2106.05(d) Well-Understood, Routine, Conventional Activity
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If the additional element (or combination of elements) is a specific limitation other than what is well-understood, routine and conventional in the field, for instance because it is an unconventional step that confines the claim to a particular useful application of the judicial exception, then this consideration favors eligibility.
- If, however, the additional element (or combination of elements) is no more than well-understood, routine, conventional activities previously known to the industry, which is recited at a high level of generality, then this consideration does not favor eligibility.
DDR Holdings, LLC v. Hotels.com, L.P. provides an example of additional elements that favored eligibility because they were more than well-understood, routine conventional activities in the field. The claims in DDR Holdings were directed to systems and methods of generating a composite webpage that combines certain visual elements of a host website with the content of a third-party merchant.
The court found that the claim had additional elements that amounted to significantly more than the abstract idea, because they modified conventional Internet hyperlink protocol to dynamically produce a dual-source hybrid webpage, which differed from the conventional operation of Internet hyperlink protocol that transported the user away from the host’s webpage to the third party’s webpage when the hyperlink was activated. Thus, the claims in DDR Holdings were eligible.
On the other hand, Mayo Collaborative Servs. v. Prometheus Labs., Inc., provides an example of additional elements that were not an inventive concept because they were merely well-understood, routine, conventional activity previously known to the industry, which were not by themselves sufficient to transform a judicial exception into a patent eligible invention.
In Mayo, the claims at issue recited naturally occurring correlations (the relationships between the concentration in the blood of certain thiopurine metabolites and the likelihood that a drug dosage will be ineffective or induce harmful side effects) along with additional elements including telling a doctor to measure thiopurine metabolite levels in the blood using any known process.
The Court found this additional step of measuring metabolite levels to be well-understood, routine, conventional activity already engaged in by the scientific community because scientists "routinely measured metabolites as part of their investigations into the relationships between metabolite levels and efficacy and toxicity of thiopurine compounds."
Even when considered in combination with the other additional elements, the step of measuring metabolite levels did not amount to an inventive concept, and thus the claims in Mayo were not eligible.
I. EVALUATING WHETHER THE ADDITIONAL ELEMENTS ARE WELL-UNDERSTOOD, ROUTINE, CONVENTIONAL ACTIVITY
When making a determination whether the additional elements in a claim amount to significantly more than a judicial exception, the examiner should evaluate whether the elements define only well-understood, routine, conventional activity.
In this respect, the well-understood, routine, conventional consideration overlaps with other Step 2B considerations, particularly the improvement consideration, the mere instructions to apply an exception consideration, and the insignificant extra-solution activity consideration.
- Thus, evaluation of those other considerations may assist examiners in making a determination of whether a particular element or combination of elements is well-understood, routine, conventional activity.
In addition, examiners should keep in mind the following points when determining whether additional elements define only well-understood, routine, conventional activity.
1. An additional element (or combination of additional elements) that is known in the art can still be unconventional or non-routine.
The question of whether a particular claimed invention is novel or obvious is "fully apart" from the question of whether it is eligible.
- For example, claims may exhibit an improvement over conventional computer functionality even if the improvement lacks novelty over the prior art.
- The eligible claims in Enfish recited a self-referential database having two key features: all entity types can be stored in a single table; and the table rows can contain information defining the table columns.
- Although these features were taught by a single prior art reference (thus anticipating the claims), the features were not conventional and thus were considered to reflect an improvement to existing technology.
- In particular, they enabled the claimed table to achieve benefits over conventional databases, such as increased flexibility, faster search times, and smaller memory requirements.
2. A factual determination is required to support a conclusion that an additional element (or combination of additional elements) is well-understood, routine, conventional activity.
However, this does not mean that a prior art search is necessary to resolve this inquiry.
- Instead, examiners should rely on what the courts have recognized, or those in the art would recognize, as elements that are well-understood, routine, conventional activity in the relevant field when making the required determination.
- For example, in many instances, the specification of the application may indicate that additional elements are well-known or conventional.
As such, an examiner should determine that an element (or combination of elements) is well-understood, routine, conventional activity only when the examiner can readily conclude, based on their expertise in the art, that the element is widely prevalent or in common use in the relevant industry.
- The analysis as to whether an element (or combination of elements) is widely prevalent or in common use is the same as the analysis under 35 U.S.C. 112(a) as to whether an element is so well-known that it need not be described in detail in the patent specification.
- If the element is not widely prevalent or in common use, or is otherwise beyond those elements recognized in the art or by the courts as being well-understood, routine or conventional, then the element will in most cases favor eligibility.
