Billye Guthrie et al.Download PDFPatent Trials and Appeals BoardJan 3, 202014169251 - (D) (P.T.A.B. Jan. 3, 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. 14/169,251 01/31/2014 Billye Guthrie JR. 005618.P11803 6209 45215 7590 01/03/2020 WOMBLE BOND DICKINSON (US) LLP/ABBOTT CARDIOVASCUL Attn: IP Docketing P.O. Box 7037 Atlanta, GA 30357-0037 EXAMINER NG, JONATHAN K ART UNIT PAPER NUMBER 3686 NOTIFICATION DATE DELIVERY MODE 01/03/2020 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): FIP_Group@bstz.com PTO.MAIL@BSTZ.COM PTO.MAIL@BSTZPTO.COM PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte BILLYE GUTHRIE JR., JOHN W. CREECH, LESLIE ORNELAS, DANA HAUDEK, and CHRISTOPHER LEWIS Appeal 2018-006893 Application 14/169,251 Technology Center 3600 Before MAHSHID D. SAADAT, MATTHEW J. McNEILL, and JASON M. REPKO, Administrative Patent Judges. REPKO, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Under 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1, 2, 4–8, 11, 13, 15, and 17. 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(a). Appellant identifies the real party in interest as Abbott Cardiovascular Systems, Inc., 3200 Lakeside Drive, Santa Clara, California 95054. Appeal Br. 3. Appeal 2018-006893 Application 14/169,251 2 CLAIMED SUBJECT MATTER The invention relates to monitoring data during medical investigations or procedures. Spec. ¶ 2. Claims 1, 8, and 17 are independent. Claim 1 is reproduced below. 1. A system for risk-based monitoring of a clinical trial, comprising: a plurality of on-site data input terminals including a first data input terminal at a first clinical research site and a second data input terminal at a second clinical research site, the onsite data input terminals including: respective terminal processors configured to: receive data from users, wherein the data includes clinical trial measurement values from the clinical research sites corresponding to a clinical variable, and wherein the data includes a first clinical trial measurement value for the clinical variable from the first clinical research site and a second clinical trial measurement value for the clinical variable from the second clinical research site, determine whether the data is valid, and dispatch the data in response to determining the data is valid; and an off-site data analysis server networked with the plurality of on-site data input terminals to receive the data, wherein the off-site data analysis server is remote from the plurality of on-site data input terminals, the off-site data analysis server including: a memory configured to store a data monitoring guideline identifying the clinical variable as a non-critical variable for both the first clinical research site and the second clinical research site, wherein the non-critical variable does not require on-site verification at the first clinical research site and the second clinical research site, and a processor configured to: apply a threshold rule having a probability function to the clinical trial measurement values to determine a Appeal 2018-006893 Application 14/169,251 3 probability of error of the clinical trial measurement values, determine, based on the probability of error of the first clinical trial measurement value, the first clinical trial measurement value is a validation failure exceeding a predetermined number of validation failures for the first clinical research site, modify, in response to determining the first clinical trial measurement value is the validation failure exceeding the predetermined number of validation failures for the first clinical research site, the data monitoring guideline to identify the clinical variable as a critical variable for the first clinical research site and not the second clinical research site, wherein the critical variable requires on-site verification at the first clinical research site for any treatment of the clinical trial performed at the first clinical research site, and dispatch, in response to modifying the data monitoring guideline to identify the clinical variable as the critical variable, an investigation request to cause an investigator to perform the on-site verification of the critical variable at the first clinical research site for any treatment of the clinical trial performed at the first clinical research site. Appeal Br. 21–22 (Claims App.).2 THE REJECTION The Examiner rejects claims 1, 2, 4–8, 11, 13, 15, and 17 under 35 U.S.C. § 101 as patent-ineligible subject matter. Final 2–5; Advisory 2–3. 