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)
`
`
`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
`
`
`
`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
`
`
`
`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
`
`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
`
`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
`
`
`
`IPR2018-00434
`
`Patent 9, 126, 160 B2
`
`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
`
`
`
`IPR2018-00434
`
`Patent 9,126, 160 B2
`
`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
`
`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
`
`
`
`IPR2018-00434
`
`Patent9, 126,160 B2
`
`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
`
`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
`
`
`
`IPR2018-00434
`
`Patent 9, 126, 160 B2
`
`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
`
`
`
`
`
`IPR2018-00434
`
`Patent 9, 126, 160 B2
`
`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
`
`
`
`IPR2018-00434
`
`Patent9, 126,160 B2
`
`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
`
`
`
`IPR2018-00434
`
`Patent9, 126,160 B2
`
`“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
`
`
`
`IPR2018-00434
`
`Patent9, 126,160 B2
`
`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
`
`
`
`IPR2018-00434
`
`Patent 9, 126, 160 B2
`
`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
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
