Eli Lilly and Company

Patent Trials and Appeals Board

Mar 25, 2022

2021003376 (P.T.A.B. Mar. 25, 2022)

UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 15/129,228 09/26/2016 Howard Allan Wolpert LLY-001US 6647 26486 7590 03/25/2022 BURNS & LEVINSON, LLP 125 HIGH STREET BOSTON, MA 02110 EXAMINER PAULSON, SHEETAL R. ART UNIT PAPER NUMBER 3626 NOTIFICATION DATE DELIVERY MODE 03/25/2022 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): docketing@burnslev.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte HOWARD ALLAN WOLPERT ____________ Appeal 2021-003376 Application 15/129,228 Technology Center 3600 ____________ Before ANTON W. FETTING, BRUCE T. WIEDER, and BRADLEY B. BAYAT, Administrative Patent Judges. WIEDER, Administrative Patent Judge. DECISION ON APPEAL Appellant1 seeks review under 35 U.S.C. § 134 from the Examiner’s final rejection of claims 1, 4, 7-11, 14, and 18-21. 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. Appellant identifies the real party in interest as Eli Lilly and Company. (Appeal Br. 3.) Appeal 2021-003376 Application 15/129,228 2 CLAIMED SUBJECT MATTER Appellant’s claimed invention relates to “determining a level of hypoglycemic unawareness displayed by a patient” and “providing a treatment regimen for the patient based on the level of hypoglycemic unawareness.” (Claim 1.) Claims 1, 11, and 21 are the independent claims on appeal. Claim 1 is illustrative. It recites: 1. A method of determining a level of hypoglycemic unawareness displayed by a patient, comprising: maintaining, in a data storage device in communication with one or more processors, a data structure including one or more glucose concentrations correlated to one or more subject prompts; receiving, by the one or more processors, a measured glucose concentration of the patient from a glucose measuring device; determining, by the one or more processors, a query based upon the measured glucose concentration and the one or more subject prompts correlated to the measured glucose concentration within the data structure, including determining, by the one or more processors, a number of prompts to include in the query based on a prompt fatigue metric associated with the patient; transmitting, to a user interface device in communication with the one or more processors, the query; receiving, by the one or more processors, a patient response to the transmitted query, the patient response including one or more answers to respective ones of the one or more subject prompts; determining, by the one or more processors, a second query including one or more additional prompts based on the one or more answers responsive to respective ones of the one or more subject prompts; Appeal 2021-003376 Application 15/129,228 3 transmitting, to the user interface device in communication with the one or more processors, the second query; determining, by the one or more processors, a level of hypoglycemic unawareness of the patient based at least upon the patient response to the one or more subject prompts and the one or more additional prompts; and providing a treatment regimen for the patient based on the level of hypoglycemic unawareness. REJECTION Claims 1, 4, 7-11, 14, and 18-21 are rejected under 35 U.S.C. § 101 as directed to a judicial exception without significantly more. ANALYSIS “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” 35 U.S.C. § 101. Section 101, however, “contains an important implicit exception: Laws of nature, natural phenomena, and abstract ideas are not patentable.” Alice Corp. v. CLS Bank Int’l, 573 U.S. 208, 216 (2014) (quoting Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589 (2013)). Alice applies a two-step framework, earlier set out in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), “for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts.” Alice, 573 U.S. at 217. Appeal 2021-003376 Application 15/129,228 4 Under the two-step framework, it must first be determined if “the claims at issue are directed to a patent-ineligible concept.” Id. at 218. If the claims are determined to be directed to a patent-ineligible concept, e.g., an abstract idea, then the second step of the framework is applied to determine if “the elements of the claim . . . contain[] an ‘ “inventive concept” ’ sufficient to ‘transform’ the claimed abstract idea into a patent-eligible application.” Id. at 221 (citing Mayo, 566 U.S. at 72-73, 79). With regard to step one of the Alice framework, we apply a “directed to” two-prong test to: 1) evaluate whether the claim recites a judicial exception, and 2) if the claim recites a judicial exception, evaluate whether the claim “appl[ies], rel[ies] on, or use[s] the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception.” See USPTO, 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50, 54 (Jan. 7, 2019) (hereinafter “2019 Guidance”). The Examiner determines that claim 1 “is directed towards users transmitting glucose records to determine [a] level of hypoglycemic unawareness, which is a method of managing personal behavior.” (Final Action 7.) Appellant argues that “[c]laim 1 is directed to a patent eligible method of treatment for hypoglycemia unawareness, comparable (for an analysis under Section 101 standpoint) to the patent eligible treatment method described in Vanda Pharmaceuticals Inc., v. West-[W]ard Pharmaceuticals International Limited, 