:o That doesn’t apply either, the court says

- H: The machine-or-transformation test – from Benson

o They leave the definition of exactly what a machine is to future interpretationo Specifically computer is left wide openo Physical or chemical transformation are good to go under this testo They don’t define what transformations are eligible for patentabilityo Data gathering steps in algorithms are not sufficient

- Why doesn’t the Bilski claim meat the test?o It’s just an “exchange” of options, which is not a transformation of any physical object or

substance, or an electronic signal representative of any physical object or substanceo In Comiskey, they tried to patent an arbitration scheme and it was rejected. Similarly, in

Meyer, they rejected a method of diagnosing the location of a malfunction in an unspecified system using numerical values – it was essentially a mathematical algorithm

o Nor was their scheme even limited to any mathematical formula- Newman; Mayer Rader Dissents

o Says the machine-or-transformation makes invalid many photonic, electric technologieso They say it’s not clear what the limits of the test areo The redefinition of “process” is contrary to 2 centuries of legislative historyo New definition of “process” was rejected in Gottschalko Parker also contraveneso Argues broad policy point that we want a broad patent granto Algorithms are allowed when they transform or reduce an article to a different state or

thing o Argue that earlier decisions don’t reflect the court’s current tenoro Concurrence’s reliance on Statute of Monopolies is unfounded, because that Statute

was designed to curb monopolistic abuseso Legislative history “art” was replaced with processo Notes that similar business method patents exist in Englando Similarly, the U.S. has always had business method patentso Says CCPA and Federal Circuit Precedent rejected by the majority o > 15,000 patents in this classification have been issued and the public has relied on this

(really not a good justification )- Mayer Dissent

o Argues that business method patents shouldn’t be grantedo He looks at historical precedent o Says State Street led us down the wrong path and allowed business methodso He says a process isn’t “technology”o Busts out the dictionarieso Looks at ridiculous patentso The test is problematic because everything can be a transformationo Supports the technological arts test

- Rader Dissent

o In Diehr, the Supreme Court adopted a very useful algorithm for determining patentable subject matter, namely, follow the Patent Act itself. After setting forth the procedural history of that case, the Supreme Court stated: "In cases of statutory construction, we begin with the language of the statute."

o Argues Bilski should’ve been overturned on abstractness or theory groundso Argues for the broad patentabilityo Says Lab Corp – it did achieve a useful and tangible resulto He’s in favor of the tangible result testo

For Next Week: p. 175 (note 8) – 194; 207 – 221;

Relevant distinction is application of an abstract idea and the abstract idea itself. Application can often shown via MORT, though MORT is not required. More appropriate is “useful, concrete, tangible result” of State Street. And this can apply across the industries, including life sciences. Though State Street was a machine claim, not method….and that test may simply just align with the ‘utility’ concept. Essentially, Bilski went overboard in defining the word “application.” An abstract idea/law of nature/physical phenomena must be applied to be patented…..the SC will hopefully give us a better definition of what “application” means.  *JUDGESBreyer (and Souter somewhat) – wants patent-eligible subject matter narrow

Found Lab Corp correlation clearly unpatentable Makes efforts to gain scientific knowledge Seems to think software is unpatentable

Rader In Bilski, dissents MORT test; supports tangible result test; Believes the Lab Corp was wrongly decided

(tangible result was diagnosis) Law-and-economics focus Supports broad patent-eligible subject matter

Newman Pays attention to mores/ideas in patent policy Makes efforts to gain scientific knowledge

Dyk Focuses on procedural issues; not interested in patent-policy

Ridge (State Street opinion) Considered to be expert in patent law

    

UTILITY §101, §112 

Policy basis: ensures that society gets appropriate benefit from the patent system Issues usually arise around timing: patents on early stages of research Three kinds of utility:

o Operable Prevent claims that violate the laws of nature or fundamental scientific principles Also prevents mistakenly drafted claims

o Beneficial Aka moral utility

o Practical Specific Credible Substantial

Procedural considerationso Every claim is viewed as presumptively correct in terms of utility and the burden is on

the PTO to show someone skilled in the art would ‘reasonably doubt’ the asserted utility and operability of the claimed invention. Then the burden shifts to the applicant to show that those skilled in the art believe the invention has utility

Lowell v. Lewis – Storey, J.o Invented an improvement to a pumpo The defendant contended there was not utility in the improvemento “All that the law requires is that the invention should not be frivolous or injurious to

the well-being, good policy, or sound morals of society.”o The upshot is that the requirement for utility is not general utility, it must only have

utility to that particular person in that field Juicy Whip v. Orange Bang

o Juicy whip had a dispenser that looked like it was a pre-mix dispenser, but it wasn’t really

o Interestingly Orange Whip wanted to be able to use the device, but they were a sort of Johnny-come-lately and wanted to invalidate on grounds there was no utility

o The district court held it invalid because it was deceptiveo The Federal Circuit overturns, saying it’s not injurious to public health, so go aheado The court here says that deceptiveness doesn’t really matter that much unless there’s a

use for the inventiono There’s a syllogism in this case

If there’s a market then people value it If people value it then it must e useful There is a market for many deceptive thins, so [conclusion 1] people must value

them; Therefore, [conclusion 2] many deceptive things must be useful

o Deceptiveness does not deprive an invention of usefulness Mixing operability and specific utility with beneficial utility?

o Nothing in the patent statute directs the PTO or courts to deny patents to deceptive inventions

o So is there a beneficial utility doctrine left after this case?

o And the problem is you’re arguing it should be invalidated, but you want to use it – so if there’s no utility, wtf?

o Also, it’s not the courts’ job to arbitrate this – leave it to legislatures Other considerations

o Courts have held chimeras animals to be invalido Congress passed a law prohibiting atomic weapons patents

In Europe:o Who should decide whether an invention is injurious? The European Patent Office has

the power to invalidateo Juicy Whip’s holding is that the FTC and the FDA, etc. should handle this

Merges argues that the patent system is not the place to be making moral judgments about biotechnologyPatent Hurdles:

- Utility, novelty, non-obviousness – utility is the smallest hurdle- Kinds of utility- Operability – has to work- Beneficial – moral utility

o Comes from the Lowell v. Lewis – o Challenge to claims for a pump

Accused infringer argue that the pumps did not operate s well as other available pumps

“All that the law requires is that the invention should not be frivolous or injurious to the well-being, good policy, or sound morals of society. The word ‘useful,’ therefore, is incorporated into the act in contradistinction to mischievous or immoral.

o- Practical utility

Specific, credible, substantial

Practical or Specific Utility- Specific, credible, substantial – the overarching doctrine is “practical”- Arises primarily in regard to chemical and biotech inventions- Contra Justice Story’s comments in Lowell v. Lewis, questions about the substantiality and

credibility of an asserted use to go to degrees of usefulness.- Playing with something (a toy) is a specific, credible, substantial use

o Can’t patent paintings- Maybe might be able to patent a mobile if there’s a new technical aspect to it- Typically utility is Brenner v. Manson- Arose out of an interference

o Priority dispute to determine who was the first inventor under the lawo Must show you conceived the invention and knew of specific utility firsto Utility always has to be shown by date of application, but for interference, it’s a race to

show you demonstrated utility before the other guyo What counts as practical utility for a chemical process? Is making the chemical enough?

No. You need something else – demonstrated utilityo Utility can be § 101 or § 112 or both for rejection, but the examiner has to give reasons

why, and they have to point to specific sections of the statute- Manson’s process makes a steroid. Precise function or effect of that synthetic steroid is not

know, perhaps it will have tumor-inhibiting properties- Wanted to patent a compound closely related to a known compound

o Closely related to a known compoundo Not enough if there are no known useso Manson did not show specific utility – must show a specific benefit in a currently

available form- The court outlines a number of possible tests for specific utility

o (1) if the process works to produce what it says it doeso (2) if the process produces a compound belonging to the class of compounds that are

the subject of researcho The applicant argued that it was homologous to other compounds, so it was usefulo And the court says being homologous isn’t enough. You have to show your invention

itself works- Key to the holding

o Process patent… that doesn’t have specific utility “creates a monopoly of knowledge” … such a patent may confer power to block off whole areas of scientific development without compensating benefit to the public… a patent is not a hunting license

- Holding:o A specific function of the chemical compound produced by a process must be known

before the process has utility- In dicta:

o The court says a chemical product patent must show similar specific utility- Special rule for the “unpredictable arts”

o P. 224 – greater unpredictability in that field-

Practical utility has to do with when in the inventive process we are willing to give a patent- 1. Idea for the invention- 2. Synthesize chemical- 3. Experiment on cells in a dish- 4. Experiment on animals

o Brana says utility is shown here

- 5. Experiment on a few humans- 6. Experiment on more humans- 7. FDA Approval

- In re Brana o USPTO Board of Patent Interferences affirmed rejection of 4 claims (10-13) o In contracts to Brenner, these are product claims

See 35 USC § 112 – specification shall contain written desc. Of the invention and of the manner and process of making and using it,…

o Challenged on utility of compoundso Applicants filed patent app on something called 5-nitrobenzoo Differ b/c they have a nitro group (N2)o In this case, they took mice w/ a cancer, transmit it to another mouse and then test the

anti-cancer drug The court points out that the Natl. Cancer Inst. Has accepted this model There’s evidence of antitumor activity in mice and in vitro

o I: if the ultimate utility is to have a drug that treats people, how much do you have to have shown before you can get an issued patent

o Rejected by patent examiner on utility grounds because it failed to fight a specific disease

Said “treatment of diseases” and “antitumor substances” not enough, citing In re Kirk

o The Fed. Cir. Says it’s OK – the doc. Proffered evidence indicating a significant antitumor

effect on mice, and that should be enougho H: yes, utility – no need to conduct clinical testing on humans to establish the utility of a

chemical compound!o Used computer simulations to show its utilityo As for testing on humans, leave that to the FDAo H: so long as a person skilled in the field would find utility, that’s enough. Don’t need to

prove it works on people The usefulness of a compound as a substrate for basic science, or a chemical

intermediate, is not enough to establish utilityo Here, an antitumor compound working in vitro and in mice is enougho Interestingly, the rejection came under § 112, which talks about the manner of “making

and using it…” Do you think it matters whether it was a § 101 or § 112 rejection ? Interestingly, § 101 is generally what’s patentable, whereas 112 is only

evaluated as of the date of filing, so should’ve been 101 if that’s the way they wanted to reject the claim

Ossorio argues that if you’re looking at utility prior to the filing date, then

o In Brenner, Manson was the junior party to the interference, and he shoulders almost the entire burden

In terms of a rejection of an application, utility is presumed

2001 Examining Guidelines- Invention must be useful for some particular practical purpose ( = specific and substantial) and

the asserted use must be credible to a person of ordinary skill in the art- POSHITA or POSA – Persona of Ordinary skill in the arts / having ordinary skill…- Keeps the law attuned to the field, to its stage of development, to its economics, etc.

- In Re Fisher o Tried to patent portions of a genome, called EST’s. o He argues the EST’s can be used as probes, to detect polymorphism on the gene, etc.o Patent office and board of interference said it didn’t meet the utility requirement under

35 USC § 101o This is an example of a “Markoush group” – TODO – LOOKUPo Background:

Completely automated – no human being had ever examined the DNAo 7 asserted uses:

Marker that will help gene mapping, measure level of mRNA in tissues; Source of primers for PCR; identify presence or absence of polymorphisms in tagged genes; Help to isolate promoters (turn genes on and off in the cell); control protein expression; locate similar genes in other organisms.

o Fisher filed a timely appeal and argued his “invention” was like a microscope, a device that can be used to detect other features of the genome

o The court disagrees, said any DNA snippet could fill this role – so it’s not specific or substantial utility

o They also say it would grant a hunting license, because you have to use the EST’s to find additional useful bits about the DNA

o Rader dissent: argues (correctly, in my opinion) that non-obviousness should’ve been used to dismiss the claims, not utility; his feeling is that if a microscope has utility, then this has utility as well

o Applicant didn’t know where the relevant genes ere in the maize genomeo They had asserted 7 utilities.o Regarding the Rader dissent:

Go back to Brenner v. Manson, where the court says research tools aren’t patentable

Ossorio thinks the line is not very clear cut He thinks it’s a research tool

o What does the majority say about this analogy to a microscope?

The court says a microscope provides a real-world result EST’s can’t provide information about the overall structure let alone the

function of a geneo They’re hypothetical useso Back to the timeline of when to patent – it seems like the EST is too early in the processo Holding:

Not specific – not directed toward any characterized gene function nor any protein with eve one known biochemical function

Not substantial – all asserted uses are “mere hypothetical possibilities”

Utility Generally- If your utility doctrine is too lenient, i.e. you allow very general research goals to count as

practical or specific utility, then you stop the patent race really early- You want an optimal amount of racing- This optimization won’t be optimized for every single race – it’s a general optimization- “Sepcific in the context of ESTs means specific to the EST that is claimed” not just to any possible

EST- Credible means not incredible – a use that POSA would recognize as valid- Substantial means not trivial

Utility and Research Tools- Is it something that has an end market in the research context?- Is it the object of research or a means of doing research?-

2/16/10 – Disclosure and Enablement- Utility: is the claim valid (does the applicant / patentee get any claim allowed?)- Enablement: how much does the applicant / patentee get to claim?

o This is a scope doctrineo Scope doctrine: cannot claim more than you have given to the world with your

disclosure; breadth of claims should be commensurate with the advances in knowledge disclosed

o Breadth of claim: how many embodiments does the claim cover or incorporate?- Apparently software claims are allowed even when the claims are really broad

o The software industry convinced the PTO that the code is the job of the technicians- Have to negotiate the tensions between incentives to the first inventor vs. incentives to follow-

on inventors- Disclosure found in § 112 – READ paragraphs 3-6 in detail- (1) enablement

o written description of the invention and of the manner and process of making and sing it in such full, clear, concise, and exact terms as to enable any POSA and shall set for th the best mode

- (2) written descriptiono Inventor must highlight what she claims and claims what she highlights

- (3) definiteness of claims ando An inventor must describe it in such a way that others can easily discern the boundaries

of her legal right- (4) best mode

o I.e. the best and most effective way of producing the inventiono If there’s reform, it won’t touch best mode requiremento Europe doesn’t have best mode

Independent and Dependent Claims Revisited- Independent claims:

o We claim a monoclonal antibody that binds an… antigen- Dependent:

o A monoclonal antibody.. in which said antibody is an IgG antibody Here, you’re saying claim 1 plus a limitation

o 3. A monoclonal antibody of claim 1 in which the antibody is an IA antibodyo 4. A monoclonal antibody of claim 2 or 3 in which the antibody is attached to a support

materialo

Incandescent Lamp Patent- Consolidated Electric filed bill in equity against McKeesport to recover damages for a patent - 1880 is the year.- Defendants said their patent fell under the Edison patent- They denied complainants utility and novelty- Sawyer and Man the plaintiffs complained that Edison couldn’t use a bamboo material, because

their claim covered all such materials- The Sawyer and Man patent didn’t even work- Whereas Sawyer & Mann found some filaments, Edison figured out the specific characteristics

of the filaments- Assume Edison’s experiments were done later than Sawyer & Mann’s filing date. Of what

significance are his experiments?o The correct question is what was known in the art about fibrous and textile materialso If someone discovers a better conductor, that’s an improvemento It doesn’t mean the earlier claim was not enabled

- My questions: okay, so enablement needs to happen at the time?

o Analysis for enablement is supposed to focus on as of the date of filing – what was known as of the date of filing

o The court could’ve reached the same conclusion by saying that you didn’t articulate why or how this genus, what makes them have a certain function

o They didn’t disclose a particular quality in vegetable fibers that made them good- Edison claimed they’re trying to monopolize all fibrous and textile materials in lights, and that

Sawyer & Man weren’t the first to discover that these were better adapted than carbon for the filament purpose

- H: Sawyer & Man’s claim for using all such materials was overly broad because they really only used carbon paper.

- They go on to discuss the lengths and distances Edison went on to find a suitable material, finally settling on bamboo

o Also, bamboo was not selected b/c it was of vegetable nature, but b/c it contained peculiarities in its fibrous structure

o There was also no way of knowing that every vegetable would be sufficient for a filament – perhaps if they’d done careful experimentation, but that’s not what had happened here

o They should’ve disclosed the general qualities in vegetable materials that would’ve made them more ideally suited

- You have to compare the patent claims with the embodiments by other inventors- Also, what about software patents? Code?- Notion of species and genus –

o Every possible embodiment is the specieso

Amgen v. Chugai Pharma- Amgen patented recombinant DNA version of EPO, used in red blood cell production

o They had a broad claim meant to cover any analogs of EPOo There were 1,000’s of analogs that could be producedo Amgen’s head of the program testified he had no idea if the 80 or so analogs Amgen had

produced actually produced the desired effecto The court tossed the patent on enablement grounds

In Re Wands- Claimed invention is an immunoassay method for the detection of hepatitis B surface antigen by

using…. Antibodies …- They put the living cells used to generate hybridoma, which then are used to produce purified

antibodies in a cell culture collection, referenced in the patent application- The patent office rejected the patent because it would require undue experimentation- I: undue experimentation for enablement?- H: no. Reversed

- R: some experimentation is allowed. Just not undue experimentation- Test:

o (1) quantity of experimentation necessaryo (2) the amount of direction or guidance presentedo (3) the presence or absence of working exampleso (4) nature of the inventiono (5) state of the prior arto (6) relative skill of those in the arto (7j) the predictability or unpredictability of the art, and o (8) the breadth of the claims

- These factors are not really very helpful, because they don’t say which way these factors go-- The process sometimes produced reliable hybridomas, but lots of the time it didn’t.- Only 2.8% fell within the claims- The applicants stored a lot of the unknown unscreened cell-lines, and against this the patent

board took issue- The court says that this is foolish, because we want people to store more data- Stands for the proposition that if your field requires lots of experimentation and has lots of

failures, that’s probably the standard for enablement- What did wands do?

o 10 fusions, the first four did not work, the next six all produced hybridomas that made the stuff, isolated and froze 143 hybridomas

o Tested MAb from 9 hybridomas and 4 fell within the claims- Why do the parties and the court care about the stored, frozen hybridomas?

o Goes to the question of how many inoperative species / embodiments are produced by the methods disclosed

o If too many inoperative species then the genus of “high affinity anti-HBsAg is not enabled.”

o Board view: only 4 of 143 have been proven to fall within the claims – too unpredictable for POSA to replicate w/o undue experimentation

- Wands’s view:o Only 9 hybridomas were tested. 4 of ht e9 worked -> 44% of the species fell within the

claims.o Implied: screening is not research, it is rote, it is mechanical, it is something that does

not require insight or inventive activity -> even screening large numbers of hybridomas does not constitute undue experimentation

o Held: the process was enabled. It is unduly harsh to treat the unscreened cell lines as “failures” as the board of patent appeals essentially was doing

- Here the court said the deposit wasn’t necessary to enable the claim- But the court doesn’t say exactly how many / if deposits are necessary

In re Fisher- Claim for a hormone containing at least 1 IU of the hormone per milligram

o Unless there’s knowledge of how high the IU’s go – essentially this is infinite w/o an upper range

o H: not enabled b/c the applicant had not taught others how to make and use ACTH with potencies greater than 2.3 units, evne though it is theoretically possible to make ATH of much greater potency

Amgen v. Chugai

- Amgen’s claim was for a DNA sequence that was “sufficiently duplicative” of that erythropoietin to allow possession of the biological property of causing bone marrow cells to increase production of reticulocytes and red blood cells, and to increase hemoglobin synthesis- They were trying to claim something sufficiently similar to what they’d actually obtained to make their rights worthwhile- They anted to make sure their claim covered the variety of changes that everybody could imagine making- Held: the claim was not enabled because it encompassed millions of proteins similar to the one disclosed in Amgen’s specification, but the patent did not teach which of the proteins would have the properties claimed- A person in the art would have to do way too much experimentation to determine which EPO analogs would have the biological properties set forth- This suggests the court was right to say the patent was invalidAmgen did not describe any structure-function relationship principle by which the sequences encompassed in the claimed genus were unified, so its claims was not enabled

Enabling Protein & DNA Claims- You need not disclose every possible DNAA or protein sequence in a biotech patent genus, nor

must one disclose the function of every possible variant (at least for enablement)o But simply knowing one could make many variants is not enough information to enable

a broad claim to a genus of sequenceso But you do need to know more than one variant and you need to know something about

the DNA or protein sequence- Enablement focuses on adequately teaching how to do what you’ve invented. And if you can’t

teach someone else what you’ve claimed, no patent

The Temporal Paradox of Enablement- You enable as of the date of filing the claim

- But you judge infringement of the alleged infringement, and things might have changed between enablement and the infringement

- So you may construe the claim differently at time 1 (filing) and time 2 (alleged infringement)- E.g. the fuzz ball invention – suppose there was nothing in the prior art for writing a claim to

claim ‘fuzz balls’. If you don’t put any limitation on the material, that’s a broad claim, but in your claim you describe all known embodiments and describe why they’ll work, then that claim could be enabled as of the date of filing

o But if after that, someone creates a new material, e.g. a synthetic, the claim may still cover fuzz balls

Blocking patents: dominant and subservient- If there was a new use for fuzz balls, e.g. you could get a new use patent- The previous patent on fuzz balls would still block the new use patent, however, but you’d have

to license from them if you wanted to use them for painting- The broadest patent is often called the “dominant” patent- And the narrower of the two is the “subservient” patent- Some cases where it makes sense, others where it doesn’t to use this language

Economics of Scope- Measure the quality of contribution in disclosure

o Pioneering inventions get a broad right of scope- If scope too stringent, then inventors / investors receive little for their expenditure,

private return on investment is low, and they’ll shift their investment to other activitieso Might discourage follow-on invention if you give too broad of an exclusionary

right- Arguments on both sides

o Want to encourage pioneering inventions vs. whether the pioneer will have the expertise to develop follow-on inventions

- Investment in R&D has high social dividendso People who free ride on other people’s work are highly beneficialo Apparently the spillover benefits are really high

p. 299 – 340 for Monday; 340 – 370 for Wednesday

Written Description Requirement- Spec. shall contain a written description of the invention, and of the manner and

process of making and using it in such full, clear, concise, and exact terms as to enable any POSA .. to make … p.2 – spec shall conclude w/ one or more claims particularly

pointing out and distinctly claiming the subject matter… which the applicant regards as his invention

- § 120 – Continuationso claimed invention may receive the benefit of an earlier application’s filing date if:

Disclosure is in the earlier app. Adequately describes and enables the later filed claims;

The two apps have some of the same inventors named; The earlier app is still in prosecution when the later app is filed.

