Patent 101 Rejection Comparing: Navigating Subject Matter Eligibility

In the landscape of intellectual property, securing a patent is a critical step for inventors. However, the path to patent approval is often fraught with challenges, particularly concerning subject matter eligibility under 35 U.S.C. 101. A common obstacle encountered is the “patent 101 rejection,” issued by patent examiners when an invention is deemed to claim ineligible subject matter. This article provides a comprehensive comparison and analysis of patent 101 rejections, leveraging insights from the Manual of Patent Examining Procedure (MPEP 2106) to guide inventors and practitioners through the complexities of subject matter eligibility in the United States. We aim to elucidate the two-step Alice/Mayo framework, compare the various judicial exceptions—abstract ideas, laws of nature, and natural phenomena—and explore how patent claims are rigorously compared against these exceptions during patent examination to ascertain patent eligibility. This guide serves as an essential resource for understanding the nuances of patent 101 rejections and formulating effective strategies for overcoming them.

I. Understanding the Two-Pronged Test for Patent Subject Matter Eligibility

The determination of patent subject matter eligibility hinges on a two-part criterion, ensuring that inventions seeking patent protection align with the statutory framework outlined in 35 U.S.C. 101. This section breaks down these criteria, drawing from established legal principles and guidelines.

1. Statutory Categories: The Foundation of Eligibility

The first criterion mandates that a claimed invention must fall within one of the four categories delineated by statute. 35 U.S.C. 101 specifies these categories as:

• Processes: Encompassing actions, methods, or series of steps to achieve a particular result. 35 U.S.C. 100(b) expands this definition to include “art or method” and “a new use of a known process, machine, manufacture, composition of matter, or material.”
• Machines: Tangible entities composed of parts or devices designed to perform specific functions and produce defined effects.
• Manufactures: Tangible articles resulting from human craftsmanship or artificial processes, imbued with new forms, qualities, properties, or combinations.
• Compositions of Matter: Combinations of two or more substances, including all composite articles, whether chemically united, mechanically mixed, or existing as gases, fluids, powders, or solids.

These categories broadly distinguish between “actions” (processes) and “things” or “products” (machines, manufactures, and compositions of matter). For a deeper understanding of these categories, refer to MPEP § 2106.03.

2. Judicial Exceptions: Navigating Beyond Statutory Categories

Even if an invention falls within a statutory category, it must further qualify as patent-eligible subject matter. This second criterion addresses “judicial exceptions”—areas that, through court rulings, have been deemed outside the scope of patent eligibility. These exceptions are limited to:

• Abstract Ideas: Concepts lacking physical embodiment, often encompassing fundamental economic practices, methods of organizing human activity, and mental processes.
• Laws of Nature: Principles or forces that exist independently of human action, including scientific principles and mathematical formulas.
• Natural Phenomena: Naturally occurring events or products, including products of nature like substances found in nature.

The landmark case Alice Corp. Pty. Ltd. v. CLS Bank Int’l (2014) and Ass’n for Molecular Pathology v. Myriad Genetics, Inc. (2013) are pivotal in defining these exceptions. Crucially, a claim directed to a judicial exception is deemed ineligible unless it incorporates “additional limitations amounting to significantly more than the exception.” Further details on judicial exceptions are available in MPEP § 2106.04.

The Supreme Court’s rationale for these exceptions stems from the concern that patenting fundamental tools of science and technology could stifle innovation. As abstract ideas, laws of nature, and natural phenomena are considered “basic tools of scientific and technological work”, granting monopolies could impede progress rather than promote it (Alice Corp., 2014; Mayo Collaborative Servs. v. Prometheus Labs., Inc., 2012).

However, it’s critical to note that the mere involvement of a judicial exception does not automatically render an invention ineligible. As Alice Corp. (2014) and Diamond v. Diehr (1981) emphasize, integrating a judicial exception into a practical application can indeed be patent-eligible. The courts distinguish between patents claiming “building blocks” of innovation and those that integrate these blocks into something “significantly more.” This integration framework is further explored in cases like Thales Visionix Inc. v. United States (2017), which clarified that the presence of a mathematical equation doesn’t inherently doom a claim to abstraction.

The Alice/Mayo test provides a framework for discerning between ineligible judicial exceptions and patent-eligible applications. This two-part test, detailed in subsection III below, is the definitive method for evaluating subject matter eligibility. The framework first determines if the claim is “directed to” a judicial exception. If so, the second part assesses whether the claim elements, in totality, offer significantly more than the exception itself. This “search for an inventive concept” guides examiners in determining whether a claim transcends the judicial exception to warrant patent protection.

It is also important to understand what tests are not to be used. The “machine-or-transformation” test, while historically significant, is not a standalone test but rather a clue for eligibility, integrated within the Alice/Mayo framework. Similarly, the “useful, concrete, and tangible result” test, stemming from State Street Bank and In re Alappat, has been superseded by subsequent Supreme Court decisions (Bilski v. Kappos, 2010). The “programmed computer” or “special purpose computer” test from In re Alappat has also been invalidated by Bilski and Alice Corp., as noted in Eon Corp. IP Holdings LLC v. AT&T Mobility LLC (2015) and Intellectual Ventures I LLC v. Capital One Bank (USA), N.A. (2015). Finally, utility, while a requirement for patentability, is not the test for patent-eligible subject matter (Genetic Techs. Ltd. v. Merial LLC, 2016).

Examiners are reminded that 35 U.S.C. 101 is a threshold inquiry. Even if an invention is deemed eligible under §101, it must still meet the other patentability requirements under 35 U.S.C. 102 (novelty), 103 (non-obviousness), and 112 (written description and enablement). As Bilski (2010) clarified, §101 is merely the first gate to pass in the patentability assessment.

II. Establishing the Broadest Reasonable Interpretation (BRI) of Claims

Before evaluating a claim for subject matter eligibility, it is paramount to establish its Broadest Reasonable Interpretation (BRI). The BRI, as defined in MPEP § 2111, sets the scope of the claim’s coverage and is crucial in determining whether the claim overreaches into non-statutory subject matter or encompasses judicial exceptions. Cases like MyMail, Ltd. v. ooVoo, LLC (2019) and Bancorp Servs., LLC v. Sun Life Assurance Co. of Can. (U.S.) (2012) underscore the importance of understanding the “basic character of the claimed subject matter” through claim construction. This step ensures that patent eligibility is evaluated based on the actual invention claimed, not merely on drafting nuances (Alice, 2014; Parker v. Flook, 1978; Mayo, 2012).

Claim interpretation impacts both eligibility criteria. For the first criterion (statutory category), Mentor Graphics v. EVE-USA, Inc. (2017) illustrates how BRI can determine if a claim falls within a statutory category. In this case, the court’s interpretation of “machine-readable medium” to include both statutory media (RAM, magnetic tape) and non-statutory carrier waves (transitory signals) led to the claim’s ineligibility.

Regarding the second criterion and the Alice/Mayo test, claim interpretation affects both steps. In Step 2A (directed to a judicial exception), Synopsys, Inc. v. Mentor Graphics Corp. (2016) demonstrates how claim interpretation influences the determination of whether claims are directed to an abstract idea. The court interpreted the claims as encompassing mental steps, thus falling under abstract ideas, because they lacked limitations requiring computer implementation. Conversely, Enfish, LLC v. Microsoft Corp. (2016) shows how claim interpretation can lead to a finding of eligibility. The court interpreted the claims as reciting a specific algorithm that improved database technology, thus not directed to an abstract idea. Similarly, McRO, Inc. v. Bandai Namco Games America, Inc. (2016) found claims eligible because the claim construction incorporated rules improving an existing technological process.

Claim interpretation is also vital in Step 2B (significantly more than the exception). Amdocs (Israel) Ltd. v. Openet Telecom, Inc. (2016) showcases how the construction of “enhance” to require unconventional technical solutions helped establish eligibility by demonstrating an inventive concept beyond the abstract idea.

III. The Alice/Mayo Two-Part Test: A Detailed Flowchart Analysis

To systematically evaluate subject matter eligibility, examiners utilize a flowchart-based approach, aligning with the Supreme Court’s Alice/Mayo two-part test. This flowchart, illustrated in MPEP § 2106, provides a structured framework for analyzing both product and process claims. It aims for examination efficiency and consistency across diverse technologies.

Step 1 of the flowchart verifies if the claim falls within one of the four statutory categories (process, machine, manufacture, or composition of matter). MPEP § 2106.03 provides detailed guidance for this step. Step 2 then applies the Alice/Mayo test, divided into two prongs:

• Step 2A: Determines if the claim is “directed to” a judicial exception (abstract idea, law of nature, or natural phenomenon). MPEP § 2106.04 offers in-depth information on Step 2A.
• Step 2B: If Step 2A is affirmative, this step assesses whether the claim includes “additional elements” that amount to significantly more than the judicial exception, indicating an “inventive concept.” MPEP § 2106.05 elaborates on Step 2B.

The flowchart presents three pathways to eligibility:

• Pathway A (Streamlined Analysis): Claims with self-evident eligibility, often due to clear technological improvements, bypass Steps 2A and 2B.
• Pathway B (Step 2A: NO): Claims not directed to a judicial exception after Step 2A are deemed eligible.
• Pathway C (Step 2B: YES): Claims directed to a judicial exception but found to have an inventive concept in Step 2B are also eligible.

Claims failing all three pathways are deemed patent-ineligible and rejected under 35 U.S.C. 101. However, a rejection under §101 does not preclude examination under other patentability requirements such as 35 U.S.C. 102, 103, and 112, ensuring a comprehensive patentability assessment.

IV. Eligibility Step 1: Assessing Statutory Categories

Step 1 of the eligibility analysis, as outlined in MPEP § 2106.03, focuses on whether the claim is directed to a process, machine, manufacture, or composition of matter. This step ensures the claimed invention aligns with the fundamental statutory categories defined in 35 U.S.C. 101. As the Federal Circuit stated in In re Nuijten (2007), these categories define the “exclusive reach of patentable subject matter.” Claims falling outside these categories are deemed non-statutory, irrespective of novelty and usefulness.

I. The Four Categories in Detail

• Process: Defined as “actions,” encompassing a series of acts or steps. The Supreme Court in Gottschalk v. Benson (1972), quoting Cochrane v. Deener (1876), described a process as “an act, or a series of acts, performed upon the subject-matter to be transformed and reduced to a different state or thing.” This category requires demonstrable action, as reiterated in Nuijten (2007) and NTP, Inc. v. Research in Motion, Ltd. (2005). The terms “process” and “method” are synonymous under 35 U.S.C. 100(b).

• Machines, Manufactures, and Compositions of Matter: These categories encompass tangible “things” or “products.” As Digitech Image Techs. v. Electronics for Imaging (2014) clarified, except for process claims, eligible subject matter must exist in a physical or tangible form.

