CHAPTER 1; OVERVIEW OF SYSTEM Intro;

o Patents create a right to exclude others. Does not create an economic monopoly – bc once an item reaches a certain price there are viable substitutes.

o Beginnings of American System; Article 1, Section 8, Clause 8 1790 – created a patent board to examine patents 1793 – Stopped examinations, only registration. Led to “unrestrained and promiscuous

grants of patent privileges” 1836 – Created the patent claim and the PTO 1870 – More attention to claims and therefore to notice 1952 – Reestablished slowly fading patent rights

o Quid pro quo; Disclosure – Earn patent rights by describing what you have done Exclusion- What one receives in the disclosure exchange with the PTO

Comparison to Trade Secret;o Protecting TS – Only can be done under supplier or consumer datao Protecting under TS or P – but must choose

Chemical formula, “business method”, manufacturing process However, in order to get a P have to choose by a certain time (bars)

o Protecting under P; Product structure, pharma formula Once start selling, will be disclosed and can no longer keep secret, so have to use the

patent process Court System and PTO;

o Before 1982, the CCPA heard appeals from PTO denials and private patent litigation was in the D CTs and Regional CT of App

o Circuit splits were an issue for a national property right

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o Now – Everything is funneled to the US CT of Appeals for the Fed. Circuit D CT appeals and PTO appeals Binding authority for Fed. Circuit

CT of Claims, CCPA, and SCOTUS cases NOT D CT and Regional Ct of App

o Inventor’s choices after Final Rejection from PTO; Appeal to BPAI, File Continuation, CIP, RCE, Abandon If rejected at BPAI;

Can go to District Court (If more helpful to you – for evidence, getting more evidence into the case)

Unusual Will be appealed to Fed. Circuit anyway

o Applications are published 18 months after filing UNLESS applicant represents that he will not seek foreign patent protection

o Not required to do prior art search, only must disclose what you knowCHAPTER 2 – CLAIMING AND DISCLOSING THE INVENTION

Intro; o The role of claims is to give public notice of the subject matter that is protected, and the spec.

is to teach, both what the invention is and how to make and use ito Inventions precede the claims and the claims attempt to capture what the invention actually

is Claim Interpretation

o Generally; Generalist judges are not chosen for their technical skill Judge’s resources;

Intrinsic; Claims, spec, pros history (includes the cited references) Extrinsic; Reference texts (dictionary, tech. material) and expert witnesses

Two Lines of cases;

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Dilemma – Problem on either side Claim can be broader than disclosed example(s)

o Drawn to Extrinsic evidence Claim is always embedded in spec, as context

o Drawn to intrinsic evidence Construction Resources;

Written description and Pros history are both Available at time of invention, Publically available and Tailored to invention

Pre-filing treatises etc. are Avail at time of invention publically avail NOT tailored to invention

Expert witness; Not avail at time of invention or pub. avail Tailored to invention

TELEGENIX (Fed Cir 2002) Says that dictionaries, encyclopedias, and treaties may be the most meaningful

sources of information to aid judges in better understanding both the technology and the terminology used by those skilled in the art…

Under TELEGENIX, in PHILLIPS the patentee wins bc would look under other references to look up baffle, find nothing – then look to spec to determine if the term was limited, it was not

o PHILLIPS (en banc) Reaffirms heavy reliance on intrinsic evidence – when it’s not agreed upon what claim

terms mean Reasons;

Extrinsic evidence is not part of the patent application Extrinsic evidence may not be for the phosita Extrinsic evidence bc of timing can suffer from bias not in intrinsic evidence Immense amount of extrin. Evidence

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What is to be obtained from reading the claims; 112 2nd – Look at the language of the claim to determine what applicant regards

as invention 112 1st – Spec must describe the invention in the claims Intent is best shown in intrinsic evidence

No magic formula for claim construction. Not barred from considering any particular source, as long as the sources are not used to contradict claim meaning that is unambiguous in light of the intrinsic evidence.

This case; “Baffles” can be at right angles, don’t have to be acute or obtuse. Only 3 requirements for baffles and an angle is not one of them. Also, later claims refer to baffles being at specific angles – meaning that in broader claims it is not limited.

o Canons of Claim Construction; 1) Claims should be so construed, if possible, as to sustain their validity. RHINE 2) Where there is an equal choice between broader and narrowing meaning of a claim,

and there is an enabling disclosure that indicates that the application is at least entitled to the narrower meaning – the notice function of the claim is best served by adopting the narrower meaning. ATHLETIC ALTERNATIVES PHILLIPS narrowed to say that must apply all available tools of claim construction first.

o MARTEK v. NUTRINOVA (2009) P says D infringes patent. Issue comes down to whether humans are included in the

patent’s term “animal” CT – Humans are included. Proper construction is provided by a definition in the spec for

animals – including humans. Patentee did not use words or expressions that manifestly exclude coverage of

humans, so it would be improper to override the express definition Since patentee explicitly defined “animal”, extrinsic evidence is irrelevant

Rule; When a patentee explicitly defines a claim term in the spec, that definition controls, UNLESS that definition is inconsistent with the remainder of the spec

Dissent – This is the “unusual situation in which a purported definition of a claim term in the written description is totally negated by the remainder of the text of the patent” Must read the patent as a whole to determine definitions

o ULTIMAX v. CTS (2009) P sued D and issue came down to the construction of “anhydride” – D CT said that P didn’t

have “anhydride” (used dictionary for definition), and the P said that it was used as a modifier (other dictionaries supported the P).

CT – With P. Although the Ct may use a dictionary, the definitions in dictionaries were conflicting with each other and with the patent document. Therefore, must look to the patent document context for the definition.

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Rule; Cts may rely on dictionary definitions when construing claim terms, so long as the dictionary definition does not contradict any definition found in or ascertained by a reading of the patent document (context).

o HAEMONETICS v. BAXTER (2010) Question of what is the “centrifugal unit”. It included tubes and vessel in one spot and

just the vessel in another. One of the uses was in a preamble. If “centrifugal unit” means vessel alone later in claim, “centrifugal component” is superfluous. If it means vessel AND tubes, stated dimensions don’t make real-world sense

CT – The term should be construed the same though out the patent. Patent claims function to delineate the precise scope of the claimed invention AND to give notice to the public of the patentee’s right to exclude That would be undermined if the Ct construed claims so as to render physical

structures and characteristics specifically described in those claims superfluous. Rule; Where claims are susceptible to only one reasonable interpretation and that

interpretation results in a nonsensical construction of the claim as a whole, the claim must be invalidated. Must construe the claim based on the patentee’s version as he drafted it It would be inappropriate to now interpret a claim differently to cure a drafting error

Enablement – 112 1st o Overview;

From the statute – A disclosure “so as to enable a (phosita) to make and use the invention. “ Don’t have to state or have a theory as to why it functions

The written disclosure usually enables a little more than it discloses – bc the person reading it (assumed to be a phosita) brings their own knowledge and skill

Looking to claim and describe what you have enabled – cannot do more. Requirement serves two functions;

Information dissemination and constraining claim scope o O’REILLY v. MORSE (1854)

The claim is basically to anything that works to accomplish the goal. Claim 8; “the use of motive power of electromagnetism, however developed, for making or printing intelligible characters at any distance…”

CT - He claims an exclusive right to use a manner and process which he has not described and indeed had not invented, and therefore could not describe when he obtained the patent. Has not provided enablement

Dissent says that blocking patents on improvements are routine – won’t hurt innovation – BUT it would actually be hard to get a “blocking patent” bc of the breadth of the claim

o INCANDESCENT LAMP CASE (1895) Genus-Species case

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Disclosure – “made use of carbonized paper, and also wood carbon”. Claims vary; No. 3; “carbonized paper”

Most closely rooted in disclosure and least comm. valuable (a bit generic) No. 2 (1); “carbonized fibrous (or textile) material”

Edison – big investigation – 3 bamboos worked and 6000 plus fibrous plant materials failed – this is what alleged infringer used

CT – Claims 1 and 2 are invalid bc of their generalities. One specific species does NOT support the generic claim. Technologically speaking, not a valid generalization bc there is NOT a generic quality in the fibers that adapts them to the purpose. Didn’t enable what was claimed here

Legal Constraint; If the description be so vague and uncertain that no one can tell, except by independent experiments, how to construct the patented device, the patent is void.

Notes; The more species within a genius, the more examples needed Harder to show in unpredictable arts Capon v. Eshhar (Fed Cir 2005); In order to support generic claims in biological

subject matter depends on factors such as; existing knowledge in particular field, the extent and content of prior art, the maturity of the science or technology, predictability of aspect at issue.

If the prior art discloses a species, applicant cannot claim a genus bc that part of the genus is not novel. Reverse is not always true – may sometimes claim a species if the prior art

discloses a genuso Best Mode;

Doesn’t really apply anymore and will be eliminated altogether. Two questions; Does the inventor subjectively have a best mode? And if so, does the

disclosure enable the phosita to practice it? o NATIONAL RECOVERY case (Fed Cir 1999)

Scope of claims must be less than scope of enablement Scope of enablement = What is disclosed in spec + what would be known by PHOSITA

without undue experimentation Two questions from this; What is undue experimentation (Cedarrapids) and How much

to lean on what PHOSITA knows (BMW)?o Undue Experimentation;

IN RE WANDS (Fed Cir 1988) Biochemical case, and these are the type with the largest enablement problem Routine end user experimentation is ok BUT Cannot require large-scale unguided experimentation Some relevant factors;

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Nature of the invention and breadth of the claimso If claims are broad, then will likely have to enable more

Skill of those in the art and state of the prior art Predictability, working examples, and guidance

o How predictable is the art? Amount of experimentation needed

o Must be put in a context – level of guidance CEDARRAPIDS v. NORDBERG (Fed Cir 1997)

Invention is a rock crusher. The method in the claim contained increased throw and gyration speed, but the size and construction of the crusher were not. In the spec, values were given for a 7 foot crusher. D Ct said not enabled – would require undue experimentation to apply the process to other sizes of crushers.

CT – This is not undue experimentation. The phosita, within the application, has been taught the requirements to experiment. CT also relies heavily on the fact that the predictability of the art.

AUTOMOTIVE TECH V. BMW (Fed Cir 2007) Invention is velocity-type side impact crash sensors. A new type of art that is said to

not be very good. Two different types in the patent, (1) Mechanical; plenty of disclosure, and (2) Electronic; Only gives a figure with hardly any detail in the spec. The claim is a means-plus-function claim and so what is covered in the spec covers the scope of the claim. P says covered and phosita’s knowledge fills the gap.

CT – Not enabled. The novel aspect of the invention must be enabled in the patent. This is a requirement for all arts. Genentac is the unpredictable arts case that says this. Newness of the field is a kind of predictability

o If it is a new field, then it is less predictable and = more disclosure required. Here there is an enablement requirement outside the unpredictable arts

Notes; Patentee’s spec must enable a phosita to practice the full scope of the claimed

invention. So when trying the expand on what the claim scope means with regard to infringers or the like, this is a requirement pulling in the other direction – double edged sword.

Enablement is measured at the time of filing. Written Description – 112 1st

o Overview; Possession rule – The patent goes to the person that describes the invention – that is

whom gets to claim it A separate requirement from enablement Claiming what is inside what is enabled BUT outside what is described, is improper

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Traditional problem that occurs w/ WDR is – claims change over time and amendments occur that broaden the claims

WD and Enablement; WD; What the applicant actually invented, proof of which requires specificity that may

be unnecessary for enablement. Primarily concerned with certainty or notice. Enablement; What the spec enables a PHOSITA to make and use – more objective

o GENTRY GALLERY (Fed Cir 1998) Control placement on couch. Filed “control means located upon center console” then

amended and issued as the control can be placed anywhere on the sofa. D says that their control is NOT on the center console. Was the WDR met by amendment?

CT – No. Applicant is entitled to claim what is adequately supported, and can broaden if disclosure supports it. However, here disclosure didn’t support. Claims can be broader than preferred embodiment, but the scope may be limited by a

narrow disclosure. Here the disclosure clearly identified the console as the only possible location.

Notes; WDR comes into play with pharma research – there is a lot of money and many groups trying to solve the same problem. Universities often know the function but not the molecule. R&D often know the molecule but not the function.

o ARIAD (Fed Cir 2010) Hypo and tied to the case; Saying that cancer is an uncontrolled growth and claim a

method for stopping an uncontrolled growth, but haven’t found a way for it to work. In this case, the function that the molecule should meet has been found, but the actual

molecule has not. Defense is that a molecule was not claimed – so don’t have to describe.

CT – Didn’t meet WDR. Regardless of whether the claims recite a compound, A still must describe some way of performing the claimed method. Not hunter’s license – Not a reward for the search, but compensation for its successful conclusion. Possession Test; To meet written description - The disclosure must clearly allow

PHOSITA to recognize that the inventor invented what is claimed Varies depending on the nature and scope of the claims and on the complexity

and predictability of the relevant technology; Factors; The existing knowledge in the particular field, extent and content of prior art,

maturity of science, predictability of the aspect at issue. Applied at the time that it enters the process

Requirement of a written description of the; Invention AND of the manner and process of making and using the invention

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Reasons for WDR: Allows PTO to examine effectively, CTs to understand the invention and construe claims, public to understand and improve upon the invention, provide an additional requirement to merely enablement, ensure that when a patent claims a genus by its function or result, the spec recites sufficient material to accomplish that function.

Notes; Must meet WDR when file application Applicant cant add new matter and retain the original filing date with respect to the

new matter Functional claim language; WDR is useful w/ these type of claims or when the claims

set forth a desired result without any indication of what it seeks to achieve. Definiteness – 112 2nd “particularly pointing out and distinctly claiming”

o Overview; Policy; Public notice of property boundary – can’t give notice if can’t be construed. Exxon Research case;

“a period sufficient to increase substantially”. Infringer said that the term is indefinite CT; Not indefinite if amenable to construction, however difficult the task may be.

Indefinite “only if reasonable efforts at claim construction prove futile,” if “insolubly ambiguous”. Reasonable really means all effort

o DATAMIZE v. PLUMTREE (Fed Cir 2005) Method for creating kiosk user interfaces. “Each element having a plurality of attributes…

aesthetically pleasing look and feel.” In the Pros History; Not discussed in the first app, but brought up and dropped in a continuation. Datamize said it wasn’t necessary.

CT; Indefinite. The phrase is purely subjective and the WD does not provide a standard for measuring the scope of the phrase. D relies on the Orthokenetics case (wheelchair in car) – but there was an objective standard – not here. Claim scope cannot depend solely on the unrestrained, subjective opinion of a

particular individual purportedly practicing the invention A claim term to be definite requires an objective anchor. Neither the claim nor the spec provide an objective test for what the phrase

means. Difficult to fail this part of 112; If the meaning of the claim is discernable, even though

the task may be a formidable and the conclusion may be one over which reasonable persons would disagree, the claim is held to be sufficiently clear to avoid invalidity on indefiniteness grounds.

o STAR SCIENTIFIC v. RJ REYNOLDS (Fed Cir 2008) Method for reducing TSNAs in curing, “an airflow sufficient to substantially prevent an

anaerobic condition around the vicinity of the said plant.” D CT; Said indefinite bc a potential infringer wouldn’t know if infringing until after practice

the process

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Fed Cir; Not indefinite – passes requirement. Definiteness doesn’t require that a potential infringer be bale to determine if they infringe before practicing the process. D Ct is confusing constriction w/ infringement detection.

o Notes; Even if a claim term’s definition can be reduced to words, the claim is still indefinite if a

phosita cannot translate the definition into a meaningfully precise claim scope. HALLIBURTON Also – indefiniteness is proper if the claim possesses multiple possible interpretations.

Means plus Function Claiming – 112 6th;o Overview;

Purely functional language – only says what the invention does, NOT the structure What the statute says; May be expressed as a means or step for performing a specified

function, without the recital of structure, material or act in support thereof, If that is done – talking about what it does, not what it is – then MUST be construed to

cover; The corresponding structure, material, or acts described in the spec – It will only

cover what is disclosed in the spec or “equivalents” HALLIBURTON (1946) was the case that led to 112-6th. How the language is activated;

When there is structure recited, that is what they go with Where no structure is recited, then usually it is a M+F claim – even if the magic words

of “mean for…” are not usedo In re HYATT;

Means for generating output signal – not a combo bc not pulling together different pieces. PTO rejected under 112-2nd

CT; Rejected under 112-1st Enablement. The claim is a single means claim and attempts to use 112-6th claim language. 112-6th doesn’t prohibit anything, BUT it SAVES ONLY combination claims. There is an enablement issue bc a single means claim covers ALL possible means BUT disclosure does NOT enable all possible means (like MORSE).

o BRAUN MEDICAL v. ABBOTT LABS (corresponding structure) Only if the spec or pros history clearly links or associates that structure to the function

recited in the claim Strict in that it must be clear BUT Liberal in that one must look at the pros history AND the

spec What you point to as the corresponding structure is it – can’t change it later

o DOSSEL (when is the link enough)

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“Means for reconstructing the current” (obvious combination claim – many elements). In the WD there are other things there in the disclosure and says “known algorithms can be used” – phosita knows how to do so. There are many other things in the spec that give necessary details; Discloses the Bio-Svart Equation – giving those in the field a way to perform the invention.

