Trials@uspto.gov
`571-272-7822
`
`
`
`
`
`Paper 20
`Date: April 19, 2021
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`NEUMODX MOLECULAR, INC.,
`Petitioner,
`
`v.
`
`HANDYLAB, INC.,
`Patent Owner.
`____________
`
`
`
`IPR2020-01136
`Patent 8,415,103 B2
`____________
`
`
`
`
`Before SHERIDAN K. SNEDDEN, JO-ANNE M. KOKOSKI, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`KOKOSKI, Administrative Patent Judge.
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`571-272-7822
`
`
`
`
`
`Paper 20
`Date: April 19, 2021
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`NEUMODX MOLECULAR, INC.,
`Petitioner,
`
`v.
`
`HANDYLAB, INC.,
`Patent Owner.
`____________
`
`
`
`IPR2020-01136
`Patent 8,415,103 B2
`____________
`
`
`
`
`Before SHERIDAN K. SNEDDEN, JO-ANNE M. KOKOSKI, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`KOKOSKI, Administrative Patent Judge.
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`IPR2020-01136
`Patent 8,415,103 B2
`
`
`INTRODUCTION
`I.
`NeuMoDx Molecular, Inc. (“Petitioner”) filed a Petition to institute an
`inter partes review of claims 1–15 (the “challenged claims”) of U.S. Patent
`No. 8,415,103 B2 (“the ’103 patent,” Ex. 1200). Paper 2 (“Pet.”).
`HandyLab, Inc. (“Patent Owner”) filed a Preliminary Response. Paper 19
`(“Prelim. Resp.”).
`Institution of an inter partes review is authorized by statute when “the
`information presented in the petition . . . and any response . . . shows that
`there is a reasonable likelihood that the petitioner would prevail with respect
`to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314
`(2018); see 37 C.F.R. § 42.4. For the reasons set forth below, we deny the
`Petition and do not institute an inter partes review.
`A. Real Parties-in-Interest
`Petitioner identifies NeuMoDx Molecular, Inc., QIAGEN North
`American Holdings, Inc., and QIAGEN N.V. as the real parties-in-interest.
`Pet. 1. Patent Owner identifies HandyLab, Inc. and Becton, Dickinson &
`Co. as the real parties-in-interest. Paper 3, 1.
`B. Related Proceedings
`The parties indicate that the ’103 patent is asserted in Becton,
`Dickinson & Co. v. NeuMoDx Molecular, Inc., Case No. 1:19-cv-01126-LPS
`(D. Del.). Pet. 1; Paper 4, 3. The parties further indicate that the ’103 patent
`is the subject of IPR2020-01133, also filed by Petitioner. Pet. 67; Paper 4,
`2.
`C. The ’103 Patent
`The ’103 patent, titled “Microfluidic Cartridge,” issued April 9, 2013.
`Ex. 1200, codes (54), (45). The ’103 patent relates to “microfluidic
`
`2
`
`
`
`IPR2020-01136
`Patent 8,415,103 B2
`
`cartridges configured to carry out PCR on nucleotides of interest,
`particularly from multiple biological samples in parallel, within microfluidic
`channels, and permit detection of those nucleotides.” Id. at 1:29–33. The
`microfluidic cartridge includes one or more sample lanes, “wherein each
`lane is independently associated with a given sample for simultaneous
`processing, and each lane contains an independently configured microfluidic
`network.” Id. at 4:41–45. Each lane can include a sample inlet port, one or
`more channels connecting the inlet port to a PCR reaction chamber via a first
`thermally actuated valve, and one or more channels connecting the PCR
`reaction chamber to an exit vent via a second thermally actuated valve. Id.
`at 6:59–65.
`The ’103 patent teaches that the valves are initially open to allow the
`sample to be pumped into the PCR reaction chamber, and, upon initiating
`the processing of the sample, the valves are closed to isolate the sample from
`the channels on either side. Id. at 10:40–48. According to the ’103 patent,
`the valves “are closed prior to thermocycling to prevent any evaporation of
`liquid, bubble generation, or movement of fluid from the PCR reactor,
`during PCR.” Id. at 10:48–51; see also id. at 38:22–26 (“[T]he reaction
`mixture is isolated (e.g., sealed off by valves) [in the PCR reactor] to prevent
`evaporation or movement (leakage) of the reaction mixture during
`thermocycling.”). The valves also prevent “both loss of liquid or vapor
`thereby enabling even a partially filled reactor to successfully complete a
`PCR thermocycling reaction.” Id. at 10:51–55.
