Navigating the PostPrometheus World
Technology Transfer Tactics
Webinar
May 3, 2012
Kevin E. Noonan, Ph.D.
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. 35
U.S.C. 101.
But there is an implicit exception: “laws of nature,
natural phenomenon, and abstract ideas are not
patentable subject matter.”
How do you know if your invention is in the
exception?
A BRIEF HISTORY OF PATENTABLE
SUBJECT MATTER
Earlier cases typically overbroad
• O’Reilly v. Morse: specific claims upheld, broad claim to
any system for transmitting information using electricity
barred
• Funk Bros. Seed Co. v. Kalo Inoculants: claims not patenteligible because encompassed any combination of noninhibiting bacteria
• Gottschaulk v. Benson: general method for converting
binary-coded decimal (BCD) numerals into pure binary
numerals on a general purpose digital computer
• Parker v. Flook: method applying an algorithm to calculate
alarm limits
• Bilski v. Kappos: general method for hedging risk, applied
to commodities trading
Patent-eligible cases more
specific
• Diamond v. Chakrabarty: specific geneticaly
engineered bacteria for breaking down oil
• Diamond v. Diehr: specific application of Arrhenius
equation to cure rubber
• State Street Bank& Trust Co. v. Signature Financial
Group (Fed Cir): “concrete, tangible and useful result
• J.E.M. AG Supply, Inc. v. Pioneer Hi-Bred, Inc : broad
interpretation of Section 101
• Particular issue involve algorithms and mathematical
formulae
Prometheus below
• Claims a method for optimizing treatment of an immunemediated gastrointestinal disorder with 6-thioguanine
• Recited steps of administering the drug to a patient and
detecting 6-thioguanine or 6-methyl-mercaptopurine
(metabolite) in blood
• Recites inferring step of therapeutic efficacy when 6thioguanine levels in red blood cells are between 230
pmol-400 pmol per 8 x 108 red blood cells
• Levels outside these ranges “indicates a need” to adjust
administration amounts accordingly – but does not recite
affirmative steps of adjusting
Prometheus below
• Steps for administering a drug and determining
metabolites can be transformative and satisfy Bilski
• Such steps can be “method of treatment” steps that are
“always transformative”
• Involving “natural processes” not determinative, since
“every transformation of physical matter . . . occurs as
the result of natural processes”
• A process for chemical or physical transformation of a
physical object or substance are “virtually self-evidently”
patent-eligible subject matter
• Inclusion of a mental step does not negate patenteligibility
Question to the U.S. Supreme Court
“This case concerns whether a patentee can
monopolize basic, natural biological relationships. …
The question presented is: Whether 35 U.S.C. §
101 is satisfied by a patent claim that covers
observed correlations between blood test results
and patient health, so that the claim effectively
preempts all uses of the naturally occurring
correlations, simply because well-known methods
used to administer prescription drugs and test blood
may involve ‘transformations’ of body chemistry.”
The Opinion: What is claimed
“The case . . . concerns patent claims covering processes
that help doctors who use thiopurine drugs to treat
patients with autoimmune diseases determine whether a
given dosage level is too low or too high. 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.”
Patentable? No
“The question before us is whether the claims do
significantly more than simply describe these natural
relations. To put the matter more precisely, do 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.”
Claim “Analysis”
A method of optimizing therapeutic
efficacy for treatment of [a disease],
comprising:
(a) administering a
drug . . .; and
(b) determining
the level of [the drug],
wherein
the level of [the drug being] less
than [a lower amount] indicates a
need to increase the amount of
said drug . . . and
wherein the
level of [the drug being] greater
than [a higher amount] indicates a
need to decrease the amount of
said drug . . .
 “administering” step
"simply refer[] to the
relevant audience,
namely doctors who
treat patients" with
thiopurine drugs
 This audience “preexisting”
Claim “Analysis”
A method of optimizing therapeutic 
efficacy for treatment of [a disease],
comprising:
(a) administering a
drug . . .; and
(b) determining the
level of [the drug],
wherein the
level of [the drug being] less than [a
lower amount] indicates a need to
increase the amount of said drug . . .
and
wherein the level of [the drug
being] greater than [a higher amount]
indicates a need to decrease the
amount of said drug . . .
no particular method
for making the
determination is
specified, and thus
the entirety of prior art
methods for making
the determination is
encompassed by the
claim
Claim “Analysis”
A method of optimizing therapeutic
efficacy for treatment of [a disease],
comprising:
(a) administering a
drug . . .; and
(b) determining
the level of [the drug],
wherein
the level of [the drug being] less
than [a lower amount] indicates a
need to increase the amount of
said drug . . . and
wherein the
level of [the drug being] greater
than [a higher amount] indicates a
need to decrease the amount of
said drug . . .
the “wherein” clauses simply
tell a doctor about the relevant
natural laws, at most adding a
suggestion that he should take
those laws into account when
treating his patient . . . these
clauses tell the relevant
audience about the laws while
trusting them to use those
laws appropriately where they
are relevant to their
decisionmaking
“Routine, Conventional”
“[T]he steps in the claimed processes (apart from
the natural laws themselves) involve wellunderstood, routine, conventional activity previously
engaged in by researchers in the field”
”[A]t the same time, upholding the patents
would risk disproportionately tying up the use of the
underlying natural laws, inhibiting their use in the
making of further discoveries"
“Routine, Conventional”
“These instructions add nothing specific to the laws
of nature other than what is well-understood, routine,
conventional activity, previously engaged in by those
in the field. And since they are steps that must be
taken in order to apply the laws in question, the
effect is simply to tell doctors to apply the law
somehow when treating their patients. The process
in Diehr was not so characterized; that in Flook was
characterized in roughly this way.”
