Introduction to this Section 101 (Patentable Subject Matter Eligibility) Index
Section 101 of the U.S. Patent Act states that a patent may be obtained for new and useful processes, machines, manufactures, and compositions of matter. In spite of the broad wording of this section, the Supreme Court has, for many years, held that there are exceptions to subject matter eligibility that are not set forth in that statute. These non-statutory exceptions include natural laws, natural phenomena, and abstract ideas. While patents may not be granted on these exceptions, patents may be granted to novel processes and structures that are based upon these exceptions. The problem is that every invention relies upon natural phenomena, as no mechanical invention could function without the laws of physics, and no medical process or pharmaceutical could function without the underlying biology that allow those methods and drugs to improve human health. One cannot patent the laws of physics or the underlying biology, even if the person applying for the patent discovered this new science. A Nobel Prize may be awarded for such a discovery, but not a patent. Patents can only be awarded on new applications of science, not on the science itself.
Similarly, almost every invention can be describe in an abstract manner. In other words, it is almost always possible to identify an abstract idea that lies behind every patentable idea. Even though one may not obtain a patent on the abstract idea itself, one can get a patent on a particular application of that abstract idea.
While these distinctions are understandable, it can be very difficult to distinguish between a patent claim that is attempting to cover an abstract idea or a natural phenomenon (which is not eligible for patent protection) and a patent claim that is attempting to cover a patentable application of that same idea or phenomenon. The Supreme Court’s decisions in Mayo and Alice laid out a test for making this determination. In the ideal world, application of this Alice/Mayo test (often referred to within BitLaw as just the Alice test) should allow one to determine when a claim should be rejected for being directed to the statutory exception, and when the claim should be granted as being directed to a patent-eligible application of that exception. Unfortunately, the test is very amorphous, which means that it is difficult to apply and can lead to seemingly contradictory results in the court cases that apply the test.
This index attempts to collect all the source materials and analysis that one should need to apply the Alice test. Readers are encouraged to read through the summary of the MPEP sections set forth below. These sections of the MPEP were first published in January of 2018 and set forth the US Patent Office's best understanding of how to apply the Alice test. Of course, the MPEP is written for patent examiners and not patent applicants, and therefore does not provide many suggestions as to how to convince the patent office to allow a patent claim once it has been subject to a Section 101 rejection. That is why we have created a comprehensive Guidance Section dealing with Section 101, which is outlined below. In this Guidance, we focus in on the test that Supreme Court and Federal Circuit have set forth (which should be the test used by the PTO, but frequently is not).
This test requires comparing the fact situation being analyzed to other court decisions that have applied the test. Finding the best, most analogous case, is therefore an important part of applying the Alice test. The Section 101 Case Law Index therefore presents most of the precedential opinions of the Federal Circuit and the Supreme Court that have applied the Alice test. The cases are provided in a searchable, sortable table, allowing users to quickly focus in on the most relevant cases that have reached a desired conclusion. Finally, the US Patent Office has created examples to help explain to examiners how the Alice test should be applied. These tests have been separated and presented below for easier searching and application when generated arguments during patent prosecution in front of the Patent Office.
BitLaw Guidance on Section 101
The Patent Guidance section of BitLaw includes pratical information on handling Section 101 issues. This guidance should prove useful whether you are prosecuting a patent application with the U.S. Patent and Trademark Office, or you are either attacking or defending a patent's validity in front of the Patent Trial and Appeal Board (PTAB), a federal district court, or the U.S. Court of Appeals for the Federal Circuit. The Guidance is divided into the following four pages:
- What is a Section 101 Rejection
- This page provides a basic overview of the subject matter eligibility requirement (Section 101) and how it is currently being applied by the federal courts. In particular, this page discusses the following topics:
- Section 101 and the Subject Matter Eligibility Requirement,
- The four statutory categories under Section 101,
- The non-statutory exceptions (abstract ideas and natural phenomena), and
- Overview of the Alice test for analyzing non-statutory exceptions.
