Theranos, Inc.Download PDFPatent Trials and Appeals BoardJul 8, 20212021000644 (P.T.A.B. Jul. 8, 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. 14/181,486 02/14/2014 Elizabeth A. Holmes 739.201 5303 107075 7590 07/08/2021 Labrador Diagnostics LLC 160 Foss Creek Cir #2369 Healdsburg, CA 95448 EXAMINER TOMASZEWSKI, MICHAEL ART UNIT PAPER NUMBER 3686 NOTIFICATION DATE DELIVERY MODE 07/08/2021 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@labradordiagnostics.com eofficeaction@appcoll.com patents@labradordiagnostics.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte ELIZABETH A. HOLMES and DANIEL YOUNG ____________ Appeal 2021-000644 Application 14/181,486 Technology Center 3600 ____________ Before JOSEPH A. FISCHETTI, BIBHU R. MOHANTY and NINA L. MEDLOCK, Administrative Patent Judges. MEDLOCK, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s final rejection of claims 28–47. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Our decision references Appellant’s Appeal Brief (“Appeal Br.,” filed June 8, 2020) and Reply Brief (“Reply Br.,” filed November 3, 2020), and the Examiner’s Answer (“Ans.,” mailed September 3, 2020) and Final Office Action (“Final Act.,” mailed June 7, 2019). Appellant identifies Labrador Diagnostics LLC as the real party in interest (Appeal Br. 2). Appeal 2021-000644 Application 14/181,486 2 CLAIMED INVENTION The claimed invention relates to “a computer-assisted method for scheduling biological or chemical assays” (Spec. ¶ 3). Claim 28, reproduced below with bracketed notations added, is the sole independent claim and representative of the subject matter on appeal: 28. A system for performing biological or chemical assays, comprising: [(a)] a cartridge for receiving a sample from a single patient; [(b)] a sample processing device for receiving the cartridge and for containing a plurality of stations, an individual station configured to accept at least a portion of said sample and perform at least one subtask for the biological or chemical assay with said portion of said sample, wherein the sample processing device performs at least an analyte measurement, a blood analysis, and nucleic acid amplification; and [(c)] a controller that generates a schedule for said plurality of subtasks performed simultaneously by said plurality of stations based on i) a comparison of the efficiency of said schedule as compared to the efficiency of a schedule in which input processes are scheduled sequentially, wherein a second schedule is determined to be more efficient than a first schedule where said second schedule requires less time, or fewer resources, or both, than said first schedule, and ii) ii) [sic] anticipated availability of said plurality of stations, and that provides instructions that effects operations of said plurality of stations to perform said subtasks in accordance with said schedule; Appeal 2021-000644 Application 14/181,486 3 [(d)] wherein reagents are provided to the sample processing device through the cartridge without requiring reagents to be pumped into the device through tubes and/or tanks located outside of the cartridge and wherein the controller is provided with cartridge layout including where each test reagent is located in the cartridge. [sic] wherein device resources comprises at least one or more pipettes and a centrifuge, wherein each device resource is further characterized by its operating characteristics and capabilities for the controller. (Appeal Br. 13 (Claims Appendix)). REJECTION Claims 28–47 are rejected under 35 U.S.C. § 103(a) unpatentable over Barnes et al. (US 2008/0020469 A1, published January 24, 2008) (“Barnes”), Van Matre (US 2008/0215409 A1, published September 4, 2008), and Pamula et al. (US 2007/0241068 A1, published October 18, 2007) (“Pamula”). ANALYSIS First, by way of background, Barnes is directed to a method for scheduling the order of analysis of multiple samples in a combinational clinical analyzer performing a plurality of different analytical tests (Barnes, Abstr.). And Barnes describes that the method comprises: (1) loading multiple samples in random order into a combinational clinical analyzer; (2) defining the test requirements of the multiple samples; (3) transferring the test requirements to a flexible scheduling algorithm; and (4) generating a schedule specifying the start times of each required test for each of the multiple samples that minimizes or maximizes a predefined