Yes, bc the specific facts of this case, the structure underlying the function in the claims are adequate to hold that 112-2nd is met.

.Rule; Failure to describe adequately the necessary structure, material or acts in the WD means that the drafter has failed to comply with 112-2nd. 112-6th does not itself implicate the requirements of 112-1st. 112-1st has its

requirements that are imposed regardless of whether the claims are in M+F form or not.

If one employs M+F language in a claim, one must set out in the spec. an adequate disclosure showing what is meant by that language

o ARISTOCRAT v. INTERNATIONAL GAME TECH (Not good enough) Electronic slot machine. “Game control means for” 3 functions – controlling images,

paying prizes for matches, defining pay line. Supporting disclosure – “Phosita can perform this on a microprocessor by appropriate programming” and also there were tables and figures of examples of output.

CT; Rejected under 112-2nd. Patent does not disclose the required algorithm, and a PHOSITA would not recognize the patent as disclosing any algorithm at all. Claim lacked sufficient disclosure of the structure under 112-6th, so therefore, indefinite under 112-2nd.

To meet 112-6th; The scope of the claim limitation had to be defined by the structure disclosed in the spec. plus any equivalents of that structure. In the absence of a structure disclosed in the spec to perform those functions – the claim limitation would lack specificity – rendering the claim invalid for indefiniteness The proper inquiry; Look at the disclosure of the patent and determine if a PHOSITA

would have understood the disclosure to encompass software (to perform the function) AND been able to implement the program. NOT WHETHER: a PHOSITA would have been able to write the software program

Notes; Compared to DOSSEL - Dossel said rely on known algorithms. Dossel had enough and

much more than what P hadCHAPTER 3 – ELIGIBLE SUBJECT MATTER (101)

Intro;o Two Different Requirements/Aspects of 101; Statutory subject matter and Utilityo Statutory subject matter

Usually not an impediment to patents, but still has quite a bit of litigation Computer implemented processes

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Biological inventions – isolated and purified DNA and micro-organisms Statute is broad and phrased positively

o Utility; Based in the IP clause – Congress has left the determination of “useful” up to the CTs. CTs have said; Operability component AND a substantiality component

Operability – Does the invention work as claimed and described in the patent? Substantial Utility – Looks at the degree of usefulness and determines the claimed

invention has enough utility given the policies of patent law Subject Matter –

o DIAMOND V. CHAKRABARTY – SCOTUS (1980) C had claims of 3 different types; Process to make bacterium (to eat oil), Claims for an

inoculum, and FOR THE BACTERIA THEMSELVES 0- this is the issue. CT; Patentable, the patentee has produced a new bacterium with different characteristics

from any found in nature and one having the potential for significant utility. Bacterium is a manufacture. Further, Congress made the statute broad for policy reasons; Want to protect pioneers in new areas and not have Congress make the decision on each new idea.

Rule; 1) Is it in one of the 4 boxes under 101 (machine, composition of matter, manufacture, method) – if yes (if no, then not patentable?) then (2) Is it one of the exclusions? (Law of nature, natural phenomena, abstract idea) – if not, then patentable.

CT held that a living, genetically altered microorganism constituted patentable subject matter.

o BILSKI – Background before case;

When computer processes are rejected, it is bc they are too abstract; Patenting abstract ideas is bad bc;

o Underuse because of over ownership and o Spectrum of abstractness;

In practicality abstract ideas themselves can be separate, but as the ideas become more concrete, they overlap. So transaction costs in the real world are too high and harms

invention No specific test to use – hard to tell.

Computer Implemented Process Claims – to the Supreme Ct Gottschalk v. Benson

o Converting binary-code decimal to pure binaryo Determined not patentable, bc too abstract

Parker v. Flooko Updating an alarm limit (catalytic conversion) – math with variables.

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o Invalid – too abstract Diamond v. Diehr

o Curing rubber in a time/temp control moldo Not invalid – allowed

The case; A method for managing and hedging risks – a claimed process CT; All agreed that claim fails 101 bc it is an abstract idea.

Also Machine or Transformation Test is NOT exclusive test But it is a “useful and important clue”, “useful” in most cases, “a critical clue”

Fed Cir’s “useful, concrete, and tangible result” test should not be used – State Street Majority; Hedging..is an unpatentable abstract idea, just like the algorithms at issue in

Benson and Flook. Notes;

Machine or Transformation Test; Protection if (1) it is tied to a particular machine or apparatus OR (2) it transforms a particular article into a different state or thing. The claimed M or T must impose meaningful limits on the claim’s scope to satisfy

101 AND The specific M or T must not merely be insignificant extra-solution activity

Come back to finisho RCT v. MICROSOFT – Post Bilski

Halftoning digital images – “A method of Halftoning of gray scale images… in which the blue noise mask is comprised of random nondeterministic, non-white noise single value function.”

Fed Cir; Patentable subject matter. Looked at the 4 categories and determined it was a “process”. Looked at the exclusions and determined it is NOT an abstract idea - A functional and palpable computer process. Guides for this “coarse eligibility filter” – Lets a lot through

Fatal abstractness “should exhibit itself so manifestly as to override the broad statutory categories… and primary… attention on the patentability criteria of the rest of the” statute. o Statute is really broad AND it has a lot of other ways to screen out claims that

shouldn’t be patentable for policy reasons. “specific applications or improvements to technologies in the marketplace are

NOT likely to be fatally abstract”o Basically, if the invention improves upon what is already out there in the

marketplace, then it should be equally patentableo CYBERSOURCE v. RETAIL DECISIONS (2011)

Two claims at issue. Claim 3 – method to verify the validity of a credit card transaction – Doesn’t say where to get information and very broadly framed. Claim 2 – A Beauregard claim, a computer readable medium that contains a process.

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CT; Not patentable subject matter. Analysis claim 3; It is a process, but it fails in the abstract category, also fails the

Machine or transformation tests (Not dispositive bc of Bilski) “Abstract ideas” subcategory – “mental process”

o “methods which can be performed mentally, or which are the equivalent of human mental work” (BENSON and COMISKEY)

o Saying for patent law purposes, the human mind is NOT a machine Theoretical basis for rejection; Would force the transaction costs to

skyrocket Claim 2; Claim recites a product, but it is really a process

CT points to “the underlying invention” and that is the process in claim 3o Claims are an effort to capture that invention, but there is an underlying

invention. “Incidental use of a computer to perform the mental process… does not impose a

sufficiently meaningful limit” “Don’t put form over substance” – Abele (1982)

o Compare Phillips (there is an invention that is trying to be captured) Utility;

o In re SWARTZ Shows procedure;

Initial burden on PTO to show reasonable doubt Shifts to Applicant to submit evidence of utility

Swartz – cold fusion. PTO’s reference shows it is not reproducible. S lacked rebuttal evidence.

Fed Cir; No utility – It is a question of fact, and since S didn’t show any evidence, no utility. Note;

Why try to patent a useless invention, what would be the harm? Deterring others from finding the use of the invention bc they won’t reap the

entire reward Also, might end up fooling people by saying that you have a patent for something

and others being scared of experimenting into that areao BRENNER v. MANSON – SCOTUS – substantial utility; applied in chem. and biotech area.

Molecule is old, but the dispute is over who invented the use, or really the method to produce.

CT Finding; Manson argues that the process makes a product with a known use.

CT: Not overturning on facts here. M says – “Process makes a product of verified interest” – significant scientific interest,

structurally similar to another anti-tumor medicine.

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CT; Rejects this argument. “A patent isn’t a hunting license.” The bargain requires a “substantial and specific use”o Seems that he fails to meet the substantial requirement – but it is specific,

“an anti-tumor medication” Policy;

o If give a patent, then will affect other’s view on finding the use – will decrease incentive for others to find use bc of “blocking patents”

Transactional-Cost Consequences; Most permissive approach; Patent on new compound without known use.

Another - Later patent on a method for using the compoundo Blocked by earlier patent (which controls all uses). Earlier patent is blocked

from using the product in this way. All that has been accomplished is that if anyone else comes along later, there

must be a license agreement Approach taken by CT here

Patent on a new compound after use is found; In same patent, claim for method of using. Don’t need a license agreement here

to practice. Fewer transaction costs Notes;

Must know the invention is useful at the time of invention in order to get that invention date.

CT adopts the standard of: A process making a product with a known use being sufficient to show utility – however, here that CANNOT be shown

o In re FISHER; Claim 5 different maize ESTs – extracting RNA and DNA codes from cells. Fisher knows

the express sequence tags and what can be accomplished with them, but does NOT know the full structure/function of the gene that the sequence tags or a function/structure of the protein. Fisher states 7 uses including – identifying polymorphisms or isolating promoters

maize ESTs – extracting RNA and DNA codes from cells PTO says NOT substantial nor specific

FED CIR; Brenner sets the standard – Use must be substantial and specific – Substantial ; Invention has a significant and presently available benefit to the public. Specific ; Invention can be used to provide a well-defined and particular benefit to the

public DON’T MEET EITHER REQUIREMENT;

The underlying genes have no known functions. Any EST has the potential to perform any one of the alleged uses

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In response to EST like a microscope - Microscope has a specific benefit of optically magnifying an object. ESTs aren’t like that – don’t let you see the overall structures or the function of the underlying gene

Note; All patent applications must show specific and substantial utility, it is just that it is mostly discussed in the biotech and chem areas bc that is where inventions run into the most trouble.

CHAPTER 4 – Novelty and Priority Intro;

o This requirement is in (a), (e) and (g)(2)o The issue is NOT which party is entitled to a patent; rather, it is whether someone other than

the inventor knew, disclosed, or invented the claimed invention before the inventor himself invented – thereby defeating novelty

o (g)(1) is the priority provision – invoked when 2 or more parties are claiming the same invention Here each party is asserting that they invented first

ATLAS;o Claim 1; “A blasting composition… in which sufficient aeration is entrapped to enhance

sensitivity…”. Claimed range – prior art ranges and species. B and E show species in claimed range What does “sufficient aeration” cover? Interstitial and porous air. Also, there is not a

quantitative standard for the term. o CT; Prior art anticipates. Inherently in B and E, there is sufficient aeration. Basically – if a

composition is made within these ranges, there must be sufficient aeration in there. Not adequate to show that if used a prior art reference – must show that the prior art

NECESSARILY AND ENEVITIBILITY has that characteristico Rules;

Recitation of a genus reads on a species – The other way is not true To find anticipation the prior art must show each and every claim limitation of the claimed

invention in a single reference, either expressly or inherently. If granting a patent on the disputed claim would allow the patentee to exclude the

public from practicing the prior art, then that claim is anticipated – regardless of whether it also covers subject matter not in the prior art

Claim limitation is inherent if; The prior art necessarily functions in accordance with, or includes, the claimed limitations – it anticipates Not coterminous with phosita – phosita may not even recognize the inherent

characteristics or functioning or the prior art Reason for the inherency doctrine; The public is already getting the benefit of the

claimed element or invention

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Anticipation requires the reference to reveal how the claim limitations are arranged – NetMoneyIn. Case - Must show how the limitations are arranged or combined in the same way as in the claim

GAYLER; Known or used by otherso Arguably 10 years before Fitz invention, Conner built the same safe – but assuming this is

true. Conner forgot about the safe – didn’t remember, the safe passed into oblivion. Fitz. Invention “reminded” him of his invention.

o CT; Not known or used by others. Says that this use by Conner was like foreign use, or lost art. “knowledge of the improvement was as completely lost as if it had never been discovered” - Someone that does something and forgets all about it, then it is as if they never did it.

If Conner knew all along, claim would be invalid ROSAIR; 1955 and 5th Circuit case, but consistent w/ Fed position

o R and H – oil prospecting method (Invented in 1936, filed appl’n in 1939). D finds that T and others, for Gulf Oil, knew and were using this same process. R & H admitted that the same method was used and admitted that T used before R and H. Know this bc D brought it forward/found that info. R&H say that it was not public enough in order to bar their patent application – they could not have found this info, they say.

o CT; Was the claimed process “used by others”? Yes. “The work was performed in the field without any deliberate attempt at concealment or effort to exclude the public and without any instructions of secrecy to the employees” involved. R&H say; (1) T’s work was never published; BUT that would make the statute superfluous.

(2) No proof that the public actually knew about it; BUT they COULD have known. o Notes

Publicity requirement of 102(a) must be understood as the absence of secrecy or absence of active steps to maintain secrecy.

Prior knowledge alone can defeat novelty MILBURN v. DAVIS-BOURNONILLE CO. – 102(e) - 1926

o C described what W claimed, but C did not claim it (if they both tried to claim the same thing – interference proceeding). C got to PTO before W, but patent didn’t issue until after W filed. We only have W’s filing date, no evidence to push the date back. 102(a) can’t apply here

o CT; W isn’t worthy of patent rights bc of the circumstances here. If W had showed up at PTO later or if C got his patent earlier, then no rights. We know that C did something to put the patent into public disclosure. The effect of what has been done is that C had done all that he could do to make his description public

o Notes; Under 102(e) - don’t get patent if;

(1) Described in an application for patent, published under 122(b), by another filed in the US before the invention by the applicant for patent

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THIS LOOKS AT INVENTION DATE – assumed to be the filing date, but can be sworn back.

(2) Described in a patent granted on a app for patent by another filed in the US before the invention by the applicant for patent - Must ISSUE as a patent – applies to both PROVISIONAL and non-provisional applications Also – under certain conditions, international applications can serve as prior art;

Conditions are; (1) Applicant must designate the US as a country in which it seeks protection, (2) The application must eventually be translated into English. – if met, then the effective prior art date is the international filing dateo PCT application can serve as prior art even though the applicant never files in

the US. Criticism of the statute; Language means that after the applicant files, it could be a period

of months until the prior art application falls under 102(e) – this would be a retroactive status. BUT response comes from holding in previous case.

THOMSON v. QUIXOTE CORP. – 102(g)(2) o T makes players, Q makes CDs. T sues Q and the invention date was determined to be

8/25/72. Critical prior art evidence is from MCA, a non-party (Laser videodisc project from before 08/1972 and MCA never sought a patent). T argues that MCA workers’ testimony is uncorroborated”

o CT; Clear and convincing standard is adequate protection. No corroboration is required for nonparty priority. Corroboration Rule is only required when the testifying inventor is asserting a claim of

derivation (102(f)) or priority AND is a named party, an employee of or assignor to a named party, or otherwise stands to directly and substantially gain.

Notes;o 102(g)(2); A patent will not issue if the claimed invention was already invented in the US.

Inventive activity must meet two conditions before it can be prior art; 1) Activity must occur in the US AND 2) It must be continuously used (NOT suppressed, abandoned or concealed)

This is a difference between (a) and (g)(2) Also, (g)(2) does NOT have the publicity requirement that (a) does

o When an application is made for a patent claiming the same subject matter as another application or issued patent - (g)(1) applies

o (g)(2) provides a novelty based statutory foundation for “secret” prior art A patent will not issue if the claimed invention “was made in this country by another

inventor who had not abandoned suppressed, or concealed it before the patent app’s date of invention

Contemplates a scenario where the first inventor decided not to patento (a) and g2;

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a does not require continued use like g a can be outside the US, but g must be in.

o At what point does secrecy become concealment? GILLMAN v. STERN; Puffing machine. No one was allowed to enter the building to see the

machine…o CT said; That prior use can not be used to defeat patent rights. Just as a secret use is not a

public use, so a secret inventor is not a first inventor. Non-informing public uses, unlike secret uses, can serve as prior art

o DUNLOP HOLDINGS v. RAM; Golf ball case synthetic material. W was secret in his formula, but he sold thousands of golf balls. CT; This was a non-informing public use bc the public was given access to the golf balls.

