MPEP § 2106.07 — Formulating and Supporting Rejections For Lack Of Subject Matter Eligibility (Annotated Rules)

§2106.07 Formulating and Supporting Rejections For Lack Of Subject Matter Eligibility

USPTO MPEP version: BlueIron's Update: 2026-01-10

This page consolidates and annotates all enforceable requirements under MPEP § 2106.07, including statutory authority, regulatory rules, examiner guidance, and practice notes. It is provided as guidance, with links to the ground truth sources. This is information only, it is not legal advice.

Formulating and Supporting Rejections For Lack Of Subject Matter Eligibility

This section addresses Formulating and Supporting Rejections For Lack Of Subject Matter Eligibility. Primary authority: 35 U.S.C. 101. Contains: 2 requirements, 8 guidance statements, 1 permission, and 1 other statement.

Key Rules

Topic

Patent Eligibility

6 rules
StatutoryRequiredAlways
[mpep-2106-07-2e63180af0e22493312a1e18]
Eligibility Rejections Must Be Based on Substantive Law Under 35 U.S.C. 101
Note:
Patent eligibility rejections must be grounded in failing to comply with the substantive law under 35 U.S.C. 101 as interpreted by judicial precedent.

Eligibility rejections must be based on failure to comply with the substantive law under 35 U.S.C. 101 as interpreted by judicial precedent. The substantive law on eligibility is discussed in MPEP §§ 2106.03 through 2106.06. Examination guidance, training, and explanatory examples discuss the substantive law and establish the policies and procedures to be followed by examiners in evaluating patent applications for compliance with the substantive law, but do not serve as a basis for a rejection. Accordingly, while it would be acceptable for applicants to cite training materials or examples 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 training materials or examples to attain eligibility.

Jump to MPEP SourcePatent Eligibility
StatutoryInformativeAlways
[mpep-2106-07-639364b5fcd9ccf19a42e329]
Substantive Law on Eligibility Is Discussed in MPEP Sections 2106.03-06
Note:
The substantive law for evaluating patent eligibility is detailed in MPEP sections 2106.03 through 2106.06.

Eligibility rejections must be based on failure to comply with the substantive law under 35 U.S.C. 101 as interpreted by judicial precedent. The substantive law on eligibility is discussed in MPEP §§ 2106.03 through 2106.06. Examination guidance, training, and explanatory examples discuss the substantive law and establish the policies and procedures to be followed by examiners in evaluating patent applications for compliance with the substantive law, but do not serve as a basis for a rejection. Accordingly, while it would be acceptable for applicants to cite training materials or examples 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 training materials or examples to attain eligibility.

Jump to MPEP SourcePatent Eligibility
StatutoryRequiredAlways
[mpep-2106-07-016f0924b70542c5d092a1f2]
Examination Guidance Cannot Serve As Basis for Rejection
Note:
Examiners must not base rejection on training materials or examples; applicants may cite them but should not be required to follow them exactly.

Eligibility rejections must be based on failure to comply with the substantive law under 35 U.S.C. 101 as interpreted by judicial precedent. The substantive law on eligibility is discussed in MPEP §§ 2106.03 through 2106.06. Examination guidance, training, and explanatory examples discuss the substantive law and establish the policies and procedures to be followed by examiners in evaluating patent applications for compliance with the substantive law, but do not serve as a basis for a rejection. Accordingly, while it would be acceptable for applicants to cite training materials or examples 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 training materials or examples to attain eligibility.

Jump to MPEP SourcePatent Eligibility
StatutoryRecommendedAlways
[mpep-2106-07-313cc522f053c3d52367b9a0]
Rejection for Lack of Eligibility
Note:
Examiners must reject claims that do not meet eligibility criteria after evaluating the invention.

