Cytonome/ST, LLC

Patent Trials and Appeals Board

Sep 1, 2020

IPR2020-00548 (P.T.A.B. Sep. 1, 2020)

Trials@uspto.gov Paper 15
571-272-7822 Date: September 1, 2020

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

NANOCELLECT BIOMEDICAL, INC.,
Petitioner,
v.
CYTONOME/ST, LLC,
Patent Owner.

IPR2020-00548
Patent 8,623,295

Before JO-ANNE M. KOKOSKI, WESLEY B. DERRICK, and
JAMES A. WORTH, Administrative Patent Judges.
DERRICK, Administrative Patent Judge.
DECISION
Denying Institution of Inter Partes Review
35 U.S.C. § 314, 37 C.F.R. § 42.4

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INTRODUCTION
Petitioner NanoCellect Biomedical, Inc., filed a Petition requesting
inter partes review of claims 1–3, 9, 17, and 18 of U.S. Patent
No. 8,623,295 B2 (“the ’295 patent”). Paper 2 (“Pet.”). Patent Owner
Cytonome/ST, LLC filed a Preliminary Response. Paper 6 (“Prelim.
Resp.”). As authorized, Petitioner also filed a Pre-Institution Reply (Paper
7, “Reply”) and Pre-Institution Supplemental Briefing (Paper 11) and Patent
Owner, in turn, also filed a Pre-Institution Sur-Reply (Paper 8) and a
Response to Petitioner’s Pre-Institution Supplemental Briefing (Paper 12).
We have authority to determine whether to institute an inter partes
review. 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). We may not institute an inter
partes review “unless . . . there is a reasonable likelihood that the petitioner
would prevail with respect to at least 1 of the claims challenged in the
petition.” 35 U.S.C. § 314(a). Applying that standard, for the reasons set
forth below, we decline to institute an inter partes review because Petitioner
has not shown a reasonable likelihood that it would prevail in establishing
the unpatentability of any of claims 1–3, 9, 17, and 18.
BACKGROUND
A. Real Parties in Interest
Petitioner identifies itself as the real party-in-interest. Pet. 3. Patent
Owner identifies itself and Inguran, LLC, as the real parties-in-interest.
Paper 4, 1.
B. Related Matters
The parties identify Cytonome/ST, LLC v. NanoCellect Biomedical,
Inc., No. 1:19-cv-00301-UNA (D. Del.) as a related proceeding. Pet. 3;
Paper 4, 1. The ’295 patent is one of a number of patents asserted in that
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district court proceeding. Pet. 3; Paper 4, 1. Other patents asserted are also
subject to filed inter partes review petitions, and are identified by Petitioner
as related proceedings: IPR2020-00545 (US 6,877,528 B2); IPR2020-00546
(US 9,339,850 B2); IPR2020-00547 (US 10,029,283 B2); IPR2020-00549
(US 10,029,263 B2); IPR2020-00550 (US 9,011,797 B2); and IPR2020-
00551 (US 10,065,188 B2). Pet. 3; Paper 4, 1.
C. The ’295 Patent (Ex. 1001)
The ’295 patent is titled “Microfluidic System Including a Bubble
Valve for Regulating Fluid Flow Through a Microchannel,” and issued on
January 7, 2014, from an application filed on September 26, 2011.
Ex. 1001, at [22], [45], [54]. The ’295 patent identifies related applications,
including a provisional application—the earliest filed—that was filed on
April 17, 2002. Id. at [60], [63], 1:5–19.
The ’295 patent relates to “[a] microfluidic system [that] includes a
bubble valve for regulating fluid flow through a microchannel.” Id. at [57].
Figure 16, reproduced below, depicts an apparatus that provides for
regulating fluid flow in a manner that allows sorting particles. Id. at 5:40–
42.
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Id., Fig. 16 (depicting a schematic of a particle sorting system). As
disclosed in the ’295 patent, “particle sorter 160 . . . for sorting particles,
such as cells. . . . comprises a first supply duct 162 for introducing a stream
of particles . . . a second supply duct 164 for supplying a carrier liquid . . . a
measurement duct 166, which branches into a first branch 172a and a second
branch 172b at branch point 171,” and “[t]wo opposed bubble valves 10a
and 10b . . . in communication . . . with the measurement duct 166 through a
pair of opposed side passages 174a and 174b, respectively.” Id. at 11:40–
57, Fig. 16. In operation, and as depicted, “[l]iquid . . . partly fill[ing] these
side passages 174a and 174b . . . form[s] a meniscus 175,” and a provided
“external actuator 176” “actuat[es] the bubble valves 10a, 10b, . . .
momentarily caus[ing] a flow disturbance in the duct to deflect the flow
therein.” Id. at 11:57–61; see also Figs. 17A–17C (depicting operation of
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particle sorter 160 to sort particles flowing from left to right in the figures
into one or the other of first branch 172a and 172b). As to the operation of
the apparatus, the ’295 patent discloses that the external actuator increases
pressure within one of the two opposed bubble valves causing a transient
discharge of fluid from the associated side channel, which causes a sudden
increase in pressure at this point in the duct, which increased pressure causes
liquid to flow into the associated side channel of the second opposed bubble
valves because of the resilient properties of the reservoir of the second
bubble valve. Id. at 12:23–33.
D. Illustrative Claim
Claim 1—the sole independent claim—is illustrative of the claimed
subject matter.
