Theranos, Inc.

Patent Trials and Appeals Board

Jul 8, 2021

2021000644 (P.T.A.B. Jul. 8, 2021)

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).
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Application 14/181,486

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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;
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[(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.).
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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
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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
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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
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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.).
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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.
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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