  • Machine: Defined as a “concrete thing” comprising parts or devices in combination, performing a function and producing a specific effect (Digitech, 2014, quoting Burr v. Duryee, 1863). It encompasses mechanical devices and combinations of mechanical powers (Nuijten, 2007, quoting Corning v. Burden, 1854).
  • Manufacture: A “tangible article” given a new form or property through artificial means (Digitech, 2014, citing Diamond v. Chakrabarty, 1980). Manufactures result from manufacturing processes using raw materials, whether by hand or machinery (Samsung Electronics Co. v. Apple Inc., 2016, quoting Diamond v. Chakrabarty, 1980; Nuijten, 2007). This category also includes machine parts considered separately (Samsung Electronics, 2016, quoting Robinson, 1890).
  • Composition of Matter: A “combination of two or more substances,” including all composite articles (Digitech, 2014). This category includes all compositions, irrespective of chemical union, mechanical mixture, or state (gas, fluid, powder, solid) (Chakrabarty, 1980, quoting Shell Dev. Co. v. Watson, 1957). Genetically modified microorganisms are considered manufactures or compositions of matter (Chakrabarty, 1980).

It is not essential to pinpoint a single category, as long as the claim clearly falls into at least one. For example, a microprocessor can be classified as a manufacture, satisfying Step 1 regardless of whether it also qualifies as a machine. Similarly, inventions may fit into multiple categories, such as a bicycle (machine and manufacture) or a genetically modified bacterium (composition of matter and manufacture).

II. Non-Statutory Subject Matter Examples

Claims not directed to any statutory category include:

• Products lacking physical or tangible form: Information “per se” or computer programs “per se” when claimed as products without structural recitations. Digitech (2014) held that a “device profile” comprising data sets was not statutory as it lacked physical form. Similarly, software code detached from any medium is considered an idea without physical embodiment (Microsoft Corp. v. AT&T Corp., 2007; Gottschalk v. Benson, 1972).
• Transitory forms of signal transmission: Signals “per se,” such as propagating electrical or electromagnetic signals or carrier waves (Nuijten, 2007; Mentor Graphics Corp. v. EVE-USA, Inc., 2017).
• Subject matter expressly prohibited: Humans “per se,” excluded by the Leahy-Smith America Invents Act (AIA).

Tangibility is a key requirement for machines, manufactures, and compositions of matter (Digitech, 2014). Intangible collections of information (Digitech, 2014), software without structural limitations (Microsoft v. AT&T, 2007), and abstract ideas (Benson, 1972) are not statutory. Even tangible but non-structural entities like transitory signals (Nuijten, 2007; Mentor Graphics, 2017) also fail to meet the statutory category requirement.

III. Eligibility Step 1 Analysis

Step 1 of the eligibility analysis, as detailed in MPEP § 2106, asks: “Is the claim to a process, machine, manufacture or composition of matter?” This evaluation, like all eligibility analyses, follows claim construction based on the broadest reasonable interpretation (BRI) and understanding the inventor’s creation as disclosed in the application (MPEP § 2106 subsection II and MPEP § 2111).

Step 1 determines if:

• Step 1: NO: The claim as a whole is non-statutory, warranting a §101 rejection.
• Step 1: YES: The claim is statutory and requires further analysis (Pathway A or Step 2A).

Claims with a BRI encompassing both statutory and non-statutory embodiments are considered non-statutory and rejected at Step 1. In such cases, examiners should recommend claim amendments to narrow the scope to statutory embodiments. For instance, a claim to a “machine readable medium” encompassing both statutory compact discs and non-statutory carrier waves would be rejected (Mentor Graphics v. EVE-USA, Inc., 2017; In re Nuijten, 2007).

If a claim is clearly non-statutory (Step 1: NO), a §101 rejection is made using form paragraphs 7.05 and 7.05.01 (MPEP § 2106.07(a)(1)). However, if amendment to a statutory category is possible, examiners should recommend such amendments and proceed with further eligibility analysis (Pathway A, B, or C).

V. Eligibility Step 2A: Determining if a Claim is Directed to a Judicial Exception

Step 1 eligibility does not conclude the analysis. Step 2A, as described in MPEP § 2106.04, addresses whether a claim, while statutory, is “directed to” a judicial exception: abstract ideas, laws of nature, or natural phenomena. This step is crucial because claims directed solely to these exceptions are patent-ineligible (Diamond v. Diehr, 1981; Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 2014; Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 2013; Diamond v. Chakrabarty, 1980; Parker v. Flook, 1978; Gottschalk v. Benson, 1972; Bilski v. Kappos, 2010).

I. Judicial Exceptions: Core Principles

Judicial exceptions, also termed “judicially recognized exceptions,” are fundamental concepts that courts have deemed outside patent eligibility. These include “laws of nature,” “natural phenomena,” and “abstract ideas” (Bilski v. Kappos, 2010, quoting Chakrabarty, 1980). Other terms used interchangeably include “physical phenomena,” “products of nature,” “scientific principles,” “systems that depend on human intelligence alone,” “disembodied concepts,” “mental processes,” and “disembodied mathematical algorithms and formulas.” It’s important to note that these categories are not strictly delineated and often overlap.

The rationale behind judicial exceptions is to prevent the monopolization of “basic tools of scientific and technological work,” which could impede innovation rather than promote it (Alice Corp., 2014; Myriad, 2013; Mayo, 2012). The Supreme Court’s primary concern is preemption—preventing claims that effectively preempt abstract ideas, laws of nature, or natural phenomena, even narrowly defined ones (Mayo, 2012; Flook, 1978; Benson, 1972).

While preemption underlies judicial exceptions, it is not a standalone test for eligibility (Rapid Litig. Mgmt. v. CellzDirect, Inc., 2016). The Alice/Mayo two-part test resolves preemption concerns (Synopsys, Inc. v. Mentor Graphics Corp., 2016; Ariosa Diagnostics, Inc. v. Sequenom, Inc., 2015). Eligibility evaluation requires the Alice/Mayo test, as the absence of complete preemption does not guarantee eligibility (Diamond v. Diehr, 1981; Synopsys v. Mentor Graphics, 2016; FairWarning IP, LLC v. Iatric Sys., Inc., 2016; Intellectual Ventures I LLC v. Symantec Corp., 2016; Sequenom, 2015).

Judicial exceptions need not be old or prevalent; even novel discoveries can be exceptions. Mathematical formulas (Flook, 1978), laws of nature (Mayo, 2012), and isolated DNA (Myriad, 2013) were all novel but considered exceptions as “basic tools” beyond patent protection. This stems from the concern that patenting even “just discovered” exceptions could “tie up” these tools and “inhibit future innovation” (Myriad, 2013, quoting Mayo, 2012). Novelty alone does not confer §101 eligibility (Myriad, 2013; Ultramercial, Inc. v. Hulu, LLC, 2014; Synopsys, Inc. v. Mentor Graphics Corp., 2016).

II. Eligibility Step 2A: Is the Claim Directed to a Judicial Exception?

Step 2A, the first part of the Alice/Mayo test (MPEP § 2106 subsection III), determines whether a claim is “directed to” a judicial exception. Like other steps, this evaluation follows claim construction under BRI and understanding the invention (MPEP § 2106 subsection II and MPEP § 2111).

Step 2A asks: “Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea?” It determines:

• Step 2A: NO: The claim is not directed to a judicial exception and is eligible at Pathway B.
• Step 2A: YES: The claim is directed to a judicial exception and requires Step 2B analysis.

A. Step 2A: A Two-Prong Inquiry

Step 2A involves a two-prong inquiry:

1. Prong One: Does the claim recite a judicial exception?
2. Prong Two: If yes, is the recited exception integrated into a practical application?

1. Prong One: Recitation of a Judicial Exception

Prong One asks: “Does the claim recite an abstract idea, law of nature, or natural phenomenon?” It evaluates whether a judicial exception is “set forth” or “described” in the claim. “Recite,” “set forth,” and “describe” are used interchangeably, indicating two ways an exception can be present in a claim. Claims may explicitly “set forth” an exception, like stating a mathematical equation (Diehr, 1981) or laws of nature (Mayo, 2012). Alternatively, claims may “describe” an exception without explicit mention, as in Alice Corp. (2014), which described intermediated settlement without using the terms explicitly.

The Supreme Court recognizes an implicit §101 exception for laws of nature, natural phenomena, and abstract ideas, considered “basic tools of scientific and technological work” (Alice Corp., 2014, citing Mayo, 2012). However, “at some level, all inventions embody, use, reflect, rest upon, or apply” these exceptions (Alice Corp., 2014). Examiners must carefully distinguish between claims that “recite” an exception (requiring further analysis) and those that merely “involve” an exception (eligible without further analysis).

A claim “recites” an exception if it sets forth or describes it. For example, “A machine comprising elements that operate in accordance with F=ma” recites the law of nature F=ma. In contrast, “A teeter-totter comprising an elongated member pivotably attached to a base member…” merely “involves” natural principles like levers but doesn’t recite them, thus not directed to a judicial exception (Step 2A: NO), and eligible at Pathway B.

If a claim recites a judicial exception (abstract idea, law of nature, or natural phenomenon), it proceeds to Prong Two. If not, it’s eligible at Pathway B without further analysis (Step 2A: NO).

2. Prong Two: Integration into a Practical Application

Prong Two asks: “Does the claim recite additional elements that integrate the judicial exception into a practical application?” It evaluates whether the claim as a whole transforms the exception into a practical application. If additional elements integrate the exception, the claim is not “directed to” the exception (Step 2A: NO) and is eligible at Pathway B. If not, the claim is “directed to” the exception (Step 2A: YES) and proceeds to Step 2B.

Reciting a judicial exception alone, or with additional elements that are merely another judicial exception, is insufficient for integration (RecogniCorp, LLC v. Nintendo Co., 2017; Genetic Techs. Ltd. v. Merial LLC, 2016). Additional elements must “transform the nature of the claim” into a patent-eligible application (Alice Corp., 2014). If no additional elements exist, the claim is ineligible. In such cases, examiners should recommend amendments to resolve eligibility if possible.

B. Evaluating Claims Reciting Multiple Judicial Exceptions

Claims may recite multiple judicial exceptions, as seen in Bilski v. Kappos (2010) and Mayo Collaborative Servs. v. Prometheus Labs. Inc. (2012). These claims are analyzed similarly to those with a single exception, as in Alice Corp. (2014).

Examiners should apply the same eligibility analysis regardless of the number of exceptions. Unless distinct exceptions are clear (e.g., law of nature and abstract idea), parsing claims into multiple exceptions should be avoided, particularly for abstract ideas. Claims should be treated as containing a single judicial exception for Prong Two and Step 2B analysis.

In cases with distinct exceptions (e.g., a law of nature and an abstract idea in separate limitations), examiners should select one exception for analysis to enhance efficiency. Eligibility hinges on whether additional elements integrate the selected exception into a practical application or amount to significantly more. If so, the claim is eligible. If not, it’s ineligible (University of Utah Research Foundation v. Ambry Genetics, 2014).

For claims reciting multiple abstract ideas or laws of nature, examiners should not parse the claim. For example, a claim with mental steps and mathematical calculations should be identified as reciting both for Prong One, but treated as a single abstract idea for Prong Two and Step 2B.

VI. Abstract Ideas: Groupings and Examples (MPEP § 2106.04(a))

The abstract idea exception, deeply rooted in jurisprudence (Bilski v. Kappos, 2010), remains challenging to define precisely. However, courts have clarified that software and business methods are not categorically excluded from patentability (Bilski, 2010; Content Extraction and Transmission, LLC v. Wells Fargo Bank, 2014). Software, even with underlying mathematical calculations, is not automatically abstract (Thales Visionix, Inc. v. United States, 2017; McRO, Inc. v. Bandai Namco Games Am. Inc., 2016; Enfish, 2016).

