Dimitri Betses et al.Download PDFPatent Trials and Appeals BoardMar 16, 20212020004497 (P.T.A.B. Mar. 16, 2021) 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. 13/090,946 04/20/2011 Dimitri G. Betses 10309-06613 US 3571 145838 7590 03/16/2021 Patent Law Works LLP/CVS Pharmacy, Inc. 310 East 4500 South, Suite 400 Salt Lake City, UT 84107 EXAMINER PORTER, RACHEL L ART UNIT PAPER NUMBER 3626 NOTIFICATION DATE DELIVERY MODE 03/16/2021 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): docketing@patentlawworks.net patents@patentlawworks.net PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ Ex parte DIMITRI G. BETSES, SIDHARTH S. SAHNI, CHRISTOPHER L. COX, and TIMOTHY A. DUCHARME ____________________ Appeal 2020-004497 Application 13/090,946 Technology Center 3600 ____________________ Before ALLEN R. MacDONALD, CAROLYN D. THOMAS, and DAVID J. CUTITTA II, Administrative Patent Judges. MacDONALD, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1–7, 10–17, 19, and 20. Appeal Br. 5. Claims 8, 9, and 18 have been cancelled. Id. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellant refers to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies real party in interest in the present appeal is CVS Pharmacy, Inc. Appeal Br. 3. Appeal 2020-004497 Application 13/090,946 2 CLAIMED SUBJECT MATTER Claim 1 is illustrative of the claimed subject matter (emphasis and bracketed material added): 1. A method for managing medication adherence of a patient, comprising the steps of: [A.] receiving patient information comprising patient name, telephone number, and prescription information; [B.] storing the patient information in one or more databases; [C.] identifying a patient type; [D.] identifying a medication type associated with a medication therapy; [E.] identifying a probability that the patient will not adhere to the medication therapy based on a combination of the patient type and the medication type using a database including probabilities of non- adherence for combinations of patient types and medication types; and [F.] in response to the probability that the patient will not adhere to the medication therapy: [i.] identifying a first time after the patient receives the filled prescription to call the patient based on an initial efficacy of the medication therapy; [ii.] placing a first telephone call to the patient at the first time; [iii.] placing a second telephone call to the patient, using an interactive voice response system, prior to the day that the prescription is refilled; and [iv.] placing a third telephone call to the patient in the event the prescription is past due for a refill. Appeal 2020-004497 Application 13/090,946 3 REFERENCES2 The Examiner relies on the following reference: Name Reference Date Akers US 6,112,182 Aug. 29, 2000 Denenberg US 6,464,142 B1 Oct. 15, 2002 Miller US 2008/0126130 A1 May 29, 2008 Hanina US 2011/0153361 A1 June 23, 2011 REJECTIONS A. The Examiner rejects claims 1–7, 10–17, 19, and 20 under 35 U.S.C. § 101 “because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more” (Final Act. 2), i.e., the claimed invention is directed to patent-ineligible subject matter. Final Act. 2–10. We select claim 1 as representative. See 37 C.F.R. § 41.37(c)(1)(iv). Appellant does not separately argue claims 2–7, 10–17, 19, and 20. Except for our ultimate decision, we do not discuss the merits of the § 101 rejection of claims 2–7, 10–17, 19, and 20 further herein. B. The Examiner rejects claims 1–7, 10–17, 19, and 20 under 35 U.S.C. § 103(a) as being as being unpatentable over the combination of Akers, Denenberg, Hanina, and Miller. Final Act. 10–26. 2 All citations herein to patent and pre-grant publication references are by reference to the first named inventor only. Appeal 2020-004497 Application 13/090,946 4 We select claim 1 as the representative claim for this rejection. The contentions discussed herein as to claim 1 are dispositive as to this rejection. Therefore, except for our ultimate decision, we do not address the merits of the § 103(a) rejection of claims 2–7, 10–17, 19, and 20 further herein. OPINION We have reviewed the Examiner’s rejections in light of Appellant’s arguments that the Examiner has erred. We concur with the Examiner’s ultimate conclusion that claims 1–7, 10–17, 19, and 20 are not patentable. We highlight the following points. 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. Alice, 573 U.S. 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 Appeal 2020-004497 Application 13/090,946 5 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.” 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. (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.”). Appeal 2020-004497 Application 13/090,946 6 If the claim is “directed to” an abstract idea, we turn to the second part 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. B. USPTO § 101 Guidance In January 2019, the U.S. Patent and Trademark Office (USPTO) published revised guidance on the application of § 101.3 The Manual of Patent Examining Procedure (“MPEP”) now incorporates this revised guidance and subsequent updates at § 2106 (9th ed. Rev. 10.2019, rev. June 2020).4 3 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019) (“2019 Revised Guidance”). 