`The ’103 patent further teaches that the microfluidic cartridge can be
`received by a bay on a diagnostic apparatus, where at least one heat source
`configured to heat individual sample lanes in the cartridge is coupled to the
`
`3
`
`
`
`IPR2020-01136
`Patent 8,415,103 B2
`
`bay. Id. at 17:7–8, 20:10–17. The ’103 patent teaches that the bay “can also
`be configured so that various components of the apparatus that can operate
`on the microfluidic cartridge (heat sources, detectors, force members, and
`the like) are positioned to properly operate on the microfluidic cartridge
`while the cartridge is received in the bay.” Id. at 20:65–21:2. “For example,
`a contact heat source can be positioned in the bay such that it can be
`thermally coupled to a distinct location at a microfluidic cartridge that is
`selectively received in the receiving bay.” Id. at 21:2–5.
`Figure 16 of the ’103 patent is reproduced below.
`
`
`Figure 16 shows a cross-sectional view of a microfluidic cartridge situated in
`a receiving bay, adjacent to a heater unit. Id. at 3:20–21. PCR chamber 901
`is shown in substrate layer 907 of the cartridge. Id. at 23:4–5. Cartridge
`laminate layer 905 is directly under PCR chamber 901. Id. at 23:5–7. Long
`heaters 909 and 911, which, when viewed from above run alongside PCR
`chamber 901, are situated in substrate layer 913 of the receiving bay,
`directly under and in contact with cartridge laminate layer 905. Id. at 23:8–
`11.
`
`4
`
`
`
`IPR2020-01136
`Patent 8,415,103 B2
`
`D. Illustrative Claims
`Petitioner challenges claims 1–15 of the ’103 patent. Pet. 1, 3–4.
`Claims 1 and 15, the only independent challenged claims, are illustrative of
`the claimed subject matter, and are reproduced below.
`
`1. A method of carrying out amplification independently
`on a plurality of polynucleotide-containing samples, the method
`comprising:
`introducing the plurality of samples separately into a
`microfluidic cartridge;
`isolating the samples in the microfluidic cartridge;
`placing the microfluidic cartridge in thermal
`communication with an array of independent heaters;
`and
`amplifying polynucleotides in the plurality of samples by
`independent application of successive temperature
`cycles to each sample.
`Ex. 1200, 47:8–18.
`15. A method of carrying out amplification
`independently on a plurality of polynucleotide-containing
`samples, the method comprising:
`introducing the plurality of samples in to a microfluidic
`cartridge, wherein the cartridge has a plurality of
`reaction chambers configured to permit thermal
`cycling of the plurality of samples independently of
`one another;
`moving the plurality of samples independently of one
`another into the respective plurality of reaction
`chambers;
`isolating the samples within the plurality of reaction
`chambers;
`placing the microfluidic cartridge in thermal
`communication with an array of independent heaters;
`and
`
`5
`
`
`
`IPR2020-01136
`Patent 8,415,103 B2
`
`
`amplifying polynucleotides contained within the plurality
`of samples, by application of successive temperature
`cycles independently to the reaction chambers.
`Id. at 48:26–42.
`E. The Asserted Grounds of Unpatentability
`Petitioner asserts that the challenged claims are unpatentable on the
`following grounds:
`Claims Challenged
`1–15
`1–15
`1–15
`1–15
`
`References/Basis
`
`35 U.S.C.
`Kellogg1
`§ 102
`Kellogg, Mian2
`§ 103
`§ 102 Mian
`§ 103 Mian, Kellogg, Zou I,3 Zou II,4
`Yoon5
`Pet. 3–4. Petitioner relies on the Declaration of Mark A. Burns, Ph.D. (“the
`Burns Declaration,” Ex. 1210) in support of its contentions.
