Aetna Inc.

Patent Trials and Appeals Board

Mar 29, 2022

2021003276 (P.T.A.B. Mar. 29, 2022)

UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 15/081,250 03/25/2016 Adam Scott 723696 3707 161644 7590 03/29/2022 LEYDIG VOIT & MAYER, LTD - AETNA TWO PRUDENTIAL PLAZA, SUITE 4900 180 NORTH STETSON AVENUE CHICAGO, IL 60601-6731 EXAMINER TOMASZEWSKI, MICHAEL ART UNIT PAPER NUMBER 3686 NOTIFICATION DATE DELIVERY MODE 03/29/2022 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): Chgpatent@leydig.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte ADAM SCOTT, HENRY GEORGE WEI, and MICHAEL PALMER ____________ Appeal 2021-003276 Application 15/081,250 Technology Center 3600 ____________ Before ANTON W. FETTING, JAMES P. CALVE, and AMEE A. SHAH, Administrative Patent Judges. SHAH, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), the Appellant1 appeals from the Examiner’s final decision to reject claims 1-5, 7-12, and 14-19, which are all the claims pending in this application. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42 (2019). The Appellant identifies the real party in interest as CVS Pharmacy Inc. Appeal Br. 3. Appeal 2021-003276 Application 15/081,250 2 CLAIMED SUBJECT MATTER The Appellant’s invention relates generally to “optimizing medical treatment” (Spec. ¶ 4) and more specifically to “methods and systems for optimization of therapeutic outcomes” (id. ¶ 11). Claims 1, 8, and 15 are the independent claims on appeal. Claim 8 (Appeal Br. 20-21 (Claims App.)) is exemplary of the subject matter on appeal and is reproduced below (with lettered bracketing added for reference). 8. A method, comprising: [(a)] receiving, at an application server comprising a processor, clinical data including genome data and clinical profile data for a plurality of patients; [(b)] for a first patient in the plurality of patients: selecting a sample of patients from the plurality of patients based on a phenotype of the first patient and phenotypes of the plurality of patients included in the clinical profile data, and selecting a subset of patients in the sample of patients based on a genotype of the first patient and genotypes of the sample of patients included in the genome data; [(c)] receiving, at the application server, a request for a therapeutic recommendation via an application programming interface (API), [(d)] comparing, by the application server, different therapeutic options for treatment of the first patient based on efficacy of the therapeutic options on the subset of patients; [(e)] generating, responsive to the request and by the application server, a therapeutic recommendation based on the comparison of the different therapeutic options; [(f)] storing, by the application server, data corresponding to the therapeutic recommendation in the database; and Appeal 2021-003276 Application 15/081,250 3 [(g)] transmitting a message including the therapeutic recommendation to a mobile device associated with the first patient or a clinical endpoint corresponding with the treatment of the first patient, wherein selecting the sample of patients from the plurality of patients based on the phenotype of the first patient and the phenotypes of the plurality of patients included in the clinical profile data comprises: [(b1)] generating a multi-dimensional vector for each patient in the plurality of patients based on the clinical profile data for the patient, and [(b2)] applying a clustering algorithm to the multi- dimensional vectors to generate disease and clinical attribute groupings among the plurality of patients. THE REJECTION Claims 1-5, 7-12, and 14-19 stand rejected under 35 U.S.C. § 101 as being directed to a judicial exception without significantly more. OPINION The Appellant argues the pending claims as a group. See Appeal Br. 10, 16. We select independent claim 8 as representative of the group. The remaining claims stand or fall with claim 8, see 37 C.F.R. § 41.37(c)(1)(iv) (2019), except we also consider the Appellant’s separate assertions with respect to dependent claims 2, 9, and 16 (see Appeal Br. 16). 35 U.S.C. § 101 Framework Section 101 An invention is patent-eligible if it claims a “new and useful process, machine, manufacture, or composition of matter.” 35 U.S.C. § 101. However, the U.S. Supreme Court has long interpreted 35 U.S.C. § 101 to include implicit exceptions: “[l]aws of nature, natural phenomena, and Appeal 2021-003276 Application 15/081,250 4 abstract ideas” are not patentable. E.g., Alice Corp. v. CLS Bank Int’l, 573 U.S. 208, 216 (2014). In determining whether a claim falls within an excluded category, we are guided by the Court’s two-part framework, described in Mayo and Alice. Id. at 217-18 (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 75-77 (2012)). In accordance with that framework, we first determine what concept the claim is “directed to.” See Alice, 573 U.S. at 219 (“On their face, the claims before us are drawn to the concept of intermediated settlement, i.e., the use of a third party to mitigate settlement risk.”); see also Bilski