Section 101 Examples
Introduction to Examples 43-46

This document is the introduction to Life Sciences & Data Processing Examples 43-46 provided by the USPTO in October of 2019 to help understand the October 2018 Update 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG). The original PDF version of examples 43-46 is found here.

Index to USPTO's Section 101 Examples.

Introduction to Examples 43-46

The following examples should be used in conjunction with the 2019 Revised Patent Subject Matter Eligibility Guidance (“2019 PEG”) and the October 2019 Update: Subject Matter Eligibility (“October 2019 Update”). The examples below are hypothetical and only intended to be illustrative of the claim analysis under the 2019 PEG, and of the particular issues noted below in the Issue Spotting Chart. These examples should be interpreted based on the fact patterns set forth below as other fact patterns may have different eligibility outcomes. That is, it is not necessary for a claim under examination to mirror an example claim to be subject matter eligible under the 2019 PEG. All of the claims are analyzed for eligibility in accordance with their broadest reasonable interpretation.

Note that the examples herein are numbered consecutively beginning with number 43 because 42 examples were previously issued. Appendix 2 to the October 2019 Update contains a comprehensive index of all 46 of the USPTO’s eligibility examples.

The examples are illustrative only of the patent-eligibility analysis under the 2019 PEG. All claims must be ultimately analyzed for compliance with every requirement for patentability, including 35 U.S.C. 102, 103, 112, and 101 (utility, inventorship and double patenting) and non-statutory double patenting. The analyses provided below do not address considerations other than subject matter eligibility under Section 101.

Issue Spotting Chart

Treating Kidney Disease

Denveric Acid

Controller For Injection Mold

Livestock Management

Example Number





Claim Type


Product (Composition of Matter, Manufacture, and/or Machine)

Judicial Exception

Abstract Idea: Mathematical Concept

Abstract Idea: Mental Process

Abstract Idea: Certain Methods of Organizing Human Activity

Law of Nature

Product of Nature

Multiple exceptions in same claim

No recited exception

Detailed Analysis

Step 2A Prong One: Generally

Step 2A Prong One: Markedly Different Characteristics analysis

Step 2A Prong Two: Exception Integrated Into A Practical Application

Step 2B: Generally

Step 2B: Claim is eligible because it provides an Inventive Concept

Considerations Discussed in Step 2A Prong Two and/or Step 2B

Improvements to Functioning of a Computer or Other Technology

Particular Treatment or Prophylaxis (Prong Two only)

Particular Machine

Particular Transformation

Other Meaningful Limitations

Mere Instructions To Apply An Exception

Insignificant Extra-Solution Activity

Field of Use and Technological Environment

Well-Understood, Routine, Conventional (WURC) Activity (Step 2B only)

Claim Interpretation Issues

Contingent limitations

Functional language

Wherein clauses