Unlike previous case bc ,there, only getting the output. Here W marketed his golf balls and promptly and effectively as possible. He placed the balls into the marketplace

o FRICTION DIVISION v. DUPONT; Invention was the use of Kelvar pulp in friction products. CT; To avoid a finding of abandonment, suppress or concealment; The prior inventor must

take affirmative steps to make the invention publicly known - this requires only that the public benefit or use the prior invention. Here; DuPont was actively disclosing its knowledge on the use and promoting the

product. Key difference between non-informing public use and secret use is; Whether the prior

user commercialized the invention. o Prior User Rights;

Idea; Prior user will be permitted to continue using his invention, but his activity cannot be used as prior art against a later inventor who decided to obtain patent rights.

Prior user would not be an infringer but can be locked into current commercial use Many European countries use this Would these rights make prior user less inclined to seek patent protection? Probably. US FORM; Only for business methods, Right can’t be licensed, or assigned or transferred

to another, A first inventor defense does not lead to the invalidation of a patent in suit. 119(a); Statute - An application for patent for an invention filed in this country by any person who

has…filed an application for a patent for the same invention in a foreign country…o Which affords similar privileges in the case of applications filed in the US or to citizens in the

US, or in a WTO member country (Reciprocity clause – only allow here when we are allowed there)

o shall have the same effect as the same application would have if filed in this country on the date on which the application for patent for the same invention was first filed in such foreign country

o if the application in this country is filed within 12 months from the earliest date on which such foreign application was filed

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What does “have the same effect” mean?o Well, here that would be that it can be prior arto Looking at 102(e);

In 102(e) it says that it has to be filed in the US In 119 – having the same effect would mean that it could do what is said in 102

o What if the “other’s” US filing relies on a foreign application to establish it’s own priority date? IN RE HILMER;

o Background Hilmer filed in US on 7/25/58. For proof, Hilmer relies on his German filing date as his

invention – 7/31/1957 (119(a)) Hab. Issued on 11/26/60. Filed in the US on 1/23/1958 102(e) PTO then says – if Hilmer can rely on earlier date, then Hab can too and has a Switzerland

filing date of 1/24/57. *(Can rely on this date for himself (unquestioned))*

But can Hab. Rely on 119(a) to defeat another?o CT; NO. 119(a) has a different purpose “priority right is to save the applicant… from patent-

defeating provisions,” NOT to defeat others 102(e) has textual limit; “filed in the US”

REALLY MEANS “FILED IN THE US” HILMER II; CCPA (1970)

o Background; PTO rejected again, relying on 102(g) + 119 Hab’s claim shows he invented it earlier 119 gives us the date of its invention in the US

o CT; 119 links back to a Switzerland date, not a US date. 102(g) says invention “made in this country” – same effect as 102(e)’s “filed in the US” Foreign activity (not publication) to defeat a patent? It has to be done through an

interference or nothing Foreign-based inventive activity can ONLY be used in the context of a priority dispute

(interference) when two or more parties are vying for the patent. CONGRESS RESPONSE TO HILMER;

o 102(e)(2); Post-Hilmer is expanded to cover international applications but with specific criteria to meet - Designate the US and published in English

Provisional Applications; Created in 1995o 111(b)(2); A claim, as required by the second through fifth paragraphs of section 112, shall

not be required in a provisional application Don’t have to have claims, but should.

o 119(e)(1); If under 111(a) (a non-provisional) and meets 1st paragraph of 112, then get the 111(b) filing date as priority if 111(a) is filed within 12 months from 111(b)

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IN RE GIACOMINI (Fed Cir 2010)o Tran issued on 5/2/06 (as prior art); Tran filed nonprovisonal app in US on 12/29/2000o G filed in US on 11/29/2000o PTO says Tran filed provisional app. In US on 9/25/2000 (119(e)(1), 102(e))

Here it is a provisional application filed in the US, not a foreign filing, so can get the priority date in Tran.

o FED CIRCUIT; Agrees with PTO, allows non-provisional application (since filed in the US) to have the priority date of the provisional application. A provisional application shows that someone else was the first to invent Distinction from HILMER I; When looking at the language of 102(e) “filed in the US”

“Hilmer involved an earlier foreign application” Here, an earlier filed provisional app is filed in the US

Printed Publications;o Comparison of Cases – Printed publication

In re Hall (1986) – yes Indexed dissertation in public stacks at Freiburg U Indexed based on topic – searchable by subject matter

In re Cronyn (Fed. Cir. 1989) – No Student theses, name-indexed card in a box at Reed “student theses were not accessible to the public bc they had not been either

cataloged or indexed in a meaningful way” Key criteria is “accessible to the public”;

Non subject matter indexing is not meaningful Although, when can search text, it would be meaningful

Does public accessibility require indexing? No. If material directed to people in the field, then can still be printed publication

IN re KLOPFENSTEIN (Fed. Cir. 2004) o Background;

Method for making double-extruded soy fiber; Filed 10/30/2000 – Critical date = 10/30/1999

Liu et al. poster presentation Oct. 98 – 2.5 days, Am Assoc Cereal Chemist; Over two years before filing; In front of

people in the art Nov. 98 – 1 day, KSU Ag Exp Station; No printed copies distributed, or catalogued or

indexed o CT; Printed publications?

Yes. The Ct says printed publication; Available for a long time, to a group of expertise, there was no norm about not copying, and info could have been copied easily bc there wasn’t much info there.

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Public accessibility has been the criterion - Indexing isn’t the only way for “public accessibility”

Factors to consider to determine whether the interested public can access, process, and retain the information – *(don’t know what the CT would do if one of the factors came out the other way) Duration of display; Public’s chance to capture, process, retain info Expertise of target audience; How easily those who see it can retain info Expectation that viewers would not copy info; Norms, protective measures

(absent here)o * Don’t know what CT would do if there was a norm of not copying, but all

others were the other way Ease with which info could have been copied; Likelihood that public can capture

key infoo Note about what a CT says;

CT said “An entirely oral presentation at scientific conference that doesn’t have slides nor copies (paper) of the presentation is not a printed publication. A presentation that includes a transient display of slides is likewise not necessarily a printed publication (slides go by so fast)

However, must take into account technological advances - Technology updates and changes MATTERS - Nearly all phones can take pictures Don’t forget about podcasts - Often these are put online and can be searched by topic

Proving date of invention; Can be disputed in A, E or Go Invention Process; Has two parts;

Conception – Forming a definite idea of the complete invention This is why research notebooks exist

Reduction to practice – physically manifesting it Actual – Making a physical embodiment that works for its intended purpose (may

need testing depending on difficulty of technology) Constructive – Filing a 112 compliant application

Meaning don’t have to have made an embodiment to get patent rights to it. o Priority Rule; Presumptive winner is party who reduced to practice first

Overcoming the presumption; Earlier conception AND reasonable diligence, from just before that other person’s conception until one’s own

RTP Diligence connects conception to RTP – makes 2 events 1 event Diligence is not required when RTP first

AND NOT abandon, suppress or conceal MAHURKAR V. BARD (Fed Cir 1996)

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o Background; D cited an article in a magazine that would be prior art under 102(a) if Dr. cannot show

that he was the first “inventor”. Dr. offered evidence to show two ways he was first inventor; Only one required – 1) Dr. conceived and actual RTP before publication of catalog, 2) Dr. conceived prior to date of publication of catalog and then preceded w/ reasonable diligence from a date just prior to publication of catalog to his filing date.

What Dr. showed; Dr. ran tests on different things after conception. Dr. provided corroboration for his testimony through oral testimony and through writings

o CT; Dr. met burden of persuasion. Dr. showed reasonable diligence between conception and reduction to practice bc – continuously searched for companies capable of extruding his tubing w/ the soft, flexible materials necessary for human use.

o Rules; When challenging the validity of a patent, then have the burden of persuasion by clear

and convincing evidence Section 102(a); Refers to the invention date- Only prior art when published before the

invention date Burdens in this scenario – invalidity proceedings;

Challenger must offer into evidence something that would invalidate Patentee then has the burden to offer evidence to rebut Then there is a question of burden of production – who met theirs? Again challenger

still has to show my clear and convincing evidence Who INVENTED???

Priority of an invention goes to the first party to reduce to practice (RTP) UNLESS the other party can show that it was the first to conceive AND that it exercised reasonable diligence in later RTP

Conception of Invention ; Inventor must have formed in his or her mind a definite and permanent idea of the complete operative invention, as it is hereafter to be applied in practice. BURROUGHS WELLCOME CO.; Idea must be so clearly defined in the inventor’s

mind that only ordinary skill would be necessary to RTP, without extensive research or experimentation.

Requires more than unrecognized accidental creation Corroboration;

Corroboration is required when a party seeks to show conception through ORAL testimony; In assessing the corroboration, the CTs apply a rule of reason analysis

Corroboration is NOT required when a party seeks to prove conception through the use of physical exhibits

Reduction to Practice; Invention must demonstrate that the invention is suitable for its intended purpose

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Whether actual testing is required to prove the invention works for its intended purpose depends on the character and complexity of the invention and the problem it addresses. o More testing required if there is more uncertainty - Less complicated

inventions and problems do not demand stringent testing; SCOTT v. FINNEYo Don’t have to duplicate all the conditions of actual useo Lab tests may be sufficient of the simulate the actual working conditionso Neither perfection NOR commercial viability is required to show actual RTP

When a party is FIRST to conceive and SECOND to RTP, then MUST demonstrate reasonable diligence toward RTP from a date just prior to the other party’s conception to its own RTP

Can either be constructive OR actualo Constructive – the date the app. Is filed o Actual – Requires proof that

1) He constructed an embodiment or performed a process that met all the limitations AND

2) he determined that the invention would work for its intended purpose o Notes;

Any inventive activity in any NAFTA or WTO country can be used to show a date of invention

A difference between using foreign-based inventive activity to obtain patent rights in the context of an interference proceeding – 102(g)(1) and using foreign based inventive activity to defeat patent rights – prohibited under 102(g)(2)

Diligence and abandonment; Come into play when determining priority of invention GRIFFITH v. KANAMURA

o Background; K relies on his US filing date (11/17/82) bc at this time, could only rely on US filing date

and couldn’t show conception or RTP outside the US - Now, under 104 can rely on what occurs in WIPO and NAFTA countries for certain parts of 102

Here, G conception 6/81 and RTP 1/84 So was there diligence from the time of K’s filing (11/82) to G’s RTP (1/84)? Period of inactivity; June 15, 1983 to Sept. 13, 1983 Gs reasons for inactivity; “Waiting for Jenkins” – a grad student and Waiting for outside

moneyo CT SAYS: These reasons are not adequate. Diligence has not been met. If you really want the

benefit, then must use resources to achieve in a vigorous and rigorous way. Jenkins not shown to be uniquely qualified Cornell chose not to use their own money, and therefore took the risk

o Rules;

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In order to get the earlier conception date, then burdened with establishing with a prima facie case of reasonable diligence from immediately before the competitor’s filing date (or priority date) until their own RTP date.

When looking at diligence; Pretty much care about every workday In looking at excuses for inactivity, CTs may consider the reasonable everyday problems

and limitations encountered by an inventor. Delays in RTP caused by an inventor’s efforts to refine an invention to the most

marketable and profitable form have not been accepted as sufficient excuses for inactivity FUJIKAWA V. WATTANASIN (Fed. Cir. 1996)

o Background; F, senior party (earlier filer); Relies on US filing – 8/20/1987 (different now bc of 104 –

could rely on earlier activity in foreign country) W, junior party; Did he conceive first? Was he diligent from just before 8/20/1987 until

some RTP? If relying on actual RTP, then abandon, suppress, or conceal after actual RTP? Timeline; Conception obviously happens in 84/85. Diligence is going on from Jan ’87-Dec

’87 (F cRTP in Aug ’87). Actual RTP in Dec ’87. W’s company said to file patent app in Jan ’88. Actually filed in Mar ’89.

o CT; Did W abandon, suppress or conceal between Dec ’87 and Mar ’89? W is allowed to rely on Jan ’87 date (earliest date of renewed activity) for priority – defeats

F here. Given a total delay of 15 months, an unexplained delay of 3 months, the complexity

of the subject matter at issue, and overall sense from the record, this case does NOT warrant an inference of suppression or concealment.

o Rules; Typically 3 years between RTP and filing, CTs have said that is too much of a delay and

therefore abandon, suppress and conceal Burden of proof from abandon, suppress or conceal is on the party alleging it Intentional Suppression; Where the inventor designedly and with the view of applying it

indefinitely and exclusively for his own profit, withholds his invention from the public Requires more than the passage of time. Requires evidence that the inventor

intentionally delayed filing in order to prolong the period during which the invention is maintained in secret

Inference of suppression; Based upon delay – but time alone is typically not enough to infer abandonment

(unless excessive). Time that elapses is NOT the controlling factor, but the total conduct of the inventor.

So, the circumstances surrounding the first inventor’s delay and the reasonableness of that delay are important factors which must be considered in deciding questions of suppression or concealment.

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Spurring – Saying that the party would not have filed at all, but did file bc another party did file. Therefore, they would not have filed an app at all, but for the other party filing

o Note; THE COURT VIEWS THE PERIODS OF DILIGENCE AND ABANDONMENT VERY DIFFERENTLY

Diligence is viewed strictly and abandonment is not really (very hard to show) Both of these cases looking at a 3 month period and different results bc that time period is

pertaining to diligence in the first case and abandonment in the second. 102(b) – On Sale Bar

o Barred from obtaining patent rights if inventor or a 3rd party sold or offered for sale the claimed invention more than 1 year before the patent application is filed.

o PFAFF v. WELLS ELEC. (S. Ct. 1998) Computer chip socket; Filed 4/19/82 and critical date is 4/19/81 Pfaff’s transaction with Texas Instruments

11/1980 – TI asks Pfaff to make a device; 4/8/81 – TI writes confirmation of earlier oral order, 30K sockets for $91K; Critical date passes; Pfaff sends TI sockets in 7/81

Contract fabricator followed Pfaff’s detailed drawings Document that enabled P’s socket; Feb/March 1981 – BEFORE TI’s purchase order Actual reduction to practice of P’s socket; Summer 1981- AFTER TI’s purchase order

Pfaff wins if to be “on-sale” must actually be reduced to practice P would lose if; to be on sale, enough that an enabling doc shows invention.

SCOTUS; P loses, when he accepted the purchase order on 4/8/81 he was ready for patenting – therefore the bar applies Invention on sale if two conditions are satisfied before the critical date;

1) Product must be the subject of a commercial offer for sale AND 2) Ready for patenting - two ways to show;

o a) Actual reduction to practice ORo b) Drawings/descriptions specific enough to enable

o SPACE SYSTEMS V. LOCKHEED – Enabling document question Background;

Method for maintaining satellite position/orientation; Ford (SLL) files 4/21/1983; critical date 4/21/1982

Ford Aerospace (SLL) subcontracts under SNIA (French); Ford sends to SNIA an Engineering Change Proposal on 3/19/1982

Obviously commercial offer, so was the method ready for patenting? Showed complete conception However, the actual inventor “did not know whether he could make it work”

CT; To be “ready for patenting” the inventor must be able to prepare a patent app., that is, to provide an enabling disclosure as required by 112.

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Here, nothing like the Pfaff drawing; A bare conception that has not been enabled is not a completed invention ready for patenting The fact that a concept is eventually shown to be workable does NOT

retrospectively convert the concept into one that was “ready for patenting” at the time of conception

Rules; To be ready for patenting, the inventor must be able to prepare a patent application,

that is, to provide an enabling disclosure under 112. For a complex concept, like here, wherein the inventor himself was uncertain

whether it could be made to work, a bare conception that has not been enabled is not a completed invention ready for patenting

Although conception can occur before the inventor has verified that his idea will work, when development and verification are needed in order to prepare a patent application that complies with 112, the invention is not yet ready for patenting.

