Shortly after the Supreme Court issued its decision, the USPTO published "Interim Guidance for Determining Subject Matter Eligibility for Process Claims in View of Bilski v. Kappos." The guidance is to be used by examiners when evaluating process claims for patent-eligibility under 35 USC § 101. The Interim Guidance was effective as of its July 27, 2010 publication date, but the USPTO is accepting written public comments until September 27, 2010.
Examiners are Advised to Consider Various Factors
The Interim Guidance sets forth a number of factors that may be considered when evaluating patent-eligibility under § 101, each falling under one of four general categories:
- Whether the method involves or is executed by a particular machine or apparatus.
(1) The particularity or generality of the elements of the machine or apparatus.
(2) Whether the machine or apparatus implements the steps of the method.
(3) Whether its involvement is extrasolution activity or a field-of-use, i.e., the extent to which (or how) the machine or apparatus imposes meaningful limits on the execution of the claimed method steps.
- Whether performance of the claimed method results in or otherwise involves a transformation of a particular article.
(1) The particularity or generality of the transformation.
(2) The degree to which the recited article is particular; i.e., can be specifically identified (not any and all articles).
(3) The nature of the transformation in terms of the type or extent of change in state or thing, for instance by having a different function or use, which would weigh toward eligibility, compared to merely having a different location, which would weigh against eligibility.
(4) The nature of the article transformed, i.e., whether it is an object or substance, weighing toward eligibility, compared to a concept such as a contractual obligation or mental judgment, which would weigh against eligibility.
(5) Whether its involvement is extrasolution activity or a field-of-use, i.e., the extent to which (or how) the transformation imposes meaningful limits on the execution of the claimed method steps.
- Whether performance of the claimed method involves an application of a law of nature, even in the absence of a particular machine, apparatus, or transformation.
(1) The particularity or generality of the application.
(2) Whether the claimed method recites an application of a law of nature solely involving subjective determinations; e.g., ways to think about the law of nature.
(3) Whether its involvement is extrasolution activity or a field-of-use, i.e., the extent to which (or how) the application imposes meaningful limits on the execution of the claimed method steps.
- Whether a general concept (which could also be recognized in such terms as a principle, theory, plan or scheme) is involved in executing the steps of the method.
(1) The extent to which use of the concept, as expressed in the method, would preempt its use in other fields; i.e., that the claim would effectively grant a monopoly over the concept.
(2) The extent to which the claim is so abstract and sweeping as to cover both known and unknown uses of the concept, and be performed through any existing or future-devised machinery, or even without any apparatus.
(3) The extent to which the claim would effectively cover all possible solutions to a particular problem; i.e., that the claim is a statement of the problem versus a description of a particular solution to the problem.
(4) Whether the concept is disembodied or whether it is instantiated; i.e., implemented, in some tangible way.
(5) The mechanism(s) by which the steps are implemented; e.g., whether the performance of the process is observable and verifiable rather than subjective or imperceptible.
(6) Examples of general concepts include, but are not limited to:
–Basic economic practices or theories (e.g., hedging, insurance, financial transactions, marketing)
–Basic legal theories (e.g., contracts, dispute resolution, rules of law)
–Mathematical concepts (e.g., algorithms, spatial relationships, geometry)
–Mental activity (e.g., forming a judgment, observation, evaluation, or opinion)
[Will this encompass diagnostic or personalize medicine method steps that involve, for example, correlating a measured quantity or detected species with a particular diagnosis or particular course of therapy?]–Interpersonal interactions or relationships (e.g., conversing, dating)
–Teaching concepts (e.g., memorization, repetition)
–Human behavior (e.g., exercising, wearing clothing, following rules or instructions)
–Instructing “how business should be conducted.”
"Machine-Or-Transformation" Remains a Guiding Principle
The Interim Guidance provides that, as a general rule:
Factors that weigh in favor of patent-eligibility satisfy the criteria of the machine-or-transformation test or provide evidence that the abstract idea has been practically applied. Factors that weigh against patent-eligibility neither satisfy the criteria of the machine-or-transformation test nor provide evidence that the abstract idea has been practically applied.
The "Quick Reference Sheet"
The Interim Guidance concludes with a "Quick Reference Sheet’ that lists "Factors Weighing Toward Eligibility" and "Factors Weighing Against Eligibility."
For claims relating to a law of nature, the following factors may support patent-eligibility:
- the law of nature is practically applied
- the application meaningfully limits the execution of the steps
On the other hand, the following factors may undermine patent-eligibility:
- the claim is not directed to an application of a law of nature
- the claim would monopolize a natural force or patent a scientific fact; e.g., by claiming every mode of producing an effect of that law of nature
- the law of nature is applied in a merely subjective determination
- the law of nature is merely nominally, insignificantly, or tangentially related to the performance of the steps
For claims relating to a general concept, the following factors may support patent-eligibility:
- the claim is more than a mere statement of a concept
- the claim describes a particular solution to a problem to be solved
- the claim implements a concept in some tangible way
- the performance of the steps is observable and verifiable
For claims relating to a general concept, the following factors may undermine patent-eligibility:
- the claim is a mere statement of a general concept
- use of the concept, as expressed in the method, would effectively grant a monopoly over the concept
- both known and unknown uses of the concept are covered, and can be performed through any existing or future-devised machinery, or even without any apparatus
- the claim only states a problem to be solved
- the general concept is disembodied
- the mechanism(s) by which the steps are implemented is subjective or imperceptible
How Would The Prometheus and Classen Claims Fare Under The USPTO Factors?
The USPTO solicits specific examples of (1) claims that do not meet the machine-or-transformation test but nevertheless remain patent-eligible because they do not recite an abstract idea and (2) claims that meet the machine-or-transformation test but nevertheless are not patent-eligible because they recite an abstract idea. The Federal Circuit soon will decide how the Prometheus and Classen claims fare in view of Bilski. How would they fare under the USPTO factors?
The Prometheus claims were upheld by the Federal Circuit under the machine-or-transformation test, but the Supreme Court vacated and remanded that decision in view of Bilski. Representative claim 1 of U.S. Patent 6,355,623 reads:
1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, 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 about 230 pmol per 8X10(8) red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and
wherein the level of 6-thioguanine greater than about 400 pmol per 8X10(8) red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
Putting aside the "machine-or-transformation" factors, do the USPTO factors support patent-eligibility because:
- the law of nature is practically applied
- the claim is more than a mere statement of a concept
- the claim describes a particular solution to a problem to be solved
- the claim implements a concept in some tangible way
- the performance of the steps is observable and verifiable
Or, do the USPTO factors weigh against patent-eligibility because
- use of the concept, as expressed in the method, would effectively grant a monopoly over the concept
The Classen claims were struck down by the Federal Circuit in a non-precedential opinion with no analysis, but the Supreme Court vacated and remanded that decision in view of Bilski. Representative claim 1 of U.S. Patent 5,723,283 reads:
1. A method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder in a treatment group of mammals, relative to a control group of mammals, which comprises immunizing mammals in the treatment group of mammals with one or more doses of one or more immunogens, according to said immunization schedule, and comparing the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder, in the treatment group, with that in the control group.
Putting aside the "machine-or-transformation" factors, do the USPTO "general concept" factors support patent-eligibility because:
- the claim is more than a mere statement of a concept
- the claim implements a concept in some tangible way
- the performance of the steps is observable and verifiable
Or, do the USPTO factors weigh against patent-eligibility because
- use of the concept, as expressed in the method, would effectively grant a monopoly over the concept
- the general concept is disembodied
How Would You Decide?