1 PATENT LAW Randy Canis CLASS 2 Introduction to Patent Law; Patent Eligibility; Utility.

PATENT LAW

Randy Canis

CLASS 2

Introduction to Patent Law; Patent Eligibility; Utility

Introduction (Chapter 1)

• Essence of the Patent System– Disclosure of a technological advance in exchange for

the right to exclude others from employing it

– Also: Improve society through technological change

Nature and Function of Patent System

• Incentive to invest in research to make new inventions.

• Patent system promotes disclosure of new inventions and thereby enlarges the public storehouse of knowledge.

• Does the patent system succeed in achieving the aforementioned goals?

Incentive to Invest

• Pros– Too easy to appropriate– Problem with free riders– No return on research and development

• Cons– Restrict output– Monopoly restricts use– Distorts economic activity– Hinders progress

Incentive to Disclose

• Pros– Absence of protection – inventors would

keep invention secret– Secrecy prevents public from full

benefits

• Cons– Secrecy is not always practical– Is the public disclosure enough?

Federal Preemption

• The displacement of a state law due to the existence of a federal law

• Why do we care about federal preemption?– Patent law is federal law.

• What if:– A state law was enacted prior to the federal law?– A state law was enacted after the federal law?– The state law governs laws not covered under federal

law?– State law provides additional rights/benefits beyond

federal law?– State law restricts benefits/rights granted under federal

Patent Eligibility (Chapter 2)

• Is a particular invention of a kind that the patent laws intended to protect?

• Subject matter open to patenting– Are there subject matters that are not

open to patenting?• Natural Laws• Phenomena of Nature• Abstract Principles

• Technology = useful arts

Three Types of Patents

• Utility Patent – an invention that is functional and useful

• Design Patent – a new, original, and ornamental design of an article of manufacture

• Plant Patent – protection on a new variety of plant that has been asexually reproduced through grafting, budding or a similar technique

§101 – Inventions Patentable

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

• What title are we talking about?– 35 USC

Patent Prosecution Basics• Patent Prosecution

– The process by which a patent application runs its course through the patent office that ultimately results in the application being issued as a patent or abandoned.

– Who are the primary parties?• Inventor(s)• Applicant• Examiner• Patent Attorney and Agent

– What is the difference between the inventor(s) and applicant, and why does it matter?

– Important Issue – Who does the attorney represent: one or more of the inventors, the applicant, a third party paying the bills, etc?

Diamond v. Chakrabarty

• Procedural Background

• Factual Background

• Issue:– Can micro-organisms qualify as

patentable subject matter (without Congress’s express authorization)?

• What are canons of construction?

• What is the legislative history?

• Why does the court focus on whether the microorganism is an unknown natural phenomenon?

• What if the technology involved a shift from one known form to another form—could the shift form then be patentable?

• Must Congress expressly authorize protection?

• What policy issue does the court discuss?

• Ruling– Court overruled the examiner’s rejection

of the claims.

• Holding– Congress hasn’t excluded organisms

produced by genetic engineering from §101.

• Dicta

Exceptions to Patentability

• Generally laws of nature and abstract ideas– Abstract mathematical algorithm with no

concrete application– Products occurring naturally in nature

Products of Nature

• Patents are not available for products of nature per se.

• However, patents on “isolated” or “purified” products that are not naturally found in nature are generally patentable.

Software

• What is software?– “a set of machine-readable instructions

capable of performing a particular task.”

• Is software patent eligible?– Gottschalk v. Benson - 1972– Diamond v. Diehr - 1981– State Street Bank -1998– In re Bilski – 2010

Gottschalk v. Benson

1972 Supreme Court Decision

• Invention– Method for converting a binary-coded

decimal (BCD) numerals into pure binary numerals

– Claims not limited to art or technology– Claims cover any use of the method in a

general purpose computer

Gottschalk v. BensonClaim 8 reads:The method of converting signals from binary coded decimal form

into binary which comprises the steps of-(1) storing the binary coded decimal signals in a reentrant shift

register,(2) shifting the signals to the right by at least three places, until

there is a binary '1' in the second position of said register,(3) masking out said binary '1' in said second position of said

register,(4) adding a binary '1' to the first position of said register,(5) shifting the signals to the left by two positions,(6) adding a '1' to said first position, and(7) shifting the signals to the right by at least three positions in

preparation for a succeeding binary '1' in the second position of said register.

