the uspto grapples with mayo v. prometheus...2012/10/25 · c. mayo v. prometheus(cont.) back to...

The USPTO Grapples With Mayo v. Prometheus

Mark Ellinger, Ph.D., J.D.Fish & Richardson Boston Seminar SeriesOctober 25, 2012

PATENT-ELIGIBLE SUBJECT MATTER: A BRIEF, SELECTIVE OVERVIEW OF RECENT HISTORY

The U.S. patent statute sets out four categories of patent‐eligible subject matter: processes, machines, manufactures, and compositions of matter.

The Supreme Court (pre‐Mayo) had called out three exceptions to these categories: laws of nature, physical phenomena, and abstract ideas.

These judicially recognized exceptions had been described using various other terms, e.g., mental processes, natural phenomena, products of nature, scientific principles, disembodied concepts, mathematical algorithms and formulas.

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Selected Recent Cases:

A. Bilski Claims to methods of hedging risk in commodity trading Federal Circuit (en banc) held the claims invalid as failing to meet the

“machine or transformation” test, which it held to be the exclusive test for patent eligible subject matter

Supreme Court affirmed invalidity, but determined that the machine or transformation test is not the exclusive test, although MOT test can be “useful”

The Supreme Court reiterated there are only three exceptions: laws of nature, physical phenomena, and abstract ideas (the Bilski case dealt with the abstract idea exception)

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B. Labcorp v. Metabolite (Supreme Court, Pre‐Bilski) Claim: Method for detecting a deficiency of cobalamin or folate, comprising

‐ assaying for an elevated level of total homocysteine; and‐ correlating an elevated level with the deficiency

The Court held the writ of certiorari to have been improvidently granted, and dismissed the case

Three dissenters, Breyer, Stevens, and Souter, stated:“There can be little doubt that the correlation [novel] between homocysteine and vitamin deficiency set forth in claim 13 is a "natural phenomenon." . . . [The claimed] process instructs the user to (1) obtain test results and (2) think about them. . . . At most, respondents have simply described the natural law at issue in the abstract patent language of a ‘process.’”


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C. Mayo v. Prometheus Claims: Methods of optimizing therapeutic efficacy, comprising

‐ administering a drug [in the prior art]‐ determining the level of a metabolite of the drug [in the prior art]‐ wherein a level less than X “indicates a need” to increase the amount

of drug administered and wherein a level greater than Y “indicates a need” to decrease the amount of drug administered

Other claims omitted the administering step District court: not patent eligible; “wherein” clause interpreted as a quasi

active step (doctor “is warned”) Federal Circuit reversed; held the claims valid as meeting the machine or

transformation (MOT) test Supreme Court granted cert., vacated the Federal Circuit panel decision,

and remanded for reconsideration in light of Bilski


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C. Mayo v. Prometheus (cont.) On Remand:

− Fed. Cir. reaffirmed its previous decision: claims are patent‐eligible− Found both types of claims (with or without administering step)

patent eligible under the machine‐or‐transformation test− Treatment steps are “always transformative” when defined

drugs are administered to a body to treat an undesired condition

− Determining step is also transformative, not “mere data‐gathering,” since it works a chemical and physical transformation on physical substances


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C. Mayo v. Prometheus (cont.) Back to Supreme Court: “To begin with, the legal principles upon which we rely—that a

patent may not preempt laws of nature or abstract ideas, and that it is not saved by embedding the law of nature in a well‐known process that does not narrow the scope of the claim—were well established before Congress recodified the Patent Act and enacted Section 101 in its current form in 1952.”

Mayo Brief on Petition for Cert., Sept. 2011


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C. Mayo v. Prometheus (cont.) Unanimous Court reversed the Federal Circuit; opinion authored

by Justice Breyer (dissenter in Labcorp) Court’s analysis:

“The ‘administering’ step simply refers to the relevant audience (treating physicians)

“The ‘determining’ step simply tells the doctor to determine the level of the relevant metabolites in the blood, through whatever process the doctor or the laboratory wishes to use”

“The ‘wherein’ clauses simply tell a doctor about the relevant natural laws…”

Considering the elements together adds nothing Claims are “not sufficient to transform unpatentable natural

correlations into patentable applications of those regularities”


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March 12, 2012 USPTO Memorandum on Mayo

Issued day after S. Ct. Mayo decision came down Said examiners should continue to examine patent

applications for compliance with section 101 using the Interim Bilski Guidance issued July 27, 2010

Said examiners should also consider “other elements or combination of elements such that, in practice, the claimed product or process amounts to significantly more than a law of nature, a natural phenomenon, or an abstract idea with conventional steps specified at a high level of generality appended thereto.”