v. Kappos, 561 U.S. 593, 611 (2010) (“Claims 1 and 4 in petitioners’ application explain the basic concept of hedging, or protecting against risk.”). Concepts determined to be abstract ideas, and thus patent ineligible, include certain methods of organizing human activity, such as fundamental economic practices (Alice, 573 U.S. at 219-20; Bilski, 561 U.S. at 611); mathematical formulas (Parker v. Flook, 437 U.S. 584, 594-95 (1978)); and mental processes (Gottschalk v. Benson, 409 U.S. 63, 67 (1972)). Concepts determined to be patent eligible include physical and chemical processes, such as “molding rubber products” (Diamond v. Diehr, 450 U.S. 175, 191 (1981)); “tanning, dyeing, making waterproof cloth, vulcanizing India rubber, smelting ores” (id. at 182 n.7 (quoting Corning v. Burden, 56 U.S. 252, 267-68 (1853))); and manufacturing flour (Benson, 409 U.S. at 69 (citing Cochrane v. Deener, 94 U.S. 780, 785 (1876))). In Diehr, the claim at issue recited a mathematical formula, but the Court held that “a claim drawn to subject matter otherwise statutory does not become nonstatutory simply because it uses a mathematical formula.” Appeal 2021-003276 Application 15/081,250 5 Diehr, 450 U.S. at 187; see also id. at 191 (“We view respondents’ claims as nothing more than a process for molding rubber products and not as an attempt to patent a mathematical formula.”). Having said that, the Court also indicated that a claim “seeking patent protection for that formula in the abstract . . . is not accorded the protection of our patent laws, and this principle cannot be circumvented by attempting to limit the use of the formula to a particular technological environment.” Id. (citations omitted) (citing Benson and Flook); see, e.g., id. at 187 (“It is now commonplace that an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.”). If the claim is “directed to” an abstract idea, we turn to the second step of the Alice and Mayo framework, where “we must examine the elements of the claim to determine whether it contains an ‘inventive concept’ sufficient to ‘transform’ the claimed abstract idea into a patent- eligible application.” Alice, 573 U.S. at 221 (citations omitted). “A claim that recites an abstract idea must include ‘additional features’ to ensure ‘that the [claim] is more than a drafting effort designed to monopolize the [abstract idea].’” Id. (alterations in original) (quoting Mayo, 566 U.S. at 77). “[M]erely requir[ing] generic computer implementation[] fail[s] to transform that abstract idea into a patent-eligible invention.” Id. USPTO Section 101 Guidance We are also guided by U.S. Patent and Trademark Office (“USPTO”) Guidance, as set forth in the 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019) (“Guidance”) and the October 2019 Update: Subject Matter Eligibility (“October 2019 Update”), incorporated into the MANUAL OF PATENT EXAMINING PROCEDURE Appeal 2021-003276 Application 15/081,250 6 §§ 2104-06, Rev. 10.2019 (“MPEP”) in June 2020. “The guidance sets out agency policy with respect to the USPTO’s interpretation of the subject matter eligibility requirements of 35 U.S.C. [§] 101 in view of decisions by the Supreme Court and the Federal Circuit.” Guidance, 84 Fed. Reg. at 51. Although “[a]ll USPTO personnel are, as a matter of internal agency management, expected to follow the guidance,” the guidance “does not create any right or benefit, substantive or procedural, enforceable by any party against the USPTO.” Id. The Guidance, by its terms, applies to all applications, and to all patents resulting from applications, filed before, on, or after January 7, 2019. Id. at 50. Under USPTO guidance, we first look to whether the claim recites: (1) any judicial exceptions, including laws of nature, natural phenomena, and products of nature (see MPEP §§ 2106.04(II)(A)(1), 2106.04(b)) (“Step 2A, Prong One”); and (2) additional elements that integrate the judicial exception into a practical application (see id. §§ 2106.04(II)(A)(2), 2106.04(d)) (“Step 2A, Prong Two”).2 Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look, under Step 2B, to whether the additional elements, individually or in combination, provide an inventive concept. See MPEP §§ 2106(III), 2106.05. “An inventive concept ‘cannot be furnished by the unpatentable law of nature (or 2 This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. See Guidance - Section III(A)(2), 84 Fed. Reg. at 54- 55; MPEP § 2106.04(d). Appeal 2021-003276 Application 15/081,250 7 natural phenomenon or abstract idea) itself.’” Id. § 2106.05 (quoting Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376 (Fed. Cir. 2016)). Among the considerations in determining whether the additional elements, individually or in combination, amount to significantly more than the exception itself, we look to whether they add a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field or simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. MPEP § 2106.05(II); Guidance, 84 Fed. Reg. at 56. Step One of the Mayo/Alice Framework Under the first step of the