• “Transformation and reduction of an article ‘to a different state or thing’ is the clue to the patentability of a process claim that does not include particular machines.”

• “It is argued that a process patent must either be tied to a particular machine or apparatus or must operate to change articles or materials to a ‘different state or thing.’ We do not hold that no process patent could ever qualify if it did not meet the requirements of our prior precedents.”

• “The mathematical formula involved here has no substantial practical application except in connection with a digital computer, which means that if the judgment below is affirmed, the patent would wholly pre-empt the mathematical formula and in practical effect would be a patent on the algorithm itself.”

Diamond v. Diehr• 1981 Supreme Court Decision• Invention

– Method of operating molding presses during the production of rubber articles

– “The process uses a mold for precisely shaping the uncured material under heat and pressure and then curing the synthetic rubber in the mold so that the product will retain its shape and be functionally operative after the molding is completed”

Diamond v. Diehr1. A method of operating a rubber-molding press for precision molded

compounds with the aid of a digital computer, comprising: providing said computer with a data base for said press including at least,

natural logarithm conversion data (ln), the activation energy constant (C) unique to each batch of said compound being molded, and a constant (x) dependent upon the geometry of the particular mold of the press,

initiating an interval timer in said computer upon the closure of the press for monitoring the elapsed time of said closure,

constantly determining the temperature (Z) of the mold at a location closely adjacent to the mold cavity in the press during molding,

constantly providing the computer with the temperature (Z), repetitively calculating in the computer, at frequent intervals during each cure,

the Arrhenius equation for reaction time during the cure, which is ln v=CZ+x where v is the total required cure time,

repetitively comparing in the computer at said frequent intervals during the cure each said calculation of the total required cure time calculated with the Arrhenius equation and said elapsed time, and

opening the press automatically when a said comparison indicates equivalence.

Diamond v. Diehr

• What is new?– “the continuous measuring of the

temperature inside the mold cavity, the feeding of this information to a digital computer which constantly recalculates the cure time, and the signaling by the computer to open the press, are all [asserted by the Respondent to be] new in the art.”

Diamond v. Diehr

• “[W]e think that a physical and chemical process for molding precision synthetic rubber products falls within the 101 categories of possibly patentable subject matter.”

Diamond v. Diehr

• Mathematical Formula v. Process– Claim does not pre-empt all use of well-

known equation– Claim seeks to protect use of equation

with other steps of claimed process– “We view respondents' claims as nothing

more than a process for molding rubber products and not as an attempt to patent a mathematical formula.”

Diamond v. Diehr

• “[W]hen a claim containing a mathematical formula implements or applies that formula in a structure or process which, when considered as a whole, is performing a function which the patent laws were designed to protect (e. g., transforming or reducing an article to a different state or thing), then the claim satisfies the requirements of 101.”

State Street Bank & Trust Co. v. Signature Financial Group Inc.

• 1998 Federal Circuit Decision• Invention

– Data processing system for implementing an investment structure for use with administering mutual funds

– “In essence, the system, identified by the proprietary name Hub and Spoke (Registered), facilitates a structure whereby mutual funds (Spokes) pool their assets in an investment portfolio (Hub) organized as a partnership. This investment configuration provides the administrator of a mutual fund with the advantageous combination of economies of scale in administering investments coupled with the tax advantages of a partnership.”