To facilitate examination, the USPTO has categorized abstract ideas into enumerated groupings, shifting from case-by-case comparison to a broader application of case law (MPEP § 2106.04(a)(2)). These groupings, grounded in Supreme Court and Federal Circuit precedents, include:

1. Mathematical Concepts: Mathematical relationships, formulas, equations, and calculations (Gottschalk v. Benson, 1972; Parker v. Flook, 1978; Diamond v. Diehr, 1981; Bilski v. Kappos, 2010).
2. Certain Methods of Organizing Human Activity: Fundamental economic principles/practices (hedging, insurance), commercial/legal interactions (contracts, advertising), and managing personal behavior/relationships (social activities, teaching, rules) (Alice, 2014; Bilski, 2010).
3. Mental Processes: Concepts performable in the human mind, including observations, evaluations, judgments, and opinions (CyberSource Corp. v. Retail Decisions, Inc., 2011; Mayo Collaborative Servs. v. Prometheus Labs. Inc., 2012; Parker v. Flook, 1978; Gottschalk v. Benson, 1972).

Examiners determine if a claim recites an abstract idea by:

1. Identifying specific claim limitations believed to recite an abstract idea.
2. Determining if these limitations fall within at least one of the enumerated groupings.

If limitations fall into any grouping, the claim recites an abstract idea (Step 2A Prong One), requiring Prong Two analysis to assess practical application (MPEP § 2106.04(d)). If limitations do not fall into any grouping, the claim generally does not recite an abstract idea, eligible at Pathway B, unless another exception is recited (MPEP § 2106.04(a)(3)).

MPEP § 2106.04(a)(1) provides examples of claims not reciting abstract ideas, eligible at Step 2A Prong One. MPEP § 2106.04(a)(2) further explains abstract idea groupings, which are not mutually exclusive. Examiners should identify at least one, and preferably all applicable groupings, before proceeding to Prong Two.

I. Mathematical Concepts Grouping (MPEP § 2106.04(a)(2)I.)

The “mathematical concepts” grouping encompasses mathematical relationships, formulas/equations, and calculations (Gottschalk v. Benson, 1972; Parker v. Flook, 1978; Diamond v. Diehr, 1981; Bilski v. Kappos, 2010). The Supreme Court views “mathematical concepts” as judicial exceptions because “’a mathematical formula as such is not accorded the protection of our patent laws’” (Diehr, 1981, citing Benson, 1972). Thus, discovering a mathematical formula alone doesn’t warrant a patent unless its application includes an “inventive concept” (Flook, 1978). While historically described as laws of nature, recent Supreme Court opinions classify mathematical relationships and formulas as abstract ideas (Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 2014; Bilski v. Kappos, 2010).

Examiners should distinguish between claims that “recite” a mathematical concept and those merely “based on” or “involve” one. Claims merely based on or involving mathematical concepts are not necessarily ineligible (Thales Visionix, Inc. v. United States, 2017). The key is whether the claim “recites” the mathematical concept itself.

Mathematical concepts need not be expressed in mathematical symbols; words can serve the same purpose (In re Grams, 1989). Claims describing “mathematical calculations based on selected information,” “organizing information through mathematical correlations,” and “managing a stable value protected life insurance policy by performing calculations” have been deemed abstract ideas (SAP America, Inc. v. InvestPic, LLC, 2018; Digitech Image Techs., LLC v. Elecs. for Imaging, Inc., 2014; Bancorp Servs., LLC v. Sun Life Assurance Co. of Can. (U.S.), 2012).

• A. Mathematical Relationships: Relationships between variables or numbers, expressed verbally or mathematically (e.g., pressure = force/area). Examples include relationships between reaction rate and temperature (Arrhenius equation, Diamond v. Diehr, 1981), binary coded decimal and pure binary conversion (Benson, 1972), directional radio activity and antenna conductor arrangement (Mackay Radio & Tel. Co. v. Radio Corp. of America, 1939), and information organization through mathematical correlations (Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 2014).

• B. Mathematical Formulas or Equations: Numerical formulas or equations, or textual equivalents (e.g., “determining a ratio of A to B,” “calculating force by multiplying mass by acceleration”). Examples include formulas for electromagnetic standing wave phenomena (Mackay Radio & Tel. Co. v. Radio Corp. of America, 1939), the Arrhenius equation (Diamond v. Diehr, 1981), alarm limit computation (Parker v. Flook, 1978), and hedging (Bilski v. Kappos, 2010).

• C. Mathematical Calculations: Mathematical operations or acts of calculating using mathematical methods to determine variables or numbers (arithmetic operations, exponentiation). The term “calculating” need not be explicitly recited; “determining” or “performing” mathematical operations can also qualify. Examples include resampling statistical analysis (SAP America, Inc. v. InvestPic, LLC, 2018), alarm limit calculation (Parker v. Flook, 1978), geospatial coordinate conversion (Burnett v. Panasonic Corp., 2018), managing insurance policies via calculations (Bancorp Servs., LLC v. Sun Life Assur. Co. of Canada (U.S.), 2012), optimal visit number algorithms (In re Maucorps, 1979), and local/average data value difference calculations (In re Abele, 1982).

II. Certain Methods of Organizing Human Activity Grouping (MPEP § 2106.04(a)(2)II.)

“Methods of organizing human activity” encompasses:

• Fundamental Economic Principles or Practices: Hedging, insurance, mitigating risk (Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 2014; Bilski v. Kappos, 2010).
• Commercial or Legal Interactions: Contracts, legal obligations, advertising, marketing, sales, business relations (buySAFE, Inc. v. Google, Inc., 2014; Fort Properties, Inc. v. American Master Lease, LLC, 2012; Ultramercial, Inc. v. Hulu, LLC, 2014; Credit Acceptance Corp. v. Westlake Services, 2017).
• Managing Personal Behavior or Relationships/Interactions Between People: Social activities, teaching, following rules/instructions (Intellectual Ventures I LLC v. Capital One Bank (USA), 2015; Voter Verified, Inc. v. Election Systems & Software, LLC, 2018; In re Marco Guldenaar Holding B.V., 2018).

The “certain” qualifier highlights that not all methods of organizing human activity are abstract ideas (In re Marco Guldenaar Holding B.V., 2018). This grouping is limited to the enumerated sub-groupings and is not expanded beyond them except in rare circumstances (MPEP § 2106.04(a)(3)). The number of people involved is not dispositive; the activity’s nature within these sub-groupings is key.

• A. Fundamental Economic Practices or Principles: Concepts related to economy and commerce, including hedging, insurance, risk mitigation (Bilski v. Kappos, 2010; Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 2014; Bancorp Services., L.L.C. v. Sun Life Assurance Co. of Canada (U.S.), 2012). “Fundamental” doesn’t necessarily mean “old” or “well-known” (OIP Techs., Inc. v. Amazon.com, Inc., 2015; In re Smith, 2016; In re Greenstein, 2019), but being old or well-known can indicate fundamentality (Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 2014; Bilski v. Kappos, 2010; Intellectual Ventures I LLC v. Symantec Corp., 2016).

• B. Commercial or Legal Interactions: Agreements (contracts), legal obligations, advertising, marketing, sales, business relations (buySAFE, Inc. v. Google, Inc., 2014; Bancorp Servs., LLC v. Sun Life Assur. Co. of Canada (U.S.), 2012; Accenture Global Services v. Guidewire Software, Inc., 2013; Fort Properties, Inc. v. American Master Lease, LLC, 2012; Bilski v. Kappos, 2010; Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 2014; In re Comiskey, 2009; Ultramercial, Inc. v. Hulu, LLC, 2014; In re Ferguson, 2009; In re Maucorps, 1979; OIP Techs., Inc. v. Amazon.com, Inc., 2015; Credit Acceptance Corp. v. Westlake Services, 2017; Dealertrack v. Huber, 2012).

• C. Managing Personal Behavior or Relationships or Interactions Between People: Social activities, teaching, following rules/instructions (Intellectual Ventures I LLC v. Capital One Bank (USA), 2015; BASCOM Global Internet v. AT&T Mobility, LLC, 2016; BSG Tech. LLC v. Buyseasons, Inc., 2018; In re Meyer, 1982; Voter Verified, Inc. v. Election Systems & Software, LLC, 2018; Interval Licensing LLC, v. AOL, Inc., 2018; In re Marco Guldenaar Holding B.V., 2018; In re Brown, 2016; Bilski v. Kappos, 2010).

III. Mental Processes Grouping (MPEP § 2106.04(a)(2)III.)

Mental processes, or “thinking,” performable in the human mind or with pen and paper, are considered abstract ideas (CyberSource Corp. v. Retail Decisions, Inc., 2011). Methods performable mentally or equivalent to human mental work are unpatentable abstract ideas, “’basic tools of scientific and technological work’ open to all’” (CyberSource, 2011, citing Gottschalk v. Benson, 1972). Examples include observations, evaluations, judgments, opinions (Mayo Collaborative Servs. v. Prometheus Labs. Inc., 2012; Parker v. Flook, 1978; Gottschalk v. Benson, 1972).

Courts don’t differentiate between purely mental processes and those using physical aids (pen and paper). Conversion of binary-coded decimal to pure binary, doable mentally or “by head and hand,” is abstract (Benson, 1972). Translating logic circuit descriptions into hardware descriptions, performable mentally or with pencil and paper, is also abstract (Synopsys, Inc. v. Mentor Graphics Corp., 2016). Mental processes remain abstract even when performed on computers. Claims requiring computers can still be directed to abstract ideas if the underlying invention is performable mentally or with pen and paper (Versata Dev. Group v. SAP Am., Inc., 2015; Intellectual Ventures I LLC v. Symantec Corp., 2016; Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 2016). Product and process claims can both recite mental processes (Versata Dev. Group. v. SAP Am., Inc., 2015; Mortgage Grader, 2016).

• A. Claims Not Reciting Mental Processes: Claims with limitations not practically performable in the human mind are not mental processes (SRI Int’l, Inc. v. Cisco Systems, Inc., 2019; CyberSource, 2011). Examples include GPS position/time calculation (SiRF Tech., Inc. v. Int’l Trade Comm’n, 2010), suspicious activity detection via network analysis (SRI Int’l, 2019), specific data encryption methods (Synopsys., 2016), and halftone image rendering (Research Corp. Techs., 2010).

• B. Claims Encompassing Mental Performance: Claims encompassing human mental performance, with or without physical aids, recite mental processes (Benson, 1972; Synopsys, 2016; CyberSource, 2011; Flook, 1978; University of Florida Research Foundation, Inc. v. General Electric Co., 2019; Symantec, 2016).

• C. Computer-Required Claims Reciting Mental Processes: Claims requiring computers can still recite mental processes (Benson, 1972; Mortgage Grader, 2016). Examiners should evaluate the specification to determine if the invention is described as a concept performable mentally, merely claimed on a generic computer, in a computer environment, or using a computer as a tool (Voter Verified, Inc. v. Election Systems & Software, LLC, 2018; Versata, 2015; Symantec Corp., 2016; FairWarning IP, LLC v. Iatric Sys., Inc., 2016; Mortgage Grader, 2016; Berkheimer v. HP, Inc., 2018).