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”). “All USPTO personnel are, as a matter of internal agency management, expected to follow the guidance.” 84 Fed. Reg. at 51; see also October 2019 Update at 1. 4 All references to the MPEP are to the Ninth Edition, Revision 10.2019 (Last Revised June 2020), unless otherwise indicated. Appeal 2020-004497 Application 13/090,946 7 Under MPEP § 2106, 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 (“Step 2A, Prong Two”).5 MPEP § 2106.04(a) and § 2106.04(d). 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 activity” in the field; 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. MPEP § 2106.05(d). C. Examiner’s § 101 Rejection - Alice/Mayo - Parts 1 and 2 C.1. 2019 Revised Guidance Step 2A – Prong One Applying the Alice/Mayo framework, the Examiner determines that claim 1 recites an abstract idea of “organizing human activity.” Final Act. 4. 5 “Examiners evaluate integration into a practical application by: (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (2) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application.” MPEP § 2106.04(d)II. Appeal 2020-004497 Application 13/090,946 8 In particular, claim(s) 1–7 and 10–12 recite: [C.] identifying a patient type; [D.] identifying a medication type associated with the medication therapy; [E.] identifying a probability that the patient will not adhere to a medication therapy based on a combination of the patient type and the medication type using a database including probabilities of non-adherence for combinations of patient types and medication types; and [F.i.] identifying a first time alter the patient receives the filled prescription to call the patient based on an initial efficacy of the medication therapy; [F.ii.] placing a first telephone call to the patient after the patient receives the filled prescription at the first time; [F.iii.] placing a second telephone call to the patient, using an interactive voice response system, prior to the day that the prescription is due for a refill; and [F.iv.] placing a third telephone call to the patient in the event the prescription is past due for a refill. Final Act. 5 (bracketed material added). C.2. 2019 Revised Guidance Step 2A – Prong Two Further applying the Alice/Mayo framework, the Examiner determines claim 1 is directed to an abstract idea. This judicial exception[] recited in the claims [is] not integrated into a practical application because the claim language does not recite any improvements to the functioning of a computer, or to any other technology or technical field (see MPEP 2106.05(a)); applying the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)); effecting a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.05(c)); or applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment see MPEP 2106.05(e). Appeal 2020-004497 Application 13/090,946 9 Final Act. 6. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional steps amount to insignificant extra-solution activity to the judicial exception (see MPEP 2106.05(g)). Final Act. 8 (emphasis added). C.3. 2019 Revised Guidance Step 2B Applying the Alice/Mayo framework, the Examiner determines: Exemplary claims 1 and 13 recite additional limitation(s), including an “interactive voice response system” (i.e. IVR) and a database. These components []are generic functions well- understood, routine and conventional components. To support the finding of the identified features being generic and conventional, the generic nature of the interactive voice response system is underscored by the applicant’s disclosure which states: “The IVR system is an automated telephone system that provides information to the patient by making a telephone call to the patient, providing a pre- recorded message, prompting the patient for information, presenting the patient with a set of options, and recording information provided by the patient. In one example, the IVR system is implemented by a Microsoft SQL Server database operating Microsoft Windows software in conjunction with a switch from Sonus Networks to initiate the telephone call to the patient, Voice XML for scripting, and software from Nuance Communications, Inc. . . .” ([Spec.] pg. 9, par 31)[.] Furthermore, the applicant’s specification describes the system database as part of the generic computer system: “The database 100 for storing the patient information may be located at the pharmacy or in a Appeal 2020-004497 Application 13/090,946 10 remote location. The database 100 may comprise a central processing unit (CPU) 102, random access memory (RAM) 104, read-only