2 Throughout this opinion, we refer to the Final Office Action (“Final”), mailed August 30, 2017; the Advisory Action (“Advisory”), mailed January 3, 2018; the Appeal Brief (“Appeal Br.”), filed February 28, 2018; the Examiner’s Answer (“Ans.”), mailed April 20, 2018; and Reply Brief (“Reply Br.”), filed June 19, 2018. Appeal 2018-006893 Application 14/169,251 4 OPINION I. Principles of Law Under § 101, patent-eligible subject matter is defined as “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” 35 U.S.C. § 101. But courts have long held that laws of nature, natural phenomena, and abstract ideas are not patentable. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 70–71 (2012) (citing Diamond v. Diehr, 450 U.S. 175, 185 (1981)). These ineligible concepts are implicit exceptions to the statutory categories. Id. at 71. The Supreme Court articulated a two-step subject-matter eligibility test in Mayo and Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014). Alice/Mayo step one asks whether a claim is “directed to” a judicial exception. Alice, 573 U.S. at 217. In Alice/Mayo step two, we consider “the elements of each claim both individually and ‘as an ordered combination’ to determine whether the additional elements ‘transform the nature of the claim’ into a patent-eligible application.” Id. (quoting Mayo, 566 U.S. at 79, 78). Step two is described as a search for an “inventive concept.” Id. The USPTO has published revised guidance on patent subject matter eligibility. 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019) (“Guidance”). Step 1 of the USPTO’s eligibility analysis asks whether the claimed subject matter falls within the four statutory categories of invention. Id. at 53–54. Under Step 2A, Prong One of the Guidance, we determine if the claim recites a judicial exception, including particular groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity, or mental processes). Id. at 52–53. If so, we then analyze the claim to determine whether the recited Appeal 2018-006893 Application 14/169,251 5 judicial exception is integrated into a practical application under Step 2A, Prong Two of the Guidance. Id. at 53–55; MPEP §§ 2106.05(a)–(c), (e)–(h) (9th ed. Rev. 08.2017, Jan. 2018). Only if the claim fails to integrate the exception and, thus, is “directed to” the judicial exception, do we then look to whether the claim adds a specific limitation beyond the judicial exception that is not “well- understood, routine, conventional activity in the field” or whether the claim simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. Guidance, 84 Fed. Reg. at 56. II. Overview of the Examiner’s Rejection and Appellant’s Arguments The Examiner determines that representative3 claim 1 is a machine under Step 1 of the USPTO’s eligibility analysis. Advisory 2. The Examiner, however, concludes that claim 1 is directed to an abstract idea. Id. According to the Examiner, the claims recite a process that analyzes data. Id. The Examiner then determines that the additional elements do not amount to significantly more than the abstract idea. Id. at 2–3. The Examiner finds that the additional elements were well-known, routine, and conventional. Id.; see also Final 4. Appellant argues that “the claims are not analogous to any established abstract idea.” Appeal Br. 15. According to Appellant, “the limitations of claim 1 do not represent merely ‘collecting . . . analyzing . . . and displaying.” Id. Rather, in Appellant’s view, the limitations “set up a sequence of events that address unique problems associated with the 3 Appellant argues all claims together. See 37 C.F.R. § 41.37(c)(1)(iv). In particular, Appellant states, “Claims 1–2, 4–8, 11, 13, 15 and 17 stand or fall together. Claim 1 is the representative claim.” Appeal Br. 14. Appeal 2018-006893 Application 14/169,251 6 changing landscape of clinical trial monitoring.” Id. (citing Spec. ¶ 6). Appellant argues that “combination of elements of the claims provide an enhanced monitoring model.” Id. at 16. III. Step 1: Does the claim fall within a statutory category of invention? Under Step 1 of the USPTO’s eligibility analysis, we agree with the Examiner’s determination that the claimed subject matter falls within one of the four statutory categories of invention because the claim recites a machine. Guidance, 84 Fed. Reg. at 53–54. Indeed, claim 1 recites a system comprising terminals and a server. Appellant does not dispute the Examiner’s determination here. See generally Appeal Br.; Reply Br. IV. Step 2A, Prong One: Does the claim recite a judicial exception? A. The Guidance We next consider whether the claim recites a judicial exception to the statutory category. Guidance, 84 Fed. Reg. at 51. “[A] claim recites a judicial exception when