- 35 USC § 132o whenever on examination any claim for a patent is rejected, or any objection or

requirement made … NO amendment shall introduce new matter into the disclosure of the invention

o Allows to tailor the claim to that covers a competitor’s later-developed technology

-- What’s the difference between enablement and written description? They’re both in the

same paragraph under 35 USC § 112- She says:

o Enablement is how to make and use the inventiono And the description is the “what” – i.e. what the invention is

- Codified in § 112, 120, 132 – o Failure to meet the § 112 requirements can render a claim invalido Up ‘til ~ ’97, the written description didn’t mean much

Came in when there was a continuation or a division where o The § 112 requirements can also determine to which filing date the claim is

entitledo They are not entirely distinct requirements

Both involve comparing what is claimed to what is disclosed in the speco Can’t add information into the claims – you can only amend them with narrower

claims (make sense – if you disclose something, you don’t want someone to be able to get in and leapfrog)

o And if an inventor gets his patent rejected, he can still get the earlier filing date - Drawings can act as a description – See Vas-Cath v. Mahurkar – ‘91

o Easterbrook sitting by appointmento The disclosure just had drawingso And the court held that the drawings did satisfy the enablement requirement,

but did not satisfy the WD requirement because the dimensions were outlined to any level of particularity

o And CAFC reversed and remanded, saying that drawings by themselves could be sufficient

o Citing in re Gostelli – “the applicant need not describe exactly the subject matter claimed, but must clearly allow POSA to recognize that the inventor invented what is claimed”

As opposed to something that was already in the public domain- Claiming essence vs. periphery

o Current practice = “peripheral claiming” – describes the outer boundaries of a genus

- Range of Variation Questiono Is the WD requirement met when the WD drawings depict a reange of design

parameters and…o CAFC – Proper test when drawings don’t’ include the full range:o Do the drawings convey to POSA with reasonable clarity, that Mahurkar had in

fact invented the catheter recited in the claims? Held: genuine issue of fact b/c expert declaration stated that POSA could

derive the range recited - Misappropriation by amendment

o When you amend the claims so that you block someone else’s producto The court does not look favorably upon this

- If you continue in part, and don’t add new matter, you can also receive the benefit of the parent filing date

- If the PTO decides you have two inventions, you’ll have to file a restriction and you’ll have a divisional application

o Split apps might not be adequately described by the original description years earlier

Claiming Essence vs. periphery- When claiming began, people claimed their essence- Now we describe the contours

Inherent DescriptionsKennecott Corp v. Kyocera Int. (1987)

- Claim for silicon carbide ceramic product with “equiaxed microsturctures” even though equiaxed microstructures were not mentioned in the parent or grandparent app.

- Yet the court held all 30 methods described would make the product with the microstructure, the inventors knew that their product had equiaxed microstructures

when the first app was filed, and anybody with a microscope could have seen the microstructure

- And it was adequately described… UNTIL ’97, ‘98

Why have a separate WD requirement?- Historical artifact.- Written description: more concerned about whether the inventor had possession of the

invention- Compliments the claim definiteness requirement in delineating the scope of the

invention, providing notice to POSA of what was and was not invented- Enablement is more about how to make the thing- It is possible to enable an invention without describing it (Regents v. Eli Lilly)- Q. If the spec teaches POSA how to make and use some species specifically described,

why does the inventor have to describe additional species? What harm is it uarding against?

- Review continuations on p. 52-53

Section 120 Deconstructed- Claimed invention may receive earlier applicant’s filing date

o Disclosure in the earlier app. Describe and enables the later filed claimso Filed b the same inventorso If filed before the patenting or abandonment of or termination of the first

application

Gentry Galelry v. Berkline Corp.- Gentry owns a patent of a sectional sofa, and it put the controls for the recliners on a

console – it allowed the recliners to be next to one another as opposed to on different ends of the “L”

- Berkline came out with a sofa where the recliners were separated by a seat that has a back cushion that can be pivoted down onto the seat

- District Court held that Gentry’s patent was valid and enforceable- Berkline argues the claims are invalid because their patent doesn’t use the console, and

they argue that Gentry’s patent only covers sofas with recliner controls on the console- Gentry argued that it was just their preferred embodiment- They argue that citing a species does not preclude the patenting of the genus, citing- Held:

o Location of the controls was an “essential element” of the invention

o Original disclosure identifies the console as the only possible location for the controls” by noting several minor variations in which the controls are located on the front, sides or top of the console.

o Inventor admitted he did not consider placing the controls anywhere beside the console until he was the competitor’s species of reclining sectional

- Cf. Gentry G. to In re Gostellio Applicant need not describe exactly the subject matter claimed, but must allow

POSA to recognize that the inventor invented what is claimedo Vs. Gentry: application complies w/ WD requirement by describing the invention

with all of its claimed limitations (the new standard)- The Court disagrees, saying that there’s no hint of coverage outside the console- Because it didn’t meet the written description requirement

o It was clear that using the written description requirement that - The inventor also admitted that he never thought of putting the controls anywhere else

on a console- The court says the location of the controls was an “essential element” of the invention

o This language makes it difficult to determine what the written description entails - The original disclosure identifies the console as the only possible location for the

controls- Compare with Gostelli- Now the standard is you need to describe the invention, with all of its claimed

limitations- Interpreting Gentry

o It considers situation where the patent’s disclosure makes crystal clear that a narrow understanding of a claim term is an ‘essential element of the inventor’s invention.’ Here, however, the disclosure does not ‘unambiguously limit the meaning”

- Regents of Univ. of Calif. V. Eli Lilly - UC claimed a CNDA that encodes the human insulin gene

o Also had genus claims to DNA that encodes mammalian insulin and vertebrate insulin

o UC disclosed the cDNA sequence of the rat insulin gene. It disclosed the entire protein sequence of human insulin and several other mammalian insulin protein sequences and a method for making the claimed DNA sequence

o What was disclosed? Sequence GGX TGX CAY ACX … where you know 2 of every 3

o Ths, any POSA could have written a generic chemical formula for the claimed human DNA

o Reasoning: See slide A description that makes a claimed invention obvious is not sufficient to

satisfy the written description requirement CAFC held that a complete protein sequence and a method of making the

corresponding DNA seq. does not make the DNA obvious Protein sequence and method of making a DNA seq. does not make the

human insulin DNA seq. obvious A disclosure that does not make the DNA obvious, without more, does

not adequately describe the DNA- Describing DNA – how do we describe it?

o Many complete seq. in the genuso By describing what particular sequences confer particular functions and / or

structure (and why?)o By hybridization to known sequences within given parameterso Generic chemical formula?

- Has been criticized for creating a super enablement standard.

Johnson Worldwide Associates- Said the patent’s disclosure in Gentry made crystal clear that a narrow understanding of

a claim is an essential element of the invention- In this case, though, the patent disclosure does not ‘unambiguously limit’ the

meaning…”- So if you’re drafting patent apps, you don’t say “it’s absolutely necessary for x”

- Subsequent embodiments

o If an inventor enables an all known embodiments, but don’t claim all the subsequent embodiments, they still get patent coverage – as long as the later discoveries were not anticipated

o In re Hogan

Regents of Univ. of Calif. V. Eli Lilly- The written description was of a DNA that produced rat insulin, and they also claimed

the DNA sequences for human, mammalian, and vertebrate insulin- They did not specify the nucleotides for the non-rat DNA- The court held this was insufficient for a POSA to discern how to produce the rest of the

DNA sequence- However, the nucleotide bases were only a few bases apart from the rat insulin

- This decision has been criticized, because a POSA could probably figure out how to make this

- They Court says a description of a chemical genus requires a precise definition, such as by structure, formula, or chemical name … What is required is a description of the DNA itself quoting Fiers, p. 322

o Fiers was a lot more like Rochester! The senior filer did not have any DNA sequence in hand when he filed

- And it was invalid because it did not distinguish the claimed genus from others, except by function

- There’s a commentator who argues that they should’ve invalidated by failure to enable the invention, not using the written description requirement

- “A description that makes a claimed invention obvious, without more, is not sufficient to satisfy the written description requirement”

- So, a disclosure that does not make the DNA obvious, without more, does not adequately describe the DNA

So how do we describe a DNA genus?- Many complete seq. in the gens- By describing what particular sequences confer particular functions and / or structures

(and why?).- By hybridization to know sequences within given parameters- Generic chemical formula?

Patent Board Policy- There is a strong presumption that an adequate written description of the invention is present when the application is filed

SciMed Life Systems, Inc. v. Cardiovascular Systems inc- The description described only a catheter that contained a guide wire lumen and an

inflation lumen- Despite the fact that the claim did not contain anything limiting the catheter

description, the court said that the lack of any broader language in the claim was an omission, so a side-by-side catheter implementation was non-infringing

University of Rochester v. G.D. Searle – Fed. Cir 2003- Rochester ‘s claim was for an assay that could find a drug that selectively inhibited COX

enzymes, i.e. it would inhibit only one of COX-1 or Cox-2 enzymes, useful for arthritis drugs

- They developed a screening assay, but the description neither disclosed the compound nor provided any suggestions how a compound could be made other than by trial-and-error research

- The claims were actually for selectively inhibiting COX-2 by administering a non-steroidal compound that inhibits activity of the gene product to a human host…

o So they’re claiming the actual treatment, when all they have is an assay that can find the drug

o So their claim was way too broad- And then drugs came out on the market that actually were selective COX-2 inhibitors,

and the drug companies were getting sued b/c Rochester invented the precursor to - Rochester argued there was no written description requirement because once claims

were included, the written description was redundant- They also argue that given the disclosure of the assay and the POSA, someone could

come up with the COX2 inhibitor. o But that’s a pretty ridiculous statement

- They also argued it would violate Bayh-Dole o If this would’ve come out the other way, the pharmaceutical industry would’ve

lobbied to no end- H: the court invalidates the patent for failure of written description- Pilar says this isn’t a written description issue, it’s an enablement issue because it

focuses on how to make the drug in question- So the federal circuit screws it up big time

Lizardtech v. Earth Resource Mapping- Lizardtech had a patent on discrete wavelet transforms for images, that were

“seamless” that is they developed a better method of doing DWT’s that did not result in pixel artifacts or false data

- They claimed EMR violated their patent for DWT- At issue is one of their claims that fails to mention seamless DWT’s. This claim is the

infringing one allegedly, because it is supposed to cover all the wasy of performing DWT-based compression that lead to a seamless DWT

- The problem is that the specification does not describe such a broad method.o Defect in WD and enablement

- CAFC: used WD to interpret claim 21 – it claimed all ways to get seamless DWT, while the WD only specifies one type

- Enablement and WD are closely tied to each other. In the late 90’s the court focused on WD as a separate requirement

o This is a defect of both enablement and WD

- Rather, it describes methods that use updated sums of DWT coefficients. It does not contemplate a more generic way of doing DWT’s. Also, it would lead to overbroad claims

- So they find claims 21-25 are invalid- Dissent by: Rader (woot)

o He argues that the court’s decisions are in opposition with one anothero In Lizardtech, the the corut says a claim in excess of the specification’s

embodiments invalidate the claimo But in JVW, a case about video game controllers, the court says the claims were

properly construed as broader than the disclosed embodiments because “the patentee did not intend for the claims and the embodiments in the specification to be coextensive.”

o And he argues the proper standard for written description is that the inventor must show “possession” of the claimed invention

- Claim Construction and § 112o Claim construction is done first, then compared to what is disclosedin the WDo

Definite Claims- Claims must be definite enough so as to outline the contours of the “monopoly” as

quoted from Justice Brandeis, although really it’s not a monopolistic right, the Court now construes patent rights as an exclusionary right

o See § 112o Looks at the claim only, not WD, unlike paragraph 1 (WD and Enablement)

- 35 USC § 112 p. 2: the spec. shall clearly conclude with one or more claims particarly pointing out and distinctly claiming the subject matter which the applicant regards as his invention

o used so POSA can invent aroundo Lowers transaction costs by clearly delineating the property right

Orthokinetics Inc v. Safety Travel Chairs, Inc. – Fed. Cir. 1986- Orthokinetics’ patent was on a char that could be put into a car for disable people- One of the claims said the chair was dimensionable as to be insertable between the car

door and the front seato This had to be determined on a car-by-car basis

- When they sued STC for infringement in a district court, the court invalidated their patent, holding that it was intended to cover use on a variety of automobiles, and that a person ordinarily skilled in the art could determine these dimensions

- Ossorio: The lower court used Paragraph 1 “full, fair and concise” analysis on claim definiteness (proper analysis is under Paragraph 2). The lower court also looked at whether the “patent” was vague, not the claim, which is what Paragraph 2 is all about! Analysis should be judged by asking whether POSA would understand what is claimed

- Holding: “So dimsneioned” is accurate as the subject matter permits. POSA would know that the dimension would depend on the car designed to.

- Definiteness generally: if an expert testifies that allegedly vague language means something in the industry, it is definite enough.

Definiteness of M-p-F claims- To satisfy definiteness, the corresponding structure describe or drawnin the narrative

spec must be definite- supposedly can’t incorporate by reference except see p. 330 for Amtel Corp. v.

Information Storage-

Standard Oil Co. v. American Cyanamid- The claim contained a term “partially soluble” that had no definition in the art- The court invalidated the claim because it’s too vague to point out the subject matter -

not a term of art. Claim language is indefinite under Paragraph 2

1. Antecedent Basis: PTO doctrine/Analytical Toola. Every word in the claim is used in the specification. So as in Cyanamide, substantive words

must appear in WD or the claim will be rejected for indefiniteness. b. CAFC: Each phrase in the claim must find a “clear support” in specification. So the Federal

Circuit allows implicit antecedent basis. c. Should CAFC give PTO deference in claim construction given that it knows of its practices

using the doctrine? It generally does not.2. Means/Step-Plus-Function Claims:

a. Way of claiming broadly. 35 USC 112 Paragraph 6: “Means or Step…for performing specific function, without recital of structure, material, or acts in support thereof… described in the specification and equivalents thereof.”

b. Cannot have a single means element: “I claim a data processing means”c. Can have: “I claim a data processing system comprising data processing means, data storage

means, …” multiple elements allowed only.d. Function: Data Processing. What does Specification say about Data Processing?

e. Equivalents thereof? What counts as equivalent – case law. “A fastening means” may contain equivalents of Velcro, safety pin, snap, etc. Look at specification for what is disclosed, and argue that other means are equivalents.

f. To satisfy definiteness requirement, “incorporation of information by reference” cannot be used, but general knowledge in the field (by expert witness) may be. You can use the title of the reference, however, because it is used in the disclosure. Pg. 331 Atmel case. Ossorio thinks this is strange.

g. Must the PTO search PA for all structures that could perform the claimed function?h. No. See p. 339 - 340

3. Best Mode Requirement: Back to Paragraph 1 of 112 a. “…and shall set forth the best mode…”]b. Why? Europe doesn’t have the requirement. It provides the public with the appropriate

benefit of the patent bargain.c. An issue arises with those filing abroad and not specifying Best Mode, and then not being

able to use the foreign filing date as priority date for filing in the US because no Best Mode was disclosed.

d. The inventor should disclose BM known to him at the time of filing. After the patent expires, or during when licensed, or if invalidated, people should be able to practice the best mode of the invention.

e. Subjective element of how best to practice the invention. This is sometimes equivalent with “preferred embodiment”

f. Randomex v. Scopus (1988) i. Patent for server storage disk cleaning system. P sued D for infringement, and D

defended on Best Mode requirement (invalid claims based on BM), stating that “91% alcohol and non-residue detergent” does not disclose the best mode cleaning solution.

ii. District Court submitted Question Survey to Jury: The jury found the invention enabled (no undue experimentation), and that P withheld information strategically. The court found that BM was not disclosed.

iii. Ossorio: BM is often described as requirement to prevent active concealment. iv. Randomex’s owner even testified that he purposefully left out the formula to

generate additional income on cleaning solution.v. The majority found it sufficient for BM. POSA isn’t the end user of the device, but

the person making the machine. They didn’t need to know the actual cleaner formula and would consult someone who knew what they should use.

vi. Ossorio: Cleaning solution itself was not claimed! BM requires disclosure of only the practice of the invention, sometimes involving things not part of the claim. This is like enabling starting material in biotech inventions under Enablement. Since cleaner is required to practice the invention, it must be disclosed if inventor is aware of a BM version. Here the inventor did experiemtn and found an optimal solution. He disclosed it along with other cleaner, including one that would potentially catch fire.

vii. Issue: Is BM met when you list multiple possible options? Yes. viii. You don’t have to say what is the BM (Pg. 342), citing BPAI language. One can

disclose a list of things including the BM by trade name, not by chemical formula. Does this raise tying, antitrust issues? He’s not trying to get people to buy unpatented stuff because they buy something patented, but its close.

ix. The Trade Name vs. Chemical Formula is not an issue because the inventor disclosed a generic category (non-residue detergent) to which their cleaner belonged. Also, POSA in the art will not spend time on experimenting with cleaner. They will find someone in the art of cleaners to make one.

x. Dissent (Mayer): Enablement and Best Mode have different standards. BM needs more. You should disclose more info than just to enable. The genus on non-residue detergents was not BM, Randomex cleaner was, and should have been disclosed.

xi. Mayer mentions that Randomex indeed experimented with cleaners and found the optimal cleaner.

g. Chemcast v. Arco (1990) i. P invented a grommet that had two parts, one harder and one softer rubber.

ii. The locking part is harder than the outer part. Instead of disclosing the hardness in the specification, they claimed a range of hardness while they only used one and kept it secret.

iii. Claim: “Less than 60 Shore A, More than 70 Shore A.” Actual inner ring hardness was 75+/- Shore D, which does not correspond to anything on the Shore A scale. (Pg. 349). Shore D is used for very hard materials, while Shore A for very soft ones.

Claim 6, depends from Claim 1 (“depends” is hanging on something, so hangs from – old fashioned def. of the word depends).

iv. District Court found BM not disclosed. On remand, making 47 factual findings, found what inventor considered BM at time of filing.

v. In Randomex, what if the disclosure was way off like in here? Would it have met BM?

vi. Here, the disclosure was nowhere near the actual BM compound hardness. The inventor also didn’t disclose the 750 hours spent by third-party developer to make this compound, which goes to the undue experimentation by a user. The compound was also the third-party’s Trade Secret.

vii. Holding: BM was not disclosed. Exact hardness, name of compound, and name of company was not mentioned.

viii. Test: 1) Subjective inquiry (Determines Necessity of Disclosure) – “scienter/mens rea” intent test: Did the inventor know a BM at the time of filing 2) If no, no issue. If yes, was the disclosure adequate – did it enable POSA to practice best mode contemplated. This is a lower standard, just enablement.

Vagueness in Claims

- The patent office strictly enforce its rule that all phrases used in the claims “must find clear support or antecedent basis in the description so that the meaning of the claims may be ascertainable by reference to the description

- Energizer Holdings v. International Trade Commission o Event though a term was not defined in the claim, the Court held that the patent

office had to consider the terminology in light of the prior arto Claim definiteness analyzed not in a vacuum but in light of the teachings of the

prior art and of the particular application disclosure

Novelty- The next hurdle after utility- What if we didn’t have novelty?

o Patents could take things out of the public domaino Harm to people / firms who acted in reliance on the item / process being in the

public domain Business disruption; Patentee could charge “hold out “ fees

- § 102 – we will focus on a,b,e, and go All have to do w/ determining if something is newo ‘new’ Is a term of art in the patent lawo Novelty: 102(a)(e)(g) – somebody else did it firsto Statutory bars: 102(b)(c)(d) – after making the invention, the patentee waited

too long to apply for a patent and so is barred from receiving oneo (f) – someone else actually invented it

Often you have the wrong inventive entity named on your applicationAnticipation

- All of the relevant must be disclosed in a single reference- If you’re looking at multiple sources, then you’re talking about non-obviousness

Interpretation of 102(a)- A person is untitled to a patentee unless the invention was

o Known or used by others [in the US], or It’s only in the U.S.

o Patented or described in a printed publicationo Patent applicants cannot defeat his / her own novelty

Has to be someone not the inventive entity- What kinds of art defeat the application?

- When? o When does the prior art count as a reference?

- Critical date = o Date of invention for § 102(a)o More than one yr. prior to date of filing for § 102(b)

(publications)- Reference

o Something that is known or used, patented or in a printed publication- Note that inventor means “same inventive entity” – so if you combine w/ an inventor,

things can get interesting- Prior Art References

o Patentso Journal articles and theseso Descriptions, product photos, drawings or illustrations in magazines or trade

publicationso Prior reduction to practice (in the U.S.) of an article or process covered by the

claimo Some other things can be prior art, too

Letters, advertisements??? These can be documentary evidence of prior reduction to practice

o Prior art can be all kinds of thingso When is the effective date?

When written? Accepted? When circulated? Etc.- Novelty Analysis

o Compare Applicant’s / patentee’s invention = the claim TO A reference in the prior art (PA) It’s all about what the patentee claimed, and does that claim read on the

prior art?

In re Robertson- Claimed invention had to deal with a fastening & disposal system for diapers- The claim was for 3 fastening mechanisms, the 3rd of which - The prior art only had two fastening mechanisms- The argument was that the prior art inherently disclosed the mechanism- H: the prior merely “suggests” that the diaper may be closed for disposal by using the

same fastening means…

- What are these elements of the claims? o It’s a means plus function claim. You have to have a means and then a structureo Then you go to the specification to go to the structures

- The specification disclosed Velcro. So what’s equivalent? o Adhesives, snaps probably

- When a claim recites three “fastening means” does this mean that it recites three necessarily distinct and physically separate fasteners?