• D. Product and Process Claims Reciting Mental Processes: Both product and process claims can recite mental processes (Mortgage Grader, 2016; FairWarning IP, 2016; Content Extraction & Transmission LLC v. Wells Fargo Bank, N.A., 2014). Examples of product claims reciting mental processes include application program interfaces (Content Extraction, 2014), computer-implemented systems for anonymous loan shopping (Mortgage Grader, 2016), computer-readable media for fraud detection (CyberSource, 2011), email post offices (Symantec, 2016), self-verifying voting systems (Voter Verified, 2018), electric power grid monitoring systems (Electric Power Group, 2016), and computer-readable storage media for price determination methods (Versata, 2015).

IV. Tentative Abstract Ideas (MPEP § 2106.04(a)(3))

In rare cases, claims may recite limitations considered abstract ideas even if not within enumerated groupings. These are “tentative abstract ideas.”

Claims with tentative abstract ideas undergo the standard eligibility framework:

• Practical Application Integration: If the claim integrates the tentative abstract idea into a practical application, it is eligible (Step 2A: NO, Pathway B).
• No Practical Application Integration: If not, Step 2B analysis is required.
  • Inventive Concept (Step 2B: YES): Claim is eligible (Pathway C).
  • No Inventive Concept (Step 2B: NO): TC Director approval is required for rejection.

Rejections based on tentative abstract ideas require TC Director approval (indicated in file record and via form paragraph 7.05.017) and justification. The TC Director informs Patents Management of this procedure for public notification. Interviews with examiners (and potentially TC Directors) may advance prosecution after such rejections (MPEP § 713). Examiners retain authority to withdraw or maintain rejections based on applicant replies without further TC Director approval.

VII. Laws of Nature, Natural Phenomena & Products of Nature (MPEP § 2106.04(b))

Laws of nature and natural phenomena, as judicial exceptions, encompass naturally occurring principles/relations and nature-based products that are either naturally occurring or lack markedly different characteristics from nature. These exceptions are described using terms like “physical phenomena,” “scientific principles,” “natural laws,” and “products of nature.”

I. Laws of Nature and Natural Phenomena: General Principles

The law of nature and natural phenomenon exceptions reflect the Supreme Court’s concern that basic scientific and technological tools should remain freely available, not monopolized by patents. “Manifestations of laws of nature” are “part of the storehouse of knowledge,” “free to all men and reserved exclusively to none” (Funk Bros. Seed Co. v. Kalo Inoculant Co., 1948). Thus, naturally occurring discoveries like minerals, plants, or scientific truths (Einstein’s E=mc², Newton’s gravity) are not patentable (Diamond v. Chakrabarty, 1980; Parker v. Flook, 1978; O’Reilly v. Morse, 1853; Funk, 1948; Le Roy v. Tatham, 1853).

Examples of laws of nature and natural phenomena include:

• Isolated DNA (Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 2013).
• Cloned farm animals (In re Roslin Institute (Edinburgh), 2014).
• Correlations between non-coding DNA variations and coding DNA allele presence (Genetic Techs. Ltd. v. Merial LLC, 2016).
• Metabolic correlations (Mayo Collaborative Servs. v. Prometheus Labs., 2012).
• Correlations between myeloperoxidase presence and cardiovascular risk (Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 2017).
• Electromagnetism for signal transmission (O’Reilly v. Morse, 1853).
• Bacterial qualities (Funk Bros., 1948).
• Single-stranded DNA fragments (primers) (University of Utah Research Foundation v. Ambry Genetics Corp., 2014).
• Chemical principles of fatty element and water union (Tilghman v. Proctor, 1880).
• Cell-free fetal DNA (cffDNA) in maternal blood (Ariosa Diagnostics, Inc. v. Sequenom, 2015).
• Natural relationship between CYP2D6 genotype and QTc prolongation risk (Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, 2018).

However, not every claim describing natural abilities or processes recites a law of nature or natural phenomenon (Rapid Litig. Mgmt. v. CellzDirect, Inc., 2016). Methods of treating cancer with chemotherapy or headaches with aspirin are not directed to laws of nature, despite involving natural responses. Similarly, methods of producing new compounds are not directed to components’ ability to combine (Tilghman v. Proctor, 1881).

Claims reciting laws of nature or natural phenomena can still be eligible. For example, claims reciting a genotype-QTc prolongation risk relationship (law of nature) were eligible due to additional treatment steps tailored to genotype (Vanda Pharms., 2018). This integration into a practical application is key.

Claims not reciting laws of nature or natural phenomena are eligible at Pathway B (Step 2A: NO) unless directed to another exception (abstract idea or product of nature).

II. Products of Nature

“Products of nature” are laws of nature or natural phenomena claimed as physical products (Myriad, 2013; Ambry Genetics, 2014). These exceptions tie up naturally occurring things, considered both laws of nature and natural phenomena (Myriad Genetics, Inc., 2013; Funk Bros. Seed Co. v. Kalo Inoculant Co., 1948). Step 2A analysis uses “law of nature” and “natural phenomenon” inclusively of “products of nature.”

Product of nature exceptions include naturally occurring products and non-naturally occurring products lacking markedly different characteristics from nature (Ambry Genetics, 2014). Synthetic, artificial, or non-naturally occurring products (cloned organisms, hybrid plants) are not automatically eligible (In re Roslin Institute (Edinburgh), 2014; J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int’l, Inc., 2001). Eligibility hinges on whether non-naturally occurring products possess markedly different characteristics from naturally occurring counterparts.

Examiners use the “markedly different characteristics” analysis (MPEP § 2106.04(c)) to evaluate nature-based product limitations. Nature-based products include both eligible and ineligible products, subject to this analysis. Examples include isolated genes, cDNA (Myriad), cloned animals (Roslin), and bacteria (Chakrabarty). Living organisms are not inherently excluded and can be eligible if markedly different.

Nature-based product claims may have a BRI encompassing both eligible and ineligible products (e.g., “cloned giraffe” covering both markedly different and non-markedly different clones). Such claims recite a product of nature exception, requiring Prong Two analysis. Examiners should recommend amendments to narrow claims to eligible embodiments.

Claims directed to inventions clearly not tying up judicial exceptions may qualify for streamlined eligibility analysis (MPEP § 2106.06), obviating the need for a markedly different characteristics analysis.

VIII. The Markedly Different Characteristics Analysis (MPEP § 2106.04(c))

The “markedly different characteristics” analysis, part of Step 2A Prong One, identifies product of nature exceptions. Chakrabarty (1980) and Roslin (2014) relied on comparing claimed products to naturally occurring counterparts. This analysis determines if nature-based products are “product of nature” exceptions.

These guidelines clarify when and how to perform this analysis for claims reciting nature-based product limitations. Nature-based products here encompass both eligible and ineligible products undergoing this analysis.

If a nature-based product exhibits markedly different characteristics, it’s not a product of nature exception, eligible at Pathway B (Step 2A: NO), unless another exception is recited. For claims solely to nature-based products, demonstrating a marked difference concludes eligibility analysis (Pathway B, no Step 2B needed). Claims with additional limitations require further eligibility analysis if another exception is present.

If a nature-based product lacks markedly different characteristics, it’s a “product of nature” exception, requiring Step 2A Prong Two analysis to assess practical application integration.

I. When to Perform the Analysis

The markedly different characteristics analysis applies to nature-based product limitations to determine if they are product of nature exceptions. It should not be overly extended to non-nature-based products.

• A. Product Claims:

  • Claims to nature-based products alone: Analysis applies to the entire product (e.g., “a Lactobacillus bacterium”). (Chakrabarty, 1980).
  • Claims to nature-based product combinations: Analysis applies to the combination, not individual components (e.g., “probiotic composition of Lactobacillus and milk”).
  • Claims to nature-based products with non-nature-based elements: Analysis applies only to the nature-based product limitation (e.g., “yogurt starter kit comprising Lactobacillus in a container…”). (Funk Bros. Seed Co. v. Kalo Inoculant Co., 1948).

• B. Product-by-Process Claims: Analysis focuses on whether the nature-based product has markedly different characteristics.

• C. Process Claims: Generally, the analysis doesn’t apply to nature-based products used in process claims, focusing instead on active process steps (Rapid Litig. Mgmt. v. CellzDirect, Inc., 2016). However, if a process claim is essentially a product claim (e.g., “a method of providing an apple”), the analysis applies to the nature-based product. Similarly, claims to detecting cffDNA were deemed directed to cffDNA itself, subject to product of nature analysis (Ariosa Diagnostics, Inc. v. Sequenom, 2015; Rapid Litig. Mgmt., 2016).

II. How to Perform the Analysis

The analysis compares the nature-based product to its naturally occurring counterpart in its natural state. Markedly different characteristics are assessed based on structure, function, and/or other properties, evaluated case-by-case based on claim recitations. If a nature-based product limitation lacks markedly different characteristics, it’s a product of nature exception. If it does exhibit markedly different characteristics, it is not a product of nature exception.

A. Selecting the Appropriate Counterpart(s)

The analysis compares the nature-based product to its naturally occurring counterpart in its natural state. The counterpart is typically the naturally occurring thing from which the nature-based product is derived. For example, deoxyacid A (derivative of naturally occurring acid A) is compared to acid A. (Chakrabarty, 1980; Roslin, 2014).

The counterpart should be in its natural state, distinct from naturally occurring materials adjacent to it. A nucleic acid with a sequence from gene B is compared to gene B, not the whole chromosome (Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 2013; Roche Molecular System, Inc. v. CEPHEID, 2018). Similarly, a single-stranded DNA primer from nucleic acid C is compared to the sense strand of C, not double-stranded C (University of Utah Research Foundation v. Ambry Genetics, 2014).

With multiple counterparts, comparison is to the closest naturally occurring counterpart. A cloned sheep from Finn-Dorset and Scottish Blackface DNA is compared to naturally occurring Finn-Dorset or Scottish Blackface sheep, not Bighorn sheep (Roslin, 2014). For combinations, counterparts are individual nature-based components. A bacterial mixture of species E and F is compared to species E and F individually (Funk Bros., 1948; Ambry Genetics, 2014; In re Bhagat, 2018).

Examiners should identify the selected counterpart in Office actions for clarity.

B. Identifying Appropriate Characteristics

Appropriate characteristics are those possessed by the claimed product, as defined by claim language and BRI. Characteristics can be explicitly recited (e.g., “deoxyribose” indicates structural characteristics) or apparent from BRI (e.g., “isolated gene B” implies nucleotide sequence and protein-encoding function).

Appropriate characteristics include structure, function, and/or other properties, evaluated case-by-case. Examples include:

• Biological/Pharmacological Functions/Activities: Protein-encoding (Myriad), nucleotide sequence binding (Ambry Genetics), bacterial properties (Funk Bros.), hydrocarbon degradation (Diamond v. Chakrabarty), vitamin C function (In re King, 1939).
• Chemical/Physical Properties: Alkalinity (Parke-Davis & Co. v. H.K. Mulford Co., 1911), ductility/malleability (In re Marden, 1931).
• Phenotypic Characteristics: Functional and structural traits, such as shape, size, color, behavior (Roslin, 2014).
• Structure/Form: Physical (plasmids in bacteria, Chakrabarty), chemical (non-salt, crystalline, Parke-Davis), genetic (nucleotide sequence, Myriad), and genotype (Roslin).