the judicial exception is ‘set forth’ or ‘described’ in the claim.” October 2019 Update: Subject Matter Eligibility 1 (USPTO Oct. 17, 2019), https://www.uspto.gov/sites/default/files/documents/ peg_oct_2019_update.pdf (“October 2019 Update”). The Guidance synthesizes the key concepts identified by the courts as abstract ideas into three primary subject-matter groupings: mathematical concepts, certain methods of organizing human activities, and mental processes. Guidance, 84 Fed. Reg. at 52. Under the broadest reasonable interpretation, claim 1 recites an abstract idea within the Guidance’s mental-process grouping. In the sections that follow, we explain how the claim sets forth or describes an evaluation or judgment that can practically be performed in the mind or with the assistance of pen and paper. See id. at 52 n. 14 (collecting cases). Appeal 2018-006893 Application 14/169,251 7 B. “determine whether data is valid” Claim 1 recites that the terminal processors are configured to “determine whether the data is valid.” Appeal Br. 12. As for that data, claim 1 recites, in part, the data includes clinical trial measurement values from the clinical research sites corresponding to a clinical variable, and wherein the data includes a first clinical trial measurement value for the clinical variable from the first clinical research site and a second clinical trial measurement value for the clinical variable from the second clinical research site. Id. This determination is an evaluation that can practically be performed in the human mind. For instance, the Specification discloses that data validation may involve determining whether a value is outside a range. See Spec. ¶ 41. Thus, the recited determination can practically be performed mentally by comparing a number to a range, for instance. See id. C. “apply a threshold rule” Claim 1 recites, in part, “apply a threshold rule having a probability function to the clinical trial measurement values to determine a probability of error of the clinical trial measurement values.” Appeal Br. 21. Applying a threshold rule, as recited, can practically be performed in the human mind. According to the Specification, “Threshold rules provide ranges in which a value is considered likely accurate, and ranges in which a value is considered likely inaccurate.” Spec. ¶ 34. Threshold rules can have a probability function. Id. ¶ 35. Table 1, below, is an example of a probability distribution. Id. Appeal 2018-006893 Application 14/169,251 8 Table 1, above, has two columns: systolic pressure (mmHg) and a probability of error. Id. In the table, “the probability is 1.0 for clearly erroneous values, and close to 0.0 for likely accurate values.” Id. Applying a threshold rule having a probability function, as recited, can practically be performed mentally by reviewing the values in this table. D. “validation failure” Claim 1 recites, in part, “determine, based on the probability of error of the first clinical trial measurement value, the first clinical trial measurement value is a validation failure exceeding a predetermined number of validation failures for the first clinical research site.” Appeal Br. 21. This step can practically be performed in the human mind, or with the assistance of pen and paper, because it involves no more than keeping track of the validation failures. For example, “a given value fails validation because it lies outside a range.” Spec. ¶ 41. A human can mentally determine whether a value is outside a range. Appeal 2018-006893 Application 14/169,251 9 E. “modify . . . the data monitoring guideline” Claim 1 recites, in part, modify, in response to determining the first clinical trial measurement value is the validation failure exceeding the predetermined number of validation failures for the first clinical research site, the data monitoring guideline to identify the clinical variable as a critical variable for the first clinical research site and not the second clinical research site, wherein the critical variable requires on-site verification at the first clinical research site for any treatment of the clinical trial performed at the first clinical research site. Appeal Br. 21. Appellant argues that the modify function is not analogous to “analyzing data.” Id. at 14. According to Appellant, “analyzing data includes examining data to understand the data but does not encompass modifying the data, e.g., to identify a clinical variable, which was previously identified as a non-critical variable, as a critical variable.” Id. at 14–15; see also Reply Br. 3–4 (discussing the modify function). We find this argument unpersuasive. In