- Just because something in the PA can achieve the same end, or perform the same function, does not make that thing the same as a means element… the PA ref. must also contain / disclose the same or an equivalent structure

- Rader concurrence:

Anticipation v. Infringement- Anticipates = comes before the applicant invents- Literally infringes = after the patent issues- “that which would anticipate before the invention” would infringe after the patent

issues

Explicit Anticipation- Found when every element is specifically mentioned in the referenceInherent Anticipation

- must necessarily be present in the item or process described in the reference AND- POSA would recognize that the missing element is necessarily present in the thing

described. But See: Schering

In re Seaborg- Patent at issue was for a method of producing and purifying Americium- But there was another prior art patent assigned to Fermi for a reactor that they used to

produce the element, - Fermi’s reactor when run at the level laid out in their patent, produced really minute

quantities of Americium, yet this was unknown to those inventors- And it was contained in a “exemplary statement” only, not the claim itself- I: does the “inherency doctrine” which infers a lack of novelty in a product if a

comparable process is found for making the product bar this patent?- H: no. They never knew there was Americium in the previous patent and it was in such a

small quantity and diluted w/ other radioactive material so as to be undetectable and it was too small: 1 billionth of 1 gram

- Isn’t this odd when their way of making the element is pretty close to someone else’s?

o A: unknown. It seems odd- How would you claim the element? “I claim element 95…”

o See: Parke-Davis-

Accidental AnticipationTilghman v. Proctor

- One perkins lubricated his steam engine with animal fat and it produced “peculiar appearances”

- Tilghman tried to patent the method Perkins had disclosed- And the court allowed it because the process that created the glycerine and acids was

not appreciated - They said the production of glycerin and fatty acids by running the engine was not an

intended result of running the engines, and was not appreciated boy those who used glycerin and fatty acids

Edison Elec. Light Co. v. Novelty Incandescent Lamp Co.- Edison figured out that the lead wires should be joined to copper wires inside the light

bulb- Prior art bulbs had the wires joined outside- But sometimes they were defectively manufactured and joined inside- The court allowed Edison’s patent because it “gave nothing to the world.”

Schering Corp v. Geneva Pharmaceuticals – (Fed. Cir. 2003) - Rader- Schering owns two patents on antihistamines- The prior art covered loratadine, which didn’t cause drowsiness- Schering was looking to keep the exclusionary right long past the original term- As the patent was about to expire, they figured out what the metabolites were that

loratadine turned into in the human body- And then anyone who produced a generic would necessarily produce the metabolite

and therefore infringe- And filing to produce a generic is a type of statutory infringement- So the question is: does the previous patent application inherently disclose the

metaboliteo Not claimed as isolated and purified because that way they could stop drug

companies from making generic loratadine that would turn into the metabolite- If the court had gone the other way on this question, then generic drugs would be

severely impeded

- How does the court distinguish this case from Tilghman or Seaborgo They added an intentionality componento The said if you intended to create the new thing, then it’s inherent in the prior

arto The earlier disclosure necessarily includes all elements of at least one

embodiment of the later claimed invention (and / or??):o The inherent product / process was a natural and necessary result of “what was

intended” in the PA- IT does not matter whether POSA knew of the inherent item/ property / process when

the PA was disclosed or usedo We do care about what POSA knows now

- Pilar is not sure whether this is the result

In re Hafner- He invented some new chemical compositions, but failed to disclose any use for the

compounds in his German patent application- Enablement for anticipation purposes is not the same as enablement for § 112- If the structure itself is disclosed in the prior art, that’s enough to anticipate even if

there’s no instruction on how to use- So he disclosed his compound, and then he statutorily barred himself from getting a

patent under § 102(b) because his earlier application and an article that had been published disclosed the chemical compound but not a use

- The point of this case:o Although you read there’s an enablement standard for anticipation, it’s not the

same enablement standard as there is for § 112o You have to teach the art how to make the thing, not how to use it

- A bit of an asymmetry here – b/c normally you have to teach how to make and use to get the patent

o But to be barred, you only need to teach how to make somethingo The book suggests the reason is that the quid pro quo for getting a patent is that

you need to know of at least one use. So you don’t get a patent w/ prior art, so lesser standard. With a patent and exclusionary rights, you need to show a use

- Remember:o You can bar yourself statutorilyo What you can’t do is destroy your own novelty

- Notes:o Titanium Metals v. Banner

o Someone discovered a # of alloys of titanium with special ductility and corrosion resistance properties

o Held: their claims had been anticipated by a Russian journal article that contained one graph of a # of different alloys, and looked at different properties

o But because some points in the graph would’ve been included in applicant’s claims, those species disclosed in the publication could not be patented due to anticipation

o Broccoli Sprout Cases o They tried to claim growing sprouts in essenceo They thought they could claim this b/c they were rich in a specific compound

that helped people fight cancero But their claims didn’t include anything that indicated they were fighting cancer

or isolating those compoundso The 3rd claim is for increasing certain protective enzymeso But we come back to inherency or inherent anticipation of those enzymes

Presumably by eating the sprouts people for centuries had obtained these benefits

o Rasmussen v. SmithKline Standard for what constitutes proper enablement for prior art reference

differs from standard under § 112. Prior art reference need not demonstrate utility to serve as an anticipating reference (p. 383)

New Use Patents- Previously not allowed, but in 1875 changed

o “if an old device or process be put to a new use which is not analogous to the old one, and the adaptation of such process to the new use is of such character as to require the exercise of inventive skill to produce it, such new use will not be denied the merit of patentability”

- Under § 100(b) new use patents are process patents- 2 problems:

o New use patent is blocked by the old patent w/o a licenseo Process patent may be difficult to enforce

- Enforcement Problemso (1) difficult to detect infringement

Can be difficult to determine whether they used the process to create a product

o (2) defects in infringement doctrines lead to

o (3) the need to file an inefficiently large # of infringement suitso and (4) (until recently) better treatment for product patents when the accused

infringer imports products from a foreign country- Solutions:

o Combine with another compound to obtain a product patent on the new combination

- Ossorio:o Lots of argument that we shouldn’t allow patents on drugs because it prices

drugs out of the reach of many peopleo Instead we should have patents on the compound to treat a certain diseaseo So how are those patents enforced?

If there’s more than one medical use, then it would be very difficult to show who’s infringing

And the infringer is the patient, and you don’t want to sue the doctors either

Inducement and contributory infringement are very hard to prove- The book suggests solutions:

o Defendant class action suits: you’re suing your customers, who you want to have good will to you

oIn re Thuau

- New use discovered for a compound used in tanneries found to be useful in treating cervical cancers

- The PTO denied the patent because of risk of tanneries contributorily infringing if pharmacies purchased large amounts of the compound

o He eventually got a patent on the purified version of the compound used for treatment

Anticipation Analysis Under § 102

Novelty: remember must be known or used in the USWhat must others know or use?What standard of proof must a party meet?

- Documented but not published can be litigated as “known or used.”- If there’s a writing or drawing then:

o Is it published within the meaning of the law?o If not, then was it known or used in the U.S.

- § 102(b)

o The language differs b/c it says “in public use or on sale”

National Tractor Pullers Ass’n. v. Watkins (N.D. Ill. 1980) – This is about what is known by others- Action for declaration of invalidity and non-infringement by NTPA against owner of the

patent, Billy K. Watkins- Defendant counterclaimed for infringement- Patent is on a tractor pulling sled- P argued the defendant’s device had been known or used- P alleges a sled the same as D’s was invented by someone else in ’64 or ‘63- No original drawings exist, but in ’77, at the request of the plaintiffs atty., Irwin was

engaged to prepare drawings which were supposed to be examples of the ’64 drawings- The device was never built and the group built another type of device instead- The defendants argue this is not prior art under § 102 because there’s no prior

knowledgeo Tablecloth drawings were not available to the public. They were never printed to

the public, and were destroyed- H: not prior art.

o The device was never constructed or reduced to practiceo Nor were the drawings available to the publico That which is prior art must have its existence established by clear & convincing

evidenceo And there must be public disclosure

- Who has to “know” of the invention before the critical date fo the knowledge to constitute prior art?

o The publico Requirement not satisfied by the knowledge of a single person ( good law )o Or a few persons working together ( bad law)

- Comes from § 102 saying known or used by others!!- And also remember burden for existence of PA

o Clear and convincing- Need corroboration of oral testimony

o See: note 5 p. 397 Barbed Wire Patento Can you have oral testimony alone to show prior art?

Yes, but it has to be clear and convincing In the barbed wire case, the witnesses couldn’t recall with sufficient

accuracyo You need to show every element of the

- Notes:

o Use must be established by “clear and convincing” evidence – goes to the presumption of validity afforded a patent holder

o There is no per se rule barring oral testimony to establish use of a prior art device

o A lost design for a safe, which could not be found did not anticipate the safe later built, because society could not derive a benefit from it

Gayler v. Wilder o Also remember 35 USC § 282 – there’s a presumption of validity for claims that

have issued Implications: a dependent claim can be valid even if the independent

claim is invalid Why? The dependent claim may be narrower than the independent claim

- Non-mutual collateral estoppelo Once you’ve litigated and lost, you cannot litigate that same issue against

another party in another jurisdiction

Rosaire v. Baroid Sales Dvision, Natl. Lead Co. (5th Cir. 1955)- Trial Ct. held two patents involved in the litigation were invalid and there had been no

infringement by the defendant- Patents for prospecting of oil- Based on hydrocarbons changing the rocks around the oil deposits- Arguably one Teplitz knew of and used the invention - I: was the work of Teplitz “an unsuccessful experiment” as claimed by appellant or was it

a successful trial and reduction to practice? And was it public enough (see note below)?- The trial court’s fact finding concluded that Teplitz’s efforts over a year resulted in their

filing a patent, so there was use and therefore the patent was invalid- Appellants argue that D’s suspended their work- The court finds that the reason for the stoppage was that the geographical area did not

lend itself properly to the test and the gas prospecting program was suspended to analyze the data not because the approach had failed

- Ossorio: note that the word “public” isn’t there, but the courts read it into § 102(a)- The court says so long as they didn’t take steps to keep it secret, that’s good enough

o Doesn’t have to be access the public actually accessed the prior art, it just has to be available to the public

- Gore v. Garlock o Prior use of a machine that carried out Gore’s claimed processo Non-secret use = no particular legal or physical steps taken to maintain a trade

secret in the PA machine or the product it produced.

o However, the machine was not operated in public and its process was not apparent to the public that received the product

o Held: the non-secret use of a claimed process in the usual course of producing articles for commercial purposes is a public use and can anticipate

o Courts allow inferences when things happen in the normal course of business, which makes the proof easier

o And also, it means it wasn’t experimental, and that it was reduced to practice

Printed Publications- Described in a printed publication in this or a foreign country

o Mirrors language of § 102(a)

Jockmus v. Leviton (2d Cir. 1928) – Learned Hand, J.- Plaintiff holder on an adjustable light built holder in the shape of a candle, sued D for

infringement- D asserted lack of novelty, b/c p’s invention was anticipated by a product pictured in a

commercial catalogue distributed to French customers of a German firm.- The trial court judged the patent to be valid- Learned hand disagrees- The catalogue, with wide circulation, despite how “ephemeral” the publication was in

existence- Compare, he says, with a publication with just one copy sitting in a library – certainly

that’s not in wider circulation and would qualify under § 102 o “50 would’ve been enough”

- And then he says that even though the entire picture of the adjustable candle holder wasn’t visible, the parts that bear on the claims certainly were, so the patent should be invalid as anticipated

- Ossorio: distributing this catalog in the ordinary course of business helps them prove that there was a publication date, b/c they do it seasonally

- Notes:o Aluminum Co. of Am. V. Reynolds Metal o Patent holder issued a progress letter mailed to 33 recipients w/o any secrecy

notice (in the defense industry)o They said it b/c within the defense industry it was customary to keep these

letters under wraps, it was confidential and not accessible to the publico What bout lost prior art?

In re Klopfenstein

- Klopfenstein appeals from PTO ruling denying their patent application for double extruding (soy?) feed for animals (has some saludatory effect on animals)

- The board held the invention was not novel because it was described in a publication already > 1 year before the date of the patent application because of a presentation given by a person, Liu, at several conferences

- One Liu presented poster boards at three conferences for a total of 6-7 days- In determining whether this was a printed publication, the court looks at:

o (1) the skill of people who would’ve seen the publicationo (2) the expectations that the material displayed would not be copiedo (3) the simplicity or ease with which the material displayed could have been

copied- The court then found that the attendees were ordinarily skilled in the art- That there were no disclaimers on the presentation, so people could easily copy the

information- And (3) that the method of single extrusion was already known, so double extrusion

used to implement the technique could have been easily implemented- Notes:

o A single copy is enough to constitute a printed publication if it is properly indexedo A publication becomes available when it is available to at least one member of

the “general public”o Grant proposals can be public art where the list was published and available

under FOIAo SIR – statutory invention registration – all the defensive rights, none of the

offensive rights of a patento If a card catalog is created w/ just a title of a thesis, but you can’t go and retrieve

the thesis, does this count? No.o You have to be able to get the documento There was another case where distributing at least 6 copies was enough to be a

printed publicationo Courts might be harsher on 102(b) rather than (a) b/c (b) is really about the

applicant dawdling

Patented Inventions as Prior Art- Most utility patents also qualify as prior art- Every U.S. patent qualifies

o Even cancelled parts of an application as long as they were available for inspection by the general public

Reeves Bros. v. United States Laminating Corp.- Action involves two inventions made by Dickey and assigned to Reeves Bros. Inc.- 1st relates to lamination of polyurethane foam to fabric by the use of flame heat- Second patent relates to an improvement in the method and apparatus for such

lamination- Third is a reissue of the second patent- These are German patents called GM’s, which are really for ‘utility methods’- I: does the GM’s constitute a patent and does it anticipate for what is claimed or also

what is disclosed? And just what’s patented be used as prior art or can the specs be used as well?

- Well, it does constitute a patent- However, only what is patented may be used to determine prior art- Notes:

o Secret foreign patent applications won’t constitute prior arto Also, the specifications in the GM may be used to explain its claims, but not to

add to themo Also, some foreign utility methods may be considered publications (the Japanese

for example)Section 102(e) Disclosures in Earlier-filed u.s. applicationsAlexander Milburn Co. v. Davis-Bournonville Co. – Holmes Opinion

- Suit for infringement on P’s patent for an improvement in welding and cutting apparatus alleged to have been the invention of Whitford

- Clifford, another guy, had disclosed the invention before, but did not claim it.o It was in a patent app.

- I: is Whitford’s patent valid?- H: No. Have to be the first to invent- Notes:- Interferences require an interference on claims this was a conflict between a claim and

a disclosure- Milburn later amended so that even if the patent didn’t issue but the patent was

published, stuff…

Patent Reform Act of 2010- § 102 – disclosures made prior to filing date and available to the public would be - If disclosed by the inventor him or herself 1 yr. prior to the filing date, - Derivation becomes more important in a first-to-file world

o B/c what if the first to file stole it from someone else?

- Response to issues of cost:o Inventors should file provisional applications regardlesso

Defining the Date of Invention- Falls under § 102(g)- (g)(1) – interferences : deconstruction

o (g)(1) during the course of a priority dispute between inventor1 and invetor2 under § 135 [interference] or in ct [§ 291 – allegedly interfering patents issued]

o The invention was made by inventor2 in the US or a WTO member country before inventor 1 made the invention AND

o Inventor2 did not abandon, suppress or conceal the invention- (g)(1) – you get an invention unless…

o during the course of an interference wherein another inventor made it for you and it was not abandoned, suppressed or concealed

The applicant must overcome all inventions in any country during an interference proceeding

Only applies to those inventors involved in the interferenceo (2) the invention was made in this country by another inventor who had not

abandoned, suppressed, or concealed ito (3) in considering the priority of invention under this subsection

Consider the respective dates of conception and reduction to practice of the invention, but also

(b) 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

o Definition of conception: Formation in the mind of a definite and permanent idea of the complete

and operative invention All that needs to be accomplished is construction

All elements must be conceived Conception is established when the invention is made sufficiently plain

that POSA would be enabled to make the invention Again, this is the § 112 enablement standard

o Definition of Reduction to practice First to actually or constructive RP has presumptive priority RP – building a working version of the invention, doing the steps of a

process of invention

Constructive RP – filing a valid patent app. (must meet reqs. Of 35 USC § 112)

- Summary of priority of inventiono (1) the first to reduce the invention to practice usually has priorityo (2) Filing a valid application constitutes a constructive reduction to practiceo (3) The first to conceive may prevail over the first to reduce to practice if the first

to conceive was diligent from a time prior to the other inventor’s conception through to her own reduction to practice

o Any reduction to practice that has been “abandoned, suppressed, or concealed” is disregarded

- 102(e) – deals w/ previous patentso for foreign apps, it’s prior art only as of its U.S. filing dateo must be in English and designate the US – only effective if it issues or is

published!o Sine qua non of that references that anticipate is that they are accessible to the

public- An interference count is a quasi-claim defining an invention the priority of which is

under review in an interferenceo The counts define the boundary of the interferenceo Get 1 yr. for the interference proceeding

Brown v. Barbacid – 275 F.3d 1327 (Fed. Cir. 2002) – Rader J.- Interference over a new assay to identify anti-cancer compounds- PTO board of appeals and interferences awarded priority to Mariano Barbacid and

Veeraswamy Manne (Barbacid) over Brown, - Brown patents owned by BMS-Squibb, Univ. TX- Patent is for compounds that inhibit farnesyl transferase (FT) enzyme involved in control

of cell growth- Brown application was filed first, therefore the senior party- Brown did not reduce to practice until ’90 based on the evidence, so the Board awarded

priority to Barbacid- Barbacid filed 1 month later, so Barbacid has the BoP here is… Preponderance of the

evidenceo Why? It hadn’t issued by the time this interference had filedo If it’s issued, then it’s clear & convincing

- Brown introduces autoradiographs which have the dates of which they occurred- The court found the doctor who took the autoradiographs didn’t give sufficient

testimony to adequately explain and authenticate them

- The CAFC finds that the board abused its discretion by excluding the evidence within the understanding of skilled artisans when considering authentication requirements

- Brown argues that the board erred in allowing the inventor’s own documentation to corroborate his conception or reduction to practice

o In order to prove conception, you have to have corroborative evidenceo No corroboration necessary for physical exhibitso So the notebooks and autoradiographs don’t require corroboration to

demonstrate the content of the physical evidence itselfo But the physical evidence in this case may not single-handedly corroborate Dr.

Reiss’s testimony- And they say the Board did not err in holding that unwitnessed documentation does not

corroborate the inventor’s testimony- To show conception, which is the permanent idea of the complete and operative

invention, which only requires ordinary skill to make the invention, you have satisfy every limitation of the count

o And they say Dr. Reiss, the inventor for Brown did not do that b/c he didn’t include a test / substrate

o It didn’t show inhibition of FT- However, a later Sept. 25th experiment did contain all the limitations,

o The court says the physical evidence shows that there was an experiment that was done on the 25th and that that experiment involved all elements of the claim

Why isn’t that good enough to show reduction to practice? There’s a very subtle distinction – why isn’t that good enough? What are the inventive facts? Reduction to practice, conception, diligence You can prove that someone did an experiment, but you have to know

that it worked!!!! To prove an inventive fact, you have to have an independent witness to

corroborate that the inventor understood that it workedo Serene asks:

What if the inventor himself authenticated it? Still needs to be corroborated – and they need to corroborate that the

person who wrote it did in fact write it and that it wasn’t someone elseo And there’s a requirement of corroboration for this experiment and the other

Dr., Dr. Casey cannot corroborate the evidence and there’s no reduction to practice

o But they say, the physical evidence shows that an experiment took place on that date w/ all the limitations in place.

o So Casey’s independent testimony corroborates Reiss’s testimony of a conception before Nov. 1989

o And they remand for findings of conception and diligenceo What’s evidence of conception?

- Notes:

o You have to show:o (1) conceptiono (2) Reduction to practice

Requires the inventor to (i) have practiced an embodiment of the invention encompassing all elements of the interference count, and

(ii) to have appreciated that the invention worked for its intended purpose.