Notes; HONEYWELL; Gulfstream case where H entered into negotiations w/ G for G to test H’s

systems w/ human pilots. H used design notes, simulators, test aircraft, and demonstrations to those w/ expertise in air safety. FED CIR; H did NOT violate on-sale bar bc the developmental stage of the invention was NOT ready for patenting – step two of Pfaff was not complete

Developmental stage is important to provide the inventor w/ some certainty regarding when his attempted commercial activity triggers the 1-year clock.

o PLUMTREE v. DATAMIZE; What is a “commercial offer for sale”? Background;

Filed 2/27/96 and critical date is 2/27/95 “Invention is not the kiosk itself, but is the software for, and the method of, creating

the kiosk.” - The method was obviously reduced to practice in 12/94 Burns (MA, his company) offers to make kiosk for SIA (Ski Industry Association) trade

show - Confirmation letter from SIA 1/25/95 Kiosk finally finished at the show 3/3/95 - NOT CLEAR if patented process used before

2/27/95 Was this a commercial offer of the invention for sale? Governed by federal common

law CT: While it is apparent that Burns used the method to create the kiosk system, it was

NOT finished until after the critical date – and unclear if Burns performed EACH of the patented method steps before the critical date. Can show commercial offer by either;

Offering to perform the method (even if actual performance after critical date)

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o Must meet the level of “offer” in the contract sense – which means that a definite offer for sale and material terms must be present.

o If the invention is a process – then just offering to perform the method can be a commercial offer

o Must be an offer for sale of THE INVENTION and the invention that is the subject matter of the offer for sale MUST satisfy EACH claim limitation of the patent.

Performing the method for promised compensationo This includes a sale by the patentee of a product made by the claimed

process Notes;

On-sale bar does NOT arise from assignment that is executed to raise funds to further develop or refine the invention

On-sale bar does NOT apply to prospectively licensing activity, an offer to license, or a mere transfer of know-how.

Unlike Space Systems – many CTs look from an objective perspective to see if the inventor thought that the invention is complete.

102(b) Public-Use Bar;o EGBERT v. LIPPMANN (S Ct 1881) – Public Use

Background; This is for an improved corset steel Barnes filed for patent in March 1866 - At this time statutory bar for public use was 2

years (1 now) Gave Frances Lee two pair (1855, 1858) - Did not expressly make Frances swear to

secrecy Also showed them to Sturgis in 1863

CT Finding/Holding; The public use bar applies here; It is obvious that Frances Lee was wearing them in public. He imposed no obligation

or secrecy or condition or restriction whatever. Not presented for experiment The invention at the time given was complete, and no evidence that it was afterwards

changed or improved She might have exhibited them to any person, or made other steels of the same kind,

and used or sold them without violating a condition or restriction by the inventor – because there was not any restrictions

Slept on patent right for 11 years Rules; To be public use –

How many units? One is enough. Use of a great number tends to strengthen to proof How many people? One is enough, if given without restriction

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If an inventor, having made his device, gives or sells it to another, to be used by the donee or vendee, WITHOUT limitation or restriction, or injunction of secrecy, AND it is so used, that is public use, even though the use and knowledge of the use may be confined to one person

How visible in use? Enough if it is PART of an item in public use (does NOT have to be seen itself)

o MOTIONLESS KEYBOARD CO. v. MICROSOFT (Fed Cir 2007) Background;

Two patents; all product claims ‘477 patent filed 6/6/91; critical date 6/6/90 ‘322 patent filed 1/11/93; critical date 1/11/92

Gambaro makes “Cherry Model 5” prototype - 2/22/87 (more than 3 years before first critical date)

G and Coulter showed the prototype to investors, but they signed 2 year NDAs and just saw the invention (didn’t use it for its intended purpose) Also shown it to friend Kathi Roberts and type-tester Sheila Lanier

o Kathi didn’t use for intended purposeo When Sheila did use for intended purpose, signed an NDA that day.

CT Finding/Holding; CM5 was never in public use Investors and friend only saw the keyboard and did NOT USE it for its

purpose/intended use. Type-tester signed an NDA on the day she performed type test Also, keyboard never was connected to be used in the normal course of business to

enter data into a system. Rule;

Public use includes “any public use of the claimed invention by a person other than the inventor who is under no limitation, restriction or obligation of secrecy to the inventor” NDAs are considered to create confidentiality

To be public use, the invention must be used for its intended purpose - This requires actual use

o Notes; Private uses; A private use, under the control of the inventor, and not for commercial

purposes, will NOT invoke 102(b) - Also the same for confidential-based uses Confidentiality was at issue in; p. 403

AMERICAN SEATING v. USSC (Fed Cir 2008); Tie down restraint system for wheel chair. Depending upon the relationship of the observers and the inventor, an understanding of confidentially can be implied. Here – The limited number of people that assisted and viewed the invention “shared a general understanding of confidentially.

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INVITROGEN (Fed Cir 2005); Patentee kept its use of the claimed process confidential. The process was only known within the company

BAXTER v. COBE (FC 1996); Invalid under 102(b) bc inventor failed the maintain confidentially and had a free flow of people into his lab who were under no duty of confidentially.

BEACHCOMBER; Case where inventor had a house party and showed her invention to the guests, they looked and touched it – it was also demonstrated. There was no secrecy or confidentiality agreement.

o CITY OF ELIZABETH V. AMERICAN NICHOLSON PAVEMENT Background;

Method for making wooden block pavement - Nicholson filed pat app in 1854 Made pavement area in June/July of 1848 - In Boston – 75 feet in length at a Toll area.

Nicholson personally paid to pave the road Toll collector testified; N was there almost daily, asking many questions and striking it

with his cane. N did NOT intend to abandon his right, he put the section there to test its usefulness and durability

Finding/Holding; Not a public use bc it was experimental use Experiment use and not public use here bc;

The only mode in which he could test was to place the specimen in the public roadway

Durability was one of the qualities to be obtained He didn’t let it go beyond his control

What is a bar; If the inventor allows his machine to be used by other persons generally or if it is, with his consent, put on sale for such use.

What is NOT a bar; If used under the surveillance of the inventor, and for the purpose of enabling him to test the machine, and ascertain whether it will answer the purpose intended

Rule; What to look at to determine experimental use; Whether the invention needs testing to see if it meets the intended purpose Whether test’s duration is reasonable Whether inventor keeps control of the test object Whether inventor monitors the test Can still be experimental use – and does NOT matter whether; General public sees

invention, Inventor changes the invention, Public receives benefit during useo GM v. GE;

Background; Pre-critical date sales of claimed bearings - Bought from contract fabricator and

included in assemblies shipped to customers

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GM says “it was our field testing phase” - Not including in all locomotives, have not generally released

What GM did NOT do; when looking for contemporaneous evidence No express confidentially agreements: No use restrictions, requirements, or

testing protocols: Not much of a test if no requirement for use and/or type of use: No data collection or reporting obligations

Holding/Findings The Fed. Cir does not believe in passive testing - Allows to help them avoid mistakes What shows a good faith purpose to experiment?

Allen Eng’g (2002); 13 factors, saying there can be more and don’t have to use all of them; 1) Necessity for public testing, 2) Amount of CONTROL over the experiment retained by the inventor, 3) Nature of the invention, 4) Length of the test period, 5) Whether payment was made, 6) Whether there was a secrecy obligation, 7) Whether records of the experiment were kept, 8) Who conducted the experiment, 9) Degree of commercial exploitation during testing, 10) Whether the invention reasonably requires evaluation under actual conditions of use, 11) Whether testing was systemically performed, 12) Whether the inventor continually monitored the invention during testing, 13) Nature of the contacts made with potential customers.

CT says that some factors are more equal than others and give a threshold step Control and customer awareness ordinarily must be proven if experimentation is

to be found Here neither are shown;

Customer awareness – They know they are using a different bearing, BUT they must be aware that they are helping you experiment on something

Control; No protocols, not monitoring, did not request or receive comments or data from user, o GM says that since the customer sends the broken part back, so customer

was aware;o BUT; They didn’t try to correlate the breakdown and basically this was

implementing the warranty, they tell everyone to send things back that break.

Rules; Threshold inquiry; Control and customer awareness ordinarily must be proven if

experimentation is to be found; Control goes to passive and active methodology and Customer awareness; Just knowing they are receiving a different part is not

enough, they must be aware that they are helping you experiment One can test durability, even if not claimed

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o LESLE CORP. v. AJ MANUFACTURING Background; Auto repair tool

Lisle – “experimental use”; Gave prototype tool to 4 repair shops in Omaha, NE AJM says “Lisle lacked control”

No formal confidentiality agreement; No restrictions on the use; No test records from the 4 repair shops

Finding/Reasoning/Holding; Control need NOT be the most highly formalized What shows Lisle’s control? Active engagement with the end user

“Company protocol” – “He and other engineers would have contacted mechanics every two or four weeks by phone or in person to receive testing feedback”

Here, was the protocol followed? No testimony from a user (mechanic) Lisle had a prior working relationship and there is feedback from users, in

“General Meeting Reports” Enough evidence to rebut prima facie case and send to fact-finder.

o Notes – Experimental use Policies behind experimental use;

Benefit to society; Society receives a more refined and commercially ready invention and permits inventors to determine if their invention is worth the time and money.

Seeks to preclude an inventor from extending the term of the patent’s statutory life while commercially exploiting the invention The scope and length of the activity must be REASONABLE in terms of its purpose.

o If the purpose is experimental and the activity reasonable, it is NOT legally significant that the inventor benefits incidentally from the activity

LOUGH v. BRUNSWICK CORP. (Fed Cir 1996); L was a repairman at a marina who designated a new seal on an indoor/outdoor motor. L made 6 prototypes, using one on his boat and giving the others away (no provisions or contract for follow-up involvement during the alleged experimentation. L neither monitored nor kept records or reports concerning the motor’s performance. CT; Not experimental use, even though independent inventor, L did NOT exert the

requisite control. When Experimental Use ends;

It ends when the inventor is either reduced to practice or is ready for patenting (PFAFF). RTP means; 1) Inventor constructed an embodiment or performed a process that

met all the limitations AND 2) Determined that the invention would work for its intended purpose.

When the issue of durability is relevant; An inventor may have to test his invention in its intended environment for several years.

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o 3rd Part Activity; LORENZ v. COLGATE (3rd Cir 1948)

Background; L files patent app. 1/24/1920 and shows Ittner (for C) after he files. C says

“uninterested”. L abandons the application - This itself doesn’t create public information bc there was not publication during this time

C files an app. (Patent issues July 1933) And claims L’s process 2/19/1931 (102(f)) L sues C for infringement

o C says the claims are invalid - “Process was in public use in our factory before L’s critical date” (2 year grace period)

o L says “They stole it from ME” CT; Sympathy for L, but L’s patent is void under prior public use. The provision is for

the public. The statute contains no qualification or exception. Inventor is “master of the situation” and since he gave up on patent app, must face consequences

EVANS COOLING v. GM (Fed Cir 1997) Background; E invents engine cooling system

Runs demo in GM test facility, Spring 1989. Says later that GM stole the tech. at this time. Files app on 7/1/1992

Was it in public use before 7/1/1991?o GM and its dealers, began offering it for sale about 4/91 – 5/91o 6/13/1991 sale from independent dealer to Najarian

Finding; Yes it was. Adopts LORENZ Notes;

Policy is to seek to discourage any delay by the inventor of filing for a patent app the invention is complete.

Also – don’t want to remove from the public domain something that customers have come to expect

BAXTER – Blood case where found prior use and it was kept pretty secret Does not matter if sale was by 3rd party Inventor and 3rd party secret commercial use;

Secret commercial use; Product being sold outside bar date, but the process cannot be discerned from the products.

If inventor engages in secret commercial use more than one year before filing patent app, he is barred by 102(b).

However, 3rd party secret commercial use does NOT give rise to the bar. Policy;

o For inventor, can’t exploit discovery competitively after it is ready for patenting – extending the monopoly. Must choose TS or patent.

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o 3rd party; Precluding alleged infringers from using 3rd party secret commercial use to invalidate a patent that disclosed to the public what the 3rd party purposefully did NOT.

Stolen or Pirated Inventions; As shown in prior cases, this activity, if outside the time bar, constitutes a baring event. Reasoning; Prompt disclosure, really it is statute interpretation issue – nothing there says theft, etc. should be barred.

OBVIOUSNESS Historical Foundation

o HOTCHKISS (1851) – First instance of obviousness Background; Patentee H sues G for making/selling clay doorknobs

H’s knob; Clay knob, dovetail shank The prior art had two different configurations; Metal with dovetail and Clay with

straight shank Here, the combination is novel, Can also say it is a substitution of materials

CT; Invalid if “no more ingenuity or skill was required to construct the knob in this way than that possessed by an ordinary mechanic acquainted with the business” “Unless more ingenuity and skill were required than were possessed by an ordinary

mechanic acquainted with the business, there was an absence of that degree of skill and ingenuity which constitute essential elements of every invention”

o AUTOMATIC DEVICES v. CUNO; (1941) Background;

Mead pat – Turn it, and then turns back when ready. Lighter, in car dashboard. Thermostat turns it off, signals user. Pulls out the dash without wires. Filed 8/24/27, issued 11/19/29

Prior art lighters; Reel lighters – 1917, Morris (pull out), issued 1921 and variations Copeland, filed 4/18/1927 (102(e)(2)); Like Mead, but a fundamental difference; A

tube to put the article into, not a pull out, still a thermostat control CT APP – Hand;

Thermostat cut-off long used in other tools. Technology existed well before Morris, or Mead. It wasn’t used, someone should explain why that is such.

Copeland is prior art and makes the step of using the thermostat with the lighter. But Copeland lighter was a tube, not a pull-out plug

The best test of what persons of routine ingenuity can do is what they have done Here, they did NOT combine available thermo-switch with Morris AND they had

every incentive to do so! Basically he says – If it would have been obvious, why did it take

SCOTUS; Overturns, “A mere exercise of the skill of the calling”

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Thermostat cut-offs were well known (but not in this art). “The advance of Mead…was the use of the removable plug bearing the heating unit, as in Morris, to establish the automatically controlled circuit of Copeland.”

“The new device, however useful it may be, must reveal the flash of creative genius, not merely the skill of the calling” – this sets a higher standard Needs “inventive genius”. Also says “strict application of the test is necessary”.

Patent on every small advance will harm innovationo GREAT A&P TEA

Background; 1917 – Piggly Wiggly opens self-service store. 1937 – Turnham works in Weingarten

store Problem is too slow check out, existed between ’17 and ’37. Others tried to solve by

adding more lines. Turnham solved the problem by extending the counter and becomes the standard in

“practically every major self serve store 6th Cir. says that claims are not invalid

SCOTUS; Claims are invalid. Reformulate the question; “What indicia of invention should the CT seek in a case

where nothing tangible is new, and invention, if it exists at all, is only bringing only elements together?”

A “negative rule” – Unpatentable if it is; A mere aggregation of old parts that do not perform a new or different function of operation

Synergism; “Only when the whole in some way exceeds the sum of its parts is the accumulation of old devices patentable” “This case is wanting in any unusual or surprising consequences from a

unification of the elements here concerned…” Concurrence – Douglas and Black; “Congress does NOT have free rein….to decide that

patents should be easily or freely given.”o Road to GRAHAM;

CUNO (1941) – “flash of creative genius” GREAT A&P TEA (1950) – Huge standard Congressional hearings – 1950-1952 Patent Act of 1952 - 103 (now 103(a))

Current Nonobviousnesso Statute – 103(a) - the burden is on the PTO in 102 and 103 to show not patentable

A patent may not be obtained…if The differences between the subject matter sought to be patented and the prior art

are such that

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The subject matter as a whole would have been obvious (Here looking at the whole claim – not specific elements)

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 madeo GRAHAM v. JOHN DEERE (S. Ct. 1966)

Background; Trilogy of cases, on two technologies Companion case – US v. Adams

SCOTUS; The statute is Constitutional. Grant of power bc Congress can make a judgment as to

how to best effectuate Constitutional aim, but limitation bc Congress may not…restrict free access to materials already available Statute is merely a codification

What the case decides as the test; Ultimately a question of law Based on “several basic factual inquiries”; Obviousness or

nonobviousness is determined at the time of invention by determining;o The scope and content of the prior art (technology factor)o Differences between the prior art and the claims at issue

(comparative factor)o The level of ordinary skill in the pertinent art (knowledge factor)

What the phosita knows and what phosita can doo Secondary considerations might be utilized to give light to the

circumstances surrounding the origin of the subject matter sought to be patented – those might be; Commercial success Long felt but unsolved needs Failure of others

Here, it would have been obvious to invert the shank and the hinge plateo US v. ADAMS (1966)

Background; Adams sues US for patent infringement. Adams battery;

Water is the electrolyte, Mg is the electropositive, and Cuprous chloride is the electronegative

Benefits – Large current, for weight; no acid or fumes; constant voltage; large temperature range; long storage life

Drawback – Doesn’t shut off Prior art; On additional page.