Mayo/Alice framework and Step 2A, Prong One of USPTO guidance, the Examiner determines that the limitations of independent claim 8 “correspond to an abstract idea including mathematical concepts, mental processes and/or certain methods of organizing human activity” and that the “claim as a whole [is] directed to the abstract idea of optimizing medical treatment by analyzing data to generate a therapeutic recommendation” and “to organizing medical treatment activity/interactions between a provider and patent to provide a therapeutic recommendation.” Ans. 4; see also Final Act. 4. Under Prong Two of USPTO guidance, the Examiner determines [the] additional elements do not integrate the abstract idea into a practical application because the additional elements merely add insignificant extra-solution activity to the abstract idea; merely link the use of the judicial exception to a particular technological environment or field of use; and/or simply append technologies and functions, specified at a high level of generality, to the abstract idea. Ans. 5; see also Final Act. 4-5. Appeal 2021-003276 Application 15/081,250 8 The Appellant disagrees and contends “the Examiner has erred in applying the wrong standard in his analysis and should have evaluated the claim as a whole under Step 2A rather than a subset of individual limitations” and that claim 8 is “not directed to an abstract idea as being a mental process” and “do[es] not recite certain methods of organizing human activity.” Appeal Br. 10-12; see also Reply Br. 3. Under Prong Two, the Appellant contends “the additional elements of: (1) a clinical database; (2) an application server; (3) an application programming interface (API); and (4) a mobile device or a clinical endpoint . . . are sufficient to integrate the judicial exception into a practical application” because they “are not merely extra solution activity,” “do not merely link the abstract idea to a particular technological environment or field of use,” and “do not simply append technologies and function, specified at a high level of generality, to the abstract idea.” Appeal Br. 13-15; see also Reply Br. 3-5. Under the first step of the Mayo/Alice framework and Step 2A of USPTO guidance, we first determine to what the claim is directed, i.e., whether the claim recites an abstract idea and if so, whether the claim is directed to that abstract idea. The Federal Circuit has explained that “the ‘directed to’ inquiry applies a stage-one filter to claims, considered in light of the specification, based on whether ‘their character as a whole is directed to excluded subject matter.’” Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335 (Fed. Cir. 2016) (quoting Internet Patents Corp. v. Active Network, Inc., 790 F.3d 1343, 1346 (Fed. Cir. 2015)). It asks whether the focus of the claim is on a specific improvement in relevant technology or on a process that itself qualifies as an “abstract idea” for which computers are invoked merely as a tool. See id. at 1335-36. Here, it is clear from the Appeal 2021-003276 Application 15/081,250 9 Specification, including the claim language, that independent claim 8 is “directed to a result or effect that itself is the abstract idea and merely invoke generic processes and machinery” rather than “a specific means or method that improves the relevant technology.” Smart Sys. Innovations, LLC v. Chi. Transit Authority, 873 F.3d 1364, 1371 (Fed. Cir. 2017). The Specification provides evidence as to what the claimed invention is directed. Here, the Specification is entitled “SYSTEMS AND METHODS FOR DYNAMICALLY GENERATED GENOMIC DECISION SUPPORT FOR INDIVIDUALIZED MEDICAL TREATMENT.” Spec. Title. The Specification discusses that a drawback with traditional approaches to genetic or DNA sequencing that “have looked to compare a set of genomic data against very large databases of known sets of gene variants, computing the combined probability of desired outcome or efficacy given a set of potential therapeutic options” is that “real-world datasets can lead to potential errors in interpretation; for example, when not properly adjusted for selection bias.” Id. ¶¶ 3, 10. The invention ostensibly addresses this problem by “provid[ing] techniques to seek out similar populations for comparison matched not only for the clinical profile of a patient, but also the propensity to be assigned to any given therapy.” Id. ¶ 12. Consistent with this disclosure, independent claim 8 recites “[a] method comprising” the steps of: (1) receiving data, i.e., limitations (a) and (c) of “receiving, at an application server comprising a processor, clinical data including genome data and clinical profile data for a plurality of patients” and “receiving, at the application server, a request for a therapeutic recommendation via an application programming interface (API);” Appeal 2021-003276 Application 15/081,250 10 (2) selecting data based on an analysis of data, i.e., limitations (b), (b1), and (b2) of for a first patient in the plurality of patients: selecting a sample of patients from