memory (ROM) 106, one or more mass data storage elements 108.” ([Spec.] pg. 5, par 19)[.] Claims 1 and 13 also recite receiving patient information comprising patient name, telephone number, and prescription information; storing the patient information in one or more databases, which are functions that are well-understood, routine and conventional activities previously known in the pertinent industry. The courts have recognized the certain 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 (See MPEP 2106.05 (d) (II)). Among these are the following features, which are recited in claims 1 and 13: Receiving or transmitting data over a network, e.g., using the Internet to gather data, [citations omitted]. Storing and retrieving information in memory [citations omitted]. Final Act. 8–10 (emphasis and formatting added; original italics omitted). D. Appellant’s § 101 Arguments & Panel’s Analysis D.1. 2019 Revised Guidance Step 2A, Prong 1 The Examiner determines that claim 1 recites an abstract idea of “organizing human activity.” Final Act. 4. As noted supra, in particular, the Examiner determines that steps C–F.iv. recite a method directed to the idea of improved patient outreach for managing medication adherence of the patient. Appellant does not dispute the Examiner’s determination. In short, the Examiner correctly determines that claim 1 recites a method directed to Appeal 2020-004497 Application 13/090,946 11 the improved patient outreach for managing medication adherence of the patient (i.e., managing personal behavior (including following rules or instructions)); and managing personal behavior is one of certain methods of organizing human activity identified in the 2019 Revised Guidance, and thus an abstract idea. MPEP § 2106.04(a). D.2. 2019 Revised Guidance Step 2A, Prong 2 Having determined that claim 1 recites an abstract idea, we now turn to whether claim 1 is directed to that abstract idea, or instead integrates the judicial exception into a practical application. D.2.a. The Examiner determines: This judicial exception[] recited in the claims [is] not integrated into a practical application because the claim language does not recite any improvements to the functioning of a computer, or to any other technology or technical field (see MPEP 2106.05(a)). Final Act. 6. D.2.b.i. In the Appeal Brief, Appellant contends: As an initial matter, the Examiner has suggested that “managing medication adherence of a patient” is an inventive concept directed to an abstract idea. [l/14/19 Office Action, p.2]. However, Appellant’s claims and supporting specification are not merely directed to managing medication adherence in the abstract, but a very real technical challenge in automated systems for scheduling customer outreach, such as pharmacy computer systems. The claimed invention uses “a combination of technology and in-person or over-the-phone interactions to provide a series of coordinated patient interventions during a patient’s continuum of care.” [Spec., para. 0014]. The technical elements are implemented through pharmacy computer systems supported by enterprise database systems [Spec., para. 0019- Appeal 2020-004497 Application 13/090,946 12 0020] and represent improvements to the functioning of those computers and technical fields. Appeal Br. 12 (emphasis added). In the present case, the claim elements from claim 1, for example: [claim 1, steps E, F.i., and F.ii. omitted] both contain additional elements and use any purportedly abstract ideas they contain in a practical application. This detailed process reflects an improvement in the functioning of pharmacy computer systems governing patient outreach. Further, the combination of identifying a probability that the patient will not adhere (using a pharmacy database) and identifying a time to call the patient based on initial efficacy corrects a problem (e.g. non-compliance) in prior patient outreach systems in a meaningful way beyond generally linking the use to a particular technological environment. These detailed claims in no way monopolize any abstract idea. In addition, other elements of the claims, for example: [claim 1, steps A, B, F.iii., and F.iv. omitted] are not “merely applying” abstract ideas, but provide a detailed technical context within the computing environment for pharmacy computer systems and related workflow. As a whole, claim 1 describes a practical application of a technology for improving patient compliance through a practical process using pharmacy computer systems. Appeal Br. 13–14 (emphasis added). D.2.b.ii. In the Reply Brief, Appellant newly contends: Example 37 in the Subject Matter Eligibility Examples includes a Claim 1 analysis that finds the claim eligible based on the combination of additional elements integrating a mental process into a practical application. [See 2019 Revised Patent Subject Matter Eligibility Guidance, Subject Matter Eligibility Examples: Abstract