- Alice test applies to both abstract ideas and natural phenomenon
- Applying Step One of the Alice test
- Here step one of the Alice test is discussed in detail in light of the relevant Federal Circuit decisions. This page discusses:
- Overview of Step One
- Applying step one in the context of abstract ideas
- Applying step one in the context of natural phenomena
- Applying Step Two of the Alice test
- In this Guidance, step two of the Alice test and the relevant case law is considered in detail. The topics covered include:
- Overview of step two of the Alice test
- What is Enough for an Inventive Concept?
- Well-understood, routine, and conventional claim elements
- Well-understood, routine, conventional activity is not inventive concept
- Must consider ordered combination of claim elements
- Question of fact--Requires a factual determination on conventionality
- Prior art search is not needed
- Not same as Section 103--Can be inventive concept even if obvious under section 103
- Machine-or-transformation test
- Where may one look to find the inventive concept?
- How to argue against a Section 101 Rejection
- The insight from the previous three Guidance pages are brought together in this discussion about hot to best address Section 101 issues. In this case, the analysis is focused on defending a patent or patent application against an allegation that the invention is non-statutory subject matter. The topics covered include:
- Claims outside one of the four statutory classes
- Proving eligibility under step one of alice test
- Explain how examiner failed to properly apply step one of the test
- Redefine the "claimed concept" using proper test
- Argue closest analogy to case that allowed claim under step one
- Argue claims do not merely gather, analyze, and output data
- Argue claims recite particular solution as oppose to claiming an outcome
- Should you argue preemption?
- Step one under the markedly different characteristics test
- Proving Eligibility under step two of alice test
- Explain how examiner failed to properly apply step two of the test
- Identify elements where inventive concept can be found
- Argue that claim elements are not well-understood, routine, and conventional
- Argue additional claim elements improve computers or technology
- Refute characterizations that claim elements can't qualify as inventive concepts
- Argue that the claims pass the machine-or-transformation test
Statutes and Regulations
- Section 101 of the U.S. Patent Act
- No regulations govern subject matter eligibility
Important Case Law Concerning Section 101
Bitlaw now provides a separate Section 101 Cases page to index and summarize recent subject matter eligibility decisions. The following index is provided here only for quick access to the most important cases.
- Gottschalk v. Benson (S. Ct. 1972)
- The Supreme Court decided that a patent on an algorithm to convert binary-coded decimal numbers into true binary numbers would pre-empt the entire mathematical algorithm. Since mathematics could be considered an abstract idea, and abstract ideas are not patentable, the Supreme Court held that the algorithm in question is not patentable.
- Parker v. Flook (S. Ct. 1978)
- Here, the Supreme Court determined that a method for updating an alarm limit (used to signal abnormal conditions) in a catalytic conversion process was unpatentable. Since the only difference between the prior art and the invention was the algorithm the invention was not patentable because once that algorithm is assumed to be within the prior art, the application, considered as a whole, contains no patentable invention."
- Diamond v. Chakrabarty, 447 US 303 (1980
- A new bacterium with markedly different characteristics from any found in nature was found to be patentable. The Supreme Court emphasized that here, the invention was not nature's handiwork, but the handiwork of the inventor.
- Diamond v. Diehr (S. Ct. 1981)
- In this 1981 case, the U.S. Supreme Court found an invention to be patetnable even though computer software was utilized. The invention utilizes a computer to calculate and control the heating times during a rubber curing process. In this case, the invention was not merely a mathematical algorithm, but was a process for molding rubber, and hence was patentable. This was true even though the only "novel" feature of this invention was the timing process controlled by the computer.
Primary Cases Guiding Current Section 101 Analysis
- Bilski v. Kappos (S. Ct. 2010)
- The Supreme court rejected the machine-or-transformation test is the sole test to determine whether a process constitutes patent-eligible subject mater. The invention at issue was not patent-eligible subject matter because it was an attempt to preempt an abstract idea.
- Mayo Collaborative Services v. Prometheus Laboratories, Inc. (S. Ct. 2012)
- The Supreme Court determined that a medical testing patent was unpatentable as nonstatutory subject matter. To be patent eligible, claims of this type must contain additional elements beyond the natural law that are not well-understood, routine, and conventional.
- Association for Molecular Pathology v. Myriad Genetics, Inc. (S. Ct. 2013)
- The Court found that isolating gene fragments did not result in the invention of anything that was not found in nature and was not patent eligible. In contrast, the creation of cDNA sequences from mRNA results in a non-naturally occurring molecule, and is patent eligible subject matter.
- Alice Corp. v. CLS Bank Int'l (S. Ct. 2014)
- The Supreme Court set forth a two-part test for analyzing Section 101 issues. First, determine if is "directed to" an abstract idea or other statutory exception. If so, the claim is not patent eligible unless it contains an "inventive concept" outside the statutory exception.
Recent Cases that Interpret Bilski, Mayo, and Alice Corp.
- DDR Holdings, LLC v. Hotels.com (Fed. Cir. 2014)
- The Federal Circuit finds a software-related invention to be patent eligible.
- ENFISH, LLC v. Microsoft Corporation (Fed. Cir. 2016)
- The Federal Circuit considers a computer-implemented invention to be patent eligible subject matter under Alice. The Enfish decision requires that, under the first step of the Alice test, the claims be considered as a whole, and that the "focus" or "character" of the claim be examined to determined whether a claim is "directed to" an abstract idea.
- Bascom Global Internet Services, Inc. v. AT&T Mobility LLC (Fed. Cir. 2016)
- The Federal Circuit takes a new approach in analyzing step two of the Alice test, explaining that "an inventive concept can be found in the non-conventional and non-generic arrangement of known, conventional pieces."
- Electric Power Group, LLC v. Alstom SA (Fed. Cir. 2016)
- Even when applying the Enfish decision, the Federal Circuit found that a claim directed to collecting and analyzing data to be ineligible for patent protection.
- McRO, INC. v. Bandai Namco Games America Inc. (Fed. Cir. 2016)
- The court in McRO analyzed the claims "as a whole" under Enfish and found claims directed toward rules that set parameters for a digital animation software process were patent eligible.
Manual of Patent Examining Procedure (MPEP)
In the January 2018 version of the MPEP, the USPTO has set forth its current thinking on Section 101 and how it should be applied to patent applications being reviewed by the office. The following sections are the most important portions of the MPEP related to subject matter eligibility. A summary of the section's contents follows each link.
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 notes that humans organism are not patent 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 machine-or-transformation test, which can be used as a clue under part two of the test. 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 for analyzing Section 101 issues.
2106.03: Eligibility Step 1: The Four Categories of Statutory Subject Matter: Examiners are first instructed 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. 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 these categories, it is not eligible for patent protection. If it does, then the two-part Alice test must be applied.
2106.04: Eligibility Step 2: Whether a Claim is Directed to a Judicial Exception: This section describes the first part of the two-part Alice test, namely whether the claim is directed to a judicially created exception. The most important of these exceptions are abstract ideas and natural phenomenon. The section describes the role of preemption: The goal of the test is to avoid claims that preempt a judicially created exception, but 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)
2106.04(a): Abstract Ideas: This subsection focuses in on apply step one of the Alice test in the context of abstract ideas. The MPEP acknowledges that the courts have never created a definition of an abstract idea, which means that abstract ideas must be determined by comparison to prior court decisions. Examiners are instructed to first clearly identify the claimed concept and the compare the concept to other concepts identified by the courts as abstract. The MPEP then emphasizes that claims that are directed to improvements to computer functionality or other improvements to other technologies are not abstract, citing Enfish, McRO, and Visual Memory. In describing the Enfish decision, the MPEP acknowledged that one should look to the specification to see how the claimed invention operates as an improvement to computer technologies. With respect to McRO, the MPEP indicated that it was important that the claimed software did not simply automate an existing, non-computerized method. And in Visual Memory, this section again noted that the technological improvements described in the specification help show that the claimed invention operated as an improved to the computer. Finally, the section noted that it is important that the claims cover "a particular solution to a problem or a particular way to achieve a desired outcome, as opposed to merely claiming the idea of a solution or outcome." The MPEP acknowledged that a claimed invention that improves a computer or other technology helps determine that the claim is not direct to an abstract idea in step one of the Alice test, and it is also relevant to whether or not the claim contains an inventive concept under step two of the Alice test. The MPEP expresses a preference for determining this issue under step one, but if the facts are insufficient they can still be used as evidence in step two.
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 are not directed to abstract ideas. The section divides these inventions into two types:
Claims that involve, but do not recite, an abstract idea. The basic concept might be a claim to a washing machine that recites various components. But the MPEP places Enfish in this category. Here the claims recited a "self-referential table for a computer database," but did not recite a "concept of organizing information using tabular formats." Similarly, DDR Holdings claimed an improved hyperlink process, but did not recite an abstract idea because the hyperlink process was not similar to any previously identified abstract ideas.
Claims that recite an abstract idea but are directed to a technological improvement. The MPEP again includes Enfish in this category, implying that the claims in that case both recite an abstract idea and do not recite an abstract idea. McRO is also recited as an example case, with the technological improvements recited in this case meaning that the claims are not directed to an abstract idea.
2106.04(a)(2): Examples of Concepts The Courts Have Identified As Abstract Ideas: Here the MPEP tries to categorize all of the cases in which a claim was found to be directed to an abstract idea. The latest edition to the MPEP has restructured these categories as follows:
- Mathematical concepts, including:
- Mathematical Relationships, which is a relationship (two sides of an equation) between variables or numbers,
- Mathematical Formulas or Equations, which is a numerical forumla or equation,
- Mathematical Calculations, which is an act of calculating using math to determine a variable or number;
- Certain Methods of Organizing Human Activity, including:
- Fundamental Economic Practices or Principles, including concepts relating to the economy and commerce, such as hedging, insurance, and mitigating risk,
- 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
- Both Product and Process Claims May Recite a Mental Process
2106.04(a)(3): Tentative Abstract Ideas: This new 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 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. Just as was 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.
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.
2106.05: Eligibility Step 2B: Whether a Claim Amounts to Significantly More: This section describes step two of the Alice test in which an analysis is performed to determine whether or not the claim contains an "inventive concept" that allows the claim to include "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.
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, 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 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 machine-or-transformation test is useful in determining whether or not the claim contains an inventive concept under part two of the test. The section then goes into detail about how to apply the test with respect to a claim to a particular machine.
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 part two of the Alice test.
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.
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 filed 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(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 that corresponds to a concept that the courts have identified as an abstract idea. This section also notes that no evidentiary support is needed by the examiner in making a rejection under Section 101.
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.
Patent and Trademark Office Documents
Set forth below are various "guidance" documents created by the USPTO to analyze patent applications with respect to Section 101. Most of this guidance has now been incorporated into the MPEP. As a result, the preceding MPEP Sections should be considered to supercede much of the guidance described below
- Current Guidance
- Guidance that pre-dates the current MPEP
- USPTO Subject Matter Eligibility webpage
- Interim Guidance
- Case Specific Guidance (Guidance provided after a particular case that has not be included in the Interim Guidance materials)
- Quick Reference Sheets
The patent and trademark office has provided a total of 27 examples that can be used to understand how the Section 101 Guidance is to be applied in particular fact situations. These examples have been separated from their original source PDF documents, and are indexed in a separate page containing the PTO's Section 101 examples.