Trials@uspto. gov
`Tel: 571-272-7822
`
`P aper 13
`Entered: June 29, 2018
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`10X GENOMICS, INC.,
`P etitioner,
`
`V.
`
`BIO-RAD LABORATORIES, INC.
`Patent Owner.
`
`Case IPR201 8—00434
`
`Patent 9, 126,160 B2
`
`Before KRISTTNA M. KALAN, JON B. TORNQUIST, and
`JEFFREY W. ABRAHAM, Administrative PatentJudges.
`
`ABRAHAM, Administrative PatentJudge.
`
`DECISION
`
`Denying Institution of Inter Partes Review
`35 US. C. §314(a)
`
`

`

`IPR2018-00434
`
`Patent 9, 126, 160 B2
`
`1.
`
`INTRODUCTION
`
`10X Genomics, Inc. (“Petitioner”) filed a Petition (Paper 2, “Pet. ”)
`
`requesting inlerparte's review of claims 1—21 of US. Patent
`
`No. 9,126,160 B2 (Ex. 1001, “the ’ 160 patent”). Bio-Rad Laboratories, Inc.
`
`(“Patent Owner”) filed a Preliminary Response to the Petition (Paper 6,
`
`“Prelim. Resp”).
`
`We have authority to determine whether to institute an interpartes
`
`review. 35 U. S.C. § 314. The standard for instituting an interpartes review
`
`is set forth in 35 U.S.C. § 314(a), which provides that an interpartes review
`
`may not be instituted “unless the Director determines .
`
`.
`
`. there is a
`
`reasonable likelihood that the petitioner would prevail with respect to at
`
`least 1 of the claims challenged in the petition.”
`
`After considering the Petition, the Preliminary Response, and the
`
`evidence of record, we determine that Petitioner has not demonstrated a
`
`reasonable likelihood that it would prevail with respect to at least 1 claim
`
`challenged in the Petition. Accordingly, we deny the Petition, and do not
`
`institute an interpartes review.
`
`A. Related Proceedings
`
`The parties identify Bio-Rad Laboratories, Inc. v. I OXGenomz'cs, Inc,
`
`Case No. 3:17-CV—4339 (N .D. Cal.) and Re: Certain Microfluidic Devices,
`
`Investigation Number 337-TA—1068 (ITC) as related matters. Pet. 1; Paper
`
`4, 1. The parties also note that the ’160 patent is at issue in IPR2018-00432
`
`and IPR2018-00433. Pet. 1;Paper 4, 1.
`
`B. The ’1 60 Patent
`
`The ’ 160 patent discloses a system for forming an array of emulsions
`
`that consist of liquid droplets disposed in an immiscible carrier liquid.
`
`2
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`

`

`IPR2018-00434
`
`Patent9, 126,160 B2
`
`Ex. 1001, 1:46—47, 10:11—12. Figure 24, reproduced below, is a schematic
`
`view of a “four-port” droplet generator of the ’ 160 patent (id. at 35:41—42):
`
`Fig. 24
`
`
`
`In the droplet generator depicted in Figure 24, oil wells 1224 are loaded with
`
`a carrier fluid (e. g., oil) and sample well 1226 is loaded with a sample (e. g.,
`
`an assay mixture, such as a PCR mixture including a sample and a reagent).
`
`Id. at 35:42—47. The wells are “connected fluidly by channels 1230 formed
`
`near the bottom” of the well. Id. at 3523 5—37. The individual channels
`
`connect at intersection 1232, where droplets are formed by “any suitable
`
`mechanism, such as flow-focusing.” Id. at 35:37—40. The ’ 160 patent
`
`explains that pressure may be applied to wells 1224 and 1226, as indicated
`
`by vertical arrows 1234, “to drive fluid flow, droplet generation, and flow of
`
`the resulting droplets as an emulsion 1236 to emulsion well 1228.” Id. at
`
`35 :47—5 1.
`
`Figures 22, 23, and 25 of the ’ 160 patent are reproduced below:
`
`
`
`

