Patenting the Unpatentable - Claim Drafting After Prometheus

Patenting the Unpatentable May 30, 2012 Brenden Gingrich, Ph.D., J.D. IP Impact®, Northern VAThe recipient may only view this work. No other right or license is granted.

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)© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 3

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)© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 4

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.© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 5

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© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 6

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.© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 7

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.© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 8

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.© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 9

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© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 10

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.© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 11

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.”© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 12

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)© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 13

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© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 14

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.© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 15

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.© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 16

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© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 17

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© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 18

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© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 19

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”© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 20

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.© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 21

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.© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 22

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.© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 23

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.© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 24

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.© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 25

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

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Patenting the Unpatentable - Claim Drafting After Prometheus

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Patenting the Unpatentable - Claim Drafting After Prometheus Presentation Transcript