Trials@uspto.gov
`Tel: 571—272-7822
`
`Paper 7
`Entered: December 10, 2018
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`10X GENOMICS, INC.,
`
`Petitioner,
`
`V.
`
`BIO-RAD LABORATORIES, INC.,
`
`Patent Owner.
`
`Case IPR2018—01207
`
`Patent 9,649,635 B2
`
`Before KRISTINA M. KALAN, JON B. TORNQUIST, and
`DEBRA L. DENNETT, Administrative Patent Judges.
`
`KALAN, Administrative Patent Judge.
`
`DECISION
`
`Denying Institution of Inter Partes Review
`35 USC. §314(a)
`
`

`

`IPR2018-01207
`
`Patent 9,649,635 B2
`
`1.
`
`INTRODUCTION
`
`10X Genomics, Inc. (“Petitioner”) filed a Petition (Paper 1, “Pet.”)
`
`requesting inter partes review of claims 1—10 and 12—27 of US. Patent
`
`No. 9,649,635 B2 (Ex. 1001, “the ’635 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 inter partes
`
`review. 35 U.S.C. § 314. The standard for instituting an inter partes review
`
`is set forth in 35 U.S.C. § 314(a), which provides that an inter partes 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 one claim
`
`challenged in the Petition. Accordingly, we deny the Petition, and do not
`
`institute an inter partes review.
`
`A. Related Proceedings
`
`The parties identify Bio—Rad Laboratories, Inc. v. 10X Genomics, 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 ’635 patent is at issue in IPR2018-
`
`01206. Pet. 1; Paper 4, l.
`
`B. The ’635 Patent
`
`’
`
`The ’635 patent, titled “System for Generating Droplets with Push-
`
`Back to Remove Oil,” is directed to a “[s]ystem, including methods,
`
`

`

`IPR2018-01207
`
`Patent 9,649,635 B2
`
`apparatus, and kits, for forming and concentrating emulsions” that “may
`
`comprise a device including a sample well configured to receive sample-
`
`containing fluid, acontinuous-phase well configured to receive continuous-
`
`phase fluid, a droplet well, and a channel network interconnecting the
`
`wells.” Ex. 1001, at [54], [57]. The instrument may apply pressure to
`
`emulsion phases held by a microfluidic chip to drive formation and
`
`collection of emulsions in the chip. Id. at 4:63—65. Figure 6 of the ’635
`
`patent is reproduced below:
`
`
`
`Figure 6 of the ’635 patent is an exploded view of a microfluidic chip 152.
`
`Id. at 3:64—67, 4:4. Figure 6 shows upper member 180 forming bottom
`
`region or base 184 and plurality of tubular projections 186 forming lateral
`
`side walls 188 of one of wells 168—170. Id. at 11:63—67. Lower member
`
`182 may form a bottom wall of each of wells 168—172. Id. at 1222—4.
`
`Figure 11 of the ’635 patent is reproduced below:
`
`

`

`IPR2018—01207
`
`Patent 9,649,635 B2
`
`Fig. 1 1
`
`
`
`Figure 11 of the ’635 patent is a “less schematic bottom View of the single
`
`emulsion formulation unit” depicted in Figure 9, which is a “somewhat
`
`schematic bottom View of a single emulsion formation unit of the chip of
`
`FIG. 6.” Id. at 429—12, 4:14—15. As shown in Figure 11, wells 168, 170, and
`
`172 are connected by network of channels 210—216, which intersect at and
`
`form droplet generator 198. Id. at 13:13—44. At droplet generator 198,
`
`droplets of sample fluid are generated, creating an emulsion that may be
`
`received and collected at output well 172. Id. at 12:16—25.
`
`Figure 20 of the’635 patent is reproduced below:
`
`Fig. 20
`
`
`
`' me:
`.
`5"" ’
`4‘14th 3—...* E‘fi
`
`
`
`1mv.nm'mlmn\mmlus _
`
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`
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`
`12
`
`t 2.
`
`
`
`Figure 20 is a sectional View of the manifold, chip, and gasket of Figure 19.
`
`Id. at 4:44—46. Figure 20 shows manifold 72, chip 152, gasket 154, ports 76,
`
`row of gasket orifices 176, and wells 172. Id. at 21:55—57. Main
`
`channel 430 may be fluidically connected to each well 172. Id. at 21 :64—65.
`
`Pressure may be applied to wells 172 Via manifold 72. Id. at 22: 15—19.
`
`