All elements of the count have to be reduced Recognition of invention’s features – means you have to know the

invention will actually work – you have to test it There is no requirement for commercial viability

o (3) diligence Only matters if you’re in an interference and you’re the second to reduce

to practice- Defining “Conception”

o A rigorous concept: - must be a definite and permanent idea of the “complete” and “operative” invention

o A mental processo You have to conceive all elements of the later claimed invention!o Does not occur until the inventive idea is “crystallized in all of its essential

attributes and becomes so clearly defined in the mind of the inventor as to be capable of being converted to reality and reduced to practice by the inventor or by one skilled in the art”

Not every nut and bolt: They have to know all the elements but not have a complete

blueprint in his / her head – the shape and location need not be known

Uncertainty as to successful operation You need only show you had the idea the discovery that it works

is part of its reduction to practice In your mind it has to be able to work, but it doesn’t actually have

to work

Conception is established when the invention is made sufficiently plain that POSA would be enabled to make the invention (rule of evidence)

This is the lower enablement standard of novelty, not the § 112 enablement standard

- Diligenceo Only relevant when one party claims an earlier conception date, but a later

reduction to practice dateo When one party is both the fist to conceive and reduce to practice, that party

has priorityo The behavior of the second inventor has no relevanceo Where an inventor can establish only a reduction to practice but not a date of

conception, the conception date is assumed to be the date of reduction to practice

o No flexibility in the diligence periodo Also, You need excuses for inactivity

- Constructive Reduction to Practiceo Patent apps and only patent apps constitute a constructive reduction to practice

- Reduction to practiceo First to actually or constructively RP the invention has presumptive priority

Reduction to practice = building a working version of the invention, doing the steps of a process invention

Constructive reduction to practice = filing a valid patent application (in particular, the disclosure must meet the requirements of 35 U.S.C. § 112)

Only patents qualify for constructive reduction to practice Not journal articles, etc. What about provisional applications?

o Ossorio thinks they count as constructive reduction to practice

o Everything in a provisional has to support the later-written claims

What about where the first to conceive is the second to RP then… The first to conceive may prevail if the first to conceive was

diligent from a time prior to the other inventor’s conception through the first inventor’s own reduction to practice

|-----C-------RP------------------------File----| C RP = Diligence RP File = Abandon, Suppress, Conceal Some older cases talk about perfecting the invention

This is synonymous with RP NOT that the invention is optimized or in its perfect form

o If you’re the junior party (last to file), the burden of proof is on youo You only need to be diligent just before the second party’s conceptiono If you want to claim an interference, the junior’s app must have been filed less

than one year after publication- The balancing act

o § 102(g) balance the value of providing incentives to the first person / group to come up with the new idea with the value of getting people to “race” to produce something of practical consequence

Christie v. Seybold- Technology at issue – a press to bind book-bindings- Seybold C in Oct. 1885- Seybold sketch of the invention and showed it to several people in Jan 1886- Seybold: First machine was made (RP’ed) in April 1889- Christie C in summer of 1886 had working drawings made and patterns ordered in ’88

press completed on about July 12th of 88’- Seybold says he did not have the proper tools in his shop to make the machine- Seybold is the senior filer- But can Seybold date his diligence all the way through?- The reason that he didn’t have a press built b/c there was no profit in it.

o And that was the end of Seybold’s opportunity of his patent opportunityo H: Lack of profit is no excuse

Peeler v. Miller- Inventors Peeler filed a patent application designed to reduce “cavitation”- Application on an identical fluid was filed b Miller and assigned to Monsanto- Patent issued to Peeler and then declared interference on the still-pending Miller

(Monsanto Application)- Miller wants to get priority over Peeler- Miller made numerous efforts to improve cavitation by including FREON, water, and

other substances- In ’66 he submitted a preliminary disclosure of invention to Monsanto’s legal

department- And he’d given talks in the aeronautical community- Peeler actually argued the tests were not reduction to practice

o But the court says it’s merely a hydraulic fluido The claim is what you have to conceive

- Four years lapsed from this date to the filing date- So the court goes another route- I: was there abandonment, suppression, or concealment in the meaning of § 102(g)- H: the court says Miller reduced it to practice- And he didn’t to abandon it despite his notebook entry indicating a need to better

assess other alternatives- And the court holds that Monsanto suppressed the invention by not acting on the

patent for over four years - Notes:

o Just required to show that there’s not an extreme delayo Other reasons: delays to perfect the inventiono Testing and refinement of the inventiono Paulik

Another Monsanto case where they delayed in the legal offices for a long time

And someone came back and took steps toward filing a patent And that activity began prior to the date of conception of the other party But the other party filed before Monsanto The court held that Paulik could rely on this new conception, reduction,

etc.o There is an intent requirement to show abandon, suppressed, concealed

- Diligenceo Technical complexity justifies a longer period of preparation and

experimentationo Some personal circumstances justify delay (illness, moving, death in the family)o Expediency, competitive advantage, “busy with other things” generally will not

sufficeo Note: “Perfects” in the old cases means RP – does not mean optimized or in its

perfect form- Peeler v. Miller

o Two issues: when did the Monsanto inventor (Miller) RP the inventiono If he RPed the invention in March 1966 or thereabout then did dhe abandon or

suppress ito Abandoned expt. Vs. RP? o Held: RPo Claims were directed to the hydraulic systems generally, not simply those in

aircraft. This influenced what kinds of expts would count as RP of the invention claimed.

Miller’s test simulated the relevant real-world conditions (what owul dPOSA tinka bout the relation to real world?)

Notebook comment – “need to better assess…” does not show “lack of conviction of success.”

Long time elapsed b/w disclsosed and filing does not show abandoned expt. b/c no doubt that Miller had RPed invention sometime in ‘66

Gillman – Learned hand, J.- A guy kept his invention secret from everyone including his wife- He licensed only the output- Then someone went to try and patent it- Held: the prior invention was not prior art and was suppressed, or concealed, etc.- Notes:

o This could have a pretty bad effect on trade secretso Apparently the rule hasn’t gained super-wide-spread tractiono The question was whether or not the quilting machine could be prior art, but

that person could not prevail in an interferenceo If you keep something as a trade secret, you will not prevail in an interference

Here prima facie unreasonable delayo Cf Peeler v. Miller to Paulik v. Rizkalla o Not necessary to show specific evidence to conceal – in general suppression or

concealment must be intention But if enough time passes, you can infer a/c/s And this shifts the burden Dow v. AVI p. 466

- Challenge to validity in litigationo Challenger has the burden of proof (production and persuasion)o Challenger must establish a prior inventor by bringing forth clear and convincing

evidence .o Once that burden is met, then the burden of production shifts to the patentee

to bring forth some evidence that the alleged prior inventor a/c/s.o Patentee must bring forth enough evidence to creat a genuine issue of material

fact regarding a/c/so If patentee can’t do this S/j against patenteeo If patentee can meet burden of production challenger may rebut evidence of

a/c/s/ and must do so w/ clear & convincgin evidence to the contrary

Dow v. AVI – see slides – Class 12

- I1: does the alleged earlier inventor have to know that she/he/it created a patentable invention

- H: No. AVI RPed Dow’s later claimed invention but did not conceive it. CAFC disagrees. Conception does not mean forming the idea that one’s new and useful entity is patentable under US law

o Seems consistent w/ inherent anticipation doctrine- I2: did AVI”s action (or inaction) raise an inference that it a/c/s’ed b/c it took 2.5yrs to

from making to put on saleo When putting on a patent, what she has to do is that she is bringing the

invention to the public in a timely fashion- Held: no. “In cases in which an invention is disclosed to the public by commercialization,

courts have excused delay upon proof that the first inventor engaged in reasonable efforts to bring the invention to market.”

102(g) vs. 102(a)- 102(g) requires technical proof of C and RP of the claimed invention, whereas 102(a)

does not.- 102(g) in the interference context requires that both inventors be able to claim the

same invention.- 102(g) has a narrower territorial reach with respect to inventions not claimed in another

patent (102(g)(2)).- On the other hand, 102(a) has a publicity requirement that 102(g) does not. A single

first inventor can invalidate a later claimed invention (see notes on Gillman, p. 464).

Secret Prior Art, Hidden Prior Art and Non-informing Public Uses- Secret inventions and 102(G)

o If a party makes an invention (= RP) and keeps it strictly secret,o And if a 2nd inventor lates files an app. w/ claims that cover the first inventiono In a priority dispute, first inventor may be deemed to have “suppressed and

concealed” contravening 102(g) p. 3o If 2nd inventor rececieves a patent, then 2nd can prevent the 1st from practicing

- Gilman v. Stern (Learned Hand)o “A completed invention will be deemed a/c/s if no steps are taken to make the

invention publicly known w/in the reasonable time Invention was machine, could be used in secret and output sold to the

public Cf. to public use where the item is not intentionally kept secret, but its

use in public does not allow anybody to examine or evaluate its features.

Its nature is such that even ordinary use does not disclose much about the invention. Underwear ?? this is ~= to abandoned and concealed

-

Dunlop- Three reasons why the t/s coating on golf balls, which coating could not be reverse

engineered easily, should not be considered a/c/so The public got benefit of inventiono Eventually the secret will be reverse engineered …o An inventor is under no duty to apply for a patent and should not be penalized

b/c she gave her invention to the public in a manner that did not disclose-

Timing of A/C/S- Does the language of 102(g)(2) mean that the first inventor’s abandonment does not

count if it happens after the second inventor’s conception or RP?- Allen v. Brady p. 477

o Only a/c/s before the inventor’s date of invention matters o Cf. to Checkpoint which took account of first inventor’s activities that occurred

after the second date of invention Which is the better rule?

Rule 131 – swearing behindAlso known as antedating a reference

- This is the way a patent applicant proves a date of invention that is earlier than her filing date

- “Swear behind” means to prove that the applicant’s date of invention is earlier than the effective date of the reference

- Used after a claim is rejected by the examiner as anticipated or obvious- Inventor submits an oath

o No requirement for independent corroboration;o Must submit exhibits, drawings, records as aprt of the affidavit, or explain why

you don’t have these. But, do not need independent corroboration (cf Brown v. Barbacid).

- Show facts such as to establish RP prior to the ref. effective date, or C prior to the ref coupled with diligence from a time prior to the ref. date

- See: p. 496

Clarification- Secret or hidden – secret or hidden – took steps to keep it that way

- Not informing – given over to someone but difficult to reverse engineer-

§ 102(b)- Was patented or described in a printed publication in this or a foreign country (this is by

anybody) – compare w/ 102(a) – where it’s by others- In public use or on sale in this country more than one year prior to the date of the

application for patent in the United States (again, by anybody )- You can bar yourself w/ a prior patent as well- Kyle asks:

o w/ 102(a) it’s about the claims – how can you claim the same thing twice?o Well it’s a bit of guile and subterfuge – sometimes people try and patent the

same thing twiceo Also, 102(e) can create prior art for 102(b)

- 102(a) – uses the all elements rule – has to be identical – has to be found entirely in one piece of prior art

- 102(b) – it was something substantially similar to the invention was …. (see above)- Apparently the “invention” in (b) differs from (a)- ---------- |-----------------------------| _----------------------------| ------------- Applicant invents 102(b) critical date File pt. app.- What if there’s a tie? On the one year – it’s more than one year. Tie goes to the inventor- 102(b) stat. bar critical date = one year prior to filing of the patent

o Can be created by the inventor and others

What are the policies underlying 102(b) ?- Makes people get to the patent office early- Means that the invention goes into the public domain more quickly- Limit public’s detrimental reliance- Give inventor / investor some time to test invention (including market testing after RP)

Pennock v. Dialogue – US 1829- Invention was an improvement of ducting or tubing- Completed in 1811. App. Not filed ‘til 1818- During this time he made and sold lots of the product in Philly- Held: the applicant had lost his right to obtain a patent. Abandoned his right or barred

himself by public use, both analyses are used- Argued by Daniel Webster, John Sargent- Held: by exploiting the invention for 7 years, the inventor had lost his right to patent

- But under what theory did he lose his right to patent?- Public use? Or was it abandoned the right to seek a patent- The process was patented, and was not shown to the public- Didn’t matter – this was still considered a public use or abandonment

Egbert v.Lippmann – 1800’s- Created new kind of corset stays for his mistress- He RP’ed it ’55, gave it to her in ’58, demoed it in ’63 and files an app. In ’66 - He began to sell it commercially somewhere in the middle- “public” in terms of public use may be even less than the public-ness of known or used

under § 102(a)- Would suggest that if you give the invention over to 1 other person w/o restriction, this

can constitute public useo Might have been a byproduct of the fact that there was a mistress involved

Moleculon v. CBS- Nichols was the inventor of a toy similar to a Rubix cube- Initial versions weren’t durable- In graduate school he’d produced models of the toy- Showed it to a couple close friends- He went to work in ’62 for Moleculon- The boss saw his invention and asked him if he intended to commercialize it- He said no, and Moleculon agreed to commercialize it in exchange, Nichols get a share

of any profits – Nichols assigned patent rights to Moleculon- They sent the thing to Ideal Toy, who expressed no interest- They filed a patent app in ‘72- CBS argues that the patented design was in public use more than a year prior to the

March 3, 1969 critical dateo Thus rendering invalid under SS 102(b)

- They allege his showing it to his roommates, etc. w/o mention of secrecy ascribes commercial purpose

- I: statutorily barred?- H: No.- R: he hadn’t given the invention to someone else for free and unrestricted use. He

always retained control over the puzzle’s use and the distribution of information concerning it

- And he retained control even though he and his boss didn’t enter into a confidentiality agreement

- Also CBS argued that an earlier oral agreement to sell the invention started the clock ticking for a bar

o The court says even if there was an earlier oral agreement, an assignment or sale of the rights in the invention and potential patent rights is not a sale of “the invention” within the meaning of 102(b)

o And also, the presence or absence of an express confidentiality agreement is not determinative of whether or not he retained control. It is but one factor to consider

- Notes:o Distinguished by Beachcombers Int’l v. WildeWood Creative Prods

The invention was demonstrated at a party w/ 20-30 friends They said it wasn’t at all times under control of the inventor and there

wasn’t an expectation of secrecy And she was statutorily barred b/c showing it counted as a public use and

she didn’t impose secrecy on her friends How is this different from Moleculon ? Implied secrecy in the work place? But it’s a jury verdict, and Ossorio

o Egbert: personal relationship, no express confidentiality = gave away to publico Moleculon: business relationship, no express confidentiality = did not give away

to publico Beachcombers: friendship relationship (casual) = gave away o TP labs: Dentist – pt relationship = did not give away

Metalizing Engineering Co v. Kenyon Bearing & Auto Parts – 1946 (Learned Hand)- Obtained a patent on an improved method of conditioning metal- Metalizing brought suit- H: the fact that he used it for commercial purposes and not experimental for > 1 yr.

prior effected the statutory bar- He actually says that his previous decision was wrongfully decided – Peerless Roll Leaf

Co. – o You either keep your invention secret and this means not using it for capital gaino Or you patent it, not both

- Notes: what was on sale here?o The guy performing the processo Decided more as a public use case than an on sale case

A bit odd b/c it wasn’t really available to the public Still applies to modern jurisprudence b/c if it’s on sale then the bar can be

triggered

o He draws a distinction between others’ prior art and the inventor’s own activities that trigger abandonment, public use, or on sale

- Compare with…. Macbeth-Evans- Also compare w/ Gore v. Garlock -

Macbeth-Evans Glass v. General Electric- Macbeth made an inventive breakthrough in the art of making glass for lightbulbs or

“globes” he kept it secret for 7 yrs.- In 1910 a former employee went to Jefferson Glass, disclosed the process, who began

making the glass according to the Macbeth method- Macbeth sued Jefferson for trade secret violation and won- Then Macbeth filed for a patent- Held: he couldn’t get a patent b/c he abandoned his right to get the patent by

commercially exploiting the invention for 7 years + as a trade secret- It did not matter what was made public – was the product of the TS process, the process

was commercially exploited and this evinced Macbeth’s intent to elect TS rather than patent protection

Pfaff v. Wells- Pfaff invented a novel socket for microprocessors- Began work in Nov. 1980 - April 9th, 1982, he files- But of course, he can’t have sold it before Apr. 19, 1981 - Mar. 17, 1981, he shows his drawings to TI, which contained the drawings which were

enough to reduce it to practice- On Apr. 8, 1981, the confirmatory memo from TI

o Confirmatory memo’s are used in K law – not much of a surprise as to when the sale occurred then

- Goods were delivered July 1981o So, you see the patent application occurred < 1 yr. after this date (approx. 9

mos.)o From Pfaff’s perspective, the contract wasn’t really fulfilled until all the parts

were delivered- So, the argument is to go after novelty

o Either show it’s not novel, or show that Pfaff had forfeited the inventiono Could this be public use? He’s showing it to a big company?

No. He’s not showing it to the public at large Just have to show a substantial amount to the public

o What other things might you have been doing with TI? You probably get an NDA so it’s protected as a trade secret

- He argues that he hadn’t actually put it on sale- At this time, there was a split in the circuits as to what constitutes on sale

o One circuit said it wasn’t on sale until it was on the shelfo The reasoning was: what if the K failed? Then you’re screwed

- But on the other hand, you might be getting advances and the publisher / manufacturer might delay the sale

o Or perhaps you get extra rounds of financingo Soo, at the end of the day, it’s not when the K was formed, but when it was

performed- TI commissioned a bunch of them, he had the plans sent to a manufacturer, but didn’t

get them back for > 1 yr. after he had created the drawing of the device, AND he marketed the invention to vendors

- Wells created a copy, basically, and Wells said that he had- The court wrestles with what constitutes a sale:

o Is it conception or reduction to practice? o Remember, conception means it can work – but you don’t have to know it works

- The Test (2 parts): see p. 297o (1) The product must be the subject of a commercial offer for sale

Note that it has to be specific enough to be an offero (2) The invention must be ready for patenting – can be satisfied by:

Either reduction to practice or by proof that prior to the date of application, the inventor had produced drawings etc. specific enough to show how the invention worked

With Pfaff’s drawings, that was enough for him to walk into the patent office

- Notes:o An invention may be deemed on sale even if it’s never consummatedo Need not contain detailed plans or schematics of the inventiono If a general offer for the widget is made, but not in specific terms, the Pfaff test is

not satisfied until the things are actually soldo General offer; invention; performance

It’s when the performance occurs (time c)o Specific offer; invention; performance

Unclear whether time b or c satisfies the Pfaff testo Fine tuning:

In some instances where fine tuning was still required, it didn’t matter. The invention was still on sale under the Pfaff doctrine

o Sham sales: Mahurkar v. Impra

He licensed the invention to Quinton instruments – remember, licensing does not trigger the statutory bar

License included a provision that voided the exclusive rights if Quinton was unable to market the catheters within 1 yr. and three days prior to the filing date

A friend of the company purchased some of the cathehers and that was not a bar under Pfaff b/c it was a sham sale

See p. 549o Marketing but no firm offers to sell

Quote sheets, circular ads, don’t bar Abbott Labs v. Geneva Pharmaceuticals

- Abbot alleged D infringed on claim 4 of abbott’s U.S. patent - Dist Ct. held claim invalid under on-sale bar of 102(B)- Compound used for treatment of benign prostatic hyperplasia- Abbott Marketed exclusively since ‘87- There are also four anhydrous crystalline forms and claim 4 claims the form IV- D bought this compound from foreign companies, didn’t tell the buyers which crystalline

form they were getting- Abbott argues the compound wasn’t invented b/c the parties must know precisely the

nature of the compound- Does it meet Pfaff?

o (1) it’s on sale and (2) it was ready for patenting b/c at least two foreign manufacturers had already reduced it to practice

- Abbott argues this case is like Tlighman – b/c it was an accidental productiono The court says those cases are off point b/c they involved the issue whether the

claimed inventions were anticipated by earlier work that produced no useful or appreciated result

o Here it was decidedly useful and appreciated- The court says no need to recognize – as long as the thing is on sale, then it can be

barred

- Cf. Abbott to Scaltech Inc v. Retac / Tetra

o Inventor’s firm offered to perform a process in exchange for $$ prior to the critical date

o CAFC remanded to lower ct. to determine whether the process contained all limitations of the later claimed invention

o Held: “If the process that was offered for sale inherently possessed each of the claim limitations, then the process was on sale whether or not the seller recognized that his process possessed the claimed characteristics.”

- Expermiental Use or Saleo Experimetns may be needed to detrmine whether an item can work for its

intended purpose

To be ready for patenting or reduced to practice the inventor must know that the item can work for its intended purpose (scienter requirement)

If an inventor is conducting experiments to determine whether an item will work for its intended purpose, then the inventor is not engaged in public use or sales of the invention

Experimental use negates public use or saleo Issues raised:

Was the inventor really engaged in experimentation or testing? What counts as evidence of this? Was the experiment / test really designed to determine whether

the invention would work for its intended purpose, or was the experiment / test for some other reason?

o Market testing can count as public use for purposes of 102(b) bars. Market testing is not “experimental use” under § 102(b)

o Experiments aimed at optimizing an invention after it has been reduced to practice can create 102(b) bars.

- City of Elizabeth Paving v. American Nicholson Pavement Co. (1877)o Invention = improvement in wooden street pavement slabso Nicholson filed a caveat w/ PTO , o Patent app filed by Nicholson on Mar. 29, 1854o 102(b) critical date, Mar. 29, 1853o ~5 yrs before, the 102(b) Nicholson constructed a 75 ft. patch on well traveled

roado I: public use or experimentalo H: experimentalo Reasoning:

Checked / examined it almost daily IN discussion w/ 3rd parties prior to lit. the inventor described the use of

pavement as expt. Inventor kept control of invention

o Court appears to apply the totality of the circumstances testo Perfection (see p. 556) – perfecting the invention means ensuring it works for

the purpose intendedo It is not public knowledge that bars the inventor from obtaining a patent… it is

public use – p. 558Experimental Sales do not create 102(b) bars

- What is an experimental sale?

- See n. 3 p. 559 – Manville Sales v. Paramount Systemso Manvill won a K to install weather resistant lighting First assembly failedo Inventor received permission from the state to try a newly designed assemblyo Inventor conveyed to state that the new design was experimentalo Inventor marked design drawings w/ confidentiality notices before disclosing

them to govt. officialso WY law prohibited officials from disclosing confidential info, such as these

drawings, to the public.o Site of use, atop pole, did not disclose the inventiono Held: although Manvill was paid, sale was experimental b/c it had indicia of

experimenting and Manvile never caused the public to believe that the invention was in the public domain.

- By definition (CAFC) if a use is experimental, then it has not been RPed

Lough v. Brunswick Corp- Invention was a new seal assembly for boat motors; was less likely to corrode- Lough was independent inventor w/ high school education- Undisputed that the inventor made and used six prototype prior to his critical date- After learning of Lough’s invention, Burnswick made its own version of an improved seal

(copied?) and sold motors with improved seal assemblies that infringed Lough’s patent claims

- Lough had given 6 prototypes of his seal out to his own boat, a friend’s, owner of a dealership, installed 4th in a marina customer, and to two friends who installed them in two other boats, one of which was sold and one of which belonged to a local charter guide.

- I: public use that should bar him from patent claims? Or experimental use?- R: no indicia of experimentation / testing

o Zero indication he was attempting to determine whether the invention worked for its intended purpose

- CAFC held use was a public use, and on these facts no reasonable jury could have found that Lough’s use was experimental b/c there was absolutely no indicia of experimentation

o It was public use b/c he completely relinquished control of the prototypeso It does not matter that people would not see the prototypes that the uses did

not disclose the inner workings of the new seal assembiles – like Lockwood v. American Airlines (the SABRE reservation booking system); this was a “iddne public use” not a “secret use.”

- Legal standards

o Totality of circumstances testo Is experimental use a question of fact or law?

