MPEP 2106: Subject Matter Eligibility — Legal Standards and Practice

Patent subject matter eligibility under 35 U.S.C. § 101 remains one of the most challenging aspects of modern patent prosecution, with rejection rates rising sharply after pivotal Supreme Court rulings. Section 2106 of the Manual of Patent Examining Procedure (MPEP) outlines the two-step framework examiners follow to determine whether claims meet patent-eligible subject matter requirements, making it critical knowledge for avoiding delays and costly setbacks.

Key Takeaways

• MPEP 2106 requires a mandatory two-step analysis to decide if patent claims satisfy patent subject matter eligibility under 35 U.S.C. § 101.
• The process first identifies any judicial exceptions, then determines if the claims add significantly more beyond the exception itself.
• Careful claim drafting and familiarity with USPTO patent examiner guidelines can reduce eligibility rejections and help move applications forward efficiently.

Understanding The Fundamentals Of Subject Matter Eligibility

Patent subject matter eligibility starts with the text of 35 U.S.C. §101 — process, machine, manufacture, composition of matter — but courts carved out three judicial exceptions: laws of nature, natural phenomena, and abstract ideas. Those exceptions are what send otherwise ordinary claims into eligibility quicksand. 

The Statutory Foundation Of Patent Eligibility

35 USC Section 101 (Inventions patentable) sets broad categories intended to capture human-made inventions. In practice, you should treat this step as your baseline: make sure every claim you draft recites at least one statutory category in plain terms (e.g., “computer-implemented method,” “device comprising,” “composition comprising”). 

If the claim’s breadth risks covering non-statutory embodiments (for example, signal media vs. tangible computer storage), tighten language in the claim or fallback dependent claims to fix the statutory footing. 

Evolution Of Judicial Interpretation

Courts have repeatedly narrowed §101’s reach by identifying exceptions that protect fundamental tools of scientific and commercial work. Alice and Mayo together produced the two-step test you’ll see in MPEP §2106: first identify the statutory class, then ask whether the claim is “directed to” an exception — and if so, whether the additional claim elements supply an inventive concept or practical application. Keep those opinions on your desk when you draft and when you respond. 

Understanding MPEP 2106 is crucial for anyone looking to protect intellectual property and ensure claims meet patent subject matter eligibility standards

The Two-Step Mayo/Alice Framework

The Mayo/Alice framework offers a structured way to assess patent subject matter eligibility under 35 U.S.C. § 101. It starts by confirming a claim falls into a statutory category, then checks if any judicial exceptions apply.

Step 1: Statutory Categories Analysis

Step 1 asks a simple question: Does the claim read on a process, machine, manufacture, or composition of matter? Most modern claims clear Step 1 if you define them as methods, devices, systems, or compositions with tangible or structural features. 

When examiners do issue a Step 1 rejection, it usually means the claim’s broadest reasonable interpretation embraces non-statutory subject matter (e.g., transitory signals), and you should narrow the claim scope or clarify the claim’s physical embodiments. 

Step 2: Judicial Exception Identification

Step 2 asks whether the claim is “directed to” an abstract idea, law of nature, or natural phenomenon. The USPTO groups abstract ideas into three buckets (mathematical concepts; methods of organizing human activity; mental processes), which helps you anticipate how an examiner will view core claim concepts. If the claim maps to one of those buckets, you must swiftly show that the claim integrates the exception into a practical application.

Special Considerations For Technology Fields

Patent subject matter eligibility attacks cluster in predictable tech areas. Below are field-specific traps and the concrete drafting moves that reduce risk.

Computer-Implemented Inventions

• Problem: Examiners often treat mere automation of a business practice or data manipulation as an abstract idea.
• What you must do: Show how the claimed implementation solves a technical problem — not just “do X on a computer,” but how you change computing behavior: reduce memory use, improve latency, eliminate a resource contention, or use a non-standard data path or hardware arrangement. Tighten claims to recite those changes (for example, “a multi-threaded scheduling module that reduces cache misses by X%” or “a specialized pipeline that offloads computation to an FPGA”). Use concrete performance numbers or measured improvements in the specification whenever possible — factual anchors help defeat “well-understood, routine, conventional” findings.

Life Sciences And Biotechnology

• Problem: Claims that merely state a natural correlation (biomarker ↔ disease) often collapse into a law of nature exception.
• What you must do: Claim specific, practical steps that apply the correlation — a measurement technique with a particular threshold, a treatment regimen tied to a measured outcome, or a deliberately engineered biological construct. If you alter a natural product (modify a protein, add a functional group) or add a concrete diagnostic/therapeutic step, emphasize those structural or procedural changes in both claims and examples—link claim elements to concrete clinical or laboratory practices in the spec to show practical application.

Business Methods And Financial Technology

• Problem: Moving a known financial practice onto generic servers triggers abstract-idea rejections post-Alice.
• What you must do: Highlight technical solutions and system architectures — cryptographic primitives implemented in a novel way, constrained real-time data flows with technical limits, or unique network topologies that solve a technological bottleneck. Claims that recite a “novel, technical interplay” between components — not just business goals — perform better in prosecution.

Procedural Aspects Of Eligibility Examination

Examiners must first establish a prima facie case before issuing a § 101 rejection. Applicants then have multiple ways to respond and demonstrate that claims provide significantly more than an abstract idea. The patent examiner guidelines under MPEP 2106 require examiners to follow a structured approach, which applicants can use to their advantage.

Prima Facie Case Requirements

Examiners must present a clear prima facie case: identify the judicial exception, explain why each claim element maps to that exception, and show that the remaining elements are routine or conventional. 

If an examiner fails to identify specific claim elements as part of the exception, press that point in a response and demand a clearer explanation or an interview. The MPEP requires examiners to ground §101 rejections in reasons that applicants can meaningfully respond to. 

Response Strategies For Applicants

You can push back on both the legal and factual fronts:

• Amend: Narrow or add elements that emphasize technological specifics (e.g., novel data structures, particular sensor configurations, precise thresholds, or timing constraints).
• Argue: Show how the claim integrates the exception into a practical application or explain why the “additional limitations” are not routine. Cite the USPTO’s examples that mirror your factual situation.
• Evidence: Submit declarations, benchmark data, whitepapers, or contemporaneous lab notes that show unexpected technical benefits or that certain elements were not well-understood/conventional at filing.
• Interview: Use examiner interviews to narrow disputes and frame claim language around the examiner’s stated concerns — interviews often reduce unnecessary office actions.

USPTO Guidance And Examination Updates

The USPTO regularly updates its patent examiner guidelines to help examiners apply eligibility rules consistently. These updates often follow major court decisions and include examples for various technologies.

For independent inventors, the patent examiner guidelines can serve as a roadmap to understand why certain claims are likely to face Section 101 rejections.

Keeping up with the latest examiner guidance and court decisions not only ensures compliance with MPEP 2106 but also helps you protect intellectual property by anticipating and addressing potential eligibility rejections.

2019 Revised Patent Subject Matter Eligibility Guidance

The 2019 PEG restructured Step 2 and formalized the “practical application” prong, grouping abstract ideas to provide practical exam examples. The Guidance lowered uncertainty in many art units by clarifying how examiners should analyze claims that mix abstract concepts and technical elements. Keep the actual guidance and its October 2019 update close — they contain examples you can rely on when arguing patent subject matter eligibility. 

Subsequent Updates And Clarifications

The USPTO periodically issues memos and training materials that refine examiner expectations for machine learning and AI inventions; these materials often emphasize drafting claims that show concrete technical improvements rather than high-level outcomes. Track the USPTO’s patent subject matter eligibility page and example sets to align your claim language with current examiner training. 

Strategic Approaches To Eligibility Compliance

Meeting MPEP 2106 requirements starts with claims that highlight specific technical improvements and concrete implementations. A strong application builds a clear record showing how the invention solves a real technical problem.

Claim Drafting Best Practices

You control the narrative. Draft claims and specs that:

• Focus on technical contributions: Show how the invention changes the way a device or computer behaves.
• Be specific: Avoid purely functional language. Give algorithmic steps, hardware constraints, timing, and measured benefits.
• Layer claims: Include dependent claims that fallback to concrete implementations (specific hardware, thresholds, interfaces).
• Link claim elements to specification embodiments: Tie each claim limitation to an example that shows how it works in practice.

Following patent examiner guidelines and drafting claims carefully helps protect intellectual property under 35 U.S.C. §101.

Application Preparation Strategies

Before filing, do these three things:

1. Identify the technical problem — Document the current system limitations, inefficiencies, or failure modes.
2. Explain the fix — For each claim element, show how it maps to a tangible improvement. Use diagrams and pseudo-code where helpful.
3. Give real examples — Provide multiple embodiments, test results, and data showing the improvement. If you can, include measurements, error rates, or comparative performance numbers that an examiner can parse. These facts make it harder to classify your claims as “routine.”

Documenting your technical improvements and providing clear examples helps patent examiners understand your invention while helping you protect intellectual property during the examination process.

Choose Amir Adibi For Subject Matter Eligibility Challenges

Want a claim-level action plan that converts vague features into USPTO-proof limitations? Contact Amir Adibi for a focused review and get a prioritized, itemized prosecution playbook that shows precisely which claim edits, spec insertions, and evidence items will best neutralize an Alice/Mayo attack.