`

`IPR2018-01207
`
`Patent 9,649,635 B2
`
`C. Illustrative Claim
`
`Petitioner challenges claims 1—10 and 12—27 of the ’635 patent.
`
`Claim 1 is reproduced below:
`
`1. A system to form and concentrate an emulsion, comprising:
`a device including a sample well configured to receive sample-
`containing fluid, a continuous-phase well configured to
`receive continuous-phase fluid, and a droplet well, the
`device also including a channel network having a first
`channel, a second channel, and third channel that meet one
`another in a droplet-generation region; and
`an instrument configured to operatively receive the device and
`to create
`(a) a first pressure differential to drive sample—containing fluid
`from the sample well to the droplet-generation region Via the
`first channel, continuous-phase fluid from the continuous-
`phase well to the droplet-generation region via the second
`channel, and sample-containing droplets from the droplet-
`generation region to the droplet well via the third channel,
`such that the droplet well collects an emulsion including
`sample-containing droplets disposed in continuous-phase
`fluid, and
`(b) a second pressure differential to decrease a volume fraction
`of continuous-phase fluid in the emulsion, after the emulsion
`has been collected in the droplet well, by selectively driving
`continuous-phase fluid, relative to sample-containing
`droplets, from the droplet well via the third channel.
`
`Ex. 1001, 33:29—55.
`
`D. The Asserted Grounds of Unpatentability
`
`Petitioner contends claims 1—10 and 12—27 of the ’635 patent are
`
`unpatentable based on the following grounds (Pet. 17, 69):1
`
`1 Petitioner also relies on a declaration from Dr. Khushroo Gandhi
`
`(Ex. 1003).
`
`

`

`IPR2018-01207
`
`Patent 9,649,635 B2
`
`Kumacheva,2 Modlin,3 and Mason4
`
`§ 103
`
`
`
`
`
`
`
`Claims Challenged
`
`1—8, 12—14, 16—21,
`and 23—37
`
`
`
`Kumacheva, Modlin, Mason, and
`Banerj e65
`
`§ 103
`
`9—10, 15, and 22
`
`11. ANALYSIS
`
`A. Claim Construction
`
`In an inter partes 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 CPR. § 42.100(b);
`
`Cuozzo Speed Techs, LLC v. Lee, 136 S. Ct. 2131, 2144—46 (2016)
`(upholding the use of the broadest reasonable interpretation standard).6
`Upon review of the parties’ arguments and supporting evidence, we
`determine that no claim terms of the ’635 patent require express construction
`
`for purposes of this Decision. See Nidec Motor Corp. v. Zhongshan Broad
`
`Ocean Motor C0., 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]nly
`
`2 US 2010/0184928 A1, published July 22, 2010 (Ex. 1004).
`3 US 2005/0266582 A1, published Dec. 1, 2005 (Ex. 1005).
`4 WO 2010/124068 A2, published Oct. 28, 2010 (Ex. 1006).
`5 WO 2007/ 123744 A2, published Nov. 1, 2007 (Ex. 1008).
`6 The revised claim construction standard for interpreting claims in inter
`partes review proceedings as set forth in the final rule published October 11,
`2018, does not apply to this proceeding, because the new “rule is effective
`on November 13, 2018 and applies to all IPR, PGR and CBM petitions filed
`on or after the effective date.” Changes to the Claim Construction Standard
`for Interpreting Claims in Trial Proceedings Before the Patent Trial and
`Appeal Board, 83 Fed. Reg. 51340 (Oct. 11, 2018) (to be codified at 37
`C.F.R. pt. 42).
`
`

`

`IPR2018—01207
`
`Patent 9,649,635 B2
`
`those terms need be construed that are in controversy, and only to the extent
`
`necessary to resolve the controversy.”)).
`
`B. Claims 1—8, 12—14, 16—21,and 23—37 over Kumacheva, Modlin,
`and Mason
`
`Petitioner contends the subject matter of claims 1—8, 12—14, 16—21,
`
`and 23—37 would have been obvious over the combined disclosures of
`
`Kumacheva, Modlin, and Mason. Pet. 17—68.
`
`1. Kumacheva (Ex. 1004)
`
`Kumacheva discloses “a multiple droplet generator integrating two or
`
`more parallel flow-focusing devices (FFDs).” Ex. 1004, Abstract. Figures 1
`
`and 2 of Kumacheva depict portions of the disclosed multiple droplet
`
`generator, and are reproduced below:
`
`3e
`
`26
`
`28
`
`t
`
`20
`
`38
`34
`/ 2
`_:v_/
`
`/
`
`32
`
`FIG. 1
`
`FIG. 2
`
`Figure 1 is a schematic of droplet formation in an individual planar
`
`microfluidic flow—focusing droplet generator, and Figure 2 is a top view of
`
`an individual droplet generator depicting the direction of fluid flow. Id.
`
`1F“ 40—41.
`
`In the FFDs of Kumacheva, immiscible liquids A (droplet phase)
`
`and B (continuous phase) are combined to form an emulsion. Id. W 31, 61—
`
`62. Liquid A enters through opening 42 (Figure 2) and travels downstream
`
`through central microchannel 30. Id. 1] 62. Liquid B enters through side
`
`microchannels 26 and travels downstream via microchannels 32. Id. As
`
`

`

`IPR2018-01207
`
`Patent 9,649,635 B2
`
`shown in more detail in Figure l, liquids A and B are forced through narrow
`
`orifice 34 where “a thread of liquid A breaks up and releases droplets 62”
`
`within outlet microchannel 38. Id. 1] 61.
`
`Figure 3 of Kumacheva is reproduced below:
`
`
`
`FIG, 3
`
`Figure 3 shows a 3D illustration of four parallel flow-focusing devices 20.
`
`Id. 1] 63. As shown in Figure 3, the device of Kumacheva uses a single
`
`inlet 22 for the continuous phase, a single inlet 52 for the droplet phase, and
`
`a single outlet 64 to remove the droplets from the system. Id. 1H 2, 13
`
`(noting that the use of “two inlets for the droplet and continuous phases” can
`
`avoid “the use of multiple pumps supplying liquids to each microreactor”),
`
`20 (noting that “two or more parallel flow-focusing devices” are provided
`
`“with a single overall inlet branching into multiple inlets associated with
`
`each of the flow-focusing devices .
`
`.
`
`. and a single outlet”). After the
`
`continuous phase is supplied through inlet 22, it is subsequently split into
`
`channels 26 and then channels 32 (shown in Figures 1 and 2). Id. 1] 66.
`
`After‘the droplet phase is injected into inlet 52, it is delivered to openings 42
`
`and subsequently travels through microchannels 30. Id. Droplets generated
`
`by flow-focusing devices 20 then travel through downstream channels 38 to
`
`outlet 64. Id.
`
`

`

`IPR2018-01207
`
`Patent 9,649,635 B2
`
`2. Modlin (Ex. 1005)
`
`Modlin discloses a “microfluidic system for performing chemical
`
`reactions or biochemical, biological, or chemical assays utilizing a
`
`rnicrofabricated device or ‘chip.”’ Ex. 1005, Abstract. Figures 49 and 50 of
`
`Modlin are reproduced below:
`
`Exemplary
`Standard Cells
`
`BEEEEBBEBEEEEBBEEEEEEEBEEBEEEBEBBEBEEEBBEBBEEBEEEEEBEEEBEEEBEEBQBEBEEBEBEEEBBBBEBEBEEEBE
`
`Exemplary S-Pon
`Standard Cell
`:32
`
`
`
`00N00
`
`E in»g? ’31W A\0
`
`’33 30
`
`L11 0
`
`As shown in Figure 49, unit cell array 804 contains standard unit cells 820,
`
`which are replicated 96 times in “an industry standard 384 well format.” Id.
`
`11 209. As shown in Figure 50, each exemplary “4 port” standard unit
`
`cell 820 has four access ports that are each connected to at least one channel.
`
`Id. M 209—210.
`
`Figures 34 and 35 of Modlin are reproduced below:
`Sample Wells
`~
`r
`.
`610:!
`Well Flam
`”Mm” Mwwlmsclgcllnm
`Mimfluidit
`Assembly
`
`614
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`
`Figure 34 is a cross sectional perspective View of a microfluidic well plate,
`
`and Figure 35 is a partial cut away perspective view of the microfluidic well
`
`plate of Figure 34. Id. 1111 177—178. As shown in Figure 35, sample
`
`9
`
`

