PTO's Process for Analyzing Section 101 as set forth in the MPEP
As explained in our Section 101 Guidance, an invention is not eligible for patent protection (no matter how novel) unless it falls within a statutory category of Section 101 and it passes the Supreme Court's Alice test for subject matter eligibility. The statutory categories are processes, machines, manufactures, or compositions of matter. The Alice test is not found in the statute, but was judicially created. This two-part test is applied to each claim in a patent (or patent application), and claims that fail this test are not eligible for patent protection even if they fall within one of the statutory categories identified in Section 101.
The first step requires a consideration as to whether the claim is "directed to" an ineligible concept (e.g., an abstract idea, natural law, or natural phenomenon). If the claimed advance is similar to other inventions previously found to be ineligible, then the claimed advance fails step one and the invention is analyzed under step two (otherwise the invention is eligible). The second step of the Alice test is to consider whether the claim contains additional elements that ‘transform the nature of the claim’ into a patent-eligible application.
The patent office (through the MPEP) also refers to two steps when considering patent eligibility of an invention, but the patent office defines different steps than that utilized by the courts. "Step 1" under the patent office's MPEP standard relates to the statutory categories. If a claim is not a process, machine, manufacture, or composition of matter, it fails Step 1 of the MPEP test and it is not eligible for patent protection. Step 1 of the MPEP test is described below in connection with MPEP 2106.03
"Step 2" of the MPEP test is the Alice test. The MPEP divides its step 2 into "step 2A", which relates to whether or not the claim is directed to an ineligible concept (step one of the Alice test). If it is not, the claim is eligible. Step 2B of the MPEP test determines whether the claim recites any additional elements that amount to more than the judicial exception (step two of the Alice test). If it does, the claim is eligible. Steps 1, 2A, and 2B of the MPEP test can be seen in the following chart taken from MPEP 2106:
A careful review of the above flow chart will notice a step between Step 1 and Step 2A that asks whether the analysis can be "streamlined." This unnumbered step allows the PTO to avoid the complex analysis of Steps 2A and 2B in cases where eligibility is self-evident, such as when it is clear that the invention improves a technology or computer functionality. This streamlined analysis will always reach the same result as the full analysis using Steps 2A and 2B, so this pathway to eligibility won't ever help avoid an adverse result that would result following the more complete analysis. This path is described below in connection with MPEP 2106.06.
Prior to the PTO's 2019 Guidance that reconsidered the MPEP test, many argued that Step 2A was effectively reduced to a determination as to whether the claim "recites" an abstract idea or law of nature. This was criticized since the court's had long held that the "directed to" inquiry of Alice's first step is something more than determining whether the claim involves or recites an ineligible concept. See Enfish and Rapid Litigation. In its 2019 Guidance, the PTO revised its Step 2A analysis to help overcome this initial failure to reflect the full Alice test. The PTO was careful to note that the 2019 revisions were not intended to exclude any additional inventions that were not excluded under the old guidance, thus claims that were eligible for patent protection before the 2019 changes are still eligible afterwards.
As the MPEP is now written, Step 2A is now divided into two "prongs." Prong One asks whether the claim "recites" an ineligible concept (an abstract idea, law of nature, or natural phenomenon). To simplify this determination in the context of abstract ideas, the PTO has effectively defined what is meant by the phrase "abstract idea"--an endeavor that the courts have refused to undertake. Under this standard, claims that recite one of the enumerated groupings of abstract ideas, (namely mathematical concepts, certain methods of organizing human activity, or mental processes) will be considered to recite an abstract idea under Prong One of Step 2A (although an examiner may request permission from a supervisor to reject a claim as abstract even if it is not directed to a listed abstract idea). This analysis is described below in connection with MPEP 2106.04. The "markedly different characteristics" analysis, which is described below in connection with MPEP 2106.04(c) forms part of the Step 2A analysis for claims relating to laws of nature and natural phenomenon.