Ideas, pp. 1-3]. Like Appellant’s database Appeal 2020-004497 Application 13/090,946 13 and interactive voice response system, Claim 1 of Example 37 only includes generic computing components, like a graphical user interface (GUI) and processor. However, when those computing components are applied in specific method steps, a patentable practical application results. Similarly, the detailed method steps of Appellant’s independent claims integrate the general components of a database and interactive voice response system into a practical application. Reply Br. 3 (emphasis added). D.2.b.iii. Further, in the Reply Brief, Appellant further newly contends: Appellant’s database isn’t just a generic database. Appellant’s database is “a database including probabilities of non-adherence for combinations of patient types and medication types”. A database configured for specific correlations is a specific technical improvement that drives the other steps of the claimed methods. Reply Br. 3 (emphasis added). D.2.c.i. Appellant’s Appeal Brief argument is not persuasive. The search for a practical application has also been referred to as the search for a technological solution to a technological problem. See Amdocs (Isr.), Ltd. v. Openet Telecom, Inc., 841 F.3d 1288, 1300 (Fed. Cir. 2016) (“[T]his claim entails an unconventional technological solution . . . to a technological problem . . . .”). As acknowledged by Appellant, Appellant’s claim 1 is solving the problem of “improved patient outreach for managing medication adherence,” which is a personal behavior problem and not a technological problem. We do not agree with Appellant that the “improved patient outreach” is either a “technological field” or a “technological problem” or a Appeal 2020-004497 Application 13/090,946 14 “technological solution.” Rather, we determine that claim 1 is directed to the field of following patient instructions and its problems and solutions. Appellant’s argument is not persuasive. The focus of claim 1 is not on an improvement in computer- functionality, as in Enfish, but on an abstract idea that uses a computer as a tool for improved patient outreach to manage medication adherence. Enfish, LLC v. Microsoft Corp., 822 F.3d 1327 (Fed. Cir. 2016). Similarly, in Trading Technologies, the Federal Circuit agreed with the district court explanation that: The claims require a specific, structured graphical user interface paired with a prescribed functionality directly related to the graphical user interface’s structure that is addressed to and resolves a specifically identified problem in the prior state of the art. Trading Techs. Int’l, Inc. v. CQG, INC., 675 F. App’x 1001, 1004 (Fed. Cir. 2017). We do not find that here. D.2.c.ii. Appellant’s new “Example 37” Reply Brief argument is not persuasive. First, in the Reply Brief, we find no meaningful explanation of how Appellant deems “improved patient outreach” to manage medication adherence has the effect of an “improved user interface” as in Example 37 (or the effect of any other improve computer or technological functionality). Although Appellant analogizes claim 1 to the USPTO’s Example 37, we determine that any such analogy is fanciful at best. Appellant’s claimed patient outreach is simply not analogous to modifying icon placement as in Example 37. Appeal 2020-004497 Application 13/090,946 15 D.2.c.iii. Appellant’s new “database isn’t just a generic database” Reply Brief argument is not persuasive. Essentially, Appellant is arguing that the claimed database operates differently than a generic database because its data is “‘probabilities of non-adherence for combinations of patient types and medication types.’” Reply Br. 2. Particularly, Appellant asserts “[t]he specific configuration of the database both improves the operation of the method . . . [and] represents the use of a ‘particular machine’ for completing the method steps.” Id. at 3. We disagree. A specific data structure (i.e., a specific configuration of the database) may improve computer functionality. Enfish, 822 F.3d at 1339 (“[T]he self- referential table recited in the claims on appeal is a specific type of data structure designed to improve the way a computer stores and retrieves data in memory”). However, contrary to Appellant’s argument, merely storing specific data in a generic database does not yield a specific data structure. Rather, the data structure underlying the generic database remains unchanged. D.2.d. We agree with the Examiner that as to claim 1, “the claim language does not recite any improvements to the functioning of a computer, or to any other technology or technical field.” Final Act. 6. In view of Appellant’s Specification, and consistent with the Examiner’s determinations, we conclude that claim 1 covers a disclosed embodiment that does not integrate the judicial exception into a practical application. We determine claim 1 does not recite: (i) an improvement to the functioning of a computer; Appeal 2020-004497 Application 13/090,946 16 (ii) an improvement to another technology or technical field; (iii) an application of the abstract idea with, or by use of, a particular machine; (iv) a transformation or reduction of a particular article to a different state or thing; or (v) other meaningful limitations beyond generally linking the use of the abstract idea to a particular technological environment. See MPEP §§ 2106.05(a)–(c), (e)–(h). We agree with the Examiner that claim 1 is directed to a judicial exception, and does not integrate the judicial exception into a practical application. D.3. 