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Recent Developments
Concerning
Patent-Eligible Subject
Matter
Down the Rabbit Hole…..
Yale University
September 11, 2014
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Supreme Court IP Cases
 Mayo v. Prometheus
 Aereo
 Alice
 Nautilus
 Limelight
 Octane
 Pom Wonderful
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Economics
 Industries that directly rely on patents and
trademarks support about 40 million jobs - about
25% of all jobs in the U.S.
 These industries account for approximately $5
trillion – about 35% of the U.S. GDP
 AUTM Licensing Activity Survey 2013
University and Non-Profit Patent Licensing Impact
1996-2010 as much as:
$388 billion on U.S. gross domestic product
$836 billion on U.S. gross industrial output*
*Biotechnology Industry Organization
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35 U.S. Code § 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.
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Judicially Created Exceptions
 Laws of Nature/Scientific Discoveries
 Applied Force equals the mass of an object
multiplied by its acceleration
 Energy content of an object equals its mass
multiplied by the square of the speed of light
 Levels of drug metabolites in human body
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Judicially Created Exceptions (Con’t.)
 Abstract Ideas/Formulas
 Mathematical Equations - 4 = 2
 Preexisting, Fundamental Truths - Pythagorean
Theorem
 Natural Phenomena
 Lightning
 Gravity
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Question Presented
 Whether claims to computer-implemented
inventions—including claims to systems and
machines, processes, and items of
manufacture—are directed to patent-eligible
subject matter within the meaning of 35
U.S.C. § 101 as interpreted by this Court.
 Focus on computer-implemented scheme
but decision applies across technologies.
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Alice v. CLS – “Technology”
 Computer-implemented scheme for mitigating
settlement risk.
 Third party intermediary maintains “shadow credit
record” and “shadow debit record” for each transacting
party.
 For each proposed transaction, third party checks if any
party would end up owing more than being owed.
Assets
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Liabilities
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Technology in Prometheus Patent
 Use of thiopurine drugs to treat an immune-mediated GI
disorder claim:
 A method of optimizing therapeutic efficacy for treatment of an
immune-mediated GI disorder, comprising:
a) administering a drug providing 6-thioguanine to a
subject. . . .,
and
b) determining the level of 6-thioguanine in said subject . . . .,
wherein the level of 6-thioguanine less than about 230
pmol 8x108 RBCs indicates a need to increase . . .
and
wherein the level of 6-thioguanine greater than about
400 pmol 8x108 RBCs indicates a need to decrease . . . .
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Issue before U.S. Supreme Court
 Do the claims do significantly more than
simply describe the natural relations in
which thiopurine compounds are
metabolized by the body?
 Conclusion: “steps are not sufficient to
transform unpatentable natural correlations
into patentable applications of those
regularities”
 A patent cannot “simply recite a law of
nature and then add the instruction apply
the law.”
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Supreme Court Two-Part Test to Determine
Subject-Matter Eligibility
 Mayo Framework applies to all judicial exceptions.
1) Is invention directed to law of nature, natural
phenomena, or abstract idea?
2) If so, search for an “inventive concept” that ensures the
claim amounts to “significantly more” than the law of
nature, natural phenomena, or abstract idea itself.
 Mayo Framework applies to all claim types.
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Step One
 Is the invention Directed to a Judicial
Exception?
 Law of Nature
 Natural Phenomenon
 Abstract Ideas
 Claims are Directed to the Concept of
“Intermediated Settlement”
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Step One (Con’t.)
 Intermediated Settlement is a Fundamental
Economic Concept
 “long prevalent in our system of commerce”
 “building blocks of the modern economy”
 “taught in any introductory finance class”
 “long standing economic practice”
 Fundamental Economic Concepts can be
Abstract Ideas
 So, YES!
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Step Two
 Is there “inventive concept” that amounts to
“significantly more” than the judicial
exception?
 More than mere conventional activity
 Can be either a new element or a combination of
old elements
 Insufficient
 Generic computer Implementation (Alice)
 Well-understood, routine, conventional activities
 Limiting use to particular technological
environment
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Step Two (Con’t.)
 Possibly Sufficient
 Improving existing technological process
 Improving another technology or technical field
 Improving the functioning of computer itself
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What Alice v. CLS Tells Us
 The abstract idea exception is broader than
mathematical formulas and preexisting,
fundamental truths
 No categorical exclusion of business
methods.
 Concurrence: Sotomeyor, Ginsburg, Breyer
would have created business method exception.
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What is an Abstract Idea?
Abstract Idea
Preexisting,
Fundamental Truths
Methods of
Organizing Human
Activities
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Mathematical
Algorithms/Formulas
Fundamental
Economic Practice
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What Alice v. CLS Does Not Tells Us:
 “In any event, we need not labor to delimit
the precise contours of the ‘abstract idea’
category in this case.”
 What standards of novelty and nonobviousness for 101 purposes?
 Same as 102 and 103?
 Since the abstract idea is considered known, is
this like a 103 rejection without a reference?
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USSN: 13/193,421, allowed 12/2013
 1. A method of diagnosing, aiding in diagnosing or
predicting risk of developing early onset neonatal sepsis
(EONS) in a newborn subject, comprising: (a) determining if
switching of an Hp 0-0 phenotype to an Hp 1-1, an Hp 2-2 or
an Hp 1-2 phenotype has occurred in the newborn subject;
 and (b) diagnosing or aiding in diagnosing the newborn
subject as having EONS, or predicting that the newborn
subject is at increased risk of developing EONS, if switching
of an Hp 0-0 phenotype to an Hp 1-1, an Hp 2-2 or Hp 1-2
phenotype has occurred.
 Canceled:
 36. (New) A method of diagnosing, aiding in diagnosing or
predicting risk of developing early onset neonatal sepsis
(EONS) in a newborn subject, comprising:
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USSN: 13/193,421, allowed 12/2013 (cont’d)
 (a) detecting haptoglobulin and
haptoglobulin-related protein (Hp&HpRP)
immunoreactivity in a biological sample of
the newborn subject; and
 (b) diagnosing or aiding in diagnosing the
newborn subject as having EONS, or
predicting that the newborn subject is at
increased risk of developing EONS, if
Hp&HpRP immunoreactivity is detected in
the biological sample.
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USSN: 13/131,787, recently allowed
1. An agent comprising
i) a first peptide comprising the amino acid
sequence of SEQ ID NO: 13,
ii) a second peptide comprising the amino
acid sequence of SEQ ID NO: 14, and
iii) a third peptide comprising the amino acid
sequence of SEQ ID NO: 16.
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