Keeling, Peter et al.Download PDFPatent Trials and Appeals BoardMar 31, 202011517591 - (D) (P.T.A.B. Mar. 31, 2020) Copy Citation 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. 11/517,591 09/08/2006 Peter Keeling 100376-0102 9862 22428 7590 03/31/2020 FOLEY & LARDNER LLP 3000 K STREET N.W. SUITE 600 WASHINGTON, DC 20007-5109 EXAMINER MISIASZEK, AMBER ALTSCHUL ART UNIT PAPER NUMBER 3624 NOTIFICATION DATE DELIVERY MODE 03/31/2020 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): ipdocketing@foley.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte PETER KEELING and DAVE SMART ____________ Appeal 2019-000123 Application 11/517,591 Technology Center 3600 ____________ Before BIBHU R. MOHANTY, AMEE A. SHAH, and MATTHEW S. MEYERS, Administrative Patent Judges. MEYERS, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s Final Rejection of claims 52–57, 61–67, 70–75, and 79–82, which constitute all the claims pending in this application. Claims 1–51, 58–60, 68, 69, and 76–78 have been cancelled. We have jurisdiction under 35 U.S.C. § 6(b). 1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Our decision references Appellant’s Appeal Brief (“Appeal Br.,” filed February 23, 2018) and Reply Brief (“Reply Br.,” filed October 2, 2018), and the Examiner’s Answer (“Ans.,” mailed August 3, 2018) and Final Office Action (“Final Act.,” mailed March 9, 2017). Appellant identifies the real party in interest as “Diaceutics” (Appeal Br. 3). Appeal 2019-000123 Application 11/517,591 2 We AFFIRM. CLAIMED INVENTION Appellant’s claims relate to “a method and system for developing a personali[z]ed medicine business plan.” Spec. 1, ll. 6–7. Claims 52, 67, 70, and 71 are the independent claims on appeal. Claim 52, reproduced below, is illustrative of the claimed subject matter: 52. A method for developing a personalized medicine business plan for adopting a diagnostic and therapy combination, the method comprising: (a) calculating a data set of variables associated with a personalized medicine business plan, wherein the variables comprise personalized medicine revenue driver values, and wherein the personalized medicine revenue driver values comprise: A. the number of patients placed on the therapy; B. the potential market size for the therapy from an indication of the number of patients that could be placed on the therapy and an allocated value for each patient; C. the uptake of the diagnostic; D. a correction of the potential market of the combined therapy and diagnostic in accordance with the uptake of the combination; E. the opportunity to test index; and F. the theranostic uptake increase slope, wherein the personalized medicine revenue driver values are calculated based on the precedents in a case-study archive related to a diagnostic test that aids therapy selection; (b) predicting a revenue or financial target based on the variables using a computer; (c) generating a hypothetical business scenario from the predicted revenue or financial target using a computer; (d) comparing the hypothetical business scenario to an archive of scenarios, wherein the archive of scenarios comprises Appeal 2019-000123 Application 11/517,591 3 data and calculations therefrom acquired from real-world case studies relating to the disease, patients having the disease, the therapy, the diagnostic, and/or the combination of the therapy and the diagnostic; (e) identifying a scenario from the archive of scenarios that most closely matches the hypothetical business scenario; and (f) providing one or more guidance parameters assessing the effect of the diagnostic on the adoption of the therapy in the personalized medicine business plan. REJECTIONS 1. Claims 52–57, 61–67, 70–75, and 79–82 are rejected under 35 U.S.C. § 101 as directed to a judicial exception without significantly more. 2. Claims 52–57, 61–67, 70–75, and 79–82 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Eder (US 2005/0246314 A1, pub. Nov. 3, 2005), Macrae (US 2003/0093310 A1, pub. May 15, 2003), and Peter Keeling, MBA, Integrating Diagnostics and Therapeutics for Targeted Therapies, Part 1: Optimizing the Comarketing Plan, April 29, 2005 (“Keeling1”). ANALYSIS Patent-Ineligible Subject Matter Appellant argues claims 52–57, 61–67, 70–75, and 79–82 as a group. Appeal Br. 7–12; Reply Br. 3–4. We select independent claim 52 as representative. The remaining claims stand or fall with claim 52. See 37 C.F.R. § 41.37(c)(1)(iv). Appeal 2019-000123 Application 11/517,591 4 A. 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 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. Appeal 2019-000123 Application 11/517,591 5 252, 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.” 