I. Two-Part Analysis for Judicial Exceptions
A. Flowchart Step 2A (Part 1 Mayo Test)
Determine whether the claim is directed to a law of nature, a natural phenomenon, or an abstract idea (judicial exceptions).
After determining what applicant has invented by reviewing the entire application disclosure and construing the claims in accordance with their broadest reasonable interpretation (MPEP 2103), determine whether the claim as a whole is directed to a judicial exception.
- A claim to a process, machine, manufacture or composition of matter (Step 1: YES) that is not directed to any judicial exceptions (Step 2A: NO) is eligible and needs no further eligibility analysis.
- A claim that is directed to at least one exception (Step 2A: YES) requires further analysis to determine whether the claim recites a patent-eligible application of the exception (Step 2B).
1. Determine What the Claim Is ‘‘Directed to’’
A claim is directed to a judicial exception when a law of nature, a natural phenomenon, or an abstract idea is recited (i.e., set forth or described) in the claim.
- Such a claim requires closer scrutiny for eligibility because of the risk that it will ‘‘tie up’’ the excepted subject matter and pre-empt others from using the law of nature, natural phenomenon, or abstract idea.
- Courts tread carefully in scrutinizing such claims because at some level all inventions embody, use, reflect, rest upon, or apply a law of nature, natural phenomenon, or abstract idea.
- To properly interpret the claim, it is important to understand what the applicant has invented and is seeking to patent.
For claims that may recite a judicial exception, but are directed to inventions that clearly do not seek to tie up the judicial exception, see Section I.B.3. regarding a streamlined eligibility analysis.
2. Identify the Judicial Exception Recited in the Claim
MPEP 2106(II) provides a detailed explanation of the judicial exceptions and their legal bases.
It should be noted that there are no bright lines between the types of exceptions because many of these concepts can fall under several exceptions.
- For example, mathematical formulas are considered to be an exception as they express a scientific truth, but have been labeled by the courts as both abstract ideas and laws of nature.
- Likewise, ‘‘products of nature’’ are considered to be an exception because they tie up the use of naturally occurring things, but have been labeled as both laws of nature and natural phenomena.
- Thus, it is sufficient for this analysis to identify that the claimed concept aligns with at least one judicial exception.
Laws of nature and natural phenomena, as identified by the courts, include naturally occurring principles/ substances and substances that do not have markedly different characteristics compared to what occurs in nature.
The types of concepts courts have found to be laws of nature and natural phenomena are shown by these cases, which are intended to be illustrative and not limiting:
- An isolated DNA (Myriad: see Section III, Example 2);
- a correlation that is the consequence of how a certain compound is metabolized by the body (Mayo: see Section III, Example 5);
- electromagnetism to transmit signals (Morse: see Section IV.A.1.); and
- the chemical principle underlying the union between fatty elements and water (Tilghman: see Section IV.A.2.).
Abstract ideas have been identified by the courts by way of example, including fundamental economic practices, certain methods of organizing human activities, an idea ‘of itself,’ and mathematical relationships/formulas.
The types of concepts courts have found to be abstract ideas are shown by these cases, which are intended to be illustrative and not limiting:
- Mitigating settlement risk (Alice: see Section III, Example 6);
- hedging (Bilski: see Section IV.A.5.);
- creating a contractual relationship (buySAFE: see Section IV.C.3.);
- using advertising as an exchange or currency (Ultramercial: see Section IV.C.4.);
- processing information through a clearinghouse (Dealertrack: see Section IV.B.3.);
- comparing new and stored information and using rules to identify options (SmartGene: see Section IV.B.4.);
- using categories to organize, store and transmit information (Cyberfone: see Section IV.B.5.);
- organizing information through mathematical correlations (Digitech: see Section IV.C.1.);
- managing a game of bingo (Planet Bingo: see Section IV.C.2.);
- the Arrhenius equation for calculating the cure time of rubber (Diehr: see Section III, Example 3);
- a formula for updating alarm limits (Flook: see Section III, Example 4);
- a mathematical formula relating to standing wave phenomena (Mackay Radio: see Section IV.A.3.); and
- a mathematical procedure for converting one form of numerical representation to another (Benson: see Section IV.A.4.)
3. Nature-Based Products
a. Determine Whether the Markedly Different Characteristics Analysis Is Needed To Evaluate a Nature-Based Product Limitation Recited in a Claim
Nature-based products, as used herein, include both eligible and ineligible products and merely refer to the types of products subject to the markedly different characteristics analysis used to identify ‘‘product of nature’’ exceptions.
- Courts have held that naturally occurring products and some man-made products that are essentially no different from a naturally occurring product are ‘‘products of nature’’ that fall under the laws of nature or natural phenomena exception.