If the evaluation of the claimed invention results in a conclusion that it is more likely than not that the claim as a whole does not satisfy both criteria for eligibility (Step 1: NO and/or Step 2B: NO), then examiners should formulate an appropriate rejection of that claim under Step 1 and/or Step 2B. The rejection should set forth a prima facie case of ineligibility under the substantive law. The concept of the prima facie case is a procedural tool of patent examination, which allocates the burdens going forward between the examiner and applicant. In particular, the initial burden is on the examiner to explain why a claim or claims are ineligible for patenting clearly and specifically, so that applicant has sufficient notice and is able to effectively respond.

Jump to MPEP SourcePatent EligibilityStatutory Authority for Examination
StatutoryRecommendedAlways
[mpep-2106-07-58768fbb6e1c1000ebbd823c]
Examiner Must Set Forth Prima Facie Case of Ineligibility
Note:
The examiner must clearly and specifically explain why a claim is ineligible for patenting, providing the applicant with sufficient notice to respond effectively.

If the evaluation of the claimed invention results in a conclusion that it is more likely than not that the claim as a whole does not satisfy both criteria for eligibility (Step 1: NO and/or Step 2B: NO), then examiners should formulate an appropriate rejection of that claim under Step 1 and/or Step 2B. The rejection should set forth a prima facie case of ineligibility under the substantive law. The concept of the prima facie case is a procedural tool of patent examination, which allocates the burdens going forward between the examiner and applicant. In particular, the initial burden is on the examiner to explain why a claim or claims are ineligible for patenting clearly and specifically, so that applicant has sufficient notice and is able to effectively respond.

Jump to MPEP SourcePatent EligibilityStatutory Authority for Examination
StatutoryRecommendedAlways
[mpep-2106-07-9d856d97db5eb13101c1a184]
Requirement for Explaining Why Claim Does Not Fall Within Statutory Categories
Note:
An examiner must provide an explanation when a claim is determined not to fall within one of the four statutory categories of invention.

When an examiner determines a claim does not fall within a statutory category (Step 1: NO), the rejection should provide an explanation of why the claim does not fall within one of the four statutory categories of invention. See MPEP § 2106.03 for a discussion of Step 1 and the statutory categories of invention.

Jump to MPEP SourcePatent EligibilityStatutory Categories of Invention
Topic

Claims

2 rules
StatutoryRecommendedAlways
[mpep-2106-07-a9ae31b1ce19838b8a57f025]
Examiners Must Review Entire Record for Eligibility
Note:
Examiners should evaluate each claim separately, considering the specification, claims, prosecution history, and relevant case law to determine if a claimed invention is patent eligible.

When evaluating a claimed invention for compliance with the substantive law on eligibility, examiners should review the record as a whole (e.g., the specification, claims, the prosecution history, and any relevant case law precedent or prior art) before reaching a conclusion with regard to whether the claimed invention sets forth patent eligible subject matter. The evaluation of whether the claimed invention qualifies as patent-eligible subject matter should be made on a claim-by-claim basis, because claims do not automatically rise or fall with similar claims in an application. For example, even if an independent claim is determined to be ineligible, the dependent claims may be eligible because they add limitations that integrate the judicial exception into a practical application or amount to significantly more than the judicial exception recited in the independent claim. And conversely, even if an independent claim is determined to be eligible, a dependent claim may be ineligible because it adds a judicial exception without also adding limitations that integrate the judicial exception or provide significantly more. Thus, each claim in an application should be considered separately based on the particular elements recited therein.

Jump to MPEP SourcePatent Application ContentPatent Eligibility
StatutoryRecommendedAlways
[mpep-2106-07-4b2efbe78a64088ee88a1008]
Claims Must Be Evaluated Separately for Eligibility
Note:
Each claim in an application must be assessed individually to determine if it qualifies as patent-eligible subject matter, regardless of the eligibility status of other claims.