1. A data processing system for managing a financial services configuration of a portfolio established as a partnership, each partner being one of a plurality of funds, comprising:

(a) computer processor means [a personal computer including a CPU] for processing data;

(b) storage means [a data disk] for storing data on a storage medium;

(c) first means [an arithmetic logic circuit configured to prepare the data disk to magnetically store selected data] for initializing the storage medium;

(d) second means [an arithmetic logic circuit configured to retrieve information from a specific file, calculate incremental increases or decreases based on specific input, allocate the results on a percentage basis, and store the output in a separate file] for processing data regarding assets in the portfolio and each of the funds from a previous day and data regarding increases or decreases in each of the funds, [sic, funds’] assets and for allocating the percentage share that each fund holds in the portfolio;

(e) third means [an arithmetic logic circuit configured to retrieve information from a specific file, calculate incremental increases and decreases based on specific input, allocate the results on a percentage basis and store the output in a separate file] for processing data regarding daily incremental income, expenses, and net realized gain or loss for the portfolio and for allocating such data among each fund;

(f) fourth means [an arithmetic logic circuit configured to retrieve information from a specific file, calculate incremental increases and decreases based on specific input, allocate the results on a percentage basis and store the output in a separate file] for processing data regarding daily net unrealized gain or loss for the portfolio and for allocating such data among each fund; and

(g) fifth means [an arithmetic logic circuit configured to retrieve information from specific files, calculate that information on an aggregate basis and store the output in a separate file] for processing data regarding aggregate year-end income, expenses, and capital gain or loss for the portfolio and each of the funds.

“[T]he transformation of data, representing discrete dollar amounts, by a machine through a series of mathematical calculations into a final share price, constitutes a practical application of a mathematical algorithm, formula, or calculation, because it produces “a useful, concrete and tangible result”--a final share price momentarily fixed for recording and reporting purposes and even accepted and relied upon by regulatory authorities and in subsequent trades.”

• The Business Method Exception– “We take this opportunity to lay this ill-

conceived exception to rest.”– “Whether the claims are directed to subject

matter within Section 101 should not turn on whether the claimed subject matter does ‘business’ instead of something else.”

Pre-Bilski

• Gold rush on software and so-called business method patents?

• Public anger on patent availability– Amazon 1-click case– Swing on a swing patent

In re Bilski (Fed. Cir.)

• 2008 Federal Circuit Decision (en Banc)

• Invention– Method for hedging risk in the field of

commodities trading– Claim is not limited to transactions

involving actual commodities and may involve options

1. A method for managing the consumption risk costs of a commodity sold by a commodity provider at a fixed price comprising the steps of:

(a) initiating a series of transactions between said commodity provider and consumers of said commodity wherein said consumers purchase said commodity at a fixed rate based upon historical averages, said fixed rate corresponding to a risk position of said consumer;

(b) identifying market participants for said commodity having a counter-risk position to said consumers; and

(c) initiating a series of transactions between said commodity provider and said market participants at a second fixed rate such that said series of market participant transactions balances the risk position of said series of consumer transactions.

• Board of Appeals– No technological arts test– No requirement of a specific apparatus if

there is a transformation– No patent-eligible transformation– No useful, concrete and tangible result

• 101 background– Threshold inquiry in determining

patentability– Issue of law subject to de novo review– Process in the statute means patent

eligible process

• Question for the Court– “[W]hether Applicants' claim recites a

fundamental principle and, if so, whether it would pre-empt substantially all uses of that fundamental principle if allowed”?

• Test identified by Federal Circuit In re Bilski– “A claimed process is surely patent-

eligible under § 101 if: (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing.”

– Sole test for determining patent eligibility of a process under 101…

• Can a process become patentable through field-of-use limitations or post solution activity?– No– “[M]ere field-of-use limitations are generally

insufficient to render an otherwise ineligible process claim patent-eligible.”

– “[I]nsignificant postsolution activity will not transform an unpatentable principle into a patentable process.”