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July 3 “2012 Interim Procedure for Laws of Nature”

Supersedes the March 12, 2012 Memo For use by USPTO personnel in determining subject matter

eligibility of process claims involving laws of nature under 35 U.S.C.§101, in view of Mayo v. Prometheus

For examination of process claims in which a law of nature, a natural phenomenon, or naturally occurring relation or correlation (a “natural principle” in this guidance) is a limiting element or step

Process claims directed to abstract ideas should continue to be examined using the 2010 Interim Bilski Guidance document

Final guidance document(s) will await resolution of the Myriadand Ultramercial cases

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2012 Interim Procedure for Laws of Nature

“Essential Inquiries”:After determining what applicant invented and establishing the broadest reasonable interpretation of the claimed invention, examiners are to conduct the following three inquiries:

1. Is the claimed invention directed to a process?2. Does the claim focus on a natural principle, i.e., is the natural

principle a limiting feature of the claim?3. Does the claim include additional elements/steps, or a combination

of elements/steps that integrate the natural principle such that the natural principle is practically applied, and are sufficient to ensure that the claim amounts to significantly more than the natural principle itself? Does the claim state more than a law of nature plus the

general instruction to simply “apply it”?

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Detailed Guidance for Using the Inquiries:

1. Is the claimed invention directed to a process? defined as an act, or a series of acts or steps process claims are sometimes called method claims

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Detailed Guidance (cont.):2. Is the natural principle a limiting feature of the claim? Definition of natural principle: “a handiwork of nature and occurs

without the hand of man;” non‐limiting examples: disinfecting property of sunlight relationship between blood glucose levels and diabetes correlation that occurs naturally when a man‐made product,

e.g., a drug, interacts with a naturally occurring substance, e.g., blood “[W]hile it takes a human action to trigger a manifestation of

the correlation, the correlation exists in principle apart from any human action.”

In a footnote, the memo acknowledges that this aspect of Mayo changes USPTO practice, which formerly did not recognize this as a law of nature

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Detailed Guidance (cont.):3. Practical Application and Preemption Analysis turns on the concept of “practical application” Must show that the inventor has practically applied, or added

something significant to, the natural principle itself Integration: additional elements must relate to the NP in a

significant way to impose a meaningful limit on claim scope A bare statement of a naturally occurring correlation, even a

newly discovered correlation or a very narrowly confined correlation, fails the inquiry

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Detailed Guidance (cont.):3. Practical Application and Preemption (cont.) The additional elements/steps must not amount to insignificant

extra‐solution activity – that imposes no meaningful limit on performance of the method

Additional elements/steps must narrow the claim such that others are not foreclosed from using the NP (a ”basic tool” of scientific/technological work) for future innovation

Can’t preempt the NP by covering every substantial practical application

Elements/steps that are “well‐understood, purely conventional, and routinely taken by others” – no

Elements/steps that only limit to a particular field of use – no

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Detailed Guidance (cont.):3. Practical Application and Preemption (cont.) Must be more than a “drafting effort” designed to monopolize the

NP itself [how ironic!] Example: recording a diagnosis on a chart – no; unrelated to the

correlation and does not integrate Claims to a new drug, methods of using new drug, and methods

of using old drug, even in combination with an NP, – OK; scope confined to patent‐eligible applications of a natural principle

Combination of steps that’s nothing more than an instruction to doctors to “apply” an NP when treating patients – no

Claim does not have to be novel or non‐obvious to qualify as a subject matter‐eligible claim

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“Helpful” factors from 2010 Bilski Memo:

Adding conventional steps, at a high level of generality – no Steps/instructions, if well‐understood, routine, conventional

activity – no Claims that cover known and unknown uses of a natural principle,

and can be performed through any existing or future‐devised machinery, or even without any apparatus – no

Particular machine or transformation recited in more than general terms, so that claim does not cover every substantial practical application of a natural principle – possibly yes

Limiting to a certain technological environment, where the claim nevertheless covers every substantial practical application in that field – no

Additional limitations, nevertheless necessary for all practical applications – no

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“Helpful” factors from 2010 Bilski Memo (cont.):

A particular MOT recited in a claim can show how the natural principle is integrated into a practical application

A MOT that is merely nominally, insignificantly, or tangentially related to the steps/elements would not show integration; if only incidental to invention – no

Complete absence of MOT signals the claim is likely directed to a natural principle and has not been instantiated (e.g., is disembodied or can be performed entirely in one’s mind)

Mere statement of a natural principle effectively monopolizes that principle and is not sufficient, in contrast to tangible implementation with elements/steps recited with specificity such that all substantial applications are not covered

Observable and verifiable steps – good; subjective or imperceptible steps ‐ bad

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Detailed Guidance (cont.): Following the “Detailed Guidance” section, the memo reviews the

Supreme Court’s analysis as specifically directed to the claims in Diehr and Mayo (will not reiterate that analysis here)

In a footnote, the memo cautions that “wherein” clauses often “do not have a limiting effect on the broadest reasonable interpretation of the claim because language that suggests a feature, or makes the feature optional, does not limit the claim scope.”

TAKE NOTE!

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Sample claim rejection:Claim 1: A method of determining effective dosage of insulin to a patient, comprising the steps of administering a dose of insulin to a patient, testing the patient’s blood for the blood sugar level, and evaluating whether the insulin dosage is effective based on the blood sugar levelAnalysis:

Inquiry 1 = OK (it’s a process claim) Inquiry 2 = OK (the naturally occurring correlation between insulin

and blood glucose levels is a limitation) Inquiry 3 = NOT OK Although the additional steps integrate or make use of the

correlation, the steps are not sufficient to ensure the claim amounts to significantly more than the correlation itself, since every application would require administration of insulin and testing of blood to observe the relationship

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Sample claim rejection (cont.): In response, the patent attorney/agent could: Amend to add additional steps/features, such as a testing

technique or treatment steps that would not be conventional or routine, and/or

Argue that the additional steps add something significantly more to the claim than merely describing the natural principle, e.g., that the steps are not routine, well known or conventional

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Claim Examples:

Example 1:

State of the art: It is a well‐documented NP that white light, such as sunlight, affects a person’s mood, via photoreceptors » chemical reaction » electrical response » modulation of neural activity

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Example 1 (cont.):Claims:1. A method of treating a behavioral disorder of a patient, the disorder

associated with a level of neuronal activity in a neural circuit within the brain of the patient, comprising exposing the patient to sunlight to alter the level of neuronal activity in the neural circuit to mitigate the behavioral disorder.

2. A method … (same as 1), comprising exposing the patient to a source of white light … (same as 1) .

3. A method of treating a behavioral disorder of a patient, the disorder associated with a level of neuronal activity in a neural circuit within the brain of the patient, comprising:

providing a light source that emits white lightfiltering the UV rays from the white lightpositioning the patient adjacent the light source at a distance between 30‐60 cm, for 30‐60 minutes etc.

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Example 1 (cont.)

Analysis: All the claims are process claims (Inquiry 1) and focus on the

use of an NP that is a limitation of the claim (Inquiry 2) Inquiry 3:

Claims 1 and 2 = NOT OK Claim 3 = OK

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Example 2:

State of the art: Anti‐IgM antibody XYZ is novel and unobvious. Assays M and N have been used for assaying antibody binding to control samples, but are not routinely used together.

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Example 2 (cont.):Claims:1. A method of diagnosing RA in a patient, comprising:

obtaining a serum sample from a patientcontacting the sample with an anti‐IgM antibody; and diagnosing the patient as having RA based upon an increased binding of the anti‐IgM antibody to IgM rheumatoid factor in the serum sample.