887 F.3d 1117 (Fed. Cir. 2018).” (Appeal Br. 9.) Under step one of the Alice framework, we “look at the ‘focus of the claimed advance over the prior art’ to determine if the claim’s ‘character as a Appeal 2021-003376 Application 15/129,228 5 whole’ is directed to excluded subject matter.” Affinity Labs of Texas, LLC v. DIRECTV, LLC, 838 F.3d 1253, 1257 (Fed. Cir. 2016) (quoting Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d 1350, 1353 (Fed. Cir. 2016)). The “directed to” inquiry . . . cannot simply ask whether the claims involve a patent-ineligible concept, because essentially every routinely patent-eligible claim involving physical products and actions involves a law of nature and/or natural phenomenon . . . . Rather, 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.” Internet Patents Corp. v. Active Network, Inc., 790 F.3d 1343, 1346 (Fed. Cir. 2015). Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335 (Fed. Cir. 2016). In other words, the first step of the Alice framework “asks whether the focus of the claims is on the specific asserted improvement in [the relevant technology] or, instead, on a process that qualifies as an ‘abstract idea’ for which computers are invoked merely as a tool.” Id. at 1335-36; see also 2019 Guidance at 54-55. The Specification provides evidence as to what the claimed invention is directed. In this case, the Specification discloses that the invention relates to “determining a level of hypoglycemic unawareness displayed by a patient.” (Spec. ¶ 4.) Claim 1 provides further evidence. Claim 1 recites “[a] method of determining a level of hypoglycemic unawareness displayed by a patient comprising: maintaining . . . a data structure including one or more glucose concentrations correlated to one or more subject prompts,” “receiving . . . a measured glucose concentration,” “determining . . . a query based upon the measured glucose concentration and the one or more subject prompts correlated to the measured glucose concentration,” “transmitting . . . the query,” “receiving . . . a patient response,” “determining . . . a second Appeal 2021-003376 Application 15/129,228 6 query,” “transmitting . . . the second query,” “determining . . . a level of hypoglycemic unawareness of the patient based at least upon the patient response,” “and providing a treatment regimen for the patient based on the hypoglycemic unawareness.” In other words, claim 1 recites maintaining/storing data, receiving data, determining/analyzing data, transmitting data, receiving data, determining/analyzing data, transmitting data, determining/analyzing data, and providing/outputting data. Storing, receiving, analyzing, transmitting, and outputting data have been determined to be directed to an abstract idea. See, e.g., Univ. of Fla. Research Found., Inc. v. General Elec. Co., 916 F.3d 1363, 1367 (Fed. Cir. 2019) (claims “directed to the abstract idea of ‘collecting, analyzing, manipulating, and displaying data’”), Interval Licensing LLC v. AOL, Inc., 896 F.3d 1335, 1344-45 (Fed. Cir. 2018) (recognizing that information “is an intangible” and that “the collection, organization, and display of two sets of information on a generic display device is abstract absent a ‘specific improvement to the way computers [or other technologies] operate.’”) (brackets in original), FairWarning IP, LLC v. Iatric Sys., Inc., 839 F.3d 1089, 1093-94 (Fed. Cir. 2016) (determining “that the ‘realm of abstract ideas’ includes ‘collecting information, including when limited to particular content’” as well as analyzing and presenting information), Content Extraction and Transmission LLC v. Wells Fargo Bank, Nat’l Ass’n, 776 F.3d 1343, 1347 (Fed. Cir. 2014) (treating as an abstract idea “1) collecting data, 2) recognizing certain data within the collected data set, and 3) storing that recognized data”), Cyberfone Sys., LLC v. CNN Interactive Grp., Inc., 558 F. App’x 988 (Fed. Cir. 2014) (claims Appeal 2021-003376 Application 15/129,228 7 directed to organizing, storing, and transmitting information determined to be directed to an abstract idea). Claim 1 does not recite how the data structure is maintained, how the glucose concentration is received from the measuring device,2 how the first query (including the number of prompts in the query) is determined, how the first query is transmitted to the user interface device, how the patient response is received, how the second query is determined, how the second query is transmitted to the user interface device, how the level of hypoglycemic unawareness is determined from the patient response, or how and to whom/what the treatment regimen is provided.3 Appellant does not argue that Appellant invented a data storage device, a processor, or a user interface device. In cases involving software innovations, such as we have here, the inquiry as to whether the claims are directed to an abstract idea “often turns on whether the claims focus on ‘the specific asserted improvement in computer capabilities ... or, instead, on a process that qualifies as an “abstract idea” for which computers are invoked merely as a tool.’” Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303 (Fed. Cir. 2018) (quoting Enfish, LLC, 822 F.3d at 1335-36). Here, the computing devices, i.e., the generically recited “data storage device,” “one or more processors,” and “user interface device,” are invoked merely as tools. “As many cases make clear, even if a process of collecting and analyzing information is ‘limited to particular content’ or a particular 2 Claim 1 recites “receiving . . . a measured glucose concentration of the patient from a glucose measuring device.” Claim 1 does not recite any steps to be performed by the glucose measuring device itself. 3 Claim 1 does not recite actually providing treatment to a patient. Appeal 2021-003376 Application 15/129,228 8 ‘source,’ that limitation does not make the collection and analysis other than abstract.” SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1168 (Fed. Cir. 2018). The “character of [the] information simply invokes a separate category of abstract ideas.” Id. Moreover, “[a] claim does not cease to be abstract for section 101 purposes simply because the claim confines the abstract idea to a particular technological environment in order to effectuate a real-world benefit.” In re Mohapatra, 842 F. App’x 635, 638 (Fed. Cir. 2021). We do not find any 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 or functionality to the claimed invention or that otherwise indicates that the claimed invention “appl[ies], rel[ies] on, or use[s] the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception.” (See 2019 Guidance at 54-55.) We agree with the Examiner that claim 1 recites elements that constitute both managing personal behavior and mental processes. (See Answer 6.) Specifically, claim 1 recites receiving patient glucose concentrations, determining queries, transmitting queries, receiving patient responses, and providing a patient treatment regimen, all “for detecting hypo-awareness and providing methods for intervention before it results in severe complications,” i.e., for managing personal behavior. (Claim 1; Spec. ¶ 3; see also 2019 Guidance at 52.) We also agree with the Examiner that at least the determining steps recited in claim 1 may be performed in the Appeal 2021-003376 Application 15/129,228 9 human mind (applying evaluation and judgment). (See Answer 6; see also 2019 Guidance at 52.) Regardless, Appellant seeks to analogize claim 1 to the claims in Vanda Pharmaceuticals. Appellant argues that Appellant’s claims and claim 1 in Vanda both “deal with treatment of a medical condition.” (Appeal Br. 10.) Specifically, Appellant argues that “both Claim 1 of the ‘610 Patent of Vanda and Claim 1 of the present application recite making determinations about the patient’s condition by taking biological samples and using those samples to learn information about the patient.” (Id.) We do not find this argument persuasive. In relevant part, claim 1 in Vanda recites “[a] method for treating a patient with iloperidone, wherein the patient is suffering from schizophrenia, the method comprising the steps of: . . . obtaining or having obtained a biological sample from the patient.” Vanda Pharm. Inc., 887 F.3d at 1121. Unlike claim 1 of Vanda, Appellant’s claim 1, does not recite obtaining a biological sample. It simply recites receiving information, i.e., a measured glucose concentration. Appellant also argues that in claim 1 of Vanda, “the CYP2D6 metabolizer genotype that is determined is then used to administer dosage ranges. Similarly, claim 1 in the present application uses the determination of hypoglycemic unawareness to provide a treatment regimen for the patient.” (Appeal Br. 11.) We do not find this argument persuasive. In relevant part, claim 1 of Vanda recites if the patient has a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount of 12 mg/day or less, and Appeal 2021-003376 Application 15/129,228 10 if the patient does not have a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount that is greater than 12 mg/day, up to 24 mg/day. Vanda Pharm. Inc., 887 F.3d at 1121. Unlike claim 1 of Vanda, Appellant’s claim 1 does not recite treating a patient. Rather, it recites “providing a treatment regimen for the patient.” There is no recitation of actual treatment of the patient. Moreover, it is unclear to whom/what the treatment regimen is provided. More analogous to Appellant’s claim 1 is claim 1 in SmartGene, Inc. v. Advanced Biological Laboratories, SA, 555 F. App’x 950 (Fed. Cir. 2014). SmartGene involved the abstract idea of generating advisory information for a therapeutic treatment regimen based on patient information and a knowledge base of expert rules for evaluating and selecting a treatment regimen. SmartGene, 555 F. App’x at 951-52. The Federal Circuit determined that the claim at issue in SmartGene did not recite patent eligible subject matter; in particular, that the claim recited “the mental steps of comparing new and stored information and using rules to identify medical options.” Id. at 955. Thus, under prong one of the two prong test in the 2019 Guidance, claim 1 recites the abstract ideas of certain methods of organizing human activity and mental processes; and, under prong two, additional elements in claim 1 do not “apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception.” (See 2019 Guidance at 54.) As such, under step one of the Alice framework, claim 1 is directed to an abstract idea, and we move to step two. Appeal 2021-003376 Application 15/129,228 11 Step two of the Alice framework has been described “as a search for an ‘ “inventive concept” ’ -i.e., an element or combination of elements that is ‘sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself.’” Alice, 573 U.S. at 217-18 (brackets in original) (quoting Mayo, 566 U.S. at 72-73). In other words, under step two we determine 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.” Id. at 217 (quoting Mayo, 566 U.S. at 78). Taking the claim elements separately, the functions performed in claim 1 by the generically recited “data storage device,” “one or more processors,” and “user interface device” are purely conventional. Storing data, receiving data, analyzing data, transmitting data, and outputting data are well-understood, routine, and conventional functions previously known to the industry. See Elec. Power Grp., 830 F.3d at 1356 (The claims “do not include any requirement for performing the claimed functions of gathering, analyzing, and displaying in real time by use of anything but entirely conventional, generic technology. The claims therefore do not state an arguably inventive concept . . . .”); see also Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1335 (Fed. Cir. 2015) (determining claims requiring “arranging, storing, retrieving, sorting, eliminating, determining” to “involve the normal, basic functions of a computer” and to be “conventional, routine, and well-known”), In re Katz Interactive Call Processing Patent Litig., 639 F.3d 1303, 1316 (Fed. Cir. 2011) (“Absent a possible narrower construction of the terms ‘processing,’ ‘receiving,’ and Appeal 2021-003376 Application 15/129,228 12 ‘storing,’ . . . those functions can be achieved by any general purpose computer without special programming.”). Considered as an ordered combination, the generically recited data storage device, processor(s), and user interface device add nothing that is not already present when the limitations are considered separately. For example, claim 1 does not purport to improve the functioning of the data storage device, processor(s), and user interface device themselves. Nor does it effect an improvement in any other technology or technical field. Instead, claim 1 amounts to nothing significantly more than an instruction to apply the abstract idea using generic computer components performing routine computer functions. That is not enough to transform an abstract idea into a patent-eligible invention. See Alice, 573 U.S. at 225-26; see also Inventor Holdings, LLC v. Bed Bath & Beyond, Inc., 876 F.3d 1372, 1378 (Fed. Cir. 2017) (sequence of receiving, analyzing, modifying, generating, displaying, and transmitting data recited an abstraction). Nonetheless, Appellant argues that claim 1 recites “components . . . necessary to effectuate the solution sought.” (Appeal Br. 12.) In particular, Appellant argues that claim 1 recites a glucose measuring device and that a “specific data structure is maintained within a processor which correlates various glucose concentrations to prompts.” (Id.) We do not find Appellant’s arguments persuasive. As discussed above, claim 1 recites receiving a measured glucose concentration, i.e., receiving information. The glucose measuring device is recited only generically; it is not recited as transmitting information or even as directly communicating with the one or more processors. At best, it is simply the source of the measured glucose concentration. Appeal 2021-003376 Application 15/129,228 13 With regard to the data structure recited in claim 1, we disagree with Appellant that the “data structure is maintained within a processor.” (See id.) Claim 1 recites “maintaining, in a data storage device in communication with one or more processors, a data structure including one or more glucose concentrations correlated to one or more subject prompts.” We find nothing in claim 1 reciting that the “data structure is maintained within a processor.” Moreover, “an improvement to the information stored by a database is not equivalent to an improvement in the database’s functionality.” BSG Tech LLC v. BuySeasons, Inc., 899 F.3d 1281, 1288 (Fed. Cir. 2018). In short, “the recited physical components merely provide a generic environment in which to carry out the abstract idea.” In re TLI Commc’ns LLC Patent Litig., 823 F.3d 607, 611 (Fed. Cir. 2016). Appellant argues that the remaining claims (claims 4, 7-11, 14, and 18-21) include limitations similar to those in claim 1 and should be allowed for similar reasons. (See Appeal Br. 18-19.) For the reasons discussed above, we are not persuaded that the Examiner erred in rejecting claims 4, 7-11, 14, and 18-21. Additionally, we note that the system claims are no different from the method claims in substance. The method claims recite the abstract idea implemented on a generic computer; the system claims recite a handful of generic computer components configured to implement the same idea. This Court has long “warn[ed] … against” interpreting § 101 “in ways that make patent eligibility ‘depend simply on the draftsman’s art.’ ” Alice, 573 U.S. at 226 (quoting Mayo, 566 U.S. at 72). Appellant’s other arguments have been considered but are not persuasive. Appeal 2021-003376 Application 15/129,228 14 CONCLUSION The Examiner’s rejection of claims 1, 4, 7-11, 14, and 18-21 under 35 U.S.C. § 101 is affirmed. Specifically: Claim(s) Rejected 35 U.S.C. § Reference(s)/ Basis Affirmed Reversed 1, 4, 7-11, 14, 18-21 101 Eligibility 1, 4, 7-11, 14, 18-21 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