`II. ANALYSIS
`A. Level of Ordinary Skill in the Art
`Petitioner contends that a person having ordinary skill in the art
`(“POSA”) “generally would have either (1) a degree in Mechanical
`Engineering, Bioengineering, Chemical Engineering, or a similar field, and
`three years of experience with microfluidic devices or systems relating the
`biochemical reactions/analysis, such as PCR,” or an advanced degree in the
`same fields “with at least one year of related experience.” Pet. 9–10. Patent
`
`
`1 WO 00/78455 A1, published Dec. 28, 2000 (Ex. 1055).
`2 U.S. Patent No. 6,319,469 B1 (Ex. 1117).
`3 U.S. Patent No. 6,509,186 B1, issued Jan. 21, 2003 (Ex. 1206).
`4 U.S. Patent No. 6,762,049 B2, issued July 13, 2004 (Ex. 1207).
`5 U.S. Patent App. Pub. No. 2005/0112754 A1, published May 26, 2005
`(Ex. 1118).
`
`6
`
`
`
`IPR2020-01136
`Patent 8,415,103 B2
`
`Owner states that it “does not currently dispute Petitioner’s proposed
`definition.” Prelim. Resp. 14.
`For purposes of this Decision, we adopt Petitioner’s proposed
`definition, which is undisputed on this record and consistent with the level of
`skill in the art at the time of the invention as reflected in the prior art in this
`proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir.
`2001) (explaining that specific findings regarding ordinary skill level are not
`required “where the prior art itself reflects an appropriate level and a need
`for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State
`Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).
`B. Claim Construction
`We construe each claim “in accordance with the ordinary and
`customary meaning of such claim as understood by one of ordinary skill in
`the art and the prosecution history pertaining to the patent.” 37 C.F.R.
`§ 42.100(b) (2019). Under this standard, claim terms are generally given
`their plain and ordinary meaning as would have been understood by a person
`of ordinary skill in the art at the time of the invention and in the context of
`the entire patent disclosure. Phillips v. AWH Corp., 415 F.3d 1303, 1313
`(Fed. Cir. 2005) (en banc). Only those terms in controversy need to be
`construed, and only to the extent necessary to resolve the controversy. See
`Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013,
`1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc.,
`200 F.3d 795, 803 (Fed. Cir. 1999)).
`Neither party proposes an explicit construction for any claim term.
`See Pet. 9; Prelim. Resp. 15. For purposes of this Decision, based on the
`
`7
`
`
`
`IPR2020-01136
`Patent 8,415,103 B2
`
`record before us, we determine that none of the claim terms requires an
`explicit construction.
`C. Anticipation Grounds
`Petitioner contends that claims 1–15 are anticipated by both Kellogg
`and Mian. Pet. 10–53, 65. Petitioner relies on the Burns Declaration in
`support of its contentions. Id.
`1. Overview of Kellogg
`Kellogg “provides apparatus and methods for performing microscale
`processes on a microplatform, whereby fluid is moved on the platform in
`defined channels motivated by centripetal force arising from rotation of the
`platform.” Ex. 1055, 5:18–20. The microplatform is “most preferably a
`disk” comprising sample inlet ports, fluidic microchannels, reagent
`reservoirs, collection chambers, detection chambers, and sample outlet ports.
`Id. at 5:22–26. The disk also includes air outlet ports and air displacement
`channels that “provide a means for fluids to displace air, thus ensuring
`uninhibited movement of fluids on the disk.” Id. at 5:29–32. Kellogg
`teaches that the disk can be used “for performing an integrated suite of
`biochemical processes for accomplishing in vitro amplification reactions,”
`such as “thermal cycling to effect PCR.” Id. at 7:17–23. Kellogg further
`teaches that the disk can be “provided with a multiplicity of microfluidics
`structures that enable [the] platform to process and amplify several samples
`simultaneously,” which allows the portion of the DNA sample to be
`amplified independently and “permit[s] amplification ‘multiplexing’ of a
`particular sample.” Id. at 7:23–33.
`
`8
`
`
`
`IPR2020-01136
`Patent 8,415,103 B2
`
`
`Kellogg’s Figure 3 is reproduced below.
`
`
`Figure 3 depicts “an expanded view of a section of the microfluidics disc,
`with the center of the disk being beyond the top of the figure.” Id. at 44:33–
`45:1. Fluid sample, cell alkaline lysis solution, and neutralizing buffer are
`introduced into reservoirs 204, 205, and 206, respectively, via loading holes
`207, 208, and 209. Id. at 45:2–8. Spinning the disk motivates fluid flow
`from reservoirs 204, 205, and 206 through a series of microchannels and
`reservoirs that mix and deliver the fluid to thermal cycling chamber 241,
`using increasing velocity to overcome the capillary junctions that impede the
`fluid flow. Id. at 51:6–54:26. Air vents 212, 221, 231, 235, 239, and 243
`permit the fluid to displace air in order to facilitate the movement of the
`fluid on the disk. Id. at 44:33–50:18.
`
`9
`
`
`
`IPR2020-01136
`Patent 8,415,103 B2
`
`
`2. Overview of Mian
`Mian “relates to microminiaturization of genetic, biochemical, and
`chemical processes related to analyses, synthesis and purification,” and
`“provides a microsystem platform and a micromanipulation device to
`manipulate the platform by rotation, thereby utilizing the centripetal forces
`resulting from rotation of the platform to motivate fluid movement through
`microchannels embedded in the microplatform.” Ex. 1117, 1:17–24. The
`microplatform “is a rotatable structure, most preferably a disk comprising
`sample, inlet ports, fluid microchannels, reagent reservoirs, reaction
`chambers, detection chambers and sample outlet ports.” Id. at 3:38–42.
`Mian explains that the disks also include air outlet ports and air
`displacement ports that “provide a means for fluids to displace air, thus
`ensuring uninhibited movement of fluids on the disk.” Id. at 3:47–50.
`“Specific sites on the disk also preferably comprise elements that allow
`fluids to be analyzed,” including by using thermal, light, and acoustic
`sources and detectors. Id. at 3:50–54.
`Figures 1A and 1B of Mian are reproduced below.
`
`
`
`
`
`10
`
`
`
`IPR2020-01136
`Patent 8,415,103 B2
`
`
`
`
`
`Figures 1A (top view) and 1B (side view) illustrate the arrangement of the
`elements that comprise the microplatforms of the disks described in Mian.
`Id. at 4:47–51. Figures 1A and 1B include reservoirs 12, 14, 18, and 20,
`valves 13, 15, 17, 19, 21, 23, and 25, and reaction chambers 16, 22, and 24.
`Id. at 4:48–49. Ports 11 and 32 and air vents 29, 33, 34, and 35 are also
`depicted. Id. at 4:49–51.
`In Example 4, Mian describes using its disks to amplify fragments of
`DNA by polymerase chain reaction, then analyzing the amplified fragments
`using capillary electrophoresis. Id. at 45:13–46:16 (Example 4). A
`schematic of the structure of the disk used in Example 4 is shown in Mian’s
`Figure 21, reproduced below.
`
`11
`
`
`
`IPR2020-01136
`Patent 8,415,103 B2
`
`
`
`Figure 21 is a schematic diagram of disk configured for DNA amplification.
`Id. at 5:59–60. The disk includes sample ports A, B, and C, wherein port A
`permits injection of linear bacteriophage lambda DNA, and ports B and C
`allow input of primer solutions. Id. at 45:24–28. The disk also includes
`reagent reservoirs D, E, and F, and “reaction chamber G that is configured to
`facilitate mixing of these reagents using a flexural-plate-wave component”
`and also includes “cooling and heating means via a Peltier component.” Id.
`at 45:34–35, 45:40–45. Mian teaches that amplification is initiated by
`introducing sample DNA and primer into each of ports A, B, and C, after
`which the disk is spun to effect mixing of the reagents into reaction chamber
`G. Id. at 45:50–54. “Simultaneously, valves controlling reservoirs D, E and
`F are opened and the contents of these reservoirs are also forced into
`reaction chamber G,” and “[m]ixing of sample DNAs, primers and reagents
`is facilitated by activation of the flexural-plate-wave component.” Id. at
`45:54–59. DNA amplification then takes place in reaction chamber G using
`
`12
`
`
`
`IPR2020-01136
`Patent 8,415,103 B2
`
`a thermal cycling program, and amplified DNA fragments are then
`“analyzed by transfer to capillary electrophoresis unit H by spinning the
`disk” and “opening a valve on reaction chamber G leading to capillary
`electrophoresis unit H.” Id. at 45:59–46:4.
`3. Claims 1–14
`Petitioner asserts that Kellogg discloses all of the elements of
`independent claim 1, and claims 2–14 that depend, directly or indirectly,
`therefrom. Pet. 22–52. In particular, Petitioner contends that Kellogg
`discloses “isolating the samples in the microfluidic cartridge” because “the
`samples cannot flow back upstream” while the substrate/disk is spinning,
`and because “capillary ‘microvalves 223, 298 and 299 also act as flow
`restrictors or microvalves to contain the samples in their networks.” Id. at
`25–26 (citing Ex. 1055, Fig. 3; Ex. 1210 ¶ 150). Petitioner contends that
`“[s]amples also are contained in reaction chambers 241 by upstream
`capillary junctions 298 and 299.” Id. at 26 (citing Ex. 1055, Fig. 3; Ex. 1210
`¶ 150). According to Petitioner, “[b]ecause the reaction chambers are
`located closest to the outer edge of the disk, centrifugal force of the spinning
`disk will contain the polynucleotide-containing samples in the reaction
`chambers and not travel upstream through air channel 242 and out vent
`243.” Id. (citing Ex. 1210 ¶ 150).
`Patent Owner argues that “Petitioner ignores the fact that the fluid in
`the microfluidic network of Kellogg is not isolated from air vents 212, 221,
`228, 231, 235 and 243 at any time during the operation of Kellogg’s disk.”
`Prelim. Resp. 30 (citing Ex. 2016 ¶ 95). Patent Owner argues that Kellogg’s
`“air vents and connected channels allow air to be displaced while liquid
`flows in the network,” and “Kellogg itself states that ‘volume loss due
`
`13
`
`
`
`IPR2020-01136
`Patent 8,415,103 B2
`
`mostly to evaporation is typically around 20% of the total input volume.’”
`Id. at 31 (citing Ex. 1055, 45:18–30, 60:16–18; Ex. 2015, 603, 605, 607–
`610, Table 1; Ex. 2016 ¶ 96). Patent Owner also argues that “even after the
`sample enters thermal cycling chamber 241, Kellogg does not isolate the
`sample from at least air channel 242 and vent 243.” Id. at 32 (citing
`Ex. 2016 ¶ 97). Patent Owner further argues that “Petitioner admits that
`sample vapors are not isolated in the reaction chamber of Kellogg Figure 3.”
`Id. at 32–33 (citing Pet. 34–35; Ex. 2016 ¶ 97).
`We are not persuaded that Petitioner sufficiently shows that Kellogg
`discloses “isolating the samples in the microfluidic cartridge” as required by
`claim 1. The ’103 patent consistently explains that the PCR reaction mix is
`isolated to “prevent any evaporation of liquid, bubble generation, or
`movement of fluid from the PCR reactor, during PCR.” Ex. 1200, 10:43–
`51; see also id. at 10:51–55 (“The use of microvalves configured such as
`valves 204 and 206 prevents both the loss of liquid or vapor thereby
`enabling even a partially filled reactor to successfully complete a PCR
`thermocycling reaction.”), 37:34–67 (“When in use to block a portion of a
`microchannel, the valves seal to prevent evaporation of fluid and/or physical
`migration of fluid from the PCR reactor during thermocycling.”), 38:22–26
`(“A reaction mixture is transported, via the inlet channel, to the PCR reactor
`where the reaction mixture is isolated (e.g., sealed off by valves) to prevent
`evaporation or movement (leakage) of the reaction mixture during
`thermocycling.”).
`Kellogg describes microfluidic networks that include air vents that
`“provide a means for fluids to displace air, thus ensuring uninhibited
`movement of fluids on the disk,” and capillaries that permit air to be
`
`14
`
`
`
`IPR2020-01136
`Patent 8,415,103 B2
`
`displaced by fluid flow from the reservoirs. Ex. 1055, 5:30–32, 48:32–34;
`see also id. at 43:32–33 (stating that “capillary valves are preferably used to
`control fluid flow in the platform”). Kellogg teaches that the cross-sectional
`area of the capillaries are “constructed to be too small to permit liquid flow
`therethrough.” Id. at 49:1–3. Kellogg recognizes, however, that volume
`loss, due mostly to evaporation, occurs gradually over the course of the
`amplification, and results in a loss of “around 20% of the total input
`volume.” Id. at 60:16–19. According to Kellogg, when using a microfluidic
`network like that described in Kellogg’s Figure 3, “the majority of the
`evaporation condenses in the channel just above the cycling chamber.” Id.
`at 60:19–21. Consequently, at least sample vapors travel upstream even if
`sample liquid is prevented from leaving Kellogg’s reaction chamber. See
`also Ex. 2014,6 240–241 (article by Kellogg describing a centrifugal system
`for DNA amplification using capillary valves to control fluid flow, “not[ing]
`that the thermal cycling chamber was not sealed; liquid loss was small,
`primarily due to vapor condensation and centrifugation during the
`heating/cooling cycles”); Ex. 2015,7 603 (Table 1), 610 (explaining that
`capillary valves “constitute liquid barriers and that they are not barriers for
`vapors”). Moreover, as Patent Owner notes, fluid traveling through
`Kellogg’s microfluidic network is exposed to several air vents as it works its
`way to the reaction chamber. Prelim. Resp. 30 (citing Ex. 2016 ¶ 95).
`Neither Petitioner nor its declarant, Dr. Burns, directs us to any disclosures
`
`
`6 Gregory J. Kellogg et al., Centrifugal Microfluidics: Applications, in Micro
`Total Analysis Systems 2000, 239–242 (A. van den Berg et al. 2000).
`7 Marc Madou et al., Lab on a CD, Annu. Rev. Biomed. Eng. 8:601–625
`(2006).
`
`15
`
`
`
`IPR2020-01136
`Patent 8,415,103 B2
`
`in Kellogg regarding restricting the flow of sample liquid or vapors through
`the open air vents.
`For these reasons, we are not persuaded that Petitioner establishes that
`Kellogg discloses “isolating the samples in the microfluidic cartridge” as
`required by claim 1.
`Petitioner also contends that Mian discloses all of the elements of
`independent claim 1, and claims 2–14 that depend, directly or indirectly,
`therefrom. Pet. 22–52, 65. Referring to Mian’s Figures 1A and 1B
`(reproduced in Section II.C.2, above), Petitioner asserts that Mian discloses
`“isolating the samples in the microfluidic cartridge” because the centrifugal
`force of Mian’s spinning disk first isolates the sample by preventing it from
`flowing back upstream after the sample passes through valve 17. Pet. 27
`(citing Ex. 1210 ¶ 151). Petitioner asserts that the sample is then isolated in
`the reaction chamber by selectively opening and closing microvalves 23
`and 25 on the upstream and downstream sides of the reaction chamber.
`Pet. 27 (citing Ex. 1210 ¶ 151; Ex. 1117, 7:38–57). According to Petitioner,
`closing microvalves 23 and 25 to isolate the sample during amplification
`prevents evaporation, loss of amplicons, and contamination, and minimizes
`reduction of reaction efficiency. Id. at 28 (citing Ex. 1210 ¶ 152).
`Patent Owner contends that “[c]losing any combination of valves 17,
`23, and 25 does not ‘isolat[e] the samples’ because the sample liquid and/or
`vapor is free to move out of vent 34 or 35, which are in direct
`communication with reaction chambers 22 and 24.” Prelim. Resp. 34 (citing
`Pet. 27–28; Ex. 2016 ¶ 100).
`We agree with Patent Owner. Mian explains that “[t]he air outlet
`ports and in particular the air displacement ports provide a means for fluids
`
`16
`
`
`
`IPR2020-01136
`Patent 8,415,103 B2
`
`to displace air, thus ensuring uninhibited movement of fluids on the disk.”
`Ex. 1117, 3:47–50; see also id. at 7:13–16 (“The movement of the sample is
`facilitated by the judicious incorporation of air holes or air displacement
`chambers that allow air to be displaced but prevent fluid and/or particle loss
`upon acceleration.”). Petitioner does not direct us to, nor do we discern, any
`disclosures in Mian regarding restricting the flow of at least some portion of
`the sample through Mian’s air vents. Therefore, even if microvalves 23 and
`25 are closed, Petitioner does not identify anything that regulates the flow of
`the sample out of the air vent that is in communication with Mian’s reaction
`chamber. For these reasons, we are not persuaded that Mian discloses
`“isolating the sample in the microfluidic cartridge” as required by claim 1.
`Claim 1 requires “isolating the sample in the microfluidic cartridge.”
`Ex. 1200, 47:12–13. Petitioner must show that liquid evaporation and the
`movement of sample liquid or vapors from the reaction chamber are
`prevented to meet this claim requirement. For the reasons set forth above,
`Petitioner fails to show that either Kellogg or Mian does so. Thus, we
`determine that the Petition does not establish a reasonable likelihood that
`Petitioner would prevail in showing that claim 1, and claims 2–14 that
`depend, directly or indirectly therefrom, are anticipated by Kellogg or Mian.
`4. Claim 15
`Petitioner contends that both Kellogg and Mian disclose all of the
`elements of independent claim 15. Pet. 52–53, 65. In particular, Petitioner
`contends that Kellogg and Mian disclose “isolating the samples within the
`plurality of reaction chambers” element of claim 15 “for the same reasons as
`previously described for” the “isolating the samples in the microfluidic
`cartridge” element of claim 1. Id. at 53; see also id. at 65 (stating that “[t]he
`
`17
`
`
`
`IPR2020-01136
`Patent 8,415,103 B2
`
`arguments in Grounds 1 and 2 regarding Mian are reiterated here” in the
`discussion of Petitioner’s challenge that Mian anticipates claims 1–15).
`Accordingly, for the reasons set forth above with respect to claim 1, we
`determine that Petitioner does not establish a reasonable likelihood that it
`would prevail in showing that claim 15 is anticipated by Kellogg or Mian.
`D. Remaining Grounds
`Petitioner contends that the subject matter of claims 1–15 would have
`been obvious over the combined teachings of Kellogg and Mian (Pet. 53–
`55), or the combined teachings of Mian and Kellogg, Zou I, Zou II, or Yoon
`(id. at 63–75). With respect to combination of Kellogg and Mian, Petitioner
`contends that claims 1–15 would have been obvious “for the reasons
`identified” in Petitioner’s anticipation argument, which “are incorporated by
`reference.” Id. at 55. With respect to the combination of Mian and Kellogg,
`Zou I, Zou II, or Yoon, Petitioner does not rely on Zou I, Zou II, or Yoon to
`remedy the deficiencies identified above with respect to Petitioner’s
`allegation that both Kellogg and Mian anticipate claims 1–15. Id. at 65–67.
`Accordingly, we determine that Petitioner does not establish a reasonable
`likelihood that it would prevail in showing that claims 1–15 would have
`been obvious over the combined teachings of Kellogg and Mian, or the
`combined teachings of Mian and Kellogg, Zou I, Zou II, or Yoon.
`III. CONCLUSION
`Based on the arguments in the Petition and the Preliminary Response,
`and the evidence of record, we determine that Petitioner has not established
`a reasonable likelihood that it would prevail on its challenge that claims 1–
`15 of the ’103 patent are unpatentable.
`
`18
`
`
`
`IPR2020-01136
`Patent 8,415,103 B2
`
`
`IV. ORDER
`In consideration of the foregoing, it is hereby
`ORDERED that the Petition is denied and no trial is instituted.
`
`
`PETITIONER:
`James K. Cleland
`Michael N. Spink
`Keith D. Weiss
`DICKINSON WRIGHT, PLLC
`jcleland@dickinson-wright.com
`mspink@dickinson-wright.com
`kweiss@dickinson-wright.com
`
`
`PATENT OWNER:
`
`Heather M. Petruzzi
`Barish Ozdamar, Ph.D.
`WILMER CUTLER PICKERING HALE and DORR LLP
`Heather.Petruzzi@wilmerhale.com
`BarishOzdamar@wilmerhale.com
`
`
`
`
`
`19
`
`
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