C. Evaluating Characteristics for “Markedly Different”

The final step compares characteristics of the claimed nature-based product to its natural counterpart to determine if they are “markedly different.” A marked difference requires a change from nature, not just inherent or incidental changes (Myriad, 2013). Inventors must cause the claimed product to possess at least one different characteristic.

If no characteristic change exists, the product lacks marked differences and is a product of nature exception. If a change exists due to inventor effort, it’s generally considered markedly different, making the product not a product of nature exception.

1. Products with Markedly Different Characteristics

Chakrabarty (1980) identified a bacterium with markedly different characteristics. It had changed functional (degrading multiple hydrocarbons) and structural (multiple plasmids) characteristics compared to natural Pseudomonas bacteria, making it eligible.

Myriad (2013) deemed cDNA of the BRCA1 gene as markedly different. While functionally similar (encoding the same protein), cDNA had a changed structural characteristic (exon-only sequence), distinguishing it from natural DNA and making it eligible.

2. Products Lacking Markedly Different Characteristics

Myriad (2013) clarified that incidental changes from isolation are insufficient. Isolated BRCA1 and BRCA2 genes, while structurally different due to severed chromosomal bonds, remained genetically identical to natural genes and were deemed ineligible. The changes were different, but not markedly different, and thus product of nature exceptions.

Ambry Genetics (2014) deemed DNA primers as products of nature due to lacking marked differences. Primers, while synthetic and single-stranded, had the same genetic structure and nucleotide sequence as corresponding natural DNA strands. Their ability to serve as PCR starting material was an innate DNA property, not a marked difference. Thus, primers were product of nature exceptions. Similarly, ductile vanadium was deemed ineligible in Marden (1931) because ductility was an inherent characteristic, not a new characteristic imparted by human intervention.

Roslin (2014) deemed cloned farm animals as products of nature lacking marked differences. Clones, genetically identical to donors, were not markedly different despite human intervention in their creation. Phenotypic differences (size, behavior) were deemed irrelevant as they were not claimed. Thus, cloned animals were product of nature exceptions. Similarly, linear primers in Roche Molecular System, Inc. v. CEPHEID (2018) lacked marked differences, even with alleged structural differences from circular chromosomal counterparts.

IX. Integration of a Judicial Exception into a Practical Application (MPEP § 2106.04(d))

Courts distinguish between ineligible principles themselves and patent-eligible integrations of these principles into practical applications (Mayo Collaborative Servs. v. Prometheus Labs., Inc., 2012; Diamond v. Diehr, 1981; Gottschalk v. Benson, 1972). Similarly, Federal Circuit decisions distinguish between claims “directed to” judicial exceptions (requiring further analysis) and those that are not, such as claims improving technology (Diamond v. Diehr, 1981; Gottschalk v. Benson, 1972; MPEP § 2106.06(b)).

Step 2A Prong Two assesses whether a claim integrates a recited judicial exception into a practical application. Such claims apply, rely on, or use the exception in a way that meaningfully limits it, becoming more than a drafting effort to monopolize the exception. Evaluation uses considerations detailed in subsection I below, following the procedure in subsection II.

Step 2A Prong Two determines:

• Step 2A: NO: Claim integrates the judicial exception into a practical application, not “directed to” the exception, eligible at Pathway B.
• Step 2A: YES: Claim does not integrate the exception, “directed to” the exception, requires Step 2B analysis.

I. Relevant Considerations for Practical Application Integration

The Supreme Court and Federal Circuit have identified considerations relevant to evaluating practical application integration. This list is not exhaustive. Additional elements can often be analyzed under multiple considerations, which are not ranked in importance.

Limitations indicating practical application integration include:

• Improvements to the functioning of a computer or other technology or technical field.
• Applying the judicial exception to a particular treatment or prophylaxis for a disease or medical condition.
• Use of a particular machine.
• Effecting a transformation or reduction of a particular article.
• Other meaningful limitations beyond generally linking the exception to a particular technological environment.

Limitations not indicating practical application integration include:

• Adding insignificant extra-solution activity.
• Simply appending well-understood, routine, conventional activity.
• Mere instructions to apply the judicial exception.
• Reciting a field of use for the judicial exception or limiting claims to a technological environment.

Step 2A Prong Two is similar to Step 2B, both evaluating judicial considerations for eligibility. While most considerations overlap between Step 2A Prong Two and Step 2B, Step 2A excludes consideration of whether additional elements are well-understood, routine, conventional activity. In Prong Two, all additional elements are weighed, conventional or not, to assess practical application integration. Well-understood, routine, conventional activities can still contribute to practical application integration in Prong Two.

Mere physicality or tangibility of additional elements is not a relevant consideration in Step 2A Prong Two (Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 2014; Genetic Technologies Ltd. v. Merial LLC, 2016). Conversely, intangible elements don’t doom claims, as tangibility isn’t necessary for eligibility under Alice/Mayo (Enfish, LLC v. Microsoft Corp., 2016; McRO, Inc. v. Bandai Namco Games Am. Inc., 2016).

Specificity of claim limitations is not a standalone consideration, but relevant to evaluating particular machine use, particular transformation, and mere instructions to apply an exception (MPEP §§ 2106.05(b), 2106.05(c), 2106.05(f); Parker v. Flook, 1978). Specificity in how to use an exception is more indicative of integration than generic instructions.

II. Evaluating Practical Application Integration

Step 2A Prong Two analysis is consistent for all judicial exceptions (abstract ideas, laws of nature, natural phenomena). Examiners:

1. Identify additional elements beyond the judicial exception(s).
2. Evaluate these elements individually and in combination to determine if they integrate the exception into a practical application, using considerations in subsection I and detailed in MPEP §§ 2106.04(d)(1), 2106.04(d)(2), 2106.05(a)-(c), and 2106.05(e)-(h).

Considerations overlap; multiple can apply to an element. Step 2A Prong Two is not a weighing test. The significance of additional elements relative to the invention is key, focusing on whether the exception is integrated into a practical application. If integrated, additional limitations meaningfully limit the exception, and the claim is eligible at Step 2A.

Each claim is evaluated separately. Dependent claims may be eligible even if independent claims are not, due to added integrating elements.

III. Examples of Practical Application Integration Evaluation

The Office evaluates practical application integration by considering the claim as a whole. Limitations containing judicial exceptions and additional elements are evaluated together. Judicial exceptions alone, or with additional judicial exceptions, are insufficient. Additional elements must use or interact with the exception to achieve integration.

Solutran, Inc. v. Elavon, Inc. (2019) exemplifies claims not integrating an exception. Claims for electronically processing paper checks, while containing limitations on merchant data, account crediting, and check scanning, were deemed directed to the abstract idea of early merchant account crediting. The court found no improvement in technical capture or electronic crediting, thus no practical application integration.

Finjan Inc. v. Blue Coat Systems, Inc. (2018) exemplifies claims integrating an exception. Claims for virus scanning using security profiles identifying both hostile and potentially hostile code were found eligible. The security profile, enabling protection against unknown viruses and customized filtering, improved computer functionality, integrating the abstract idea of virus screening into a practical application.

X. Improvements to Technology or Computer Functionality (MPEP § 2106.04(d)(1) & 2106.05(a))

A claim reciting a judicial exception is not “directed to” that exception if it includes additional elements that demonstrate integration into a practical application, notably through improvements to computer functionality or other technologies. This application of the exception must meaningfully limit the claim, going beyond merely linking it to a technological environment, thereby transforming the claim into patent-eligible subject matter. Such claims are eligible at Step 2A Prong Two (Pathway B).

Courts haven’t defined an explicit test for this consideration but have illustrated its evaluation through numerous decisions. These decisions, and detailed examiner guidance, are in MPEP § 2106.05(a). In brief:

1. Specification Evaluation: Assess if the specification sufficiently details how the claimed invention provides a technological improvement, apparent to a person of ordinary skill in the art. Explicitly stating the improvement is unnecessary, but the description must make it evident. Conclusory assertions of improvement without detail are insufficient.
2. Claim Alignment: Verify the claim reflects the disclosed technological improvement. The claim must include components/steps providing the improvement. Explicitly reciting the improvement in the claim language is not required.

While “improvements” are often evaluated in Step 2A, they also feature in Step 2B analysis (BASCOM Global Internet v. AT&T Mobility LLC, 2016). However, Step 2A Prong Two’s “improvements” analysis focuses on improvements to computer or technology functionality, irrespective of whether it is well-understood, routine, conventional activity. The claimed invention may improve technology even if not an improvement over routine activities.

Examples of claims improving technology and not directed to judicial exceptions include: Enfish, LLC v. Microsoft Corp. (2016), McRO, Inc. v. Bandai Namco Games Am. Inc. (2016), Visual Memory LLC v. NVIDIA Corp. (2017), Finjan Inc. v. Blue Coat Systems, Inc. (2018), SRI Int’l, Inc. v. Cisco Systems, Inc. (2019). Further examples are in MPEP § 2106.05(a).

I. Improvements to Computer Functionality

In computer-related technologies, the examiner should determine if the claim improves computer capabilities or merely uses computers as tools (Enfish, LLC v. Microsoft Corp., 2016). Enfish found claims to a self-referential database eligible as improvements to computer functionality, not abstract ideas. The specification’s discussion of prior art and the invention’s improvement in data storage/retrieval, coupled with the specific claimed data structure, demonstrated eligibility.

Examples of potential improvements in computer functionality:

• Modifying hyperlink protocol for dual-source webpages (DDR Holdings, 2014).
• Inventive distribution of network functionality for content filtering (BASCOM Global Internet, 2016).
• Halftone digital image rendering methods (Research Corp. Techs., 2010).
• Distributed network architecture for reduced congestion (Amdocs (Israel), Ltd., 2016).
• Memory systems with programmable operational characteristics (Visual Memory, LLC, 2017).
• Virus scanning methods generating security profiles for unknown viruses (Finjan Inc. v. Blue Coat Systems, 2018).
• Improved user interfaces for application summaries (Core Wireless Licensing S.A.R.L., 2018).
• Interfaces for navigating complex 3D spreadsheets (Data Engine Techs., LLC, 2018).
• Methods of restricting software operation within licenses (Ancora Tech., Inc., 2018).

Method claims improving computer functionality must be limited to computer implementation. Claims performable mentally cannot improve computer technology (Synopsys, Inc. v. Mentor Graphics Corp., 2016; RecogniCorp, LLC v. Nintendo Co., 2017).

Examples not sufficient for computer-functionality improvement:

• Generating restaurant menus (Ameranth, 2016).
• Accelerating audit log data analysis solely via general-purpose computer capabilities (FairWarning IP, LLC v. Iatric Sys., 2016).
• Mere automation of manual processes (Credit Acceptance Corp. v. Westlake Services, 2017; LendingTree, LLC v. Zillow, Inc., 2016).
• Recording, transmitting, archiving images using generic technology (TLI Communications, 2016).
• Affixing barcodes for mail object information communication, lacking technical detail (Secured Mail Solutions, LLC, 2017).
• Displaying information without disrupting primary activity, lacking specific implementation (Interval Licensing LLC, 2018).
• Considering historical usage during data input for database information improvement, not database functionality improvement (BSG Tech LLC v. Buyseasons, Inc., 2018).
• Arranging transactional information on GUIs for faster trader information processing (Trading Technologies v. IBG LLC, 2019).