- To determine whether a claim that includes a nature-based product limitation recites a ‘‘product of nature’’ exception, use the markedly different characteristics analysis to evaluate the nature-based product limitation (discussed in section I.A.3.b).
- A claim that recites a nature-based product limitation that does not exhibit markedly different characteristics from its naturally occurring counterpart in its natural state is directed to a ‘‘product of nature’’ exception (Step 2A: YES).
Care should be taken not to overly extend the markedly different characteristics analysis to products that when viewed as a whole are not nature based.
- For claims that recite a nature based product limitation (which may or may not be a ‘‘product of nature’’ exception) but are directed to inventions that clearly do not seek to tie up any judicial exception, see Section I.B.3. regarding a streamlined eligibility analysis.
- In such cases, it would not be necessary to conduct a markedly different characteristics analysis.
A nature-based product can be claimed by itself (e.g., ‘‘a Lactobacillus bacterium’’) or as one or more limitations of a claim (e.g., ‘‘a probiotic composition comprising a mixture of Lactobacillus and milk in a container’’).
- The markedly different characteristics analysis should be applied only to the nature-based product limitations in the claim to determine whether the nature based products are ‘‘product of nature’’ exceptions.
- When the nature-based product is produced by combining multiple components, the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts.
- In the example above, the mixture of Lactobacillus and milk should be analyzed for markedly different characteristics, rather than the Lactobacillus separately and the milk separately.
- The container would not be subject to the markedly different characteristics analysis as it is not a nature-based product, but would be evaluated in Step 2B if it is determined that the mixture of Lactobacillus and milk does not have markedly different characteristics from any naturally occurring counterpart and thus is a ‘‘product of nature’’ exception.
For a product-by-process claim, the analysis turns on whether the nature based product in the claim has markedly different characteristics from its naturally occurring counterpart.
A process claim is not subject to the markedly different analysis for nature based products used in the process, except in the limited situation where a process claim is drafted in such a way that there is no difference in substance from a product claim (e.g., ‘‘a method of providing an apple.’’).
b. Markedly Different Characteristics Analysis: Structure, Function and/or Other Properties
The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state.
- When there is no naturally occurring counterpart to the nature based product, the comparison should be made to the closest naturally occurring counterpart.
- In the case of a nature-based combination, the closest counterpart may be the individual nature-based components that form the combination, i.e., the characteristics of the claimed nature-based combination are compared to the characteristics of the components in their natural state.
Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties, and will be evaluated based on what is recited in the claim on a case-by-case basis.
- As seen by the examples that are being released in conjunction with this Interim Eligibility Guidance, even a small change can result in markedly different characteristics from the product’s naturally occurring counterpart.
- In accordance with this analysis, a product that is purified or isolated, for example, will be eligible when there is a resultant change in characteristics sufficient to show a marked difference from the product’s naturally occurring counterpart.
- If the claim recites a nature-based product limitation that does not exhibit markedly different characteristics, the claim is directed to a ‘‘product of nature’’ exception (a law of nature or naturally occurring phenomenon), and the claim will require further analysis to determine eligibility based on whether additional elements add significantly more to the exception.
Non-limiting examples of the types of characteristics considered by the courts when determining whether there is a marked difference include:
- Biological or pharmacological functions or activities;
- Chemical and physical properties;
- Phenotype, including functional and structural characteristics; and
- Structure and form, whether chemical, genetic or physical.
If the claim includes a nature-based product that has markedly different characteristics, the claim does not recite a ‘‘product of nature’’ exception and is eligible (Step 2A: NO) unless the claim of nature or abstract idea, or a different natural phenomenon).
- If the claim includes a product having no markedly different characteristics from the product’s naturally occurring counterpart in its natural state, the claim is directed to an exception (Step 2A: YES), and the eligibility analysis must proceed to Step 2B to determine if any additional elements in the claim add significantly more to the exception.
- For claims that are to a single nature based product, once a markedly different characteristic in that product is shown, no further analysis would be necessary for eligibility because no ‘‘product of nature’’ exception is recited (i.e., Step 2B is not necessary because the answer to Step 2A is NO).
- This is a change from prior guidance because the inquiry as to whether the claim amounts to significantly more than a ‘‘product of nature’’ exception is not relevant to claims that do not recite an exception.
- Thus, a claim can be found eligible based solely on a showing that the nature-based product in the claim has markedly different characteristics and thus is not a ‘‘product of nature’’ exception, when no other exception is recited in the claim.
If a rejection under 35 U.S.C. 101 is ultimately made, the rejection should identify the exception as it is recited (i.e., set forth or described) in the claim, and explain why it is an exception providing reasons why the product does not have markedly different characteristics from its naturally occurring counterpart in its natural state.