2019 Revised Guidance Step 2B The Examiner determines that in claim 1 the additional elements perform functions that are “well-understood, routine and conventional.” Final Act. 8. Appellant contends: Even if the claims as a whole were not found to be a practical application, . . . their limitations are not well-understood, routine, conventional activity in the field. . . . [U]sing initial efficacy of specific medical therapies to schedule pharmacy outreach is not well-understood in the art. Appeal Br. 15 (emphasis added). In Appellant’s claim 1, we find only abstract improvements to patient outreach (using initial efficacy of specific medical therapies to schedule pharmacy outreach) for managing medication adherence of the patient. A claim directed to a unique and advantageous method for improved patient Appeal 2020-004497 Application 13/090,946 17 outreach is nonetheless directed to an abstract idea.6 “[U]nder the Mayo/Alice framework, a claim directed to a newly discovered law of nature (or natural phenomenon or abstract idea) cannot rely on the novelty of that discovery for the inventive concept necessary for patent eligibility.” Genetic Techs. Ltd. v. Merial L.L.C., 818 F.3d 1369, 1376 (Fed. Cir. 2016); see Diehr, 450 U.S. at 188–89. We determine that the Examiner correctly determines that in addition to the abstract idea, claim 1 recites only well-understood, routine, conventional elements/combination of elements previously known in the industry. In view of Appellant’s Specification, and consistent with the Examiner’s determinations, we determine that beyond the abstract idea, the claims do not recite: (vi) a specific limitation other than what is well-understood, routine, conventional activity in the field or unconventional steps that confine the claim to a particular useful application. See MPEP § 2106.05(d). 6 See Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709 (Fed. Cir. 2014). In that case, the patentee argued that its financial arrangement (a method of using advertising as an exchange or currency) was distinguishable from the “routine,” “long prevalent,” or “conventional” abstract idea in Alice because it was “directed to a specific method of advertising and content distribution that was previously unknown.” Id. at 714. The court rejected the patentee’s position that “abstract ideas remain patent-eligible under § 101 as long as they are new ideas, not previously well known, and not routine activity.” Id. Appeal 2020-004497 Application 13/090,946 18 E. § 103 – Claim 1 We have reviewed the Examiner’s rejections in light of Appellant’s arguments that the Examiner has erred. Appellant’s contentions we discussed are dispositive as to the rejections on appeal. Therefore, Appellant’s other contentions are not discussed in detail herein. E.1. As reproduced supra, part F.i. of claim 1 requires (emphasis added): [F.] in response to the probability that the patient will not adhere to the medication therapy: [i.] identifying a first time after the patient receives the filled prescription to call the patient based on an initial efficacy of the medication therapy; E.2. In rejecting claim 1, the Examiner finds that the “based on an initial efficacy of the medication therapy” limitation of part F.i. is taught by Miller. Miller teaches a system and method wherein a time to contact a patient who has received a patient is determined based upon initial efficacy (e.g. initial response) to the medication. (par. 114–115[).] Final Act. 15 (emphasis added). E.3. Appellant contends that the Examiner erred in rejecting claim 1 under 35 U.S.C. § 103 because: The Examiner has failed to make a prima facie case of obviousness due to a missing element in the combination of references. None of Akers, Denenberg, Hanina or Miller disclose or suggest the use of “initial efficacy” for determining an outreach time after filling a prescription. The Examiner relies on Miller for this element, where “a time to contact a patient . . . is determined based on initial efficacy (e.g. initial response).” [7/25/19 Office Action, p. 15]. However, “initial efficacy” and Appeal 2020-004497 Application 13/090,946 19 “initial response” are not equivalent. In plain meaning, efficacy is having the intended effect of the treatment. The patient responses