CyberSource, for instance, the Federal Circuit determined that “constructing a map of credit card numbers,” as recited by the claims at issue in that case, could be performed “by writing down a list of credit card transactions made from a particular IP address.” CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372–73 (Fed. Cir. 2011). Yet the court concluded that the constructing step was a mental process. Id. Also, the October 2019 Update instructs Examiners that a claim encompassing a human mentally performing steps with the aid of a pen and paper recites a mental process. October 2019 Update 9 (discussing CyberSource, 654 F.3d at 1372–73). Appeal 2018-006893 Application 14/169,251 10 Here, the modify function, as recited above, can practically be performed in the human mind with the assistance of pen and paper. According to the Specification, the data monitoring guideline (DMG) lists each data point in the case report form. Spec. ¶ 25. The DMG “describes which data points are reviewed remotely and which data points must be reviewed during an on-site monitoring visit” and “includes guidance regarding data checks and other information needed to assist the CRA during on-site and remote data review and to help ensure consistency.” Id. Because the step merely involves modifying this information, it can practically be performed with the assistance of pen and paper by recording the modifications, for instance. Thus, this step is part of the recited mental process. F. Conclusion to Step 2A, Prong One Considering all the limitations together, claim 1 recites a method that falls within the Guidance’s subject-matter grouping of mental processes. Thus, claim 1 recites an abstract idea. V. Step 2A, Prong Two: Is the claim “directed to” the recited judicial exception? A. The Guidance Because claim 1 recites an abstract idea, we now proceed to determine whether the recited judicial exception is integrated into a practical application. Guidance, 84 Fed. Reg. at 51. When a claim recites a judicial exception and fails to integrate the exception into a practical application, the claim is “directed to” the judicial exception. Id. We use the term “additional elements” for claim features, limitations, or steps that the claim recites beyond the identified judicial exception. See Appeal 2018-006893 Application 14/169,251 11 id. at 55 n.24. In claim 1, the additional elements include (1) “on-site data input terminals,” (2) “off-site data analysis server,” and (3) sending, receiving, and storing data with these devices. For the reasons discussed below, we determine that these additional elements—individually and in combination—do not indicate that the judicial exception is integrated into a practical application. B. “receive data from users” Claim 1 recites, in part, “receive data from users, wherein the data includes clinical trial measurement values from the clinical research sites corresponding to a clinical variable, and wherein the data includes a first clinical trial measurement value for the clinical variable from the first clinical research site and a second clinical trial measurement value for the clinical variable from the second clinical research site.” Appeal Br. 21. The receive function “adds insignificant extra-solution activity to the judicial exception.” Guidance, 84 Fed. Reg. at 55. Courts have found that such activity may not integrate the judicial exception into a practical application. Id. The Guidance explains that insignificant extra-solution activity includes “mere data gathering such as a step of obtaining information about credit card transactions so that the information can be analyzed” to detect fraudulent transactions. Id. at 55 n.31; CyberSource, 654 F.3d at 1372 (analyzing the step of obtaining transaction data and determining that “such data-gathering steps cannot alone confer patentability”); see also MPEP § 2106.05(g) (instructing examiners that “[a]n example of pre-solution activity is a step of gathering data for use in a claimed process”). Appeal 2018-006893 Application 14/169,251 12 In the system of claim 1, the receive function merely collects the data to be processed. Apart from its role in data gathering, this function does not impose any meaningful limitation on the claimed system, when considering the claim as a whole. At most, claim 1’s receive function only further limits the content itself, which is insufficient to impart patent eligibility. See CyberSource, 654 F.3d at 1370. Thus, the receive function, considered individually and in combination with the other limitations, does not indicate that the claim integrates the abstract idea into a