the plurality of patients based on a phenotype of the first patient and phenotypes of the plurality of patients included in the clinical profile data, and selecting a subset of patients in the sample of patients based on a genotype of the first patient and genotypes of the sample of patients included in the genome data . . . wherein selecting the sample of patients from the plurality of patients based on the phenotype of the first patient and the phenotypes of the plurality of patients included in the clinical profile data comprises: generating a multi-dimensional vector for each patient in the plurality of patients based on the clinical profile data for the patient, and applying a clustering algorithm to the multi- dimensional vectors to generate disease and clinical attribute groupings among the plurality of patients; (3) comparing data, i.e., limitation (d) of “comparing, by the application server, different therapeutic options for treatment of the first patient based on efficacy of the therapeutic options on the subset of patients;” (4) generating data based on the comparison, i.e., limitation (e) of “generating, responsive to the request and by the application server, a therapeutic recommendation based on the comparison of the different therapeutic options;” (5) storing data resulting from the analyses, i.e., limitation (f) of “storing, by the application server, data corresponding to the therapeutic recommendation in the database;” and (6) sending data of the results of the analyses, i.e., limitation (g) of “transmitting a message Appeal 2021-003276 Application 15/081,250 11 including the therapeutic recommendation to a mobile device associated with the first patient or a clinical endpoint corresponding with the treatment of the first patient.” Appeal Br. 20-21 (Claims App.). We consider the claim as a whole3 giving it the broadest reasonable construction4 as one of ordinary skill in the art would have interpreted it in light of the Specification5 at the time of filing. Limitations (a), (c), (d), (e), and (f) of method claim 8 are performed at or by an “application server;” limitations (b), (b1), (b2), and (g) are not recited as being performed by any particular structure, although we note that in independent claim 1, these limitations are performed by a processor included in the application server. Appeal Br. 18-21 (Claims App.). The Specification describes application server 126 as “compris[ing] one or more network interfaces, one or more processors, one or more storage elements, memory, and one or more interface devices for inputting and outputting of data,” i.e., a generic computer. Spec. ¶¶ 15, 21-26, Fig. 1. Limitations (a) and (c) of receiving clinical data and a request recite extra-solution activity of receiving data and abstract ideas of collecting and communicating data. See In re Bilski, 545 F.3d 943, 963 (Fed. Cir. 2008) 3 “In determining the eligibility of respondents’ claimed process for patent protection under § 101, their claims must be considered as a whole.” Diehr, 450 U.S. at 188. 4 Guidance, 84 Fed. Reg. at 52 n.14 (“If a claim, under its broadest reasonable interpretation . . . .”) (emphasis added). 5 “First, it is always important to look at the actual language of the claims. . . . Second, in considering the roles played by individual limitations, it is important to read the claims ‘in light of the specification.’” Smart Sys., 873 F.3d at 1378 (J. Linn, dissenting in part and concurring in part) (citing Enfish, 822 F.3d at 1335, among others). Appeal 2021-003276 Application 15/081,250 12 (en banc), aff’d Bilski v. Kappos, 561 U.S. 593 (2010) (characterizing data gathering steps as insignificant extra-solution activity); Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d 1350, 1353 (Fed. Cir. 2016) (collecting information is an abstract idea); ChargePoint, Inc. v. SemaCONNECT, Inc., 920 F.3d 759, 766 (Fed. Cir. 2019) (identifying communicating requests between servers over a network as an abstract idea). Limitations (b), (b1), (b2), (d), and (e) of selecting, comparing, and generating data are recited functionally without details on how, technologically or by what algorithm(s), they are performed. The Specification provides no further details for any of these limitations, but discusses that “[a] multi-dimensional vector is generated for each individual’s clinical profile” and provides known examples for “clustering and nearest-neighbor algorithms [that] may then be applied to these high- dimensional data.” Spec. ¶ 30, Fig. 2. Further, the application server may comprise “engines for the purpose of clustering cohorts of similar individuals and comparing different therapeutic options” (Spec. ¶ 23), may “include a predictive modeling apparatus to incorporate both static and also to compute and then incorporate dynamically-generated predictive models in order to support prioritization of pre-computation of potential clinical scenarios an individual may face” (Spec. ¶ 23), “uses above mentioned rules and algorithms to determine which individuals within the