“Routine, Conventional”
“They tell a treating doctor to measure metabolite
levels and to consider the resulting measurements in
light of the statistical relationships they describe. In
doing so, they tie up the doctor’s subsequent
treatment decision whether that treatment does, or
does not, change in light of the inference he has
drawn using the correlations. And they threaten to
inhibit the development of more refined treatment
recommendations (like that embodied in Mayo’s
test), that combine Prometheus’ correlations with
later discovered features of metabolites, human
physiology or individual patient characteristics.”
“Not Enough” Added
”The upshot is that the three steps simply tell doctors to
gather data from which they may draw an inference in
light of the correlations," merely "inform[ing] a relevent
audience of certain laws of nature.”
“To put the matter more succinctly, the 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.”
Natural Law
“Prometheus’ patents set forth laws of nature—namely,
relationships between concentrations of certain metabolites in
the blood and the likelihood that a dosage of a thiopurine
drug will prove ineffective or cause harm. While it takes a
human action (the administration of a thiopurine drug) to
trigger a manifestation of this relation in a particular person,
the relation itself exists in principle apart from any human
action. The relation is a consequence of the ways in which
thiopurine compounds are metabolized by the body—entirely
natural processes. And so a patent that simply describes that
relation sets forth a natural law.”
Law of Nature
“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.”
Flook and Diehr
“The claim before us presents a case for patentability that is
weaker than the (patent-eligible) claim in Diehr and no stronger
than the (unpatentable) claim in Flook. Beyond picking out the
relevant audience, namely those who administer doses of
thiopurine drugs, the claim simply tells doctors to: (1) measure
(somehow) the current level of the relevant metabolite, (2) use
particular (unpatentable) laws of nature (which the claim sets
forth) to calculate the current toxicity/inefficacy limits, and (3)
reconsider the drug dosage in light of the law. “
Example
“Einstein, we assume, could not have patented his
famous law by claiming a process consisting of
simply telling linear accelerator operators to refer to
the law to determine how much energy an amount
of mass has produced (or vice versa). Nor could
Archimedes have secured a patent for his famous
principle of flotation by claiming a process consisting
of simply telling boat builders to refer to that
principle in order to determine whether an object will
float.”
Keep in Mind: Policy Considerations
“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.”
The Patent Goldilocks
“Patent protection is, after all, a two-edged sword. On
the one hand, the promise of exclusive rights provides
monetary incentives that lead to creation, invention,
and discovery. On the other hand, that very exclusivity
can impede the flow of information that might permit,
indeed spur, invention, by, for example, raising the
price of using the patented ideas once created,
requiring potential users to conduct costly and timeconsuming searches of existing patents and pending
patent applications, and requiring the negotiation of
complex licensing arrangements.”
Diagnostic method claim structure

General problem of “determine and
infer” claims (Prof. Kevin Collins,
Washington U):



Characterized by one or more “determining”
steps that involve assays, etc.
Include “mental step” of reaching a
conclusion or arriving at an inference based
on outcome of determining steps
Claim preamble directs method to activity
(e.g., diagnosing) based on inference
DMC produce information
 Information per se not patent-eligible
 Not one of the categories set forth in
Section 101
 Methods for manipulating data (software)
subject to variable Supreme Court
precedent (Benson, Flook, Diehr, Bilski)
 Information (data) not a “manufacture” for
purposes of Section 271(g) – Bayer AG v.
Housey Pharm, Inc.
Are medical DMC’s different?
• Hypothetical claim #1:
A method for predicting a nuclear power plant reactor
failure, comprising the steps of assaying pressure
in a reactor coolant tank and correlating pressure
fluctuations with the likelihood of failure, wherein
a pressure fluctuation of +/- 7% indicates a
greater than 90% likelihood that the reactor will
fail.
Are medical DMC’s different?
• Hypothetical claim #2:
A method for predicting escalation of a hurricane to
Category 5 status, comprising the steps of
assaying ocean temperature along a predicted
storm track, wherein the hurricane is predicted to
achieve Category 5 status if the ocean
temperature changes by more than 5 degrees
Celsius over less than 100 miles of the storm
track.
Are medical DMC special?
• Differences in structure or differences in
application?
• Subject matter differences – medical DMCs relate to
human body
• Implicates doctor/patient relationship:
• “As construed by the Federal Circuit, claim 13
provides those researchers with control over
doctors' efforts to use that correlation to diagnose
vitamin deficiencies in a patient.” Labcorp v.