• All other identified tests are explicitly overruled by the court– Freeman-Walter-Abele test– “Useful, concrete, and tangible result”

test of State Street and Alappat– Technological Arts test– Business method exception

• What is an article?– Doesn’t have to be a physical object– Courts have taken a “measured

approach to this question”– Transformation of raw data into a

particular visual depiction of a physical object on a display is eligible

Bilski at the PTO

• In response, Examiners at the PTO required structure in the body method claims, machine readable claims, and system claims

• Guidelines for Patent Examiners were issued on August 24, 2009

In re Bilski at the Supreme Court

1. Whether the Federal Circuit erred by holding that a “process” must be tied to a particular machine or apparatus, or transform a particular article into a different state or thing (“machine-or-transformation” test), to be eligible for patenting under 35 U.S.C. § 101, despite this Court’s precedent declining to limit the broad statutory grant of patent eligibility for “any” new and useful process beyond excluding patents for “laws of nature, physical phenomena, and abstract ideas.”

In re Bilski at the Supreme Court

2. Whether the Federal Circuit’s “machine-or-transformation” test for patent eligibility, which effectively forecloses meaningful patent protection to many business methods, contradicts the clear Congressional intent that patents protect “method[s] of doing or conducting business.” 35 U.S.C. § 273.

In re Bilski – Supreme Court Decision

• Who delivered the opinion of the court?– Kennedy

• Section §101– Four independent categories of

inventions or discoveries that are eligible for protection

– Processes, machines, manufactures, and compositions of matter

– Permissive approach to patent eligibility– Ingenuity should receive a liberal

encouragement

• Definition of a Process from Section §100(b)

• “process, art or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material.”

• Potential Categorical Limitations considered by Supreme Court– Machine-or-transformation test – Categorical exclusion of business

method patents.

• Analysis– words interpreted with their ordinary,

contemporary, common meaning– Past interpretations of 101 consistent with

ordinary meaning– “Concerns about attempts to call any form of

human activity a “process” can be met by making sure the claim meets the requirements of §101.”

– Machine or transformation test violates statutory principles

• Machine-or-transformation test– not endorsed as the exclusive test– was not intended to be an exhaustive or

exclusive test– provides “a useful and important clue, an

investigative tool, for determining whether some claimed inventions are processes under §101”

– is not the sole test

• Business method patents are not categorically excluded

• At least some business methods may be allowed

• Court gave some deference to enacting of §273 that provided a defense to methods of doing business– No suggestion of broad patentability

• Decision in this case– Attempting to patent an abstract idea– “[I]t is clear that petitioners’ application is

not a patentable ‘process.’”– “Allowing petitioners to patent risk

hedging would preempt use of this approach in all fields, and would effectively grant a monopoly over an abstract idea.”

• No such limitations on §101

• Rejected under abstract ideas

• No further definition of process

• Federal Circuit may further developing limiting criteria

• 4 Justices Majority Part II–B–2 (w/o Scalia)• §101 is dynamic and should adjust to new

technology• The machine-or-transformation test may not be

good for the information age• “[T]he machine-or-transformation test would create

uncertainty as to the patentability of software, advanced diagnostic medicine techniques, and inventions based on linear programming, data compression, and the manipulation of digital signals.”

• Court takes no position on patentability of these types of technology

• 4 Justices Majority Opinion Part II–C-2 (w/o Scalia)– “If a high enough bar is not set when

considering patent applications of [the Information Age], patent examiners and courts could be flooded with claims that would put a chill on creative endeavor and dynamic change.”

– “[P]recedents on the unpatentability of abstract ideas provide useful tools.”

• 4 – Justice Concurrence by Stevens

• The entire court agrees that the machine-or-transformation test is not the exclusive test

• Restore §101 to its historical and constitutional moorings

• 4 – Justice Concurrence by Stevens• Machine-or-transformation test is a

“critical clue”• “[A]lthough a process is not patent-

ineligible simply because it is useful for conducting business, a claim that merely describes a method of doing business does not qualify as a ‘process’ under §101.”

• 4 – Justice Concurrence by Stevens• Points on Majority Opinion

– Don’t take the ordinary meaning portion of the interpretation of the word “method” literally

– “[T]he machine-or-transformation test remains an important test for patentability [and] [f]ew, if any, processes cannot effectively be evaluated using these criteria.”

– The majority does not explain what is an unpatentable abstract idea

• 4 – Justice Concurrence by Stevens• What does process mean?