The CAFC judges do not really agree. Probably mixed, but depends on individual case

- Baxter International v. Cobe Laboratories, Inc. o Held patent and it sued Cobe for infringing ‘089’s claims to a sealless centrifuge

for separating blood into its component cell fractions and liquidso Prior to Baxter’s critical date, scientists at NIH built and used a a centrifuge

covered by the relevant ’089 claims One NIH scientist, Suaudeau, used thi scentrigue in his NIH laboratory to

separate blood into its component parts. He then used it in his own experiments. He also modified the sealless centrigue to better suit his purposes

The NIH scientists were not party to this suit b/w Baxter and Cobeo I: was this public or experimental use?o H: public use even thought eh use did not disclose the invention to the public

No restrictions on who could enter the lab, many people visited and observed the centrifuge

There were no professional obligations of condifentiality among people who visited or looked at it

Worked as separator as Suaudeau first used it; he immediately comprehended it worked for its intended purpose

o Also held: Dist. Ct. found that they weren’t attempting to refine the invention b/c he was using it in experiments doesn’t mean he was experimenting

on it or perfecting it. Modified it ot better suit his needs does not change the fact that when it

was 1st build and displayed it was cleared the centrifuge worked for separating blood into its constituents

o Newman dissent: Concerned the ruling creates a secret prior art that cannot be found by

other inventors no matter how many resources they put into searching for prior art

See not 3, p. 577 – decision in Baxter cannot disadvantage an inventor who files an application w/in one yer of inventing. Why not?

o

Nonobviousness

- Tries to measure technical accomplishment – more abstract than novelty or utility- Intended to measures technical not economic triviality

o Making a technical advance not the same as marketing something or even making something better from the consumer perspective

o Also we’re not asking if the invention is not functionally better – just an accomplishment

- Needs to be new, useful and something more- Ossorio says we’re back to a situation similar to Graham- If the differences between the subject matter sought to be patented and the prior art

are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made

- Do NOT say would be obvious the correct answer is would have been obvious as of the date of invention

- What does the patentability shall not be negatived language mean?o Doesn’t matter how long the invention took to invent, how much $$ it took etc.

- § 103 also contains (b) biotech process non-obviousness- ( c ) - inventions made by different inventors but owned by a single owner or under

obligation of assignment to one owner do not make each other obvious- Although you can’t defeat your own novelty, you can make your own later invention

obvious by creating prior art that will make it obviouso Say a prior patent, publication, etc.

- What’s the policy rationale?- If we know that there’s going to be a profitable and easy result (i.e. obvious), then

there’s no need to incentivize- We need to incentivize difficult research- Economic theory would say that too many patents on obvious inventions would reduce

patent system’s incentives for inventors to produce non-obvious inventionso If producer of a patent that includes numerous obvious components they have

to license, costs go up, consumers won’t buy

Cases we didn’t read

- Hotchkiss v. Greenwood o Doorknob of clay was obvious over doorknobs of wood and metal – simply the

substitution of one material for anothero It was “destitute of originality”

- Cuno Engineering o Patented invention was cigarette lighters that popped out of your car when it

was readyo Contained a control to turn it off after it had reached a set temp.o Said it’s new and useful, but obvious where’s the something more ?o The case said it “must reveal the flash of creative genius” – which is no longer

the case. Explicitly disclaimed by the last sentence of 103

- Great A. & P. Tea Co. v. Supermarket Equip. Corp. (1950) o A frame that you could put on a table that when pushed or pulled could move

groceries within it to the clerko Held: more elongation (change of dimension) of an old device does not count as

“invention”o “only when the whole exceeds the sum of its parts” is the accumulation of old

devices or parts patentableo “the aggregation of old parts must produce a new or different function or

operation to be patentable” the heart of the functionality test

Obvious = unpatentable- determination that an invention is obvious (and therefore unpatnetable) is ultimately a

determination of law, reviewed without deference to the lower ct., but o Obviousness determinations rely on many factual findings that the ct. reviews

for clear error. o Some of the factual findings include:

Level of skill in the art Scope and content of the PA Evidence of a motivation or suggestion to combine teachings in PA

references Evidence of secondary factors (objective indicia)

Graham v. Deere

- Links § 103 to the constitutional language promote the progress of the useful arts.- Congress added another requirement for obviousness to the Patent Act- There was a plow and a prior art plow

- You’re supposed to determine through the prior art whether the invention was obvious or not- This case gets cited a lot in other cases from a philosophy standpoint- Gets cited in novelty, licensing cases- The court really re-enforced the statutes

o Art. I § 8 cl. 8 – needs to promote the invention the useful arts The court says the invention passes the limitation part Ossorio says the statute has to be interpreted in light of the Constitutional clause So part of what they’re saying about the statute is that if the statute can’t be too broad

or it’ll be unconstitutional And they basically say it basically re-codifies the old common law And they kind of ignore Cuno –

o Also Graham didn’t argue that his new invention had superior characteristics So the court says there should be deference to the PTO

o Interestingly the USPTO missed the prior art But the court reads it in – which they shouldn’t do

- Top of p. 302 – the test of non-obviousness:o It’s a mixed question of law & fact

Ultimately a question of law (thus it’s a question of fact), but based on factual underpinnings:

Level of skill in the art Scope and content of the PA Evidence of a motivation or suggestion to combine teachings in PA references Evidence of secondary factors

When an appellate ct. reviews, it reviews finding of law de novo, but the facts are given deference

o Under § 103, you first have to figure out (1) the scope and content of prior arto (2) Next, identify the differences between the prior art and the claims at issue and the level of

skill in the art Under novelty, you’re looking at the similarities – is there something in the prior art

that’s identical to this invention? If yes, the this invention is not novel

o Non-obviousness: look at the invention and prior art and determine the differences E.g. Snuggie: blanket w/ sleeves, not really like a sweater Or in Graham v. Deere the flex arms are on opposite sides of the plow

o (3) identify the level of ordinary skill in the pertinent art – Sometimes referred to as the PHOSITA std. Person Having Ordinary Skill In The Art Similar to the reasonable person std. – but they’re from a technical field

o The court doesn’t give a particular test of how to determine obviousness against this background Later CAFC created TSM

o Who would be a person having ordinary skill in the snuggie? Someone in fashion?- The TSM approach- Teach, suggest motivate – found in the KSR case- Perhaps there’s something that suggests or teaches you how to do something and it’s in the prior art,

then not going to fly under non-obviousness- If you challenge under non-obviousness, the challenger had to find something in the prior art that either

taught, suggested or motivated.- If they failed to show this, they failed to show it was obvious

o You have to articulate why this invention becomes obvious- Examples:

o Say a trash bag w/ a jack o’lanterno What’s the prior art? There’s lots of prior arts in the crafts area with jack o’lanterns

o And lots of garbage bags that have the gusseting and resistance that would form it into a shapeo Bottom line: no combination of the two in prior art – so TSM satisfiedo But a lot of controversy over the TSM test

Calmar Inc v. Cook Chemical Co. – part of Graham- Cook had a patent for a bottle sprayer cap- It used a rib and a gasket and had a spray pump attached- Why didn’t the court say this was a novelty issue?

o When we say all elements, we’re saying that for nonobviousness you’d have to have all the same elements in the same places

o I.e. if all the pieces aren’t arranged in the same way, then the claims don’t read on into the same way

- 3 pieces of prior art were looked at by the court- One was only for a pouring bottle, but had a similar sort of device where the cap wasn’t

sealed using a rib, but using a tongue and groove seal, but the hold-down cap never contacted the container cap

- So basically the differences are that one’s a pouring bottle and uses a tongue and groove seal while the other uses a rib seal and is for a pump spray

- Other prior art shows hold down caps that contact the container cap but that spray- The court finds that someone to POSA it would’ve been obvious- The court doesn’t really talk about the level of skill in the art

o If anything they talk about the secondary factors, that all of these people are searching for solutions to this problem

o The court says yes, secondary factors are present, but they’re not enough to overcome the obviousness

- Another thing the court says is you have to look at the subject matter as a wholeo Interpreted to mean “distinguishing features clearly incorporated not the

claims.” – a very narrow statutory interpretation- Interpreted the “pertinent prior art” as that which solves the same or similar problem

art from different fields of invention can count- They say “ to us .. the claims are clearly evident”

o This doesn’t focus on POSA!!- About POSA in this context:

o It’s not asking what a real person knewo And we’re definitely not asking what the inventor knew at the time of inventiono And of course when this happens, it changes in the state of the art matter

- Ossorio says this is kind of like Hodgekiss b/c it’s like a substitution

U.S. v. Adams- Came up from the Ct. of claims – the ct. used to sue the federal govt.- Patents given an exclusionary right to everyone except the federal govt.

- You can sue the fed govt. for infringing but all you can get it is $$ damages- No injunctions- Patent was for non-rechargeable battery- The court in its facts gives a cool description of the invention (so you think they’ll uphold

it)- And later it was found that the battery was really good- He told the army about the invention, they entered into K with the army- This was right during WWII- He makes an inquiry and they were totally using it- And the court finds it to be nonobvious- Issue was whether he’d just substituted magnesium for zinc or merely substituted

cuprous chloride for something else- And the court held it didn’t teach substitution of cuprous chloride for silver chloride- Also it was the first water battery- Even though one claim didn’t have water activated as a limitation, they said the claim

should be interpreted in light of the spec. – which is of course wrong b/c you’re reading in a limitation

- And NO b/c PZOSA doubted that cuprous chloride would be functional- And it had unexpectedly good characteristics

o Therefore not a mere substitution b/c you’d expect similar performance if it were a ‘mere’ substitution

o This goes to “teaching away”-

Notes:- The court also mentioned secondary factors in Graham which included “commercial

success, long but unsolved needs, failure of others, and commercial success.” – and they’ve had a major impact on the CAFC

Subtests of Nonobviousness- CAFC when it was first created began to say that reference to “combination” patents

meaningless

- This did not comport with SCOTUS holdings that hold mechanical combination patents to a more stringent standard

- TSM test (pre-KSR)o First found in ACS Hosp Sys. V. Montefiore Hosp.o For an invention that combines old features or components in new and useful

ways: teaching of PA reference can be combined by the ct. or PTO to prove obviousness only if there is some suggestion or incentive to do so.

o If the suggestion or motivation comes from the problem to be solved then applying the test properly requires a showing that…

An artisan of ordinary skill in the art at the time of invention, c Confronted by the same problems as the inventor, and With no knowledge of the claimed invention, Would have selected the various elements from the prior art and

combined them in the claimed manner.o Where is the suggestion or motivation to be found?

The PA (written down or implicit) In the amient or tacit knowledge in the art In the nature of the problem to be solved

o Need factual findings on nonobviousness to justify the determination and to facilitate appellate review

- Re-examined by SCOTUS in KSR v. Teleflexo They said only obvious if some motivation or suggestion to combine the PA

teachings can be found in the PA, the nature of the problem, or the knowledge of a POSA

o CAFC’s Ruiz case actually laid out a pretty broad TSM test – allowed explicit or implicit suggestion

o PO says that the CAFC was trying to create a rule of evidence. They wanted something to be able to review – they wanted lower courts to set out findings for review

o But also the CAFC was not unified on its application of the TSM test prior to KSRo Why not in accord? Well, if you have a rigid TSM test, then nothing is obvious

KSR v. Teleflex- Teleflex sued KSR, patentee is Engelgau- Claim is a mechanism for combining an electronic sensor with adjustable automobile

pedal so the pedal’s position transmitted to computer that controls the throttleo Tele. Accused KSR of infringing by adding an electronic sensor to their ordinary

pedals

o KSR alleges Teleflex’s patent is invalid b/c obvious- The art = pedal assembly- Prior art:

o There were computer controlled pedals already, esp. one that taught that you should put the sensor on the pedal assembly

o Another that taught you shouldn’t put the sensor on the footpad because the wires would wear out

o And there were self-contained add-on “modular sensors” that you could add to any computer-controlled car

This Rixon patent known to suffer from wire chafing- POSA = undergrad mech. engineering degree or equiv. work experience w/ pedal

controls systems- KSR took a normal design and added a modular sensor- USPTO rejected one of Teleflex’s claims b/c it was similar to but broader than claim 4.

That claim did not include the requirement that the sensor be placed on the pivot point (to avoid chafing)

- dealt w/ gas pedals on automobiles; could come up or move back to accommodate someone based on their height

- And the gas pedal also has to adjust the amt. of pressure required to push the pedal- The patent Teleflex had wasn’t a retractable version of the pedal, it used electronic

sensors- Is this something that would be deemed non-obvious? The District ct. said it was

obvious- The Fed. Cir. Reversed, saying that TSM test did not indicate prior art

o Nature of the problem solved could not supply the motivation to combine refs. From the prior art “unless the PA references addressed[ed] the precies problem that the patentee was trying to solve.”

o Obvious to try does not = obvious under the lawo

- So, the Supreme Ct. granted cert. - Held:

o Claim 4 of the Engelgau patent was obvious b/c there was little difference b/w the claimed invention and the teachings of the Asano adjustable pedal with a fixed pivot point combined with the Smith electronic sensor mounted on a pedal’s support structure.

At the time, market provided strong incentives to convert mechanical pedals to electronic ones

Market success of Engelgau’s invention (2ary factor) does not change the obviousness analysis )

o They said, look at it a bit more common-sensicallyo Don’t’ look at TSM so mechanically, sometimes the patent examiner or the court

might have their own common sense It’s a useful test, but not the only way to determine

Analysis of obviousness need not seke out precise teachings directed to the specific subject matter of the challenged claim.

The analysis of obviousness need not seek out precise teachings directed to the specific subject matter of the challeneged claim. Ct (PTO ) can take account of the inferences and creative steps that a POSA would employ

“A POSA is also a person of ordinary creativity, not an automaton”

o And PHOSITA’s common sense might be at play hereo To challenge, might need to show why it was a difficult thing to do, others have

tried and failedo Note that SCOTUS’s use of the phrase “combination of old elements” does not

necessarily mean “element” as a patent law term of art (i.e. limitation)- They say:

o For 50 years the Court held that a patent for combination… withdraws what is already known into the field of its monopoly… diminishes resources available to skillful men.

o “a combination of old elements is obvious if the combo does nomore than the individual elements would do if used in equence, and if the old elements perform functions they were already known to perform. From Anderosn’s-Black Rock and Sakraida

o And if the claimed invention is an improvement of a PA (or a variation??) a court must ask whether the improvement is more than the predictable use of prior elements according to their established functions – p. 674

o They cite Adams the battery case- And they touch on Anderson’sBlack Rock

o Where combining a radiant-heat burner with a paving machine did not create a new synergy. They did no more than sequential operations

- And Sakraidao Simply arranging elements with each performing the same function … it’s

obvious.- Their test:

o When a work is available in one field variations in the same field or a different one where a POSA can implement a predictable variation, likely bars its patentability under SS 103

o The court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions

o Often it will be necessary for the court to look to interrelated teachings of multiple patents; the effects of demands known to the design community or present in the marketplace; and the background knowledge possessed by a person having ordinary skill in the art, all in order to determine whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.

And then you use these factors to determine whether there was “an apparent reason” for combining existing items as the claimed invention did

o Analysis of obviousness need not seek out precise finding. PTO can take account of the inferences and creative steps that a POSA would enjoy

Where did this come from? An FTC report, which showed that there were too many obvious patents being granted patents

- POo Combination of familiar elements, according to known methods, that does no

more than yield predictable resultso OR it claims a structure already known in the PA and does no more than

Substitute one material or element for another known in the field And produces a predictable results

- Purpose of § 103 is to incentivize investment in risky, uncertain researcho Why?

- The analysis should be made explicit. In re Kahno But the court need not say the precise teachings directed tow the specific

subject matter of the challenged claim- But Adams teaches that just b/c all elements were independently known in prior art,

doesn’t mean it’s obvious- And they say: it can be helpful to look to the reason that would’ve prompted a person of

ordinary skill to combine the elements- But helpful insights need not be rigid and mandatory formulas

o Cannot be confined by a formalistic conception of the TSM or overemphasis on published article and explicit content of issued patents

- Errors of the CAFC – they weren’t objective in its analytical frameworko Foreclose this reasoning by looking only the problem the patentee was trying to

solveo They assumed POSA would only be led by those elements of prior art designed

to solve the same problem So they didn’t consider the Asano patent for constant ratio

o They assumed that if a new invention is “obvious to try” then it can’t be obvious This factor points to common sense

o They drew the wrong conclusion re: the risk of hindsight bias- SCOTUS reasons for being obvious

o There was a significant advantage to creating a constant ratio pedal and one that used an electronic sensor

- Notes:o Supposed to focus on the objective breadth of the claim, not the subjective

motives of the inventoro Also, the POSA is not an “automaton” – give credit to POSA that they could

connect the dots (i.e. easier to prove obviousness)o Obvious to try:

Prior CAFC law held that where the prior art makes a wide variety of combinations “obvious to try”, none of the combinations are patentable if most or all of them can reasonably be expected to work. Merck v. Biocraft Labs

o There is still considerable question about what standard should be applied for obviousness

Clear and convincing or preponderance?o Apparently the court also shifted the obviousness question from one of fact to

one of lawo We don’t want to give patents to obvious inventions b/c there’s no public

benefit for inventions that are obvious. We want to reward risko What happens to the TSM test?

The CAFC didn’t just walk away from the test. They just tried to modify it to be in compliance with KSR

Obvious to Try Standard- Does not mean obvious, according to SCOTUS- But the jurisprudence was always more complicated – not clear that KSR changed this

jurisprudence- KSR said it was obvious IF:

o Obvious to try somethingo AND the motivation to try b/c it came from design need, market pressure, or

regulatory pressure, o AND there are a finite number of identified, predictable solutions ANDo One can anticipate success that actually materializes

- The unpredictable arts – much harder for obviouso You have to able to predict not only that you’ll get the gene, but every single

building block of the DNA you’ll get else not obvious- Ex: In re Bell – entire protein sequence + method of cloning w/ high likelihood of

successfully cloning the DNA does not make it obvious- In re Deuel

o Portion of the sequence + method of cloning w/ high likelihood of success does not make a DNA sequence obvious

- UNTIL… (cases discussed on Wed.)- Also, if the PA makes a large # of combinations obvious to try AND likely to be functional

then the solutions are all obvious

Hindsight Bias- People consistently exaggerate what could have been anticipated - Basically, hindsight bias is a huge problem- TSM test doesn’t work very well to combat hindsight bias- Ortho McNeil Pharma v. Mylan Laboratories – March 31, 2008

o Patent on anticonvulsant drug. Mylan accused of infringement

o Held: b/c Dist. Ct. correctly ruled on claim construction, inequitable conduct, obviousness and enablement, … Ct. affirms

o Patients part of experiment for diabetes, noticed a couple of people reported epilepsy better under control

o Found that a chemical intermediate was very effective in controlling seizureso Claim was written in a continuation of original disclosureo Disclosure only disclosed intermediate in a way that was part of a very generic

chemical formula (lots of R’s in it = variables)o The question is: is it objectively obvious ?? o Held: no. They say: TSM test is a guarantor of nonobviousnesso Also “objective indicia”

Record shows powerful unexpected results Skepticism by POSA that the invention would work or should be pursued Copying Commercial results (these are secondary factors)

o Also there werent’ a ton of possibilities – POSA wouldn’t be likely to start w/ the chemical compound, so not a small finite # of alternatives

Teaching AwayArkie Lures v. Gene Larew Tackle (1997)

- Larew appeals from MSJ of Dist. Ct. for Western Dist. Of AR invalidating his patent- Larew set out to make a salty lure that would better keep fish on the line- Salt is ordinarily an undesirable additive to plastic. It weakens it and can cause

explosions in manufacturing- Arkie lures copied it, and brought a declaratory judgment action- Dist. Ct. granted MSJ for Arkie- Prior art:

o Fishing fly w/ squirrel hair and yeast and salt baked ino Plastic lure containing organic compound to attract fish

- Differences in PAo Doesn’t work by odor, but b/c it keeps them on the bait longero And it retains its salty power for lifeo Previously thought infeasibleo People thought the salt would ruin the lure’s texture

- Skill in the Art:o High level of skepticism that the invention would work even by those w/ PhD’s

- Held:o That nothing taught that invention. It counseled against it

- Dissent:o Salt is miscible in plastic, and people already knew thato This is likely a broader construction of prior arto Also soluble != miscible

- Notes:o Teaching away from the invention – counts in terms of nonobviousness analysiso Suggestions can be implicit or explicito If the party trying to challenge the patent will be more likely to prevail if they can

show an “exogenous” reason the invention wasn’t patented So if you can show that something wasn’t patented b/c there was some

market force not to do so, say FDA approval, then that would work against the patentee

o PO says teaching away is a good holding even after KSRHow do we take into account the differences in various fields?

Standards of Review- Underlying factual inquirires (i.e., level of the skill in the art) are reviewed

o For clear error if CAFC hearing an appeal of a Dist ct. caseo For lack of substantial evidence if the CAFC is hearing an appeal from the BPAIo Obviousness determination is reviewed de novo b/c obviousness is ultimately a

question of law- Even though obviousness is reviewed de novo, the party challenging an issued patent

claim still has a clear and convincing evidence burden on the obviousness question (and on all other q’s of patent validity, e.g., novelty and utility).

o Patents are “born valid” - § 282- New prior art:

o “Product of new PA or other invalidty evidence not before the PTO… eliminate[s] or at least reduce[s] the elemtn of deference due the PTO, thereby partially if not wholly discharging the attacker’s burden.” American Hoist & Derrick Co.

o

Hybritech Inc. v. Monoclonal Antibodies, Inc.

- Court relied on 2 secondary factors- Graham said utilized “… to give light to the circumstances surrounding the origin of the

claimed subject matter.”- “Objective evidence” … of nonobviousness = secondary factors a.k.a. objective indicia- The list:

o Long-felt, unmet needo Trial and failure by others

Comes from the parties - discoveryo Commercial success

See: the analysis belowo Copying o Licensing activityo Unexpected results

Sometimes teaching away Sometimes an unexpected property that no one would’ve expected

E.g. Adams batteryo Other… (make up your own!)

- When should 2ndary factors be considered? What role should they play? Which more authoritative?

- Notes about Hybritech- When you do nonobviousness analysis using POSA’s POV- Determine scope and content of the pertinent PA (In re Clay)- Determine the level of ordinary skill in the pertinent art.

o Consider: (illustrative, not exhaustive)o Educational level of the inventor; -- PO says often not that crucial

B/c we want objective analysiso Education level of active workers in the field

This is what you want to focus on more than the previouso Type of problems encountered in the art;o Prior art solutions to the problems;o Rapidity of innovations in this art; ando Sophistication of the technology

- The CAFC didn’t like the § 103 analysis of the lower ct.o Don’t ask whether the invention ‘would be’ obviouso It’s ‘would have been’ obvious and ‘as a whole would have been obvious’o

- Environmental Designs Ltd v. Union Oil – (Fed. Cir. 1983)- - The court laid out a list of factors relevant to a determination of the level of skill in the

art:o (1) education level of the inventor;o (2) type of problems encountered in the art;o (3) prior art solution to the problems;o (4) rapidity with which innovations are made;o (5) sophistication of the technology; ando (6) education level of active workers in the field

- Also, Judge Rich, says that there should be a nexus between the patent and secondary considerations

o As well as the commercial success of the patentee and the patented product Alco Standard

- So, nonobviousness leads itself to several factual inquiries, but is ultimately a question law, at least at the present day. Graham

o Justified b/c it allows quick resolution of patent validity without necessitating that cases be remanded to the trial court

o But, the federal circuit gives deference to a lower court’s factual findings (as per usual), but not its

- Apparently the court underwent a shift after Graham?o A fourth factor “objective evidence” (of nonobviousness) is now considered a

secondary factor- CAFC has elaborated on a “nexus” requirement, which requires that before secondary

considerations can be used to demonstrate nonobviousness, a showing must be made that their appearance is attributable to the inventive characteristics of the discovery as claimed in the patent.

o The “nexus” requirement means that there must be an actual connection between the invention and the secondary factor. I.e. it must be relevant?