objective function (id.). Appeal 2021-000644 Application 14/181,486 4 In rejecting claim 28 under 35 U.S.C. § 103(a), the Examiner cited Barnes as disclosing a system for performing biological or chemical assays comprising (1) a sample processing device containing a plurality of stations and (2) a controller that generates a schedule for a plurality of subtasks performed simultaneously by the plurality of stations based on the anticipated availability of the plurality of stations, as called for in limitations (b) and (c) of claim 28 (Final Act. 4–5). The Examiner also relied on Barnes as disclosing that reagents are provided to the sample processing device, i.e., limitation (d). The Examiner, however, acknowledged that Barnes does not explicitly disclose, inter alia, that the controller generated schedule is based on “a comparison of the efficiency of said schedule as compared to the efficiency of a schedule in which input processes are scheduled sequentially,” i.e., limitation (c)(i). And the Examiner cited Van Matre to cure this deficiency (id. at 5–6). Van Matre is titled “Iterative Resource Scheduling,” and discloses a system and method for iteratively creating an optimal schedule of resources to accomplish a given task (Van Matre ¶¶ 2–7). Van Matre describes that, in one embodiment, after a request is received to accomplish a task using a plurality of resources, attributes of the resources and the assigned task are retrieved from memory, along with both hard and soft constraints that limit the attributes (id. ¶ 7). A first schedule is created using a subset of the resources and resource hard constraints, and a score is determined for the first schedule based on the degree of compliance of each soft constraint (id.). Thereafter, the first schedule is modified to form a second schedule, again complying with each hard constraint; a score for the second schedule is determined and compared to the first schedule score to determine and select Appeal 2021-000644 Application 14/181,486 5 the more optimal schedule (id.). The process then continues iteratively until modifications of the schedule no longer yield an improving schedule (id.). The Examiner concluded that it would have been obvious at the time of Appellant’s invention “to include the resource scheduling system and method, as taught by Van Marie [sic], with the clinical analyzer scheduling system and method, as taught by Barnes, with the motivation of optimizing schedules” (Final Act. 6 (citing Van Matre ¶¶ 2–8)). But, the Examiner acknowledged that Barnes and Van Matre do not explicitly teach “a cartridge for receiving a sample from a single patient”; “a . . . device for receiving the cartridge and . . . perform[ing] . . . nucleic acid amplification”; or that reagents are provided to the device “through the cartridge without requiring reagents to be pumped into the device through tubes and/or tanks located outside of the cartridge” (id. at 6). The Examiner cited Pamula to cure the deficiencies of Barnes and Van Matre (id. at 6–7 (citing Pamula, Abstr.; ¶¶ 23, 26, 28, 54, 56, 67, 150, 167, 177, 461, 489, 499; and Figs. 1–21D)). And the Examiner concluded that it would have been obvious to a person of ordinary skill in the art at the time of Appellant’s invention “to include the biochemical assay system and method, as taught by Pamula, with the resource scheduling system and method, as taught by Van Marie [sic], with the clinical analyzer scheduling system and method, as taught by Barnes, with the motivation of improving sample collection testing efficiency” (id. at 7 (citing Pamula ¶¶ 5, 14)). Pamula discloses methods, devices, and systems for amplifying nucleic acids, analyzing the sequences of nucleic acids, conducting affinity- based assays, and/or analyzing components of bodily fluids (Pamula ¶¶ 54, 56), and describes that the methods make use of a sample that includes a Appeal 2021-000644 Application 14/181,486 6 nucleic acid template for amplification (id. ¶ 67). Pamula discloses that, in one embodiment, a droplet microactuator includes a substrate for immobilization of a nucleic acid, reagents for immobilizing the nucleic acid to the substrate, and a nucleic acid sample; and Pamula describes that the reagents and samples may be stored in reservoirs on the droplet microactuator or in other containers, e.g., a cartridge, off the droplet microactuator (id. ¶¶ 150, 177). Pamula discloses a portable hand-held analyzer