Metabolite
• Precedent for treating medical methods differently –
35 U.S.C. §287(c)
Additional considerations
• Potential for a patent “thicket”
• Involves reagents for performing the assays
– need to license dozens/thousands of
genes correlated with disease
• Some efforts around this (patent pooling,
standard setting SNP consortium,
Navigenics “ASCAP” solution)
• Will get worse before it gets better,
particularly regarding personalized medicine
29
What do we do now?
First, don’t panic!
 Prometheus decision not as sweeping as it
first looks
 Analytically flawed based on conflating 101
with rest of patent statute
 Like many Supreme Court patent cases,
cabined to some extent by its facts (claims
overbroad and encompassed prior art)
 However, some discomfort in the short term
The culprits: patent attorneys
Prior precedent "warn us against interpreting
patent statutes in ways that make patent
eligibility depend simply on the draftsman's art
without reference to the principles underlying
the prohibition against patents for [natural
laws]. They warn us against upholding patents
that claim processes that too broadly preempt
the use of a natural law.”
Challenges are opportunities
• “The name of the game is the claim.” Rich, J.
• Whether there is “enough” more to be more
than “stating a natural law and then the
words ‘apply it’” will depend on how the
invention is claimed
• But this means we need to assess how
claims will be evaluated
In assessing patent eligibility, will the
claims be considered as a whole?
 Conflict in Supreme Court precedent
 In Diamond v. Diehr, the Court instructed: “It is
inappropriate to dissect the claims into old and new
elements and then to ignore the presence of the old
elements in the analysis.”
 In Prometheus, the Court pays lip service to Diehr (“[A]
new combination of steps may be patentable . . .”), but still
focuses on whether specific claim steps are “conventional
or obvious”
 Consequence: the more conventional the
method steps the easier to dissect them
Distinctions between §§101, 102 and
103
• Less significant than they were before
Prometheus
• Consistent with Supreme Court’s aversion
to substantive patent law
• According to the court, the analysis can
“overlap”
• Once the “natural law” is discerned,
assessment of whether the method recites
“well-understood, routine, conventional”
steps controlling
Claim-drafting Strategies
• Good news: the Court did not adopt the
“pretend the invention is in the prior art”
method
• Avoid claims that only produce information
• Include active steps directing more than
mental activity
• Make sure the “law of nature” does not
constitute the only novel feature of the
claim
• Remember joint infringer problem
Claim-drafting Strategies: Biomarkers
• “Novelty” associated with new biomarker
or (perhaps) new association of known
biomarker for new disease
• Not enough to recite detection of known
biomarker known to be associated with
known disease without more
• Limited to method claims
Claim-drafting Strategies: Prometheus
A method of administering 6-thiopurine to a
patient in need thereof for treating an immunemediated gastrointestinal disorder, comprising
the step of administering a therapeutically
effective amount of the drug that produces no
less than 230 pmol and no more than 400 pmol
per 8x108 red blood cells in blood from the
patient.
Claim-drafting Strategies: Classen
A method of immunizing a mammalian
subject comprising the step of administering
to a patient an immunogen that is
immunologically specific for an infectious
disease-causing organism according to an
immunization schedule that has a reduced
risk for developing a chronic immunemediated disorder(s).
Claim-drafting Strategies: Myriad
A method for diagnosing a predisposition
for breast cancer in a human subject
comprising the steps of: a) obtaining a
biological sample from the subject; b)
determining a sequence for BRCA1 or
BRCA2 from the sample; and c) detecting
a breast cancer-related mutation in either
BRCA1 or BRCA2 from the subject
sample.
Consequences for Universities
 Alternatives to patenting (trade secret, etc.)
not viable
 Some proprietary positions (what doesn’t
work) but not as valuable
 Prometheus v. Bayh-Dole compliance
dilemma
 Requires legislative fix – political solution
“[W]e must recognize the role of Congress in
crafting more finely tailored rules where
necessary. Cf. 35 U.S.C. §§161–164
(special rules for plant patents). We need
not determine here whether, from a policy
perspective, increased protection for
discoveries of diagnostic laws of nature is
desirable.”
Our task, rather, is the narrow one of determining what
Congress meant by the words it used in the statute;
once that is done our powers are exhausted. Congress
is free to amend §101 so as to exclude from patent
protection organisms produced by genetic engineering.
Compare 42 U.S.C. §2181, exempting from patent
protection inventions “useful solely in the utilization of
special nuclear material or atomic energy in an atomic
weapon.” Or it may choose to craft a statute specifically
designed for such living things. But, until Congress takes
such action, this Court must construe the language of
§101 as it is.
Diamond v. Chakrabarty
Thank you!
Kevin E. Noonan, Ph.D.
noonan@mbhb.com
www.patentdocs.org
MBHB
300 South Wacker Drive
Chicago, Illinois 60606-6709
312 913 0001 phone
312 913 0002 fax
www.mbhb.com