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. (citation 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 (quotation marks 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. Appeal 2019-000123 Application 11/517,591 6 B. USPTO Section 101 Guidance In January 2019, the U.S. Patent and Trademark Office (USPTO) published revised guidance on the application of § 101. 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019) (“2019 Revised Guidance”).2 “All USPTO personnel are, as a matter of internal agency management, expected to follow the guidance.” Id. at 51; see also October 2019 Update at 1. Under the 2019 Revised Guidance and the October 2019 Update, we first look to whether the claim recites: (1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes) (“Step 2A, Prong One”); and (2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)–(c), (e)–(h) (9th ed. Rev. 08.2017, Jan. 2018)) (“Step 2A, Prong Two”).3 2019 Revised Guidance, 84 Fed. Reg. at 52–55. 2 In response to received public comments, the Office issued further guidance on October 17, 2019, clarifying the 2019 Revised Guidance. USPTO, October 2019 Update: Subject Matter Eligibility (the “October 2019 Update”) (available at https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.p df). 3 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 2019 Revised Guidance - Section III(A)(2), 84 Fed. Reg. 54–55. Appeal 2019-000123 Application 11/517,591 7 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 claim: (3) adds a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field (see MPEP § 2106.05(d)); or (4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. 2019 Revised Guidance, 84 Fed. Reg. at 52–56. Step One of the Mayo/Alice Framework With regard to the first step of the Mayo/Alice framework and Step 2A, Prong One of the 2019 Revised Guidelines, 84 Fed. Reg. at 54, the Examiner determines that exemplary independent claim 52 broadly recites “developing a personalized medicine business plan.” Final Act. 4; Ans. 3. More particularly, the Examiner states that the limitations of independent claim 52 “are directed to developing a personalized business plan by calculating the variables associated with the personalized business plan, predicting revenue, comparing the hypothetical business scenario to an archive of scenarios in order to provide the guidance parameters as described in the [S]pecification.” Final Act. 5. The Examiner considers this to be an abstract idea, inasmuch as the claimed concept is “similar to that of organizing information through mathematical correlations, which is one of the concepts found by the courts to be an abstract idea.” Id. In response, Appellant argues that independent claim 52 is not directed to an abstract idea because the “claims account for considerably Appeal 2019-000123 Application 11/517,591 8 more than ‘calculating, comparing and providing steps.’” Appeal Br. 8. According to Appellant, the Examiner erred in oversimplifying the steps recited in independent claim 52 without considering the claims as a whole. Id. We are not persuaded that the Examiner erred in determining that independent claim 52 is directed to an 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 claims 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 Specification (including the claim language) that the claims focus on an abstract idea, and not on any improvement to technology and/or a technical field. The Specification is entitled “Method and System for Developing a Personalised Medicine Business Plan” (emphasis omitted), and states that the disclosure “relates to a method and system for developing a personali[z]ed business plan.” Spec. 1, ll. 6–7. According to the Specification, “[p]ersonali[z]ed medicine refers to the use of a test (or diagnostic) to target a drug (or therapy) at patients that are most likely to benefit therefrom, or to identify patients who may be at risk of harm from said therapy.” Id. at 1, ll. 11–13. The Specification discloses that “a personali[z]ed medicine business model requires interdisciplinary Appeal 2019-000123 Application 11/517,591 9 collaboration between the traditionally separate diagnostics and pharmaceutical industries” (id. at 2, ll. 20–22), and further describes that “the logistic and commercial challenges of co-marketing of a diagnostic with a therapy mean that pharmaceutical companies must seriously consider whether a personali[z]ed medicine business model will provide sufficient commercial return to justify a change from their