population set are closely matched phenotypically to the patient, and selects this smaller sample for further analysis” (Spec. ¶ 39), uses the grouping of individuals with genotypes matching that of the patient to identify treatment procedures and therapies (Spec. ¶ 40), and provides a therapeutic recommendation after comparing the outcomes of the treatments (Spec. ¶ 40). See also Fig. 2. As Appeal 2021-003276 Application 15/081,250 13 such, the selecting, comparing, and generating of data comprise analyses using mathematical equations and algorithms, which comprise a mental process and an abstract idea. See Elec. Power Grp., 830 F.3d at 1354 (“[W]e have treated analyzing information by steps people go through in their minds, or by mathematical algorithms, without more, as essentially mental processes”). Limitations (f) and (g) of storing and transmitting the results of the analyses are post-solution activities and “abstract as an ancillary part of such collection and analysis.” Elec. Power Grp., 830 F.3d at 1354. Outside of storing and transmitting the results of the analysis, the claim does not recite a concrete application for the therapeutic treatment. When considered collectively and under the broadest reasonable interpretation, we agree with the Examiner that the limitations of claim 8 recite a way of “optimizing medical treatment by analyzing data to generate a therapeutic recommendation.” Ans. 4. This is an abstract idea falling within USPTO guidance categories of “[c]ertain methods of organizing human activity-. . . managing personal behavior or relationships or interactions between people, (including social activities, teaching, and following rules or instructions” and “[m]ental processes-concepts performed in the human mind (including an observation, evaluation, judgment, opinion).” Guidance, 84 Fed. Reg. at 52; MPEP § 2106.04(a)(2)(II)(C), (a)(2)(III). Our reviewing courts have held similar concepts to be abstract. For example, the courts have held abstract the concepts of: “optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:” administering a drug and determining the level of a Appeal 2021-003276 Application 15/081,250 14 metabolite to indicate a need to increase or decrease the drug in Mayo, 566 U.S. at 74-75; “resolving haplotype phase” comprising receiving data, determining an inheritance state using a model and a haplotype phase, and storing and providing the phase in response to a request in In re Board of Trustees of Leland Stanford Junior Univ., 989 F.3d 1367, 1373 (Fed. Cir. 2021); collecting and analyzing data, and displaying the results in Elec. Power Grp., 830 F.3d at 1354; selecting certain information, analyzing it using mathematical techniques, and reporting or displaying the results of the analysis in SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1167 (Fed. Cir. 2018); and “a process that employs mathematical algorithms to manipulate existing information to generate additional information” in Digitech Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344, 1351 (Fed. Cir. 2014). Thus, we disagree with the Appellant’s contention that the Examiner’s characterization that the claims recite an abstract idea of a mental process and method of organizing human activity is in error, and as such, we are also not persuaded of Examiner error by the Appellant’s arguments that the claims do not recite an abstract idea because they do not recite a method of organizing human activity. Appeal Br. 10-12, see also Reply Br. 3. To the extent the Appellant argues that claim 8 does not recite an abstract idea because it recites structural elements in that “the request that triggers the generation of the therapeutic recommendation is received ‘via an application programming interface (API)’ and that the therapeutic recommendation is generated by a processor included in the application server, which is in communication with a database of clinical data” (Appeal Br. 11, 16), we note that “[c]ourts have examined claims that required the Appeal 2021-003276 Application 15/081,250 15 use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind.” Versata Dev Grp., Inc. v. SAP Am., Inc., 793 F.3d 1306, 1335 (Fed. Cir. 2015). As discussed more fully below, the use of the API and server merely limits the invention to a particular computer environment. Having concluded that claim 8 recites a judicial exception under the Guidance, Step 2A, Prong One, we next consider whether the claim recites additional elements that integrate the judicial exception into a practical application. To do so, we look to whether the claim “appl[ies], rel[ies] on, or use[s] the judicial 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,” i.e., “integrates a judicial exception into a practical application.” Guidance, 84 Fed. Reg. at 54; MPEP § 2106.04(d). We agree with and adopt the Examiner’s findings and conclusion that the additional limitations of claim 8 do not integrate the abstract idea into a practical application, as the term is used in USPTO guidance. See Final Act. 4-5; Ans. 5-7. We add the