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PATENT LAW FOR EMERGING TECHNOLOGIES
THE EFFECT OF ABSTRACT EXAMPLES IN BIOTECH
Roy P. Issac, Ph. D., J. D.
AIPLA Biotechnology Committee Webinar
21 April, 2015
.

This presentation is intended for educational
purposes only. It is not intended to convey legal
advice pertaining to any particular situation and is
not a substitute for legal advice.
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Issues to consider for claims involving
abstract ideas or laws of nature
When is the use of the abstract idea or law nature analysis
necessary?
The rule from the recent Supreme Court cases has been used since
O’Reilly v. Morse (1854) and Nielson v. Harford (1841). Has the
recent cases changed the application of this rule?
Are the recent cases providing a rationale for the increased use of
abstract ideas/ law of nature analysis?
Should the abstract idea/ law of nature analysis be limited to cases
where the claims wholly preempt the application of the law of nature
or abstract idea in all fields?
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Recent Supreme Court Cases Addressing Patent Eligibility
of Claims Involving Abstract Ideas/ Laws of Nature
 Bilski v. Kappos
 Mayo v. Prometheus
 Alice v. CLS Bank
 The abstract idea or laws of nature analysis is applied when
the claim purports to entirely preempt the application of the
law of nature or abstract idea.
 These cases follow dissection analysis of claims rather than
considering the claim as a whole.
– Dissect out the abstract idea of law of nature and analyze
what is left for an inventive concept.
 Preemption is a focus in all three cases.
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Is the claim directed to an abstract idea?
i. A method of organizing human activity
ii. An idea itself
iii. A mathematical relationship
iv. Fundamental economic practice
Determine whether an element in the claim directed to a law of nature
or abstract idea will tie-up the subject matter and pre-empt others
from using the judicial exception.
Do the patent claims add enough to their statements of abstract ideas
or laws of nature to allow the processes they describe to qualify as
patent-eligible processes that apply natural laws?
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Does any element, or combination of elements, in the claim sufficient to
ensure that the claim amounts to significantly more than the judicial
exception?
Here the claim elements are analyzed by dissecting the judicial
exception out of the claim and determining if the additional elements
add sufficiently more.
Inventive concept: Does the claim as a whole amount to significantly
more than the exception itself?
– Claim is analyzed as a whole.
– Individual elements viewed on their own may not appear to add
significantly more to the claim, but when combined may amount to
significantly more than the exception.
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Bilski v. Kappos
Method of hedging
Dissect out abstract idea or law of nature from the claim and
consider as it is in the prior art and analyze the rest of the claims to
see if the elements alone or in combination amounts something
more than conventional or routine activity.
Follows Parker v. Flook (1978), O’Reilly v. Morse (1854) and
Neilson v. Harford (1841, English case)
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“[I]t is clear that petitioners’ application is not a patentable
“process.” Claims 1 and 4 in petitioners’ application explain
the basic concept of hedging, or protecting against risk.”
“The concept of hedging, described in claim 1 and reduced to
a mathematical formula in claim 4, is an unpatentable
abstract idea, just like the algorithms at issue in Benson and
Flook.”
“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.”
Court’s Analysis
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Mayo v. Prometheus
 Patent application directed to adjusting dosing regimen based on a
precise correlation between metabolite levels and likelihood for side
effects.
– A method of optimizing therapeutic efficacy …..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 …. indicates a need to increase the
amount of said drug subsequently administered to said subject
the level of 6-thioguanine greater than….indicates a need to decrease the amount
of said drug subsequently administered to said subject.
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Law of nature
Correlations between thiopurine metabolite levels and the toxicity
and efficacy of the thiopurine drug dosage.
The administering step, determining step and the wherein clause are
not themselves natural laws. However, they failed to transform the
nature of the claim.
The administering step simply refers to the relevant audience, i.e.,
doctors who treat patients with certain diseases with thiopurine drugs.
Prohibition against patenting abstract ideas cannot be
circumvented by attempting to limit the use of the formula to the
relevant audience.
Court’s Analysis
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“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 set forth) to calculate the current toxicity/inefficacy
limits, and (3) reconsider the drug dosage in light of the law [of
nature].”
In the Court’s view the claim amounted to merely stating the law of
nature and asking the doctors to apply it.
Court’s Analysis
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 Has the claimed process transformed unpatentable natural
laws into patent eligible applications of those laws?
 Is there an “inventive concept?”
 Are the steps in the claimed processes (apart from the
natural laws themselves) involve well-understood, routine,
conventional activity previously engaged in by researchers
in the field?
 Adding insignificant post-solution activity is said to be not
sufficient.
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Alice v. CLS Bank
Claims directed to the use of computers for the intermediate settlement of
banking transactions.
Computer acts as the third party intermediary for mitigating the
settlement risk that one of the parties to a transaction will not satisfy
his obligations.
Two-step analysis:
First determine whether the claims at issue are directed to a patent-
ineligible concept. Intermediate settlement, like hedging (Bilski) was
deemed an abstract idea.
Secondly, examine the elements of the claim to determine whether it
contains an “‘inventive concept’” sufficient to “transform” the claimed
abstract idea into a patent-eligible application.
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• Abstract ideas are not limited to claims involving
mathematical formulas.
• Hedging in Bilski and intermediated settlement are
“squarely within the realm of abstract ideas.”
• The Court “need not labor to delimit the precise
contours of the “abstract ideas” category in this case.
Court’s Analysis
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Take home points
 Determine whether the claim is directed to abstract idea or law
of nature
 Determine whether the claim preempts all uses of the abstract
idea or law of nature.
 Determine when to analyze the claim as a whole and when to
focus on the nature-based product element.
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Let’s not forget
 Too broad an interpretation of this exclusionary principle could eviscerate patent
law. (Mayo v. Prometheus)
 All inventions at some level embody, use, reflect, rest upon, or apply laws of
nature, natural phenomena, or abstract ideas.
 A process is not unpatentable simply because it contains a law of nature or a
mathematical algorithm. (Parker v. Flook)
 An application of a law of nature or mathematical formula to a known structure
or process may well be deserving of patent protection. (Diamond v. Diehr)
 While a scientific truth, or the mathematical expression of it, is not a patentable
invention, a novel and useful structure created with the aid of knowledge of
scientific truth may be. (Mackay Radio)
 At the same time, we tread carefully in construing this exclusionary principle lest
it swallow all of patent law. (Alice)
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Thank you!
Questions?
Elmore Patent Law Group, P.C.
484 Groton Rd.
Westford, MA 01886
978.251.3501
rissac@elmorepatents.com
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