If a claim does recite an ineligible concept under Prong One, then Prong Two asks whether the claim "recites additional elements that integrate the judicial exception into a practical application." It is in this Prong that the PTO is attempting to reflect the judicial opinions that have found inventions eligible under step one of Alice when the the "claimed advance" in a claim is not directed to an abstract idea even if the claim otherwise recites or involves an abstract idea. Prong Two is described below in connection with MPEP 2106.04(d). It is interesting to note that the language and analysis for Prong Two of Step 2A is similar to the language and analysis described for Step 2B. One difference is that Step 2A-Prong Two does not evaluate whether the additional elements in the claim are "well-understood, routine, or conventional activities", which is the standard under Step 2B. Thus, conventional claim elements may integrate an exception into a practical application under Prong Two of Step 2A, while those claim elements would not be helpful under Step 2B.
The revision to Step 2A under the 2019 changes is shown in the following flow chart found in the 2020 MPEP:
Step 2B of the PTO's Section 101 process implements step two of the Alice test for subject matter eligibility. Some refer to this step as the search for an "inventive concept," as this step was described using this terminology in the Alice case. Step 2B is described below in connection with MPEP 2106.05.
Relevant Sections of the Manual of Patent Examining Procedure (MPEP)
The U.S. Patent and Trademark Offices analyzes the subject matter eligibility of patent applications under Section 101 utilizing Sections 2103 through 2106.07(c). Each of these sections of the MPEP are described separately below.
2103: Patent Examination Process: This section gives basic overview of the examination process, including Sections 101, 102, 103, and 112. The MPEP explains that while Section 101 is a "threshold inquiry" for patentability, the examiner should not focus solely on Section 101 in an office action rejection.
2104: Requirements of 35 U.S.C. 101: This section covers the four elements of Section 101, namely: i) only a single invention can be filed per patent, ii) the patent application must be filed by the inventor (pre-AIA) or at least name the inventor, iii) the invention must be patent eligible (not on an abstract idea or natural phenomenon), and iv) the invention must be useful (have utility). The third element is the aspect of Section 101 that we are most concerned about with respect to subject matter eligibility.
2104.01: Barred by Atomic Energy Act: Inventions relating to atomic weapons and "special nuclear material" are barred from patenting and therefore ineligible for patent protection under the Atomic Energy Act.
2105: Patent Eligible Subject Matter — Living Subject Matter: This section covers the patentability of life forms after the Supreme Court's decision in Diamond v. Chakrabarty. This section confirms that living subject matter may be patent eligible, but human organisms are not eligible under Section 33 of the AIA.
2106: Patent Subject Matter Eligibility: This section introduces the MPEP's approach to analyzing Section 101 issues. It discusses that an invention must first fall within one of the four statutory categories before analyzing the two-part Alice test. Examiners are instructed to use this two-part test instead of the older machine-or-transformation test, which can be used as a clue under part two of the test (see the Supreme Court's Bilski decision). Examiners are also instructed to use the broadest reasonable interpretation of the claims when applying the two-part Alice test. Finally, this section provides the USPTO's flow chart (the first flow chart above) for analyzing Section 101 issues.
2106.03: Eligibility Step 1: The Four Categories of Statutory Subject Matter: Examiners are first instructed (as part of step 1 of the MPEP's test for subject matter eligibility) to ensure that the claimed invention falls under one of the four explicitly provided categories of statutory subject matter under Section 101, namely process, machine, manufacture, or composition of matter. This section identifies items that fall into one or more of these categories including a bicycle (a machine and an article of manufacture) and a genetically altered bacterium (a composition of matter and a manufacture). Inventions that do not fall under these four categories include information in the abstract ("data per se") or a computer program not tied to anything physical ("software per se"), and transitory forms of signal transmission ("signals per se"). If an invention doesn't fall under any of four statutory categories, it is not eligible for patent protection. If it does, then the two-part Alice test must be applied. If a claim can be interpreted under its broadest reasonable interpretation to cover something outside of these categories, then it fails this step 1 test.