following for emphasis. Here, the only additional elements recited in the independent claims beyond the abstract idea are, as the Examiner finds, “a clinical database; an application server; an application programming interface (API); and a mobile device or a clinical endpoint” - elements that are specified at a high level of generality and are described in the Specification as known, generic computer elements. See supra, e.g., Spec. ¶ 15, Fig. 1. As is clear from the Specification, there is no indication that the operations recited in claim 8 require any specialized computer hardware or other inventive computer Appeal 2021-003276 Application 15/081,250 16 components, i.e., a particular machine, invoke any asserted inventive programming, or that the claimed invention is implemented using other than generic computer components to perform generic computer functions. See DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1256 (Fed. Cir. 2014) (“[A]fter Alice, there can remain no doubt: recitation of generic computer limitations does not make an otherwise ineligible claim patent- eligible.”); see also Ans. 5-6. The Appellant does not direct attention to, and we do not see, where the Specification provides that each component acts in an abnormal manner or outside of its ordinary capacity. The Appellant does not contend that it invented any of the claimed components or their basic functions or that those components, claimed generally, were unknown in the art as of the time of the invention. See Affinity Labs of Texas, LLC v. Amazon.com, Inc., 838 F.3d 1266, 1270 (Fed. Cir. 2016). As such, we disagree with the Appellant’s contentions that “the additional elements do not merely link the abstract idea to a particular technological environment or field of use” and “are not merely generic computer components specified at a high level of generality.” Appeal Br. 13-14. We also find no indication in the Specification that the claimed invention as recited in the claim effects a transformation or reduction of a particular article to a different state or thing. Nor do we find anything of record that attributes an improvement in technology and/or a technical field to the claimed invention or that otherwise indicates that the claimed invention integrates the abstract idea into a “practical application,” as that phrase is used in USPTO Guidance. Thus, we disagree with the Appellant’s contention “that these additional elements are sufficient to integrate the Appeal 2021-003276 Application 15/081,250 17 judicial exception into a practical application.” Appeal Br. 13; see also Reply Br. 4-5. The Appellant argues “[g]enerating the therapeutic recommendation by way of determining a specific subset of patients that match a particular patient based on both phenotype and genotype is not extra-solution activity.” Appeal Br. 13. We agree. However, generating the recommendation by making determinations is an abstract idea. See supra; Elec. Power Grp., 830 F.3d at 1354. Any improvement in the generation of a recommendation and/or determinations is an improvement to the abstract idea itself. The claim’s focus is “not a physical-realm improvement but an improvement in a wholly abstract idea,” that is not eligible for patenting. SAP Am., 898 F.3d at 1168 (Fed. Cir. 2018); see also Bridge & Post, Inc. v. Verizon Commc’ns, Inc., 778 F. App’x 882, 893 (Fed. Cir. 2019) (“Where a claim’s ‘essential advance’ is abstract, a novel method of performing that advance ‘does not avoid the problem of abstractness.’” (quoting Affinity Labs of Texas, LLC v. DIRECTV, LLC, 838 F.3d 1253, 1263 (Fed. Cir. 2016)). The benefits here “flow from performing an abstract idea in conjunction with” well-known computer structure. BSG Tech LLC v. BuySeasons, Inc., 899 F.3d 1281, 1289 (Fed. Cir. 2018). The Appellant further argues that the generating of a multi- dimensional vector and application of a clustering algorithm as recited in limitations (b1) and (b2) are “not well-understood, routine, or conventional activity.” Appeal Br. 13. The Appellant does not explain how this integrates the abstract idea into a practical application, as the term is used in USPTO guidance. Appeal 2021-003276 Application 15/081,250 18 The Appellant also argues that the claim “requires computer components to perform the analysis, as a practical matter, because of the large size of the data set.” Appeal Br. 13; see also id. at 16. However, as noted above, “[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind.” Versata, 793 F.3d at 1335. In order for the addition of a machine to impose a meaningful limit on the scope of a claim, it must play a significant part in permitting the claimed method to be performed, rather than function solely as an obvious mechanism for permitting a solution to be achieved more quickly, i.e., through the utilization of a computer for performing calculations. SiRF Tech., Inc. v. Int’l Trade Comm’n, 601 F.3d 1319, 1333 (Fed. Cir. 2010). Claim 8 does not meet this test; the computer components here function solely as a mechanism for permitting the determinations to be performed more quickly. Versata, 793 F.3d at 1335. The claim is not directed to improving computer performance, but in improving determinations for therapeutic recommendations and “merely use[s] a computer to improve the performance of that determination-not the performance of a computer” (id.) and at best, merely limits the abstract idea to a particular technological environment. See Alice, 573 U.S. at 223 (holding that attempting to limit the use of an abstract idea to a particular technological environment does not make a claim patent-eligible); Affinity Labs, 838 F.3d at 1259 (“The Supreme Court and [the Federal Circuit] have repeatedly made clear that merely limiting the field of use of the abstract idea to a particular existing technological environment does not render the Appeal 2021-003276 Application 15/081,250 19 claims any less abstract.”). The “generic steps of implementing and processing calculations with a regular computer do not change the character of claim [8] from an abstract idea into a practical application.” Board of Trustees, 991 F.3d at 1250. The Appellant attempts to draw an analogy between claim 8 and hypothetical claim 1 of Example 42 of the USPTO’s 2019 Subject Matter Eligibility Examples: Abstract Ideas (“Eligibility Examples” available at https://www.uspto.gov/sites/default/files/documents/101_examples_37to42_ 20190107.pdf) as supporting its position. Appeal Br.14-15; see also Reply Br. 4-5. Yet, we can find no parallel between hypothetical claim 1 of Example 42 and pending claim 8 here at issue. Hypothetical claim 1 of Example 42 was deemed patent eligible because it provided “a specific improvement over prior systems by allowing remote users to share information in real time in a standardized format regardless of the format in which the information was originally input.” Eligibility Examples 18-19. Hypothetical claim 1, thus, addressed technological difficulties related to incompatible computer formats, disparate geographic locations, and the untimely sharing of information. See id. at 17. The Appellant has not demonstrated that claim 8 provides a comparable technological improvement. See Ans. 6-7. Regarding dependent claims 2, 9, and 16, the Appellant argues “automatically obtaining pre-authorization for a recommended treatment, as provided as a function of a claims processing system connected to the application server, are additional elements to the claim that transform the alleged abstract idea into a practical application of the abstract idea” because they “improve the efficiency of administering an insurance product without Appeal 2021-003276 Application 15/081,250 20 human intervention by automatically processing therapeutic recommendations identified by the application server as being effective based on genotype and phenotype of the patient prior to the treatment being ordered by a physician or other primary care provider.” Appeal Br. 16. Obtaining pre-authorization is not an additional element, but an abstract idea itself of collecting information and part of the abstract idea as a whole. Further, “improv[ing] the efficiency of administrating an insurance product without human intervention” (Appeal Br. 16) is not an improvement to the computer system/server itself, but to the abstract idea itself and/or the financial field of insurance products. Thus, we are not persuaded of error in the Examiner’s determination that the claims are directed to an abstract idea. Step Two of the Mayo/Alice Framework Under the second step in the Mayo/Alice framework and USTPO guidance Step 2B, we “[e]valuat[e] additional elements to determine whether they amount to an inventive concept [which] requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” MPEP § 2106.05(I). Here, the Examiner finds that, considering the claimed limitations individually and as an ordered combination, claim 8 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. See Final Act. 5-6; Ans. 7-8. We agree with and adopt the Examiner’s findings and conclusions. We add the following for emphasis. The Appellant contends that claim 8 “recite[s] significantly more than the judicial exception” because “[t]he specific algorithms for identifying the Appeal 2021-003276 Application 15/081,250 21 therapeutic recommendation set forth in claim [8] are not ‘functions that are well-understood, routine, and conventional activities previously known to the pertinent industry.’” Appeal Br. 15; see also id. at 16; Reply Br. 5-6. Specifically, the Appellant argues “the specific application of the clustering algorithm to identify patients having phenotypes that match the particular patient, followed by selecting a subset of patients having matching genotype information, is not well-understood, routine, and conventional.” Appeal Br. 16. However, the algorithms to which the Appellant refers are abstract themselves and part of the abstract idea as a whole; thus, they are not additional elements to transform the nature of the claim into a patent-eligible invention. Alice, 573 U.S. at 217; see also Mayo, 566 U.S. at 72-73 (requiring that “a process that focuses upon the use of a natural law also contain other elements or a combination of elements, sometimes referred to as an ‘inventive concept,’ sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself”). In other words, the inventive concept under Step Two of the Mayo/Alice framework cannot be the abstract idea itself: “It is clear from Mayo that the ‘inventive concept’ cannot be the abstract idea itself, and Berkheimer [v. HP Inc., 881 F.3d 1360 (Fed. Cir. 2018) (“Berkheimer”)] . . . leave[s] untouched the numerous cases from this court which have held claims ineligible because the only alleged ‘inventive concept’ is the abstract idea.” Berkheimer v. HP, Inc., 890 F.3d 1369, 1374 (Fed. Cir. 2018) (Order, On Petition for rehearing en banc, May 31, 2018) (Moore, J., concurring) (Berkheimer II); see also BSG Tech, 899 F.3d at 1290 (“It has been clear since Alice that a claimed invention’s use of the ineligible concept to which Appeal 2021-003276 Application 15/081,250 22 it is directed cannot supply the inventive concept that renders the invention ‘significantly more’ than that ineligible concept.”). To the extent the Appellant argues that the limitations are not well- understood, routine, and conventional because they are not shown in the prior art (see Appeal Br. 16; Reply Br. 5 (“the Examiner has withdrawn any rejections of the claims under 35 U.S.C. § 103 in response to these features being added to the claims, which suggests that such functions are not well- understood, routine, or conventional”)), we note that an abstract idea does not transform into an inventive concept just because the prior art does not disclose or suggest it. See Mayo, 566 U.S. at 78. “Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry.” Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 591 (2013). Indeed, “[t]he ‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter.” Diehr, 450 U.S. at 188-89; see also Mayo, 566 U.S. at 91 (rejecting “the Government’s invitation to substitute §§ 102, 103, and 112 inquiries for the better established inquiry under § 101”); Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 716 (“That some of the eleven steps were not previously employed in this art is not enough- standing alone-to confer patent eligibility upon the claims at issue.”). Taking the claimed elements separately, the functions performed by the claimed system including the processor are purely conventional. The claimed generic components operate in their ordinary and conventional capacities to perform the well-understood, routine, and conventional functions of receiving data, determining data, and storing and presenting the Appeal 2021-003276 Application 15/081,250 23 results of the analysis. See supra, e.g., Spec. ¶ 15, Fig. 1 (describing generic computer components); see also, e.g., Elec. Power Grp., 830 F.3d at 1355 (gathering, sending, monitoring, analyzing, selecting, and presenting information does not transform the abstract process into a patent-eligible invention); Alice, 573 U.S. at 226 (“Nearly every computer will include a ‘communications controller’ and ‘data storage unit’ capable of performing the basic calculation, storage, and transmission functions required by the method claims.”), Board of Trustees, 991 F.3d at 1252 (“the recited steps of receiving, extracting, and storing data amount to well-known, routine, and conventional steps when executing a mathematical algorithm on a regular computer”). Considered as an ordered combination, the components of the Appellant’s claim add nothing that is not already present when the steps are considered separately. The sequence of receiving data, determining data, storing and presenting the results of the analysis is equally generic and conventional or otherwise held to be abstract. See, e.g., Elec. Power Grp., 830 F.3d at 1354-56 (holding that the sequence of gathering, analyzing, and displaying in real-time was abstract); Board of Trustees, 991 F.3d at 1252 (holding that the “specific combination of steps . . . simply appends the abstract calculations to the well-understood, routine, and conventional steps of receiving and storing data in a computer memory and extracting a predicted haplotype” and does not transform the abstract idea into a patent- eligible invention). Thus, we are not persuaded of error in the Examiner’s determination that the additional elements of independent claim 8, considered individually Appeal 2021-003276 Application 15/081,250 24 and as an ordered combination, do not amount to significantly more than the abstract idea itself. For at least the reasons above, we sustain the Examiner’s rejection under 35 U.S.C. § 101 of claim 8 and thus also of claims 1-5, 7, 9-12, and 14-19. CONCLUSION The Examiner’s decision to reject claims 1-5, 7-12, and 14-19 is sustained. In summary: Claims Rejected 35 U.S.C. § References/ Basis Affirmed Reversed 1-5, 7-12, 14-19 101 Eligibility 1-5, 7-12, 14-19 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv) (2019). AFFIRMED