`

`IPR2018-00434
`
`Patent 9,126,160 B2
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`
`
`Figures 22 and 23 show exemplary device 1220 equipped with an array of
`
`droplet generators 1222. Id. at 35:27—30. As shown in Figure 23, each
`
`droplet generator 1222 may include wells or reservoirs 1224, 1226, and
`
`1228, which can be accessed from above plate 1220. Id. at 35:32—35. The
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`wells are fluidly connected by channels 1230. Id. at 35:3 5—40. Figure 25 is
`
`a section view of plate 1220 assembled with pressure manifold 1238, which
`
`is connected to one or more pressure sources (6. g., pressure sources 1248
`
`and 1250) that exert pressure on the oil and sample wells to drive fluid flow.
`
`Id. at 35:47—51, 35:56—59, 36:20—22, 36:36—41.
`
`C. Illustrative Claim
`
`Petitioner challenges claims 1—21 of the ’ 160 patent. Independent
`
`claim 1 is illustrative of the challenged claims and is reproduced below:
`
`1. A system for forming an array of emulsions in parallel,
`comprising:
`
`

`

`IPR2018-00434
`
`Patent 9, 126, 160 B2
`
`a plate providing an array of emulsion production units each
`configured to produce a separate emulsion and each
`including a set of wells interconnected by a set of channels
`forming a channel junction, each channel being bounded
`circumferentially, each set of wells including at least one
`first input well to receive a continuous phase, a second
`input well to receive a dispersed phase, and an output well;
`
`two input
`least
`wherein the set of channels includes at
`channels extending separately from the input wells to the
`channel junction, at which droplets of the dispersed phase
`are generated in the continuous phase, and an output
`channel extending from the channel junction to the output
`well, in which an emulsion is collected.
`
`Ex. 1001, 161 :59—162:7. Claim 20 is the only other independent claim, and
`
`is substantially similar to claim 1, except for the additional recitations of “a
`
`plate having an upper member attached to a lower member” and “wherein
`
`the lower member has an upper surface that is flat and that abuts a lower
`
`surface of the upper member to form a bottom wall of openings formed in
`
`the lower surface and corresponding to the wells and the channels of each
`
`unit.” Id. at 163:15—164216.
`
`D. The Asserted Grounds of Unpatentabz'lz'ty
`
`Petitioner contends claims 1—21 of the ’ 160 patent are unpatentable
`
`based on the following grounds:1
`
`1 Petitioner also relies on a declaration from Dr. Khushroo Gandhi
`
`(Ex. 1003).
`
`

`

`IPR2018-00434
`
`Patent 9, 126, 160 B2
`
`
`
`
`
`Quake2 and Gandhi3
`
`Quake, Gandhi, andHsieh4
`
`Quake, Gandhi, and Soane5
`
`Quake, Gandhi, and Beer6
`
`Quake, Gandhi, and Chien7
`
`0......)
`
`§ 103
`
`1, 3—7, and 15
`
`O U.)
`
`§ 1 _
`
`N
`
`
`
`
`
`
`§ 103
`
`8—13, 20, and 21
`
`§ 103
`
`14
`
`§ 103
`
`16—19
`
`A. Claim Construction
`
`II.
`
`ANALYSIS
`
`In an interpartes review, claim terms in an unexpired patent are
`
`construed according to their broadest reasonable interpretation in light of the
`
`specification of the patent in which they appear. 37 C.F.R. § 42.100(b);
`
`Cuozzo Speed Techs, LLCv. Lee, 136 S. Ct. 2131, 2144—46 (2016)
`
`(upholding the use of the broadest reasonable interpretation standard).
`
`Neither party proposes express constructions for any claim terms of
`
`the ’ 160 patent and, upon review of the parties’ arguments and supporting
`
`2 US 2002/0058332 A1, published May 16, 2002 (Ex. 1004).
`3 US 2004/0228770 A1, published Nov. 18, 2004 (Ex. 1005).
`4 US 2008/0166720 A1, published July 10, 2008 (Ex. 1019).
`5 US. PatentNo. 6,176,962 B1, issued Jan. 23, 2001 (Ex. 1021).
`6 Beer et al., On—Chip, Real-Time, Single-Copy Polymerase Chain Reaction
`in PicoliterDroplets, Anal. Chem., 79, 8471—8475 (2007) (Ex. 1032).
`7 Ring-Ling Chien and J. Wallace Parce, Multiportflow-control systemfor
`lab-on-a—chip microfluia’ic devices, Fresenius J. Anal. Chem. 371 :1 06—1 1 1
`(2001) (Ex. 1035).
`
`