- Analysis of why commercial success analysis is rubbisho It relies on the fact that there was a race, that success was attributable to the

patented invention, that other firms failed b/c another firm was the first to develop, that success was perceived before development

o Specifically, commercial success might have been due to some non-patented feature – indeed economic analysis bears this out. It may be due to marketing and perceived quality, not technological advances

o Also, they would’ve had to have perceived that the patented - What about simultaneous development?

o The federal circuit doesn’t buy this factor Maybe there was technology that got released But racing can be coincidence

Implicates hindsight bias Could’ve taken a long time to develop, so doesn’t necessarily

show biaso

IN Re Kubin- Kubin, Goodwin appeal from decision from USPTO Board- Rejecting claims of ‘859 app as obvious for lack of written desc.- What’s patented:

o Isolation and sequencing of a human gene that encodes a particular domain of a protein

o They claim polynucleotides that encode a protein known as the Natural Killer Cell Activation Inducing Ligand (NAIL)

o So, they claim the genus that will bind to NK cells, and will cause the natural killers on

o Why do they do this? There’s a binding portion of the protein that they disclose, and if they get

everything that can bind to the protein, then they will get commercial value

- What does that mean?o They play a major role in fighting tumors and viruses

o They say the NAIL protein binds w/ CD48, which increases cytotoxicity and production of interferon

o They disclose 2 sequences of polynucleotides: (1) that codes for NAIL (2) codes for the full NAIL gene including upstream and downstream non-

coding sequences- The specification also “contemplates” variants of NAIL that have the same binding

properties w/ one insertion, deletion, or substitutiono They comprise from one to ten deletions, insertions or substitutions of amino

acid residues when compared to a native sequence- PTO:

o You didn’t specify which members of the genus would actually bind to CD48o This sort of information is normally known about protein binding siteso Giving only two of the possible sequences in the genus and you don’t dell what

makes something into a CD48 binding site, then that’s not enabledo You haven’t provided other examples of what will work

- So, they invadidate:o Valantine patent – discloses the protein which is basically the same thing

But doesn’t disclose the nucleotide sequence and no knowledge of the protein sequence

Sambrook had knowledge of a standard method of making the DNA sequence, therefore a method of deducing the protein sequence

Matthew – prior cloning of a ell surface protein gene from NK cells of mice and determination that human NK cells possessed a similar gene

PO says: yeah, so all these do add up to this thing High ex ante likelihood that standard methods could, in fact, be used to

obtain the gene of interest and deduce the protein sequence And Motivation to try to clone NAIL b/c of POSA’s prior knowledge of its

important role in the human immune response Also note, there’s no knowledge of the underling specific DNA or protein

sequence in humans!! So even though we’re talking about the exact sequence of DNA,

apparently having the mouse DNA known is enougho Under KSR

High likelihood of success, combination of elements, etc. they’re all here, so it’s obvious kachoWW!!

Essentially invalidates Deuel and Bell

- What’s the relationship of making the gene vs. the obviousness of the gene sequenceo Even though Kubin disclosed a different way of making the gene, o That doesn’t go to the question of whether having any known process previously

disclosed, etc. That can make the sequence obvious

- But their specification doesn’t include any example variants of NAIL that make these amino acid substitutions

- The board rejected under 112 and 103 – they found claim 73 unsupported by an adequate written desc.

o B/c they hadn’t disclosed any variant species w/ the amino acid substitutions- The Board also rejected on obviousness grounds

o They found the claims to be cumulative of 3 other patents- Rader says:

o The Board missed the point. They should’ve been looking at whether or not the gene sequence was obvious, not whether or not the combination of the inventions would produce the desired result

oo Instead, Kubin’s claim of a library of sequences is deficient b/c they rely on

standard methods outlined in another patent (Sambrook) while at the same time they say their invention is not obvious

o They also say that In re Deuel means that “obvious to try” does not mean obvious in the unpredictable arts, at least. But that KSR casts doubt on Deuel

Remember that Deuel said that you have know every portion of the DNA sequence (can’t just know a portion of it w/ a high likelihood of success) – ergo, obvious to try != obvious b/c there are 100’s of k’s of sequences

- Obvious to try analysis:o They say the rejection of “obvious to try” resurrects CAFC’s analysis in O’Farrell,

which cautioned that “obvious to try” is an incantation whose meaning is often misunderstood:

But that, an invention that would have been obvious under 103 would have been obvious to try

Presumably the reverse doesn’t hold o Under O’Farrell, the CAFC outlined two classes of situations where “obvious to

try” is erroneously equated w/ obviousnesso (1)

Varying parameters or to try each of numerous possible choices until one possibly arrived at a successful result where the prior art gave no indication of which parameters or no direction

I.e. throwing darts != obvious to try The inverse of this is KSR, where an artisan pursues “known options”

from a “finite number of identified, predictable solutions”o (2)

It’s not obvious where what was “obvious to try” was to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior at gave only general guidance as to the particular form of the claimed invention or how to achieve it

- Again, because they cite to the manual for Valiante, the second nor first classes apply, so it was obvious to try and was therefore obvious

o Citing KSR, the invention is the product not of innovation, but ordinary skill and common sense

- CAFC also says that KSR does not just apply to the predictable arts, but to unpredictable as well

o So this is predictable according to the courto Apparently the court used the wrong metaphor, small molecule chemistry,

- And there was a market-driven reason for achieving and expecting success- PO: obvious to try, high likelihood of success, used known and common methods

produced an obvious DNA and protein sequence- Essentially invalidates Deuel and Bell - Bell not as clearly, but if we have the whole protein sequence, then there are so many

well-known ways, then it invalidates it as well- In this case, obvious to try = obvious!

Standards of Review

- factual inquiries reviewed for clear error if a Dist. Ct. case- For lack of substantial evidence if BPAI

- obviousness determination is reviewed w/o deference b/c obviousness is ultimately a question of law

- Even though obviousness is reviewed de novo, the party challenging an issued patent still has a clear and convincing evidence burden on the obviousness question (and on all other q’s of patent validity, e.g., novelty and utility) on an issued patent

o Patens are “born valid” – presumption of validity § 282- What if the challenge is based on PA that was not before the PTO when the application

was issued?o The CAFC has held: “production of new PA or other invalidating evidence not

before the PTO.. eliminates[s], or at least reduces the elemnt of deference due the PTO, thereby partially if not wholly discharging the attacker’s burden.”

American Hoist & Derrick Co. v. Sowa & Sons, Inc. , 725 F.2d 1350 This question ducked in KSR

D. The Scope and Content of Prior Art

- Steps:o (1) decide whether a reference may be considered “prior art” for purposes of

103

o (2) determine whether the reference is part of the pertinent prior art – whether it is part of the art wto which the invention pertains

In re Winslow – Judge Rich – C.C.P.A., 1966- Winslow figured out how to take a stack of plastic bags and open the topmost bag in the

stack to fill it- He used an air jet to open the top bag, held the bags in place w/ a flap on one side of

each bag’s opening- Flap had one or more hold and rods passed through the holes - Flap was perforated so it could be torn away after the bag was filled- PTO

o Rejected claims for opening and filling bags, citing three primary references, Gerbe, Hellman, and Rhoades

- Gerbe patent disclosed bag filling machine opens bag w/ jet of airo Used a clamp to hold one side of bagso Held the bags only by friction, so the bags could blow away

- Hellman used air-blast packaging in which envelopes are hung vertically from a rod running through the flaps

- Rod is tipped at a slight angle from the horizontal, air blast opens the envelope at the bottom of the rod, item dropped in, weight of the item tears the envelope free

o Was designed for heavy piston rings, so easy to do the tearing, requires gravity to tear

- The Rhoades patent hangs paper bags from a pin, but they have a crescent cutout so the pin only pierces one side of the bag, but leaves a cut

- Holding:o It’s still obviouso If you imagine the POSA inventor working in his workshop with the prior art

references, which he is presumed to know, hanging around him that combining the three patents would result in the new invention

o POSA knows ALL of the PERTINENT prior art references!!- Smith, J. Dissenting:

o He argues that it’s not so simple to do what Winslow did.o And that b/c it’s simple technology, the majority was biasedo Goes to show that great minds can differ over nonobviousness

- Notes:o Law does not assume knowledge of all art, but of all pertinent prior art o Second, the knowledge isn’t about the inventor’s knowledge, but about POSA

This keeps things objective, not subjectiveo With these qualifications, Winslow is good law

Prior Art For the Purposes of Section 103- Prior art is not limited to the contents of Sec. 102- So, it’s a bit ambiguous

Hazeltine Research v. Brenner – SCOTUS - 1965- I: whether an application for patent pending in the PTO at the time a second app. Is filed

constitutes “prior art”- Regis filed an app. For an improvement on a microwave switch, was denied

o B/c not new or unobvious o Joint effect of patents by one Carlson and Wallaceo Wallace application was pending when the Regis app. Was filed

- Petitioners argue that Prior art is only what is known, citing the reference to the drafting history of 102

- H: secret prior art is still prior art. We can’t allow patenting for inventions that aren’t really patentable

o They uphold a previous case, Milburn

Notes:- Some countries use secret prior art for anticipation, but not for nonobviousness analysis- You can’t anticipate your own work, but if the inventive entity changes, then

anticipation becomes an issueo There is an exception where a sole inventor discloses something and then joins

up with another to makean invention – no anticipate. In re Land & Rogerso Though you have to prove that the joint entity was responsible for the work

disclosed in the earlier applicationo There’s a further exception to 103(C) that states that you can’t have stuff used in

obviousness analysis when it’s assigned to or owned by the same entity – so companies can’t compete with themselves, effectively

In re Bass – C.C.P.A. 1973- Inventors Bass, Jenkins, Horvat, created vacuum system for use on a textile processing

machine known as a “carding machine”- In ruling it obvious, the court relied on two patents

o One issued to Jenkins in ‘67o And one to Bass and Horvat in ’67 (filed in ’65 and ’65 respectively)

- B/J/H filed their application in ’65, several months after the filing of the other apps, so the art could qualify as prior art

- However, they showed that their date of conception and reduction to practice were before the Jenkins and B/H filing dates

- So, the issue is whether prior art under 102 can be also considered in an obviousness consideration under 103

- The court holds that it can- It also finds for the inventors in this case b/c one of the pieces of prior art was found to

be developed simultaneously with the invention in question- This analysis applies only to what’s claimed in patent applications

o Sun Studs v. ATA Equip. Leasing – p. 742o You can’t backdate disclosures – only claims

Statutory bars of Sec. 102In re Foster

- Foster filed a patent application covering new synthetic rubber compounds on Aug. 21 ‘56

- Established his date of invention was prior to Dec. 26, 1952- Claims rejected as unpatentable b/c an article by Binder published in Aug. ‘54- So, this would be prior art under 102(b) , which requires 1 yr. prior, but Sec. 103 says the

prior art is at the time of invention- So, do we get to include this as prior art or not?- Foster contends only Sec. 103 applies, not 102- It’s not very clear whether the patent was rejected on 102 or 103 grounds- The court first concludes that the Binder article didn’t fully anticipate, so we have to

look at nonobviousness grounds- So they hold that because it’s against public policy to allow patenting something that’s

been disclosed 1 yr. prior to filing. So the language in Sec. 103 effectively reads wrong, as it should be thought of at the time of filing, not the time of invention

- They say it doesn’t have any effect on 103 when a statutory time-bar is not involved!!o So for other nonobviousness analysis, you do look to the time of invention

- They say whether there has been a loss of a right to patent is statutory, not based on obviousness in this case

- Notes:o 102(b) references can be incorporated together, but Foster does not hold that it

can be combined with (e), (f) and (g) referenceso But courts apparently have held that 102(b) references qualify as prior art under

103

Nonanalagous Arts Exception for Nonobviousness- While all references are included for 102 analysis, the same isn’t true of 103- References aren’t considered if they pertain to “nonanalagous art”

In re Clay- Fed. Cir. 1992- Clay appeals ruling by the PTO- Affirmed rejection of claims 1-11 and 13 as being unpatentable under 103- Clay worked for Marathon Oil, developed a process for storing refined liquid

hydrocarbon product in a storage tank having a dead volume between the tank bottom and its outlet port

o Process involves preparing a gelation solution which gels asfter it is placed in the tank’s dead volume – the gel can be easily removed by adding a degrading agent

- PAo Hetherington patent, an apparatus for displacing dead space liquid using

impervious bladders and Sydansk patent, also assigned to Marathon, which discloses a process for reducing the permeability of hydrocarbon-bearing formations and thus improving oil production using a similar gel

- So, of course they have to look to the prior art and what is exactly constitutes prior art- The test: whether the art is analogous or not or whether the art is “too remote to be

treated as prior art”- They say that the Sydansk patent isn’t prior art because

o Even though it involves petroleum, it involved using gel to get oil in underground formations to flow and under extreme conditions – not the same as filling an oil tank

- They note that if an invention has the same purpose as the patent in question, it can still be prior art, but here we’re dealing with oil flow vs. storage, essentially.

Patent litigation- The party accused says:

o Your claims are invalid or unenforceableo Patent misuseo Inequitable conduct

- We didn’t’ do it! (argues that he / she does not infringe)Validity Issues- Your relevant claims are invalid if

o – 101 not patentable subject matter, not useful

o 10

not novel barred

o – 103 Claims obvious

o 112 claims not properly enabled or described claims indefinite or otherwise do not meet something or other

Infringement overview- Literal equivalents

o What would infringe before would literally infringe aftero 35 U.S.C. § 271

Whoever makes, uses, offers to sell, or sells any patented invention within the United States or imports in to the United States any patented invention during the term of the patent therefore, infringes the patent

oo Doctrine of equivalents

- Indirect infringemento Inducement to infringe – 35 U.S.C. § 271o Contributory infringement: 35 usc § 271

Direct Infringement Analysis - § 271 continued- (1) Interpret the claim- (2) Literal infringement – determine whether all elements of the claim read on the

accused device or process- (3) if (2) is no, is there infringement under doctrine of equivalents (DOE)

Interpreting Claims- Should be interpreted in accordance with ordinary dictionary meaning

o But apparently there’s quite a battle in the Federal Circuit about this- Should look at:- Claim- Written description- Drawings - Prosecution history – these are all intrinsic evidence- Extrinsic evidence:

o Dictionaryo Practice manuals and textbookso Expert testimony

- Why do we have claims?o Claims should give notice to potential infringerso Uniformity of claim interpretation

For the same patent in different jurisdictions Across different patents in related fields

- Fairness (this inventor and others)o What scope of right does this inventor deserve given her contribution to

knowledge?- Markman

o “it has long been understood that a patent must describe the exact scope of an invention and its manufacture to secure [to the patentee] all to which he is entitled [and] to apprise the public of what is still open to them.’” Quoting McClain v. Ortmayer

o Markman held the patent for an inventory control and reporting system that could monitor and report the status, location and movement of clothing in a dry cleaning establishment

It’s a product patent b/c it’s a product patent!!!!!!!!! System = PRODUCT PATENT, machine or device of some sort

o Claim at issue stated that the Markman device would “maintain an inventory total” and “detect and locate spurious additions to the inventory.”

o Markman sued Wesstview and others for contributory infringement. Westview made a machine that recorded inventory #’s

o At trial, Westview argued its device didn’t infringe b/c it only tracked the $$ Whereas Markman did both $$ and the physical location of the clothing

o So the trial centered around the definition of “inventory”o Dist. Ct. gave JMOL to Westviewo Held: claim construction is a matter of law for the court to decide! A patentee or

accused infringer has a right to a jury trial under the 7th Amendment, but that right does not include a right to have the jury decide every issue

o The court gave a # of reasons for this: Why? Judges are uniquely trained for and experienced in this Howver, they also recognized that experts are often required to help the

ct. understandt he technology and the meaning of technical language in claims does not mean that claim construction is a matter of fact

Allocating claim construction to judges will promote uniformity in claim construction

This really hasn’t been the case Now we have Markman hearings

o If the judge doesn’t do the claim construction theory right at the beginning, then you have to try and lit. some of the claim construction issues under two different theories of the claim construction

Also might not know what to ask for in discovery if you have different theories

- READ the RADER opinion in FAS!!! TODO!!- Some judges like to have late Markman hearings. Why?

o Why? They want to learn about the tech. before they do the claim constructiono Or, you could have late Markman hearings to bleed your client or opposition out

of $$After Markman

- Fromson, CAFC ‘97o Expert evidence showed the meaning “anodization” was more nuanced than the

stated dictionary definition of the process. Enhanced understanding came from expert guidance as to the finer points of the technology at issue

- Pitney Bowes, CAFC 1999o Precedent does not prohibit our court from examining extrinsic evidence

Phillips v. AWH Corporation- Phillips invented modular steel-shell panels that can be welded together to form

vandalism-resistant walls- I: how should the court go about claim interpretation?

o 7 questions briefed:o What evidence should be valuated?o In what order or with what weight should each typed of evidence be evaluated?o What role should the spec. play in the court’s claimconstruction?o What role should prosecution history play?o What role should dictionaries play?

- Useful in prisons, obtained a patent- IN Feb. ’97 Phillips brought suit in Dist. Ct. for the Dist. Of CO- Court focused on the language of claim 1, “further means disposed inside the shell for

increasing its load bearing capacity comprising internal steel baffles extending inwardly from the steel shell walls.”

o Court interpreted the language as “a means… for performing a specified function”

o I.e. it was a MPF claimo § 112 ¶ 6

- The court decided that under this interpretation that Phillips could not prove infringement, so he lost on MSJ

- The court notes that the term “means” is used, but…o “internal steel baffles” are being used as a structure that performs the recited

function of increasing the shell’s load-bearing capacityo The reference to “baffles” does not use the word “means”o And the court has held that the absence of the term “means” creates a

rebuttable presumption that § 112 p. 6 does not apply- They further hold:

o Means-plus-function claiming applies only to purely functional limitations that do not provide the structure that performs the recited function

o And because the baffles “extend[] inwardly” they are structures- The court then moves on to determine the correct construction of the structural term

“baffles”o Why did the CAFC say it’s not a MPF element?o “a further means for” is the language in the claim. Normally this creates a

rebuttable presumption the element is MPF. Here it’s not. Why? It says “internal steel baffles.” This is structural language

- Why does the MPF matter?o B/c if baffles are MPF, the embodiments all had acute or obtuse angleso So if you’d interpreted it as MPF, then the baffles that were actually disclosed

would be at obtuse and acute b/c you’re limited to the embodiments You want to put in as many embodiments as possible You do get get equivalents in MPF, as well (112 ¶ 6)

- The Fed. Cir construes MPF by looking at the elements, not the claim. This is stupid, probably.

o This might be on the exam! Step Plus Function!!!o Don’t’ forget an element can be a MPF or SPF if all it does is recite a function

without anything structural. o Means can signal something is MPF

- Claim terms re generally given their “ordinary and customary meaning.” But for the CAFC, “ordinary and customary” is a term of art.

o It’s the meaning the term would have to POSA at the time the invention was made

o POSA is deemed to comprehend the term “in the context of the entire patent”- Principles:

o “the claims of a patent define the invention to which the patentee is entitled the right to exclude.”

o Because the patentee is required to “define precisely what his invention is,” the Court explained it is “unjust to the public, as well as an evasion of the law, to construe it in a manner different from the plain import of its terms.”

o And the terms in the claim are generally given their ordinary and customary meaning – and that to a person of ordinary skill in the art in question at the time of the invention

o But POSA is deemed to read the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification

o When language is used idiosyncratically, the court looks to sources available to the public that show what a POSA would have understood disputed claim language to mean

o They say the spec. is the single best tool for interpreting the claimso The court should also consider the patent’s prosecution history if it’s in evidence

Consists of the complete record of proceedings before the PTO and includes the prior art cited during the examination of the patent

o Claim termsa re generally given their “ordinary and customary meaning.” But for the CAFC, “ordinary anc customary” is a term of art.

Means the meaning that the terms would have to POSA at the time the invention was made!! [PO is not sure this is correct]

She thinks it should be at the time of the infringement Also, POSA is deemed to comprehend the term “in the context of the

entire patent” For interpretive aid, the court looks at sources of info available to the

public. Needs aid b /c:

o Terms may have distinctive meaning oro Patentees may use terms “idiosyncratically”

Public sources include:o Intrinsic and Extrinsic

o Claims must be read in view of the specification but the court should not import limitations (elements) from the spec into the claims

o If it was a MPF and it only saw acute + obtuse, it would still have to ask about equivalents

o And extrinsic evidence is allowed: Expert testimony, dictionaries, and learned treatises Less significant than the “intrinsic record”

o What are other reasons that the spec. is the best interpretive guide?

Ptee can be her own lexicographer PTO doctrines, a/a “no antecedent basis” mean that the spec should

contain claim language in a clarifying context. The spec may disclaim certain meanings of the word Context, such as the purpose of the invention, is found in the spec. Intrinsic record must be consulted to determine which if any dict. Term is

appropriate (all this really points to the canons of analysis below)

o Reasons that extrinsic evidence is or is not great: Not generated as part of lit. and therefore “disinterested” sources of info

“objective” Courts will be less likely to read limitations into the spec

o Courts not barred from any extrinsic meaning as long as it doesn’t contradict any unambiguous meaning in the intrinsic evidence

o Reasoning: b/c ther were claims specifically directed to baffles that stop bullets, the

most general claim should not be so restricted or the other, dependent claims, would be redundant. Canon of claim differentiation

Here, the meaning of baffles was unambiguous so the court does not use the interpretive canon that recommends construing language narrowly to save validity.