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CT Finding; It’s operation characteristics were unexpected – experts were skeptical “To combine them as Adams did required (one to) ignore that…. Water-activated

batteries were successful only when combined with electrolytes detrimental to the use of magnesium”. “Long accepted factors…deter any investigation into such a combination as used by Adams”

Additionally, once proved, Signal Corps used it Analysis of what Ct says - Basically says that phosita follows conventional wisdom. When

conventional wisdom is defied, then that is patentable area (not the only way though)o Notes;

Nonobvious and Novelty; Obviousness can be met by combining references, anticipation cannot Secondary considerations in 103, not in 102 102 can be proven inherently, not true for 103. Cohesive Tech case; A particular alloy of metal can be nonobvious –long felt need,

commercial success, failure by others – but there could be a centuries old book that, while not describing the metal, describes a method, that if practiced precisely, actually produces the claimed alloy. Therefore, the textbook could anticipate under 102, but said to be non-obvious under 103.

Legal Consideration; Although there are underlying factual considerations, the ultimate judgment is a legal determination. P 324 – Juries have made the decision previous, but it has been determined to be bad policy to allow that.

Graham Factors; 103 is a standard, not a rule, for determining obviousness Analysis of difference between rules and standards, p 325 Nonobviousness on the standard side bc; Infinite and unpredictable nature of

innovation, Congress could not enact a rule that would include or foresee what is necessary

The factors don’t unambiguously reveal what is and is not obvious, but they provide boundaries within which the 103 decision-maker must stay.

Teaching away; Possibly the strongest argument an applicant can make is that the prior art actually

teaches away from the claimed invention or execution of the prior art resulted in a failure. CROCS case example

Suing US Govt for patent infringement; 28 USC 1498. Must bring in CT of Federal Claims, not D Ct.

When alleged infringer is a non-govt entity, the accused activity is for the US if it is conducted for the Government or with the authorization or consent of the Govt.

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o Examples p 328 Difference between 28 Infringement and 35 Infringement;

Under 35, can deny a private party use. However, can’t deny the Govt’s use under 28 – they just have to pay reasonable compensation for it.

Injunctive relief is not available under 28, so the Govt can invoke a compulsory license.

o Hindsight Bias; To avoid the bias, the Fed Cir used the “Suggestion Test”

This allows them to fight hindsight bias – using the t-s-m test Initially says that it doesn’t have to be explicit, but overtime cases basically say

that it does have to be explicit First stated in In re Dembiczak (Fed Cir ’99); Best defense against bias is rigorous app

of the requirement for a showing of a teaching or motivation to combine prior art references – to find obviousness

Federal Circuit’s phosita; Won’t (can’t) remix known components Standard Oil v. Am. Cyanamid (Fed Cir ’85); Phosita is not one who undertakes to

innovate Literature recognizes this; Professor Vermont; “If a mediocre artisan has to do more

than read the prior art and myopically follow its suggestions, the invention is not obvious”

o KSR (S. Ct. 2007); Background;

Claim 4 of the ‘565 patent; Combined (a) adjustable gas pedal, (b) sensor for computer-controlled throttle

D Ct; Summary judgment of invalidity – “obvious” Fed Cir; Reversed… “fact question” on Suggestion Test

This is the extreme view of preventing hindsight bias SCOTUS;

Rejects the rigid approach of Fed Cir – only applying the t-s-m Test to determine if obvious

Asserted claim; The marketplace created a strong incentive to convert mechanical to electronic

pedals Phosita would know to place the sensor on a nonmoving part of the pedal

structure View of PHOSITA – new view from this case

“Phosita is also a person of ordinary creativity, not an automation”. And a CT can take account of the inferences and creative steps that a phosita would employ

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Phosita is good at remixing components; “Will be able to fit the teachings of multiple patents together like pieces of a puzzle”

Fate of Great Atlantic case; “Neither the enactment of 103 nor the analysis of Graham disturbed this CT’s earlier instructions concerning the need of caution in granting a patent based on the combination of elements found in the prior art.

Overarching 103 question; Whether the improvement is MORE than the predictable use of prior art elements according to their established functions Applying the overarching question; Rules of thumb

o Likely would have been obvious if Combination of familiar elements according to known methods, with

predictable results Substitution, in a known structure, of one known elements for another,

with predictable resultso Likely would NOT have been obvious if;

Prior art teaches away from the combination Elements work together in an unexpected way

When there is a design need or market pressure to solve a problem and there are a FINITE number of identified, predictable solutions, a phosita has good reason to pursue known options within his/her technical grasp. o If this leads to anticipated success, it is likely the product NOT of innovation

but of ordinary skill and common sense. o In this instance, the fact that a combination was obvious to try might show

that it was obvious under 103. Sources of information for a properly flexible obviousness inquiry; Shown in notes

belowo Market forceso Design incentiveso Interrelated teachings of multiple patentso Any need or problem known in the field of endeavor at the time of invention

and addressed by the patent ANDo The background, knowledge, creativity, and common sense of the phosita

Notes; Important that the SJ was reinstated here - Fed Cir approach makes to so hard to

obtain SJ Remember GREAT A&P TEA (1950) - Combination claims require skepticism. “CTs

should scrutinize them with a care proportioned to the difficulty and improbability of finding invention in an assembly of old elements”

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This statement above is appropriate IF the phosita is good at remixing “old elements” - Ct brings back this relevance.

P. 349 and 350 MPEP list for obviouso PERFECT WEB TECH (Fed Cir 2009)

Background; Method for managing bulk email distribution Difference from prior art – step D - Repeated selection and delivery, until target

number is reached CT Findings; SJ of obviousness is affirmed

Affirms that you can rely on “common sense” Role of phosita’s “common sense”

Can be a source of reasons to combine or modify Can supplement record evidence For simple technology, expert testimony may not be required

Notes; Ability of SJ makes it much cheaper for accused infringer to overcome suit.o Notes p 345-350;

Test for Obviousness Graham factors are the framework and TSM test can be helpful when used in this

framework Sources of information for a properly flexible obviousness inquiry;

Market forces Design incentives Interrelated teachings of multiple patents Any need or problem known in the field of endeavor at the time of invention and

addressed by the patent AND The background, knowledge, creativity, and common sense of the phosita

Another factor weighing in favor of obviousness is simultaneous invention It remains necessary for the PTO to show some articulated reason with some rational

underpinning to support the legal conclusion of obviousness – BUT that reasoning does NOT have to seek out precise teachings directed to the specific subject matter of the challenged claim (Basically don’t need a TSM)

MPEP – Section 2141’s guide for Obviousness Analysis; Exemplary rationales upon which to base obviousness rejections; A) Combining prior art elements according to known methods to yield predictable

results B) Simple substitution of one known element for another to obtain predictable results C) Use of known technique to improve similar device (methods, or products) in the

same way

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D) Applying a known technique to a known device (method or products) ready for improvement to yield predictable results

E) “Obvious to try” – Choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success

F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to a phosita

G) Some teaching, suggestion or motivation in the prior art that would have led a phosita to modify the prior art reference or to combine prior art reference teaching to arrive at the claimed invention

o PROCTOR & G v. TEVA (Fed Cir 2009) Background;

Osteoclasts break bones down and osteoblasts build bone up - The claimed invention either slows down or speeds up these respectively. The prior art compound is one of eight compounds that is said to be promising to

help with bone disease. Change the position of bisphosphonate from one position on the nitrogen atom to

another position – would it be obvious? From 2 to 3 P&G’s expert; At this time, there just wasn’t enough of an understanding in this

science to understand how a change in structure would change the result or effect

It wasn’t just the expert, there was also a publication stating - each of the structures have to be considered on its own

Finding; CT says assuming 2-pyr was a lead compound, the changes it takes were still not

obvious. Here there were unexpected results; Potency – effective at a lower dose than

expected and Toxicity - Threshold dose is 3x that of 2-pyr EHDP Under KSR’s finite number of identified predictable solutions – applied to

unpredictable arts If can only vary parameters and try numerous possible choices, and the prior art

doesn’t give an indication of which parameters are crucial or no direction as to which choices would be successful- NOT obvious

Patents aren’t barred just bc it is obvious to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance- NOT obvious

Since Teva did not establish a prima facie case, P&G does not have to rely on evidence.

Rules;

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To determine if there is obviousness – Must determine whether, at the time of invention, a phosita would have had 1) Reason to attempt to make the composition AND 2) A reasonable expectation of success in doing so

Prima facie case of obviousness for chemical compounds; 1) Proof of a lead compound (structurally similar enough to indicate similar

properties) AND 2) A set of changes that are either

o Routine and predictable (for the desired effect) ORo Small enough in number for the phosita to simply work through the list – i.e.

obvious to try In unpredictable arts, structural similarity is thought to produce similar results.

In addition to structural similarity – a prima facie case of obviousness can be shown by adequate support in the prior art for the change in structure

Change from 2-pry to 3-pry – obvious? Assuming that the prior art was a lead compound (pry-2), were the changes it takes to get the new compound obvious? Lead compound; the one that would be further explored and used in the future –

most promising Unexpected results – can rebut a prima facie case of obviousness

Here however when looking at unexpected results must have a base line of expectations - Here not enough information to know what to expect – so no baseline

Notes; Here a lay person might think that it is obvious, but the phosita would most likely not

think so. Since KSR, “obvious to try” is a valid argument This is an example of a post KSR, in an unpredictable art; Also since the art was so

immature at this time, that conventional wisdom does not point in a particular way. Post-KSR obviousness; Predictable arts are having a tough time proving non-

obviousness, but unpredictable arts are doing just fine. Contrary to “a finite number of identified, predictable solutions” as noted in KSR,

there was nothing here to suggest that molecular modification was routine or susceptible to common sense

Nonobviousness will become more difficult to overcome as biotech techniques become more sophisticated and knowledge more nuanced

KUBIN – stating scenarios when “obvious to try” may and may NOT be used; May NOT be used;

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o 1) Varying all parameters or try each of a number of possible choices until one possibly arrived at a successful result, where the prior art gave either NO indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful

o 2) To explore new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it

May be used;o 1) Prior art “contained detailed enabling methodology for practicing the

claimed inventiono 2) A suggestion to modify the prior art to practice the claimed invention ANDo 3) Evidence suggesting that phosita would have a reasonable expectation of

success Level of Skill

o Before KSR – parties jointly stipulated to skill-level findingo Now it may become more hotly contested

Under Graham, it is a question of fact Experts will usually have to testify about techniques and skills, not just knowledge

HOWEVER, THERE IS TENSION BETWEEN THE LEVEL OF SKILL FOR NON-OBVIOUSNESS AND ENABLEMENT For a given level of skill, it will take a certain amount of enablement – Level of skill is a

Wands factor Meaning patentee might be trying to say that the level of skill is low and would not be

obvious to phosita, but when saying that then can run into enablement issues – bc then there might not be enablement based on the disclosure and the level of skill of the phosita

o DAIICHI SANKYO V. APOTEX Argument about level of skill; P says pediatrician and D says Ear Nose and Throat Doctor CT Holding;

Why level of skill matters? Pediatrician would not have understood key prior art

o Ganz article – 1986 – topical ciprofloxacin for otopathyo D CT says the article is for an otologists (ear doctor)

This determination of ordinary skill was incorrect, therefore, so, too was the dismissal of the article

Factors for phosita; Education level; Active workers in the field

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Inventor(s) of the asserted claim Sophistication of the technology Technology history; Types of problems, Solutions to those problems and Speed

with which solutions are found Here;

The named inventors have the skill to solve an ear problem – They were specialists in drug and ear treatmento Also “Others working in the same field… were of the same skill level”

The specification was written in a particular way – talks about toxicity, by animal testingo “Traditionally outside the realm of a general practitioner or pediatrician”

Notes; Maybe inappropriate to include the Inventor’s education level bc making them too

close to the phosita This is a way to talk about tech history and not including it in the secondary

considerations Patents are always interpreted from level of ordinary skill in art Level of skill matters – can be determinative on the issue of obviousness

Available Prior Art and Analogous Art Doctrine;o Intro;

Under 102, doesn’t matter if analogous art Ways to show if something is analogous or pertinent;

1) From the same field of endeavor, regardless of the problem addressed, OR if this is not met then;

2) Reasonably pertinent to the problem the invention solves – content shows, so the phosita would look to it

103[c]; Common ownership exception; Doesn’t preclude patentability under 103 – Section covers 1) Covers if it would qualify as prior art under 102 e, f, or g if owned by the same

company or subject to assignment to the same person 2) Describes what it means to have common ownership

This includes JVs In the statute in order to protect companies or persons working together or on the same

thing from tripping each other up.o In Re BIGIO – (Same field of endeavor – Ct interprets expansively)

Background; Invention is a hair brush with a bristle substrate defining an hour glass shape and

each substrate w/ brush bristles The claim just says hair brush, so could be any hair

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It is the PTO’s job is to read every claim w/ the broadest reasonable construction Prior art is said to be Fleming (British) + Cohen or Fleming + Tobias; ALL OF THESE

ARE TOOTHBRUSHES, not hair brush PTO; Defines the field of endeavor as the “structure” – not the same type of art

Findings; Fed Cir says – sufficiently predictable

Need to look at the disclosure’s explanation of the invention Also, look at the function and structure of the invention

There are structural similarities between toothbrushes and small brushes for hair - So what the PTO said is true and relevant

Rule; This CT looks 1) at the disclosure’s explanation of the invention and 2) (more controversially) at function and structure when determining field of endeavor

Notes; Outcome could be described bc it is from the PTO, and must affirm on what the PTO

says or not at all The claim construction determines what is pertinent in the prior art Is looking at function and structure part of the first or second category?

If look at in the first, then it seems to make the second category superfluouso In RE ICON HEALTH AND FITNESS INC.

Background; Invention is a treadmill that folds up, key piece is a spring (gas spring) Prior art piece trying to keep out is Teague; A bed that has a spring and the bed folds

up. Although a dual action spring here, doesn’t matter about the invention bc it just says

gas spring (not single or dual action). Finding;

Not under the first part of the test – beds aren’t treadmills (all agree) Under the second test – it is pertinent to the same problems

Supporting the weight of a folding mechanism Providing a stable rest position

Teague is determined to be pertinent, so since it is now part of prior art, is Teague + Damark make the invention obvious? Yes obvious; “The finding that Teague, by addressing a similar problem, provides

analogous art… goes a long way towards demonstrating a reason to combine”o {Meaning – once it gets on the table, phosita’s are very good at combining

the references or material that they have} Notes;

This test says that phosita looks in areas of other arts that are directed to the same problem

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But they don’t look to things outside their art that don’t appear to be directed to the same problem

Policy; An incentive giving to people – if a way that you invent is going out to other art and it doesn’t appear to be helpful but turn out to be, then you can get a patento This is riskier

o INNOVENTION TOYS V. MGA ENTERTAINMENT (Fed Cir 2011) Background;

Chess type game, with lasers, moveable rotatable pieces and mirrors. Alleged infringing game is “Laser Battle” – very similar References;

Swift – 3d laser based strategy game – shortcoming is that it is not moveable (so not 102, would need to be combined with something else)

Laser Chess articles – Describes that the pieces are moveable D CT: Not pertinent bc computer games are not board games

Finding; Agree on the first category (not same field of endeavor), but need to look at the

second test; It is addressed to the same purpose bc it is directed to the same problem –

question to determine if second category Same purpose - Details the specific elements; Looks at playing pieces and board,

rules, and final goal The problem of game design; Medium - “Game elements remain the same regardless

of the medium in which they are implemented” – SEEMS VERY BROADo IN RE KLEIN (Fed Cir 2011) – Only succeeding example

Background; Invention is a mixing device to make sugar water for birds or butterflies. It has slots

where the divider should go. When take divider out, then know the right mixture is there and can mix and use.

PTO has 5 references; For each reference it says there is a divider and it can be moved.

Finding; Obviously not the same field of invention here; On to the second test – What is the purpose/problem?

PTO Board defined purpose and problem as; “Making a moveable divider to prepare different rations of sugar and water” - Patentee agrees and doesn’t challenge the finding.