cited by the Examiner in Miller are “potentially adverse health outcomes” or side effects of the medication, not initial efficacy. Drugs are not administered for their side effects; they are administered for the intended therapeutic effect. . . . Appellant’s specification distinguishes side effects and initial efficacy. Independent claims 1 and 13 were narrowed by amendment to be limited to “initial efficacy” rather than any other clinically relevant time. By relying on the cited portions of Miller, the Office Action does not accord proper scope to “initial efficacy” under its plain meaning or as presented in the specification. Beyond the plain meaning, “efficacy” is used in medical and pharmaceutical industries in distinct contrast with safety (e.g. potentially adverse health outcomes). Distinct meanings and management of efficacy versus safety are the basis of drug regulations under the Food & Drug Administration, where, for example, Phase I clinical trials focus on safety, while Phase II clinical trials seek to establish efficacy. One of ordinary skill in the art of managing pharmacy operations would readily understand the distinction between “initial efficacy” and the cited “potentially adverse health outcomes”. Therefore, neither Miller, nor the other cited references, disclose: identifying a first time after the patient receives the filled prescription to call the patient based on an initial efficacy of the medication therapy [Claims 1 and 13] and a prima facie case of obviousness has not been made. Appeal Br. 16–17. E.4. As articulated by the Federal Circuit, the Examiner’s burden of proving non-patentability is by a preponderance of the evidence. See In re Caveney, 761 F.2d 671, 674 (Fed. Cir. 1985) (“[P]reponderance of the Appeal 2020-004497 Application 13/090,946 20 evidence is the standard that must be met by the PTO in making rejections”). “A rejection based on section 103 clearly must rest on a factual basis[.]” In re Warner, 379 F.2d 1011, 1017 (CCPA 1967). “The Patent Office has the initial duty of supplying the factual basis for its rejection. It may not . . . resort to speculation, unfounded assumptions or hindsight reconstruction to supply deficiencies in its factual basis.” Id. We conclude the Examiner’s analysis fails to meet this standard because the rejection does not adequately explain the Examiner’s findings of fact. E.5. We agree with Appellant that the meaning of the term “efficacy” as used in claim 1 precludes the Examiner’s “adverse outcome” based claim interpretation. Ans. 32. Appellant’s use of the term “efficacy” is consistent with Dictionary.com,7 which states that the term “efficacy” means: 1) capacity for producing a desired result or effect; effectiveness. 2) the quality of being successful in producing an intended result; effectiveness. Contrary to the Examiner’s finding, we conclude that an artisan would understand the term “efficacy” to require a “desired result” or an “intended result.” We conclude, consistent with Appellant’s argument, that there is currently insufficient articulated reasoning to support the Examiner’s finding 7 Dictionary.com, https://www.dictionary.com/browse/efficacy#. The Random House Dictionary of the English Language (2nd Ed. Unabridged; 1987); and Collins English Dictionary - Complete & Unabridged 2012 Digital Edition © William Collins Sons & Co. Ltd. 1979, 1986 © HarperCollins Publishers 1998, 2000, 2003, 2005, 2006, 2007, 2009, 2012 (Accessed March 5, 2021). Appeal 2020-004497 Application 13/090,946 21 that Miller (in combination with Akers, Denenberg, and Hanina) teaches, suggests, or otherwise renders obvious part F.i. as required by claim 1. Therefore, we conclude that there is insufficient articulated reasoning to support the Examiner’s final conclusion that claim 1 would have been obvious to one of ordinary skill in the art at the time of Appellant’s invention. CONCLUSION The Examiner has not erred in rejecting claims 1–7, 10–17, 19, and 20 under 35 U.S.C. § 101, as being directed to patent-ineligible subject matter. Appellant has shown that the Examiner erred in rejecting claims 1–7, 10–17, 19, and 20 as being unpatentable under 35 U.S.C. § 103(a). The Examiner’s rejection of claims 1–7, 10–17, 19, and 20 under 35 U.S.C. § 101, as being directed to patent-ineligible subject matter, is affirmed. The Examiner’s rejection of claims 1–7, 10–17, 19, and 20 as being unpatentable under 35 U.S.C. § 103(a) is reversed. Because at least one rejection encompassing all claims on appeal is affirmed, the decision of the Examiner is affirmed. Appeal 2020-004497 Application 13/090,946 22 DECISION SUMMARY In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–7, 10–17, 19, 20 101 Eligibility 1–7, 10– 17, 19, 20 1–7, 10–17, 19, 20 103(a) Akers, Denenberg, Hanina, Miller 1–7, 10– 17, 19, 20 Overall Outcome 1–7, 10– 17, 19, 20 TIME PERIOD FOR RESPONSE 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