II. Improvements to Other Technologies or Technical Fields

Improvements beyond computer functionality can also demonstrate patent eligibility. McRO (2016) found claims for automatic lip synchronization and facial animation eligible as improvements in computer animation. The court emphasized the specification’s explanation of how claimed rules automated previously manual animation tasks. McRO (2016) distinguished itself from cases where computers were merely tools, highlighting the improved technological process of computer animation. The claims described a specific solution (rules for morph weights and phoneme transitions) rather than just the idea of a solution.

Improvement considerations apply across technologies, not just computer-related ones (Rapid Litigation Management v. CellzDirect, Inc., 2016). CellzDirect found a process for preserving hepatocytes potentially eligible as a technological improvement in hepatocyte preservation, even when based on a natural discovery. However, improving the abstract idea itself (e.g., a fundamental economic concept) does not constitute a technological improvement (Trading Technologies Int’l v. IBG, 2019).

Examples of potential improvements to existing technology:

• Computerized rubber molding press control (Diamond v. Diehr, 1981).
• New telephones, servers, or combinations (TLI Communications LLC v. AV Auto. LLC, 2016).
• Advances in content download for streaming (Affinity Labs of Tex. v. DirecTV, LLC, 2016).
• Improved digital data compression methods (DDR Holdings, LLC. v. Hotels.com, L.P., 2014; Intellectual Ventures I v. Symantec Corp., 2016).
• Methods of incorporating virus screening into the Internet (Symantec Corp., 2016).
• Components/methods generating new data, such as measurement devices (Electric Power Group, LLC v. Alstom, S.A., 2016).
• Specific inertial sensor configurations and data usage methods (Thales Visionix, Inc. v. United States, 2017).
• Structured GUIs improving trader transaction accuracy (Trading Techs. Int’l, Inc. v. CQG, Inc., 2017).
• Improved hepatocyte preservation processes (Rapid Litig. Mgmt. v. CellzDirect, Inc., 2016).

To show computer assistance in technological improvement, claims must detail how computers aid the method, the extent of computer aid, and computer significance. Generic computer components performing generic functions are insufficient. Claims must include more than mere instructions to perform methods on generic machinery (TLI Communications, 2016; Secured Mail Solutions, LLC, 2017; Interval Licensing LLC, 2018; BSG Tech LLC, 2018; Trading Technologies, 2019).

Examples not sufficient for technological improvement:

• Commonplace business methods on general-purpose computers (Alice Corp., 2014; Versata Dev. Group, Inc., 2015).
• Using standard lab techniques for biomarker detection (Cleveland Clinic Foundation, 2017).
• Gathering/analyzing information using conventional techniques (TLI Communications, 2016).
• Delivering broadcast content to cellular phones at high generality (Affinity Labs of Tex. v. Amazon.com, 2016; Affinity Labs of Tex. v. DirecTV, LLC, 2016).
• General email screening methods on generic computers (Symantec, 2016).
• Advances in informational content of streaming downloads (Affinity Labs of Tex. v. DirecTV, LLC, 2016).
• Selecting content types or generic computer hardware functions (Affinity Labs of Tex. v. DirecTV, LLC, 2016).

XI. Particular Machine (MPEP § 2106.05(b))

When evaluating Step 2A Prong Two and Step 2B, examiners should consider if a judicial exception is applied by or with a “particular machine.” The machine-or-transformation test provides a “useful and important clue” to eligibility (Bilski v. Kappos, 2010). While important, it is not a standalone test. All claims are evaluated using the Alice/Mayo test. Claims passing Alice/Mayo are eligible even if failing the machine-or-transformation test, and vice versa (Bilski v. Kappos, 2010; McRO, Inc. v. Bandai Namco Games Am. Inc., 2016; DDR Holdings, LLC v. Hotels.com, L.P., 2014).

Relevant factors in determining if a machine provides significantly more:

I. Particularity or Generality of Machine Elements

The degree to which the machine is specifically identifiable, not any and all machines. Mackay Radio & Tel. Co. v. Radio Corp. of America (1939) exemplifies a particular machine, using standing wave phenomena in a specific antenna type with detailed conductor arrangement. Eibel Process (1923) used gravity in a specifically structured Fourdrinier machine to optimize papermaking.

Generic computers applying judicial exceptions via conventional functions do not qualify as particular machines (Ultramercial, Inc. v. Hulu, LLC, 2014; TLI Communications LLC v. AV Automotive LLC, 2016; Eon Corp. IP Holdings LLC v. AT&T Mobility LLC, 2015). Adding generic computers or components to an abstract idea does not automatically overcome ineligibility (Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 2014).

II. Machine Implementation of Method Steps

Integral machine use in method performance can indicate integration or significantly more, unlike merely operating on a machine (CyberSource v. Retail Decisions, 2011). Machines must play a significant role in method performance, not just be obvious mechanisms for faster solutions (Versata Development Group v. SAP America, 2015).

III. Extra-Solution Activity or Field-of-Use

Whether machine involvement is extra-solution activity or field-of-use, i.e., the meaningfulness of machine-imposed limits. Machines contributing nominally or insignificantly (data gathering, field-of-use) do not integrate or provide significantly more (Bilski, 2010; CyberSource, 2011).

XII. Particular Transformation (MPEP § 2106.05(c))

Transformation or reduction of a particular article to a different state or thing is another clue to eligibility, especially for process claims without particular machines (Bilski v. Kappos, 2010). Such transformation suggests claims are significantly more than a judicial exception or integrate the exception into a practical application.

Like “particular machine,” “transformation” is a clue, not a standalone test (Bilski v. Kappos, 2010; McRO, Inc. v. Bandai Namco Games Am. Inc., 2016; DDR Holdings, LLC v. Hotels.com, L.P., 2014).

“Article” includes physical objects or substances, specifically identifiable. “Transformation” implies change to a different state or thing, beyond mere use or relocation. New function or use can indicate transformation. Purely mental processes or “manipulation of basic mathematical constructs” (CyberSource v. Retail Decisions, 2011) are not eligible transformations.

Tilghman v. Proctor (1881) exemplifies transformation, with a process transforming fat and water into fatty acids and glycerine via heat and pressure.

Relevant factors for transformation analysis:

1. Transformation Particularity or Generality: Particular transformations, like tanning or smelting ores (Gottschalk v. Benson, 1972), are more likely to provide significantly more.
2. Article Particularity: Transformation applied to particular articles is more likely to be significant than to generic or any articles.
3. Nature of Transformation: Change in state or thing, especially leading to a different function or use, is more significant than mere relocation. Rubber curing in Diehr (1981) is a significant transformation.
4. Nature of Article Transformed: Physical transformations are more significant than intangible concept transformations.
5. Extra-Solution Activity or Field-of-Use: Transformations that are insignificant extra-solution activity do not contribute to eligibility (Mayo, 2012).

XIII. Well-Understood, Routine, Conventional Activity (MPEP § 2106.05(d))

In Step 2B, examiners consider whether additional elements are well-understood, routine, conventional activities previously known in the industry. This consideration is exclusive to Step 2B.

If additional elements are specific and unconventional, they favor eligibility. If they are well-understood, routine, conventional activities, they do not favor eligibility (Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 2014; Mayo Collaborative Servs. v. Prometheus Labs., Inc., 2012; Parker v. Flook, 1978).

DDR Holdings, LLC v. Hotels.com, L.P. (2014) exemplifies elements beyond routine activity. Claims modifying Internet hyperlink protocol to produce hybrid webpages were eligible, deviating from conventional hyperlink operation.

Mayo Collaborative Servs. v. Prometheus Labs. (2012) exemplifies routine activity. Claims measuring metabolite levels, a well-understood and conventional lab technique, were not significantly more than the law of nature.

I. Evaluating Well-Understood, Routine, Conventional Activity

Examiners determine if additional elements are well-understood, routine, conventional activity to assess if they amount to significantly more than a judicial exception. This consideration overlaps with improvement, instructions to apply exceptions, and insignificant extra-solution activity (MPEP § 2106.05(a), 2106.05(f), 2106.05(g)).

Key points to consider:

1. Known elements can be unconventional: Known elements can still be unconventional or non-routine in combination, distinct from novelty or obviousness considerations (Diamond v. Diehr, 1981; Enfish, LLC v. Microsoft Corp., 2016; Microsoft Corp. v. Enfish, LLC, 2016). Enfish claims, while anticipated, were deemed eligible due to unconventional database structure improvements.
2. Factual determination required: Concluding that elements are well-understood, routine, conventional activity requires factual support (Berkheimer v. HP, Inc., 2018). This doesn’t necessitate prior art searches but relies on examiner expertise and common knowledge in the art. Specifications often indicate conventionality. Examiners should rely on established court precedent and industry recognition. For eligibility rejections based on well-understood, routine, conventional activity, express written support is required.
3. Combination of elements: Even individually conventional elements can create an inventive concept in combination (Diamond v. Diehr, 1981; Rapid Litig. Mgmt. v. CellzDirect, 2016; BASCOM Global Internet Servs., 2016). BASCOM found a non-conventional arrangement of known components inventive.

Rejections should only be made if examiners, based on expertise, conclude that additional elements do not amount to significantly more (Step 2B: NO). If elements are beyond routine activity, they generally amount to significantly more (Step 2B: YES).

II. Court-Recognized Well-Understood, Routine, Conventional Activities

Courts have recognized certain activities as well-understood, routine, conventional in specific fields when claimed generically or as insignificant extra-solution activity.

• Computer Functions: Receiving/transmitting data, repetitive calculations, electronic recordkeeping, data storage/retrieval, electronic scanning/data extraction, web browser back/forward button functionality (Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 2014; Ultramercial, Inc. v. Hulu, LLC, 2014; Bancorp Services v. Sun Life, 2012; Parker v. Flook, 1978; Symantec, 2016; TLI Communications LLC v. AV Auto. LLC, 2016; OIP Techs., Inc., v. Amazon.com, Inc., 2015; buySAFE, Inc. v. Google, Inc., 2014; Internet Patent Corp. v. Active Network, Inc., 2015). However, combined generic components can perform non-generic functions and be eligible (DDR Holdings, LLC v. Hotels.com, L.P., 2014).

• Laboratory Techniques: Biomarker level determination, PCR amplification/detection, DNA/enzyme detection, immunization, DNA analysis for sequencing/variant detection, nucleic acid amplification/sequencing, gene probe hybridization (Mayo, 2012; Cleveland Clinic Foundation, 2017; Genetic Techs. Ltd., 2016; Ariosa Diagnostics, Inc., 2015; Classen Immunotherapies, Inc., 2011; Rapid Litig. Mgmt., 2016; University of Utah Research Foundation v. Ambry Genetics, 2014).

• Other Activities: Recording customer orders, shuffling/dealing cards, restricting public access to media via advertisements, presenting offers/gathering statistics, price optimization (Apple, Inc. v. Ameranth, Inc., 2016; In re Smith, 2016; Ultramercial, Inc. v. Hulu, LLC, 2014; OIP Techs., Inc., 2015; Versata Dev. Group, Inc., 2015).