practical application. C. “a memory configured to store a data monitoring guideline” Claim 1 recites, in part, “a memory configured to store a data monitoring guideline identifying the clinical variable as a non-critical variable for both the first clinical research site and the second clinical research site, wherein the non-critical variable does not require on-site verification at the first clinical research site and the second clinical research site.” Appeal Br. 21. The MPEP instructs examiners that courts have recognized that the function of “[s]toring and retrieving information in memory” can be “insignificant extra-solution activity.” MPEP § 2106.05(d)(II)(collecting cases). Thus, claim 1’s store function also “adds insignificant extra-solution activity to the judicial exception.” Guidance, 84 Fed. Reg. at 55. The recited memory is limited by the type of data stored: a data monitoring guideline. Yet “[t]he mere combination of data sources, however, does not make the claims patent eligible.” FairWarning IP, LLC v. Iatric Sys., Inc., 839 F.3d 1089, 1097 (Fed. Cir. 2016). Like the claims here, the Federal Circuit found that a server used in its ordinary capacity to store images was not an improvement to computer functionality. In re TLI Commc’ns LLC Patent Litig., 823 F.3d 607, 612–13 (Fed. Cir. 2016), cited Appeal 2018-006893 Application 14/169,251 13 in MPEP § 2106.05(f). Thus, the recited memory, considered individually and in combination with the other limitations, does not indicate that the claim integrates the abstract idea into a practical application. D. “dispatch” Claim 1 recites, in part, “dispatch the data in response to determining the data is valid.” Appeal Br. 21. Claim 1 further recites, dispatch, in response to modifying the data monitoring guideline to identify the clinical variable as the critical variable, an investigation request to cause an investigator to perform the on-site verification of the critical variable at the first clinical research site for any treatment of the clinical trial performed at the first clinical research site. Id. at 22. Appellant argues that the “additional limitations of claim 1 include dispatching data from an on-site data input terminal responsive to a validity determination,” which “allows real-time identification of errors, which facilitates remote review.” Id. at 16 (citing Spec. ¶ 67). The recited “dispatch” functions, however, encompass sending information over a network. For example, dispatching may include sending data via “email or instant message.” Spec. ¶ 29. The Federal Circuit explained that the “computers in Alice were receiving and sending information over networks connecting the intermediary to the other institutions involved, and the Court found the claimed role of the computers insufficient.” buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355 (Fed. Cir. 2014). Similarly, the recited dispatch functions are insignificant extra solution activity. Guidance, 84 Fed. Reg. at 55. So these functions do not indicate that the claim integrates the abstract idea into a practical application. Appeal 2018-006893 Application 14/169,251 14 E. The Terminals and Server Claim 1 recites, in part, “a plurality of on-site data input terminals including a first data input terminal at a first clinical research site and a second data input terminal at a second clinical research site, the onsite data input terminals including: respective terminal processors configured to:” perform the functions discussed above. Appeal Br. 21. Claim 1 further recites “an off-site data analysis server networked with the plurality of on- site data input terminals to receive the data, wherein the off-site data analysis server is remote from the plurality of on-site data input terminals, the off-site data analysis server including” a memory and processor. Id. at 21–22. An additional element may integrate a judicial exception into a practical application when, for example, the “additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim.” Guidance, 84 Fed. Reg. at 55. But claim 1 does not require a particular machine. Here, claim 1 uses the terminals and servers in their ordinary capacity to send, receive, and store data. Unlike a particular machine, claim 1 recites general-purpose processors that merely execute the abstract idea. Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 716–17 (Fed. Cir. 2014), cited in MPEP § 2106.05(b)(I). Considering the terminals and server in combination with the other limitations, they are merely token additions. Claim 1, for example, does not recite a particular technical improvement to how the recited processors carry out the operations. For all these reasons, the claimed method does not use the recited computing devices in a way that indicates that the judicial exception has been integrated into a practical application. Appeal 2018-006893 Application 14/169,251 15 F. The Combination Appellant argues that “[t]he combination of elements of the claims provide an enhanced monitoring model, which is a system for risk-based monitoring of a clinical trial that increases efficiency and decreases costs as compared to conventional clinical study monitoring.” Appeal Br. 16 (citing Spec. ¶ 61). According to Appellant, “the enhanced monitoring model is an integrated approach that utilizes mutually dependent parts of: increased on- site monitoring intervals; remote review; and targeted source data verification.” Id. (citing Spec. ¶¶ 62–66); see also Reply Br. 4 (discussing technological environments and solving problems with clinical-study monitoring). Appellant points to the dispatching and the steps that are part of the abstract idea itself (e.g., determining a probability of error and an excess of validation failures, and modifying data monitoring guidelines). Appeal Br. 16–17. In Appellant’s view, “the additional limitations combine to solve the specific problems associated with conventional clinical study monitoring, which can require on-site monitoring visits to review all clinical data variables regardless of criticality.” Id. at 17. An improvement to technology or a technical field, for example, indicates that the claim may have integrated the judicial exception into a practical application. Guidance, 84 Fed. Reg. at 55. But Appellant has not shown that this is the case here. Apart from the abstract idea, claim 1 uses general-purpose processors and generic memory systems to receive, send, and store data. The problem being solved relates to organizing a clinical study and on-site monitoring. Appeal Br. 17. That is, instead of improving technology or a technical field, claim 1 merely uses the terminals and servers as tools to execute the recited Appeal 2018-006893 Application 14/169,251 16 abstract idea. See Ans. 4 (discussing technological problems). Thus, Appellant’s arguments concerning the improvement to technology are unpersuasive. Appeal Br. 15–17; Reply Br. 4. G. Other Indicia of Integration Claim 1 does not recite the other indicia of integration listed in the Guidance. Guidance, 84 Fed. Reg. at 55. For instance, “[t]ransformation and reduction of an article ‘to a different state or thing’ is the clue to patentability of a process claim that does not include particular machines.” Bilski v. Kappos, 561 U.S. 593, 604 (2010) (quoting Gottschalk v. Benson, 409 U.S. 63, 70 (1972)) (emphasis added); see also MPEP § 2106.05(c). Yet “not all transformations . . . infuse an otherwise ineligible claim with an ‘inventive concept.’” DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1256 (Fed. Cir. 2014). Unlike some eligible transformations, the claimed system here does not transform a physical object or substance. See, e.g., Diehr, 450 U.S. at 184 (a process that transforms rubber). H. Conclusion to Step 2A, Prong Two For all the reasons above, claim 1 is directed to the identified abstract idea. VI. Step 2B: Does the claim provide an inventive concept? A. The Guidance To determine whether a claim provides an inventive concept, the additional elements are considered—individually and in combination—to determine whether (1) they add a specific limitation beyond the judicial exception that is not well-understood, routine, and conventional in the field or (2) they simply append well-understood, routine, and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. Guidance, 84 Fed. Reg. at 56. Also, we Appeal 2018-006893 Application 14/169,251 17 reevaluate our conclusions about the additional elements that we presented in Step 2A, Prong Two. Id. B. “receive data from users” and “dispatch” Claim 1 recites, in part, receive data from users, wherein the data includes clinical trial measurement values from the clinical research sites corresponding to a clinical variable, and wherein the data includes a first clinical trial measurement value for the clinical variable from the first clinical research site and a second clinical trial measurement value for the clinical variable from the second clinical research site. Appeal Br. 21. Claim 1 recites, in part, “dispatch the data in response to determining the data is valid.” Id. Claim 1 further recites, dispatch, in response to modifying the data monitoring guideline to identify the clinical variable as the critical variable, an investigation request to cause an investigator to perform the on-site verification of the critical variable at the first clinical research site for any treatment of the clinical trial performed at the first clinical research site. Id. at 22. In OIP Technologies, Inc. v. Amazon.com, Inc., the Federal Circuit determined that, in the claims at issue, “sending a first set of electronic messages over a network to devices” encompassed well-understood, routine, and conventional activity. 