Patenting the Unpatentable - Claim Drafting After Prometheus

Patenting the Unpatentable May 30, 2012
Brenden Gingrich, Ph.D., J.D. IP Impact®, Northern VA

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Patentable Subject Matter

• §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…”
• Congress intended statutory subject matter to “include
anything under the sun that is made by man.”
– Diamond v. Chakrabarty, 447 U.S. 303 (1980)

© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 2

Exceptions to §101

• Judge made exceptions to patentable subject matter
– Natural Products
– Natural Laws / Natural Phenomena
– Abstract Ideas / Mental Processes
• They are “part of the storehouse of knowledge … free
to all men and reserved exclusively to none.”
– Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127
(1948)


Supreme Court Case Summary

• Parker v. Flook, 437 U.S. 584 (1978)
• Diamond v. Diehr, 450 U.S. 175 (1981)
• Bilski v. Kappos, 130 S. Ct. 3218 (2010)


Parker v. Flook, 437 U.S. 584 (1978)

1. A method for updating the value of at least one alarm limit in
the catalytic chemical conversion of hydrocarbons
comprising:
(1) Determining the present value of a process variable;
(2) Determining a new alarm base B1, using the following
equation:
B1=Bo(1.0-F) + PVL(F);
(3) Determining an updated alarm limit which is defined as
B1 + K; and thereafter
(4) Adjusting said alarm limit to said updated alarm limit
value.


Parker v. Flook, 437 U.S. 584 (1978)

Holding:
• A formula cannot be patented; the case must “be considered
as if the principle or mathematical formula were well known.”
– “[O]nce that algorithm is assumed to be within the prior
art, the application… contains no patentable invention.”
• A patent involving a law of nature or mathematical formula
must include some other inventive concept in its application
• “[A] claim for an improved method of calculation, even when
tied to a specific end use, is unpatentable subject matter
under § 101.”
• Post-solution activity is insufficient


Diamond v. Diehr, 450 U.S. 175 (1981)

1. A method of operating a rubber-molding press, comprising:
providing a computer with a data base,
initiating an interval timer upon the closure of the press,
constantly determining the temperature (Z) of the mold and
constantly providing the computer with the temperature (Z),
repetitively performing in the computer integrations to
calculate the Arrhenius equation, which is ln v = CZ + x,
where v is the total required cure time,
repetitively comparing in the computer said calculation of
the total required cure time and said elapsed time, and
opening the press automatically when a said comparison
indicates completion of curing.


Diamond v. Diehr, 450 U.S. 175 (1981)
Holding:
• Claims are “drawn to an industrial process” and do not
wholly preempt the equation’s use
• Claims are directed to method for curing rubber, which is a
transformative process
• “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. … The “novelty” of any element or steps in a
process, or even of the process itself, is of no relevance” in
the §101 analysis.


Bilski v. Kappos, 130 S. Ct. 3218 (2010)

1. A method for managing the consumption risk costs of a
commodity comprising the steps of:
• (a) initiating a series of transactions wherein said
consumers purchase said commodity at a 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 at a second fixed
rate such that said series of market participant transactions
balances the risk position of said series of consumer
transactions.


Bilski v. Kappos, 130 S. Ct. 3218 (2010)

Holding:
• Hedging risk is an unpatentable abstract idea
• Patent would preempt use of this approach in all fields and
grant a monopoly over an abstract idea
• Limiting an abstract idea to one field of use or adding token
post-solution components is not sufficient


Prometheus Representative Claim

1. A method of optimizing therapeutic efficacy for treatment of
an immune-mediated gastrointestinal disorder,
comprising:
(a) administering a drug X to a subject having said
disorder; and
(b) determining the level of metabolite Y in said subject,
wherein the level of metabolite Y less than about 230 units
indicates a need to increase the amount of said drug
subsequently administered to said subject and
wherein the level of metabolite Y greater than about 400
units indicates a need to decrease the amount of said drug
subsequently administered to said subject.


Prometheus Opinion

• The administering and detecting steps aren’t sufficient
– Identifies the audience; routine and conventional
– “[T]he steps are not sufficient to transform
unpatentable natural correlations into patentable
applications of those regularities.”
• “Transformation” alone is not sufficient
– “[I]n stating that the ‘machine-or-transformation’
test is an ‘important and useful clue’ to patentability,
we have neither said nor implied that the test
trumps the ‘law of nature’ exclusion.”


Summary of Supreme Court Caselaw
• Specific applications of natural laws are patentable,
however:
– The “application” must amount to an “inventive
concept” in addition to the natural law (Parker v. Flook)
– If the additional steps are “conventional,” it is less likely
there is an “inventive concept” (Mayo v. Prometheus)
– “Insignificant” extra-solution activity isn’t enough
(Parker v. Flook)
– Limiting claims to a particular technological field is not
the same as a “specific application” (Parker v. Flook;
Bilski v. Kappos)
– No preemption: the “application” cannot amount to
claiming the natural law (Mayo v. Prometheus)

Prometheus – not just a concern for biotech

• Ultramercial v. Hulu recently vacated by Supreme Court
• Claimed subject matter
– Method of providing copyrighted material over the
internet in exchange for viewer watching an
advertisement
• Federal Circuit’s holding: patentable method
– Abstract idea: using advertising as currency
– Specific application: requires 10 specific steps,
including providing content on the internet, an
extensive computer interface, and specialized
programming

Is this an “application” of the natural law?

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

(a) administering a drug X to a subject having said disorder; and

(b) determining the level of metabolite Y in said subject,

wherein the level of metabolite Y less than about 230 units
indicates a need to increase the amount of said drug
subsequently administered to said subject and

wherein the level of metabolite Y greater than about 400 units
indicates a need to decrease the amount of said drug
subsequently administered to said subject;
(c) administering an increased or decreased amount of said drug
as indicated by said level of metabolite Y.

Easy Improvements to Prometheus

• Integrate: don’t state the natural law / algorithm in a
separate, easily identified “wherein” clause
1. A method of treating disease A comprising:
measuring a level of metabolite Y in a patient
being treated with an amount of drug X,
administering an increased amount of drug X to the
patient when the amount of the metabolite Y in the
patient’s blood is less than 230 units, and
administering a decreased amount of drug X to the
patient when the amount of the metabolite Y in the
patient’s blood is greater than 400 units.

Consider Multiple Perspectives

• Doctor: diagnosing, administering drug, instructing patient,
ordering tests, reviewing tests, adjusting dose, monitoring
efficacy and adverse events
• Patient: administering drug, being informed, adjusting dose,
being treated, experiencing adverse events
• Hospital: coordinating treatment, providing drug, administering
drug, instructing patient, ordering tests, reviewing tests,
adjusting dose, monitoring patient populations
• Pharmacist: providing drug, providing instructions and
information
• Lab: acquiring sample, measuring drug levels, providing results
• Insurer: requiring testing, authorizing treatment, providing
payment


Use Multiple Claim Types

• Draft claims in view of multiple actors
• Draft claims to devices, systems, and methods
• Be sure to have multiple levels of specificity in
dependent claims

• Keep and Application Pending
– Allows for adaptation to later court opinions


What about Divided Infringement?

• Avoid when possible:
1. A method of treating disease X comprising:
administering a first amount of drug Z to a patient in
need thereof,
administering an increased amount of drug Z to the
patient when an amount of the metabolite Y in the
patient’s blood is less than 230 pmol/ml, and
administering a decreased amount of drug Z to the
patient when an amount of the metabolite Y in the
patient’s blood is greater than 400 pmol/ml.
• But don’t exclude all divided infringement claims – the
law may change

Drafting the Specification

• Telling a story to avoid “preemption”
– Define the “natural law / algorithm” abstractly
• e.g., the mechanism of action of a drug
– Disclose multiple applications of the “natural law /
algorithm”
• e.g., list the numerous diseases that could be treated
based on this mechanism
– Claim only a “specific application”
• e.g., treatment of one disease, dose and route of
administration
• But it must be more than limiting claim to a particular
“technological field”

Medical Devices and Methods

1. A method of reducing wrinkles comprising: applying
ultrasound energy of frequency X to wrinkled skin for
a sufficient period of time to reduce said wrinkles.
2. A device for reducing wrinkles comprising: an
ultrasound generator configured to apply ultrasound
energy of frequency X to wrinkled skin for a sufficient
period of time to reduce said wrinkles.


Medical Devices and Methods

1. A method of reducing wrinkles comprising: applying
ultrasound energy of frequency X to wrinkled skin for
a sufficient period of time to reduce said wrinkles.
• 1. A method of reducing wrinkles using an ultrasound
transmitter configured therefor, comprising:
• selecting a portion of skin having wrinkles for
treatment using said ultrasound transmitter;
• placing said ultrasound transmitter in proximity to
said portion of skin; and
• transmitting ultrasound energy of frequency X to said
portion of skin for at least 5 minutes.

Diagnostic Claims

1. A method of detecting cancer X comprising:
• obtaining a tissue sample from a patient at risk of
cancer X;
• measuring/detecting the level of marker Y in said
sample;
• wherein the presence of marker Y indicates the
presence of cancer X.


Diagnostic Claims

1. A method of detecting cancer X comprising:
• obtaining a tissue sample from a patient at risk of
cancer X;
• measuring/detecting the level of marker Y in said
sample;
• administering treatment Z to said patient when
marker Y is present in said sample.


New Uses of Known Drugs

• “Unlike, say, a typical patent on a new drug or a new
way of using an existing drug, the patent claims [of
Prometheus] do not confine their reach to particular
applications of those laws.”
1. A method of treating disease X comprising:
• identifying a patient suffering from disease X, and
administering to said patient a therapeutically
effective amount of compound Y.


Brenden Gingrich, Ph.D., J.D. Brenden.Gingrich@knobbe.com
858-707-4118

Patenting the Unpatentable - Claim Drafting After Prometheus

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