II. Formulating a § 101 Rejection
After determining what the applicant invented and establishing the broadest reasonable interpretation of the claimed invention, the eligibility of each claim should be evaluated as a whole using the two-step analysis detailed in the Interim Eligibility Guidance.
- If it is determined that the claim does not recite eligible subject matter, a rejection under § 101 is appropriate.
- When making the rejection, the Office action must provide an explanation as to why each claim is unpatentable, which must be sufficiently clear and specific to provide applicant sufficient notice of the reasons for ineligibility and enable the applicant to effectively respond.
A subject matter eligibility rejection under Step 2 should:
- identify the judicial exception by referring to what is recited (i.e., set forth or described) in the claim and explain why it is considered an exception;
- identify any additional elements (specifically point to claim features/limitations/steps) recited in the claim beyond the identified judicial exception; and
- explain the reason(s) that the additional elements taken individually, and also taken as a combination, do not result in the claim as a whole amounting to significantly more than the judicial exception.
A. When making a rejection, identify and explain the judicial exception recited in the claim (Step 2A)
A subject matter eligibility rejection should point to the specific claim limitation(s) that recites (i.e., sets forth or describes) the judicial exception.
- The rejection must identify the specific claim limitations and explain why those claim limitations set forth a judicial exception (e.g., an abstract idea).
- Where the claim describes, but does not expressly set forth, the judicial exception, the rejection must also explain what subject matter those limitations describe, and why the described subject matter is a judicial exception.
When the examiner has determined the claim recites an abstract idea, the rejection should identify the abstract idea as it is recited (i.e., set forth or described) in the claim, and explain why it corresponds to a concept that the courts have identified as an abstract idea.
- Citing to an appropriate court decision that supports the identification of the subject matter recited in the claim language as an abstract idea is a best practice that will advance prosecution.
Sample explanation:
The claim recites the steps of sorting information by X, which is an abstract idea similar to the concepts that have been identified as abstract by the courts, such as organizing information through mathematical correlations in Digitech or data recognition and storage in Content Extraction.
When the examiner has determined the claim recites a law of nature or a natural phenomenon, the rejection should identify the law of nature or natural phenomenon as it is recited (i.e., set forth or described) in the claim and explain using a reasoned rationale why it is considered a law of nature or natural phenomenon.
Sample explanation:
The claim recites the correlation of X, and X is a law of nature because it describes a consequence of natural processes in the human body, e.g., the naturally-occurring relationship between the presence of Y and the manifestation of Z.
Sample explanation: The claim recites X, which is a natural phenomenon because it occurs in nature and exists in principle apart from any human action.
When the examiner has determined the claim recites a product of nature, the rejection should identify the exception as it is recited (i.e., set forth or described) in the claim, and explain using a reasoned rationale why the product does not have markedly different characteristics from its naturally occurring counterpart in its natural state.
Sample explanation:
The claim recites X, which as explained in the specification was isolated from naturally occurring Y. Xis a nature-based product, so it is compared to its closest naturally occurring counterpart (X in its natural state) to determine if it has markedly different characteristics. Because there is no indication in the record that isolation of X has resulted in a marked difference in structure, function, or other properties as compared to its counterpart, X is a product of nature exception.
B. When making a rejection, explain why the additional claim elements do not result in the claim as a whole amounting to significantly more than the judicial exception (Step 2B)
After identifying the judicial exception in the rejection, identify any additional elements (features/limitations/steps) recited in the claim beyond the judicial exception and explain why they do not add significantly more to the exception.
- The explanation should address the additional elements both individually and as a combination when determining whether the claim as whole recites eligible subject matter.
- It is important to remember that a new combination of steps in a process may be patent eligible even though all the steps of the combination were individually well known and in common use before the combination was made.
- Thus, it is particularly critical to address the combination of additional elements, because while individually-viewed elements may not appear to add significantly more, those additional elements when viewed in combination may amount to significantly more than the exception by meaningfully limiting the judicial exception.
A rejection should be made only if it is readily apparent to an examiner relying on his or her expertise in the art in the Step 2B inquiry that the additional elements do not amount to claiming significantly more than the recited judicial exception.
- When making a rejection, it is important for the examiner to explain the rationale underlying his or her conclusion so that applicant can effectively respond.
- On the other hand, when appropriate, the examiner should explain why the additional elements provide an inventive concept by adding a meaningful limitation to the claimed exception.
For example, when the examiner has concluded that particular claim limitations are well understood, routine, conventional activities (or elements) to those in the relevant field, the rejection should explain why the courts have recognized, or those in the relevant field of art would recognize, those claim limitations as being well-understood, routine, conventional activities.
- A prior art search should not be necessary to resolve whether the additional element is a well-understood, routine, conventional activity because lack of novelty (i.e., finding the element in the prior art) does not necessarily show that an element is well-understood, routine, conventional activity previously engaged in by those in the relevant field.
- For example, even if a particular laboratory technique was discussed in several widely-read scientific journals or used by a few scientists, mere knowledge of the particular laboratory technique or use of the particular laboratory technique by a few scientists is not sufficient to make the use of the particular laboratory technique routine or conventional in the relevant field.
- Instead, the evaluation turns on whether the use of the particular laboratory technique was well-understood, routine, conventional activity previously engaged in by scientists in the field.
- If it is determined that the additional element is widely prevalent and its combination with any other additional elements is well understood, routine, conventional activity, the examiner should provide a reasoned explanation that supports that conclusion.
For claim limitations that recite a generic computer component performing generic computer functions at a high level of generality, such as using the Internet to gather data, examiners can explain why these generic computing functions do not meaningfully limit the claim.
- The July 2015 Update lists some computer functions that the courts have recognized as well-understood, routine, conventional functions when they are claimed in a merely generic manner.
- This listing is not meant to imply that all computer functions are well-understood, routine, conventional functions, or that a claim reciting a generic computer component performing a generic computer function is necessarily ineligible.
- Examiners should keep in mind that the courts have held computer-implemented processes to be significantly more than an abstract idea (and thus eligible), where generic computer components are able in combination to perform functions that are not merely generic (DDR).
For claim limitations that add insignificant extra solution activity to the judicial exception (e.g., mere data gathering in conjunction with a law of nature or abstract idea, or that generally link the use of the judicial exception to a particular technological environment or field of use), examiners can explain why they do not meaningfully limit the claim.
- For example, adding a final step of storing data to a process that only recites computing the area of a space (a mathematical relationship) does not add a meaningful limitation to the process of computing the area.
- As another example, employing well-known computer functions to execute an abstract idea, even when limiting the use of the idea to one particular environment, does not add significantly more, similar to how limiting the computer implemented abstract idea in Flook to petrochemical and oil-refining industries was insufficient.
C. Examples should not be relied upon in 35 U.S.C. 101 rejections
The USPTO issued examples in conjunction with the Interim Eligibility Guidance, including Examples: Nature-Based Products; Examples: Abstract Ideas; July 2015Update Appendix I: Examples; and, Examples: Life Sciences (issued in May 2016).
- These examples, many of which are hypothetical, were drafted to show exemplary analyses under the Interim Eligibility Guidance and are intended to be illustrative of the analysis only.
- While some of the fact patterns draw from U.S. Supreme Court and U.S. Court of Appeals for the Federal Circuit decisions, the examples do not carry the weight of court decisions.
- Therefore, the examples should not be used as a basis for a subject matter eligibility rejection.
- Additionally, while it would be acceptable for applicants to cite an example in support of an argument for finding eligibility in an appropriate factual situation, applicants should not be required to model their claims or responses after the examples to attain eligibility.