788 F.3d 1359, 1363 (Fed. Cir. 2015). Also, the MPEP instructs examiners that courts recognize that receiving or transmitting data over a network may be well‐understood, routine, and conventional activity when claimed generically. MPEP § 2106.05(d)(II)(i) (collecting cases). Here, the receiving and dispatching functions are claimed generically. Apart from the limitations to the data type, claim 1 does not recite how the Appeal 2018-006893 Application 14/169,251 18 data is received or sent. Thus, we agree with the Examiner that claim 1 merely uses a computer to receive data in a well‐understood, routine, and conventional way. See Advisory 2–3 (determining that the claimed data collection uses “[g]eneric computer functions that are well-understood, routine, and conventional activities previously known to the pertinent industry”); Ans. 5 (finding that the additional elements are “arranged, and used, in well-known, routine and conventional fashion(s)”). C. “a memory configured to store a data monitoring guideline” Claim 1 recites, in part, “a memory configured to store a data monitoring guideline identifying the clinical variable as a non-critical variable for both the first clinical research site and the second clinical research site, wherein the non-critical variable does not require on-site verification at the first clinical research site and the second clinical research site.” Appeal Br. 21. Courts recognize that storing and retrieving information in memory may be well‐understood, routine, and conventional activity when claimed generically. Versata Dev. Grp. v. SAP Am., Inc., 793 F.3d 1306, 1334 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, cited in MPEP § 2106.05(d)(II)(iv). Because the claimed memory merely stores the data monitoring guideline, the recited computer memory is used in a well‐ understood, routine, and conventional way. See Ans. 5 (finding that the additional elements are “arranged, and used, in well-known, routine and conventional fashion(s)”). D. The Terminals and Server Claim 1 recites, in part, “a plurality of on-site data input terminals including a first data input terminal at a first clinical research site and a second data input terminal at a second clinical research site, the onsite data Appeal 2018-006893 Application 14/169,251 19 input terminals including: respective terminal processors configured to:” perform the functions discussed above. Appeal Br. 21. Claim 1 further recites “an off-site data analysis server networked with the plurality of on- site data input terminals to receive the data, wherein the off-site data analysis server is remote from the plurality of on-site data input terminals, the off-site data analysis server including” a memory and a processor. Id. at 21–22. The recited terminals and server perform operations that can practically be performed mentally. See supra § IV. The Specification discloses that the recited processor can be a general-purpose processor. See, e.g., Spec. ¶¶ 13, 29 (disclosing general-purpose computers to carry out some of the functions). Using a computer “only for its most basic function, the performance of repetitive calculations,” may not impose meaningful limits on the claim’s scope. Bancorp Servs. v. Sun Life Assurance Co. of Can. (U.S.), 687 F.3d 1266, 1278 (Fed. Cir. 2012). Because the recited terminals and servers merely execute the abstract idea, the recited terminals and servers add nothing more than well-understood, routine, and conventional activity, specified at a high level of generality, to the abstract mental process. See MPEP § 2106.05(d)(II)(ii) (citing Parker v. Flook, 437 U.S. 584, 594 (1978); Bancorp, 687 F.3d at 1278). E. The Combination Appellant argues that claim 1’s additional limitations are like those in BASCOM Global Internet Services, Inc. v. AT&T Mobility LLC, 827 F.3d 1341 (Fed. Cir. 2016). Appeal Br. 17–18. For instance, Appellant contends that the on-site and off-site devices require a “distribution of functionality within a network.” Id. at 18. In Appellant’s view, “[t]he technology-based solution locates the function of modifying monitoring guidelines at the off- site server, which