`

`IPR2018-00434
`
`Patent 9,126,160 B2
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`evidence, we determine that no claim terms of the ’ 160 patent require
`
`express construction for purposes ofthis decision. See Nidec Motor Corp. v.
`
`Zhongshan Broad Ocean Motor Co. , 868 F.3d 1013, 1017 (Fed. Cir. 2017)
`
`(citing Vivid Techs, Inc, v. Am. Sci. & Eng ’g, Inc. , 200 F.3d 795, 803 (Fed.
`
`Cir. 1999) (“[O]n1y those terms need be construed that are in controversy,
`
`and only to the extent necessary to resolve the controversy.”)).
`
`B. Claims 1, 3—7, and I 5 over Quake and Gandhi
`
`Petitioner contends the subject matter of claims 1, 3-—7, and 15 would
`
`have been obvious over the combined disclosures of Quake and Gandhi.
`
`I . Quake (Ex. 1004)
`
`Quake discloses a device and methods for analyzing and/or sorting
`
`biological materials, including, proteins, enzymes, viruses, and cells. Ex.
`
`1004, Abstract. The devices and methods of Quake comprise “at least one
`
`analysis unit having an inlet region in communication with a main channel at
`
`a droplet extrusion region (e. g., for introducing droplets of a sample into the
`
`main channel),” a detection region, and a detector associated with the
`
`detection region. Id. 1] 76. As the droplets pass into the detection region,
`
`they are examined by the detector for a predetermined characteristic. Id.
`
`1] 78. Quake teaches that some embodiments may include multiple detection
`
`regions and detectors, as well as “a discrimination region or branch point in
`
`communication with the main channel and with branch channels, and a flow
`
`control responsive to the detector” for sorting droplets. Id. 1111 77, 79 (noting
`
`that a “plurality of analysis units of the invention may be combined in one
`
`device,” and that such a multiplexed system “can be adapted to provide a
`
`very high throughput”). Quake further discloses the option of using “a
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`

`

`IPR2018-00434
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`Patent 9, 126, 160 B2
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`plurality of inlet regions, each of which introduces droplets of a different
`
`sample .
`
`.
`
`. into the main channel.” Id. {l 77.
`
`Quake’s droplet extrusion regions “are designed to compartmentalize
`
`small droplets of aqueous solution within microfluidic channels filled with
`
`oil.” Id. 11 3. Specifically, Quake explains
`
`[t]he droplet extrusion region generally comprises a junction
`between the sample inlet and the main channel such that a
`pressurized solution of a sample (i.e., a fluid containing a sample
`such as cells, virions or molecules) is introduced to the main
`channel in droplets. Preferably, the sample inlet intersects the
`main channel such that
`the pressurized sample solution is
`introduced into the main channel at an angle perpendicular to a
`stream of fluid passing through the main channel. For example,
`in preferred embodiments, the sample inlet and main channel
`intercept at a T-shapedjunction; i.e., such that the sample inlet is
`perpendicular (90 degrees) to the main channel.
`
`Id. 1] 84.
`
`Figure 16B of Quake, reproduced below, shows an exemplary
`
`architecture for droplet extrusion regions in a microfabricated device. Id.
`
`11 39.
`
`- 1603
`
`4 1606 1684
`
`FIG. 168
`
`“.605
`
`In Figure 16B, inlet channel 1603 intersects main channel 1605, forming a
`
`T-shaped junction. Id. 11‘“ 15, 299—300. As an aqueous solution is
`
`8
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`