`

`IPR2018-01207
`
`Patent 9,649,635 B2
`
`wells 614 are preferably positioned over access ports 622. Id. 11 178.
`
`Channel 106f is formed between the surface of fabricated substrate 118f and
`
`the surface of membrane 1 10f and provides a fluid connection between
`
`access ports 622. Id. Modlin explains that the well to well spacing, or well
`
`pitch, of the standard unit cells “is designed to match industry standard
`
`microplate well pitches including but not limited to 96, 384, and 1536 well
`
`formats,” which ensures that the microfluidic well plates are “compatible
`
`with standardized fluid handling equipment.” Id. 1] 211.
`
`Figure 44 of Modlin, reproduced below, depicts pressure
`
`manifold 754 connected to microfluidic well plate 610:
`750
`
`
`
`
`
`757
`
`759
`
`Robot
`Controller
`
`755b
`
`
`Chip
`
`Controller]
`Reader
`
`755.
`
`
`—/
`
`754
`
`IIIIIIIIIIIIIIII
`Microfluidic
`WellPIale 610
`(Packaged Chip)
`
`‘
`F18. 44
`
`Manifold 775 may be mechanically aligned and sealably mounted to well
`
`plate 610 to distribute “pneumatic, hydraulic, electronic, mechanical, or
`
`optical signals” to their intended destinations on well plate 610. Id. 1111 201—
`
`202.
`
`3. Mason (Ex. 1006)
`
`Mason, titled “System and Method for Recycling Surfactant in
`
`. Emulsion Production,” is directed to a surfactant recovery system connected
`
`to an emulsification system to receive the emulsion when produced from
`
`first and second liquids. Ex. 1006, at [54], [57]. Mason discloses a
`
`10
`
`

`

`IPR2018-01207
`
`Patent 9,649,635 B2
`
`surfactant recovery system that “recovers at least a portion of surfactant
`
`from the emulsion when the emulsion is received from the emulsification
`
`system.” Id. Till 3—4. The system and method of Mason does so by draining
`
`the continuous phase, in which the surfactant is dissolved, from the droplets
`
`by, e. g., gravitational draining, filtering, osmosis, wicking, sedimentation,
`
`sieving, draining, or by using pumps. Id. {[11 24-26.
`
`4. Banerjee (Ex. 1008)
`
`Banerjee, titled “Systems and Devices for Sequence by Synthesis
`
`Analysis,” is directed to systems and devices for sequencing of nucleic acid,
`
`such as short DNA sequences from clonally amplified single—molecule
`
`arrays. Ex. 1008, at [54], [57]. Banerjee’s systems and devices may include
`
`a planar solid substrate having one or more polynucleotides displayed
`
`thereon, a temperature control system, an optical system, a light source, a
`
`detector component, and a computer. Id. 11 7. Banerjee teaches that its
`
`system can. be “equipped with pressure sensors that automatically detect and
`
`report features of the fluidic performance of a system, such as leaks,
`
`blockages, and flow volumes.” Id. 1i 90.
`
`5. Summary of the Parties ’ Arguments
`
`Petitioner contends a skilled artisan would have found it obvious to
`
`configure Kumacheva’s FFD 36 in Modlin’s 3-1 combiner unit cell 822, as
`
`shown below (Pet. 25):
`
`822
`
`
`
`ll
`
`

`

`IPR2018-01207
`
`Patent 9,649,635 B2
`
`In Petitioner’s proposed configuration, access ports 1 and 4 of unit cell 822
`
`contain the continuous phase and are connected to channels 32 of
`
`Kumacheva’s FFD. Id. Access port 3 of unit cell 822 contains the aqueous
`
`(dispersion) phase and is connected to channel 30 of Kumacheva’s FFD. Id.
`
`According to Petitioner, droplets are generated “at the cross-shaped
`
`junction” of Kumacheva and “routed through output channel 38 of
`
`Kumacheva’s FFD 36 to output port 2 of unit cell 822.” Id.; Ex. 1003 11 63.
`
`To drive fluid flow, the combined well plate assembly is sealably mated with
`
`a pressure manifold, as described in Modlin. Pet. 26; Ex. 1005, Fig. 44.
`
`This proposed configuration is part of an overall proposed “Combined
`
`System,” illustrated by Petitioner as follows (Pet. 18):
`
`Standard
`384 Well
`
`Standard Cell
`
`Fig. 52
`
`XXXXXXXX
`
`XXXXXXXX
`
`XXXXXXXX
`
`XXXXXXXX
`
`XXXXXXXX
`
`XXXXXXXX
`
`XXXXXXXX
`
`XXXXXXXX
`
`XXXXXXXXmXXXXXXXXgXXXXXXXX
`
`6l0a
`\Vell Flam
`5 Microfluldi:
`Assembly
`r;I
`
`“1,in
`
`Micmplzne Well Frame
`6‘2
`
`'B’VS'B’B“! mum-‘1‘-
`
`Access Pm Accus PM
`
`Fig. 34
`620
`
`(Pmkngndnaip)
`
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`
`i
`
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`
`Combined
`
`System
`
`Petitioner contends the Combined System of Kumacheva, Modlin, and
`
`Mason teaches or suggests every limitation of independent claim 1. More
`
`specifically, Petitioner contends that the Combined System includes an array
`
`12
`
`

`

`IPR2018-01207
`
`Patent 9,649,635 B2
`
`of Kumacheva’s droplet or emulsion generators on Modlin’s microfluidic
`
`chip, and concentrates the emulsion as suggested by Mason. Id. at 37.
`
`Petitioner contends the proposed system has an array of emulsion production
`
`units (id. at 19), a microplate well configuration for parallelizing multiple
`
`microfluidic circuits (id. at 20), a system for operating a microfluidic chip
`
`and associated reagents (id. at 21), an air pressure reservoir, valves for
`
`coupling the air pressure source to the wells on the microfluidic chip, and
`
`pressure sensors (id. at 22). Regarding the elements of claim 1, Petitioner
`
`argues that Kumacheva has a surfactant-containing continuous phase and a
`
`droplet phase (id. at 39—40), Modlin has upwardly-extending wells (id.
`
`at 40—41), Kumacheva has a network of channels that meet at a droplet
`
`generating junction (id. at 42—43), Modlin’s instrument receives the
`
`microfluidic device and includes a fluidic pressure system configured to
`
`create a pressure differential (id. at 43—45), and Mason teaches the
`
`advantages of removing surfactant-containing continuous phase from
`
`emulsions by draining the continuous phase (id. at 46—49).
`
`Petitioner contends one of ordinary skill in the art would have sought
`
`to make the proposed Combined System in order to increase the number of
`
`different droplet and continuous phases that may be used simultaneously, to
`
`permit analysis of multiple different samples from multiple different patients
`
`at the same time, to increase Kumacheva’s compatibility with standard
`
`laboratory equipment, and to increase the degree of parallelization of
`
`Kumacheva’s device. Id. at 28—30. Petitioner further argues that it “would
`
`have been obvious to use reverse flow effected by Modlin’s instrument to
`
`drain the surfactant-containing continuous phase, thereby permitting reuse or
`
`recycling of the surfactant as described by Mason.” Id. at 33. Petitioner
`
`13
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`