1. A microfluidic system comprising:
a microfluidic flow channel formed in a substrate and adapted
to facilitate analysis or processing of a sample having one
or more particles suspended in a suspension medium
flowing through the flow channel;
a first reservoir operatively associated with the flow channel
and adapted for dampening or absorbing a pressure pulse
propagated across the flow channel; and
a second reservoir operatively associated with the flow channel
and adapted for generating the pressure pulse based on a
change in volume or pressure in the second reservoir;
wherein the flow channel defines a first aperture for connecting
the flow channel relative to the first reservoir and a second
aperture for connecting the flow channel relative to the
second reservoir, wherein the first aperture is substantially
opposite the second aperture.
Ex. 1001, 13:42–14:3.
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E. Prior Art Relied Upon
Petitioner relies on the references listed below (Pet. 16, 18–19):
Reference Date Exhibit No.
WO 00/70080 (“Wada”) Nov. 23, 2000 1006
WO 97/02357 (“Anderson”) Jan. 23, 1997 1012
US 5,101,978 (“Marcus”) Apr. 7, 1992 1005
The status of these references as prior art printed publications is not
contested by Patent Owner. See generally Prelim. Resp.
F. The Asserted Grounds of Unpatentability
Petitioner challenges the patentability of the claims on the following
grounds, relying on the Declaration from Bernhard H. Weigl, Ph.D.
(Ex. 1002). Pet. 5, 20–69.
Claim(s) Challenged 35 U.S.C. § Reference(s)/Basis
1–3, 9, 18 103 Wada
1–3, 9, 17, 18 103 Wada, Anderson
1–3, 9, 17, 18 103 Marcus, Anderson
ANALYSIS
A. Level of Ordinary Skill in the Art
Petitioner contends that a person of ordinary skill in the art “would
have had a bachelor’s or master’s degree in the field of bioengineering,
mechanical engineering, chemical engineering, or analytical chemistry; or a
bachelor’s or master’s degree in a related field and at least three years of
experience in designing or developing microfluidic systems.” Pet. 14 (citing
Ex. 1002 ¶¶ 46–49).
Patent Owner reserves the right to dispute Petitioner’s proposed
definition of the level of ordinary skill in the art, but applies Petitioner’s
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proposed definition “[s]olely for purposes of [the Patent Owner Preliminary
Response].” Prelim. Resp. 29.
On this record, we have no reason to fault Petitioner’s definition of
the level of ordinary skill and, therefore, adopt it for the purposes of this
Decision. We further note that the prior art itself demonstrates the level of
skill in the art at the time of the invention. See Okajima v. Bourdeau,
261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that “specific findings on
the level of skill in the art . . . [are not required] ‘where the prior art itself
reflects an appropriate level and a need for testimony is not shown’”
(quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158,
163 (Fed. Cir. 1985))).
B. Claim Construction
We apply the claim construction standard from Phillips v. AWH
Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). 37 C.F.R. § 42.100(b)
(2019).
Claim terms are generally given their ordinary and customary
meaning as would be understood by one with ordinary skill in the art in the
context of the specification, the prosecution history, other claims, and even
extrinsic evidence including expert and inventor testimony, dictionaries, and
learned treatises, although extrinsic evidence is less significant than the
intrinsic record. Phillips, 415 F.3d at 1312–1317. Usually, the specification
is dispositive, and it is the single best guide to the meaning of a disputed
term. Id. at 1315.
Only those claim terms that are in controversy need to be construed
and only to the extent necessary to resolve the controversy. Nidec Motor
Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed.
Cir. 2017); see also U.S. Surgical Corp. v. Ethicon, Inc., 103 F.3d 1554,
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1568 (Fed. Cir. 1997) (holding claim construction is not necessary when it is
not “directed to, or has been shown reasonably to affect, the determination
of obviousness”).
Petitioner contends that no “express claim constructions are required
for the Board to conclude the asserted prior art renders the challenged claims
unpatentable.” Pet. 11–12. Petitioner does, however, contend that Patent
Owner has made relevant “admissions about the meanings of claim terms in
the asserted patents.” Id. at 12. In particular, Petitioner maintains that
Patent Owner’s declarant in the district court proceeding has maintained
“that the terms ‘reservoir’ and ‘chamber’ as used in the challenged claims
. . . should be understood as a physical structure that contains fluid” (id. at
12 (citing Ex. 1002 ¶ 43; Ex. 1042, 20; Ex. 1043 ¶¶ 25–27, 31, 34, 44–48)),
“that the term ‘absorbing’ as used in the challenged claims . . . means to
receive, take up, or take in the pressure pulse” (id. at 13 (citing Ex. 1043
¶¶ 50–52; Ex. 1002 ¶ 44; Ex. 1042 1, 7–8, 18–19; Ex. 1045, 8–10, 18–20)),
and “that the terms ‘dampen’ or ‘dampening’ . . . means to meaningfully
dissipate so as to prevent a pressure wave from affecting the flow of the
remaining particles in the stream of particles” (id. (citing Ex. 1043 ¶¶ 56–
57; Ex. 1002 ¶ 45; Ex. 1042, 13–14)).
Patent Owner contends that the terms “pressure pulse” and “first
reservoir” should be construed. Prelim. Resp. 29. Patent Owner contends
that that “the plain and ordinary meaning of ‘pressure pulse,’ . . . is a
pressure increase that is inherently transient in nature” (id. at 30), and that
“[t]he prosecution history further confirms that a ‘pressure pulse’ is a
transient increase in pressure” (id. at 31). Patent Owner further contends
that the ’295 patent “never suggests that [“pressure pulse”] is a ‘flow.’” Id.
at 30 (citing Ex. 1001, 12:13–32). Patent Owner contends that “the Board
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should confirm that the prior art must disclose the ‘functional’ language, . . .
that [the first reservoir] must be ‘adapted for dampening or absorbing a
pressure pulse propagated across the flow channel.’” Id. at 32.
Petitioner responds that a “pressure pulse” is a transient increase in
pressure and that these claim terms do not “require that the flow stream (as
opposed to the pressure pulse it generates) cross the entire channel and enter
the buffer/reservoir.” Reply 3.
For the purposes of this Decision, based on the current record, we
determine that the claim term “pressure pulse” means “a transient increase in
pressure” because this is the plain and ordinary meaning of the term and is
consistent with the use of this term in the ’295 patent. We further note that
this determination is consistent with the district court’s determination that
the claim term “pressure pulse” has its “plain and ordinary meaning.”
Ex. 2012, 5–6.
Turning to the claim term “reservoir,” for the purposes of this
Decision, based on the current record, we determine that the claim term has
its plain and ordinary meaning of “a physical structure that contains fluid,”
but decline to reach any determination as to the nature or type of fluid as it is
not necessary to resolve the issues here. Wellman, 642 F.3d at 1361. This
determination is consistent with the construction adopted by the district
court. Ex. 2012, 4–5. As to the recited reservoir being “adapted for
dampening or absorbing a pressure pulse” (claim 1), this, and other,
limitations are addressed to the limited extent necessary in reaching our
Decision that Petitioner has not established a reasonable likelihood that it
would prevail in establishing the unpatentability of at least one challenged
claim. Wellman, 642 F.3d at 1361.
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C. Principles of Law
Petitioner has asserted that each of the challenged claims of
the ’295 patent is unpatentable as obvious under 35 U.S.C. § 103. A claim is
unpatentable under § 103 if “the differences between the subject matter
sought to be patented and the prior art are such that the subject matter as a
whole would have been obvious at the time the invention was made to a
person having ordinary skill in the art to which said subject matter pertains.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of
obviousness is resolved on the basis of underlying factual determinations,
including: (1) the scope and content of the prior art; (2) any differences
between the claimed subject matter and the prior art; (3) the level of skill in
the art; and (4) objective evidence of nonobviousness, i.e., secondary
considerations. See Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
“In an [inter partes review], the petitioner has the burden from the
onset to show with particularity why the patent it challenges is
unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed.
Cir. 2016) (citing 35 U.S.C. § 312(a)(3) as “requiring inter partes review
petitions to identify ‘with particularity . . . the evidence that supports the
grounds for the challenge to each claim’”); cf. Intelligent Bio-Systems, Inc. v.
Illumina Cambridge, Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016) (quoting
35 U.S.C. § 312(a)(3)) (addressing “the requirement that the initial petition
identify ‘with particularity’ the ‘evidence that supports the grounds for the
challenge to each claim’”). This burden never shifts to Patent Owner. See
Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378
(Fed. Cir. 2015) (citing Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d
1316, 1326–27 (Fed. Cir. 2008)) (discussing the burden of proof in inter
partes review). Furthermore, Petitioner cannot satisfy its burden of proving
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obviousness by employing “mere conclusory statements.” In re Magnum
Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016).
Thus, to prevail in an inter partes review, Petitioner must explain how
the proposed combinations and/or alterations of the prior art would render
them unpatentable as obvious. At this preliminary stage, we determine
whether the information in the Petition shows there is a reasonable
likelihood that Petitioner would prevail in establishing that at least one of the
challenged claims would have been obvious over the proposed combinations
and/or alterations of the prior art.
D. Overview of Prior Art
1. Wada (Ex. 1006)
Wada relates to microfluidic devices, and also describes methods and
apparatus and includes “methods for providing substantially uniform flow
velocity to flowing particles” and “[m]ethods of sorting members of particle
populations, such as cells and various subcellular components.” Ex. 1006, at
[57]. An example of a device described in Wada is depicted schematically
in Figure 22, reproduced below:
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Id. at Fig. 22 (depicting a schematic representation of a particle sorting
configuration). As disclosed in Wada, “cells 2200 are generally flowed into
a main microchannel that includes . . . sets of opposing microchannels for
focusing and/or otherwise directing the flow of cells 2200 using
hydrodynamic flow 2202” and operation of the disclosed microchannels
“direct[s] selected cells 2208 (e.g., fluorescently-labeled cells) and non-
selected cells 2206 into, in this case, one of two microchannels, each
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terminating in particular collection wells 2210.” Id. at 19:24–20:2, Fig. 22.
Detector 2204 is used to identify cells so that they can be sorted as required.
Id.
2. Anderson (Ex. 1012)
Anderson relates to “a miniaturized integrated nucleic acid diagnostic
device and system (522),” which “device (522) . . . is generally capable of
performing . . . sample acquisition and preparation operations in
combination with . . . sample analysis operation.” Ex. 1012, at [57].
Anderson discloses the use of controllable microvalves and micropumps to
direct fluid samples in a miniature fluidic system. See, e.g., 2:30–34, 5:14–
26, 9:24–27, 46:23–29, 63:1–13. Anderson sets forth that valves used “can
employ a variety of structures, but [are] preferably . . . flexible diaphragm
type valve[s] which may be displaced pneumatically, magnetically or
electrically.” Id. at 53:6–10, see also id. at 38:23–27 (identifying different
ways that a diaphragm valve may be deflected to actuate). Anderson also
sets forth a number of different types of pumps, and alternatives to pumps,
including providing pressure or motive force to the liquid sample external to
the microfluidic device. See, e.g., id. at 46:23–29, 62:18–64:31. Among the
pumps disclosed, Anderson sets forth that “pumps which hav[e] a bulging
diaphragm” and those “powered by a piezoelectric” actuator “may be used to
move the sample through the various operations of the device.” Id. at
62:18–63:13. Anderson further notes that such a “diaphragm pump will
generally be fabricated from any one of a variety of flexible materials, e.g.,
silicon [sic], latex, teflon, mylar, and the like.” Id. at 45:8–12.
3. Marcus (Ex. 1005)
Marcus relates to “[a] fluidic sorting device for the separation of two
or more visually different materials or materials which react differently to an
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externally applied force. . . . [that] are suspended in a fluid.” Ex. 1005, at
[57]. The device includes a “machine vision apparatus” that decides
whether a particle is to be sorted out, which “controls a fluidic logic element
which facilitates the separation of the particles or materials.” Id. Such a
device is depicted schematically in Figure 1, reproduced below:

Id. at Fig. 1 (depicting a schematic representation of a fluidic sorting
device). The device is described as including: a machine vision apparatus
16, which includes a machine vision camera lens 9, an image capture device
10, an image interpretation device 11, and a decision control device 12, and
optionally a counter device 13; a fluidic controller device 14; and a fluidic
logic element 1, which includes input flow port 2, control ports 3 and 4, and
output ports 5 and 6. Id. at 3:29–48, Fig. 1. As described, the machine
vision apparatus detects and arrives at a decision as to particulate matter 7
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and 8, and relays that decision to fluidic controller device 14, which
transmits signals via leads 17 and 18 to control ports 3 and 4 (of fluidic logic
element 1) in order to sort particulate matter 7 and 8 into separate output
ports 5 and 6 as required. Id. at 3:29–62.
E. Asserted Unpatentability Over Wada
Petitioner contends that claims 1–3, 9, and 18 are unpatentable under
35 U.S.C. § 103 over Wada. Pet. 5, 20–42. Patent Owner disagrees.
Prelim. Resp. 42–64. We focus our discussion on the dispositive claim
limitations of independent claim 1.
1. Petitioner’s Contentions
Petitioner first contends that “some embodiments [of Wada] . . .
reasonably would have been viewed by a [person of ordinary skill in the art]
as anticipating the claimed subject matter” and would, accordingly, render
the claims obvious. Pet. 20–21 (citing Ex. 1002 ¶¶ 107–170; Ex. 1006, Figs.
22–23); In re McDaniel, 293 F.3d 1379, 1385 (Fed. Cir. 2002) (“anticipation
is the epitome of obviousness”). Petitioner also contends that a person of
ordinary skill in the art “would have had good reason to use all the
[disclosed] elements in a single embodiment and a reasonable expectation of
success of thereby obtaining what is claimed.” Pet. 21 (citing Ex. 1002
¶¶ 107–111).
Petitioner relies on “Wada teach[ing] a first reservoir operatively
associated with the flow channel and adapted for dampening or absorbing a
pressure pulse propagated across the flow channel,” as recited in claim 1.
Id. at 26 (citing id. at 16–17; Ex. 1002 ¶¶ 125–139). Petitioner reproduces
Figures 22 and 23 of Wada, with annotations identifying what Petitioner
contends is a “first reservoir.”
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Id. (citing Ex. 1006, Figs. 22–23; Ex. 1002 ¶ 125) (depicting schematic
representations of a particle sorting configuration of Figure 23 on the left
and Figure 22 on the right, with Petitioner’s annotations that highlight in
yellow the areas it labels as “First Reservoir”). In each of the annotated
figures, Petitioner identifies the “opposing microchannel structure disposed
opposite of the actuated sorting microchannel” as a “reservoir,” where the
actuated microchannel has within it an arrow, which Petitioner identifies as a
“pressure pulse.” Id. at 26–27 (citing Ex. 1006, 19:23–20:14). Petitioner
further contends that a person of ordinary skill in the art “would have
recognized that the opposing microchannel structure . . . is a physical
structure that contains a fluid, receives a pressure pulse, and is operatively
associated with the flow channel via its fluid communication with the flow
channel,” and “is configured to . . . dampen and absorb the pressure pulse
because the structure opening is aligned with the direction of the pressure
pulse (substantially perpendicular to the main microchannel).” Id. at 27.
Petitioner further contends that a person of ordinary skill in the art “would
thus have understood that the opposed microchannel structure . . . [is] not
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only a reservoir, but . . . is also . . . adapted for dampening or absorbing a
pressure pulse propagated across the flow channel as recited in [claim 1].”
Id. at 28 (citing Ex. 1002 ¶¶ 126–130 (citing Ex. 1005, Fig. 1; Ex. 1007,
Fig. 2; Ex. 1016, 1:49–2:19, 5:44–54, Fig. 1; Ex. 1018, 341–42; Ex. 1032,
8:4–8; Ex. 1033, 198; Ex. 1034, 2:23–34, 39:25–34, 40:20–25; Ex. 1035,
377, 382–83).
Petitioner further relies on “Wada disclos[ing] its fluid direction
components ‘nudge materials across the width of a first channel’ in order to
‘direct sample flow towards or away from’ a first flow channel, and ‘into,
e.g., an additional intersecting channel or . . . channel region.’” Pet. 28
(some internal quotations omitted) (citing Ex. 1006, 18:26–19:13).
Petitioner also contends that “[w]hen the actuator in only one of the two
opposed sorting microchannel structures of Wada is activated at a given
time, . . . the well at the distal end of the opposite (non-actuated)
microchannel dampens or absorbs the pressure pulse propagated across the
flow channel.” Id. at 29 (citing Ex. 1002 ¶¶ 133–137). Petitioner also
contends on this basis that Wada teaches a structure like that in Figure 24,
but including a “first reservoir” opposite branched particle sorting
microchannel 2418, where Figure 24 depicts none. Pet. 27–29 (citing
Ex. 1006, 49:13–20; Ex. 1002 ¶¶ 129–134).
Petitioner further contends that Wada discloses a Joule heating
electrode as an exemplary actuating mechanism to generate a pressure pulse,
and that such a “Joule heating [electrode] is typically . . . positioned within a
well, microscale channel, or other cavity within the device” and that this
would have been recognized “as teaching a chamber.” Pet. 29–30 (citing
Ex. 1006, 20:23–25; Ex. 1002 ¶¶ 134–138); id. at 28–29 (citing Ex. 1006,
7:25–29, 8:12–23, 22:30–23:24). Petitioner contends that a person of
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ordinary skill in the art “would thus have had good reason to place the Joule
heating electrode . . . on the substrate within a chamber at the distal end of
each opposed sorting microchannel to generate a pressure pulse that will
propagate across the flow channel . . . to deflect a selected particle into a
selected branch of the flow channel.” Id. at 30 (citing Ex. 1006, 43:5–14;
Ex. 1002 ¶¶ 134–138).
2. Patent Owner’s Contentions
Patent Owner contends that Petitioner fails to show both that Wada
discloses a “second reservoir” for generating a “pressure pulse” (Prelim.
Resp. 46–55) and a “first reservoir” for “dampen[ing] or absorb[ing]” the
“pressure pulse” (id. at 55–61). Patent Owner further contends that
modification of Wada so as to achieve the claimed invention would modify
the operating principle of Wada’s device, and that Petitioner relies on
impermissible hindsight. Id. at 61–64.
Regarding the first reservoir, Patent Owner contends, with supporting
testimony from its declarant Don W. Arnold, Ph.D., that Petitioner’s reliance
on Wada’s Figures 22 and 23 falls short because “the ‘opposing
microchannels,’ . . . do not ‘dampen’ or ‘absorb’ anything—they are
described as useful solely for introducing ‘hydrodynamic flow.’” Id. at 57
(citing Ex. 2001 ¶¶ 130–134). Patent Owner highlights Petitioner’s reliance
on Petitioner’s characterization of “Wada’s opposed side channel as ‘non-
actuated’ and ‘aligned’ with the actuated side channel” and “conclu[sion]
that it therefore constitutes the claimed ‘reservoir,’” and Petitioner’s
determination, “alternatively, that [persons of ordinary skill in the art] would
simply know to attach a dampening/absorbing ‘reservoir.’” Id. at 59 (citing
Pet. 26–33). Patent Owner relies on Wada teaching that the “second
opposed side channel is optional and [is] for the expressly-stated purpose of
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. . . ‘introducing’ . . . ‘hydrodynamic flow.’” Id. (citing Ex. 1006, 19:29–
20:13). Patent Owner also contends that “Petitioner’s [own] expert
acknowledges as much by illustrating and discussing that precise usage”—
the introduction of hydrodynamic flow. Id. (citing Ex. 1002 ¶¶ 129–136);
see also Ex. 2001 ¶¶ 93–95 (citing Ex. 1006, 19:29–20:14), 126–127 (citing
Ex. 1006, 22:23–24:18, Fig. 24).
Patent Owner also contends, with testimony from Dr. Arnold, that
Wada’s “Joule heaters are employed solely to induce hydrodynamic flow out
of a side channel, . . . [and] Wada certainly never explains that the Joule
heating wells dampen or absorb a pressure pulse or fluid.” Id. (citing Pet.
29–30; Ex. 1006, 20:23–25; Ex. 2001 ¶¶ 74, 96–97, 127–128)).
Patent Owner also addresses a number of “background references”
cited in Dr. Weigl’s declaration—and in the citation to the portions of
Dr. Weigl’s declaration addressing both the contention that the claimed
“pressure pulse” was known in the art (id. at 53–55) and the contention that
reservoirs adapted to dampen or absorb a pressure pulse were known in the
art (id. at 60–61).
3. Analysis
On this record, Petitioner’s contention that Wada discloses a
“reservoir . . . adapted for dampening or absorbing a pressure pulse
propagated across the flow channel” amounts to little more than an assertion,
which we find lacking in support. Figure 22 of Wada depicts top and bottom
pairs of opposing microchannels that introduce hydrodynamic flow into the
main microchannel through which particles to be sorted pass. See, e.g.,
Ex. 1006, 19:27–20:2. Specifically, Wada states that “[o]ne set of opposing
microchannels is typically located, e.g., upstream from detector 2204 for
simultaneously introducing hydrodynamic flow 2202 from both
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microchannels to focus cells 2200.” Id. at 19:27–29. Wada also states that
“[a] second set of opposing microchannels is typically located downstream
from detector 2204 for introducing at least one hydrodynamic flow 2202 so
as to direct selected cells 2208 . . . and non-selected cells 2206 into, in this
case, one of two microchannels, each terminating in particular collection
wells 2210.” Id. at 19:29–20:2. Thus, both microchannels are for providing
such hydrodynamic flow into the main microchannel, as depicted in each of
Figures 22 and 23.
Wada does not indicate that any of the side microchannels is a
reservoir that absorbs or dampens a pressure pulse. The required function of
the side microchannels is wholly different, and there is no showing that what
is required to absorb or dampen a pressure pulse is included in the disclosed
structure for introducing hydrodynamic flow into the central microchannel
that cells to be sorted pass through. See generally Pet. Petitioner and
Dr. Weigl rely on Wada “describing that the fluid direction components
‘nudge’ materials across the width of the first channel,’” however, that is
insufficient to support Petitioner’s contention that “the opposed
microchannel structure in each of Figures 22 and 23 is configured to receive
. . . and to dampen and absorb the pressure pulse.” Pet. 27–29; Ex. 1002
¶ 126. On the record before us, thus, we are not persuaded that Wada
includes any reservoir adapted for dampening or absorbing a pressure pulse
such as recited in the claims. As to Dr. Weigl’s testimony to the contrary,
we find it conclusory, largely unsupported as applied to Wada, and entitled
to little weight. Dr. Weigl contends that the orientation of opposing
microchannels across from one another indicates that one, or both, of them
function as a reservoir that is adapted to dampening or absorbing a pressure
pulse, and then points to structures in other references that are not shown to
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be similar or to have the same function as support. See Ex. 1002 ¶¶ 125–
139. This position is not sufficiently supported, though, particularly where
there is insufficient explanation provided as to why what Dr. Weigl contends
is disclosed in the further “background references” is what is also present in
Wada’s disclosed structure, and what would follow based on its function.
See generally Pet.; Ex. 1002. For example, while Dr. Weigl contends that
the use of microchannel structure geometry with a channel, chamber or
reservoir structure across the source of the transient pressure pulse for
dampening or absorbing the transient pressure pulse was well known, and
that it was understood that they can be used to mitigate undesirable flow
fluctuations (see, e.g., Ex. 1002 ¶¶ 126–130), it simply does not follow that a
pair of oppositely-oriented microchannels, as disclosed in Wada for
providing fluid flow into the main microchannel, have similar structure or
that they function in like manner, and Petitioner fails to set forth clearly how
the structures are sufficiently similar at a level of detail sufficient to
establish like function (see generally Pet.). Similarly, Petitioner’s reliance
on the disclosed Joule heating wells in Wada as dampening or absorbing a
pressure pulse or fluid (id. at 29–31) fails to establish sufficient basis for
including structure that is adapted to dampen or absorb a pressure or fluid
(see generally Pet.; Ex. 1002).
As discussed above, as to “a first reservoir . . . adapted for dampening
or absorbing a pressure pulse propagated across the flow channel,” what
Wada discloses falls short, and Petitioner provides no reasonable basis for
modifying what is, in fact, disclosed in Wada to arrive at the claimed
invention. See generally Pet. Instead, as discussed above, Petitioner merely
sets forth what one of ordinary skill in the art could have done. This is not
sufficient to reasonably support a ground of obviousness. See Belden Inc. v.
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Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (“[O]bviousness
concerns whether a skilled artisan not only could have made but would have
been motivated to make the combinations or modifications of prior art to
arrive at the claimed invention.”). Further, “[c]are must be taken to avoid
hindsight reconstruction by using ‘the patent in suit as a guide through the
maze of prior art references, combining the right references in the right way
so as to achieve the result of the claims in suit.’” Grain Processing Corp. v.
American Maize-Prods. Co., 840 F.2d 902, 907 (Fed. Cir. 1988) (quoting
Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1012 (Fed. Cir.
1983)). Here, absent a sufficient explanation as to why the opposing
microchannels in Wada function to dampen or absorb a pressure pulse, or
would be adapted to do so, there is an insufficient showing that the ground
set forth by Petitioner is not grounded on hindsight reconstruction. See
Grain Processing, 840 F.2d at 907.
Petitioner fails, accordingly, to meet its burden for instituting inter
partes review on the basis of Wada. Harmonic Inc., 815 F.3d at 1363.
F. Asserted Unpatentability Over Wada and Anderson
Petitioner contends that claims 1–3, 9, 17, and 18 are unpatentable
under 35 U.S.C. § 103 over Wada and Anderson. Pet. 5, 42–49. Petitioner
relies on Anderson as “provid[ing] additional disclosures regarding specific
actuators, including the use of a reservoir or chamber that comprises a
flexible membrane suitable for generating or absorbing a pressure pulse.”
Id. at 42. Patent Owner contends that Petitioner fails to establish that
Anderson discloses the limitations missing from Wada and why the two
references would have been combined. Prelim. Resp. 64–68. We focus our
discussion on the dispositive limitations of independent claim 1.
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1. Petitioner’s Contentions
Petitioner relies on Wada directing a person of ordinary skill in the art
“to Anderson to provide additional details on actuators useful to provide
fluid flow in Wada’s microfluidic channels.” Pet. 42–43 (citing Ex. 1006,
43:13–14; Ex. 1002 ¶¶ 173–177). In particular, Petitioner relies on Wada
“stat[ing]: Examples of microfabricated pumps have been widely described
in the art. See, e.g., published international Application No. WO 97/02357,”
and notes that “WO 97/02357 is the Anderson reference.” Id. at 44–45
(citing Ex. 1012, 43:13–14); Ex. 1012, at [11].
On this basis, Petitioner contends that a person of ordinary skill in the
art would have “looked to Anderson” and “had good reason to employ, in
the microfluidic system taught by Wada, a micropump comprising a flexible
membrane, as taught by Anderson, in each of the opposing sorting
microchannel structures (i.e., first and second reservoirs), including at the
distal end of the structures.” Id. at 45–46. Petitioner relies on Anderson
disclosing particular, suitable pumping devices, those with a diaphragm or
which comprise a diaphragm pump, including those made from any of a
number of exemplary flexible materials. Id. (citing Ex. 1012, 38:17–27,
45:3–12, 63:1–13). Petitioner further contends that when actuating one of
the opposed microchannel structures to generate a pressure pulse to sort a
particle, the “non-actuated opposed sorting microchannel structure will
dampen or absorb the pressure pulse and act as the recited first reservoir.”
Id. at 46. Petitioner also contends that “[i]t would have been obvious for
each of the reservoirs to include a resilient wall, including a deflectable
membrane, for facilitating dampening or absorbing of the pressure pulse (in
the non-actuated reservoir) and for increasing pressure (in the actuated
reservoir).” Id.
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On this basis, Petitioner contends that Anderson further renders
obvious the recited “first reservoir . . . adapted for dampening or absorbing
a pressure pulse propagated across the flow channel.” Id. at 44–45 (citing
Ex. 1002 ¶¶ 173–177).
2. Patent Owner’s Contentions
Patent Owner contends that the combination with Anderson fails to
remedy the deficiencies of Wada because the “actuators and pumps in
Anderson” apply constant pressure and, thus, fail to provide “pulses” and
“do not ‘dampen or absorb’ anything.” Prelim. Resp. 64–65. Patent Owner
further contends that Petitioner fails to show that a person of ordinary skill in
the art would have had reason to combine Wada and Anderson. Id. at 65–
68.
3. Analysis
On this record, Petitioner fails to sufficiently establish that it would
have been obvious to modify Wada with the teachings of Anderson as would
be required to meet the claims. As set forth above, Petitioner has failed to
sufficiently establish both that Wada disclosed a “first reservoir . . . adapted
for dampening or absorbing a pressure pulse propagated across the flow
channel,” and that one of ordinary skill in the art would have modified Wada
so as to include such. Petitioner’s proposed combination with Anderson
does not remedy these deficiencies, in large part, because the actuators and
micropumps in Anderson are not shown to be limited to those that would
dampen or absorb a pressure pulse. See generally Pet.; Ex. 1012. Petitioner
does identify actuators and pumps that include a diaphragm in Anderson,
and that such diaphragm pumps include a flexible material as a diaphragm.
Pet. 45–46. What is lacking, however, is a sufficient reason for a person of
skill in the art to pick a diaphragm pump instead of any of the other
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micropumps disclosed in Anderson, and then include it in Wada’s device.
See, e.g., Ex. 1012, 2:30–34, 5:14–26, 9:24–27, 46:23–29, 63:1–13. Further,
while Petitioner relies on the inclusion of a flexible element as meeting the
limitation, it is not clear that even a micropump including a flexible
diaphragm is adapted to dampen or absorb a pressure pulse simply because it
includes a flexible element, as Anderson discloses that the deflectable
diaphragm flexible elements can be deflected by a variety of methods, not all
of which would appear to allow for deflection by a pressure pulse. See, e.g.,
Ex. 1012, 38:23–27.
In sum, as above, Petitioner sets forth merely what the skilled artisan
could have made, and not a sufficient basis for what they would have been
motivated to make. See Belden Inc., 805 F.3d at 1073. Also as above, there
is an insufficient showing that the ground set forth by Petitioner is not
grounded on hindsight reconstruction. See Grain Processing, 840 F.2d at
907.
Petitioner fails, accordingly, to meet its burden for instituting inter
partes review on the basis of Wada and Anderson. Harmonic Inc., 815 F.3d
at 1363.
G. Asserted Unpatentability Over Marcus and Anderson
Petitioner contends that claims 1–3, 9, 17, and 18 are unpatentable
under 35 U.S.C. § 103 over Marcus and Anderson. Pet. 5, 50–69. Petitioner
relies on Marcus’s description of a fluidic sorting device that combines
conventional sensors, fluidic sorting devices, and fluidic logic elements
produced using conventional micromachining technology, and on
Anderson’s disclosure of conventional fluidic sorting components for use in
microfluidic systems. Id. at 50–51. Patent Owner contends that Petitioner
fails to establish that Marcus and Anderson disclose the recited “pressure
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pulse” and “first reservoir . . . adapted for dampening or absorbing a
pressure pulse propagated across the flow channel,” and fails to establish
that a person of ordinary skill in the art would have had reason to combine
Marcus and Anderson to achieve the claimed invention. Prelim. Resp. 68–
74. We again focus our discussion on the dispositive limitations of claim 1.
1. Petitioner’s Contentions
Petitioner contends that Marcus and Anderson disclose or suggest all
limitations of claims 1–3, 9, 17, and 18. Pet. 50–69.
Petitioner relies on Marcus disclosing, and depicting in Figure 1, a
device with fluidic element control ports 3 and 4 controlled by a fluidic
controller device 14, and contends that a person of ordinary skill in the art
would have recognized that, upon direction by the fluidic controller device
14, fluid control ports 3 and 4 propagate a pressure pulse across the flow
channel to facilitate analysis of a particle sample. Pet. 54–56 (citing
Ex. 1002 ¶¶ 202–209; Ex. 1005, 3:37–62, Fig. 1). Figure 1 of Marcus is
reproduced below.
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Ex. 1005, Fig. 1 (depicting a schematic representation of a fluidic sorting
device).
Petitioner further relies on Figure 1 as “depict[ing] a reservoir in the
form of an opposing microchannel structure disposed opposite the actuated
sorting microchannel structure (through which the actuator selectively
applies a pressure pulse represented by the arrow associated with fluidic
control port 4).” Id. at 56–57 (citing Ex. 1005, 3:28–62; Ex. 1002 ¶¶ 210–
216). Petitioner asserts that a person of ordinary skill in the art “would have
understood the opposed microchannel structure (3) is configured to receive
the pressure pulse (flow from fluidic control port 4) and to dampen or absorb
the pressure pulse because the structure opening is aligned with the direction
of the pressure pulse (substantially perpendicular to the main
microchannel).” Id. at 57–58 (citing Ex. 1005, Fig. 1; Ex. 1002 ¶ 213).