- The court then goes on to set aside Texas Digital Systems, which emphasized using trade dictionaries

o Why did that court decide that way? Uniformityo But it’s counter to the way patent law has been practiced for > 100 yrs.o Because you can be your own lexicographer

- So, the court goes through and analyzes the claim and description languageo One of the claims states the baffles should be at angles for deflecting projectileso Others state that the baffles can be filled with o The basically construe the claims so as not to be redundant and then they find

that his claim for infringement should be reversed and remanded- Notes:

o § 112 p. 6 says an element in a claim for a combination may be expressed as a means or step for performing a specified function w/o recital of structure, material, or acts in support thereof and shall be construed to cover the corresponding structure, material, or acts describe in the spec. and equivalents thereof

o The author notes that the court essentially read the claims to be broader than they were by reading a broad definition of baffles that weren’t in the claims

This is the opposite approach taken in Lizardtech

Notes on Canons of Construction- When two constructions are possible, choose the one that preserves the validity of the

patento Rhine v. Casio – this canon has a long pedigreeo Now said to be a last resort, not a first principle by the Fed. Cir.

- Ordinary v. contextual meaningo Claims are supposed to be read with their ordinary meaning, but it’s in the light

of POSA, so that’s contextual- Contextual Meaning may trump Ordinary Meaning

o Big dispute in Nystrom v. TREXo Over the word “board” – initially MSJ for D’s, o Fed. Cir said board means a piece of wood

- The “Lexicographer” ruleo Ordinarily courts say that patentees are free to define claim terms as they wish,

but sometimes the words are still ambiguouso Jack Guttman v. Kopykake

System for printing an image on an edible sheet, which then could be placed ont a take for decoration

The competing tech. used a scanner w/ inkjet printer The patent in question said “photocopy machine”:

Scanning and an image reproducer need not be in the same housing…

o Kopykake argued that the definition meant a photocopier with scanning and printing components in separate housings. The court disagreed

- Disclaimer of subject Mattero Patentee’ statements in the spec. Or more commonly in the prosecution history

may limit or disclaim apparently broad claim languageo Cultor Corp. v. A.E. Staley Mfg. – Cultor was ad ispute over patent on improved

process for making “water-soluble polydextrose” a flour and sugar substitute o The spec stated:

“water-soluble polydextrose” … specifically refers to the water-soluble polydextrose prepared by melting and heating dextrose… preferably with about 5-15% by weight of sorbitol present in... of citric acid

The court held that the spec. limited the WSPD to that prepared in the presence of citric acid

- Claim Differentiation: Contextual meaning From Other Claimso Patent law version of principle requiring written instrument to be interpreted so

as not to render some language mere surplusage- Purpose or goal of the invention

o 3M had a series of patents related to resin-based orthopedic casting systems, which replaced plaster casts

o Several claims required bandages for forming cast to include a “lubricant”o Some chemicals identified in the spec. as effective lubricants had been used in

prior art bandages D argued claims were anticipated therefore invalid

o 3M found a way of using the lubricant to create a slippery surface –previously not done

o Court looked to the purpose of the invention: To produce a non-sticky resin to permit smoothing and forming of the

casting tapes overcoming the “tacky resin problem in the prior art”

Unique Concepts Inc v. Brown – Fed Cir. 1991- UC sued Brown for infringement on patent on a frame for hanging fabric- Brown defended that UC’s patent claims required “right angle corner pieces” and

Brown’s products included no corner pieces preformed at a right angle, but did include 2 pieces that were mitered to be placed together to form a right angle

- Dist ct. held that the mitered pieces even though they could be used to create a corner piece did not meet the language “right angle corner border pieces” either literally or under the doctrine of equivalents

o Fed Cir. Affirms- Claim is for “assembly of border pieces” consisting of “right angle corner border pieces”

and “linear border pieces”- In reviewing the claims, claim construction is an issue of law, reviewed de novo- They examine the claims, spec. and the prosecution history- The spec says that corner pieces can be mitered, but a preformed piece would be easier

for a do-it-yourselfer to work with- Also, cancelled claims included those for mitered corner pieces- Rich, J. Dissenting:

o He notes the spec outlines mitered corner pieceso And basically rips the majority a new one

Markman Notes- “Markman” hearings – a hearing held by a trial judge to decide the meaning of any

disputed matter of claim interpretation - Typically occur prior to trial b/c the trial court’s view on the meaning of claims is needed

for determining what evidence to introduce at trial and how best to show infringement- They’re not required by the decision itself, however.

o Because they generally occur before trial, they tend to isolate claim interpretation from other issues like nonobviousness

- Markman decided that the jury would have no role in claim interpretationo It didn’t allocate decide the proper allocation between appellate t., trial ct. and

agencyo Most Fed. Cir. Cases they decide the claim interpretations de novo

Cybor Corp. v. FAS Technologies – Fed. Cir. 1998 (en banc)- Cybor brought declaratory judgment that it was not infringing on FAS’s patent on a

pump;- I: what standard of review should be used to review claims?- FAS counterclaimed for infringement. Tried before a jury, Dist. Ct. interpreted FAS’s

patent claims in charging the jury- Jury found FAS’s claims were valid and infringed- Cybor argued Dist. Ct. erred in construing the claims- They start off by saying Markman means they decide claim construction de novo on

appeal- Apparently in some cases, courts have been following a “clearly erroneous” standard for

reviewing patent claims- Rader dissent:

o We should defer more to Dist. Ct.’so They’re closer to the issues

- Also note: PTO stuff reviewed de novo and with deference

Phillips v. AWH Corp.- The CAFC asked the parties to brief the court on whether it is appropriate for this court

to accord any deference to any aspect of trial court claim construction rulingso They ducked the issue

- But Mayer, Newman JJ. Dissento They say some degree of deference should be paid to the district courts

Warner-Jenkinson co. v. Hilton Davis Chemical Co.

- Graver Tank – laid out the doctrine of equivalents – a product or process that does not literally infringe can be found to infringe if there is “equivalence” between the elements of the accused product or process and the claimed elements of the patented invention

- I: proper scope of DOE- Patent at issue:

o A patent for the purification of dye through a membrane having a certain diameter and at a certain pressure

o The inventors added the phrase ‘at a PH from 6.0 to 9.0” during prosecutiono This was done to avoid infringing on the “Booth” patent

- Hilton Davis sues, b/c they have the “Booth” patent, and win on DOE- CAFC affirms ( but they’re divided)- Test for DOE:

o Whether the substituted element makes the DOE inapplicable; or conversely whether under the circumstances, the change as so insubstantial that the tiral court’s invocation of DOE was justified…

o What constitutes equivalency must be determined against the context of the patent, the prior art, and the particular circumstances of the case. Equivalence in the patent law, is not the prisoner of a formula and is not an absolute to be considered in a vacuum. It does not require complete identity for every purpose and in every respect. In determining equivalents, things equal to the same thing may not be equal to each other, and by the same token, things for most purposes different may sometimes be equivalents. Consideration must be given to the purpose for which an ingredient is used in a patent, the qualities it has when combined with the other ingredients, and the function which it is intended to perform. An important factor is whether persons reasonably skilled in the art would have known of the interchangeability of an ingredient not contained in the patent with the one that was.

- The accused device or process must be more than “equivalent overall…”- The court also noted that prosecution history, in this case the fact that the PTO made

Warner-Jenkinson change their app w/ the limitation can be read into the DOE analysis- Certain reasons for a claim amendment ma avoid the application of prosecution history

estoppels is not tantamount to holding that the absence of a reason for an amendment may similarly avoid such an estoppels

o Burden should be on the patent hold to establish the reason for an amendment required during the patent prosecution. The court then would decide whether the reason is sufficient to overcome prosecution history estoppels as a bar to application of the DOE to the element added by that amendment.

- The DOE’s purpose is not limited just to thwarting piracy and unscrupulous copying

o The Court argues for a broader interpretation of the doctrine- And finally, the court dismisses the notion that DOE should be limited to equivalents

that are disclosed within the patent itself.- Then the court talks about the “triple identity test” vs. the “insubstantial difference” test- Notes:

o Infringement is about the comparison between the accused product and the patentee’s claims, not the accused product and the patentee’s product

o DOE uses the “all elements test” that is, when considering all elements in the claim, there must be equivalence

o Warner-Jenkins creates a presumption in favor of prosecution history estoppel for all unexplained amendments, thereby barring DOE

Festo Corp. v. Shoketsu Kzoku Kogoyo Kabushiki Co.- Festo had a patent on some sort of cylinder-piston combo- They had amended their claim b/c the PTO said they had to - Their patent disclosed making the piston out of a magnetizable alloy and that it had to

have a pair of sealing ringso SMC, the Japanese corp. used one sealing ring and made their product out of o They had to amend the filings w/ additional prior art and to fix some other issues

- I: is Festo estopped from bringing a suit under DOE?o I.e. do all sorts of amendments all automatically create prosecution history

estoppel? B/c Warner-Jenkinson was about an amendment that read on the prior

arto In this case, one of the rejections dealt w/ § 125 being multiply dependent and

another due to the claim lacking definiteness- H: no, they’re not, but we need to look at why they had to amend their claims

o Burden’s on the patentee to show that they didn’t surrender the thing in question

o Any claim-narrowng amendment may give rise to PHE, including amendments made in response to § 112 rejections

Courts must take context-specific look at the reason for the amendment and the type of the amendment made in each case

Need to look at what was given up- Issue 2:

o If a claim amendment creates PHE, then what range of equivalents, if any, is available for the claim element so amended?

Some CAFC judges wanted to say that once a claim has been amended, the amended element must be held to its literal meaning. The amended element, or perhaps the entire claim, would have NO equivalents

This would be PHE as a complete, inflexible bar to DOE- Holding2:

o Amendment does not create a complete bar. By narrowing the claim, the inventor is deemed to concede that the

patent does not extend as far as the original claim. “ It does not follow however, that the amended claim becomes so perfect

in its description that no one could devise an equivalent.”- Held3:

o Patentee bears the burden of showing that she did not surrender a particular equivalent (so if you’ve amended, you have the burden to show you didn’t give up that particular equivalent as a matter of PHE)

- Estopping prosecution is applied only when claims have been amended for a limited set of reasons, such as to avoid prior art, otherwise address a specific concern such as obviousness

- Notes:o Any amendment may give rise to estoppels, but the court has to look at it to see

if there’s actual estoppelso One exception is when the equivalent couldn’t have been foreseen. Usually you

get DOE protection even if you’ve amended- Comparing W-J to Festo

o W-J: estoppel arises when the amendment was for a substantial reason related to patentability

o Festo: “.. a narrowing amendment made to satisfy any requirement of the patent art may give rise to PHE”

o Emhasis: reason for DoE is the inexactitude of language – sometimes you can’t write the claim to capture the essence of all the equivalents you did invent

o But PHE is there as part of a public notice functiono Narrowing a claim means surrendering subject matter.o Gives rise to the question: what counts as narrowing

- Narrowing does not relinquish equivalents that…o Were unforeseeable at the time the amendment was written;o Were beyond a fair interpretation of what was surrenderedo Have only a peripheral / tangential relation to the reason for the amendment

( no one is quite sure what will count in this amendment)

- “The patentee must show that at the time of the amendment one skilled in the art could not reasonably be expected to have drafted a claim that would have literally encompassed the alleged equivalent”

o To which POSA is the Ct. referring here?o Inventor or claim drafter or some fictional combination?

- PO says:o If you could’ve claimed something obvious but you didn’t, you’ve probably given

it up to the public- Remember: literal infringement is judged as of the date of the alleged infringement

o But we construe the claim as of the date of invention (usually the filing date)o Note that enablement is judged as of the first effective filing date; thus, the

inventor can enable a claim that covers later-developed technologies- DoE is also judged as of the date of alleged infringement

o However, in understanding whether something canb e an equivalent we look to…

The Prosecution History (claim construction and PHE) Whether a claim covers the accused equivalent could have been written

as of the date of filing (both Festo and Wilson require this, but for different reasons).

Wilson: something cannot be an equivalent as of the date of alleged infringement if a literal claim that covered the equivalent would have read on the PA as of the date of filing!

I.e. you can’t get by DoE something you couldn’t have gotten w/o DoE

The Statutory Exception for Experimental Use and Indirect Infringement

- Overall structure of § 721:o (a) ordinary infringement

without authority makes, uses, offers to sell, or sells any patented invention or imports … infringes the patent.

Strict liability – no intent Note: you don’t have to be engaged in a commercial activity

o (b) inducemento © contributoryo (d) enforcement not misuse or trying

o (e)(1) safe harbor; (e)(2) orange booko (f) supplying componenets in or from the USo (g) importing a product that was made by an infringing process outside of the

U.S.- Infringement Exemption

o Alleged infringer must plead and prove themo Should not be confused w/ experimental use as an alternative to public use in §

102(b) analysiso Common law exception:

Whitemore v. Cutler Exception merely for philosophical experiments, or for the purpose of

ascertaining the sufficiency of the machine to produce its described effects

o Up until the ‘90’s, very few cases on the common law exceptiono Pitcairn v. United States , Roche Prods., Inc. v. Bolar Pharm. Co. (Fed. Cir. 1984)

Pitcairn held that testing helicopters was used for a business purpose, no exception

Roche – D was maker of generic drugs, used patented drug to do experiments to prepare its submissions, so Bolar did some experiments and in order to get a generic, you need a functional equivalent, so you’ve gotta do testing

The FDA’s rules almost required infringement So Bolar argues they should get experimental use exception Contrary to Congress’s intent

o In response, Congress passes hatch-Waxmano Madey v.Duke Univ.

First application of the research exemption doctrine to a non-profit institution

Physicist invents lasers at Stanford, Duke hires him, they had a parting of ways, Duke continued using patented lasers against Prof’s wishes.

CAFC said no go. : cognizable and insubstantial commercial purposes” and Universities are in the business of research

ON remand, ct. looked for “solely for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry”

Under common law, an infringing activity has a definite, cognizable and not insubstantial commercial purpose if it either:

Has the slightest commercial implication;” or

“is in keeping with the illegitimate business of the alleged infringer.”

Doing research with the patented invention probably not exempt.- The statutory exception - § 271(e)(1)

o Shall not be an act of infringement … a patented invention .. solely for sues reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use or sale of drugs or veterinary biological products.

- Immunized tests not only of drugs, but also of medical devices, provided tests are used to generate information for FDA regulatory activities

o Eli Lilly & co. v. Medtronic - Applies to any patented invention and that immunity is conferred to research

generating information for submission under a Federal law some part of which regulates drugs

o Any part of the Food, Drug, and Cosmetics Act even if the particular provision relates to medical devices b/c some provisions of the Act regulate drugs

o Intermedics Inc. v. Ventritex – doing experimentation on patented devices to make their own. And the court says it’s OK, as long as it’s reasonably related to submission to the FDA

Also implicates clinical activities, and marketing and funding activitieso Merck v. Integra

Pre-clinical Activities are covered – they hadn’t done animal studies yet.- Also available in “pre-clinical” tests – to discover a new drug

o However, doesn’t categorically exclude experimentation on drugs that are not ultimately subject to FDA submission or use of patented compounds in experiments that are ultimately not submitted to the FDA

o CAFC says Congress exempted all patented compounds “reasonably related” to FDA submission

- How far back does this exemption go?o Well it depends on whether the researcher has a “reasonable basis” for

believing the compound might work in producing a particular physiological effecto So the more experimental, the less likely the exemption

- 2-face law:o once someone can actually make an application to the FDA, then they can be

sued for infringement and that portion of the research can be held up. Not clear exactly the degree to which this law helped get generics on the market

- Research tools:o No opinion has been rendered

Indirect Infringement or “contributory” infringement- Occurs where the infringer sells a key part of the overall device - Policy justification = free riding!!- Or what if the infringer merely participates with others in a course of conduct that leads

to infringement?- Genesis in the Wallace case

o Wallace made a new burner for a lamp, but also patented wick, reservoir, chimney

o Someone came along and made just the burner,o Contributory infringement found, and the patent rights were still allowed to be

enforced- All this stuff is covered under § 271- (b) whoever actively induces infringement shall be liable as an infringer- ( c) offers to sell or sells w/in the U.S. or imports a component of a patented machine,

manufacture, combination or composition, or a material or apparatus for use in practicing a patented process, constituting a material part of the invention knowing the same to be especially made or especially adapted for use in an infringement of such patent, and not a staple article or commodity of commerce suitable for substantial noninfringing use, shall be liable as a contributory infringer.

- 2 questions courts ask:o (1) what actions can trigger indirect infringement liability o (2) what scienter requirements are imposed by the statute?

Aro Manufacturing Co. v. Convertible Top (Aro II)- The convertible top is patented by Convertible Top Replacement (CTR)

o The Mackie-Duluk patent, one part of which was the fabric for the top- Aro manufactures replacement cloth tops for convertibles

o They were not licensed to make or sell these fabrics used to replace worn out portions of convertible tops

o Aro fabrics were specially tailored for installation in particular makes and models of cars, including Ford convertibles bade btwn ’52 and ‘54

o Note: you can license in different regions o Note that: had the end user not been infringing, then Aro wouldn’t have been

infringing- CTR sues them for patent infringement b/c:

o They licensed the patent to GMC, but not Ford, and Ford knew it was infringing In the GMC case, it was held to be permissible repair

o And apparently Aro knew it was infringing too- Who was the direct infringer?

o Ford during a particular time period and the actual car ownerso Note: no contributory infringement w/o direct infringement

Also note: has to be a knowing sale of a non-staple item specifically adopted for infringing activities

- I: if someone repairs the unlicensed convertible top, is it infringement?- H: yes, it is.- R:

o The statute under §271 says whoever makes, uses or sells is guilty of infringement

- Then they look to see if Aro was a contributory infringer and they hold that Aro iso Looking at § 271(c) the Court says that one who knowingly produces a

component of an unlicensed invention, he is guilty of infringemento However, the court also holds that the contributory infringer must know the

combination for which his component was designed was both patented and infringing

- And they find this as well- Notes:- Repair v. Reconstruction

o When you sell a patented article, you sell the right to repair that article, but not to reconstruct it. This speaks to the intentions of the parties

And by that, we mean inferring the intention of the parties, the default expectations of the parties

Repair = authorized use Reconstruction = re-making the thing

o And the parties can always K around this to say exactly what’s covered- The knowledge requirement of contributory infringement

o There’s a N.C. Cal. Opinion in Sandisk that contributory infringement is (1) knowledge of the activity that is alleged to be infringing and (2) knowledge of the patent

- What knowledge is required for D to infringe under § 271 ( c )o The sale has to be made knowing that the thing has to be designed for infringingo According to this case, you need to know it was both patented AND likely

infringingo CTR had sent a letter to ARO, so they were on notice

Inducing Infringement

Patent Exhaustion

- LGE had a few patents for write forwarding, stale memory, and bus allocation- Intel sold chips to Quanta who turned around and made computers using non-Intel

memory, boards, and sold those- LGE brought an infringement suit alleging that Intel wasn’t licensed to combine these

o Basically, there were 2 separate agreements, a license agreement and a master agreement

- License agreement – permitted Intel to make, use, sell and offer to sell… items covered by the patents

- Generally you license your entire portfolio b/c otherwise it’ll make it obvious what you’re doing

- The license has unusual language saying: these two parties are not granting each other a license that allows 3rd parties to make combinations w/ other 3rd party components to make computers

o In another portion of the license, it says Intel’s allowed to sell products to others- In the master agreement, it required Intel to notify its customers of the lack of license

for 3rd party combinations, which it did- Quanta asserted that it was not an infringer b/c the patents were exhausted when the

components were sold to it w/o restriction- Patented exhaustion doctrine:- If a patented items is sold, without limitation, then the law presumes that all rights to

use and sell have been transferred to the buyer. The patentee’s rights of use and sale are extinguished w/ respect to that item

- I: Does Intel’s limited right under the license agreement mean that it could only transfer a limited right to use under the sale, or does the ordinary patent exhaustion doctrine apply?

- Held: applies to method patents and patent exhaustion occurred here. Intel sold (without limitation?) and the patentees rights in those sold components were exhausted

o If a component made by the method substantially embodies the method then the sale of the component exhausts the patent with respect to that component

-

- Some courts have held that a defendant could be held liable if he “knew or should have known his actions would induce actual infringement”

- No passive inducement:o Courts have held no liability for indirect infringement for failing to take action to

stop a corporate affiliate from engaging in infringing actso TEA infringed in Tegal Corp v. Tokyo EleectronCorp., had an injunction

restraining them, but another subsidiary of the same parent couldn’t be enjoined under the same ruling

- Pre-Patent Inducemento Natioal Presto Indus v. West Bend Co. – Presto tried to hold WB liable for

flooding the market w/ soon-to-be patented products on the theory that customers would continue using the products

o The CAFC established a per se rule against pre-issuance inducemento They said the issuance of a patent is too speculative and that would be a sort of

ex post facto rule- Paper Converting Mach. Co. v. Magna-Graphics Corp.

o Selling parts of a machine and agreeing not to assemble it until after the patent expired was held to be infringement b/c doing sell basically stole a sale from the patent holder

Inducement- Not covered much by us, but § 271(b) – everything else that’s not contributory- § 271(d) – aspects of patent law that had been gotten rid of the courts

o Resurrected the opportunity to sue someone for contributory infringement

Extraterritorial Effects- Brown demonstrates the modern approach of construing patents narrowloy to avoid

extraterritorial effects- Exporting componenets of a patented combination for quick assembly overseas was not

an infringement. Deepsouth Packaging- Congress departed from this tradidiotn in ’84 when it enacted § 271(f) which effectively

makes component exporters liable for an infringement where they (i) sell the components to an invention for foreign assembly and (ii) they would be liable under §§ 21 (b) or ( c) had the assembly taken place in the U.S.

o (f) is the section litigated in MSFT v.AT&T

- Later, Congress passed the Process Patent Amendment of ’88 in § 271(g) which changed the longstanding rule that importation of the product of an infringing process did not constitute infringement

o This rule grants process patent holders the right to exclude from the U.S. market products made overseas by their patented processes

o

Microsoft Corp. v. AT&T – SCOTUS 2007 (Brennan, J.)- MSFT sold master CD’s or electronic masters of their Windows software to other

countries- I: are the master CD’s components under § 271(f) so that mere transmission / sending

of the master constitutes infringement when foreign manufacturers take the master / e-copy and put it on machines that then do infringing speech recognition functions

- I.e. does MSFT’s shipping of the software on a master disk to China constitute exporting a significant component

o Background: part of Windows’ speech recognition software infringedo Interestingly the court got it right that it doesn’t infringe until it’s loaded onto a

computero Or rather, is a copy of software a component under the law?

- MSFT conceded that if sold in the U.S. it would infringe if it were installed on a computero Uninstalled software does not infringeo AT&T’s claim was tied to a machine programmed in a particular fashion

- They look at code in the abstract (notes of a symphony) vs. code for production (the sheet music)

- They say it’s sheet music, so not components- H: software “in the abstract” cannot qualify as an exported component under § 271(f)

The Corollary - § 271(g)- Whoever offers to sell.. a product which is made by a process patented in the U.S. shall

be liable as an infringer .. if the importation…. Product occurs during the term of such process patent…

o A product which is made by a patented process will, for purposes of this title, not be considered to be so made after

(1) it is materially changed by subsequent processes; or (2) it becomes a trivial and nonessential component of another product

- Eli Lilly had a patent for producing “chemical compound 6” which is an intermediate in the production of the antibiotic cefaclor,

o Lilly argues the product of a process patent should not be considered “materially changed” if its principal commercial use undercuts the commercial value of the product patent at issue

o Held: CAFC could not stretch the concept of “materially changed” that far. The statute refers to changes in the product made by the process, not to how or whether the activity impairs the economic value of the claims in suit

- Biotechnology General v. Genentech o People in Israel were making HGH, importing it into the U.S.o Genentech had a process patent on the process of making the piece of DNA that

included the HGH geneo Genentech used that process patent, sued Biotech. General for importing the

protein HGHo They hold for Genentech! B/c the legislative history contains this example as an

example of infringement under § 271(g) Someone in Genentech actually wrote the legislative history b/c he knew

they were going to sue as soon as the legislation passed

Before and After the Patent- Once the patent term expires, the patented tech. enters the public domain- Patent is still enforceable right up until the last day of its term

o See Paper Converting Machine o They had a sale, but said you can’t assemble until after the patent expireso The court said this was inducement (though Pilar says it probably doesn’t meet

the inducement requirements b/c there has to be an actual infringemento It’s about the offer to sell, not the actual sale

- There’s no infringement prior to the existence of a patent, nor is there inducement or contributory

o National Presto Indus v. West Bend o One of the parties raced out and sold a bunch of things that were later covered

under a patento The Ct. said no infringement b/c you don’t know exactly what their claims will

look like or if it will issue- But see 35 USC § 154 (d)(1)(A)(1)

o A person who makes, uses, sells, offers to sell, or imports… covered by a published claim and who had actual knowledge of the published claim, can be liable for reasonable royalties for the pre-issuance activity after the patent issues (IFF it issues)

Remedies – Injunctions- Remedies governed by §§ 283 & 284- § 283 – injunctive relief

o Principles of equity involvedo Such terms as the court deems reasonable

- § 284 – damageso No less than a reasonable royalty for use made of the invention by the infringer,

together with interests and costs as fixed by the courto May treble when there’s willful infringement

Prior to Ebay…- PI would be granted to holder if:

o Claims were valid, patent was enforceable, and the accused was found to infringe

o Remember, injunction is an equitable doctrine, so equitable “defenses” apply Unclean hands, laches

Ebay v. Mercexchange – 2006, SCOTUS- Mercexchange wants a permanent injunction b/c there’s found to be infringement on

one of its business method patents- Fed. Cir said it’s always in the public interest to have the patent system upheld

o B/c we’ll have more new and useful stuff o They weren’t looking at it instance by instance – a very utilitarian reasoning

instead- P seeking Perm. Injunction (PI) must establish a four factor test:

o (1) that is has suffered an irreparable injuryo (2) that remedies available at law, such as monetary damages are inadequate to

compensate for that injuryo (3) that considering the balance of hardships between the plaintiff and D, a

remedy in equity is warranted; and o (4) that the public interest would not be disserved by a permanent injunction

Note that this is a lot different from what the Ct. said in Amazon- I: whether PI’s should be favored over damages (i.e. not using the four factor test) b/c

patents provide an exclusionary right- H: nope. Apply the four factor test- They also don’t look to eager to overturn their long-established jurisprudence- Difference between the two camps:

o Chief justice says like cases should be treated alike

o Kennedy on the other hand, doesn’t want people who aren’t using their patent to be able to get Perm. Injunctions

Z4 Techs v. Microsfot Corp – E.D. Tex. 2006- Z4 moved for a perm. Injunction, and the ct. denied it- They sued Autodesk and Mcirosoft for a patent on product activation- Jury awarded damages to Z4- They look to the 4 Ebay factors - Reasoning: Z4 won’t be affected by Microsoft’s infringement b/c MS doesn’t sell any

activation software on its own- They say that MS can’t deactivate all of its public servers lest the market get flooded w/

pirated software- And The public interest won’t be served b/c consumers would get nailed and the public

might suffer negative effects- Note:

o A showing of irreparable hr must be shown by the plaintiff – no presumption is inferred in the language

o Can’t enjoin the government. Except in states – you can enjoin states And you can’t get damages!

Preliminary Injunctions- Resisting a PI: if the accused raises a substantial question regarding infringement or

validityo This is a lesser standard than clear and convincing

Amazon.com v. Barnesandnoble.com, Fed. Cir. 2001- Amazon moved for a prelim. Injunction to prohibit BN’s use of a feature called its

“express lane”- BN claimed the feature did not infringe and substantial questions exist as to the validity

of Amazon’s patento W.D. Wash. Ct. rejected this and granted the prelim. Injunctiono BN appeals

- I: Prelim. Justified? (and what’s the standard?)- H: no.- R: So, this is the one-click patent- Amazon is entitled to a preliminary injunction if it can succeed in showing:

o (1) a reasonable likelihood of success on the meritso (2) irreparable harm if an injunction is not granted;o (3) a balance of hardships tipping in its favor;

o (4) the injunction’s favorable impact on the public interest If the public interest either favors or will not be harmed by the injunction

- Irreparable harm is presumed when a clear showing of patent validity and infringement has been made

- In order to demonstrate success on the merits:o (1) that P will likely prove that the D infringes on the patento and (2) that the infringement claim will likely withstand D’s challenges to the

validity and enforceability of the patent- In this case, the BN challenged the obviousness of the patent (anticipation)

o The court said it’s too early to tell whether or not BN will prevail on its claim, but this is enough to stop a prelim. Injunction

- There was prior art from Compuserve- “validity challenges during preliminary injunction proceedings can be successful on

evidence that would not suffice to support a judgment of invalidity at trial”- Notes:

o If you’re going after a preliminary injunction under a doctrine of equivalents challenge, the standard is much higher We care v. Ultramark

o Prelim. Injunctions have been available to patentees who don’t actually practice the invention

Sometimes they do, sometimes they don’t.o Also, courts have the ability to tailor preliminary injunctions

Can require the moving paty to post a bond Require the non-moving party to post a bond to avoid an injunction Provide “partial relief”

Rebutting the Presumption of Harm- Rosemount v. U.S. Int’l Trade Comm’n

o Rosemount’s delay in bringing an infringement actiono Grant of two licenseso Lrge market shareo Presence of 12 major non-infringing substitutes o Availablility of damages

All of these factors allowed presumption of harm to be rebutted

Reasonable Royalty Damages35 USZC § 284

- Upon finding for the claimant, the court shall award the claimant damages adequate to compenste for the infringement, but in no event less than a reasonable royalty for the

use made of the invention by the infringer, together with interest and costs as fixed by the court.

- When the damages are not found by a jury, the court shall assess them. In either event the court MAY increase the damages up to three times the amount found or assessed…

- The court may receive expert testimony as an aid to the determination of damages or of what royalty what would be reasonable under the circumstances

- Reaosnable royalties- Given When

o Actual damages (lost profits) are not determinable or …

Panduit Corp v. Stahlin Bros. Fibre Works- Dist. Ct. awarded 2.5% royalty - Panduit sued Stahlin Bros. for infringement on two types of duct- It ordered an injunction, but they disregarded it, so held in contempt and a royalty was

entered- Panduit wants damages for lost profits or a 35% royalty b/c this is how much they would

have madeo Stahlin sold $1.788 M worth of producto They alleged $808k in lost profits for its own sales (Stahlin made)o And $4,069 for sales it did make (had to lower its prices)o Dist. Ct. awarded a permanent injunction plus $44,709

- Panduit seeks lost profits, but cannot produce the necessary proof. What did it lack?- To obtain damages the lost profits on the sales the patentee would have made absent

the infringement:o (1) demand for the patented product, o (2) absence of acceptable noninfringing substituteso (3) his manufacturing and marketing capability to exploit the demando (4) the amount of the profit he would have made.

But Panduit couldn’t establish #4, b/c it can’t show its fixed costs But how is it hard to show fixed costs?

o So the master found that there were acceptable non-infringing substitutes, so there should be a low royalty rate

o But they say it’s not the bargain the parties would have struck; the infringer chose to keep selling his product, so the royalty is much higher

o It would also encourage infringers to do just that – infringe, so they could get a reasonable royalty – that way they don’t get hurt if they get sued, and if they don’t get sued, they still win

- They say that the lower Ct. judge made his findings on the royalty based on the fact that there were noninfringing substitutes

o But there weren’t, the Ct. says, because the noninfringing substitutes were the Defendant’s own products that they switched their customers over to once they couldn’t sell the preferred product

So really, it was just a sort of necessity for the customers – doesn’t prove they would’ve chosen the products beforehand

And that “switching” occurred years after the infringement occurred And they admitted that the patented ducts had unique and

desirable attributes Also the royalty rate gets calculated as of the day the infringement begins

– so you look at the past market, not at if, say a price drop occurred after infringement began

o Note: if you’re in licensing negotiations and you walk away, it looks like willful infringement treble damages

- Reasonable royalty:o “… an amt which a person desiring to manufacture, sell and a patented article

would be willing to pay as a royalty and yet be able to make and sell the patented article… in the market, at a reasonable profit” p. 971

o Must be “reasonable under the circumstances” and always tied back to the statutory notion of “adequate to compensate of the use made of the invention by the infringer” p. 978

o Setting reasonable royalty is not the equivalent of an actual royalty negotiation among the parties

No efficient patent infringement! Note that the reasonable royalty is determined at the time of 1st

infringemento Also the expert witness had no experience crafting royalties after infringement

under § 35 USC 284 (this was the D’s expert witness)- They remand – factors to consider:

o Panduit’s actual profit margin in Mar. 1962o Customary profit allowed licenses in the electrical duct industry

Except that reasonably royalty cases are WAY highero (1) the lack of acceptable noninfringing substitutes (contradicts with #2 and

customary licensing rates)o (2) Policy of not licensing the patento (3) the future business and attendant profit patentee would expect to lose by

licensing a competitor, and

o (4) that the infringed patent gave the entire marketable value to the infringed duct [patent]

I.e. whether the entire market value of product was due to the patented invention

- Notes:o Fromson v. Western Litho – argues that the bargain should be restitutiono Hanson v. Alpine Valley – Percentages of annual cost savings to infriner of having

that snow machine as opposed to another snow machineo Analytical method:

Use infringer’s own profit projection from the infringement Subtract overhead from that to get anticipated net profit Subtract industry standard net

Using this method, the court in TWM Mfg v. Dura assessed a 30% reasonable royalty – p. 982

Lost Profits- To obtain lost profits, the patent hole rust show (Panduit test), or something similar

(Rite Hite):o Demand for a product covered by the relevant claimso Absence of … (see: above)

- Rite Hite: these establish a reasonable inference of but-for causation, but the Panduit test is not the only way to establish but-for causation

o The ultimate thing you must show is that but-for your infringement, this is what I would have made

Rite-Hite v. Kelley Co.- Dist. Ct. determined R-H was entitled to lost profits for lost sales of its devices that were

in direct competition with the infringing devices, but which themselves were not covered by the patent in suit

- I: are such damages legally compensable?- H: yes.- Rite sued Kelley for infringement on it’s patent for a manual device that secured trucks

to a loading dock- And as for damages, Rite-Hite got both damages for its manual lock and its automatic

locko But-for Kelley’s infringement, Rite Hite Would have sold:

80 more MDL’s 3,243 more ADL’s

They give damages for both- The automatic lock wasn’t covered in the infringing patent

o However, there was a patent on the automatic lock hook- Whether profits at issue are legally compensable is an issue of law – de novo- The Ct. says: § 284 requires damages that are “adequate to compensate for

infringement”o Congress sought to ensure full compensation for damageso And when Congress wished to limit an element of recovery in a patent

infringement action, it said so explicitly- They affirm the same “but for” test under Panduit

o (1) demand for patented product;o (2) absence of acceptable non-infringing substitutes;o 3() manufacturing and marketing capability to exploit the demando (4) the amount of the profit it would have madeo AND

“a showing under Panduit permits a court to reasonably infer that the lost profits claimed were in fact caused by the infringing sales, thus establishing a patentee’s prima facie case with respect to “but for’ causation.

The burden then shifts to the infringer to show that the inference is unreasonable for some or all of the lost sales

o The question of legal compensability is one “to be determined on the facts of each case upon mixed considerations of logic, common sense, justice, policy, and precedent

o And they say “Panduit is not the sine qua non for proving “but for causation””o They say the only substitute for the infringing product would’ve been the ADL-

100, the automatic hook Why wasn’t this a non-infringing substitute? Because it would’ve infringed on another patent, the ADL-100 Judge Nies (in the dissent) objected to this b/c it wasn’t litigated yet

o Also, whether a patentee sells its patented invention is not crucial in determining lost profit damages…”

Meaning if you have another product, you could get damageso What limits the damages then ?

Foreseeability- Dissent:

o Argues that the patent rights only extend to what’s claimed, so you’ve effectively broadened the right of exclusivity

o But for shouldn’t encompass any and all damage to the patenteeo And that this doesn’t encourage people to put new products into the market if

they can get damages for their other products – What if you don’t really want to invest in building a new kind of scanner

b/c of all sorts of sunk costs, so you just keep the patento And they never asserted the claims for the other patented invention against

Kelley- Notes:

o In King Instruments, the patentee did not sell any invention that was infringed, but did sell other inventions

They still got lost profits for that other invention Note that: something has to be sold to get lost profits

o The majority in Rite-Hite argues that all that matters is whether the products compete in the same market

o And this sort of protection will gives ex ante incentives to invento The dissent on the other hand argues that it’s improper to extend a property

right over a set of claimed embodiments into a mechanism of market exclusivityo This is b/c it extends the scope of the patento Again, however, the majority argues

(1) it serves the goal of compensating the patentee for foreseeable harm to the patent, and (2) it is strictly limited to ex post compensation, i.e. no injunction is available

o Also the scope of Rite-Hite is limited to when the patentee can prove: That it is selling unclaimed products; That the sale of infringing products has caused a loss in sales of the

patentee’s unclaimed products, and That it was reasonably foreseeable on the part of the infringer that sales

of these infringing products would cause the patentee to lose sales of unclaimed products

o Also the patents on the ADL-100 are important for 2 reasons (1) they provide support for the notion that there are no acceptable

noninfringing substitutes (2) that the patent in suit is only one of many patents owned by Rite Hite,

so Rite Hite is engaging in a long-term project of R&D

Grain Processing Corp v. American Maize-Products Co. (Fed. Cir. 1999)- Dist. Ct. in IN denied Gran Processing corp. lost profits for American Maize-Product’s

infringement

- Dist. Ct. also found that a non-infringing substitute was available- Initially Am-Maize had produced Maltodextrin (called Lo-Dex 10) under three different

processes, all of which were later found to be infringing b/c of the test Am.-Maize used to measure the “D.E.” value of its maltodextrin

- So it took them 2 wks. To develop a new process w/ a new enzyme that didn’t infringe, and once that patent had run a few months later, they reverted to using the original processes, which were more efficient and less costly

o The enzyme was known at the time it started making Maltodextrose, i.e. the 70’s, so it could’ve begun making this process in the 70’s

- Dist. Ct. found that process iv was available and that it was an acceptable substitute, so Grain processing could not prove lost profits

- But to be an acceptable substitute, the product has to have been on the market at the time or available at the time of infringement

- The test:o A fair and accurate reconstruction of the “but for” market must take into

account, where relevant, alternative actions the infringer foreseeably would have undertaken had he not infringed. Without the infringing product, a rational would-be infringer is likely to offer an acceptable non-infringing alternative, if available, to compete with the patent owner rather than leave the market altogether

- They note that the cost of the enzyme was sufficiently low as not to prohibit its use in the market

o Can also get lost profits for your proven market share even when there are non-infringing substitutes in the market (Mor Flo)

- When basing alleged lost profits on lost slaes, the patent owner has an initial burden to show a reasonable probability that it would have made the asserted sales but for the infringement

o The burden then shifts to the patentee to show …- They affirm the ruling- Notes:- Non-infringing substitutes need not be on the market to be considered available

acceptable alternativeso After a patentee has proven Panduit Factor (1) demand, o The infringer can prove that consumers do not demand every claimed feature,

and if they can do this, the infringer may be able to prove its non-infringing substitute is acceptable to consumers

- Effects of Grain Processingo A. lower Damage awards (better defenses)

o B. litigating next-best alternatives – infringers get to show what they would have done

o C. legal strategy –may affect how inventors seek to patent their inventionso D. Preemptive litigation – Waiting to sue may lead to less massive awards, so

seeking to enjoin ASAPo E. Possibly increases the burden on infringers to show that they’re not willfully

infringing- Crystal Semiconductor Corp. v Tritech Microelectronics

o Crystal held patents on computer audio chipso Had tried to make a damages analysis based on Apple computer’s market share

for audio chipso This was held to be an inappropriate benchmark b/c Apple held an oligopoly

whereas the PC audio chip market was far more competitive- Micro Chemical v. Lextron

o Fed. Cir. Found that Lextron had infringed micro Chemical’s patent o After the ruling, Lextron modified its design the next dayo But the Fed. Cir. Held that there wasn’t a readily available alternative b/c the

technology wasn’t known at the time, - Bose v. JBL

o Ct. found that JBL infringed a Bose loudspeaker patent under the Doeo They held that JBL could have offset or negated lost profits by presenting ‘sound

economic proof” that it could have produced acceptable substitutes during the “accounting period.”

o It attempted to design around it by creating a virtually indistinguishable curvature

o And this indicated that no acceptable substitutes existed

- Spot the rule, name the test, cite the case, hit the legal issueo Then 2 more points for creativityo 102(b) = 103 – nonobviousneso 1st name of case, and pg. #o she likes the IRAC style

Topic sentence, rule analysiso If what you have in mind is a note case, it’s helpful if you cite to that and the pg.

#o It’s your opportunity to show what you learned – shotgun method!!

Myriad Genetics- Claims at issue were for - Why is the gene patentable? Isolated and purified- Claim 1: isolated DNA coding for the protein, having protein building block sequence – - Then they claimed particular sequences of DNA that were known to cause mutations- They also had method claims

o There’s a Markoush group – a method for detecting these groups in a human which comprises analyzing the sequence of the gene – that’s the claim

o Reminds you of metabolite – where SCOTUS backed out of the caseo Case where the claim had to do w/ measuring an amount of a chemical in

people’s blood and correlating it w/ vitamin B deficiency- Metabolite didn’t answer the question of patentable subject matter

o Not argued in the CAFC- Similar to Bilski – nothing is being transformed

o So is this valid? That is the undecided question- That’s why ACLU argued 1st amendment – this is a claim that’s stopping people from

thinking about thingso Why did the judge in Myriad – write so much about the policy argument behind

the gene patents? o He was teeing it up for the Supreme Court and you’re supposed to interpret the

statute in light of the Constitutional directive to increase progress in the useful arts

- In the end, what the judge said regarding the isolated purified DNA, and said all the case law that would suggest that something is patentable b/c it’s isolated and purified was decided before we separated the law into § 101 and § 102, and when we created § 102 – we should think of these cases as novelty cases, not patentable subject matter cases

o So he dismissed them by looking at Chakrabartyo And another case where a person didn’t transform bacteria – so here the DNA

doesn’t do anything new and excitingo The judge looked at those kinds of cases and merely isolating something dos not

make it patentable – it’s only patentable if [by isolating and purifying it, it obtains a new property or is otherwise transformed

a Bilski argument, IMO- Unfortunately, this is inconsistent with precedent that Hand, j. laid out in Parke-Davis

o It’s a metaphysical argument about whether there’s new useo So if we need new physical properties, you could make that argument with

respect to DNA Myriad made this argument, and the judge didn’t buy it

Under that analysis, some DNA sequences could be patentableo There’s also a pseudo-gene that hangs around in the human genome that’s like a o Pilar says the isolated purified argument can go either way b/c there are things

you can’t do w/o isolated, purified DNA But on the other hand, it still has exactly the same nucleotide sequence

o If you take judge hand’s focus on the usefulness of the something, then you wouldn’t agree w/ the patent

If you look at SCOTUS, CCPA, CAFC, then these sorts of claims definitely encompass a sequence that is in the body and that actual molecule of DNA is complex w/ other proteins, but still not really materially changed the molecule of DNA itself

And this might bring you back to the progress in the useful arts questiono KSR’s obvious-to-try test

Best place to look is the slides where Pilar lays out = Obvious only when several factors are met As a test, it’s more likely now that obvious to try = Obvious

In re Kubin But maybe not soo much more likely

She doesn’t think the jurisprudence changed that much on obvious to try

Method of trying would have be pretty well known, there would have to be a good likelihood of success

- Utility – beneficial utility = moral utility – not used anymore (I’m missing a type)o Might be used for transgenic human embryos but hasn’t been usedo Operability – cold fusion – incredible under the laws of physics, then you’d have

to bring forward additional evidence that this actually worksoo In the bio world: to patent it, it has to have use

How much use? If you’re thinking of it as a drug, you don’t have to go through clinical trials,

If you show that drug has some effectiveness, that’s enough