Problems w/ references;

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o 3 of them wouldn’t work – They are for separating solids, NOT solids and liquids. Not made to hold or separate water. Different structure and purpose

o 2 other references; They do hold liquid, but the ratio is fixed – can’t change between the

different ratios. No help when one wants 1 container many ratioso Notes;

The source of prior art for 103 purposes comes from 102 102 has a dual function; 1) Defining novelty – as well as priority and statutory bars AND 2)

Defining what constitutes prior art A considerable majority of prior art used for obviousness is based on 102(a) Reason there is analogous art requirement for 103; Bc 103 references by definition do

NOT disclose each limitation and can be combined, it becomes more difficult for inventors through searching to fully appreciate the full scope of the prior art In response; Requirement of analogous art in order the ease the burden on the

inventor, making it more realistic by only presuming knowledge by the inventor of prior art in the field of his endeavor AND analogous art

Secondary Considerations – also “objective evidence”o Intro;

Most direct evidence for secondary considerations; Others in the art were trying and failing – with the means to solve readily available This includes recognizing there is a problem – but adds to it

Long Felt Need; If only evidence that people recognized the existence of the problem – weaker evidence and only showing there is a need (maybe long time) Which is the first half of above – do not have evidence that people tried and failed to

solve Commercial success - The most frequently used – it is the cheapest

Weaker – even indirect evidence; Attempting to tie together inferences “If in fact a product attains a high degree of commercial success, there is a basis

for inferring that such attempts have been made and have failed.” – Law Review Note

If, as the patentee, you want this to work – the must rule out alternative causes People are skeptical of this arguments – THEREFORE, there is the nexus

requiremento IRON GRIP BARBELL CO. V. USA SPORTS

Background Weight plate – 3 hand openings. Prior art plates – 1, 2, 4 Art did not teach away from using 3 slots and no unexpected results from using 3

slots Finding/Holding;

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No objective evidence to rebut the strong showing of obviousness based on prior art Commercial success; 3 licenses, but no showing that tech caused success

o License can be cheaper than litigation and if competitors license too, it is just a common cost

Long felt, unmet need – Evidence here shows lapsed time, not unmet need Not copying – bc it requires a replication of a specific product

Rules; If something falls within the prior art range – it is presumptively obvious (CCPA ’74) To show commercial success; A nexus must be established between the merits of the

claimed invention and evidence of commercial success before that evidence may become relevant to the issue of obviousness The nexus may be inferred when the patentee shows both that there is

commercial success, and that the thing (product or method) that is commercially successful is the invention disclosed and claimed in the patent

Notes; Secondary Considerations; Commercial Success; If the invention were obvious, then competitors would have

already produced the product Sometimes may be the result of factors that have very little to do with the

product’s technical quality; Therefore, there must be a NEXUS or causal relationship between the commercial success of a product and the technical merit to the claimed invention

It is to be considered as part of all the evidence, not just when the decisionmaker remains in doubt

Long-Felt Need; If people are looking for a solution for years, and the best minds don’t find it for years, that is evidence of the state of knowledge.

Failure of Others; Basically the same premise as Long-Felt Need, but additionally others have tried and failed to solve the problem

Copying; If a competitor copies the invention, then that is a good indication that it might not be obvious. More later

Licensing/Acquiescence; Not as strong of evidence, bc often companies will pay a licensing fee in order to avoid litigation, bc financially it makes sense to do so.

o MERCK v. TEVA PHARMA Background;

Bisphosphonate dose – size and frequency (patent in 1997) Alendronate sodium – prior art medicine Weekly dose – treat at 70 mg; prevent @ 35 mg

Prior art; Lunar News articles. Suggests weekly doses 80 and 40 respectively (pill sizes are already in use). A 7x dose is the same as 7 daily doses

Problems;

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Primary problem – Esophageal injury, irritation. Pill, stuck in throat, harms tissueo So less frequent the pill – the less frequent “stuck in throat”

Secondary problem – dose size (not solved); If anything, suggests reduction from prior art

There is a strong prima facie case of obviousness – based on prior art – even though T CT found the other way So secondary considerations? Merck turns to commercial success

Finding/Holding; Commercial success is not persuasive – It only shows compliance with FDA law and

Patent law. Others were legally barred from commercially testing the Lunar News idea - FDA approval requirement Dominating patent – Merck had exclusive FDA permission

o TRANSOCEAN DRILLING V. MAERSK CONTRACTORS USA, INC Background;

Improved offshore drilling derrick for 1 well. 2 advancing stations, main and auxiliary (Transfer assembly for moving between them)

Prior art; Horn – 2 advancing stations on 1 derrick (2 wells). Lund – Transfer mech (prep station – advancing station)

Prima facie obviousness, so Trans offers secondary considerations Industry skepticism; “radical departure”, “underwater collision”, “not realistic” Industry praise; After the invention – “One of the top 50 in offshore history” Commercial success; A higher licensing premium than standard rig – bc it differs

in this way (way of the invention) Finding/Holding;

The D CT ignored the secondary consideration – NOT a harmless error. Must ALWAYS consider any such evidence Different than Iron Grip – bc there, the evidence was so weak that the evidence

could NOT have made a differenceENFORCING PATENT RIGHTS

Intro;o Reverse engineering, independent creation and lack of intent are NOT defenses to patent

infringemento A patent is the right to exclude – does NOT provide the right to make, use, and sell the

patented inventiono Chair example – inventor 1 (chair) and inventor 2 (reclining chair)

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While the reclining feature may have allowed Inv. 2 to patent his chair, that feature does NOT save Inv. 2 from infringement of Inv. 1’s chair.

Inv. 1 cannot practice Inv. 2’s invention either. In these cases there is an incentive to cross-license.

o To enforce must file in Fed. District Ct. A potential infringer may also take the initiative and file a declaratory judgment (DJ)

alleging invalidity or noninfringement o Claim Interpretation precedes a determination of validity and infringement o Infringement can be either direct or indirect;

Direct infringement - Literal infringement; Every limitation must be in at least one claim Non-literal infringement (DOE); Allows liability when an accused infringing device (or

process) is an equivalent. 4 Limitations; Pros History Estoppel; Precludes patent owner in infringement proceeding from

obtaining broader claim scope than the issued claims (as construed), when the original claims in the app would have encompassed the equivalent at issue and where the claim was narrowed to exclude the equivalent – which was foreseeable at the time of such narrowing.

Public dedication Rule; Subject matter disclosed in the spec, but not claimed is dedicated to the public domain

All-Limitations Rule; Each limitation of a patent claim is material to defining the scope of the patented invention and must NOT be vitiated or rendered meaningless

Prior Art; Can’t use the doctrine in order to get something that was in the prior art (102) or would have been obvious in light of the prior art (103). Nonensnarement

o Markman Hearings; A procedural device used by district Ct judges designed to determine the meaning of the claim language at issue Broad discretion in; When during the trial the CT should construe. What input the CT may

properly receive to help in the claim construction. How the CT may use the inputo CYBOR CORP v. FAS (1998 Fed Cir); En banc decision that unequivocally held claim

construction is a purely legal question that is reviewed de novo including any fact based questions relating to claim construction ---- This has led to a high reversal rate of D. Ct.’s claim construction Critics on the decision; Although it creates uniformity, a large amount of uncertainty

occurs bc Fed Cir often construes the claims differently, it doesn’t give comparative advantage to T CT who heard and saw all the evidence, and inundates CTs w/ this litigation.

Procedural devices to enhance predictability; Issue Preclusion; Only some districts apply, concerned with finality concers Stare Decisis; To use as a basis for adopting the prior claim construction

Federal Circuit has NOT applied

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Interlocutory Appeals – Fed Cir has refused to granto Literal infringement depends on the claim interpretation. Therefore, the Markman hearing will

determine what if there is the literal infringement or not LARAMI (ED Pa 1993) Supersoaker case

o The claim; A toy comprising An elongated housing having a chamber therein for a liquid, a pump including a piston,

and means for controlling the ejection (of liquid). o Under Phillips – even though this is before – the claim language must be consistent with what

is stated in the disclosureo TTMP (Amron) claims that Larami (Supersoaker) infringes; In the patent ‘129 – Discloses the

chamber in the barrel and figures show that as well. o In the Supersoaker, the chamber is OUTSIDE of the barrel (housing) -- Therefore CT says –

NOT literal infringemento Notes

Each and every limitation matters for literal infringement. Not found in FELIX v. AMERICAN HONDA MOTORS

Infringement of Method Claims; Patentee must prove that the accused infringer performs each and every step of the

claimed method Sale of equipment to perform a process is NOT a sale of the process within the

meaning of 271(a) Also not found when manufacturer performed the first step and customers

performed the rest However, under BMC Resources v. Paymentech, a party who performs fewer than the

claimed steps may be liable for direct infringement if the party exercises “control and discretion” Can’t avoid infringement merely by contracting out steps of the patented process

to another entity Additional Elements; If claim A and B, accused still infringes if practice A B and C - Must

use “comprising” Transitional Terms; “Comprising” – List of non exclusive elements, “Consisting of” –

exclusive list, “Consisting essential of” – Excludes items that would materially affect the basic and novel characteristics of the claimed composition

WINANS v. DENMEAD (S Ct 1854) –Not in book– Intro to Doctrine of Equivalentso Intro –

At this time still claiming centrally – claiming what you have and protect from that or anything “substantially” like that - This is how copyright and trademark are (even though there aren’t claims)

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Patent claiming used to be centrally, but has now evolved to peripheral claiming; Marking off a boundary of what you claim

o Background; Railcar improvement patent – in the form of a frustum of a cone Accused infringer has an octagonal car

o SCOTUS; Infringement, indirect Makes a distinction of Form v. substance; Even though didn’t copy the form, the D copied

the substance of the cone “Where the whole substance of the invention may be copied in a different form, it is

the duty of the CTs and juries to look through the form for the substance of the invention”

“The exclusive right to the thing patented is NOT secured, if the public are at liberty to make substantial copies of it, varying its form or proportions.”

So the question is, in substance, is one as good as the other? Here – for practical purposes, one was as good as the other By having many sides, and approaching a circle – it is as close enough to a circle to

get the benefit of the invention of bearing more weight (load on the railcar) There was a dissent that said this would advance too far

o Notes; The DOE hurts the notice factor – don’t know if infringe until after you have already done

it. Split DOE; 2 questions

Matter of fact – is it an equivalent? But to get here, have to meet the legal constraints The DOE is subject to legal constraints that might prevent you from asking the first

question GRAVER TANK MFG. V. LINDE AIR PRODS. (SCOTUS 1950)

o Background; Submerged-arc-welding improvements. Flux compositions and welding process Different composition claims; “Any silicate” – Invalidated, “Metallic silicate” – Invalidated,

“Alkaline earth metal silicate” – These survived If the others survived, then probably literal infringement

Accused composition – Lincolnwood; Key silicate is manganese Does NOT literally infringe claim comprising “alkaline earth metal silicate”

o SCOTUS; Here, infringement under DOE; “If two devices do the same work in substantially the same

way, and accomplish substantially the same result, they are the same” Policy behind DOE; If literal infringe were the only infringement to be used, patent would

be “hollow and useless” Using the Function, Way, Result test; Determining fact of equivalency

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Function – Looking at performance and known interchangeability (as of the time of infringement)

When applying this test; Must be “substantially the same F-W-R Dissent;

DOE is inconsistent with; Statutory requirements for distinct claims, Availability of reissue procedure and Patentee’s choose the claim language Also talks about uncertainty brought out in the dissent of WINANS

o Notes; DOE us all about protecting a patentee against unpredicted changes in technology that

change the form but NOT the substance. Don’t want unpredicted changes in technology that don’t affect substance to harm the patent right

Themes from WINANS and GRAVER; Impossible to fully capture invention in words

Patent worth too little if infringement is limited to literal infringement alone Focus on the substance of the invention, not “verbalism”

Liability for non-literal infringers makes public uncertain of its rights; Claim requirement is important Applicants should write thorough claims

What happens in order to meet the conflicting themes– creating constraints on the DOE; Pros History Estoppel, Disclosure Dedication Rule, All Limitations Rule, Prior Art

Pros History Estoppel; Typically occurs when amend claim to make smaller than original claim in order to get around prior art. Patentee always ends up bearing the risk

WARNER-JENKINSON V. HILTON DAVIS (SCOTUS 1997)o Background;

Improved dye purification process “at a pH from approximately 6.0 to 9.0” This was added to overcome the Booth reference – pH>9.0

Accused process – pH of 5.0 Not literal infringement, but Jury says substantially same function, way, result D attacks the DOE; Clashes with statutory claiming requirement, Circumvents the reissue

procedure, Clashes with the PTO’s role in examining patents D says that Congress eliminated the DoE bc it added 112 6th – Means plus function

saying that there it said “and its equivalents” and therefore it is not applied anywhere else - CT say NO – that was a limited solution to a particular problem

o Finding/Reasoning; CT says that Congress can eliminate the DOE if it wants – but it hasn’t Addressing the DoE; It has taken a life of its own, unbound by the patent claims. So

applies the constraints

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All-limitations rule – Each element is deemed material; DoE must be applied to individual elements of the claim, NOT the invention as a whole (Looking for the elements literally or by DoE). Important to ensure that the DoE is NOT allowed such broad play as to effectively

eliminate that elements in its entirety {Here – that would mean that can’t say ANY pH level would work; would need to

talk about 5.0}o Also called the claim vitiation rule

PHE; What types of amendments create estoppel? Those that overcome a patentability

rejection (prior art for instance) Why did P add pH limit? Booth for 9.0. Unknown why 6.0 was added

o If reason for amendment is unclear – Presume a patentability reason Incentive to always explain amendments

What is the scope of this estoppel? Covered in FESTOo Note; If all we care about is the fact question, then P would win. However, there is also a legal

decision of whether we should even get to the fact question Notes before FESTO

o What Warner-Jenkins did; 1) CT adopted the all-limitations rule; Patentee has the burden of presenting

particularized evidence that links the accused products to the patent on a limitations by limitation basis

2) Created a rebuttable presumption, barring application of DOE, when a patentee is unable to provide a reason for a narrowing amendment

3) Strict liability for patent infringement was reaffirmed o Timing issue;

Literal infringement is measured at the time of filing Equivalents are measured at the “time of infringement”

Reasons; (1) To address the temporal constraints of literal infringement. (2) The cumulative and unforeseeable nature of complex technologies, whereby the patentee opens a door for a subsequent improver-inventor, permitting the improver-inventor to benefit from the patentee’s disclosure, thereby lowering the costs, accelerating the development or making possible subsequent activity. (3) Allowing a patentee to capture after-arising technologies may provide an additional ex ante incentive, but may also negatively affect incentives associated with improvement activity

HUGHES AIRCRAFT v. US (Fed Cir 1983); Satellite technology, altitude was adjusted by communication between satellite and ground control station. New technology evolved, allowing on board microprocessor to control. These microprocessors were unknown at the time the Hughes patent was filed.

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CT – The inventor can capture after-arising technologies and is NOT required to predict all future developments that enable the practice of his invention in substantially the same way

o DOE’s relationship w/ 112; Enablement is measured at the time of filing and equivalents are measured at the time of

infringement In re Hogan; (CCPA 1977); Issue involved the PTO’s use of later “state of the art” to

support a 112 rejection based on lack of commensurability. Applicant filed several continuations, all of which, applicant argues, enjoys the filing date of the original app of 1953. PTO relied on numerous references that had an effective date prior to 1971, but after 1953. PTO says that claims of the 1971 app covered A and B. B did NOT exist in 1953 – and the PTO said the disclosure of the 1971 app is NOT

commensurate in scope with the breadth of the claims. PTO pointed to a reference filed in 1962 – which first disclosed B as evidence that B

did not exist in 1953. CCPA – reversed the rejection. Improper for the PTO to use a later state of the art to

prove that B did NOT exist in 1953. The filing date (assuming sufficient disclosure) locks in compliance with the enablement requirement (enabled what was known at the time of filing) AND it is impermissible to use later state of the art to prove non-compliance

o Patenting the Accused Device; A patent on an accused product or process does NOT give the owner of the patent a right

to exploit the product or process BUT some Fed Cir decisions suggest that a patent on the accused device may be

relevant to the substantiality of the difference between the patent claim and the accused device – at least when the patent in suit was cited and considered by the PTO in issuing a subsequent patent

Comparison between non-obviousness and insubstantial differences If the second patent requires practice of the first – i.e. the second merely adds an

element D to a patented combination A+B+C, the combination A+B+C+D clearly infringes

If the second patent is granted for A+B+D over one claiming A+B+C, the change from C to D must NOT have been obvious to be validly patented Judge Nies believes that a substitution in a patented invention cannot be both

nonobvious and insubstantial FESTO (SCOTUS 2002)

o Background;

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Festo’s patent claims; Originally no sealing ring limitation. Amended – two one-way rings. Claims are narrowed to include this limitation

SMC’s accused product; One two-way ring Would literally infringe the original claims – now after the amendment definitely would

NOT literally infringe o SCOTUS;

Going against the purpose of the DOE; Here – the narrowing amendment “rebuts the inference that a thing not described was indescribable” – went from not talking about sealing rings to using sealing rings.