B. Flowchart Step 2B (Part 2 Mayo test)—Determine whether any element, or combination of elements, in the claim is sufficient to ensure that the claim amounts to significantly more than the judicial exception.
A claim directed to a judicial exception must be analyzed to determine whether the elements of the claim, considered both individually and as an ordered combination, are sufficient to ensure that the claim as a whole amounts to significantly more than the exception itself—this has been termed a search for an ‘‘inventive concept.’’
- To be patent-eligible, a claim that is directed to a judicial exception must include additional features to ensure that the claim describes a process or product that applies the exception in a meaningful way, such that it is more than a drafting effort designed to monopolize the exception.
- It is important to consider the claim as 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.
- Every claim must be examined individually, based on the particular elements recited therein, and should not be judged to automatically stand or fall with similar claims in an application.
1. ‘‘Significantly More’’
The Supreme Court has identified a number of considerations for determining whether a claim with additional elements amounts to significantly more than the judicial exception itself.
- The following are examples of these considerations, which are not intended to be exclusive or limiting.
Limitations that may be enough to qualify as ‘‘significantly more’’ when recited in a claim with a judicial exception include:
- Improvements to another technology or technical field;
- Improvements to the functioning of the computer itself;
- Applying the judicial exception with, or by use of, a particular machine;
- Effecting a transformation or reduction of a particular article to a different state or thing;
- Adding a specific limitation other than what is well-understood, routine and conventional in the field, or adding unconventional steps that confine the claim to a particular useful application; or
- Other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment.
Limitations that were found not to be enough to qualify as ‘‘significantly more’’ when recited in a claim with a judicial exception include:
- Adding the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer;
- Simply appending well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well understood, routine and conventional activities previously known to the industry;
- Adding insignificant extra solution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea; or
- Generally linking the use of the judicial exception to a particular technological environment or field of use.
Section III provides examples of claims analyzed under this framework.
If the claim as a whole does recite significantly more than the exception itself, the claim is eligible (Step 2B: YES), and the eligibility analysis is complete.
- If there are no meaningful limitations in the claim that transform the exception into a patent-eligible application, such that the claim does not amount to significantly more than the exception itself, the claim is not patent-eligible (Step 2B: NO) and should be rejected under 35 U.S.C. 101.
- In the rejection, identify the exception by referring to where it is recited (i.e., set forth or described) in the claim and explain why it is considered an exception.
- Then, if the claim includes additional elements, identify the elements in the rejection and explain why they do not add significantly more to the exception.
2. A Claim Reciting a Plurality of Exceptions
For a claim that is directed to a plurality of exceptions, conduct the eligibility analysis for one of the exceptions.
- If the claim recites an element or combination of elements that amount to significantly more than that exception, consider whether those additional elements also amount to significantly more for the other claimed exception(s), which ensures that the claim does not have a pre-emptive effect with respect to any of the recited exceptions.
- Additional elements that satisfy Step 2B for one exception will likely satisfy Step 2B for all exceptions in a claim.
- On the other hand, if the claim fails under Step 2B for one exception, the claim is ineligible, and no further eligibility analysis is needed.
3. Streamlined Eligibility Analysis
For purposes of efficiency in examination, a streamlined eligibility analysis can be used for a claim that may or may not recite a judicial exception but, when viewed as a whole, clearly does not seek to tie up any judicial exception such that others cannot practice it.
- Such claims do not need to proceed through the full analysis herein as their eligibility will be self-evident.
- However, if there is doubt as to whether the applicant is effectively seeking coverage for a judicial exception itself, the full analysis should be conducted to determine whether the claim recites significantly more than the judicial exception.
For instance, a claim directed to a complex manufactured industrial product or process that recites meaningful limitations along with a judicial exception may sufficiently limit its practical application so that a full eligibility analysis is not needed.
- As an example, a robotic arm assembly having a control system that operates using certain mathematical relationships is clearly not an attempt to tie up use of the mathematical relationships and would not require a full analysis to determine eligibility.
- Also, a claim that recites a nature-based product, but clearly does not attempt to tie up the nature-based product, does not require a markedly different characteristics analysis to identify a ‘‘product of nature’’ exception.
- As an example, a claim directed to an artificial hip prosthesis coated with a naturally occurring mineral is not an attempt to tie up the mineral.
- Similarly, claimed products that merely include ancillary nature-based components, such as a claim that is directed to a cell phone with an electrical contact made of gold or a plastic chair with wood trim, would not require analysis of the nature-based component to identify a ‘‘product of nature’’ exception because such claims do not attempt to improperly tie up the nature-based product.