allows for customization of critical variables for individual Appeal 2018-006893 Application 14/169,251 20 sites based on data received from all sites.” Id. We find these arguments unpersuasive. Specifically, the claims in BASCOM involved an inventive distribution of function between a local computer and a server. See 827 F.3d at 1350–51. The Federal Circuit noted that “[t]he inventive concept described and claimed in the ’606 patent is the installation of a filtering tool at a specific location, remote from the end-users, with customizable filtering features specific to each end user.” Id. at 1350. “Because the filtering tool on the ISP server contains each user’s customized filtering mechanism, the filtering tool working in combination with the ISP server can apply a specific user’s filtering mechanism to the websites requested by that user.” Id. at 1345. Unlike the claims in BASCOM, claim 1 does not recite an inventive distribution of function between the recited terminals and servers, for example. Rather, the computers here simply execute the abstract idea, and the memory stores data. For instance, the terminal processors receive the data, execute part of the mental process (see supra § IV) and then send data. Likewise, the server has a processor to execute the mental process (see supra § IV), and then it too merely sends data. Thus, the computing components, in combination, carry out the abstract idea and add nothing similar to BASCOM’s filtering tool working in combination with an ISP server. See BASCOM, 827 F.3d at 1345. That is, it is insufficient to simply have some kind of “distribution of functionality within a network.” See Appeal Br. 17– 18. Here, unlike BASCOM, claim 1 is simply an “abstract-idea-based solution implemented with generic technical components in a conventional way.” 827 F.3d at 1351. Appeal 2018-006893 Application 14/169,251 21 Appellant argues that the additional limitations include unconventional functions, such as determining the recited probability and modifying the data monitoring guidelines. Reply Br. 4. These steps, however, are part of the abstract idea itself. See supra § IV. And “a claim for a new abstract idea is still an abstract idea.” Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1151 (Fed. Cir. 2016). So the limitations on the mental process do not make claim 1 any less abstract. None of the argued limitations provide an inventive concept in the non-abstract application realm. See Appeal Br. 15–18; Reply Br. 4. Considering all the additional elements discussed above, we reevaluate our conclusions about whether the recited additional elements integrate the abstract idea into a practical application. Because the additional elements add nothing more than well-understood, routine, and conventional activity, those conclusions stand. Considering both our previous conclusions and the findings about well‐understood, routine, and conventional activity, we determine that the claimed method does not use the additional elements in a way that indicates that the claim provides an inventive concept. F. The Factual Determinations Appellant argues that the Examiner has not made the requisite factual determinations in determining that the additional elements were well- understood, routine, and conventional. Reply Br. 5 (citing Robert W. Bahr, Deputy Commissioner for Patent Examination Policy, Changes in Examination Procedure Pertaining to Subject Matter Eligibility, Recent Subject Matter Eligibility Decision (Berkheimer v. HP, Inc.) (USPTO April 19, 2018)). We disagree. Here, the Examiner supports the factual findings by citing paragraph 36 of the published application (paragraph 29 of the Specification) and Figure 1. Advisory 2; Final 4. Indeed, paragraph 29 of the Appeal 2018-006893 Application 14/169,251 22 Specification discusses generic computing components, such as a “desktop computer.” Spec. ¶ 29. G. Conclusion to Step 2B Thus, claim 1’s limitations—considered individually and in combination—do not provide an inventive concept. H. Summary Appellant has not persuaded us of error in the rejection of representative claim 1 under 35 U.S.C. § 101. Thus, we sustain the rejection. We also sustain the rejection of claims 2, 4–8, 11, 13, 15, and 17, which are not argued separately. See supra n.3. CONCLUSION We affirm the Examiner’s decision to reject claims 1, 2, 4–8, 11, 13, 15, and 17. DECISION SUMMARY Claims Rejected 35 U.S.C. § Reference(s) Affirmed Reversed 1, 2, 4–8, 11, 13, 15, 17 101 Eligibility 1, 2, 4–8, 11, 13, 15, 17 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)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation