2106.05(d) Well-Understood, Routine, Conventional Activity [R-07.2022]
Another consideration when determining whether a claim recites significantly more than a judicial exception is whether the additional element(s) are well-understood, routine, conventional activities previously known to the industry. This consideration is only evaluated in Step 2B of the eligibility analysis.
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., 773 F.3d 1245, 113 USPQ2d 1097 (Fed. Cir. 2014), 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. 773 F.3d at 1248, 113 USPQ2d at 1099. 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. 773 F.3d at 1258-59, 113 USPQ2d at 1106-07. Thus, the claims in DDR Holdings were eligible.
On the other hand, Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 67, 101 USPQ2d 1961, 1964 (2010) 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. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 79-80, 101 USPQ2d 1969 (2012) (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, 199 (1978) (the additional elements were "well known" and, thus, did not amount to a patentable application of the mathematical formula)). 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. 566 U.S. at 77-79, 101 USPQ2d at 1967-68. 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." 566 U.S. at 79, 101 USPQ2d at 1968. 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. 566 U.S. at 79-80, 101 USPQ2d at 1968-69.
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 (see MPEP § 2106.05(a)), the mere instructions to apply an exception consideration (see MPEP § 2106.05(f)), and the insignificant extra-solution activity consideration (see MPEP § 2106.05(g)). 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. Diamond v. Diehr, 450 U.S. 175, 190, 209 USPQ 1, 9 (1981). For example, claims may exhibit an improvement over conventional computer functionality even if the improvement lacks novelty over the prior art. Compare, e.g., Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 118 USPQ2d 1684 (Fed. Cir. 2016) (holding several claims from U.S. Patent Nos. 6,151,604 and 6,163,775 eligible) with Microsoft Corp. v. Enfish, LLC, 662 Fed. App'x 981 (Fed. Cir. 2016) (holding some of the same claims to be anticipated by 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. Enfish, 822 F.3d at 1332, 118 USPQ2d at 1687. Although these features were taught by a single prior art reference (thus anticipating the claims), Microsoft Corp., 662 Fed. App'x at 986, 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. Enfish, 822 F.3d at 1337, 118 USPQ2d at 1690.
- 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. Berkheimer v. HP, Inc., 881 F.3d 1360, 1368, 125 USPQ2d 1649, 1654 (Fed. Cir. 2018). 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. See, e.g., Intellectual Ventures v. Symantec, 838 F.3d 1307, 1317; 120 USPQ2d 1353, 1359 (Fed. Cir. 2016) ("The written description is particularly useful in determining what is well-known or conventional"); Internet Patents Corp. v. Active Network, Inc., 790 F.3d 1343, 1348, 115 USPQ2d 1414, 1418 (Fed. Cir. 2015) (relying on specification’s description of additional elements as "well-known", "common" and "conventional"); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 614, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (Specification described additional elements as "either performing basic computer functions such as sending and receiving data, or performing functions ‘known’ in the art.").
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. See Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1377, 118 USPQ2d 1541, 1546 ( Fed. Cir. 2016) (supporting the position that amplification was well-understood, routine, conventional for purposes of subject matter eligibility by observing that the patentee expressly argued during prosecution of the application that amplification was a technique readily practiced by those skilled in the art to overcome the rejection of the claim under 35 U.S.C. 112, first paragraph); see also Lindemann Maschinenfabrik GMBH v. Am. Hoist & Derrick Co., 730 F.2d 1452, 1463, 221 USPQ 481, 489 (Fed. Cir. 1984) ("[T]he specification need not disclose what is well known in the art."); In re Myers, 410 F.2d 420, 424, 161 USPQ 668, 671 (CCPA 1969) ("A specification is directed to those skilled in the art and need not teach or point out in detail that which is well-known in the art."); Exergen Corp., 725 Fed. App’x. 959, 965 (Fed. Cir. 2018) (holding that "[l]ike indefiniteness, enablement, or obviousness, whether a claim is directed to patent eligible subject matter is a question of law based on underlying facts," and noting that the Supreme Court has recognized that "the inquiry 'might sometimes overlap' with other fact-intensive inquiries like novelty under 35 U.S.C. § 102"). 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, as discussed in MPEP § 2106.07(a). 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). For more information on supporting a conclusion that an additional element (or combination of additional elements) is well-understood, routine, conventional activity, see MPEP § 2106.07(a), subsection III.
- 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. Diamond v. Diehr, 450 U.S. at 188, 209 USPQ at 9 (1981) ("[A] new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made."). 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. See, e.g. Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1051, 119 USPQ2d 1370, 1375 (Fed. Cir. 2016) (holding that while the additional steps of freezing and thawing hepatocytes were well known, repeating those steps, contrary to what was taught in the art, was not routine or conventional). 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. BASCOM Global Internet Servs. v. AT&T Mobility LLC, 827 F.3d 1341, 1350-51, 119 USPQ2d 1236, 1243-44 (2016).
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). For more information on formulating a subject matter eligibility rejection involving well-understood, routine, conventional activity, see MPEP § 2106.07(a).
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, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink." (emphasis added));
- ii. Performing repetitive calculations, Flook, 437 U.S. at 594, 198 USPQ2d at 199 (recomputing or readjusting alarm limit values); Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012) ("The computer required by some of Bancorp’s claims is employed only for its most basic function, the performance of repetitive calculations, and as such does not impose meaningful limits on the scope of those claims.");
- iii. Electronic recordkeeping, Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 225, 110 USPQ2d 1984 (2014) (creating and maintaining "shadow accounts"); Ultramercial, 772 F.3d at 716, 112 USPQ2d at 1755 (updating an activity log);
- iv. Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93;
- v. Electronically scanning or extracting data from a physical document, Content Extraction and Transmission, LLC v. Wells Fargo Bank, 776 F.3d 1343, 1348, 113 USPQ2d 1354, 1358 (Fed. Cir. 2014) (optical character recognition); and
- vi. A Web browser’s back and forward button functionality, Internet Patent Corp. v. Active Network, Inc., 790 F.3d 1343, 1348, 115 USPQ2d 1414, 1418 (Fed. Cir. 2015).
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. See e.g. Amdocs (Israel), Ltd. v. Openet Telecom, Inc., 841 F.3d 1288, 1316, 120 USPQ2d 1527, 1549 (Fed. Cir. 2016), BASCOM Global Internet Servs. v. AT&T Mobility LLC, 827 F.3d 1341, 1348, 119 USPQ2d 1236, 1241 (Fed. Cir. 2016). 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. DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1257-59, 113 USPQ2d 1097, 1105-07 (Fed. Cir. 2014).
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, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017);
- ii. Using polymerase chain reaction to amplify and detect DNA, Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377, 115 USPQ2d 1152, 1157 (Fed. Cir. 2015);
- iii. Detecting DNA or enzymes in a sample, Sequenom, 788 F.3d at 1377-78, 115 USPQ2d at 1157); Cleveland Clinic Foundation 859 F.3d at 1362, 123 USPQ2d at 1088 (Fed. Cir. 2017);
- iv. Immunizing a patient against a disease, Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1063, 100 USPQ2d 1492, 1497 (Fed. Cir. 2011);
- v. Analyzing DNA to provide sequence information or detect allelic variants, Genetic Techs., 818 F.3d at 1377; 118 USPQ2d at 1546;
- vi. Freezing and thawing cells, Rapid Litig. Mgmt. 827 F.3d at 1051, 119 USPQ2d at 1375;
- vii. Amplifying and sequencing nucleic acid sequences, University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 764, 113 USPQ2d 1241, 1247 (Fed. Cir. 2014); and
- viii. Hybridizing a gene probe, Ambry Genetics, 774 F.3d at 764, 113 USPQ2d at 1247.
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, Apple, Inc. v. Ameranth, Inc., 842 F.3d 1229, 1244, 120 USPQ2d 1844, 1856 (Fed. Cir. 2016);
- ii. Shuffling and dealing a standard deck of cards, In re Smith, 815 F.3d 816, 819, 118 USPQ2d 1245, 1247 (Fed. Cir. 2016);
- iii. Restricting public access to media by requiring a consumer to view an advertisement, Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 716-17, 112 USPQ2d 1750, 1755-56 (Fed. Cir. 2014);
- iv. Presenting offers and gathering statistics, OIP Techs., 788 F.3d at 1362-63, 115 USPQ2d at 1092-93;
- v. Determining an estimated outcome and setting a price, OIP Techs., 788 F.3d at 1362-63, 115 USPQ2d at 1092-93; and
- vi. Arranging a hierarchy of groups, sorting information, eliminating less restrictive pricing information and determining the price, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1331, 115 USPQ2d 1681, 1699 (Fed. Cir. 2015).