These lists are not exhaustive. Examiners should evaluate claims as a whole, considering all relevant factors. Ineligibility findings require explanation of why additional elements do not amount to significantly more.

XIV. Other Meaningful Limitations (MPEP § 2106.05(e))

The “other meaningful limitations” consideration is relevant to both Step 2A Prong Two and Step 2B. Claims should include meaningful limitations beyond generally linking judicial exceptions to technological environments to be patent-eligible. “Meaningful limitations” describe elements providing an inventive concept, as seen in Supreme Court jurisprudence. Considerations in MPEP § 2106.05(a)-(d) are meaningful limitations when they amount to significantly more or integrate an exception into a practical application. “Other meaningful limitations” signals additional, unlisted considerations can also transform claims into patent-eligible subject matter.

Diamond v. Diehr (1981) exemplifies meaningful limitations. The claim used the Arrhenius equation in rubber molding, with additional elements like mold installation, temperature measurement, cure time calculation, and automatic press opening. These limitations, unlike a mere field-of-use limitation, confined the equation to a practical rubber molding application.

Alice Corp. v. CLS Bank International (2014) lacked meaningful limitations. Computer systems, media, and methods for mitigating settlement risk, while reciting computer functions and hardware, merely linked the abstract idea to a technological environment without adding an inventive concept.

Classen Immunotherapies Inc. v. Biogen IDEC (2011) provides another example of meaningful limitations. Claims analyzing immunization schedules and subsequent immunization based on lower risk schedules were deemed eligible. While the analysis step was abstract, the immunization step was meaningful, integrating the analysis result into a practical application. Conversely, OIP Technologies, Inc. v. Amazon.com, Inc. (2015) found steps to “test prices and collect data” as not meaningfully limiting the abstract idea of price optimization, as they were routine data-gathering activities.

Treatment or prophylaxis limitations, like immunization in Classen, also fall under “other meaningful limitations,” overlapping with the particular treatment or prophylaxis consideration in Step 2A Prong Two (MPEP § 2106.04(d)(2)).

When evaluating meaningful limitations, consider additional elements individually and in combination. Even individually insufficient elements can become significant when combined, creating an inventive concept. Examiners should explain why additional elements do or do not meaningfully limit the judicial exception in their analysis.

XV. Mere Instructions to Apply an Exception (MPEP § 2106.05(f))

Another crucial consideration in Step 2A Prong Two and Step 2B is whether additional elements are merely “apply it” instructions, or more than mere instructions to implement a judicial exception on a computer. Claims must offer more than just stating an exception with the words “apply it” (Alice Corp. v. CLS Bank, 2014, quoting Mayo Collaborative Servs. V. Prometheus Labs., Inc., 2012). Claims merely instructing to apply an abstract idea using a generic computer do not become eligible (Alice Corp., 2014).

Mayo (2012) found metabolite level measurement to be mere instructions to apply laws of nature. Alice Corp. (2014) deemed generic computer implementation of intermediated settlement as mere instructions to apply an abstract idea. Gottschalk v. Benson (1972) found BCD-to-binary conversion, applicable only to computers, as mere instructions to apply a judicial exception on a computer.

Requiring more than “apply it” instructions doesn’t necessitate narrow claims. Broad claims can be eligible (McRO, Inc. v. Bandai Namco Games Am. Inc., 2016; Thales Visionix Inc. v. United States, 2017), and narrow claims can be ineligible (Ultramercial, Inc. v. Hulu, LLC, 2014; Electric Power Group, LLC v. Alstom, S.A., 2016). Examiners should assess each claim individually and consider all relevant factors.

When determining if claims are mere “apply it” instructions, consider:

1. Idea of Solution or Outcome vs. Specific Implementation: Claims reciting only solution ideas or outcomes, lacking implementation details, are “apply it” instructions (Intellectual Ventures I v. Capital One Fin. Corp., 2017; Electric Power Group, LLC v. Alstom, S.A., 2016; Intellectual Ventures I v. Symantec Corp., 2016; Internet Patents Corp. v. Active Network, Inc., 2015). Claims with specific solutions or implementations are not mere instructions (DDR Holdings, LLC v. Hotels.com, L.P., 2014; BASCOM Global Internet Servs. v. AT&T Mobility LLC, 2016; Thales Visionix, Inc. v. United States, 2017).

2. Computers/Machinery as Tools: Claims invoking computers or machinery merely as tools for existing processes are “apply it” instructions (TLI Communications; Alice Corp. Pty. Ltd. V. CLS Bank Int’l, 2014; Gottschalk v. Benson, 1972; Versata Development Group v. SAP America, 2015; Apple, Inc. v. Ameranth, Inc., 2016; FairWarning IP, LLC v. Iatric Sys., 2016; Credit Acceptance Corp. v. Westlake Services, 2017; LendingTree, LLC v. Zillow, Inc., 2016; Secured Mail Solutions, LLC v. Universal Wilde, Inc., 2017; Interval Licensing LLC v. AOL, Inc., 2018; BSG Tech LLC v. Buyseasons, Inc., 2018; Trading Technologies v. IBG LLC, 2019; In re Brown, 2016). Claims improving computer capabilities or technology are not mere instructions (McRO, Inc. v. Bandai Namco Games Am. Inc., 2016; Enfish, LLC v. Microsoft Corp., 2016).

3. Generality of Application: Broadly applicable claims, covering any solution or mode of achieving a result, are “apply it” instructions (Internet Patents Corporation v. Active Network, Inc., 2015; O’Reilly v. Morse, 1854; The Telephone Cases, 1888). Claims confined to particular, practical applications are not mere instructions (BASCOM Global Internet Servs. v. AT&T Mobility LLC, 2016).

XVI. Insignificant Extra-Solution Activity (MPEP § 2106.05(g))

Another Step 2A Prong Two and Step 2B consideration is whether additional elements are more than insignificant extra-solution activity. “Extra-solution activity” refers to activities incidental to the primary process or product, nominally or tangentially added. It includes pre-solution (data gathering) and post-solution activity (outputting reports).

Adding insignificant extra-solution activity, particularly if well-understood or conventional, does not constitute an inventive concept (Parker v. Flook, 1978; Mayo Collaborative Servs. v. Prometheus Labs. Inc., 2012). In Flook, post-solution alarm limit adjustment was deemed insignificant. Mayo deemed metabolite measurement insignificant extra-solution activity.

When determining insignificant extra-solution activity, consider:

1. Well-Known Limitation: Is the extra-solution limitation well-known? (Bilski v. Kappos, 2010; Flook, 1978; Intellectual Ventures I LLC v. Erie Indem. Co., 2017).
2. Significance of Limitation: Is the limitation significant, imposing meaningful claim limits? (Ultramercial, Inc. v. Hulu, LLC, 2014; Apple, Inc. v. Ameranth, Inc., 2016).
3. Necessary Data Gathering/Outputting: Is the limitation merely necessary data gathering or outputting for all uses of the exception? (Mayo, 2012; OIP Techs., Inc. v. Amazon.com, Inc., 2015).

Examples of insignificant extra-solution activity:

• Mere Data Gathering: Clinical testing (In re Grams, 1989), system response testing (In re Meyers, 1982), offer presentation/statistics gathering (OIP Technologies, 2015), transaction information gathering via Internet (CyberSource, 2011), activity log consultation/update (Ultramercial, 2014), biomarker level determination (Mayo, 2012), ultrasound scan data assessment (PerkinElmer, Inc. v. Intema Ltd., 2012).
• Selecting Data Source/Type: XML tag database index limitation (Intellectual Ventures I LLC v. Erie Indem. Co., 2017), table/drive-through customer order limitations (Ameranth, 2016), power-grid data selection (Electric Power Group, LLC v. Alstom S.A., 2016), advertisement-viewing request/public access restriction (Ultramercial, 2014).
• Insignificant Application: Hair cutting post-hair design determination (In re Brown, 2016), printing/downloading generated menus (Ameranth, 2016).

Insignificant computer implementation is also considered extra-solution activity (Fort Props., Inc. v. Am. Master Lease LLC, 2012; Bancorp Servs., LLC v. Sun Life Assur. Co. of Canada, 2012). These limitations may also be categorized as mere instructions to apply exceptions (MPEP § 2106.05(f)).

Rejections should explain why extra-solution limitations do not meaningfully limit claims.

XVII. Field of Use and Technological Environment (MPEP § 2106.05(h))

Another Step 2A Prong Two and Step 2B consideration is whether additional elements are more than generally linking judicial exception use to a technological environment or field of use. Limiting a formula’s application to a specific technological use alone does not make it eligible (Diamond v. Diehr, 1981). Field-of-use or technological environment limitations do not amount to significantly more or integrate judicial exceptions into practical applications.

Parker v. Flook (1978) is a classic example of field-of-use limitation. Limiting an alarm limit calculation formula to “catalytic chemical conversion of hydrocarbons” (petrochemical/oil-refining fields) was insufficient for eligibility. This limitation was merely incidental and didn’t alter the calculation process.

Diamond v. Diehr (1981) differed. Additional elements like temperature monitoring and press control in rubber molding transformed the Arrhenius equation application beyond mere field-of-use.

Affinity Labs of Texas v. DirecTV, LLC (2016) provides a recent example. Limiting wireless delivery of regional broadcast content to cellular phones was deemed a technological environment limitation, not adding an inventive concept.

Examples of limitations considered mere field-of-use or technological environment links:

• Administering drugs to patients with gastrointestinal disorders (Mayo Collaborative Servs. v. Prometheus Labs. Inc., 2012).
• Hedging risk for commodity providers and consumers (Bilski, 2010).
• Limiting the circumference formula to wheels (Flook, 1978).
• Limiting audit log data monitoring to computer environments (FairWarning v. Iatric Sys., 2016).
• Virus screening within telephone networks or the Internet (Intellectual Ventures I v. Symantec Corp., 2016).
• Limiting information collection/analysis to electric power grid data (Electric Power Group, LLC v. Alstom S.A., 2016).
• Informing doctors to apply linkage disequilibrium for genetic polymorphism detection (Genetic Techs. Ltd. v. Merial LLC, 2016).
• Budgeting via “communication media” including Internet and telephone networks (Intellectual Ventures I v. Capital One Bank, 2015).
• Limiting advertising-as-currency use to the Internet (Ultramercial, Inc. v. Hulu, LLC, 2014).
• Limiting contract guarantee to online transactions or computer environments (buySAFE Inc. v. Google, Inc., 2014).

“Technological environment” and “field of use” are often used interchangeably by courts. This consideration overlaps with insignificant extra-solution activity (MPEP § 2106.05(g)). Data gathering limited to a particular data source or type may be considered both.

Rejections should explain why field-of-use or technological environment limitations do not meaningfully limit claims.

XVIII. Streamlined Analysis (Pathway A) (MPEP § 2106.06)

For examination efficiency, a streamlined eligibility analysis (Pathway A) can be used when claim eligibility is self-evident, such as claims clearly improving technology or computer functionality. However, if there’s doubt about tying up a judicial exception, the full Alice/Mayo test should be used.

Streamlined analysis results always align with full analysis outcomes. Claims eligible via Pathway B or C would also be eligible via Pathway A. Streamlined analysis simply bypasses detailed Step 2A/2B analysis when eligibility is obvious. Eligibility is concluded at Pathway A. Records may reflect eligibility via absent rejections or clarifying remarks.