traditional blockbuster model.” Id. at 3, ll. 2–6. The Specification notes, however, that “in view of the relatively recent emergence of personali[z]ed medicine, there is a lack of precedents for assessing such models” (id. at 3, ll. 6–8), and indicates that the lack of precedents “makes it difficult for decision makers to estimate the return on investment (ROI) from a personali[z]ed medicine business plan.” Id. at 3, ll. 8–10. To address these drawbacks, the present invention provides a “hybrid predictive-modelling case-based reasoning approach for predicting revenue from a personalized medicine business plan and validating the same.” Id. at 11, ll. 29–12, ll. 1. Consistent with this disclosure, independent claim 52 recites a method comprising steps for: (1) calculating variables comprising revenue driver values and predicting a revenue or financial target based on the calculated variables, i.e., “calculating a data set of variables” and “predicting a review of financial target” (steps (a), (b)); (2) generating a hypothetical business scenario, comparing the hypothetical business scenario to archived scenarios, and identifying an archived scenario that most closely matches the hypothetical business scenario, i.e., “generating a hypothetical business scenario,” “comparing the hypothetical business scenario to an archive of scenarios,” and “identifying a scenario from the archive of scenarios” (steps Appeal 2019-000123 Application 11/517,591 10 (c)–(e)); and (3) providing guidance parameters for assessing the effect of the diagnostic on the adoption of the therapy, i.e., “providing one or more guidance parameters” (step (f)). Upon reviewing the Specification and independent claim 52, as summarized above, we agree with the Examiner that independent claim 52 recites broadly a series of steps for “developing a personalized medicine business plan.” (Final Act. 4), which can be characterized as a certain method of organizing human activity. Here, independent claim 52 predicts a revenue target based on calculated personalized medicine revenue driver values (steps (a), (b)), identifies an archived scenario by generating a hypothetical business scenario and comparing the hypothetical business scenario to archived scenarios (steps (c)–(e)), and then provides assessment parameters (step (f)). In other words, claim 52 broadly recites a method for developing a personalized medicine plan by calculating, predicting, generating, comparing, identifying, and providing medicine business plan information. Thus, it is clear that independent claim 52 recites a form of commercial interaction that, under the 2019 Revised Guidance, falls under the category of “[c]ertain methods of organizing human activity” and more specifically “commercial or legal interactions (including agreements in the form of . . . sales activities or behaviors; business relations).” 2019 Revised Guidance, 84 Fed. Reg. at 52. Accordingly, independent claim 52 recites an abstract idea. Cf. Univ. of Fla. Research Found., Inc. v. Gen. Elec. Co., 916 F.3d 1363, 1366–68 (Fed. Cir. 2019) (claim for standardizing data to be conveyed to a bedside device for graphical display was directed to the abstract idea of “collecting, analyzing, manipulating, and displaying data”); Appeal 2019-000123 Application 11/517,591 11 Intellectual Ventures I LLC v. Capital One Fin. Corp., 850 F.3d 1332, 1339– 40 (Fed. Cir. 2017) (claim for manipulating XML documents by organizing, identifying, mapping, defining, and modifying data was directed to the abstract idea of “collecting, displaying, and manipulating data”); and Electric Power Grp., LLC v. Alstom S.A., 830 F.3d 1350, 1351–54 (Fed. Cir. 2016) (claim for detecting events by receiving, detecting, analyzing, displaying, accumulating, and updating data, and deriving a composite indicator from that data was directed to the abstract idea of “collecting information, analyzing it, and displaying certain results of the collection and analysis”). Having concluded that claim 52 recites a judicial exception, i.e., an abstract idea, we turn to the Step 2A, Prong Two of the 2019 Revised Guidance and determine whether the claim integrates the recited judicial exception into a practical application of the judicial exception. Here we look to see if, for example, any additional elements of the claim (i) reflect an improvement in the functioning of a computer or to another technological field, (ii) implement the judicial exception with, or by use of, a particular machine, (iii) effect a transformation or reduction of a particular article to a different state or thing, or (iv) use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment. See 2019 Revised Guidance, 84 Fed. Reg. at 55; see also MPEP §§ 2106.05(a)–(c), (e)–(h). Here, the only additional element recited in claim 52 beyond the abstract idea is “a computer,” which is limited to the “predicting” and “generating” steps. However, the additional element is described generically in the Specification (see, e.g., Spec. 27, ll. 12–15). We find no indication in Appeal 2019-000123 Application 11/517,591 12 the Specification, nor does Appellant direct us to any indication, that the steps recited in claim 52 invoke any assertedly inventive programming, require any specialized computer hardware or other inventive computer components, i.e., a particular machine, 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.”). We also find no indication in the Specification that the claimed invention 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 computer technology and/or functionality 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 the 2019 Revised Guidance.4 Appellant argues that independent claim 52 solves a specific technological problem. Appeal Br. 8–10. Appellant attributes this purported technical improvement as enabling “pharmaceutical companies to optimize the net present value of a targeted therapeutic by indicating how to most 4 The 2019 Revised Guidance references MPEP § 2106.05(a)–(c) and (e) in describing the considerations that are indicative that an additional element or combination of elements integrates the judicial exception, e.g., the abstract idea, into a practical application. 2019 Revised Guidance, 84 Fed. Reg. at 55. If the recited judicial exception is integrated into a practical application, as determined under one or more of these MPEP sections, the claim is not “directed to” the judicial exception. Appeal 2019-000123 Application 11/517,591 13 efficiently allocate resources in a specific situation,” and as such, addresses a technical problem in the industry by “coordinating the co-marketing of a therapeutic and companion diagnostic.” Id. 9–10. Appellant’s argument is not persuasive. Here, the focus of independent claim 52 is not on any technological advancement, but rather on the implementation of the abstract idea, “for which computers are invoked merely as a tool.” See Enfish, 822 F.3d at 1336. In this regard, the Specification merely discloses that Software, web, and computer readable data storage implementations of the various embodiments and method steps described herein can be accomplished with methods known in the art including programming techniques with rule based logic and other logic. Spec. 27, ll. 12–15. Independent claim 52, unlike the claims found non-abstract in prior cases, uses generic computer technology to predict a revenue or financial target and generate a hypothetical business scenario, and does not recite an improvement to a particular computer technology. See McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314–15 (Fed. Cir. 2016) (finding claims not abstract because they “focused on a specific asserted improvement in computer animation”). Appellant also argues that the present claims are patent eligible in view of Trading Technologies Int’l, Inc. v. CQG, Inc., 675 F. App’x 1001 (Fed. Cir. 2017) because the “claimed method addresses this particular technical problem in this specific industry.” Appeal Br. 10. We disagree. In Trading Technologies, the district court found that the claimed devices “have no ‘pre-electronic trading analog,’” and “do not simply claim displaying information on a graphical user interface.” 675 Fed. App’x at Appeal 2019-000123 Application 11/517,591 14 1004. The court concluded “the claimed subject matter is ‘directed to a specific improvement to the way computers operate,’ . . . for the claimed graphical user interface method imparts a specific functionality to a trading system ‘directed to a specific implementation of a solution to a problem in the software arts.’” Id. at 1006. We distinguish the claims before us from those in Trading Technologies, because, unlike in Trading Technologies, independent claim 52 merely ultizes a generic and conventional “computer.” Spec. 27, ll. 12–15. Independent claim 52 does not overcome a problem associated with prior art computers or improve the way computers operate. Instead, independent claim 52 simply addresses a business problem related to “coordinating the co-marketing of a therapeutic and companion diagnostic.” Appeal Br. 10. Based on the above, we conclude that independent claim 52 recites a method of organizing human activity, i.e., an