2. The method of claim 1, further comprising:providing a positive control sample; andcontacting the positive control sample with an anti‐IgM antibody,wherein the step of diagnosing the patient as having RA comprises a step of comparing the anti‐IgM antibody in the serum sample to the positive control sample

3. The method of claim 1 or 2, wherein the anti‐IgM antibody is antibody XYZ4. The method of claim 2, wherein the step of comparing to the control sample includes

performing assay M and then performing assay N.

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Example 2 (cont.):Analysis:

Inquiry 1: All the claims are process claims

Inquiry 2: All the claims include the limitation of the correlation between RA and the rheumatoid factor IgM, which is an NP

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Example 2 Analysis (cont.) Inquiry 3:

Claim 1 = NOT OK Additional steps of obtaining and contacting are well‐

understood steps routinely conducted to analyze a serum sample. Also, steps are recited at a high level of generality (e.g., generic antibody). Taken together, the steps amount to no more than recognizing the law of nature itself

Claim 2 = NOT OK Additional step of using a control sample is routinely taken by

those in the field, does not add anything substantial.

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Example 2 Analysis (cont.) Inquiry 3 (cont.):

Claim 3 = OK Using a particular antibody, and especially a novel antibody, is

sufficient to limit the application of the NP. While it is not necessary that the antibody be novel/non‐obvious, in this case use of the particular antibody XYZ means the claim does not cover all practical applications.

Claim 4 = OK Claim is limited to particular assays M and N in a particular

combination, so claim does not cover all practical applications. Also, use of the assays together is not well‐known, routine or conventional, but at this stage of examination it has not been determined whether such use is novel or non‐obvious. While claim 4 is eligible, further examination required to determine if patentable. (And Examiner also should examine claims 1 and 2 for patentability to promote compact prosecution)

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Themes/Take-Aways:

The overlap of 101 and 102/103 Additional steps must not be “insignificant extra‐solution

activity,” “data gathering,” or “well‐understood, routine, or conventional” but memo makes clear that the step need NOT be novel and unobvious

PTO trying to do what it did in WD guidelines – valiantly distinguish two doctrines (e.g., WD and Enablement [level of knowledge in the art and skill of the practitioner vs. unpredictability]) – fruitlessly?

Note importance of the ‘state of the art” – highlighted in Examples; patent eligibility a moving target over time

Highlight any non‐conventional steps (e.g., testing techniques or treatment steps) that apply the NP

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Themes/Take-Aways:

Distinguishing new drugs/new uses for old drugs Patent eligible, even in combination with a recited

natural principal (e.g., mechanism of action; although be cautious about this) Were Prometheus’ claims “old uses for old drugs?”

Maybe an evil patent drafter could have fixed them?

If possible, describe methods in terms of use of a new drug or new use of old drug e.g., method of treating patient with particular dose optimized

for that patient based on prior diagnostic test focus on applying the information rather than obtaining it

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Themes/Take-Aways:

Preemption – how does it fit? Claims must be limited so as not to preempt – by

covering every substantial practical application – so others not foreclosed from using for future innovation

Permissible to use “well‐understood, routine, or conventional” steps if they avoid preemption?

Can’t hope to save an NP claim by limiting to a particular field of use (technological environment), even a narrow field of use

Question: what if using a novel biomarker, not simply an old biomarker in a new correlation (Labcorp) or an old biomarker in an old correlation (Mayo/Prometheus)

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Themes/Take-Aways:

Miscellaneous Compact prosecution – examiners should not focus

solely on 101 except in most extreme cases – so should be able to consider the 101 rejection in conjunction with other rejections (e.g., use non‐obviousness arguments for non‐conventional issue)

Examiners are directed to use an analytical framework of the “claim as a whole,” but then of course the major focus of the interim guidance memo is the adequacy or inadequacy of individual “additional steps”

“Real world” experiences to date

Questions/Comments/Discussion?

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Mark S. Ellinger, Ph.D., J.D.

Fish & Richardson P.C.3200 RBC Plaza

60 South Sixth StreetMinneapolis, MN612‐337‐[email protected]

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the uspto grapples with mayo v. prometheus...2012/10/25 · c. mayo v. prometheus(cont.) back to...

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