Reject Fed Cir’s approach of “absolute bar” when narrowing amendment. Although it is certain, it goes against the meaning behind PHE and DOE

New Rule; Presumption against patentee – narrowing amendment rebuttably waives DOE Patentees try to claim as much as possible typically and an amendment is usually a

concession that they can’t claim something that broad. Can always appeal if disagree When/how the presumption can be rebutted;

The equivalent that he is seeking to capture was unforeseeable at the time of amendmento “At the time of the amendment a phosita could NOT reasonably be expected

to have drafted a claim that would have literally encompassed the alleged equivalent”

The rationale underlying the amendment bears no more than a tangential relation to the equivalent in questiono The reason for the amendment was focused on one thing and the equivalent

at issue is in relation to a tangential issue Some other reason suggests that the patentee could not reasonably be expected

to have described the insubstantial substitute in questiono No case yet has found this to be the case

Here, CT says foreseeable – could reasonably expect one in the art to draft a different amendment

o FESTO Remand; Interaction of WJ and FESTO presumptions

“An unexplained amendment – just like a narrowing amendment made for a reason of patentability – triggers a rebuttable presumption that the patentee has surrendered the entire (middle) territory…”

How to apply the rebuttables Unforeseeable; Unforeseeability of substitute technology

Evidence to consider? o Later-developed technology

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o Old technology is GENERLLY foreseeable. Could have written the claims to support these from the outset

o Expert testimony and other extrinsic evidence Whose job to decide? T Judge as fact finder, from phosita’s perspective (This case

must be remanded to T CT) This means between first filing and amendment – should amend to include in

disclosure if need it there Tangentially of reason for amendment

Evidence to consider?o Pros history docs; “objectively apparent reason” (Don’t leave critical things

unwritten)o “An amendment made to avoid prior art that contains the equivalent..is not

tangential” Whose job? The CT construing the official documents (Can’t establish here)

Some other reason Evidence? “While vague, must be a narrow one”

o Pros history docs, at least for now o Can’t be used if substitute tech was in prior art

Whose job? CT does by it self and same sort of application as above. Not here. o Notes from after case;

Note 3; What constitutes a narrowing of claim scope is not always straight forward; Honeywell v. Hamilto (Fed Cir 2004); The patentee rewrote a dependent claim into

independent form, which contained an additional limitation. Fed Cir said that amendment constituted a narrowing of claim scope, and therefore, the Festo presumption applied

Note 4; Defining Foreseeability; Fed Cir said Foreseeable if; A phosita would have known that the alternative existed in

the field of art as defined by the original claim scope, even if the suitability of the alternative for the particular purpose defined by the amended claim scope were unknown. Objective inquiry – asking whether it would have been foreseeable to a phosita

Usually if the alleged equivalent represents later developed technology or technology that was not known in the art – it would NOT have been foreseeable

SMITH-KLEIN v. EXCEL PHARMA; Patent related to an antidepressant, which were developed to avoid multiple dosages. The key ingredient for this release was HPMC, but the claim didn’t originally cite that limitation – it was added in a narrowing amendment to a 112 rejection. The alleged infringer used PVA instead of HPMC D said can’t argue PVA is equivalent to claimed HPMC bc amended to include

HPMC

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P said it could NOT have claimed PVA bc its patent disclosure only recited HPMC, and therefore, there was no support for PVA as required by 112.

Fed Cir; Rejected Ps argument bc it did NOT fit into one of the 3 Festo exceptions; PVA was not an unforeseeable equivalent at the time of the amendment The rational underlying the amendment was germane to the equivalent question –

not merely tangentially related. Note 5; Additional –

The relevant time period for evaluating Unforeseeability is time of amendment Festo applies to all granted patents and to all pending litigation that has not been

concluded with a final judgment, including appeals PHE can be invoked by arguments made during prosecution regardless of whether

claim language is amended. MEDTRONICSo Review of what FESTO does to DOE by PHE;

Front page of book. If only looking at FESTO and phe, people would disclose alternatives and start w/ a narrow claim – only claim 1 of the alternatives and seek to enforce all of them. This is bad if want PTO to determine if something is patentable, this would get around PTO – therefore there is the public dedication rule

J&J v. R.E. SERVICE (Fed Cir 2002) – Public Dedication Ruleo Background;

Patents; First patent, asserted against RES; “a sheet of aluminum” Continuation; “a metal substrate sheet” 1997 Continuation; “Sheet of stainless steel”

{This litigation is actually about J&J seeking damages before 1997. It is obvious literally infringe by RES after 1997.}

What is in the patent; Claim – aluminum Spec; While aluminum is the preferred embodiment, other metals such as stainless

steel or nickel may be used. RES uses steel – can J&J allege infringement under DOE?

o Finding; Dedicated to the public, so CANNOT use DOE. Can’t say it was PHE, BUT it is Dedicated to

the public bc in the spec Previous cases;

Maxwell – shoe tabs, distinct alternatives; Dedicated to the public; included in the spec but not claimed

YBM – A broad range in the spec and a subset claimed. CT says not dedicated to the public

Here CT sides with MAXWELL and uses that rule

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Not creating a conflict with GRAVER TANK In GT, the disclosure had different silicates listed, tried to claim them all, and only

got a patent on a type of silicate Integrity of PTO examination; “Patentee cannot narrowly claim an invention to avoid

prosecution scrutiny...and then use the DOE to establish infringement based on disclosure.”

o Rule; Public Dedication Rule; If describe something in disclosure and fail to try to claim it, can’t use DOE to try to capture it. Can do this if you want – BUT will be limited to what was actually claimed, can’t use the

DOEo Notes after the case;

PSC Computer v. Foxconn (Fed Cir 2004); CT – A mere generic reference in a written spec does not necessarily dedicate all

members of that particular genus to the public For subject matter to be dedicated to the public, a phosita must be able to

understand the unclaimed disclosed teaching upon reading the written description

The disclosure must be of such specificity that a phosita could identify the subject matter that had been disclosed and not claimed – but doesn’t impose a 112 enablement requirement on the disclosed but not unclaimed subject matter

PFIZER v. TEVA (Fed Cir 2005); Seems to require more express language to invoke public dedication rule. Public notice function of patents suggests that before unclaimed subject matter is

deemed to have been dedicated to the public, that unclaimed subject matter must have been identified by the patentee as an alternative to the claim limitation.

The rule is consistent w/ Festo bc disclosed but unclaimed subject matter is foreseeable SCIMED LIFE v. ADVANCED CARDIO (Fed Cir 2001) – All-limitations Rule

o Background; Balloon catheters – dual lumen is what ACS is using and what SLS discloses is coaxial

lumens First SLS says literal infringement – CT says that coaxial, not dual

NOT literal infringement – claim construction (look back to case) Equivalent infringement – precluded as a matter of law?

Specification; Discloses and then denigrates prior art adjacent-lumen design. What is says is that the inventor is saying – this is what I do and it is better Also, Coaxial is “the basic sleeve structure for all embodiments of the present

invention contemplated”o Finding/Reasoning;

All-limitations Rule applies. Dual lumens are “clearly excluded”

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A patent serves as fair public notice and have given the public reason to believe that coaxial lumens are it

o Rule; All-Limitations Rule; Each limitation of a patent claim is material to defining the scope of

the patented invention and must NOT be vitiated or rendered meaningless. The DoE applies to each limitation, not to the invention as a whole. So for there to be infringement under DoE, an equivalent of each claim

limitation must be found in the accused deviceo Notes;

Like the 6-9 pH case where trying to say that pH doesn’t matter- it must matter bc its in the claim

Cases in opinion where all-limitations rule is applied Moore v. Standard Register; CT said would defy logic to conclude a minority – the very

antithesis of majority (what was claimed) – could be insubstantially different from a claim limitation requiring a majority

Kodak v. Goodyear; Claimed inert gas and not allowed to apply DoE to reactive gas Sage v. Devon; Slots claimed on the top and not allowed to apply DoE to slot on side.

In all of these cases – there is a good common English word that is the opposite of what is in the claim. When drafting claims, don’t want to have a natural language opposites that could be

used to avoid. Note 1; Specific Exclusion Rule; The DoE is unavailable to capture subject matter that the

claim specifically excludes. COOK BIOTECH; The concept of equivalency cannot embrace a structure that is

specifically excluded from the scope of the claim Note 2; If the CT, by apply the all-limitations rule finds that the proffered equivalent to be

substantially different from the claim limitation – CT can find that DoE cannot be applied to that limitation

Note 3; CORNING GLASS; Equivalency will result when two components of the accused perform a single function of the patented invention OR when separate claim limitations are combined into a single component of the accused. But a claim limitation cannot be totally missing from the accused

Indirect Infringement o Intro;

Contributory patent infringement – The lamp with a dynoburner and glass chimney – someone selling the burner alone and another selling glass chimneys alone and it is the first time that a CT finds contributory infringement. Must less certain that glass chimney seller is selling to create a kit compared to the dynoburner seller.

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The case was against the person selling the burner alone – held liable. The only thing it is good for is making the claimed invention.

The statute reflects this now. Someone selling a piece of the larger whole and customers buy it to create the claimed invention 271[c]; Contributory Infringement; Whoever sells a component of patented machine…

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 uses. Ambiguity with knowledge requirement -

NO requirement of knowledge for direct infringement – but there is a requirement for indirect infringement.

271(b) – Inducing Infringement – Active inducement; “Whoever actively induces infringement of a patent shall be liable as an infringer.” - knowledge isn’t listed explicitly as a requirement

CT in this case (Global-Tech) – “When a person actively induces another to take some action, the inducer obviously knows the action that he or she wishes to bring about.” – BUT is that; 1) Merely that the inducer lead another to engage in conduct that HAPPENS TO

amount to infringement OR 2) The inducer must persuade another to engage in conduct that the inducer KNOWS

is infringement. o GLOBAL-TECH v. SEB (S CT 2011)

Background; SEB sues Pentalpha (Global-Tech sub) Sunbeam asks Pentalpha to make a fryer (cool exterior) – Then Pentalpha bought SEB

product in Hong Kong – no pat # on it bc it is a unit destined to be sold outside the US - Copied design and changed a little of the exterior Then they hired an attorney for clearance letter – and atty says that it is all-clear.

Pentalpha “refrained from telling the atty that its design was copied directly from SEB”

Finding/Holding; CT finds active inducement of infringement. SCOUTUS requires knowledge of the

patent – reasons; Statutory text is ambiguous for [b] and [c], Pre-1952 cases are ambiguous, Aro II – 271[c] requires knowledge of the patent - Strange if [c] requires knowledge and [b] didn’t.

Fed Cir’s “deliberate indifference” test is WRONG bc it requires no active effort by D to avoid knowledge

Adopts “Willful Blindness” from Criminal law

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Elements; D (1) Subjectively believes a high probability that a fact exists and (2) Take deliberate action to avoid learning/confirming it

Error in this case was harmless; Bc no reasonable jury could find that D didn’t meet willful blindness; “willfully blinded” themselves to the patent Didn’t give the name of SEB to atty for opinion letter and Knew that it was

copying SEB Rule; Knowledge is REQUIRED in order to show active inducement of infringement;

HOWEVER- this can be shown (1) even if the patent was NOT sent to you (as notice) or (2) Through willful blindness.

Defining Geographic Scope of the Patent Rights;o Intro;

Want to harmoniously interact with other country rights Basis is 271(a); “Except as otherwise provided in the title, whoever without authority

makes, uses, offers to sell, or sells any patented invention – within the US or import into the US any patented invention during the term of the patent, infringes

There are process and product claims – what within the US means is different depending on which it is and what the activity is

o NTP v. RIM (Fed Cir 2005) Background;

5 patents on mobile email. This is done over the internet and the RELAY/interface switch is located in Canada. There are Blackberrys in the US and the RF networks are within the US

So the question is “is this within the US?” Since Blackberry is Canadian, there is no reason to think that they are trying to evade

patents. RIM is the owner of Blackberry NTP – had 5 patents on mobile email

Some claims are systems/product and others are methods – this MAKES A DIFFERENCE in the end.

The direct infringers are Blackberry customers. Blackberry gives customers all the tools they need to infringe.

RIM’s defense – the Relay is in Canada. So part of the product is in Canada. Also, some of the method steps are in Canada

FED CIR; CT focuses on the different “infringing acts” AND different types of claims. DECCA (1976) – Claim to navigation systems that relied on pieces in different areas.

One part was in Norway and the other two were in the US. Some claims didn't require all 3 stations and only on the ones in the US – obviously in the US Other claims had to use all 3 – Decided for these that US didn’t make the system

in the US, but used it in the US. Not a making, but a using

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Did US customers use RIM’s system in the US? Product Use within the US; “To place where control of the system is exercised AND

beneficial use of the system is obtained” So this is enforceable

Did US customers use RIM’s METHOD in the US? Method If you fail to do an element of the claimed method, then haven’t

practiced the method SO since a method claim requires all of the steps to be performed, “it necessarily involves doing each of the steps” within the US.

Not enforceable here. Sell or offer for sale; At the end says that not saying that no method claim can be sold

or offered for sale – BUT just that THIS method claim can’t be sold or offered for sale. Rule;

Carefully separate the kind of infringing act that is being discussed Use within the US; “To place where control of the system is exercised AND beneficial

use of the system is obtained” Basically saying, whether or not the item being used is in the US at all or in part

Notes; Products can be written as process claims and process claims can be written as

product claims So if what you own is a process claim and carrying out the process necessitates

performing a step outside of the US – then enforcement of that process will be difficult to obtain

As the global technology is more intertwined and more people rely on this type of technology, this will become more important. Also good policy to not have engineers worrying about what borders they are

crossing Under use – there is not a discussion of making – this is bc of the Deepsouth case. Sell or offer for sale; With method claim??

Here – CT says, when interpret sale there is a notion of transferring or a title passes and methods don’t necessarily entail that. Unsure if this can be done but it doesn’t look at the question in deptho Basically says that it is not sensible to think of selling or offering for sell a

method. o Also says that Legislative history says that method claims aren’t sold

IMPORTANT NOTE AND DISTINCTION; If look at 102(b) CTs have said that process claims can be offered for sale or sold – and therefore bars can occur. But CT says that they don’t have to be symmetrical to one another On sale bar context, can sale method

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BUT – that process claim CANNOT be enforced against someone selling or carrying out a process for money.

Attached chart; Making/Product claims;

o DEEPSOUTH case; Claimed invention is to a machine that takes the vein out of scrimp. Accused infringer makes all of the pieces for the machine, but doesn’t assemble – sends to people outside the US and those people put together. The people that put it together are NOT in the US – so there is not direct infringement and therefor the person that makes the assembly pieces can’t be contributory infringers. This rules out this theory in the case here bc would be an easy win for D. This generated a Congressional response in 271(f) – which will

take this out Use/product claim is covered in case Use/method claims are covered in case Nothing covered with Makes/method OR offers/sells and product claims

Notes after Case; NTP held that the geographic test for infringement was whether control and beneficial

use of RIM’s system was within the US – NOT whether the actual infringement occurs in the US

A contract executed outside the US that provides an offer for sale of a patented product in the US invokes the “within the US” language of 271(a) – even though the actual product eventually sold did NOT infringe the patent TRANSOCEAN v. DEEPWATER –Two US companies executed a K in Norway that

called for the delivery and installation of a potentially infringing oil rig in US waters. But the rig that was ultimately delivered had a work around design that differed from the rig in the K. o CT; The focus should NOT be on the location of the offer, but RATHER the

location of the future sale that would occur pursuant to the offer. So – the potentially infringing article is the rig sold in the K, NOT the altered rig that was delivered to the US

Export Activity 271(f)o Intro to 271(f);

Response to Deepsouth – response being one who supplies unassembled parts of a patented device is an infringer

In DEEPSOUTH; CT said that a reason was bc patent law and other US law shouldn’t be thought of to pertain to extraterritorial (outside the US)

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Presumption that statutory language in a case of ambiguity does not apply to extraterritorially – if Congress wants it to apply extraterritorially – then it should clearly state so

Infringement to; supply components of a patented invention OR cause components to be supplied that are to be combined outside the US

This led to 271(f); Subsection (1) parallels 271(b) and (2) parallels 271[c] 271(f)(1)

To be liable as an infringer – must supply or caused to be supplied “all or a substantial portion” of the components in a manner that would infringe if such a combination occurred in the US. o The supply or causing to supply must start in the US

Under (f)(1) – components may be staple articles or commodities of commerce which are also suitable for non-infringing use

Actively induce is drawn from 271[b]o The combination does NOT actually have to occur – just have to actively

induce Basically aligns with the facts of DEEPSOUTH

271(f)(2); Components must be especially made or adapted for use in the invention

o Comes from 271[c] – requires infringer have knowledge that the component is especially made or adapted

o Also must have intent that components will be combined outside the US in a manner that would infringe if the combination occurred in the US

Want to hold someone accountable for especially made or especially adapted for use in the invention even – basically to hold someone accountable (although what is supplied doesn’t make it as obvious- higher culpability required)

o MICROSOFT v. AT&T (SCOTUS 2007) – 271(f)(1) Background;

Facts are not disputed. Microsoft has their operating system that is encoded in a physical medium and then copy the encoding to a master disk from transportation. Then sent to foreign country. The Master disk is used to create COPIES of the operating system. These copies are put on the computer.

AT’s claimed invention; Computer capable of digitally encoding and compressing speech

Neither software alone NOR processor alone infringers D CT and Fed Cir said that software was a component and it was supplied – Infringement

under 271 Questions/Issues;

In what form is software a “component”?

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Did M “supply” components from the US that were combined to make infringing products?

SCOTUS: When is software a “component”?

Looking at the physical embodiment Statutory Text for clues; Components must be combinable with other components

– by definition Software is NOT combinable until it is on a disk BUT if on a disk, then a

component Here, when put on a disk – it was overseas

Were the copies of Windows “supplied” from the US? Fed Cir; They supplied bc they gave the master that was then copied

o SCOTUS; No “The very component supplied from the US, and NOT copies thereof, triggers

271(f) liability when combined abroad”o Copying what is supplied from here is NOT the same thing as what is supplied

from here. This is NOT what happened here

o Microsoft sent abroad a single component and it was never combined – it was copied, so 271(f) is not triggered

o The copies did not originate from here – on disks - are what was combined with the computers to create the infringement.

Presumption against extraterritoriality applies with particular force to patent law. And even shapes legislative response, like 271(f). The presumption always applies

Notes; Business aspect;

What is the concern; Software is unlike sharply geographic constraint to production products and geographic constraints to sale.

What software industry is saying to the US is – if this case comes out to cause infringement overseas for Microsoft, then the software companies might go somewhere else where they will get protection.

Why take this narrow approach? Presumption against extraterritoriality applies with particular force to patent law.

Even though there is a general presumption in other areas of law 271(f) does NOT apply to method claims – ONLY about product claims. This is

from the Cardiac Pacemakers, Inc. v. St. Jude Medical case (2009). 271(g); Import Activity

o Statute; Whoever without authority Imports into the US or offers for sell, sells or uses within the US a product

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Which is made by a PROCESS patented in the USShall be liable as an infringer if the importation offer to sell, sell or use of the product occurs during the term of such process patent

(Exception) A product which is made by a patented process will, for purposes of this title, NOT be considered so made after; 1) It is materially changed by subsequent processes OR 2) It becomes a trivial or nonessential component of another product

o BTG v. GENENTECH (Fed Cir 1996) Background;

G owns 2 process patents. 1) ‘980 – Process for making hgh; Makes hgh without leader sequence (an unneeded bit). 2) ‘832 – Process for making plasmid (not hgh)

Scope of hgh in ‘980; Includes an extra amino acid (mhgh) AND also includes hgh WITHOUT the extra amino acid

BTG’s plan – seeks to import hgh made in Israel Here what is imported is the hgh and the patented process is for something that is a

necessary first step in making the importing process. Is that hgh “made by” either of G’s patents’ process?

FED CIR ‘980 patent – process for making hgh

BTG arguments - Really claim construction argumentso Our bacteria make insoluble, inactive mhgh

CT says; It does NOT matter – bc this is covered in the claim languageo Our mhgh is “materially changed” into hgh

CT – But the claim literally covers both forms o We have our own patent on purification

CT – Irrelevant, given literal language of claim in step #2. There are blocking patents

‘832 patent – process for making a plasmid BTG says retroactive problem bc the statute didn’t exist at that time – made once

five years before the statute was passedo CT; No – 271(g) does NOT prohibit mere process use AND BTG’s product

import is POST-enactment BTG; Is its hgh “made by” a plasmid-making pro’s?

o CT; BTG did literally make a plasmid, first, to make hgh. When looking at the Leg history – it describes protein as “made by” DNA of the process claim. This exact fact pattern

CT looks at practical and commercially viable alternatives when talking about “materially changed” – this is what determines the relationship between “materially changed” and “made by”

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o ELI LILLY V. AM CYANAMID (Fed Cir 1996) Background;

Lilly, invented cefaclor. Expired patent on cefaclor. Process patent for making an enol cephem – “Compound 6”. Process for making an intermediate on the way to making cefaclor

AC has approval to sell generic cefaclor, would import it from firm in Italy Makes cefaclor from Compound 6 – with a 4 step process, which is a relatively

routine process but still vitally important Commercial connections

Compound 6 can be used to make other cephalosporins Cefaclor can be made without making Compound 6. Not a total overlap - This is

shown bc Lilly itself does NOT make Compound 6. Findings; Is C6 materially changed by subsequent processes?

L’s theory of 271(g); Purpose is to preventing value-defeating scheme

o Should say; Liability if patented-process-product’s main commercial use is to make the accused product

o This test doesn’t look at chemical process – it looks at business industry BUT – Text seems to target structural change

L’s test gives no cap for amount of change Assuming L was right; Same process steps could be material change for one

product, but not another AND/OR Accused product’s status could change, if other commercial uses for the process-product arise

MATERIAL CHANGE = SIGNIFICANT STRUCTURAL CHANGE Here – 4 key changes mean that going from something that isn’t an antibiotic to

something that is a powerful one Notes;

Here – these facts are not set forth in the legislative history Conceding that cefaclor is made by Compound 6. Non-essential component exclusion does NOT apply Would BTG case come out this way?

Structurally they were different things These are still the leading two cases; If the leg history applies directly to the fact

pattern, then can use it – but if it does NOT then must look at the structure?o BAYER V. HOUSEY (FED CIR 2003)

Background; H owns process patents; “method for determing whether a substance is an inhibitor or

an activator of a protein” Product is INFORMATION about a substance

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B- let’s assume in this case; Uses claimed process to get info and Uses info to make a drug Can Bayer bring drug into US? Can B bring the info into the US?

Finding; INFO is NOT a “product which is made by…”

Dictionary definitions are ambiguous and Other sections of the statute equate making and manufacturing

“Materially changed by” seems physical “Becomes a component” seems physical Leg Hist; Congress focused on manufacturing – tangible goods

Drug compound is NOT made by the claimed ID process ID process is not used in physical drug synthesis

Notes; Statute does not apply to method claims that generate information

Came up in Blackberry case; Bringing in information – is NOT covered by the statute

Experimental Use – 271(e)(1) and Common Lawo Background beforehand;

Activity where people are tinkering around with things that fall under the patented product or process.

Also – drugs and selling generics, do you have to wait until the patent expires to experiment and submit approval?

o ROCHE PRODS. V. BOLAR PHARMA (Fed Cir 1984) – Case that led to the statute (didn’t read – not in book) Background;

Someone wants to enter as a generic and needs approval. Bolar begins testing its generic formulation.

Preparing to submit info to FDA, for post-Roche. Need to show that it is bio-equivalent – safety isn’t a factor bc the name product already showed that.

Roche sues under 271(a) – making unauthorized use Fed Cir;

Infringement – “prohibits, on its face, any and all uses” Also – not within common law experimental use exception bc Bolar’s goal is sale

for profit Notes;

Experimental use; 2 uses/types; Experimental use negation – to the 102 bar Here – experimental use exception to infringement

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o W/ this, it will be limited to experimental use that is NOT for eventual commercial use

Bc of this case 271(e)(1) – a safe harbor – is included (an exception to infringement) in the Hatch/Waxman Act right after 1984

Statute – 271(e)(1); It shall be an act of infringement

To make use offer to sell or sell within the US or import into the USA patented invention (other than a new animal drug or veterinary biological product)Solely for uses 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

Notes from Statute; Fine making the animal people wait – but not for humans “Development and submission of information”;

Does that mean – only the information that is DEFINITELY given to an agency OR information that MAY OR MAY NOT be given to the agency – Rule is it’s the type that would be submitted, but may not submit

What is reasonably related? What does “under a Federal law” mean?

Only the little part of the FDA which talks about drug approval or The whole FDC(osmetic)A?

o ELI LILLY v. MEDTRONICS – didn’t read either (S CT 1990) Background;

Lilly holds patent on implantable defibrillator FDA approval required to sell such medical devices Medtronic develops, tests a competing defibrillator

SCOTUS; The safe harbor applies 271(e)(1)

Covers device approval – as well as drug approval “A federal law” is the whole FDCA

o The same problem is being solved here as well as with drugs and that includes provisions on medical-device approval

o MERCK v. INTEGRA (S CT 2005) Background;

I owns patents on RGD peptide and binds with integrins (cell surface receptors) M funds research at Scripps on angiogenesis. Dr. Cheresh – can inhibit by blocking

integrins Would be using the patent on the experiment

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1995-1996 testing Tests multiple compounds than final clinical-trial-choice. Tests more than safety

(efficacy, mechanism, movement) I says infringement bc – 271(e)(1) covers data given to FDA and Safe harbor applies

only to the tests that were run and the results actually given to the FDA Finding;

Disagrees w/ I - reading is too narrow. If read that way – safe harbor would cover only generic-drug data

It deals with “scientific testing and that is a process of trial and error” Statutory text provides a wide berth – since error is part of testing, not going to

submit error results to FDA for approval I’s approach basically says that the safe-harbor applies only to what is submitted

for approval to the FDA – but that would mean that you would know what you were going to submit before you tested, if this were the case, why would you test?

Safe Harbor certainly applies where; Reasonable basis for thinking compound may work, AND It is “research that, if successful, would be appropriate to include in a

submission to the FDA” (Applies to devices and drugs, not research tools – from next case)

Still must have the goal of filing with the FDAo PROVERIS V. INNOVASYS (Fed Cir 2008) – answering research tool question

Background; P holds patent on lab analysis equipment, which measures aerosol spray

characteristics I sells “Optical Spray Analyzer” and used P’s equipment to gather data for submission

to FDA. Sold only to pharma companies, FDA Fed Cir;

Use of Proveris patent is NOT “reasonably related” NO FDA approval needed for the device

This is the boundary bc there is NO RISK of de facto extension of Proveris patent term - Since approval is NOT needed (This is not like defibulator case bc here FDA approval is not required)

o MADEY v. DUKE UNIVERSITY (Fed Cir 2002) – Common law exception Background;

M ran Free-electron laser lab at D. Owns FEL patents from his time at Stanford. Duke removed M from lab in 1997. M sues on FEL patents when lab continutes

Finding; Scope of judge made experimental use defense

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As a defense, it’s a burden the accused infringer carries The exception is “very narrow and strictly limited”

When it can be used; If performed for amusement, to satisfy idle curiosity, or for strictly philosophical

inquiry When can NOT use;

In a way commercial, or part of regular businesso “Part of regular business” is said bc: Duke is a private University that is not

doing the research for a commercial way BUT CT says; The projects unmistakably furthers the institution’s legit business

objectives, including educating and enlightening students and faculty participating in these projects

Notes; So CL experimental use would not really apply to people that are worth suing Before this case – there was a fairly conventional view that although experimental use

didn’t cover commercial use – it would still cover universities – After this case – that is NO longer allowed.

PREEMPTION Preemption;

o The key question is – What was Congress’s intent in passing the statute. Which can either be; Express;

ERISA (employment retirement) – “shall supersede any and all State laws insofar as they may now or hereafter relate to any employee benefit plan described..”

In IP, the copyright statute has something like this Patent does not have Implied;

Field preemption; The Federal statute or law on the issue is “so pervasive as to occupy the field” Ex; Immigration law

Conflict preemption; 2 types Mutual impossibility - one forbids what the other requires The particular state-law in question, obstacles to accomplishing federal purpose;

Question becomes; is there an accomplishment of the state law (in question) that conflicts/goes against the purpose of the federal law?

o PhRMA v. DC (DDC 2005) Background;

DC local law; Only covers patented drugs. “It shall be unlawful for any drug manu or licensee thereof, excluding a point of sale retail seller, to sell or supply for sale a patented prescription drug that results in the prescription drug being sold in the District for an excessive price.”

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This exempts most of the sellers – this was done in order to try to pass. Doesn’t define excessive price, but gives a way to show prima facie case

PhRMA – conflict preemption; DC local law is in conflict with Hatch-Waxman (1984) – which sought to smooth over the system between patent/drug approval law

Finding; What is the federal purpose/policy?

Patent owner sets its own price, during patent term – that is the prize/goal Price competition comes from generic entry Generic entry is carefully managed; Term extension for delays in FDA review –

156 and Infringement safe harbor for generic entrant – 271(e)(1) The federal law purpose is threatened by DC law – The DC law will limit the price that

can be charged for the drug – the purpose of the fed law is the incentive (price at whatever you want) – Can’t do that. It interferes with, and second guesses, the balance set by Congress, in favor of

foreign-market prices. Rule;

Must look at what the state law accomplishes – do any of those accomplishments conflict with the purpose of the federal law at issue? If so, then preemption

Notes; The fact that it is pointed to “a patented prescription drug” is an issue – this is a DC

regulation and it is affecting patents, which has always been Federal law – this brings out that it might be an issue immediately.

o KEWANEE OIL v. BICRON (S CT 1974) Patent law does NOT preempt trade secret law

There are things where only trade secret law can protect and only things that patent law can protect (things that can’t be protected once sold – it will be revealed, can reverse engineer etc.)

But there is some overlap; Many of these things are processes, can better protect bc these processes are going on at your business

So the issue here; Frustration of federal purpose – 3 of those; Encourage invention – TS does not frustrate, it only encourages it in other ways and

the same way Protecting public domain (novelty, nonobv., etc.)– TS doesn’t frustrate – if they are

kept secret it is not harming the public domain Promoting disclosure ; Patent law is encouraging disclosure and TS is staying away

from disclosure. So conflict? Looking at the overlap section, 3 different possibilities to determine if TS or

patent; it is patentable subject matter. The answers will be yes, no or maybe;

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o If say not patentable – then NOT less likely to get a patent, bc can’t get one anyway

If answer is maybe – Some will be patentable and others will not o If TS were cancelled, then would increase the number of patents that should

NOT be issued – this would be a social cost. If answer is yes – certain it is patentable, but the alternative is TS - CT says it is

NOT a conflict bc some will choose and others will not. o Patent law has advantages/disadvantages compared to TS law

CT concludes that states haven’t set up an alternative regime that will definitely frustrate the purpose of patent law. Part of what is playing a factor here is – SCOTUS disfavors preemption in an area where states have been governing for a long time – like Trade Secret law.

o BONITO BOATS V. THUNDER CRAFT BOATS (S Ct. 1989) Background;

FL state law protects vessel hull design “Unlawful…to use the direct molding process to duplicate for…sale any

manufactured vessel hull…made by another without…permission” Unlawful to “knowingly sell” a duplicate so made

The direct molding process is the most efficient way to make the vessel hull This is a sell or make prohibition and B sues T in 1984

Couldn’t obtain patent protection bc 102(b) would bar him since he had been selling it for 7 years

FL Supreme Ct strikes down the statute – “preempted” Dissenters prohibited only one duplicated method

SCOTUS; Federal policy of patent act;

Patent Act strikes a particular balanceo Protection for invention and Trade protection for disclosure

Competition from imitation o “free exploitation of ideas is the rule” – patent law is an exception

Novelty requirements and expiration protect the public domain “State may not render the exchange (patent bargain) fruitless”

o BUT can – e.g. prevent confusion as to source (trademark systems that include product design), and trade secret

Guidepost; Cannot “offer patent-like protection to intellectual creations which would otherwise go unprotected”

Results of FL statute fails; Patent-like right, not confusion prevention But NO Patent Act limits No novelty, nonobvious requirements – never expires

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Right to copy inefficiently does NOT save FL law Notes;

Compare what people would do with the FL statute and what would do without the statute – does it affect patent law? – that is the main lesson here

Vessel Hull Design Protection Act (1998); 10 year term. People hoped that this would become a GENERAL industrial design statute – which we don’t have. There is a novelty like rule – 2 year grace period. Original is the same as ©. Run by the © office

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