– “was neither intended nor understood to encompass any series of steps or any way to do any thing.”

– Statutory definition is ambiguous– Process does not have ordinary meaning in 101– History shows that a method of doing business

is not a process under 101

• 4 – Justice Concurrence by Stevens• Provides some guidance on what is a

business method– a method for organizing human activity– Described examples include business

organization, business models, management techniques, and novel solutions to the challenges of operating global firms in which subordinate managers could be reached only by a long sea voyage.

– Business methods are not useful arts

• 4 – Justice Concurrence by Stevens• Congress passed 273 to limit the effect of

business method patents and not to validate their existence

• Serious doubt whether business method patents are needed to encourage innovation

• Patents on business methods may prohibit a wide swath of legitimate competition and innovation

• 4 – Justice Concurrence by Stevens• Comment regarding patent holding

companies/trolls– “[P]atent laws are not intended to ‘creat[e] a

class of speculative schemers who make it their business to watch the advancing wave of improvement, and gather its foam in the form of patented monopolies, which enable them to lay a heavy tax upon the industry of the country, without contributing anything to the real advancement of the arts.”

• 2 – Justice Concurrence with Breyer• A method of engaging in business transactions is

not a patentable process – 1 of the 2 justices only• 101 is not without limit• Machine-or-transformation test has never been the

sole test• 101 is an important example for determining

patentable but is not the exclusive test• Anything which passes the useful, concrete, and

tangible results test is not necessarily patentable.

• In summary– Majority – some business methods may

be patentable– Concurrence – business methods are

not patentable

• Result– Computer software is still patentable– Business methods that don’t involve

technology have a limited chance of being patentable

– What about methods for treatment?• More in a minute

Strategy After Bilski

• Explain to clients the risk of seeking a pure business method patent

• Include claims that can satisfy machine-or-transformation test– Can the claims be performed in the mind or on a piece of

paper?– Indicate the transformation in the claims

• Doing XXXXX to create YYYYY

• Include support in the specification for hardware• Machine-readable medium should be non-

transitory to avoid signal claim problems per Kappos on 1/26/10

101 Decisions After Bilski

Cybersource Corp v. Retail Decisions

• Fed. Circuit Patent Decision

• Patent invalidated at District Court for failing to claim patent-eligible subject matter

• Fed. Circuit Affirmed

• Example Claims…• 3. A method for verifying the validity of a credit

card transaction over the Internet comprising the steps of:

• a) obtaining information about other transactions that have utilized an Internet address that is identified with the [ ] credit card transaction;

• b) constructing a map of credit card numbers based upon the other transactions and;

• c) utilizing the map of credit card numbers to determine if the credit card transaction is valid.

2. A computer readable medium containing program instructions for detecting fraud in a credit card transaction between a consumer and a merchant over the Internet, wherein execution of the program instructions by one or more processors of a computer system causes the one or more processors to carry out the steps of:

a) obtaining credit card information relating to the transactions from the consumer; and

b) verifying the credit card information based upon values of plurality of parameters, in combination with information that identifies the consumer, and that may provide an indication whether the credit card transaction is fraudulent,

wherein each value among the plurality of parameters is weighted in the verifying step according to an importance, as determined by the merchant, of that value to the credit card transaction, so as to provide the merchant with a quantifiable indication of whether the credit card transaction is fraudulent,

wherein execution of the program instructions by one or more processors of a computer system causes that one or more processors to carry out the further steps of;

[a] obtaining information about other transactions that have utilized an Internet address that is identified with the credit card transaction;

[b] constructing a map of credit card numbers based upon the other trans-actions; and

[c] utilizing the map of credit card numbers to determine if the credit card transaction is valid.