with reference to Figures 19A and 19B, reproduced below: Figures 19A and 19B are illustrations of a portable hand-held analyzer Appeal 2021-000644 Application 14/181,486 7 As shown in Figure 19B, the device includes a slot 1902 for insertion of a droplet microactuator (Pamula ¶ 572). And Pamula describes that the portability of the droplet microactuator facilitates point of care or point of sample collection (id.). Citing Figure 1 of Barnes, Appellant argues that the obviousness rejection cannot be sustained because the “lab-on-a-chip design of Pamula is technically incompatible with the large, floor-standing, high throughput combinatorial device of Barnes” (Appeal Br. 5). Appellant asserts that “[m]odifying Barnes to have a design set forth in Pamula that is a handheld and just accepts ONE patient sample is INCOMPATIBLE with the described purpose of Barnes” and would change the principle of operation of the Barnes device (id. at 6–10; see also Reply Br. 5–11).2 Appellant also maintains that the proposed combination fails to provide the purported benefit of “improving sample collection testing efficiency,” because “the Barnes reference which teaches a HIGH-THROUGHPUT testing device is being modified by a handheld system designed to test a SINGLE sample” (Appeal Br. 10 (“The Office states on page 7 of the Final Office Action that the motivation for making the combination is ‘improving sample collection efficiency.’”); see also Reply Br. 11). 2 In other words, according to Appellant, the proposed modification would render Barnes unsatisfactory for its intended purpose, e.g., to achieve maximum sample or volume throughput capacity; to rapidly process a plurality of patient samples through a variety of different sample treatments and measurement steps; to enable an operator to input samples in any order, without regard to the type or quantity of tests (i.e., assays) required of the samples; and to aspirate and meter samples by random access from any point in the metering zone (id.). Appeal 2021-000644 Application 14/181,486 8 Responding to Appellant’s arguments, the Examiner notes that “Pamula teaches using a well-known cartridge feature to store reagents and samples for use in conducting biochemical and other assays” (Ans. 4 (citing Pamula ¶ 150)). And the Examiner takes the position that although “Pamula teaches using the cartridge feature in a hand-held device . . . , this is merely an exemplary embodiment and multiple cartridges and samples may be used with the microactuator thereby achieving higher volume throughput” (id. (citing Pamula ¶ 150)). The Examiner similarly opines that although “Barnes teaches a clinical analyzer that may achieve maximum volume throughput capacity, this is merely an exemplary embodiment and does not preclude lower volume or even single sample assays; and/or coupling hand-held devices and/or the use of well-known cartridges, as claimed by Appellant’s claims and disclosed by Pamula” (Ans. 4–5). But, the Examiner does not explain how Barnes’s device would be modified to use the Pamula cartridge, while achieving the maximum sample or volume throughput capacity and maintaining the minimal elapsed time and minimal turnaround time that is the intended purpose of the Barnes device. The Examiner also does not explain why a person of ordinary skill in the art would have had an apparent reason, given Barnes’s emphasis on these features, to restrict the use of Barnes’s device to lower volume or single sample assays. Indeed, although the Examiner asserts that the proposed combination would improve sample collection testing efficiency. We fail to see how, and the Examiner does not explain how or in what way, sample collection testing efficiency is improved. Appeal 2021-000644 Application 14/181,486 9 We are not persuaded, on the present record, that the Examiner properly rejected independent claim 28 as obvious over the combination of Barnes, Van Matre, and Pamula. Therefore, we do not sustain the Examiner’s rejection of claim 28 under 35 U.S.C. § 103(a). For the same reasons, we also do not sustain the rejection of dependent claims 29–47. Cf. In re Fritch, 972 F.2d 1260, 1266 (Fed. Cir. 1992) (“dependent claims are nonobvious if the independent claims from which they depend are nonobvious”). CONCLUSION In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 28–47 103(a) Barnes, Van Matre, Pamula 28–47 REVERSED Copy with citationCopy as parenthetical citation