abstract idea, and that the additional elements recited in the claim are no more than generic components used as tools to perform the recited abstract idea. As such, they do not integrate the abstract idea into a practical application. See Alice Corp., 573 U.S. at 223–24 (“[W]holly generic computer implementation is not generally the sort of ‘additional featur[e]’ that provides any ‘practical assurance that the process is more than a drafting effort designed to monopolize the [abstract idea] itself.’”) (alterations in original) (quoting Mayo, 566 U.S. at 77). Accordingly, we agree with the Examiner that independent claim 52 is directed to an abstract idea. Having determined under step one of the Mayo/Alice framework that claim 52 is directed to an abstract idea, we next consider under Step 2B of the 2019 Revised Guidance, the second step of the Mayo/Alice framework, Appeal 2019-000123 Application 11/517,591 15 whether claim 52 includes additional elements or a combination of elements that provides an “inventive concept,” i.e., whether the additional elements amount to “significantly more” than the judicial exception itself. 2019 Revised Guidance, 84 Fed. Reg. at 56. Appellant argues that the Examiner has failed to “show that the pending claims are ‘well understood, routing or conventional’ as required by Berkheimer v. HP Inc., 881 F.3d 1360 (Fed. Cir. 2018) and Aatrix Software, Inc. v. Green Shades Software, Inc., 882 F.3d 1121 (Fed. Cir. 2018). Reply Br. 3–4. However, “the relevant inquiry is not whether the claimed invention as a whole is unconventional or non-routine.” BSG Tech LLC v. BuySeasons, Inc., 899 F.3d 1281, 1290 (Fed. Cir. 2018). Instead, the question is whether the claim includes additional elements, i.e., elements other than the abstract idea itself, that “‘transform the nature of the claim’ into a patent-eligible application.” Alice Corp., 573 U.S. at 217 (quoting Mayo, 566 U.S. at 79, 78). Here, the Examiner determines that the additional limitations of claim 52 “include a computer system.” Ans. 5. The Examiner further determines that the additional elements “are merely generic computing elements performing generic computing functions as described in the [S]pecification,” and as such, do not “amount[]to ‘significantly more’ than the abstract idea. Id. We agree with the Examiner that the steps performed by the “computer” of independent claim 52 are well-understood, routine, or conventional. As discussed above, there is nothing in the Specification to indicate that the steps recited in claim 52 require any specialized hardware or inventive computer components or that the claimed invention is Appeal 2019-000123 Application 11/517,591 16 implemented using anything other than a generic computer to perform generic computer functions, e.g., predicting and generating. Viewed as a whole, independent claim 52 simply recites a series of steps instructing how to predict revenue, identify a matching scenario, and provide guidance parameters. See Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 716 (Fed. Cir. 2014) (“[T]he claimed sequence of steps comprises only ‘conventional steps, specified at a high level of generality,’ which is insufficient to supply an ‘inventive concept.’”) (Citing Alice, 134 S. Ct. at 2357). Here, independent claim 52 does not, for example, purport to improve the functioning of the computer itself. Nor does it effect an improvement in any other technology or technical field, as discussed above with respect to Prong Two of Step 2A. Instead, independent claim 52 amounts to nothing significantly more than an instruction to apply the abstract idea using a generic computer , which under our precedents, is not enough to transform an abstract idea into a patent-eligible invention. See Alice, 134 S. Ct. at 2360. We also are not persuaded by Appellant’s argument that “it is inaccurate to state that the functions being performed are ‘generic’” (Appeal Br. 11) or that “[t]he Examiner has failed to make any supporting citation or take official notice” that the recited steps are well-understood, routine, and conventional in the field. Reply Br. 3–4. At the outset, we note that the Federal Circuit, in accordance with Alice, has “repeatedly recognized the absence of a genuine dispute as to eligibility” where claims have been defended as involving an inventive concept based “merely on the idea of using existing computers or the Internet to carry out conventional processes, with no alteration of computer functionality.” Berkheimer, 890 F.3d at 1373 Appeal 2019-000123 Application 11/517,591 17 (Moore, J., concurring); see also BSG Tech, 899 F.3d at 1291 (“BSG Tech does not argue that other, non-abstract features of the claimed inventions, alone or in combination, are not well-understood, routine and conventional database structures and activities. Accordingly, the district court did not err in determining that the asserted claims lack an inventive concept.”). Moreover, as discussed in greater detail above, there is no indication in the record that the “computer” requires any specialized computer hardware or that it requires any programming atypical from conventional programming. Instead, the Specification discloses utilizing a conventional computer (see, e.g., Spec. 27, ll. 12–15). See Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, (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.”). We are similarly unpersuaded by Appellant’s argument that the present claims are similar to the patent-eligible claims in McRO because “[t]he claims provide specific rules and inputs that create a desired result” Appeal Br. 12. We cannot agree. In McRO, the Federal Circuit premised its determination that the claims were patent-eligible, not merely on the specificity of the claimed animation scheme, but rather on the fact that the claims, when considered as a whole, were directed to a technological improvement over the existing, manual 3-D animation techniques and used limited rules in a process specifically designed to achieve an improved technological result in conventional industry practice. We are not persuaded that a comparable situation is presented here. As our reviewing court has made clear, “relying Appeal 2019-000123 Application 11/517,591 18 on a computer to perform routine tasks more quickly or more accurately is insufficient to render a claim patent eligible.” OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363 (Fed. Cir. 2015). We further note that there is a fundamental difference between technological or computer functionality improvements, on the one hand, and uses of existing computers as tools to perform a particular task, on the other. Here, the Specification discloses that “implementations of the various embodiments and method steps described herein can be accomplished with methods known in the art including programming techniques with rule based logic and other logic.” Spec. 27, ll. 12–15. Indeed, the Federal Circuit applied this distinction in Enfish, 822 F.3d at 1335–36 in rejecting a § 101 challenge at the step one stage of the Mayo/Alice analysis because the claims at issue focused on a specific type of data structure, i.e., a self-referential table for a computer database, designed to improve the way a computer carries out its basic functions of storing and retrieving data, and not on asserted advances in uses to which existing computer capabilities could be put. Id. Finally, Appellant argues that the present claims “are related specifically to personalized medicine” and “do not preempt processes outside of this field.” Appeal Br. 12. Appellant’s preemption argument does not, however, alter our § 101 analysis. Preemption concerns are fully addressed and made moot where a patent’s claims are deemed to disclose patent ineligible subject matter under the two-part framework described in Mayo and Alice. Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1379 (Fed. Cir. 2015). “While preemption may signal patent ineligible Appeal 2019-000123 Application 11/517,591 19 matter, the absence of complete preemption does not demonstrate patent eligibility.” Id. Appellant’s other arguments, including those directed to now- superseded USPTO guidance, have been considered but are not persuasive of error. (See 2019 Revised Guidance, 84 Fed. Reg. at 51 (“Eligibility- related guidance issued prior to the Ninth Edition, R-08.2017, of the MPEP (published Jan. 2018) should not be relied upon.”))). We are not persuaded, on the present record, that the Examiner erred in rejecting independent claim 52 under 35 U.S.C. § 101. Therefore, we sustain the Examiner’s rejection of independent claim 52, and claims 53–57, 61–67, 70–75, and 79–82, which fall with independent claim 52. Obviousness We are persuaded by Appellant’s argument that the Examiner erred in rejecting independent claims 52, 67, 70, and 71 under 35 U.S.C. § 103(a) because Keeling1, upon which the Examiner relies, fails to disclose or suggest “calculating a data set of variables associated with a personalized medicine business plan, wherein the variables comprise personalized medicine revenue driver values, and wherein the personalized medicine revenue driver values comprise: the theranostic uptake increase slope,” as recited by limitation (a)(F) of independent claim 52, and similarly recited by independent claims 67, 70, and 71. Appeal Br. 12–14; Reply Br. 5–6. The Examiner maintains that the rejection is proper, and cites Keeling1, as disclosing “[t]he calculation steps.” Ans. 9 (citing Keeling1, 3- 2–3-13); Final Act. 9 (citing Keeling1, 3-9–3-13). However, we agree with Appeal 2019-000123 Application 11/517,591 20 Appellant that there is nothing in the cited portions that discloses or suggests the argued limitation. In making this determination, we note that Keeling1 is directed to the “comarketing of diagnostics and therapeutics.” Keeling1, 3-1. Keeling1 discloses the emergence of “theranostics (combined diagnostics and therapy) and personalized medicine (targeted therapy)”. Id. at 3-2. For example, Keeling1 describes that “a combined test-and-treatment approach to a medical condition is likely to elevate the market share of such a drug.” Id. at 3-8–3-9. Keeling1 further describes that by enabling joint marketing and avoiding “the expensive need to build separate diagnostic brand equity, pharmaceutical companies should ask their diagnostic partners to orient their marketing spend toward the brand objectives of the therapy.” Id. at 3-10. Keeling1 notes, however, that “resistance to the diagnosing process will hinder the uptake of the drug – from creating a delay in prescribing to causing a bottleneck in disease management” (id.), and asserts that “[a] joint budget can allocate resources toward total market development (in particular, to diagnosis or monitoring bottlenecks), not only to uptake of the therapy.” Id. at 3-12. We have reviewed the cited portions of Keeling1 and agree with Appellant that none of the cited portions of Keeling1, alone or in combination, discloses or suggests the argued limitation. Instead, we agree with Appellant that, although Keeling1 generally discloses co-marketing of therapeutics and diagnostics, Keeling1 “does not teach or suggest the limitations of . . . how to calculate uptake increase slope,” as required by limitation (a)(F) of independent claim 52, and similarly required by independent claims 67, 70, and 71. Appeal Br. 13; Reply Br. 5. We further Appeal 2019-000123 Application 11/517,591 21 agree with Appellant that Keeling1 does not “teach any of the expressly recited variables that one would use in the calculation of” the theranostic uptake increase slope, as defined by the Specification. Appeal Br. 14. In responding to Appellant’s arguments, the Examiner broadly takes the position that the “calculation steps claimed are part of business analyses and marketing research covered by Keeling1 in developing a business plan for personalized medicine, and are taught by Keeling1 and further outlined in Table 1 and the corresponding scenarios described in Keeling 1 at pages 3-7 and 3-8.” Ans. 9. Although we agree with the Examiner that Keeling1 broadly discloses developing a business plan for personalized medicine based on business and marketing analyses (id.), we cannot agree with the Examiner that Keeling1 discloses “calculating . . . the theranostic uptake increase slope,”as required by independent claim 52. In this regard, we note that the Specification defines calculating an uptake increase slope of the theranostic by combining a calculated diagnostic uptake increase slope (%/yr) with user inputs of a diagnostic launch year, a diagnostic uptake start value (%), and a maximum level of diagnostic uptake. Spec. 21, ll. 4–8. Although Keeling1 generally discusses drug and therapy uptake, Keeling1 does not disclose “calculating . . . the theranostic uptake increase slope,” under a broadest reasonable interpretation consistent with Appellant’s Specification. Specifically, Keeling1 discloses therapy uptake, in general terms, without disclosing a theranostic uptake increase slope calculation or describing any of the relevant calculation inputs identified in the Specification. In view of the foregoing, we do not sustain the Examiner’s rejection of independent claims 52, 67, 70, and 71 under 35 U.S.C. § 103(a). For the Appeal 2019-000123 Application 11/517,591 22 same reasons, we also do not sustain the Examiner’s rejection of dependent claims 53–57, 61–66, 72–75, and 79–82, which are not argued separately. CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 52–57, 61– 67, 70–75, 79–82 101 Eligibility 52–57, 61– 67, 70–75, 79–82 52–57, 61– 67, 70–75, 79–82 103 Eder, Macrae, Keeling1 52–57, 61–67, 70–75, 79–82 Overall Outcome 52–57, 61– 67, 70–75, 79–82 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation