Trials@uspto.gov
`571-272-7822
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`
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`
`Paper 21
`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.
`____________
`
`
`
`IPR2020-01133
`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 21
`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.
`____________
`
`
`
`IPR2020-01133
`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
`
`
`
`
`
`IPR2020-01133
`Patent 8,415,103 B2
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`
`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 20
`(“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 3, 2. The ’103 patent is the subject of IPR2020-
`01136, also filed by Petitioner. Paper 3, 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
`cartridges configured to carry out PCR on nucleotides of interest,
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`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
`bay. Id. at 17:7–8, 20:10–17. The ’103 patent teaches that the bay “can also
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`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.
`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.
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`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
`amplifying polynucleotides contained within the plurality
`of samples, by application of successive temperature
`cycles independently to the reaction chambers.
`Id. at 48:26–42.
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`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
`
`References/Basis
`35 U.S.C.
`§ 102(e) Handique-Publ’941,1 Handique-
`Prov’2842
`§ 102(b) Ganesan-Publ’4243
`Ganesan-Publ’424, Jensen,4
`§ 103
`Kellogg,5 Yoon6
`§ 102(e) Handique-Publ’941, Handique-
`Prov’0077
`Pet. 3–4. Petitioner relies on the Declaration of Mark A. Burns, Ph.D.
`(Ex. 1101) 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 to
`
`1–15
`
`
`1 U.S. Patent App. Pub. No. 2007/0292941 A1, published Dec. 20, 2007
`(Ex. 1205).
`2 U.S. Provisional App. No. 60/859,284, filed Nov. 14, 2006 (Ex. 1206).
`3 U.S. Patent App. Pub. No. 2005/0084424 A1, published Apr. 21, 2005
`(Ex. 1109).
`4 U.S. Patent App. Pub. No. 2006/0246493 A1, published Nov. 2, 2006
`(Ex. 1115).
`5 WO 00/078455 A1, published Dec. 28, 2000 (Ex. 1055).
`6 U.S. Patent App. Pub. No. 2005/0112754 A1, published May 26, 2005
`(Ex. 1118).
`7 U.S. Provisional App. No. 60/786,007, filed March 24, 2006 (Ex. 1207).
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`biochemical reactions/analysis, such as PCR,” or an advanced degree in the
`same fields “with at least one year of related experience.” Pet. 9. Patent
`Owner states that it “does not currently dispute Petitioner’s proposed
`definition.” Prelim. Resp. 10.
`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)).
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`Neither party proposes an explicit construction for any claim term.
`See Pet. 9; Prelim. Resp. 10. For purposes of this Decision, based on the
`record before us, we address the interpretation of “placing the microfluidic
`cartridge in thermal communication with an array of independent heaters” as
`set forth in independent claims 1 and 15.
`Patent Owner contends that “the prosecution history of the ’103 patent
`shows that the heaters recited in the limitation ‘placing the microfluidic
`cartridge in thermal communication with an array of independent heaters’
`does not refer to integrated heaters.” Id. at 18 (citing Ex. 1200, claims 1, 15;
`Ex. 2016 ¶¶ 73–74). We understand Patent Owner to argue that we should
`apply prosecution history disclaimer to this limitation.
`“[I]n a proceeding in which [a] . . . patent has been brought back to
`the [Office] . . . for a second review,” our reviewing court instructs us that, if
`in evidence, we should “consult the patent’s prosecution history.” Microsoft
`Corp. v. Proxyconn, Inc., 789 F.3d 1292, 1298 (Fed. Cir. 2015). Though
`“less useful for claim construction purposes” than the claim language and
`written description, prosecution history plays various roles in resolving
`uncertainties about claim scope. Phillips v. AWH Corp., 415 F.3d 1303,
`1307 (Fed. Cir. 2005). When, as here, the prosecution history is used solely
`to support a conclusion of a disclaimer, the standard for justifying the
`conclusion is a high one. For prosecution disclaimer to attach, “the alleged
`disavowing action or statement made during prosecution must be clear and
`unmistakable.” Omega Eng’g, Inc. v. Raytek Corp., 334 F.3d 1314, 1325–
`26 (Fed. Cir. 2003).
`Patent Owner directs us to the applicant’s response to the Examiner’s
`rejection of the then-pending claims based on U.S. Patent No. 6,334,980
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`(“Hayes”), in which the applicant added the “placing the microfluidic
`cartridge in thermal communication with an array of independent heaters”
`limitation to pending independent claims 1 and 15. Prelim. Resp. 18–19
`(citing Ex. 1201, 2–8; Ex. 1202, 6–8). Patent Owner points to the
`applicant’s explanation “that adding this limitation distinguished the claims
`from Hayes because the reference does not contemplate a ‘cassette in
`communication with an array of independent heaters.’” Id. at 19 (citing
`Ex. 1202, 7). Patent Owner then notes that the Examiner agreed that the
`integrated heaters described in Hayes “would not be ‘placed’ in thermal
`communication with an array of independent heaters as required by the
`claims,” and withdrew the rejection. Id. at 20 (citing Ex. 1203, 3).
`Upon reviewing the statements made by the applicant of the ’103
`patent during the original prosecution, we agree with Patent Owner that
`integrated heaters are not within the scope of the “placing the microfluidic
`cartridge in thermal communication with an array of independent heaters”
`limitation of claims 1 and 15. The Examiner rejected then-pending claim 1
`as being anticipated by Hayes, stating that Hayes discloses a method that
`comprises introducing the plurality of samples separately into a microfluidic
`cartridge, isolating the samples in the microfluidic cartridge upon loading
`the samples into individual chambers, and amplifying polynucleotides by
`thermocycling until the PCR reaction is complete. Ex. 1201, 3–4. The
`applicant responded by amending the claim to add the “placing the
`microfluidic cartridge in thermal communication with an array of
`independent heaters” limitation. Ex. 1202, 3. The applicant explained:
`Hayes teaches a “compact unitary reaction and analysis
`chamber” (10). Hayes, col. 4, line 6. The apparatus includes
`three reaction chambers (40, 41, 42) positioned in a substrate
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`(20). Circumventing each reaction chamber is a U-shaped
`heater (50, 51, 52). The apparatus “incorporates reaction
`chambers, heaters and analysis chambers into a miniature self-
`contained compact structure or cassette.” Hayes, col. 3, ll. 10–
`12. Thus, the heaters and reaction chambers used in Hayes are
`part of the same cassette.
`Id. at 7. The applicant further stated:
`In contrast to the integrated cassette disclosed in Hayes,
`amended Claim 1 recites “placing the microfluidic cartridge in
`thermal communication with an array of independent heaters.”
`It is not contemplated in Hayes to place the cassette in
`communication with an array of independent heaters because
`the heaters in Hayes are already incorporated into the structure
`of the cassette.
`Id.; see also id. at 9 (arguing that Hayes does not disclose the limitations of
`amended claim 15 for the same reasons). Upon withdrawing the Hayes
`anticipation rejection in light of the amendment, the Examiner stated that
`Hayes’ “microfluidic device comprises integrated heaters which are
`independently controllable, and therefore, the microfluidic device would not
`be ‘placed’ in thermal communication with an array of independent heaters.”
`Ex. 1203, 2.
`We are persuaded, on this record, that there is a clear and
`unmistakable disclaimer of claim scope that excludes heaters that are
`integrated into the microfluidic cartridge. The applicant explicitly states that
`“the heaters and reaction chambers used in Hayes are part of the same
`cassette,” and that “[i]t is not contemplated in Hayes to place the cassette in
`communication with an array of independent heaters because the heaters in
`Hayes are already incorporated into the structure of the cassette.” Ex. 1202,
`7. The Examiner confirms that heaters that are integrated in the microfluidic
`device “would not be ‘placed’ in thermal communication with an array of
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`independent heaters.” Ex. 1203, 2. These statements are not amenable to
`any reasonable interpretation other than that “placing the microfluidic
`cartridge in thermal contact with an array of independent heaters” does not
`include heaters that are already integrated in the microfluidic device.
`Accordingly, on this record, we adopt Patent Owner’s position that
`“placing the microfluidic cartridge in thermal contact with an array of
`independent heaters” does not include heaters that are integrated in the
`microfluidic device.
`C. Grounds Based on Ganesan-Publ’424
`Petitioner contends that claims 1–15 are anticipated by Ganesan-
`Publ’424. Pet. 31–52. Petitioner also contends that the subject matter of
`claims 1–15 would have been obvious over Ganesan-Publ’424 alone or in
`combination with Jensen, Kellogg, or Yoon. Pet. 59–84.
`1. Overview of Ganesan-Publ’424
`Ganesan-Publ’424 relates to microfluidic devices, and systems and
`methods for operating microfluidic devices. Ex. 1109 ¶ 2. The
`“[m]icrofluidic devices generally include a substrate that defines one or
`more microfluidic networks, each including one or more channels, process
`modules, and actuators.” Id. ¶ 58. The process modules and actuators are
`typically thermally actuated; “[f]or example, a process module can include a
`reaction chamber or lysing chamber that is heated by a heat source.” Id.
`¶ 59. Ganesan-Publ’424 teaches that process modules can be configured to
`amplify DNA by PCR. Id. ¶ 69. Ganesan-Publ’424 also describes
`microfluidic systems that include the microfluidic device, as well as the heat
`sources, thermally actuated modules, fluid control elements, and actuators of
`the microfluidic device. Id. ¶ 75.
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`Ganesan-Publ’424 further teaches that during operation of the
`microfluidic system, “heat sources and temperature sensors are typically
`disposed within thermal contact of a localized region of” the microfluidic
`device. Id. ¶ 79. These components can be integral with the microfluidic
`device, “e.g., the components are fabricated within and/or upon one or more
`substrates that also define the microfluidic network.” Id. “Alternatively or
`in combination, the components are fabricated within or upon another
`portion of” the microfluidic system, such as a chip carrier that is mated with
`the microfluidic device “to bring the heat sources and elements of the
`microfluidic network into thermal communication.” Id. The microfluidic
`device mated with the chip carrier can then be inserted into, or removed
`from, an interface hardware receptacle. Id. ¶ 82.
`Ganesan-Publ’424’s Figure 3 is reproduced below.
`
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`Figure 3 schematically illustrates the general structure of an exemplary
`microfluidic device. The microfluidic device includes a microfluidic
`network with “four separate sub-assemblies: two micro-droplet metering
`sub-assemblies, metering1 and metering2; one mixing sub-assembly,
`mixing1; and one reaction/detection sub-assembly, reaction/detection1.” Id.
`¶ 88. Sub-assemblies metering1 and metering 2 include, respectively, inlet1
`and inlet 2, overflow1 and overflow2, valve1 and valve2, heater1 and
`heater2, and passage 1 and passage2. Id. ¶ 89. Sub-assembly mixing1
`includes heater1, heater2, valve3, valve4, vent1, vent2, Y-shaped passage3,
`and passage4, and sub-assembly reaction/detection1 includes valve5, valve6,
`and passage5. Id.
`“Operation of the sub-assemblies generally result from the
`coordinated operations of their component actuators under the control of an
`external controller, DAQ 26 [not pictured].” Id. ¶ 90. Fluid is introduced
`into inlet1 to first hydrophobic region h3, DAQ 26 instructs sub-assembly
`metering1 to measure a determined-volume micro-droplet from the fluid,
`and sub-assembly metering2 operates similarly to extract a measured micro-
`droplet from fluid introduced at inlet2. Id. DAQ 26 then supplies current to
`heater1 and heater2 to generate pressure and propel the two micro-droplets
`through Y-shaped passage3 and along passage4 to a stable position in
`passage5, causing the two micro-droplets to merge, mix, and form a single,
`larger micro-droplet. Id. ¶ 92. Next, DAQ 26 supplies current to valve5 and
`valve6 to close the valves and isolate the micro-droplet along passage5, and
`directs sub-assembly reaction/detection1 to stimulate a reaction in the micro-
`droplet by supplying current to heater3, which heats the micro-droplet. Id.
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`¶ 93. DAQ 26 “then monitors the results of the stimulated reaction by
`optically detecting radiation conducted by optical paths.” Id.
`2. Anticipation
`Petitioner contends that Ganesan-Publ’424 discloses all of the
`elements of independent claims 1 and 15. Pet. 37–44, 51–52. With respect
`to the “placing the microfluidic cartridge in thermal communication with an
`array of independent heaters” limitation of the claims, Petitioner first points
`to Ganesan-Publ’424’s Figure 3, and contends that it “depicts the array of
`heaters formed by Heater1, Heater2, Heater3 and the heaters for the valves,”
`and that, “[w]hen microfluidic device 10 is mated with cartridge 20, the
`components of device 10 are placed in thermal communication with the heat
`sources formed within cartridge 20.” Pet. 41 (citing Ex. 1109 ¶ 82; Ex. 1101
`¶¶ 342–343).
`Petitioner also contends that Ganesan-Publ’424 “discloses that the
`heaters may be fabricated within the substrate of device 10 itself, or they
`may be formed within other portions of the system 99.” Id. (citing Ex. 1109
`¶ 79; Ex. 1101 ¶ 344). Petitioner contends that Ganesan-Publ’424’s
`Figure 11 depicts a heater substrate that is separate from the microfluidic
`substrate that defines a microfluidic network between layers. Id. (citing
`Ex. 1109 ¶¶ 158–161; Ex. 1101 ¶ 344). Finally, Petitioner contends that
`Ganesan-Publ’424 incorporates parent application Ganesan-Prov’264,8
`which Petitioner contends discloses that heater/sensors may be formed
`separately from a microfluidic device. Id. at 42–43 (citing Ex. 1208, 12:20–
`25).
`
`
`8 U.S. Provisional App. No. 60/491,264, filed July 31, 2003 (Ex. 1208).
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`Patent Owner argues that because the heaters in both of Figures 3 and
`11 of Ganesan-Publ’424 “are part of the cartridge assembly in both of these
`embodiments, Petitioner fails to identify a disclosure in Ganesan-Publ’424
`of ‘placing the microfluidic cartridge in thermal communication with an
`array of independent heaters’ as recited in the challenged claims.” Prelim.
`Resp. 16 (citing Ex. 2016 ¶ 71). Patent Owner argues that Ganesan-
`Publ’424’s integrated heaters are “analogous to the Hayes configuration that
`was overcome during prosecution with the amended language,” and that a
`microfluidic cartridge with integrated heaters is already “in thermal
`communication with those heaters” so “placing” is not necessary. Id. at 20
`(citing Ex. 1203, 3; Ex. 2016 ¶ 76).
`The ’103 patent states that a microfluidic cartridge includes “a
`plurality of microfluidic networks, each network having various components
`configured to carry out PCR on a sample.” Ex. 1200, 4:35–40. It also
`includes “one or more sample lanes in parallel, 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. The ’103 patent also teaches that, “[i]n use, a microfluidic
`cartridge, as described herein, is typically thermally associated with an array
`of heat sources configured to operate the components (e.g., valves, gates,
`and PCR reactor) of the microfluidic networks.” Id. at 8:55–58.
`When the microfluidic device in Ganesan-Publ’424’s Figure 3, in
`which the heaters are integrated, is mated with a chip carrier cartridge, it
`forms a microfluidic cartridge, which, in turn, has integrated heaters. See
`Ex. 1109 ¶¶ 79, 82. As set forth above, we determine that the claim element
`“placing the microfluidic cartridge in thermal communication with an array
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`of independent heaters” does not encompass such integrated heaters.
`Accordingly, we agree with Patent Owner that Ganesan-Publ’424’s Figure 3
`does not meet the “placing the microfluidic cartridge in thermal
`communication with an array of independent heaters” limitation of
`independent claims 1 and 15.
`Likewise, Ganesan-Publ’424’s Figure 11, reproduced below, also
`depicts a microfluidic cartridge with integrated heaters.
`
`Figure 11 depicts “a portion of a microfluidic system having a microfluidic
`device defining a microfluidic network in thermal communication with heat
`sources of a substrate.” Ex. 1109 ¶ 55. Substrate 3200, which includes heat
`sources 3339, 3341, and 3343, “is received by (or is integral with) a chip
`carrier cartridge 3345.” Id. ¶¶ 157–158. Cartridge 3345 includes
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`connections 3349 that “are generally in communication with” an external
`controller configured to operate the heat sources. Id. ¶ 158. In use, substrate
`3200 (which is integrated with cartridge 3345) mates with microfluidic
`device 3220 comprising microfluidic network 3222 such that “active regions
`3208 and 3218 are disposed in thermal communication with thermally
`actuated elements of the microfluidic network.” Id. ¶ 161. This
`combination of cartridge 3345, substrate 3200, and microfluidic device 3220
`forms a microfluidic cartridge in which the heaters in substrate 3200 are
`integrated. The microfluidic cartridge in Figure 11, therefore, integrates an
`array of independent heaters; it is not placed in thermal communication with
`an array of independent heaters.
`To the extent that Petitioner also relies on Ganesan-Prov’264 to
`establish anticipation by Ganesan-Publ’424, we determine that such reliance
`is improper. Petitioner relies on Ganesan-Prov’264’s statement that “one or
`more heater/sensors may be formed as part of a device configured to
`operatively receive a microfluidic device” to support its contention that
`Ganesan-Publ’424’s heater array “may be formed integrally with the
`network-containing microfluidic substrate, or may be formed separately in a
`testing device into which the microfluidic substrate is placed or another part
`of the system.” Pet. 42–43.
`We have considered Petitioner’s reliance on Ganesan-Prov’264, and
`we disagree with Petitioner’s contention that it necessarily forms a part of
`Ganesan-Publ’424 for purposes of anticipation. Our reviewing court
`has held that anticipation requires that the four corners of a
`single, prior art document describe every element of the
`claimed invention, either expressly or inherently, such that a
`person of ordinary skill in the art could practice the invention
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`
`without undue experimentation. Material not explicitly
`contained in the single, prior art document may still be
`considered for purposes of anticipation if that material is
`incorporated by reference into the document. Incorporation by
`reference provides a method for integrating material from
`various documents into a host document—a patent or printed
`publication in an anticipation determination—by citing such
`material in a manner that makes clear that the material is
`effectively part of the host document as if it were explicitly
`contained therein. To incorporate material by reference, the
`host document must identify with detailed particularity what
`specific material it incorporates and clearly indicate where that
`material is found in the various documents.
`Advanced Display Sys., Inc. v. Kent State Univ., 212 F.3d 1272, 1282 (Fed.
`Cir. 2000) (citations omitted; emphasis added). Thus, only subject matter
`identified with detailed particularity forms part of Ganesan-Publ’424 for
`purposes of anticipation. Ganesan-Publ’424 generally incorporates
`Ganesan-Prov’264 by reference, and Petitioner does not point us to any
`subject matter from Ganesan-Prov’264 that is identified with particularity
`within Ganesan-Publ’424. Ex. 1109 ¶ 1 (listing related applications,
`including Ganesan-Prov’264, and stating that “[a]ll of the foregoing
`applications are incorporated herein by reference”); Pet. 42–43.
`Accordingly, we do not address Petitioner’s contentions with regard to
`Ganesan-Prov’264 in determining whether Petitioner establishes a
`reasonable likelihood of showing that Ganesan-Publ’424 anticipates
`independent claims 1 and 15.
`Claims 1 and 15 require “placing the microfluidic cartridge in thermal
`communication with an array of independent heaters.” Ex. 1200, 47:14–15,
`48:38–39. Petitioner must show that the array of independent heaters is
`separate from the microfluidic cartridge to meet this claim requirement. For
`
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`IPR2020-01133
`Patent 8,415,103 B2
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`the reasons set forth above, Petitioner fails to show that Ganesan-Publ’424
`does so. Thus, we determine that the Petition does not establish a reasonable
`likelihood that Petitioner would prevail in showing that independent claims
`1 and 15, and claims 2–14 that depend, directly or indirectly, from claim 1,
`are anticipated by Ganesan-Publ’424.
`3. Obviousness
`Petitioner argues that “[c]laims 1–15 are invalid as obvious based
`upon the obvious duplication of the microfluidic network of Ganesan-
`Publ’424 . . . in view of Ganesan-Publ’424 alone or in combination with
`Jensen, Kellogg, or Yoon, for the reasons given” in Petitioner’s anticipation
`challenge based on Ganesan-Publ’424, and provides additional arguments
`that include Jensen, Kellogg, and Yoon for a number of the claims. Pet. 64–
`84. Petitioner does not rely on Jensen, Kellogg, or Yoon to remedy the
`deficiencies identified above with respect to Petitioner’s allegation that
`Ganesan-Publ’424 anticipates claims 1–15. See id. at 64–66 (discussing
`claim 1), 84 (discussing claim 15). 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 Ganesan-Publ’424
`alone or in view of Jensen, Kellogg, or Yoon.
`D. Anticipation by Handique-Publ’941 and Handique-Prov’007
`Petitioner contends that claims 1–15 are anticipated by Handique-
`Publ’941 and Handique-Prov’007, which is incorporated by reference
`therein. Pet. 74–78. Petitioner states that in addition “to incorporating
`Ganesan-Publ’424 by reference, Handique-Publ’941 incorporates by
`reference Handique-Prov’007 filed March 24, 2006.” Id. at 74 (citing
`Ex. 1205 ¶¶ 1, 320). Petitioner also states that “Handique-Prov’007 itself
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`IPR2020-01133
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`incorporates by reference Handique-Pat’391,” and contends that “Handique-
`Pat’391 and Ganesan-Publ’424 disclose the same microfluidic network for
`PCR amplification” as discussed with respect to Petitioner’s challenge that
`claims 1–15 are anticipated by Ganesan-Publ’424. Id. at 75 (citing
`Ex. 1207, 39:28–30; Ex. 1101 ¶ 392). Petitioner then states that, “[a]s the
`microfluidic device and network shown in Handique-Pat’391 and Ganesan-
`Publ’424 was already analyzed in Ground 2 above, Claims 1–15 of the ’103
`Patent are anticipated by Handique-Prov’007 for all the reasons given in
`Ground 2 above and in this Ground 4.” Id. at 78.
`Pursuant to 35 U.S.C. § 312(a)(3), a petition must identify, “in writing
`and with particularity, each claim challenged, the grounds on which the
`challenge to each claim is based, and the evidence that supports the grounds
`for the challenge to each claim.” Upon review of the Petition and the
`supporting evidence, we determine that the Petition does not articulate, with
`reasonable clarity, the evidence that supports Petitioner’s contention that
`Handique-Publ’941, and Handique-Prov’007 incorporated by reference
`therein, discloses all of the elements of claims 1–15 of the ’103 patent.
`Petitioner’s only support for its contentions is its reference to the
`arguments made with respect to Ground 2 (anticipation by Ganesan-
`Publ’424), but, as Patent Owner notes, “Ground 2 does not cite to any
`disclosures in Handique-Publ’941 or Handique-Prov’007.” Prelim.
`Resp. 36. Additionally, Petitioner does not map the disclosures of
`Handique-Publ’941 or Handique-Prov’007 to the elements of the claims, as
`it does for the other asserted grounds. See Pet. 74–78. We determine,
`therefore, that the Petition does not
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