2106.04: Step 2A: Eligibility Step 2: Whether a Claim is Directed to a Judicial Exception: This section describes step 2A of the MPEP test, which is the first part of the two-part Alice test, as to whether the claim is directed to a judicially created exception. The most important of these judicial exceptions are abstract ideas, natural phenomenon, and laws of nature. The section describes the role of preemption. In particular, while it is true that the goal of the subject-matter eligibility test is to avoid claims that preempt a judicially created exception, preemption is not a standalone test for determining eligibility. In fact, the two-part Alice test automatically analyzes issues of preemption, meaning that preemption should not be considered separately from applying the Alice test. In applying part one of the Alice test, examiner's must remember the following:
- judicial exceptions need not be old or long-prevalent, and that even newly discovered or novel judicial exceptions are still exceptions;
- this part of the test should be applied only after determining what applicant has invented by reviewing the entire application disclosure
- the claims must be construed according to the broadest reasonable interpretation before any analysis;
- this inquiry cannot simply ask whether the claims involve a patent-ineligible concept, because "every routinely patent-eligible claim involving physical products and actions involves a law of nature and/or natural phenomenon" (citing Enfish).
In this section, the PTO introduces Prong One and Prong Two of Step 2A, which were added to this analysis in their 2019 Guidance on subject matter eligibility. Thus, it is here that the second flow chart set forth above appears in the MPEP. These separate prongs are described in more detail below in connection MPEP 2106.04(a) (Prong One for abstract ideas), MPEP 2106.04(b) (Prong One for laws of nature and natural phenomenon) and MPEP 2106.04(d) (Prong Two). Prong One asks whether the claim recites a judicial exception, and this section emphasizes that the claim may recite the exception either by "setting forth" the exception explicitly, or by merely describing the exception without explicitly stating it in the claim itself. Prong Two asks whether the claim recites additional elements that integrate the exception into a practical application.
2106.04(a): Step 2A Prong One: Abstract Ideas: This subsection focuses in on apply Prong One of the Step 2A in the context of abstract ideas (as part of step one of the Alice test). The MPEP acknowledges that the courts have never created a definition of an abstract idea. Therefore, rather than relying upon a judicial definition, and rather than relying upon comparisons to prior court decisions (which was the process prior to 2019), the MPEP now has established three groupings of abstract ideas. These groupings are:
- mathematical concepts – mathematical relationships, mathematical formulas or equations, and mathematical calculations;
- certain methods of organizing human activity, namely:
- fundamental economic principles or practices (including hedging, insurance, and mitigating risk)
- commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; and business relations)
- managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions); and
- Mental processes – concepts performed in the human mind (including an observation, evaluation, judgment, opinion).
If an examiner believes that a claim recites an abstract idea under Prong One of Step 2A, they are to identify particular claim elements that recite the abstract idea, and also identify one of these three enumerated groupings. At this point, the analysis should continue with Prong 2 of Step 2A. If the claim does not recite any of these three groupings of abstract idea, the claim is generally considered eligible (although a limited exception for other types of abstract ideas under MPEP 2106.04(a)(3).
2106.04(a)(1): Examples of Claims That Are Not Directed To Abstract Ideas: This section of the MPEP describes inventions that are patent eligible because they do not recite an abstract ideas. These examples do not cover situations where an abstract idea is integrated into a practical application, which is discussed below in connection with Prong Two. The examples set forth include a printer, a washing machine, an earring that takes blood glucose measurements, a method for sequencing gene sequences, a method for loading BIOS into a computer, a method for rearranging icons on a GUI, and a method for training a neural network. Note that the PTO has provided significant analysis outside of the MPEP for some of these examples, which are described in the Bitlaw Section on the PTO's Examples for Section 101 Analysis.
2106.04(a)(2): Abstract Idea Groupings: This section sets forth the scope of the three enumerated abstract idea groupings set forth in MPEP 2106.04(a).
- Mathematical concepts. This category includes mathematical relationships (relationships between numbers or variables), forumlas (using symbols or text/words), and calculations (including "determining a value" claim elements). The MPEP takes care to distinguish claim limitations that are based on a mathematical concept that is described in the specification but not recited in the claim, which may not be sufficient to fall within this grouping.
- Certain Methods of Organizing Human Activity, which is limited to the three types specified immediately below.
This section provides examples of each type of abstract idea:
- Fundamental Economic Practices or Principles, including concepts relating to the economy and commerce, such as hedging, insurance, and mitigating risk (which is not limited to old or well-known techniques, although this may be factual evidence of a practice being fundamental),
- Commercial or Legal Interactions, which covers contracts, legal obligations, advertising, marketing activities, and business relationships,
- Managing Personal Behavior or Relationships or Interactions Between People, including social activities, teaching, and following rules or instructions;
- Mental Processes, which are processing that can be performed in the human mind, or by a human using a pen and paper.
These processes include observations, evaluations, judgments, and opinions. The MPEP provides the following additional guidance on this category:
- a claim with limitation(s) that cannot practically be performed in the human mind does not recite a mental process;
- a claim that encompasses a human performing the step(s) mentally with or without a physical aid recites a mental process;
- a claim that requires a computer may still recite a mental process; and
- both product and process claims may recite a mental process
2106.04(a)(3): Tentative Abstract Ideas: This section of the MPEP deals with the "rare circumstances" where an examiner wishes to treat an invention as directed toward an abstract idea even though it does not fall within any of the groupings set forth in MPEP 2106.04(a)(2). In this case, the examiner is not to reject the application without approval by the director of the examiner's Technology Center. Although the director's signature will appear on any rejection given under this provision, the examiner retains the right to prosecute the application and allow the patent.
2106.04(b): Laws of Nature, Natural Phenomena & Products of Nature: This portion of the MPEP discusses Laws of Nature, Natural Phenomena & Products of Nature. As was also the case with abstract ideas, not all claims that include or discuss one of these elements is actually directed to that statutory exception. The MPEP explains that case law does not distinguish between a product of nature, and a synthetic, non-naturally occurring item that does not possess any markedly different characteristics from the naturally occurring item. This creates an obligation to analyze marketedly different characteristics, which is discussed in the next section.
2106.04(c): The Markedly Different Characteristics Analysis: Here, the MPEP sets forth guidelines for performing the markedly different characteristics analysis that was introduced in the previous section. In summary, if a claim includes a nature-based product that has markedly different characteristics than what is naturally occurring, then the claim does not recite a product of nature exception and is eligible for patent protection under Step 2A, Prone One of the PTO's test. This section reminds examiners that if the claim recites a product that is actually naturally occurring, then there is no need to perform this analysis as the claim falls under the product of nature exception. The section also explains that the markedly different analysis is primarily used with product claims made to the nature-based product, either by itself or in a combination. While it is also useful for product-by-process claims, it is generally not applicable to process claims.
2106.04(d): Step 2A Prong Two: Integration of a Judicial Exception Into A Practical Application: This section of the MPEP was added in 2020 to describe Prong Two of Step 2A, which analyses whether the claim integrates the judicial exception into a "practical application." This "integration into a practical application" test was derived from Federal Circuit decisions that found some claims to be directed to improve the functioning of a computer or other technology, and therefore were not "directed to" an abstract idea even when the abstract idea was recited in the claim. A claim is considered to integrate the exception into a practical application when it applies, relies upon, or uses the exception "in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception." Beyond this relatively unhelpful definition, the MPEP gives examples of i) improving the functioning of a computer or technology, ii) effecting a treatment for a medical condition, or iii) using with a particular machine or relating to a transformation of an article. This section also notes that claiming a specific way to achieve a result is not a stand-alone consideration, but this may be relevant in weighing the strength of other considerations. Finally, the section acknowledged that this Prong Two of Step 2A is very similar to Step 2B, and that most of the considerations in MPEP 2106.05(a) through (h) (although not part (d)) that are established for Step 2B overlap are also to be considered as part of this Prong Two. The distinction is that Step 2B excludes consideration of elements that are well-understood, routine, and conventional, while such elements are to be considered under this Step 2A Prong Two.
2106.04(d)(1): Evaluating Improvements in the Functioning of a Computer, or an Improvement to Any Other Technology or Technical Field in Step 2A Prong Two: If a claim improves the functioning of a computer or improves another technology, then the claim integrates any judicial exception into a practical application and it is not directed to that exception under Prong Two of Step 2A. The MPEP here does instruct the examiner to evaluate the specification to see if it is sufficient to allow one of ordinary skill to recognize the improvement. The improvement must not be presented in a merely conclusory manner (such as a bare assertion of improvements), and the claim must include the components or steps that provide this improvement. However, the specification is not required to explicitly recite the improvement. This analysis differs than the similar improvement analysis under Step 2B (the inventive concept analysis) in that, under Step 2A Prong Two, the improvement "may not be an improvement over well-understood, routine, conventional activity."
2106.04(d)(2): Particular Treatment and Prophylaxis in Step 2A Prong Two: Similar to the previous section, the section of the MPEP explains that if a claim applies or uses a judicial exception to effect a particular treatment or prohylaxis for a disease or medical condition, then the claim integrates any judicial exception into a practical application and it is not directed to that exception under Prong Two of Step 2A. The claim must "affirmatively recite an action that effects" the treatment or prophylaxis, such as by administering a drug to a patient. Thus, a claim of "prescribing" the same drug would not fall under this section. Furthermore, the claim limitation must have more than a nominal relationship to the treatment.
2106.05: Eligibility Step 2B: Whether a Claim Amounts to Significantly More: This section describes Step 2B of the PTO's test for subject matter eligibility, which is the same as step two of the Alice test. In this step, an analysis is performed to determine whether or not the claim contains an "inventive concept" that includes "significantly more" than the statutory exception. If such an inventive concept is found, the claim is patent eligible even if it is directed to an abstract idea or natural phenomenon. The court notes that one must look beyond the abstract idea or other exception to find the inventive concept--it cannot be found in the exception itself. In making this determination, the conventionality of the elements in the claim are to be considered, but this is not the same as obviousness analysis under Section 103. In fact, the inventive concept can be found in aspects of a claim that are insufficient to meet the obviousness standard. The types of elements that can constitute an inventive concept are described in the following sections. One does not need to consider every one of these elements. Most of these elements should have been considered in Step 2A, Prong Two, as described above. The differences appear to be that part 2106.05(d) should be evaluated in this Step 2B, and insignificant extrasolution active in 2106.05(g) may be considered more significant under Step 2B if it is not routine or is unconventional.
2106.05(a): Improvements to the Functioning of a Computer or To Any Other Technology or Technical Field: The MPEP notes that whether or not a claim relates to an improvement to technology was relevant to step one of the Alice test (step 2A of the PTO's MPEP test), and it is also relevant here under step two. An indication that the claim focuses on a technological improvement can be supported by a "discussion in the specification that identifies a technical problem and explains the details of an unconventional technical solution expressed in the claim, or identifies technical improvements realized by the claim over the prior art." Assuming such support is found in the specification, the examiner will then ensure that the claim is directed toward that improvement. The claim should specify "a particular solution to a problem" as "opposed to merely claiming the idea or a solution or outcome." The section then includes a list of technological solutions found in the case law.
2106.05(b): Particular Machine: This section describes the role of the machine-or-transformation test addressed in Bilski within the two-part Alice test. In particular, the MPEP indicates that machine-or-transformation test can be useful in both parts of the test. The section then goes into detail about how to apply the test with respect to a claim to a particular machine. In particular, the MPEP emphasizes that the machine must play a significant part in permitting the method to be performed, rather than functioning "solely as an obvious mechanism for permitting a solution to be achieve more quickly."
2106.05(c): Particular Transformation: This section is similar to MPEP 2106.05(b), except that this section provides instructions on applying the transformation part of the machine-or-transformation test.
2106.05(d): Well-Understood, Routine, Conventional Activity: This section explains how examiners are to determine whether claim elements are well-understood, routine, and conventional. Such claim elements are not sufficient to find an inventive concept under part two of the Alice test. However, just because a claim element is not new under Section 102 or is not non-obvious under Section 103, that claim element may still be non-conventional and therefore be sufficient to find an inventive concept under part two of the Alice test. Furthermore, this section indicates that the examiner is not to conduct a prior art search, and should instead rely only on their own expertise in the art that the element is widely prevalent or in common use.
2106.05(e): Other Meaningful Limitations: This section explains that claim limitations must meaningfully limit the judicial exception if they are to constitute an inventive concept under Step 2B of the PTO's test part two of the Alice test) or if they are to be used as part of Step 2A Prong Two of the PTO's test. In other words, the limitations being evaluated must do more than limit the claim to a particular technological environment.
2106.05(f): Mere Instructions To Apply An Exception: The section confirms that often repeated statement that if a claim element only effectively adds instructions to "apply" a statutory exception, that claim element will not constitute an inventive concept. This section does include a good listing of court decisions that have considered and applied this requirement.
2106.05(g): Insignificant Extra-Solution Activity: Similarly, this MPEP section confirms rule that insignificant, extra-solution activity" will not be enough to create an inventive concept. In particular, any steps that can be dismisses as "mere data gathering" can be ignored under this rule. Interestingly, this section emphasizes that routine, well-known extra-solution activity which could not constitute an inventive concept under numerous case decisions could be considered under Prong Two Step 2A to determine whether the exception is integrated into a practical application. Examiners should consider whether the extra-solution activity is significant (only "significant" activities will aid in finding eligibilty) and whether it is always necessary (if data gathering is always necessary to use an ineligible concept, then it will not aid in finding eligibility)
2106.05(h): Field of Use and Technological Environment: Finally, the MPEP reminds us that claim limitations that merely limit the statutory exception to a particular technological environment or field of use is not enough to constitute an inventive concept. The MPEP explains that claims that simply limit an exception to a particular process will not become patent eligible, but claims that integrate the exception as an intergral part of the process may well be.
2106.06: Streamlined Analysis: The section explains that if the "eligibility of the claim is self-evident," the examiner can avoid performing the two-part Alice test. Since the results of the streamlined analysis will always be the same as the full analysis, this pathway will never alter the determination that would have been made by applying steps 2A and 2B of the PTO's test.
2106.06(a): Eligibility is Self Evident: The section describes the application of the streamlined analysis when eligibility is self-evident. One example given is a complex manufactured industrial product that recites meaningful limitations along with a judicial exception may sufficiently limit the exception's practical application so that a full eligibility analysis is not needed.
2106.06(b): Clear Improvement to a Technology or to Computer Functionality: This section uses Enfish and McRO as examples of applying the streamlined analysis. However, these cases fully applied step one of the Alice test, and the streamlined analysis should occur before step one is fully considered.
2106.07: Formulating and Supporting Rejections For Lack Of Subject Matter Eligibility: This section explains how an examiner should give a rejection under Section 101. In particular, the examiner should identify why what is recited in the claims is a judicial exception, and why the additional elements in the claim do not constitute an inventive concept.
2106.07(a): Formulating a Rejection For Lack of Subject Matter Eligibility: This section gives additional detail concerning the examiner's rejection. Under step one of the Alice test, the examiner should identify the abstract idea recited in the claims, and explain why it is a judicial exception. For abstract ideas, the examiner should identify which of the groupings of abstract ideas identified in 2106.04(a)(2) applies to the claim. The examiner should then examine the claim for elements outside the exception, and explain either i) that now such elements exist, or ii) those elements do not integrate the exception into a practical application under Prong Two, Step 2A. Finally, the examiner should explain why those elements constitute an inventive concept under Step 2B. This section also notes that no evidentiary support is needed by the examiner in making a rejection under Section 101.
2106.07(a)(1): Form Paragraphs for use in Lack of Subject Matter Eligibility Rejections: The section provides the examiners with form paragraphs to use when making a subject matter eligibility rejection.
2106.07(b): Evaluating Applicant's Response: The section suggests the types of responses that might be filed by an applicant in responding to a Section 101 rejection. The MPEP suggests how the examiner should reconsider various aspects of their analysis in response to these different types of rejections.
2106.07(c): Clarifying the Record: The examiner is encouraged to make clarifying remarks in the record when claims are deemed eligible. Remarks may also be made to clarify why a rejection is made, such as clarifying the broadest reasonable interpretation considered by the examiner when making the rejection.