• Applicability– Any method or system for detecting

credit card fraud which utilizes information relating credit card transactions to particular Internet addresses

• Claim 3– Obtain and compare intangible data pertinent to

business risks– Does not require method to be performed by a

machine– Internet is only a source of the data– Unpatentable mental process– Not limited to a particular fraud detection

method– No algorithms are disclosed

• Claim 2– Computer readable version of claim 3– “[W]e have never suggested that simply reciting

the use of a computer to execute an algorithm that can be per-formed entirely in the human mind falls within the Alappat rule. Thus, despite its Beauregard claim format, under Abele, we treat claim 2 as a process claim for patent-eligibility purposes.”

• “[M]erely claiming a software implementation of a purely mental process that could otherwise be performed without the use of a computer does not satisfy the machine prong of the machine-or-transformation test.”

• What did we learn?– Data gathering steps cannot alone

confer patentability– If the method can be performed entirely

in the mind, a machine readable version of the claim is likewise not patent eligible

Once the Supreme Court Rules…

• It normally doesn’t touch subject matter for a while

• However, here it rules again on a 101 issue…

Mayo Collaborative Services v. Prometheus Labs., Inc.

• 2012 Supreme Court Decision• Laws of nature v. patentable subject matter• Prometheus

– sole and exclusive licensee of the ’623 and ’302 patents

– sells diagnostic tests that embody the processes the patents describe

• Mayo– Originally bought Prometheus tests– Later decided to use its own tests

• Laws of nature, natural phenomena, and abstract ideas are not patentable

• They are the basic tools of scientific and technological work’

• Monopolization of these tools would impede, instead of encourages, innovation

• Applications of laws of nature are not per se unpatentable

• “The claims purport to apply natural laws describing the relationships between the concentration in the blood of certain thiopurine metabolites and the likelihood that the drug dosage will be ineffective or induce harmful side-effects. We must determine whether the claimed processes have transformed these unpatentable natural laws into patent eligible applications of those laws. We conclude that they have not done so and that therefore the processes are not patentable.”

• “[Precedent] insist[s] that a process that focuses upon the use of a natural law also contain other elements or a combination of elements, sometimes referred to as an “inventive concept,” sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself.”

• What is the technology?

• What was the state of the research in this area?

Claim 1

“A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:

(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and

(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder, wherein the level of 6-thioguanine less than about 230 pmol per 8x108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6-thioguanine greater than about 400 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.”

• What happened at D.C.?– Finding that Mayo infringed claim 7– But ruled summary judgment in favor of Mayo

on grounds that the patent claimed natural laws

• What happened at Fed. Cir.?– Reversed– Additional steps involve the transformation of

the human body or of blood taken from the body and thus satisfied the machine or transformation test

• “[D]o the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws? We believe that the answer to this question is no.”

• “If a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself.”

• “[T]he claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.”

• “[S]imply appending conventional steps, specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patentable.”

• “And so there is a danger that the grant of patents that tie up their use will inhibit future innovation premised upon them, a danger that becomes acute when a patented process amounts to no more than an instruction to ‘apply the natural law,’ or otherwise forecloses more future invention than the underlying discovery could reasonably justify.”

Post Mayo Claim Drafting

• In the claims, have something beyond steps or combination of steps that are in context obvious, already in use, or purely conventional

• If your claims include a natural law, make sure to structure the claim (or step(s) of the claim) as an inventive application of the natural law

Utility (Chapter 3)

• 35 USC §101 - “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title”

• Utility = usefulness

Utility

• Should the claimed invention be useful for some practical purposes in and of itself, or should it be superior to known technologies?

Lowell v. Lewis

• “All that the law requires is, that the invention should not be frivolous or injurious to the well-being, good policy, or sound morals of society.”

• The patent system is not looking for something better, but rather is just looking for something different.

Juicy Whip, Inc. v. Orange Bang, Inc.

• Question – is a patent on an invention that is “designed to deceive customers by imitating another product and thereby increasing sales of a particular good” invalid for lack of utility?

“The threshold of utility is not high: An invention is useful under section 101 if it is capable of providing some identifiable benefit.”

“The fact that one product can be altered to make it look like another is in itself a specific benefit sufficient to satisfy the statutory requirement of utility”

Utility

• Courts and the PTO have used the utility requirement to reject wholly inoperable inventions.

• Why is the standard for usefulness a low standard?

• Should we have a standard at all?• What guidelines do PTO examiners have

for considering the utility requirement?– See M.P.E.P. 2107 Guidelines for Examination

of Applications for Compliance with the Utility Requirement - 2100 Patentability

In Practice

• What do you do with an invention disclosure form?

Approval Process

• Ordinarily, once the invention disclosure is completed and approved by the patent committee, the inventor(s) will meet or have a teleconference with the attorney to discuss the invention

Approval Factors

What factors may be consider by in-house counsel and/or a patent committee when determining whether to file?

• Company total patent budget

• Competitors in the area

• Ease of infringement detection

Inventor Interview

• The attorney will attempt to obtain sufficient information from the inventor(s) to be able to draft the patent application

Purpose of the Meeting

• Understand the invention• Understand how the invention ties into the

company’s business• Be able to write claims based on the

invention disclosure meeting• Claim drafting during the meeting• Educate inventors on general patent

process and company’s internal patent process

Questions Asked

Questions that are typically asked by an attorney when interviewing the inventor:

• Has the invention been used publicly?

• When will the invention be publicly used or launched?

Invention Disclosure

• What is an invention disclosure form?

• What are the benefits of using an invention disclosure form?

• How do you prepare an invention disclosure form?

Program

Completed

Appendix

• Slides for a few biotechnology related cases regarding utility that are included in the book but not covered in class (or on a test)

Brenner v. Manson

• A substance that is known to be useful only as an intermediate in the production of other compounds that have no established utility is not itself useful.

• “[A] process patent in the chemical field, which has not been developed and pointed to the degree of specific utility, creates a monopoly of knowledge which should be granted only if clearly commanded by the statute.”

• “[A] patent is not a hunting license.”

In Re Fisher

• Invention– Five purified nucleic acid sequences

(ESTs) that encode proteins and protein fragments in maize plants

In Re Fisher

Claim 1 of the ’643 application recites: • A substantially purified nucleic acid

molecule that encodes a maize protein or fragment thereof comprising a nucleic acid sequence selected from the group consisting of SEQ ID NO: 1 through SEQ ID NO: 5.

In Re Fisher

• Why did the Examiner reject the application?

• What happened before the Board?– “The Board found that using the claimed

ESTs in screens does not provide a specific benefit because the application fails to provide any teaching regarding how to use the data relating to gene expression.”

In Re Fisher

• What are Fisher’s asserted uses?• “We agree with both the government

and the amici that none of Fisher’s seven asserted uses meets the utility requirement of § 101.”

In Re Fisher

• “[T]o satisfy the ‘substantial’ utility requirement, an asserted use must show that that claimed invention has a significant and presently available benefit to the public.”

• Not so vague as to be meaningless

• What could Fisher have shown to establish utility?

In Re Fisher

• Fisher’s uses are not specific• Fisher failed to “identify the function for the

underlying protein-encoding genes.”• “Absent such identification, we hold that

the claimed ESTs have not been researched and understood to the point of providing an immediate, well-defined, real world benefit to the public meriting the grant of a patent.”

Proof Required

• Proof that a compound will cause certain effects in laboratory animals may be sufficient utility; there is no requirement of therapeutic utility in humans.

• Patents and the Federal Circuit, 7th Edition.

In Vivo Issues• In vitro utility may be sufficient.• A claimed method of administering a compound to a

patient to achieve a particular result will require in vivo testing.

• If a person of skill in the pertinent art would conclude, upon reading the specification, that the patentee intends that the invention be used for the treatment of humans, then the compound must be shown both safe and effective for use on humans.

• Patents and the Federal Circuit, 7th Edition.• See 2107.03 Special Considerations for Asserted

Therapeutic or Pharmacological Utilities - 2100 Patentability

• http://www.uspto.gov/web/offices/pac/mpep/documents/2100_2107_03.htm#sect2107.03

1 PATENT LAW Randy Canis CLASS 2 Introduction to Patent Law; Patent Eligibility; Utility.

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