`

`IPR2018-01207
`
`Patent 9,649,635 B2
`
`contends that one of ordinary skill in the art would have made this
`
`modification to reduce the cost of producing emulsions, particularly
`
`microemulsions, that it was commonplace to recover surfactants in the
`
`context of non-microemulsions, and that the droplets could be stored in a
`
`more compact manner. Id. at 33—34 (citing Ex. 1003 fl 72).
`
`Patent Owner contends Petitioner has failed to provide a reasoned
`
`explanation as to why one of ordinary skill in the art would have sought to
`
`combine Kumacheva, Modlin, and Mason in the manner proposed in the
`
`Petition. Prelim. Resp. 16—24. According to Patent Owner, “the centerpiece
`
`of the Petition .
`
`.
`
`. is actually nothing more than a collage of figures put
`
`together by Petitioner to follow the blueprint set forth in the ’635 patent,”
`
`which Patent Owner contends is “the epitome of impermissible hindsight.”
`
`Id. at 23. Patent Owner also contends that assignor estoppel bars Petitioner
`
`from challenging the validity of the ’635 patent. Id. at 30—33. In View of the
`
`recent Federal Circuit determination that assignor estoppel does not apply in
`
`inter partes review proceedings, we need not address this argument. Arista
`
`Networks, Inc. v. Cisco Systems, Inc, No. 17-1525 (Fed. Cir. Nov. 9, 2018).
`
`6. Analysis
`
`Although the elements of Petitioner’s Combined System appear
`
`similar to the elements of the emulsion generator depicted in the ’635 patent,
`
`for the reasons set forth below, we agree with Patent Owner that neither
`
`Petitioner nor Dr. Gandhi explains persuasively why one of ordinary skill in
`
`the art, absent resort to hindsight and/or use of the ’635 patent as a roadmap,
`
`would have sought to make such a combination. See KSR Int ’1 Co. v.
`
`Teleflex Inc., 550 US. 398, 418 (2007) (“[A] patent .
`
`.
`
`. is not proved
`
`14
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`

`

`IPR2018-01207
`
`Patent 9,649,635 B2
`
`obvious merely by demonstrating that each of its elements was,
`
`independently, known in the prior art”).
`
`First, Petitioner contends that Kumacheva discloses that adding
`
`manifolds may be useful where “mixing, concentration, dilution, or change
`
`in composition of droplet phase or continuous phases is needed,” and asserts
`
`that incorporating Modlin’s teaching of connecting each fluidic circuit to its
`
`own input and output well in a unit cell would “permit use of a wide variety
`
`of different droplet phases and continuous phases on the same plate
`
`simultaneously, increasing efficiency of running large numbers of droplet
`
`generation operations.” Pet. 28; Ex. 1004 1] 68; Ex. 1003 1[ 65.
`
`Kumacheva’s device, however, already allows a user to change the
`
`composition of the droplet and/or continuous phases. Ex. 1004 11 68. Thus,
`
`it is not evident why an ordinary artisan would have combined Kumacheva
`
`and Modlin to achieve this result. It is also not evident why Kumacheva’s
`
`device, which is used to produce polymers, would benefit from the use of a
`
`wide variety of different droplet phases at the same time. Finally, to the
`
`extent an ordinarily skilled artisan would have recognized a benefit in being
`
`able to use a wider variety of droplet and continuous phases than what
`
`Kumacheva’s device is capable of, Petitioner does not explain sufficiently
`
`why this ordinary artisan would have been prompted to abandon
`
`Kumacheva’s assertedly advantageous single inlet/single outlet design to
`
`achieve this goal, much less have sought to do so in the device of Modlin,
`
`which was not designed to produce emulsions.7 Prelim. Resp. 18 (a person
`
`7 Petitioner and Dr. Gandhi assert that disposing Kumacheva’s droplet
`generators in a unit cell arrangement “would enable the droplet generators to
`be used to prepare and perform assays on a large number of different
`
`’
`
`15
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`

`

`IPR2018—01207
`
`Patent 9,649,635 B2
`
`of ordinary skill in the art “would not read Kumacheva and then modify the
`
`FFDs of Kumacheva according to the designs of Modlin, which would result
`
`in more ‘inlets’ and ‘channels,’ not fewer”).
`
`Second, Petitioner also asserts that, because Kumacheva “expressly
`
`suggests” using the disclosed device “to perform biological and biochemical
`
`analyses,” such as “DNA separation” and “parallel PCR assays,” one of
`
`ordinary skill in the art would have sought to implement Kumacheva’s
`
`droplet generator in Modlin to assay samples from multiple different patients
`
`on a single chip or, alternatively, to prepare different emulsions at the same
`
`time. Pet. 28—29 (citing Ex. 1004 11 14); Ex. 1003 11 66 (citing Ex. 1004
`
`11 14). Contrary to Petitioner’s assertion, however, we are directed to no
`
`disclosure in Kumacheva of using the disclosed single inlet/single outlet
`
`droplet generators for “biological and biochemical assays,” “such as DNA
`
`separation” and “parallel PCR assays.” Ex. 1004 1111 13 (discussing the
`
`challenges faced in scaling up the “microfluidic synthesis of polymer
`
`particles in multichannel microfluidic reactors”), 19 (“This present invention
`
`provides multiple continuous microfluidic reactors for parallel scaled up
`
`synthesis in polymer particles, and methods of use thereof”). The portion of
`Kumacheva relied upon by Petitioner is part of the “Background of the
`
`Invention” section, and distinguishes Kumacheva’s disclosed invention from
`
`certain prior art devices that “have been used” for, among other things,
`
`“DNA separation” and “parallel PCR assays.” Pet. 28 (citing Ex. 1004
`
`11 14); see also Ex. 1004 11 15 (“In these reports, emulsification in parallel
`
`emulsions in parallel as disclosed by Modlin.” Ex. 1003 11 66; Pet. 29. We
`are directed to no disclosure in Modlin, however, of producing emulsions,
`much less a large number of different emulsions in parallel.
`
`16
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`IPR2018—01207
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`Patent 9,649,635 B2
`
`combined microfluidic channels was not used”). Petitioner does not explain
`
`sufficiently why the generalized disclosure in the “Background of the
`
`Invention” section would have suggested using Kumacheva’s specific
`
`droplet generators for “biological and biochemical assays,” or Why one of
`
`ordinary skill in the art would have been prompted to remove Kumacheva’s
`
`single inlet/single outlet design to do so. Prelim. Resp. 17 (asserting that
`
`Kumacheva “teaches the use of multiple substrates with as few ‘inlets’ and
`
`‘channels’ as possible”) (citing Ex. 1004 fi[ 15). The number of mental steps
`
`and physical modifications necessary to achieve the proposed Combined
`
`System suggests it is proposed out of hindsight, and not in view of the
`
`knowledge and skill in the art as of the earliest priority date of the ’635
`
`patent. See Metalcraft ofMayville, Inc. v. The Toro Co., 848 F.3d 1358,
`
`1367 (Fed. Cir. 2017) (“[W]e cannot allow hindsight bias to be the thread
`
`that stitches together prior art patches into something that is the claimed
`
`invention”).
`
`Third, Petitioner contends that one of ordinary skill in the art would
`
`have implemented Kumacheva’s droplet generator in Modlin in order to
`
`“substantially increase compatibility with industry standard laboratory
`
`equipment and reduce cost.” Pet. 29. According to Petitioner, configuring
`
`Kumacheva’s droplet generators according to Modlin’s microwell plate
`
`design would constitute the use of a known technique to improve similar
`
`devices in the same way. Id. at 29—30 (citing KSR, 550 US. at 415—421).
`
`The evidence of record supports Petitioner’s assertion that Modlin’s
`
`well plate design provides compatibility with industry standard equipment.
`
`Ex. 1005 1111 105, 312; Pet. 29—30. As noted above, however, Petitioner’s
`
`Combined System involves abandoning Kumacheva’s single inlet/outlet
`
`l7
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`

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`IPR2018—01207
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`Patent 9,649,635 B2
`
`design in favor of Modlin’s plate design. Petitioner does not adequately
`
`explain why one of ordinary skill in the art would have been prompted to
`
`abandon the single inlet/single outlet design of Kumacheva to increase
`
`compatibility with certain industry standard equipment or to reduce costs.
`
`For example, Petitioner does not direct us to any evidence that Kumacheva’s
`
`design suffers from compatibility problems with industry equipment or cost
`
`issues. Nor does Petitioner explain why any such compatibility problems or
`
`cost issues could not be addressed by adjusting, as opposed to abandoning,
`
`Kumacheva’s single inlet/single outlet design that is the focus of the
`
`reference. Ex. 1004 W 2, 19—20 (utilizing “a single overall inlet branching
`
`into multiple inlets associated with each of the flow-focusing devices”),
`
`Figs. 2, 3; see Ex. 1005 M 215—217, Figs. 54—55 (disclosing the use of two
`
`input wells and a routing network of channels in Modlin to deliver two
`
`common reagents to each unit cell). Petitioner’s proposed modifications
`
`once again appear to be proposed out of hindsight.
`
`Fourth, Petitioner contends that one of ordinary skill in the art would
`
`have sought to incorporate Kumacheva’s droplet generator in the system of
`
`Modlin in order to “increase the degree of parallelization from four (as
`
`disclosed in Kumacheva) to 24, 96 or more.” Pet. 30 (asserting that
`
`parallelization of emulsion generators was well known in the art). This
`
`argument is not persuasive because, as Patent Owner notes, Kumacheva
`
`specifically discloses that its device may be used in “parallelization (scaling
`
`up) of the production of droplets” and is not limited to the use of only four
`
`droplet generators. Ex. 1004 W 20 (disclosing that the invention “can be
`
`used in parallelization,” and may have “two or more parallel flow-focusing
`
`devices”), 64 (noting that the device of Kumacheva is not limited to four
`
`18
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`

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`IPR2018-01207
`
`Patent 9,649,635 B2
`
`droplet generators, and may have “a plurality” of flow-focusing devices 20),
`
`83 (describing the results of an integrated droplet generator comprising
`
`sixteen individual droplet generators); Prelim. Resp. 20 (noting that
`
`Kumacheva specifically states that its design “can be used in parallelization
`
`(scaling up) of the production of droplets”) (quoting Ex. 1004 1] 20).
`
`Moreover, even if one of ordinary skill in the art would have sought to
`
`increase parallelization beyond what Kumacheva’s device was capable of,
`
`Petitioner does not explain adequately why such an ordinarily skilled artisan
`
`would have been prompted to abandon the assertedly advantageous single
`
`inlet/single outlet design of Kumacheva to do so.
`
`Petitioner contends one of ordinary skill in the art, in view of the
`
`disclosures of Mason, would have sought to reverse the flow in Modlin’s
`
`system to recover surfactant. Pet. 33—36, 38, 46—48. Petitioner’s arguments
`
`with respect to Mason, however, do not cure the deficiencies noted above
`
`with respect to Kumacheva and Modlin.
`
`In view of the foregoing, Petitioner has not explained sufficiently why
`one of ordinary skill in the art would have sought to combine the identified
`
`disclosures of Kumacheva, Modlin, and Mason to arrive at the subject matter
`
`of the ’635 patent. Accordingly, Petitioner has not demonstrated a
`
`reasonable likelihood that the subject matter of claims 1—8, 12—14, 16—21,
`
`and 23—37 would have been obvious over Kumacheva, Modlin, and Mason.
`
`C. Ground Based on Kumacheva, Modlin, Mason, and Banerjee
`
`The remaining ground asserted in the Petition relies, at least in part,
`
`on the combined teachings of Kumacheva, Modlin, and Mason. Pet. 69—76.
`
`Petitioner’s arguments and supporting evidence with respect to these
`
`additional grounds do not resolve the deficiencies noted above with respect
`
`l9
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`IPR2018-01207
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`Patent 9,649,635 B2
`
`to the reasons to combine Kumacheva, Modlin, and Mason in the manner
`
`proposed in the Petition. Accordingly, Petitioner has not demonstrated a
`
`reasonable likelihood that the challenged claims would have been obvious
`
`over the recited prior art references.
`
`III.
`
`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 inter partes
`
`review.
`
`It is hereby,
`
`IV. ORDER
`
`ORDERED that, pursuant to 35 U.S.C. § 314, the Petition is denied
`
`and no inter partes review is instituted.
`
`20
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`

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