Trials@uspto. gov
`Tel: 571-272-7822
`
`Paper 1 1
`Entered: June 29, 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 IPR2018-00586
`
`Patent 9,636,682 B2
`
`Before KRISTINA M. KALAN, JON B. TORNQUIST, and
`DEBRA L. DENNETT, Administrative Patent Judges.
`
`DENNET T, Administrative Patent Judge.
`
`DECISION
`
`Denying Institution of Inter Partes Review
`35 US. C. §314(a)
`
`
`Tel: 571-272-7822
`
`Paper 1 1
`Entered: June 29, 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 IPR2018-00586
`
`Patent 9,636,682 B2
`
`Before KRISTINA M. KALAN, JON B. TORNQUIST, and
`DEBRA L. DENNETT, Administrative Patent Judges.
`
`DENNET T, Administrative Patent Judge.
`
`DECISION
`
`Denying Institution of Inter Partes Review
`35 US. C. §314(a)
`
`
`
`IPR2018-00586
`
`Patent 9,636,682 B2
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`1.
`
`INTRODUCTION
`
`10X Genomics, Inc. (“Petitioner”) filed a Petition (Paper 2, “P et.”)
`
`requesting interpartes review of claims 1—12 and 14—21 of US. Patent
`
`No. 9,636,682 B2 (Ex. 1001 , “the ’682 patent”). Bio-Rad Laboratories, Inc.
`
`(“Patent Owner”) filed a Preliminary Response to the Petition (Paper 7,
`
`“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 one claim
`
`challenged in the Petition. Accordingly, we deny the Petition, and do not
`
`institute interpartes review.
`
`A. Related Proceedings
`
`The parties identify Bio-Rad Laboratories, Inc. v. 1 0X Genomics, Inc,
`
`Case No. 3 :1 7-cv-4339 mD. 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 ’682 patent is at issue in IPR2018-
`
`00587. Pet. 1; Paper 4, 1.
`
`B. The ’682 Patent
`
`The ’682 patent discloses a system for forming emulsions. Ex. 1001,
`
`3 :3 9—40. The system comprises an instrument and a microfluidic cassette.
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`
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`IPR2018-00586
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`Patent 9,636,682 B2
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`Id. at 6:65—67. The instrument applies pressure to emulsion phases held by a
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`microfluidic chip of the cassette to drive formation and collection of
`
`emulsions in the chip. Id. at 4:67—5 :2. The cassette may include a cartridge,
`
`a microfluidic chip, and a gasket. Id. at 9267—102. Figure 4 is reproduced
`
`below:
`
`
`
`
`Figure 4 is a plan view of a cassette 52 showing microfluidic chip 54
`
`and cartridge 150. 1d at 423—6). Figure 6 is reproduced below:
`
`The microfluidic chip illustrated in Figure 6 forms a plurality ofwells
`
`that serve as input containers for prospective emulsion phases and output
`
`
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`IPR2018-00586
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`Patent 9,636,682 B2
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`containers for collected emulsions. Id. at 10:37—40. Figure 9 is reproduced
`
`below:
`
`Fig. 9
`
`
`
`Figure 9 is a schematic bottom view of a single emulsion formation
`
`unit 200 of microfluidic chip 152. Id. at 12:59—60. Input reservoirs 194,
`
`196 (wells 168, 170 in Figure 4) hold and supply emulsion phases such as
`
`oil phase 206 and aqueous sample 208. Id. at 12:59—63. Collection
`
`container 172 (well 172 in Figure 4) receives and collects an emulsion 209
`
`formed by droplet generator 198 from oil phase 206 and sample 208. Id. at
`
`12:63-66. The reservoirs and collection container are fluidically
`
`interconnected via channels 210—216 that intersect at droplet generator 198,
`
`and include one or a pair of oil inlet channels 210, 212, a sample inlet
`
`channel 214, and an emulsion outlet channel 216. Id. at 12266—133.
`
`A fluidics assembly of the instrument operates on the cassette to form
`
`and concentrate emulsions. Id. at 15:41—44. Figure 16 is reproduced below:
`
`
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`IPR2018-00586
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`Patent 9,636,682 B2
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`fig. 16
`
`
`6"
`PUMP 2
`
`(OPRESSURE)
`
`
`
`(VACUUM)
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`
`
`Figure 16 is a schematic view of fluidics assembly 58 operatively
`
`interfaced with chip 152 via cassette interface structure 74 (manifold 72 with
`
`ports 76). Id. at 15 145—47. Each port 76 may be fluidically connected to one
`
`or more wells 172 of chip 152. Id. at 15 247—49. Pressure may be applied to
`
`the chip with a negative pressure portion 300 and a positive pressure portion
`
`302 of the fluidics assembly to form and concentrate a set of emulsions. Id.
`
`at 15:49—57.
`
`C. Illustrative Claims
`
`Petitioner challenges claims 1—12 and 14—21 of the ’682 patent.
`
`Independent claims 1 and 14, reproduced below, are illustrative of the
`
`challenged claims:
`
`1. A system for generating droplets, 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
`
`5
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`
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`IPR2018-00586
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`Patent 9,636,682 B2
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`channel, and a third channel that meet one another in a droplet-
`generation region;
`
`a holder for the device; and
`
`an instrument configured to operatively receive an assembly
`including the device and the holder and 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.
`
`14. A system for generating droplets, comprising:
`
`a device including a row of sample wells each configured to
`receive sample-containing fluid, a row of continuous-phase
`wells each configured to receive continuous-phase fluid, and a
`row of droplet wells, the device also including a corresponding
`channel network for each sample well, the channel network
`including a droplet-generation region and fluidically
`connecting the sample well to one of the continuous-phase
`wells and one of the droplet wells;
`
`a holder for the device;
`
`a gasket configured to be attached directly to the holder, such
`that the gasket extends over each sample well, each
`continuous—phase well, and each droplet well; and
`
`an instrument configured to
`
`(a) receive an assembly including the device, the holder, and
`the gasket,
`
`(b) engage the gasket with a manifold, and
`
`(c) apply positive pressure and/or negative pressure to the
`device via the manifold, such that sample-containing fluid
`flows from each sample well to the corresponding droplet-
`generation region, continuous-phase fluid flows from each
`continuous-phase well to the corresponding droplet—generation
`
`
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`IPR2018-00586
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`Patent 9,636,682 B2
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`region, and sample-containing droplets flow from each droplet-
`generation region to the corresponding dr0plet well.
`
`Ex. 1001, 33:29—46; 34:20—45. Claim 20 is the only other
`
`independent claim and is substantially similar to claim 1 except for
`
`additional recitations of “detect that the holder has been received”
`
`and “create a pressure differential.” Id. at 34:65—3 5:15.
`
`D. The Asserted Grounds of Unpatentabz'lizy
`
`Petitioner contends claims 1—1 2 and 14—21 of the ’682 patent are
`
`unpatentable based on the following grounds (Pet. 20, 69, 72):'
`
`
`
`
`
`Kumacheva2 and Modlin3
`
`§ 103
`
`Claim 8 Challen-ed
`
`1—4, 6—9, 11, 14, 15, 17,
`18, and 20
`
`Kumacheva, Modlin, and
`Fernwood4
`
`Kumacheva, Modlin, and
`Bennett5
`
`§ 103
`
`5, 10, and 16
`
`§ 103
`
`12, 19, and 21
`
`
`
`11.
`
`ANALYSIS
`
`A. Claim Construction
`
`
`
`
`
`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 CPR. § 42.100(b);
`
`‘ Petitioner also relies on a declaration from Dr. Khushroo Gandhi
`
`(Ex. 1003).
`2 US 2010/0184928 A1, published July 22, 2010 (Ex. 1004).
`3 US 2005/0266582 A1, published Dec. 1, 2005 (Ex. 1005).
`4 US 4,493,815,issuedJan. 15, 1985 (Ex. 1007).
`5 US 8,061,211 B1, issuedNov. 22, 2011 (Ex. 1011).
`
`7
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`
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`IPR2018-00586
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`Patent 9,636,682 B2
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`Cuozzo Speed Techs, LLCv. Lee, 136 S. Ct. 2131, 2144—46 (2016)
`
`(upholding the use of the broadest reasonable interpretation standard).
`
`Upon review of the parties’ arguments and supporting evidence, we
`
`determine that no claim terms of the ’682 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]nly
`
`those terms need be construed that are in controversy, and only to the extent
`
`necessary to resolve the controversy.”)).
`
`B. Claims 1—4, 6—9, 11, 14, I 5, I 7, 18, and 20 over Kumacheva and
`Modlin
`
`Petitioner contends the subject matter of claims 1—4, 6—9, 1 1, 14, 15,
`
`17, 18, and 20 would have been obvious over the combined disclosures of
`
`Kumacheva and Modlin. P et. 20—68.
`
`1. Kumacheva
`
`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 ofthe disclosed multiple droplet
`
`generator, and are reproduced below:
`
`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
`
`
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`IPR2018-00586
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`Patent 9,636,682 B2
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`an individual droplet generator depicting the direction of fluid flow.
`
`Id.
`
`1111 40—4 1.
`
`In the FFDs of Kumacheva, immiscible liquids A (droplet phase) and
`
`B (continuous phase) are combined to form an emulsion. Id. 111] 31, 61—63.
`
`Liquid A enters through opening 42 (Figure 2) and travels downstream
`
`through central microchannel 30. Id. W 61—62. Liquid B enters through
`
`side microchannels 26 and travels downstream via microchannels 32. Id.
`
`As shown in more detail in Figure 1, 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. 111] 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”),
`
`2O (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
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`
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`IPR2018-00586
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`Patent 9,636,682 B2
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`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. 1166.
`
`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.
`
`2. Modlin
`
`Modlin discloses a “microfluidic system for performing chemical
`
`reactions or biochemical, biological, or chemical assays utilizing a
`
`microfabricated device or ‘chip. ’” Ex. 1005, Abstract. Figures 49 and 50 of
`
`Modlin are reproduced below:
`
`Excrmlary
`Sumdnnl Cells
`
`mammary S-Pun
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`Walt”. Fig- 49
`
`823% F',,.
`
`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-P ort” standard unit
`
`cell 820 has four access ports that are each connected to at least one channel.
`
`Id. {[11 209—210.
`
`10
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`
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`IPR2018-00586
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`Patent 9,636,682 B2
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`Figures 34 and 35 of Modlin are reproduced below:
`
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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 ofFigure 34. Id. W 177—178. As shown in Figure 35, sample
`
`wells 614 are preferably positioned over access ports 622. Id. 11 178.
`
`Channel 106f is formed between the surface of fabricated substrate 1 1 8f 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. 11 211.
`
`Figure 44 of Modlin, reproduced below, depicts pressure
`
`manifold 754 connected to microfluidic well plate 610:
`
`m
`
`Pl‘cxmru Mmimld
`_,
`Micnafluillic
`m mm 61 a
`(Pnclwmfl Ebip)
`
`-
`Fig. 44
`
`11
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`
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`IPR2018-00586
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`Patent 9,636,682 B2
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`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. Summary ofthe 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. 27):
`
`
`
`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 to output
`
`port 2. Id. ; Ex. 1003 11 57. To drive fluid flow, the combined well plate
`
`assembly is sealably mated with a pressure manifold, as described in
`
`Modlin. Pet. 28; Ex. 1005, Fig. 44. This proposed configuration is part of
`
`an overall proposed “Combined System,” illustrated by Petitioner as
`
`follows:
`
`12
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`Patent 9,636,682 B2
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`Petitioner contends the Combined System of Kumacheva and Modlin
`
`teaches or suggests every limitation of independent claim 1. In particular,
`
`Petitioner contends the proposed system includes a device that includes a
`
`sample well configured to receive sample—containing fluid, a continuous-
`
`phase well configured to received continuous-phase fluid, a droplet well
`
`(Pet. 35—3 8), and a channel network having channels extending from a
`
`continuous phase well and sample well to a channel junction and an output
`
`channel extending from the channel junction to a droplet (outlet) well (id. at
`
`38—3 9), with the channels forming a droplet generation junction (id. ).
`
`Petitioner further contends that the proposed system includes a holder (id. at
`
`40—42). Petitioner contends the proposed system includes an instrument to
`
`receive the device and holder (id. at 43), and which provides pneumatic
`
`pressure to the wells to drive the fluids through the microfluidic circuit (id.
`
`at 44—45).
`
`Petitioner also contends the Combined System of Kumacheva and
`
`Modlin teaches or suggests every limitation of independent claim 14. The
`
`device, holder, and instrument of claim 14 are similar or identical to those of
`
`claim 1 (see id. at 57—62). Further, with respect to claim 14, Petitioner
`
`13
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`IPR2018-00586
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`Patent 9,636,682 B2
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`contends the proposed system includes a gasket disposed on the holder such
`
`that the assembly comprising the holder, microfluidic device, and gasket are
`
`received by the instrument (id. at 60—61).
`
`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 fluid
`
`handling equipment, and to increase the degree of parallelization of
`
`Kumacheva’s device. Id. at 29—32.
`
`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 and Modlin in the manner proposed in the Petition.
`
`Prelim. Resp. 15—19. According to Patent Owner, “the centerpiece ofthe
`
`Petition .
`
`.
`
`. is actually nothing more than a collage of figures put together by
`
`Petitioner to follow the blueprint set forth in the ’682 patent,” which Patent
`
`Owner contends is “the epitome of impermissible hindsight.” Id. at 21.
`
`4. Analysis
`
`Although the elements of Petitioner’s Combined System appear
`
`similar to the elements of the droplet generator depicted in the ’682 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 ’682 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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`obvious merely by demonstrating that each of its elements was,
`
`independently, known in the prior art.”).
`
`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. 31 (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
`
`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. 18 (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 further 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
`
`15
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`IPR2018-00586
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`Patent 9,636,682 B2
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`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. 29; Ex. 1004 1] 68; Ex. 1003 1] 59.
`
`Kumacheva’s device, however, already allows a user to change the
`
`composition of the droplet and/or continuous phases. Ex. 1004 1[ 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’ 5 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
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`achieve this goal, much less have sought to do so in the device of Modlin,
`
`which was not designed to produce emulsions.6 Prelim. Resp. 16
`
`(“Kumacheva teaches the use of multiple substrates with as few ‘inlets’ and
`
`‘channels’ as possible”).
`
`6 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
`emulsions in parallel as disclosed by Modlin.” Ex. 1003 fl 60; Pet. 30. We
`are directed to no disclosure in Modlin, however, of producing emulsions,
`much less a large number of different emulsions in parallel.
`
`l6
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`IPR2018-00586
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`Patent 9,636,682 B2
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`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. 30 (citing
`
`Ex. 1004 1114gEx 1028, pp. 9—10); Ex. 1003 1] 60 (citing Ex. 10041] 14;
`
`Ex. 1028, pp. 9—10).
`
`Contrary to Petitioner’s assertion, however, we are directed to no
`
`disclosure in Kumacheva ofusing the disclosed single inlet/single outlet
`
`droplet generators for “biological and biochemical assays,” “such as DNA
`
`separation” and “parallel PCR assays.” Ex. 1004 W 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. 30 (citing Ex 1004
`
`11 14); see also Ex. 1004 11 15 (“In these reports, emulsification in parallel
`
`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
`
`17
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`single inlet/single outlet design to do so. Prelim. Resp. 16 (asserting that
`
`Kumacheva “teaches the use of multiple substrates with as few ‘inlets’ and
`
`‘channels’ as possible”) (citing Ex 1004 11 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 ’682
`
`patent. See Metalcraft ofMayvilie, Inc. v. The Toro C0., 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”).
`
`Petitioner also 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. 30. Accordingto 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 31 (citing KSR, 550 US. at415—421).
`
`The evidence of record supports Petitioner’s assertion that Modlin’s
`
`well plate design provides compatibility with industry standard equipment.
`
`Ex. 1005 W 105, 312; Pet. 30—3 1. As noted above, however, Petitioner’s
`
`Combined System involves abandoning Kumacheva’s single inlet/outlet
`
`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
`
`18
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`Patent 9,636,682 B2
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`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. 1004111] 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 W 215—217, Figs. 54—55 (disclosing the use oftwo
`
`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.
`
`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 and Modlin to arrive at the subject matter of
`
`the ’682 patent. Accordingly, Petitioner has not demonstrated a reasonable
`
`likelihood that the subject matter of claims 1—4, 6—9, 11, 14, 15, 17, 18,
`
`and 20 would have been obvious over Kumacheva and Modlin.
`
`C. Remaining Grounds Based on Kumacheva and Modlz'n
`
`Each of the remaining grounds asserted in the Petition relies, at least
`
`in part, on the combined teachings of Kumacheva and Modlin. Pet. 69—75.
`
`Petitioner’s arguments and supporting evidence with respect to these
`
`additional grounds do not resolve the deficiencies noted above with respect
`
`to the reasons to combine Kumacheva and Modlin 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.
`
`19
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`111.
`
`CONCLUSION
`
`For the forgoing reasons, Petitioner has not demonstrated a reasonable
`
`likelihood that at least one challenged claim of the ’682 patent would have
`
`been obvious over the prior art of record. Accordingly, we do not institute
`
`interpartes review.
`
`It is hereby,
`
`IV. ORDER
`
`ORDERED that, pursuant to 35 U. S.C. § 314, the Petition is denied
`
`and no interpartes review is instituted.
`
`20
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`IPR2018-00586
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`Patent 9,636,682 B2
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`PETITIONER:
`
`Greg H. Gardella
`Natalie J. Grace
`
`GARDELLA GRACE P .A.
`
`ggardella@gardellagrace.com
`ngrace@,gardellagrace.com
`
`David J. Ball
`
`Jennifer H. Wu
`
`Megan Raymond
`Josephine Young
`PAUL, WEISS, RIFKIND, WHARTON & GARRISON LLP
`dball@pau1weiss.com
`jwu@paulweiss.com
`mraymond@paulweiss.com
`' oun
`aulweiss.com
`
`Sarah Brashears
`
`sbrashears@convergentlaw.com
`
`PATENT OWNER:
`
`James M. Glass
`
`Kevin Johnson
`QUINN EMANUEL URQUHART & SULLIVAN LLP
`j img!ass@guinnemanuel.com
`kevinj ohnson@guinnemanuel. com
`
`21
`
`
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