`

`IPR2018-00434
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`Patent 9,126, 160 B2
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`pneumatically driven through channel 1603, it is sheared into droplets as it
`
`enters the oil stream in main channel 1605. Id. 111 290, 299—300. These
`
`droplets then are driven through outlet channel 1604, and may subsequently
`
`be routed through different channel architectures to allow individual droplets
`
`to be sorted and/or analyzed. Id. 1111 16, 290, 294, 300.
`
`Quake teaches that the channels of its device are “microfabricated, for
`
`example by etching a silicon chip.” Id. 1] 87.
`
`In this process, the fluids may
`
`be loaded into separate syringes fitted with high-pressure connection fittings
`
`for loading into a microfabricated device. Id. 1] 288. According to Quake,
`
`[t]he pressures of the different fluids are then adjusted so that
`their pressures are balanced at the droplet extrusion region. .
`.
`.
`Droplet extrusion can then be initiated by slightly adjusting the
`pressure difference between the different fluids (i.c., at the
`different inlet lines) so that the droplet fluid (e. g., water) enters
`the main channel and is sheared off at a fixed frequency.
`
`Id. 1[ 290. Quake discloses that air may be used in place of water or another
`
`fluid. Id. 11291.
`
`2. Gandhi (Ex. 1005)
`Gandhi is directed to microfluidic devices “with improved material
`
`handling characteristics and reduced costs for manufacturing.” Ex 1005 11 8.
`
`Specifically, Gandhi discloses microfluidic devices that have
`
`a body structure comprising at least a first microscale channel
`network disposed therein. The body structure has a plurality of
`ports or wells disposed in the body structure, where each port is
`in fluid communication with one or more channels in the first
`
`channel network. The devices also include a cover layer
`comprising a plurality of apertures disposed through the cover
`layer. The cover layer is mated with the body structure whereby
`each of the apertures is aligned with a separate one of the
`plurality of ports.
`
`

`

`IPR2018—00434
`
`Patent 9, 126, 160 B2
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`Ex. 1005, Abstract. An example of Gandhi’s microfluidic device body
`
`structure is depicted in Figure 1, reproduced below.
`
`
`
`
`110
`
`Fig. 1
`
`Figure 1 of Gandhi shows body structure 100, which includes upper
`
`layer 102 mated to lower layer 110. Id. W 23—24. The upper surface 112 of
`
`lower layer 110 includes grooves/wells 114, and upper layer 102 includes
`
`ports 106 that communicate with specific points of grooves/wells 114, to
`
`provide fluid access to the device. Id. 1111 24, 27.
`
`10
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`

`

`IPR2018-00434
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`Patent9, 126,160 B2
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`Gandhi illustrates a “fully assembled microfluidic device” in Figure
`
`3A, reproduced below. Id. {l 86.
`
`200
`
`
`—_..._.—..—__
`
`
`
`—_—-_~q
`“\m%.lhil-\tl'h"l\‘fi\\lfil
`\\
`
`
`
`100
`
`
`
`
`
`l
`
`Fig. 3A
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`Figure 3A shows layered body structure 100 mated with cover layer 200,
`
`forming a device which can be inserted into a controller/detector instrument.
`
`Id. 111] 84—86. Gandhi teaches that typical controller instruments include
`
`material transport systems that affect fluid movement within the channels
`
`and chambers of the microfluidic device. Id. {l 96. According to Gandhi,
`
`this can be achieved by systems employing pressure-based fluid flow, which
`
`typically include[] pressure sources as well as appropriate
`manifolds
`for
`delivering
`the
`appropriate pressures
`to
`complementary ports on the microfluidic device. The instrument
`then applies pressure/vacuum to activate the pumps and valves,
`or directly to fluids, to move those fluids through the channels of
`the device in a controlled fashion.
`
`Id.
`
`Gandhi further explains that its microfluidic devices can be used in a
`
`variety of applications, including “the performance ofhigh throughput
`
`screening assays in drug discovery, immunoassays, diagnostics, genetic
`
`analysis, and the like. As such, the devices described herein, will often
`
`11
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`

`

`IPR2018-00434
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`Patent 9, 126, 160 B2
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`include multiple sample introduction ports or reservoirs, for the parallel or
`
`serial introduction and analysis of multiple samples.” Id. 1129.
`
`3. Analysis
`
`Petitioner contends that claims 1, 3—7, and 15 would have been
`
`obvious in view of the combined teachings of Quake and Gandhi. Pet. 13.
`
`Petitioner contends that Quake discloses microfluidic emulsion generators,
`
`teaches that the emulsion generators are provided on a microfluidic chip or
`
`plate, and“suggests parallelizing the emulsion production units.” Id. at 15—
`
`17 (emphasis omitted).
`
`Petitioner contends that Gandhi also teaches “parallelizing
`
`microfluidic circuits in an array.” Id. at 17 (emphasis omitted). Petitioner
`
`notes that Gandhi discusses using microfluidic devices to perform “high
`
`throughput screening assays” and teaches that devices are miniaturized to
`
`“multiplex the particular operation, e. g., incorporate multiple operations
`
`within the same unit space occupied by the device.” Id. (emphasis omitted)
`
`(quoting Ex 1005 1111 29, 38).
`
`Petitioner asserts that “Quake taken in view of Gandhi renders
`
`obvious the provision of multiple droplet generators on a single microfluidic
`
`chip, for multiple reasons.” Id. at 18 (emphasis omitted). Petitioner’s first
`
`reason is that it was well known that parallelization provided higher
`
`througiput and enabled multiplexing of different reactions, and, therefore,
`
`“[p]ara11elizing Quake merely involved use of a known technique (placing
`
`multiple units on a single chip) to improve similar devices (emulsion
`
`generators) in the same way (providing increased throughput)” Id. (citing
`
`KSR Int ’Z‘Co. v. Teleflex Inc. , 550 US. 398, 415—421 (2007) and Ex. 1003
`
`W 60—61). Petitioner’s second reason is that Quake and Gandhi both
`
`12
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`

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`IPR2018-00434
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`Patent 9, 126, 160 B2
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`suggest providing multiple units on a single chip to enable multiplexed
`
`processing, or processing of the same sample by different processes at the
`
`same time. Id. (citing Ex. 1003 11 62). Petitioner concludes “[i]t was thus
`
`obvious that multiple instances of Quake’s droplet generator could be
`
`disposed on a single chip as depicted below to increase throughput and
`
`enable multiplexed reactions.” 1d. at 19 (emphasis omitted).
`
`Patent Owner argues Petitioner has failed to provide a reasonable
`rationale for why a person of ordinary skill in the art would have been
`
`motivated to combine Quake with Gandhi. Prelim. Resp. 27—28. Patent
`
`Owner asserts that Gandhi, unlike Quake, is not directed to emulsion
`
`generation. Id. at 27. In View of this, Patent Owner contends Petitioner’s
`
`obviousness argument is flawed because Petitioner fails to explain why a
`
`person of ordinary skill in the art would
`
`take just a portion ofthe multi-layered Quake device and attempt
`to replicate solely that portion in parallel in the body or the cover
`of Gandhi? Petitioners provide no explanation how a [person of
`ordinary skill in the art] would go about combining the disparate
`elements of the references, or what modifications a [person of
`ordinary skill in the art] would necessarily have made in order to
`combine the disparate elements.
`
`Id. at 27—28. Patent Owner also argues that Petitioner irnpermissibly relies
`
`on hindsight in arguing the claimed invention would have been obvious to a
`
`person of ordinary skill in the art. Id. at 31.
`
`After reviewing the Petition, Preliminary Response, and evidence of
`
`record, we are not persuaded by Petitioner’s arguments that it would have
`
`been obvious to a person of ordinary skill in the art to add several of
`
`Quake’s droplet generators to Gandhi’s plate. First, an assertion that a
`
`person of ordinary skill in the art “could have” disposed several of Quake’s
`
`l3
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`

`

`IPR2018-00434
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`Patent9, 126,160 B2
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`droplet generators on Gandhi’s plate (Pet. 19) is not sufficient, on its own, to
`
`support a finding of obviousness. KSR, 550 US. at418 (holding that “a
`
`patent composed of several elements is not proved obvious merely by
`
`demonstrating that each of its elements was, independently, known in the
`
`prior art,” and that “it can be important to identify a reason that would have
`
`prompted a person of ordinary skill in the relevant field to combine the
`
`elements in the way the claimed new invention does”).
`To the extent Petitioner is arguing that a person of ordinary skill in the
`
`art would have been motivated to add Quake’ 5 emulsion generators to
`
`Gandhi’s system “to increase throughput and enable multiplexed reactions”
`
`(Pet. 19) (emphasis omitted), we note that Petitioner acknowledges that
`
`Quake itself already discloses parallelization and the benefits associated with
`
`it, i.e., multiplexed processing. Id. at 16—17. Accordingly, we do not
`
`consider this to be a convincing reason to remove the emulsion generators
`
`from Quake and insert them into Gandhi’s system.
`
`We turn next to Petitioner’s arguments based on the “Combined
`
`System” formed from Quake and Gandhi. Petitioner depicts the Combined
`
`System in the graphic shown below, reproduced from the Petition (id. at 22).
`
`14
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`IPR2018-00434
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`Patent9, 126,160 B2
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`“Controller Instrument”
`
`"pressure sources"
`
`Quake + Gandhi
`
`“manifolds for‘ delivering
`
`the appropriate pressures
`
`to comptementary ports on
`the microfluid’i‘cdevice.”
`
`This graphic shows Petitioner’s proposed Combined System involving
`
`adding the junction shown in Figure 16B of Quake to the microfluidic chip
`
`100 of Gandhi, snapping chip 100 into place within cover 200 of Gandhi,
`
`and placing the device into a controller instrument. Id.
`
`According to Petitioner, in the Combined System,
`
`four of Quake’s emulsion generation units are provided in a
`parallel array (as suggested by both Quake and Gandhi) on the
`microfluidic chip 100 of Gandhi, each emulsion generator
`corresponding to a row of input/output wells 106/206. (Ex. 1003
`1164.) The microfluidic chip 100 is adhered to or snapped into
`place within the cover 200. (Id) The device or plate 300 is then
`placed into a controller instrument which applies positive or
`negative air pressure to each well to drive the fluids as desired
`from input reservoir, through the emulsion generators, to output
`reservoirs. (Id)
`
`15
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`

`

`IPR2018-00434
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`Patent9, 126,160 B2
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`Id.
`
`Petitioner contends the Combined System has input and output wells
`as recited in claim 1. Id. at23 (citing Ex. 1003 1] 65). Petitioner argues that
`
`a person of ordinary skill in the art would have had at least four reasons to
`
`use Gandhi’s control instrument to drive fluids through the emulsion
`
`production units of Quake in the Combined System. Id. at 24—26 (citing
`
`Ex. 1003 W 67—68). These include (1) Gandhi’s system simplifies the
`
`interface of the chip to the pneumatic control system, (2) Gandhi’s cover
`
`provides enhanced fluid reservoir volume, (3) Gandhi’s system facilitates
`
`handling and reduces overall cost of manufacturing, and (4) using air to
`
`control pressure in the headspace above fluid wells was known to improve
`
`precision and reproducibiliy of the fluidic drive. Id. In View of these
`
`reasons, Petitioner concludes that “[a] skilled artisan would have been
`
`strongly motivated to combine the teachings of Quake and Gandhi
`
`references to arrive at the Combined System.” Id. at 26 (citing Ex. 1003 111]
`
`55—69).
`
`We are not persuaded by Petitioner’s arguments. Petitioner’s
`
`Combined System specifically requires inserting Quake’s emulsion
`
`production units into Gandhi’s system, as shown in the graphic above. Id. at
`
`22 (describing the Combined System as involving “four of Quake’s
`
`emulsion generation units” that “are provided in a parallel array (as
`
`suggested by both Quake and Gandhi) on the microfluidic chip 100 of
`
`Gandhi”). Petitioner, however, never explains sufficiently why a person of
`
`ordinary skill in the art would do so. For example, Petitioner does not
`
`explain sufficiently whether Quake’s emulsion production units are
`
`advantageous, and/or whether or how Quake’s emulsion production units
`
`16
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`IPR2018-00434
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`Patent 9, 126, 160 B2
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`would improve Gandhi’s system. Nor does Petitioner provide evidence of a
`
`design need or market pressure to solve a problem that would have led a
`
`person of ordinary skill in the art to the proposed combination. KSR, 550
`
`US. at 402. Although Gandhi does address using air to control pressure, we
`
`note that Quake already teaches the use of a pressurized stream of oil in the
`
`main channel of its device, and that pressures ofdifferent fluids can be
`
`adjusted so they are balanced at the droplet extrusion region to control
`
`droplet size and frequency. Ex. 1004 11'” 287—290.
`
`Petitioner’s attempt to rely on the positive attributes of Gandhi’s
`
`system to support its argument that a person of ordinary skill in the art
`
`would have been motivated to form the Combined System is misguided.
`
`Petitioner‘s evidence may support an argument that a person of ordinary
`
`skill in the art would have been motivated to mock)? Quake’s system in view
`
`of Gandhi to benefit from the purported advantages noted in Gandhi. As
`
`discussed above, however, the Combined System does not involve modzfi/ing
`
`Quake ’s system in view of Gandhi. Instead, Petitioner specifically argued
`
`that the Combined System involves removing one piece of Quake’s system
`
`and inserting it into Gandhi’s system.
`
`Petitioner directs us to paragraph 67 of the Gandhi Declaration to
`
`support the conclusion that a person of ordinary skill in the art would have
`
`had a reason to form the Combined System. Pet. 25. In paragraph 67, Dr.
`
`Gandhi discusses the same benefits attributed by the Petition to Gandhi’s
`
`system, but concludes that “one of ordinary skill in the art [would] have
`
`been motivated to modify Quake to incorporate the pneumatic fluid drive
`
`technique taught in Gandhi.” Ex 1003 1] 67. Dr. Ghandi’s statement does
`
`not support Petitioner’s conclusion regarding the Combined System because,
`
`17
`
`

`

`IPR2018—00434
`
`Patent 9, 126, 160 B2
`
`as noted above, Petitioner’s Combined System does not involve modifying
`
`Quake to incorporate the fluid drive technique taught in Gandhi. Rather, it
`
`involves removing Quake’s emulsion generator from Quake’s system, and
`
`inserting it into Gandhi’s system.
`
`In the absence of sufficient arguments and evidence demonstrating
`
`that a person of ordinary skill in the art would have had a reason to form the
`
`Combined System, Petitioner’s combination of Quake’s emulsion generator
`
`and Gandhi’s system appears to be based on impermissible hindsight. See In
`
`re Fritch, 972 F.2d 1260, 1266 (Fed. Cir. 1992); see Prelim. Resp. 30—3 1.
`
`Even if we were persuaded by Petitioner’s arguments that a person of
`
`ordinary skill in the art would have had a reason to form the Combined
`
`System, Petitioner would still need to demonstrate that a person of ordinary
`
`skill in the art would have had a reasonable expectation of success in doing
`
`so. CRFD Research, Inc. v. Mata], 876 F.3d 1330, 1340 (Fed. Cir. 2017)
`
`(“An obviousness determination requires finding both ‘that a skilled artisan
`
`would have been motivated to combine the teachings of the prior art
`
`references to achieve the claimed invention, and that the skilled artisan
`
`would have had a reasonable expectation of success in doing so.”’). In that
`
`regard, Petitioner contends that a person of ordinary skill in the art would
`
`have had a “strong expectation that the Combined System could be readily
`
`fabricated and would work as intended” because the components of the
`
`Combined System were wcll known and “could be predictably combined.”
`
`Pet. 26 (emphasis omitted) (citing Ex. 1003 W 68-69).
`
`Whether or not the Combined System would work as intended,
`
`however, involves an analysis beyond the question of whether a person of
`
`ordinary skill in the art could place Quake’s devices on Gandhi’s plates.
`
`18
`
`

`

`IPR2018-00434
`
`Patent 9, 126, 160 B2
`
`Neither Petitioner nor Dr. Gandhi address sufficiently whether Quake’ s
`
`emulsion generation units would actually work as intended (i.e., form
`
`emulsion droplets) in Gandhi’s system. F abricatingPetitioner’s Combined
`
`System appears to involve placing Quake’s devices within microfluidic body
`
`100 of Gandhi, attaching cover 200, and placing the plate within a controller
`
`instrument, which applies positive or negative air pressure to drive the fluids
`
`through the channels in the plate. See id. at 22. As noted above, Quake’s
`
`emulsion generators operate within a system that includes the use of a
`
`pressurized stream of oil in the main channel of its device, wherein pressures
`
`of different fluids can be adjusted at the droplet extrusion region to control
`
`droplet size and frequency. Ex. 1004 1111 287—290. Petitioner does not
`
`address whether and/or how Quake’s emulsion generators would operate in a
`
`different system, such as that used in Gandhi, which, as Patent Owner points
`
`out, does not explicitly refer to emulsion generation.
`
`Accordingly, Petitioner’s and Dr. Gandhi’s conclusory statements that
`
`a person of ordinary skill in the art could arrange several of Quake’s
`
`emulsion generating units on Gandhi’s plate, and that a person of ordinary
`
`skill in the art would have a “strong expectation” that the Combined System
`
`would work as intended, do not address sufficiently whether the Combined
`
`System would actually work as intended. KSR, 5 50 U. S. at 41 8
`
`(“[R] ejections on obviousness grounds cannot be sustained by mere
`
`conclusory statements; instead, there must be some articulated reasoning
`
`with some rational underpinning to support the legal conclusion of
`
`obviousness”) (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)).
`
`In view of the foregoing, and upon review of Petitioner’s arguments
`
`and supporting evidence, including Dr. Gandhi’s declaration testimony, we
`
`19
`
`

`

`IPR2018-00434
`
`Patent 9, 126,160 B2
`
`are not persuaded that one of ordinary skill in the art, absent hindsight and
`
`the use of the ’ 160 patent as a roadmap, would have combined the teachings
`
`of Quake and Gandhi to arrive at the claimed subject matter, or that a person
`
`of ordinary skill in the art would have had a reasonable expectation of
`
`successfully doing so. Accordingly, Petitioner has not demonstrated a
`
`reasonable likelihood that the subject matter of independent claim 1 would
`
`have been obvious over the combined disclosures of Quake and Gandhi. We
`
`reach the same conclusion regarding claims 3—7 and 15, which depend from
`
`claim 1, because Petitioner’s arguments and evidence with respect to these
`
`claims do not remedy the defects identified above. As a result, Petitioner
`
`has not demonstrated a reasonable likelihood that the subject matter of these
`
`claims would have been obvious over the combined teachings of Quake and
`
`Gandhi.
`
`C. Remaining Grounds Based on Quake, Gandhi, and either Hsieh,
`Soane, Beer, or Chi en
`
`Petitioner’s remaining challenges to claims 2, 8—14, and 16—19 (which
`
`depend from claim 1), independent claim 20, and claim 21 (which depends
`
`from claim 20) all rely on the aforementioned arguments regarding the
`
`proposed combined teachings of Quake and Gandhi. Pet. 48—72.
`
`Petitioner’s arguments with respect to the remaining challenges do not
`
`resolve the deficiencies noted above with respect to the combined teachings
`
`of Quake and Gandhi. Accordingly, Petitioner has not demonstrated a
`
`reasonable likelihood that independent claim 20 or dependent claims 2, 8—
`
`14, 16—19 and 21 would have been obvious over the combined teachings of
`
`Quake and Gandhi with either Hsieh, Soane, Beer, or Chien.
`
`2O
`
`

`

`IPR2018-00434
`
`Patent9, 126,160 B2
`
`111.
`
`CONCLUSION
`
`For the reasons discussed above, Petitioner has not demonstrated a
`
`reasonable likelihood that it would prevail with respect to at least one claim
`
`challenged in the Petition. Accordingly, we do not institute interpartes
`
`review.
`
`1V. ORDER
`
`It is hereby,
`
`ORDERED that no interpartes review is instituted.
`
`21
`
`

`

`IPR2018-00434
`
`Patent 9, 126,160 B2
`
`PETITIONER:
`
`Greg Gardella
`ggardella@gardellag§ace.com
`
`Dianna DeVore
`
`ddevorechonvergentlaw.corn
`
`Sarah Brashears
`
`sbrashears@convergentlaw.com
`
`PATENT OWNER:
`
`Jim Glass
`
`1' img!ass@g uinnemanuel. com
`
`Kevin Johnson
`
`kevinj ohnson@guinnemanuel. com
`
`David Bflsker
`
`davidbilsker@guinnemanuel.corn
`
`Joseph Milowic III
`josephmilowic@guinnernanuel.com
`
`Nancy Zhang
`nzhan ws
`
`.com
`
`22
`
`

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