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Petitioner further asserts that “[t]his symmetrical geometry, . . . was well-
reported and well known in the art as allowing for more precise flow
manipulations during particle sorting” (id. at 58–59 (citing Ex. 1002 ¶¶ 210–
216)), and, on this basis, that a person of ordinary skill in the art “would
have recognized that Marcus’ first reservoir is configured for absorbing or
dampening the pressure pulse” (id. at 59 (citing Ex. 1002 ¶¶ 202–217)).
2. Patent Owner’s Contentions
Patent Owner contends that “Marcus provides no specifics on its
‘sorting apparatus,’” except that “it is comprised of ‘conventional and
commercially available components’ and instructs both ‘control ports 4 and
3’ to sort particles, as depicted generically in Figure 1.” Prelim. Resp. 68–
69 (citing Ex. 1005, 3:9–12, 3:57–62, Fig. 1). In particular, Patent Owner
contends that “Marcus . . . certainly never describes employing a cross-
channel ‘pressure pulse’” (id. at 69 (citing Ex. 2001 ¶¶ 151–158)), and that
there is no basis for control ports 3 or 4 in Marcus being adapted to dampen
or absorb a pressure pulse (id. at 70–71). Patent Owner highlights that
Marcus depicts both control port 3 and 4 as indicating supplied flow, and
argues that “the mere fact that control ports are ‘aligned’ does not mean one
of them ‘dampen[s] or absorb[s]’ fluid or pressure.” Id. at 71 (citing id. at
55–61; Ex. 2001 ¶ 166). Patent Owner further contends that Anderson does
not address or remedy these deficiencies in Marcus (id. at 69–70, 71) and
that “Petitioner is again endow[ing] structures with the claimed functions
based on hindsight” (id. at 71). Patent Owner also contends that Petitioner’s
rationale to combine Marcus and Anderson falls short because there is no
sufficient guidance for what components would be combined, given the lack
of detailed teaching as to the character of Marcus’ control ports and their
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function, and the failure of Marcus to provide a reason to seek reservoirs that
operate as claimed. Id. at 72–73 (citing Ex. 2001 ¶¶ 167–168).
3. Analysis
On this record, Petitioner fails to sufficiently establish that it would
have been obvious to modify Marcus with the teachings of Anderson as
would be required to meet the claims. As highlighted by Patent Owner,
there is insufficient basis set forth forth by Petitioner for Marcus to
reasonably constitute disclosure of a “first reservoir . . . adapted for
dampening or absorbing a pressure pulse propagated across the flow
channel.” Rather, as Patent Owner contends, control ports 3 and 4 in
Marcus are only identified as ports to provide flow into the flow channel,
and Petitioner’s argument that one of the two opposed control ports must
dampen or absorb a pressure pulse simply because it is disposed opposite the
actuated port is deficient. Prelim. Resp. 71–72 (citing Pet. 54–59; Ex. 2001
¶ 166).
To the extent that Petitioner relies on the testimony of Dr. Weigl (see
Pet. 56–58 (citing Ex. 1002 ¶¶ 210–216)), we find it conclusory, largely
unsupported as applied to Marcus, and entitled to little weight. Dr. Weigl
contends that the orientation of opposing microchannels across from one
another indicates that one, or both, of them function as a reservoir that is
adapted to dampen or absorb a pressure pulse, and then points to differing
structure in other references that are not shown to be similar or to have the
same function as support. Ex. 1002 ¶¶ 210–216. This is not adequate
support for his contentions, particularly where there is inadequate
explanation provided as to why what Dr. Weigl contends is disclosed in the
further “background references” is what is also present in Marcus’ disclosed
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structure, or what would follow based on its function. See generally Pet.;
Ex. 1002.
Again, as in the combination with Wada, Anderson does not remedy
the deficiency in Marcus because there is no particular reason to use
actuators and micropumps from Anderson that would dampen or absorb a
pressure pulse for control ports 3 and/or 4, particularly as opposed to any of
the other actuators and micropumps in Anderson that would not dampen or
absorb a pressure pulse.
In sum, as above, Petitioner sets forth merely what the skilled artisan
could have made, and not a sufficient basis for what they would have been
motivated to make. See Belden Inc., 805 F.3d at 1073. Also as above, there
is an insufficient showing that the ground set forth by Petitioner is not
grounded on hindsight reconstruction. See Grain Processing, 840 F.2d at
907.
Petitioner fails, accordingly, to meet its burden for instituting inter
partes review on the basis of Marcus and Anderson. Harmonic Inc., 815
F.3d at 1363.
CONCLUSION
Based on the arguments and evidence of record, we determine that
Petitioner has not established a reasonable likelihood of prevailing on any of
its assertions that claims 1–3, 9, 17, and 18 of the ’295 patent are
unpatentable. Because of this, we need not reach the other issues raised by
the parties, including the exercise of discretion under 35 U.S.C. § 314(a).
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ORDER
For the reasons given, it is:
ORDERED that the Petition is denied as to all challenged claims of
the ’295 patent and no trial is instituted.
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FOR PETITIONER:
Michael T. Rosato
Lora Green
Douglas Carsten
Jad A. Mills
WILSON SONSINI GOODRICH & ROSATI
mrosato@wsgr.com
lgreen @wsgr.com
dcarsten@wsgr.com
jmills@wagr.com

FOR PATENT OWNER:
Kirt S. O’Neill
Daniel L. Moffett
Andy Rosbrook
Dorian Ojemen
AKIN GUMP STRAUSS HAUER & FELD LLP
koneill@akingump.com
dmoffett@akingump.com
arosbrook@akingump.com
dojemen@akingump.com