I. Self-Evident Eligibility (MPEP § 2106.06(a))

Streamlined analysis applies to claims that, viewed holistically, clearly don’t seek to monopolize judicial exceptions. Claims with self-evident eligibility do not require full analysis. Claims ineligible after Step 2B lack self-evident eligibility.

Examples include complex industrial products or processes with meaningful limitations alongside judicial exceptions (robotic arm assembly with mathematical control systems). Claims reciting nature-based products, but clearly not tying them up (artificial hip prosthesis with natural mineral coating), also qualify. Claims with ancillary nature-based components (cellphone with gold contacts, plastic chair with wood trim) don’t require product of nature analysis.

II. Clear Improvement to Technology or Computer Functionality (MPEP § 2106.06(b))

Claims directed to clear improvements to computer or other technologies may bypass full analysis (Enfish, LLC v. Microsoft Corp., 2016; McRO, Inc. v. Bandai Namco Games Am. Inc., 2016; MPEP § 2106.05(a)). Enfish (2016) and McRO (2016) found claims eligible at Step 2A due to clear technological improvements. Examiners can reasonably find such claims eligible at Pathway A or B.

“Close calls,” where technological improvement is unclear, require full Alice/Mayo analysis (BASCOM Global Internet v. AT&T Mobility LLC, 2016). Streamlined analysis is reserved for claims with self-evident eligibility, particularly clear improvements to technology or computer functionality. BASCOM claims, directed to content filtering (a method of organizing human behavior), presented a “close call,” necessitating Step 2B analysis, and were ultimately found eligible at Pathway C, or reasonably at Pathway A or B, due to their “technology-based solution” improving filtering technology.

XIX. Formulating and Supporting § 101 Rejections (MPEP § 2106.07)

§101 rejections must be based on substantive law under 35 U.S.C. 101, as interpreted by judicial precedent, not merely on examination guidance or examples. While guidance clarifies the law, it’s not the rejection basis.

Examiners evaluate each claim individually, reviewing the record as a whole (specification, claims, prosecution history, case law, prior art). If a claim is likely ineligible (Step 1: NO and/or Step 2B: NO), a §101 rejection is appropriate, establishing a prima facie case of ineligibility.

Rejections must be clear and specific, providing sufficient notice and rationale for applicant response. Examiners must explain:

• Step 1: NO Rejections: Why the claim fails to fall within statutory categories (MPEP § 2106.03).
• Step 2B: NO Rejections: For claims directed to judicial exceptions (Step 2A: YES), explain each part of Step 2 analysis:
  • Step 2A Prong One: Identify the judicial exception recited in the claim and explain why it is an exception.
  • Step 2A Prong Two: Identify additional claim elements and explain why they do not integrate the exception into a practical application, referencing considerations in MPEP §§ 2106.04(d), 2106.05(a)-(c), and 2106.05(e)-(h). Give weight to all additional elements, even if conventional.
  • Step 2B: Explain why additional elements, individually and combined, do not amount to significantly more than the exception. If asserting elements are well-understood, routine, conventional activity, support this assertion with evidence (MPEP § 2106.07(a)III.).

Compact prosecution requires complete examination under 35 U.S.C. 102, 103, and 112 even with §101 rejections, stating all non-cumulative rejection reasons in the first Office action.

I. Step 2A Prong One Rejection Formulation

§101 rejections should point to specific claim limitations reciting judicial exceptions. Explanations must detail why these limitations are exceptions (abstract ideas, laws of nature, etc.). If claims describe exceptions without explicitly setting them forth, the rejection must explain what subject matter is described and why it’s a judicial exception. (MPEP § 2106.04).

For abstract ideas, identify the abstract idea as recited in the claim and explain its alignment with abstract idea groupings (MPEP § 2106.04(a)(2)). For “tentative abstract ideas” (MPEP § 2106.04(a)(3)), justify why limitations are treated as abstract ideas even if outside groupings. Citing relevant court decisions can strengthen explanations, ensuring alignment with case facts and avoiding out-of-context reliance. Examiners should avoid expanding beyond enumerated abstract idea groupings except when identifying tentative abstract ideas, and should avoid relying on non-precedential decisions unless facts uniquely match. The USPTO website provides a chart of court decisions (www.uspto.gov/PatentEligibility).

For laws of nature or natural phenomena, identify them as recited in claims and explain why they are considered such, providing reasoned rationales (MPEP § 2106.04(b)).

For products of nature, identify them as recited in claims and explain why they lack markedly different characteristics compared to naturally occurring counterparts (MPEP § 2106.04(b) and MPEP § 2106.04(c)).

II. Step 2A Prong Two and Step 2B Rejection Formulation

After identifying the judicial exception, identify additional claim elements beyond it and explain why they do not integrate the exception into a practical application or amount to significantly more than the exception. Explain why additional elements, individually and combined, fail to integrate or add significantly more. Address both Prong Two and Step 2B aspects in the rejection. Remember that new combinations of known steps can be patentable (Diamond v. Diehr, 1981). Thus, addressing the combination of additional elements is critical. Explain rationales clearly for effective applicant response.

In Step 2B, if concluding claim limitations are well-understood, routine, conventional activities, provide written factual support as per Subsection III below. (MPEP § 2106.05(d)).

For limitations reciting generic computer components performing generic functions, explain why these do not meaningfully limit claims. Explain why limitations adding insignificant extra-solution activity or generally linking exceptions to technological environments do not meaningfully limit claims. For example, storing data after area calculation is not a meaningful limitation. Similarly, generic computer implementation, even in a specific environment, may not add significantly more than the exception (Parker v. Flook, 1978).

Examiners should consult specifications for potentially eligibility-enhancing amendments and suggest these to applicants in Office actions.

III. Evidentiary Requirements for § 101 Rejections

Claim eligibility is a legal determination, not requiring “evidence” of judicial exceptions (Rapid Litig. Mgmt. v. CellzDirect, 2016; OIP Techs. v. Amazon.com, 2015; DDR Holdings v. Hotels.com, 2014; In re Roslin Institute (Edinburgh), 2014; In re Bilski, 2008). Courts decide eligibility without resolving factual issues (FairWarning IP, LLC v. Iatric Sys., 2016; Genetic Techs. Ltd. v. Merial LLC, 2016; OIP Techs., 2015; Content Extraction & Transmission LLC v. Wells Fargo Bank, N.A., 2014). However, whether additional elements are well-understood, routine, conventional activity is sometimes considered an underlying factual issue (Interval Licensing LLC v. AOL, Inc., 2018; Berkheimer v. HP, Inc., 2018).

Examiners need not provide evidence to support judicial exception identification in Step 2A Prong One. Reasoned rationales explaining why limitations recite exceptions are sufficient (Affinity Labs of Tex., LLC v. Amazon.com Inc., 2016; OIP Techs., Inc. v. Amazon.com, Inc., 2015; Content Extraction & Transmission LLC v. Wells Fargo Bank, N.A., 2014).

Evidence is also not required for Step 2A Prong Two or Step 2B findings unless asserting additional limitations are well-understood, routine, conventional activities in Step 2B.

Examiners should not assert elements are well-understood, routine, or conventional without written support from:

(A) Specification/Applicant Statements: Citation to express statements in the specification or applicant arguments during prosecution demonstrating the well-understood, routine, conventional nature of additional elements.

(B) Court Decisions: Citation to court decisions (MPEP § 2106.05(d)) noting the well-understood, routine, conventional nature of additional elements.

(C) Publications: Citation to publications demonstrating the well-understood, routine, conventional nature of additional elements.

(D) Examiner’s Statement of Official Notice: A statement that the examiner is taking official notice of the well-understood, routine, conventional nature of additional elements, based on examiner expertise in the art.

I. Form Paragraphs for § 101 Rejections (MPEP § 2106.07(a)(1))

Use form paragraphs 7.04.01, 7.05, and 7.05.01 for Step 1 rejections (failure to claim statutory category).

Use form paragraphs 7.04.01, 7.05, and 7.05.016 for Step 2B rejections (directed to judicial exception without inventive concept). For “tentative abstract ideas,” also use form paragraph 7.05.017 and include TC Director signature.

XX. Evaluating Applicant’s Response (MPEP § 2106.07(b))

After a §101 rejection, the burden shifts to the applicant to amend claims or show claim eligibility. Applicants may: (i) amend claims, (ii) present persuasive arguments against rejection, and/or (iii) submit evidence traversing rejection (MPEP § 716.01 and 37 CFR 1.132).

Examiners must carefully evaluate all applicant responses. If amendments, evidence, or arguments persuasively establish eligibility, the rejection should be withdrawn. Applicant arguments may focus on practical application integration or claims amounting to significantly more, considering additional elements individually and in combination.

If applicant challenges examiner findings but the rejection is maintained, a rebuttal is required in the next Office action. Examples of appropriate examiner responses:

1. Tentative Abstract Idea Challenge: If applicant challenges a tentative abstract idea identification based on case law, and the challenge is unpersuasive, explain why the claimed abstract idea is similar to the cited case.
2. Well-Known, Routine, Conventional Activity Challenge: If applicant disputes that additional elements are well-understood, routine, conventional activity with specific arguments or evidence, re-evaluate the determination. Re-evaluation is crucial when specifications don’t explicitly describe elements as known or conventional, and courts haven’t treated them as such. If maintaining the rejection, consider providing evidence and clarifying the record for appeal, especially if official notice was taken per item (D) of subsection III above. If applicant directly challenges official notice assertion under item (D), specific factual statements and explanations or items from paragraphs (A) through (C) of subsection III above, or a 37 CFR 1.104(d)(2) affidavit/declaration, are required to support the examiner’s position.
3. Generic Computer Amendment: If applicant amends claims by adding generic computers or components and argues eligibility based on “specially programmed” computers (Alappat, superseded) or “particular machines” (Bilski), assess if added elements integrate the exception or provide significantly more. Generic computer additions performing generic functions are insufficient (Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 2014; OIP Techs. v. Amazon.com, 2015).
4. Specificity and Preemption Arguments: If applicant argues claim specificity and non-preemption of all exception applications, reconsider Step 2A, particularly whether claims improve technology or computer functionality. If still directed to an exception, reconsider in Step 2B whether additional elements in combination amount to an inventive concept, such as non-conventional arrangements of known elements (BASCOM Global Internet v. AT&T Mobility LLC, 2016). Reconsideration is crucial because preemption concerns underlie the Alice/Mayo framework (Synopsys, Inc. v. Mentor Graphics Corp., 2016; Rapid Litig. Mgmt. v. CellzDirect, Inc., 2016; Ariosa Diagnostics, Inc. v. Sequenom, Inc., 2015).

XXI. Clarifying the Record (MPEP § 2106.07(c))

When claims are deemed patent-eligible, examiners may add clarifying remarks to the record. For instance, if eligibility is due to technological improvement, examiners could reference specification sections describing the improvement and claim elements achieving it, both during prosecution and with a notice of allowance.

Clarifying remarks are also useful for rejections. Explaining the BRI of claims in rejections helps applicants understand and respond effectively. For example, a §101 rejection on a computer-readable medium claim could explain that BRI encompasses non-statutory carrier waves and suggest amendments to cover only statutory embodiments.