- For example, even if a particular technique (e.g., measuring blood glucose via an earring worn by a person with diabetes) would have been obvious to one of ordinary skill in the art because it was discussed in several widely-read scientific journals or used by a few scientists, mere knowledge of the particular technique or use of the particular technique by a few scientists is not necessarily sufficient to make the use of the particular technique routine or conventional in the relevant field.
- The examiner in this situation would already know, based on the examiner's expertise in the field, that blood glucose is routinely and conventionally monitored by other techniques (e.g., via placing a small droplet of blood on a diagnostic test strip, or via an implanted insulin pump with a glucose sensor).
- Thus, the examiner would not need to perform a prior art search in order to determine that the particular claimed technique using the glucose-sensing earring was not well-understood, routine, conventional activity previously engaged in by scientists in the field.
The required factual determination must be expressly supported in writing. Appropriate forms of support include one or more of the following:
- (a) A citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates the well-understood, routine, conventional nature of the additional element(s);
- (b) A citation to one or more of the court decisions discussed in Subsection II below as noting the well-understood, routine, conventional nature of the additional element(s);
- (c) A citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and
- (d) A statement that the examiner is taking official notice of the well-understood, routine, conventional nature of the additional element(s).
3. Even if one or more additional elements are well-understood, routine, conventional activity when considered individually, the combination of additional elements may amount to an inventive concept.
For example, a microprocessor that performs mathematical calculations and a clock that produces time data may individually be generic computer components that perform merely generic computer functions, but when combined may perform functions that are not generic computer functions and thus be an inventive concept.
- For example, in BASCOM, even though the court found that all of the additional elements in the claim recited generic computer network or Internet components, the elements in combination amounted to significantly more because of the non-conventional and non-generic arrangement that provided a technical improvement in the art.
A rejection should only be made if an examiner relying on the examiner's expertise in the art can conclude in the Step 2B inquiry that the additional elements do not amount to significantly more (Step 2B: NO).
- If the elements or functions are beyond those recognized in the art or by the courts as being well‐understood, routine, conventional activity, then the elements or functions will in most cases amount to significantly more (Step 2B: YES).
II. ELEMENTS THAT THE COURTS HAVE RECOGNIZED AS WELL-UNDERSTOOD, ROUTINE, CONVENTIONAL ACTIVITY IN PARTICULAR FIELDS
Because examiners should rely on what the courts have recognized, or those of ordinary skill in the art would recognize, as elements that describe well‐understood, routine activities, the following section provides examples of elements that have been recognized by the courts as well-understood, routine, conventional activity in particular fields.
- It should be noted, however, that many of these examples failed to satisfy other considerations (e.g., because they were recited at a high level of generality and thus were mere instructions to apply an exception, or were insignificant extra-solution activity).
- Thus, examiners should carefully analyze additional elements in a claim with respect to all relevant Step 2B considerations, including this consideration, before making a conclusion as to whether they amount to an inventive concept.
The courts have recognized the following computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity.
- i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec;
- ii. Performing repetitive calculations;
- iii. Electronic recordkeeping;
- iv. Storing and retrieving information in memory;
- v. Electronically scanning or extracting data from a physical document; and
- vi. A Web browser’s back and forward button functionality.
This listing is not meant to imply that all computer functions are well‐understood, routine, conventional activities, or that a claim reciting a generic computer component performing a generic computer function is necessarily ineligible.
- Courts have held computer‐implemented processes not to be significantly more than an abstract idea (and thus ineligible) where the claim as a whole amounts to nothing more than generic computer functions merely used to implement an abstract idea, such as an idea that could be done by a human analog (i.e., by hand or by merely thinking).
- On the other hand, courts have held computer-implemented processes to be significantly more than an abstract idea (and thus eligible), where generic computer components are able in combination to perform functions that are not merely generic.
The courts have recognized the following laboratory techniques as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity:
- i. Determining the level of a biomarker in blood by any means;
- ii. Using polymerase chain reaction to amplify and detect DNA;
- iii. Detecting DNA or enzymes in a sample;
- iv. Immunizing a patient against a disease;
- v. Analyzing DNA to provide sequence information or detect allelic variants;
- vi. Freezing and thawing cells;
- vii. Amplifying and sequencing nucleic acid sequences; and
- viii. Hybridizing a gene probe.
Below are examples of other types of activity that the courts have found to be well-understood, routine, conventional activity when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity:
- i. Recording a customer’s order;
- ii. Shuffling and dealing a standard deck of cards;
- iii. Restricting public access to media by requiring a consumer to view an advertisement;
- iv. Presenting offers and gathering statistics;
- v. Determining an estimated outcome and setting a price; and
- vi. Arranging a hierarchy of groups, sorting information, eliminating less restrictive pricing information and determining the price.