When evaluating a claimed invention for compliance with the substantive law on eligibility, examiners should review the record as a whole (e.g., the specification, claims, the prosecution history, and any relevant case law precedent or prior art) before reaching a conclusion with regard to whether the claimed invention sets forth patent eligible subject matter. The evaluation of whether the claimed invention qualifies as patent-eligible subject matter should be made on a claim-by-claim basis, because claims do not automatically rise or fall with similar claims in an application. For example, even if an independent claim is determined to be ineligible, the dependent claims may be eligible because they add limitations that integrate the judicial exception into a practical application or amount to significantly more than the judicial exception recited in the independent claim. And conversely, even if an independent claim is determined to be eligible, a dependent claim may be ineligible because it adds a judicial exception without also adding limitations that integrate the judicial exception or provide significantly more. Thus, each claim in an application should be considered separately based on the particular elements recited therein.

Jump to MPEP SourcePatent EligibilityOptional Claim Content
Topic

Optional Claim Content

2 rules
StatutoryPermittedAlways
[mpep-2106-07-4fb7c2f8fdc034dd969d2f75]
Dependent Claims May Be Eligible Despite Ineligible Independent Claim
Note:
Even if an independent claim is ineligible, dependent claims may still be eligible by adding limitations that integrate the judicial exception into a practical application or providing significantly more.

When evaluating a claimed invention for compliance with the substantive law on eligibility, examiners should review the record as a whole (e.g., the specification, claims, the prosecution history, and any relevant case law precedent or prior art) before reaching a conclusion with regard to whether the claimed invention sets forth patent eligible subject matter. The evaluation of whether the claimed invention qualifies as patent-eligible subject matter should be made on a claim-by-claim basis, because claims do not automatically rise or fall with similar claims in an application. For example, even if an independent claim is determined to be ineligible, the dependent claims may be eligible because they add limitations that integrate the judicial exception into a practical application or amount to significantly more than the judicial exception recited in the independent claim. And conversely, even if an independent claim is determined to be eligible, a dependent claim may be ineligible because it adds a judicial exception without also adding limitations that integrate the judicial exception or provide significantly more. Thus, each claim in an application should be considered separately based on the particular elements recited therein.

Jump to MPEP SourceOptional Claim ContentIndependent Claims
StatutoryRecommendedAlways
[mpep-2106-07-9b6d0efc5fc99785750d13c5]
Each Claim Must Be Separately Evaluated For Eligibility
Note:
Independent and dependent claims must be individually assessed for patent eligibility, even if the independent claim is eligible. Dependent claims can still be ineligible if they do not integrate the judicial exception or provide significantly more.

When evaluating a claimed invention for compliance with the substantive law on eligibility, examiners should review the record as a whole (e.g., the specification, claims, the prosecution history, and any relevant case law precedent or prior art) before reaching a conclusion with regard to whether the claimed invention sets forth patent eligible subject matter. The evaluation of whether the claimed invention qualifies as patent-eligible subject matter should be made on a claim-by-claim basis, because claims do not automatically rise or fall with similar claims in an application. For example, even if an independent claim is determined to be ineligible, the dependent claims may be eligible because they add limitations that integrate the judicial exception into a practical application or amount to significantly more than the judicial exception recited in the independent claim. And conversely, even if an independent claim is determined to be eligible, a dependent claim may be ineligible because it adds a judicial exception without also adding limitations that integrate the judicial exception or provide significantly more. Thus, each claim in an application should be considered separately based on the particular elements recited therein.

Jump to MPEP SourceOptional Claim ContentDependent ClaimsIndependent Claims
Topic

Significantly More Analysis

2 rules
StatutoryRecommendedAlways
[mpep-2106-07-dc88b203f130814200a3f0f0]
Examiner Must Explain Step 2 Analysis for Ineligible Claims
Note:
An examiner must provide an explanation for each part of the Step 2 analysis when a claim is directed to a judicial exception and lacks an inventive concept.

When an examiner determines that a claim is directed to a judicial exception (Step 2A: YES) and does not provide an inventive concept (Step 2B: NO), the rejection should provide an explanation for each part of the Step 2 analysis. For example, the rejection 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, 1) do not integrate the judicial exception into a practical application and 2) do not result in the claim as a whole amounting to significantly more than the judicial exception. See MPEP § 2106.04 et seq. for a discussion of Step 2A and the judicial exceptions, MPEP § 2106.05 et seq. for a discussion of Step 2B and the search for an inventive concept, and MPEP § 2106.07(a) for more information on formulating an ineligibility rejection.

Jump to MPEP SourceSignificantly More AnalysisStep 2A Prong 1 – Judicial ExceptionStep 2B – Inventive Concept
StatutoryRecommendedAlways
[mpep-2106-07-aa4a40279af8819eca4c5f1b]
Requirement for Significantly More Than Judicial Exception
Note:
Identify judicial exception, additional elements, and explain why they do not integrate the exception into a practical application or result in significantly more.

When an examiner determines that a claim is directed to a judicial exception (Step 2A: YES) and does not provide an inventive concept (Step 2B: NO), the rejection should provide an explanation for each part of the Step 2 analysis. For example, the rejection 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, 1) do not integrate the judicial exception into a practical application and 2) do not result in the claim as a whole amounting to significantly more than the judicial exception. See MPEP § 2106.04 et seq. for a discussion of Step 2A and the judicial exceptions, MPEP § 2106.05 et seq. for a discussion of Step 2B and the search for an inventive concept, and MPEP § 2106.07(a) for more information on formulating an ineligibility rejection.

Jump to MPEP SourceSignificantly More AnalysisStep 2B – Inventive ConceptAlice/Mayo Two-Step Framework
Topic

Statutory Authority for Examination

1 rules
StatutoryInformativeAlways
[mpep-2106-07-d1715f7f4f86ba41a45fcc53]
Prima Facie Case for Ineligibility Rejections
Note:
Examiners must establish a prima facie case of ineligibility by clearly explaining why claims are not patentable, allowing applicants to respond effectively.

If the evaluation of the claimed invention results in a conclusion that it is more likely than not that the claim as a whole does not satisfy both criteria for eligibility (Step 1: NO and/or Step 2B: NO), then examiners should formulate an appropriate rejection of that claim under Step 1 and/or Step 2B. The rejection should set forth a prima facie case of ineligibility under the substantive law. The concept of the prima facie case is a procedural tool of patent examination, which allocates the burdens going forward between the examiner and applicant. In particular, the initial burden is on the examiner to explain why a claim or claims are ineligible for patenting clearly and specifically, so that applicant has sufficient notice and is able to effectively respond.

Jump to MPEP SourceStatutory Authority for ExaminationExamination ProceduresPatent Eligibility
Topic

Responding to 101 Rejections

1 rules
StatutoryInformativeAlways
[mpep-2106-07-e6b61c8ed20b38c62a04c22b]
Examiner Must Clearly Explain Ineligibility Rejections
Note:
The examiner is required to clearly and specifically explain why a claim is ineligible for patenting, ensuring the applicant has sufficient notice and can effectively respond.

If the evaluation of the claimed invention results in a conclusion that it is more likely than not that the claim as a whole does not satisfy both criteria for eligibility (Step 1: NO and/or Step 2B: NO), then examiners should formulate an appropriate rejection of that claim under Step 1 and/or Step 2B. The rejection should set forth a prima facie case of ineligibility under the substantive law. The concept of the prima facie case is a procedural tool of patent examination, which allocates the burdens going forward between the examiner and applicant. In particular, the initial burden is on the examiner to explain why a claim or claims are ineligible for patenting clearly and specifically, so that applicant has sufficient notice and is able to effectively respond.

Jump to MPEP SourceResponding to 101 RejectionsPatent Eligibility
Topic

Step 1 – Not Directed to Exception

1 rules
StatutoryRecommendedAlways
[mpep-2106-07-47554810c6d7c1794c021fe4]
Claim Not Rejected If Statutory Category and Significantly More Than Exception
Note:
If the claimed invention falls within a statutory category and is not directed to a judicial exception or amounts to significantly more than an exception, the claim should not be rejected.

If the evaluation of the claimed invention results in a conclusion that it is more likely than not that the claimed invention falls within a statutory category (Step 1: YES) and is either not directed to a judicial exception (Step 2A: NO) or is directed to a judicial exception and amounts to significantly more than the judicial exception (Step 2B: YES), then the examiner should not reject the claim. When evaluating a response by applicant to a subject matter eligibility rejection, examiners must carefully consider all of applicant’s arguments and evidence presented to rebut the rejection. If applicant properly challenges the examiner’s findings, the rejection should be withdrawn or, if the examiner deems it appropriate to maintain the rejection, a rebuttal must be provided in the next Office action. This is discussed in greater detail in MPEP § 2106.07(b).

Jump to MPEP SourceStep 1 – Not Directed to ExceptionSignificantly More AnalysisStep 2A Prong 1 – Judicial Exception
Topic

Traversing 35 U.S.C. 101 Rejections

1 rules
StatutoryRequiredAlways
[mpep-2106-07-41762cda425237e67e305d1c]
Examiners Must Evaluate All Applicant Evidence Against Subject Matter Eligibility Rejections
Note:
Examiners are required to carefully consider all of applicant’s arguments and evidence when evaluating responses to subject matter eligibility rejections.

If the evaluation of the claimed invention results in a conclusion that it is more likely than not that the claimed invention falls within a statutory category (Step 1: YES) and is either not directed to a judicial exception (Step 2A: NO) or is directed to a judicial exception and amounts to significantly more than the judicial exception (Step 2B: YES), then the examiner should not reject the claim. When evaluating a response by applicant to a subject matter eligibility rejection, examiners must carefully consider all of applicant’s arguments and evidence presented to rebut the rejection. If applicant properly challenges the examiner’s findings, the rejection should be withdrawn or, if the examiner deems it appropriate to maintain the rejection, a rebuttal must be provided in the next Office action. This is discussed in greater detail in MPEP § 2106.07(b).

Jump to MPEP SourceTraversing 35 U.S.C. 101 RejectionsBerkheimer Evidence RequirementsResponding to Rejections
Topic

Office Actions and Responses

1 rules
StatutoryRequiredAlways
[mpep-2106-07-17ac9b59b71c8bac71437159]
Proper Challenge Requires Rejection Withdrawal Or Rebuttal
Note:
If applicant properly challenges the examiner’s findings, the rejection should be withdrawn or a rebuttal must be provided in the next Office action.

If the evaluation of the claimed invention results in a conclusion that it is more likely than not that the claimed invention falls within a statutory category (Step 1: YES) and is either not directed to a judicial exception (Step 2A: NO) or is directed to a judicial exception and amounts to significantly more than the judicial exception (Step 2B: YES), then the examiner should not reject the claim. When evaluating a response by applicant to a subject matter eligibility rejection, examiners must carefully consider all of applicant’s arguments and evidence presented to rebut the rejection. If applicant properly challenges the examiner’s findings, the rejection should be withdrawn or, if the examiner deems it appropriate to maintain the rejection, a rebuttal must be provided in the next Office action. This is discussed in greater detail in MPEP § 2106.07(b).

Jump to MPEP SourceOffice Actions and ResponsesResponding to 101 RejectionsExamination Procedures

Citations

Primary topicCitation
Patent Eligibility35 U.S.C. § 101
Patent EligibilityMPEP § 2106.03
Significantly More AnalysisMPEP § 2106.04
Significantly More AnalysisMPEP § 2106.05
Significantly More AnalysisMPEP § 2106.07(a)
Office Actions and Responses
Step 1 – Not Directed to Exception
Traversing 35 U.S.C. 101 Rejections
MPEP § 2106.07(b)

Source Text from USPTO’s MPEP

This is an exact copy of the MPEP from the USPTO. It is here for your reference to see the section in context.

BlueIron Last Updated: 2026-01-10