Trials@uspto.gov
`571-272-7822
`
`Paper 15
`Date: August 31, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`NANOCELLECT BIOMEDICAL, INC.,
`Petitioner,
`v.
`CYTONOME/ST, LLC,
`Patent Owner.
`
`IPR2020-00546
`Patent 9,339,850 B2
`
`
`
`
`
`
`
`
`
`Before ULRIKE W. JENKS, SUSAN L. C. MITCHELL, and JAMES A.
`WORTH, Administrative Patent Judges.
`WORTH, Administrative Patent Judge.
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314, 37 C.F.R. § 42.4
`
`INTRODUCTION
`I.
`A. Background and Summary
`On February 11, 2020, NanoCellect Biomedical, Inc. (“NanoCellect”
`or “Petitioner”) filed a Petition (Paper 2, “Pet.”) requesting an inter partes
`review of claims 1 and 6–12 (the “challenged claims”) of U.S. Patent No.
`9,339,850 B2 (Ex. 1001, “the ’850 patent”). On June 4, 2020,
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`Patent 9,339,850 B2
`Cytonome/ST, LLC (“Cytonome” or “Patent Owner”) filed a Preliminary
`Response (Paper 6, “Prelim. Resp.”). With authorization, the parties filed
`further pre-institution briefing related to the issue of discretion under 35
`U.S.C. § 314(a), as follows. On June 19, 2020, Petitioner filed a reply to the
`preliminary response (Paper 7, “Prelim. Reply”). On June 26, 2020, Patent
`Owner filed a sur-reply (Paper 8, “Prelim. Sur-Reply”). On July 17, 2020,
`Petitioner filed a supplemental brief (Paper 11, “Prelim. Supp. Br.”). On
`July 22, 2020, Patent Owner filed a supplemental brief in response (Paper
`12, “Prelim. Supp. Resp.”).
`Petitioner relies on the declaration of Bernhard Weigl, Ph.D. as expert
`testimony. Ex. 1002. Patent Owner relies on the declaration of Don W.
`Arnold, Ph.D. as expert testimony. Ex. 2001.
`Institution of an inter partes review is authorized by statute when “the
`information presented in the petition filed under [35 U.S.C. §] 311 and any
`response filed under [35 U.S.C. §] 313 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(a). For the reasons set
`forth below, we determine that Petitioner has not demonstrated that there is a
`reasonable likelihood that any of the challenged claims are unpatentable, and
`we do not institute an inter partes review on the grounds set forth in the
`Petition.
`
`B. Real Parties in Interest
`Petitioner identifies itself as the real party-in-interest. See Pet. 2.
`Patent Owner indicates that it and Inguran, LLC are the real-parties-in-
`interest. Paper 4, 1.
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`IPR2020-00546
`Patent 9,339,850 B2
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`C. Related Matters
`The parties note as related litigation in federal district court,
`Cytonome/ST, LLC v. NanoCellect Biomedical, Inc., Case No. 1:19-cv-
`00301-UNA (D. Del., filed Feb. 12, 2019). See Pet. 2–3; Paper 4, 1.
`NanoCellect has filed petitions for inter partes review challenging the
`following related patents (see Pet. 2–3):
`Case No.
`IPR2020-00545
`IPR2020-00547
`IPR2020-00548
`IPR2020-00549
`IPR2020-00550
`IPR2020-00551
`
`U.S. Patent No.
`6,877,528
`10,029,283
`8,623,295
`10,029,263
`9,011,797
`10,065,188
`
`
`
`D. The ’850 Patent
`The ’850 patent is titled “Method and Apparatus for Sorting Particles”
`and relates to “a method and apparatus for the sorting of particles in a
`suspension, where the input flow path of a sorting module can be split into
`several output channels.” Ex. 1001, code (54), 1:25–27. The ’850 patent
`describes problems with various then-existing devices, e.g., bubble
`formation could clog flow channels or foul constituents (id. at 2:24–37) and
`pressure waves could influence flows in neighboring units (id. at 2:50–65,
`3:12–14).
`Figures 1–4 of the ’850 patent are reproduced below:
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`Patent 9,339,850 B2
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`Figure 1 is a schematic view of a particle sorting system according to
`an illustrative embodiment of the invention. Ex. 1001, 4:52–53. Figures 2
`through 4 illustrate the operation of the particle sorting system of Figure 1.
`Id. at 4:54–55.
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`IPR2020-00546
`Patent 9,339,850 B2
`As illustrated in Figure 1, particle sorting system 10 comprises a
`closed channel system of capillary size for sorting particles including first
`supply duct 12 for introducing stream of particles 18 and second supply
`duct 14 for supplying carrier liquid. Id. at 5:61–66. First supply duct 12
`forms nozzle 12a. Id. at 5:66–6:1. First supply duct 12 and second supply
`duct 14 are in fluid communication with measurement duct 16. Id. at 6:1–3.
`Measurement duct 16 branches into first branch channel 22a and second
`branch channel 22b at branch point 21. Id. at 6:4–5. Measurement duct 16
`includes measurement region 20 that is associated with detector 19. Id. at
`6:5–8. System 10 also includes two opposed bubble valves 100a and 100b
`positioned relative to measurement duct 16 in fluid communication
`therewith through opposed side passages 24a and 24b. Id. at 6:9–16. Liquid
`is allowed to partly fill side passages 24a and 24b to form meniscus 25
`therein. Id. at 6:16–17. The meniscus defines an interface between the
`carrier liquid and another fluid, such as a gas in the reservoir of the
`associated bubble valve 100. Id. at 6:17–20. Actuator 26 is coupled to
`bubble valve 100b. Id. at 6:23–24. Second bubble valve 100a serves as a
`buffer for absorbing the pressure pulse created by the first bubble valve
`100b. Id. at 6:24–26.
`As illustrated in Figure 2, upon activation of actuator 26, the pressure
`within reservoir 70b of first bubble valve 100b is increased, deflecting
`meniscus 25b and causing a transient discharge of liquid from first side
`passage 24b, as indicated by the arrow. Id. at 8:23–30. The sudden pressure
`increase caused at this point in the duct causes liquid to flow into second
`side passage 24a, because of the resilient properties of the reservoir of
`second bubble valve 100a. Id. at 8:30–33. This movement of liquid into
`second side passage 24a is indicated with an arrow. Id. at 8:33–34.
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`IPR2020-00546
`Patent 9,339,850 B2
`As illustrated in Figure 3, actuator 26 is deactivated, causing the
`pressure inside reservoirs 70a, 70b to return to the normal pressure. Id. at
`8:52–54. During this relief phase, there is a negative pressure difference
`between reservoirs 70a, 70b of the bubble valves, causing a liquid flow
`through first side passage 24b and second side passage 24a opposite to the
`liquid flow shown in the previous figure and as indicated by the arrows. Id.
`at 8:54–59.
`As illustrated in Figure 4, the pressures inside the reservoirs of the
`bubble valves are equalized, allowing the flow through measurement duct 16
`to normalize. Id. at 8:60–63. As particle of interest 18b has been displaced
`radially, it will flow into first branch 22a, while the other particles continue
`to flow into second branch 22b. Id. at 8:63–66.
`E. Illustrative Claims
`Claim 1, reproduced below, is the sole independent claim and is
`illustrative of the subject matter:
`1.
`A particle sorting system, comprising:
`a duct for conveying a stream of particles, comprising an
`inlet, and a plurality of outlets including a first outlet and a
`second outlet, wherein the particles normally flow from the inlet
`into the first outlet;
`an actuator for selectively applying a pressure pulse to
`deflect a selected particle in the stream of particles into the
`second outlet when a predetermined characteristic is detected;
`and
`
`a buffer configured to fluidically co-operate with the
`actuator for absorbing or dampening the pressure pulse to allow
`other particles in the stream of particles to normally flow into the
`first outlet while the deflected particle flows into the second
`outlet.
`Ex. 1001, 14:17–30.
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`IPR2020-00546
`Patent 9,339,850 B2
`F. Prior Art and Asserted Grounds
`Petitioner asserts that claims 1 and 6–12 would have been
`unpatentable on the following grounds (Pet. 4–5):
`Claim(s) Challenged
`35 U.S.C. §
`Reference(s)/Basis
`1, 7–12
`1031
`Wada2
`1, 7–12
`103
`Wada and Anderson3
`6
`103
`Wada, Anderson, and Riley4
`6
`103
`Wada, Anderson, and Bargeron5
`1, 7–12
`103
`Marcus6 and Anderson
`6
`103
`Marcus, Anderson, and Riley
`Marcus, Anderson, and
`6
`103
`Bargeron
`
`
`
`II. ANALYSIS
`A. Legal Standards
`A patent claim is unpatentable under 35 U.S.C. § 103 if the
`differences between the claimed subject matter and the prior art are such that
`the subject matter, as a whole, would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said
`subject matter pertains. 35 U.S.C. § 103; KSR Int’l Co. v. Teleflex Inc., 550
`U.S. 398, 406 (2007). “[W]hen a patent claims a structure already known in
`the prior art that is altered by the mere substitution of one element for
`
`
`1 The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29, 125
`Stat. 284, 287–88 (2011), amended 35 U.S.C. § 103. Because the ’850 patent
`was filed before the effective date of the relevant amendment, the pre-AIA
`version of § 103 applies.
`2 Wada, WO 00/70080, pub. Nov. 23, 2000 (Ex. 1006, “Wada”).
`3 Anderson, WO 97/002357, pub. Jan. 23, 1997 (Ex. 1012, “Anderson”).
`4 Riley, US 2002/0122167 A1, pub. Sept. 5, 2002 (Ex. 1013, “Riley”).
`5 Bargeron, US 4,148,585, iss. Apr. 10, 1979 (Ex. 1036, “Bargeron”).
`6 Marcus, US 5,101,978, iss. Apr. 7, 1992 (Ex. 1005, “Marcus”).
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`another known in the field, the combination must do more than yield a
`predictable result.” KSR, 550 U.S. at 416 (citing United States v. Adams,
`383 U.S. 39, 50‒51 (1966)). The question of obviousness is resolved based
`on underlying factual determinations including: (1) the scope and content of
`the prior art; (2) any differences between the claimed subject matter and the
`prior art; (3) the level of ordinary skill in the art; and (4) objective evidence
`of non-obviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
`In an inter partes review, a petition must identify “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.” 35 U.S.C. § 312(a)(3) (2018); see also 37 C.F.R. § 42.104(b) (2018)
`(requiring a petition for inter partes review to identify how the challenged
`claim is to be construed and where each element of the claim is found in the
`prior art patents or printed publications relied upon).
`B. Level of Ordinary Skill in the Art
`Petitioner argues that a person of ordinary skill in the art (POSA) at
`the relevant times would have had a bachelor’s or master’s degree in the
`field of bioengineering, mechanical engineering, chemical engineering, or
`analytical chemistry; or a bachelor’s or master’s degree in a related field and
`at least three years of experience in designing or developing microfluidic
`systems. Pet. 13 (citing Ex. 1002 ¶¶ 3–9, 53–56). Patent Owner does not
`dispute Petitioner’s assertion in its preliminary response. Prelim. Resp. 27.
`For purposes of this Decision, we accept Petitioner’s undisputed assertion.
`See Ex. 1002 ¶¶ 3–9, 53–56.
`C. 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
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`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).
`Petitioner asserts that the Board need not expressly construe any
`claims. Pet. 10–12. Patent Owner requests construction of the terms
`“pressure pulse” and “a buffer . . . for absorbing or dampening the pressure
`pulse.” Prelim. Resp. 27–32. We construe these terms as follows.
` “pressure pulse”
`1.
`Noting that “[t]he district court rejected Petitioner’s proposed
`construction of ‘pressure pulse’—‘a unidirectional flow to the
`[microchannel/supply duct]’—and will apply the term’s ‘plain and ordinary
`meaning,’” Patent Owner contends that “the Board should also apply the
`plain and ordinary meaning, which is ‘a transient increase in pressure.’”
`Prelim. Resp. 27 (citing Ex. 2012, 6–7). Patent Owner argues that a
`“pressure pulse” is not a flow, and that the claims know how to use the word
`“flow” when they want to express that concept, such as “the particles
`normally flow.” Id. at 27–29 (citing Ex. 1001, claims 1, 2, 3, 8).
`Patent Owner also argues that the prosecution history distinguished
`several references on this basis during prosecution of the related ʼ528 Patent
`and U.S. Patent No. 7,584,857, citing Research in Motion for the proposition
`that the court may construe common terms the same across related patents.
`See Prelim. Resp. 30 (citing NTP, Inc. v. Research In Motion, Ltd., 418 F.3d
`1282, 1293 (Fed. Cir. 2005); Ex. 2011; Ex. 2013). Patent Owner argues that
`the applicant (1) distinguished the Dunaway reference, when the applicant
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`stated that Dunaway “does not create a pressure variation or pressure pulse,
`which are transient increases in pressure, but rather a pressure differential”
`(citing Ex. 2011, 43); (2) distinguished the Zold reference, explaining that
`Zold “does not rely on a pressure pulse, i.e., a positive, momentary flow
`disturbance” (citing Ex. 2013, 319–320); and (3) distinguished the Glaettli
`reference because Glaettli employs “prolonged suctioning (negative
`pressure),” which “is different from the use of a positive, transient pressure
`pulse” (citing id. at 320–321). Prelim. Resp. 30 (emphases in brief).
`Patent Owner contends further that “in light of surrounding claim
`language, the Board should find that the claimed ‘pressure pulse’ must travel
`across the transport channel to reach a ‘buffer’ to be ‘absorb[ed] or
`dampen[ed]’ by it as claimed.” Id. at 27–28.
`In reply, Petitioner argues that “[a]fter prevailing in arguing the terms
`should be given their plain meaning, [Patent Owner] now attempts to rewrite
`them to categorically exclude pressure pulses generated using hydrodynamic
`flow.” Prelim. Reply. 3. Petitioner asserts that Patent Owner’s proposed
`definition would require “that the flow stream (as opposed to the pressure
`pulse it generates) cross the entire channel and enter the buffer/reservoir, and
`to require increasing the pressure within the channel instead of simply
`propagating a pulse of pressure (i.e., transient application of force).” Id.
`Patent Owner’s declarant, Dr. Arnold, opines that, after reviewing the
`Specification and the claims, the ordinary and customary meaning of the
`term “pressure pulse” in the ’850 patent is “a transient increase in pressure.”
`Ex. 2001 ¶ 50. Dr. Arnold opines that he disagrees with Dr. Weigl’s opinion
`that a pressure pulse is a type of flow because there is no net flow of fluid
`into the main fluid stream of particles as a result of the sorting process, and
`there is no source of fluid from which flow could be induced. Id. ¶ 53
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`(discussing Ex. 1002 ¶¶ 144–156). We do not understand Dr. Weigl to offer
`an opinion on claim construction per se but understand him to discuss how
`the prior art might map onto the claims (Ex. 1002 ¶¶ 144–156) in opining
`that Wada would have been understood to describe “a transient pressure
`pulse.” See id. ¶ 149.
`We agree with the district court that for the claim term “pressure
`pulse,” the plain and ordinary meaning applies. Ex. 2028, 3. We also agree
`with Patent Owner that the plain and ordinary meaning of “pressure pulse” is
`“a transient increase in pressure,” because this meaning is consistent with
`the use of this term in the Specification of the ’850 patent and is supported
`by the testimony of Dr. Arnold as to the knowledge of a person of ordinary
`skill. Ex. 1001, 7:25–37; Ex. 2001 ¶ 50. The Specification at 7:35 uses the
`term “pressure pulse” in referring to the “transient pressure variations” and
`these passages are consistent with Patent Owner’s understanding of pressure
`being transient. See Ex. 1001, 7:25–37. We do not agree with Petitioner
`that Patent Owner’s discussion of the context in which this claim term is
`used in the claims in any way changes this definition, because Patent
`Owner’s assertions do not require the flow stream to cross the channel as
`argued by Petitioner. Prelim. Reply 3. Accordingly, for purposes of this
`Decision and based on the record before us, we construe the claim term
`“pressure pulse” to mean “a transient increase in pressure.”
` “a buffer . . . for absorbing or dampening the pressure pulse”
`2.
`In the Memorandum Opinion for claim construction, the district court
`defined ‘“buffer’ to mean ‘a reservoir of fluid that absorbs a pressure
`pulse.’” Ex. 2012, 3–4. Petitioner asserts that we need not construe this
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`term. Pet. 11.7 Patent Owner agrees, then asserts that “in light of
`Petitioner’s arguments, the Board should confirm that the prior art must
`disclose the ‘functional’ language associated with ‘buffer,’ namely that it
`must be ‘for absorbing or dampening the pressure pulse.’” Prelim. Resp. 31.
`We adopt the district court’s definition of buffer, i.e., “a reservoir of
`fluid that absorbs a pressure pulse,” because it is consistent with the
`Specification, and, as the district court explains, it is consistent with the
`prosecution history of the family of related patents. Ex. 1001, 4:14–16 (“A
`second of the side passages is hydraulically connected with a buffer chamber
`of a second bubble valve for absorbing pressure variations.”), id. at 6:24–27
`(“The second bubble valve 100a serves as a buffer for absorbing the pressure
`pulse created by the first bubble valve 100b.”), id. at 6:32–35 (“The second
`side passage 24a, positioned opposite of the first side passage 24b is
`hydraulically connected to a buffer chamber 70a in the second bubble valve
`100a for absorbing pressure transients.”); Ex. 2012, 3; see also Ex. 2011, 43,
`67, 86 (prosecution history of the ’528 patent). Thus, for purposes of this
`Decision, we construe “buffer” to mean “a reservoir of fluid that absorbs a
`pressure pulse.” In the context of claim 1, we, therefore agree with Patent
`Owner that the functional language of “for absorbing or dampening a
`pressure pulse” is also limiting.8
`
`7 Dr. Weigl argues that the term “buffer” in claim 1 is broader than its usage
`in dependent claims. See Ex. 1002 ¶ 43.
`8 We note that Petitioner proposed before the district court to construe
`“buffer” under 35 U.S.C. § 112 ¶ 6, although it did not pursue this
`construction before the Board. See Prelim. Resp. 10. The district court
`rejected this proposed construction. Prelim. Resp. 31; Ex. 2012, 3. Because
`we find below that Petitioner has not adequately shown that the asserted
`prior art teaches the “for absorbing or dampening” limiting language as
`applied to the “buffer,” our conclusion on whether to institute would be
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`D. Obviousness of Claims 1 and 7–12 Over Wada
`Petitioner contends that claims 1 and 7–12 would have been obvious
`over Wada. Pet. 18–42. Patent Owner disagrees. See Prelim. Resp. 44–61.
`1. Wada
`Wada is titled “Focusing of Microparticles in Microfluidic System” and
`relates to “methods of focusing particles in microchannels, e.g., to improve
`assay throughput, to sort particles, to count particles, or the like.” Ex. 1006,
`code (54), 3:13–15.
`Wada describes a problem in the prior art where faster fluid and
`material flow, i.e., non-uniform flow, reduces throughput for flowing assays
`because assay runs need to be spaced well apart in the fluid stream to
`prevent overlap of materials moving at different velocities. Id. at 3:4–6.
`Wada discloses that its device provides substantially uniform flow velocity,
`or optionally provides substantially non-uniform flow velocity, to particles
`flowing in the microchannel. Id. at 3:22–26. Particles are optionally
`focused using one or more fluid direction components, e.g., a fluid pressure
`force modulator, an electrokinetic force modulator, a capillary force
`modulator, a fluid wicking element, or the like). Id. at 4:3–4.
`Figures 22, 23, and 24 of Wada are reproduced below:
`
`
`unchanged if “buffer” were functionally defined or defined under 35 U.S.C.
`§ 112 ¶ 6.
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`Figure 22 is a schematic illustration of a particle sorting configuration
`utilizing sets of opposing microchannels to focus and/or otherwise direct the
`flow of the members of, e.g., a cell population to achieve cell sorting. Id. at
`11:3–5. Figure 23 is a schematic representation of a microchannel
`configuration that includes one separation element embodiment. Id. at 11:6–
`7. Figure 24 is a schematic depiction of a microchannel configuration that
`includes Joule heating electrodes for use in particle sorting. Id. at 11:8–9.
`As to the embodiment of Figure 22, Wada discloses cells 2200 are
`generally flowed in a main microchannel that includes at least two sets of
`opposing microchannels for focusing and/or otherwise directing the flow of
`cells 2200 using hydrodynamic flow 2202 (e.g., cell buffer flow). Id. at
`19:23–27. Wada discloses that one set of opposing microchannels is
`typically located upstream from detector 2204 for simultaneously
`introducing hydrodynamic flow 2202 from both microchannels to focus cells
`2200. Id. at 19:27–29. Wada discloses a second set of opposing
`microchannels is typically located downstream from detector 2204 for
`introducing at least one hydrodynamic flow 2202 so as to direct selected
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`cells 2208 into one of two microchannels, each terminating in particular
`collection wells 2210. Id. at 19:29–20:2.
`Wada discloses that the “inverse relationship between temperature and
`viscosity for various buffers, gels, and other materials is also optionally
`exploited in the present invention to effect particle sorting.” Id. at 20:15–17.
`Wada provides as an example that “upon detection of a desired particle, e.g.,
`a buffer or gel disposed in a downstream side-channel is typically heated to
`decrease fluid viscosity (i.e., to induce fluid flow) to thus direct particles
`within the microfluidic device.” Id. at 20:17–20. Wada discloses that Joule
`heating is the preferred method, which is typically produced by flowing
`current through an electrode. Id. at 20:20–24.
`Wada discloses that the flow of a suspension of cells or other particles
`along one or more channels is optionally pressure-based flow or
`electrokinetic. Id. at 42:8–10.
`In a further example, Wada discloses that a pressure source (positive
`or negative) is applied at the cell suspension reservoir at one end of a
`channel, and the applied pressure forces the suspension through the channel.
`Id. at 43:3–5. The pressure source is optionally pneumatic, e.g., a
`pressurized gas, or a positive displacement mechanism, i.e., a plunger. Id. at
`43:5–7.
`
`2. Analysis of Independent Claim 1
`a) “a buffer configured to fluidically co-operate with the actuator for
`absorbing or dampening the pressure pulse”
`(1) Petitioner’s allegations
`Petitioner provides annotated copies of Wada’s Figures 23 and 22,
`reproduced below:
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`Annotated versions of Wada Figures 23 and 22
`Pet. 29 (citing Ex. 1002 ¶¶ 157–159). Figure 23, as annotated by Petitioner
`and Dr. Weigl, differs from the copy of Wada’s Figure 23 reproduced in
`Section II.C.1 above in that the top right side microchannel is highlighted in
`yellow and labeled “Buffer.” In annotated Figure 22 the top left side
`microchannel is also highlighted in yellow and labeled “Buffer.”
`Petitioner asserts that Wada discloses the buffer in the form of the
`non-actuated sorting microchannel structure opposite the actuated sorting
`microchannel structure. Pet. 28–29 (citing Ex. 1002 ¶¶ 157–159).
`According to Petitioner, a person of ordinary skill in the art “would have
`understood the non-actuated, opposed sorting microchannel structure
`contains a fluid, and is configured to absorb the pressure pulse because it is
`aligned with the direction of the pressure pulse (substantially perpendicular
`to the duct).” Pet. 29 (citing Ex. 1002 ¶¶ 159–160). Dr. Weigl opines that:
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`The non-actuated microchannel structure located across the duct,
`opposite the actuated sorting microchannel structure, as shown
`in Figures 22–23 is thus a buffer. And a person of ordinary skill
`in the art would have recognized that Wada’s non-actuated,
`opposite sorting microchannel structure acts as a buffer
`configured to fluidically co-operate with the actuator for
`absorbing or dampening the pressure pulse to allow other
`particles in the stream of particles to normally flow into the first
`outlet while the deflected particle flows into the second outlet, as
`recited in claim element.
`Ex. 1002 ¶ 160.
`
`(2) Patent Owner’s Response
`Patent Owner contends that “[b]ecause there is no ‘pressure pulse’
`disclosed in Wada, there is no ‘buffer . . . for absorbing or dampening the
`pressure pulse’ as recited in the challenged claims.” Prelim. Resp. 53.
`According to Patent Owner, “[r]egarding the ‘opposing microchannels,’ they
`do not ‘absorb’ or ‘dampen’ anything—they are described as useful solely
`for introducing ‘hydrodynamic flow,’” because “Wada explains that, in
`Figure 22, ‘[a] second set of opposing microchannels is typically located
`downstream from detector 2204 for introducing at least one hydrodynamic
`flow 2202 so as to direct selected cells 2208 . . . [into] collection wells
`2210.” Id. at 54–55 (citing Ex. 1006, 19:29–20:2, 20:8–13). In other words,
`Patent Owner explains, “when two downstream side channels are employed,
`both are used to introduce flow.” Id. at 55–56 (citing Ex. 1006, Fig. 22; Ex.
`2001 ¶ 136). Patent Owner asserts further that “[t]his is entirely consistent
`with Wada’s reliance on Ramsey to teach the sorting operation of Figures
`22–23, wherein one of the two side channels increases flow, but fluid from
`the opposed side channel nonetheless continues flowing into the transport
`channel.” Id. at 55–56 (citing Ex. 2014, Figs. 16–17 (as annotated in Prelim.
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`Resp. 55), 7:24–50). Thus, Patent Owner asserts that “fluid is never
`received by either side channel.” Id. at 56 (citing Ex. 2001 ¶¶ 137–138).
`Patent Owner asserts that Wada’s second side channel is optional
`(citing Ex. 1006, 19:29–20:2, 20:8–13), and that Wada never states that the
`Joule heating wells absorb or dampen a pressure pulse or fluid. Id.
`(3) Analysis
`We agree with Patent Owner that Wada does not disclose a buffer for
`absorbing or dampening the pressure pulse as required by the challenged
`claims. Figure 22 of Wada depicts top and bottom pairs of opposing
`microchannels that introduce hydrodynamic flow into the main
`microchannel. Ex. 1006, 19:27– 20:2. Specifically, Wada states that “[o]ne
`set of opposing microchannels is typically located, e.g., upstream from
`detector 2204 for simultaneously introducing hydrodynamic flow 2202 from
`both microchannels to focus cells 2200.” Id. at 19:27–29. Wada also states
`that “[a] second set of opposing microchannels is typically located
`downstream from detector 2204 for introducing at least one hydrodynamic
`flow 2202 so as to direct selected cells 2208 . . . and non-selected cells 2206
`into, in this case, one of two microchannels, each terminating in particular
`collection wells 2210.” Id. at 19:29–20:2. Thus, both microchannels are for
`the flow of fluid. Wada does not indicate that any of the side microchannels
`is a reservoir or otherwise absorbs or dampens a pressure pulse. On the
`record before us, we see no indication that a reservoir is used in Wada’s
`system, much less one that absorbs a pressure pulse, and we are not
`persuaded that use of such a reservoir would have been taught or suggested
`to one of ordinary skill in the art in light of Wada at the time of the
`invention.
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` Dr. Weigl does not provide support in paragraphs 159 and 160 of his
`declaration for his opinion that Wada’s non-actuated opposing channels
`would absorb pressure pulses, but in paragraph 157 refers to paragraphs 41–
`53 of the declaration, which appear to refer to claim construction positions
`and the views of Patent Owner’s expert in another proceeding. See Ex. 1002
`¶¶ 159–160. Nevertheless, Dr. Weigl elsewhere relies, inter alia, on Zold
`and Glaettli for the understanding that oppositely-facing buffers can mitigate
`undesirable flow fluctuations. Ex. 1002 ¶ 89–91 (citing Ex. 1007, 21:68–
`22:7; Ex. 1016, 5:44–54). However, Dr. Weigl also indicates that those
`references used cavities and/or gas bubbles (see id.) and does not aver that
`Wada uses such cavities and/or gas bubbles. Therefore, Dr. Weigl does not
`provide sufficient support for his assertion that Wada’s non-actuated
`opposing channels would absorb or dampen pressure.
`For these reasons, Petitioner fails to establish a reasonable likelihood
`that it would prevail with respect to this challenge.
`3. Analysis of Dependent Claims 7–12
`Because Petitioner has not demonstrated a reasonable likelihood of
`prevailing on its contention that claim 1 would have been obvious over
`Wada, we determine that Petitioner has also not demonstrated a reasonable
`likelihood as to its contention that dependent claims 7–12 would have been
`obvious over Wada.
`E. Obviousness of Claims 1 and 7–12 Over Wada and Anderson
`Petitioner contends that claims 1 and 7–12 would have been obvious
`over Wada and Anderson. Pet. 43–47. Patent Owner disagrees. See Prelim.
`Resp. 61–65.
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`
`1. Anderson
`Anderson is titled “Integrated Nucleic Acid Diagnostic Device” and
`relates to “a miniaturized integrated nucleic acid diagnostic device and
`system (522). The device (522) of the invention is generally capable of
`performing one or more sample acquisition and preparation operations in
`combination with one or more sample analysis operations.” Ex. 1012, code
`(54), code (57). Anderson’s system utilizes an inlet/outlet valve structure to
`seal its reaction chamber (see id. at 38:1–5), as shown in Figure 2B
`reproduced below:
`
`
`Figure 2B is a schematic representation of a reaction chamber design
`in cut-away view. Id. at 6:22–23. The reaction chamber includes polymeric
`part 102 having well 104 manufactured into its surface. Id. at 36:37–37:1. It
`also has one or more fluid channels 110, 120 connecting it to an inlet/outlet
`port 108. Id. at 37:9–11. Diaphragm valve 114 attached to planar member
`112 extends across inlet 108. Id. at 38:17–19. Anderson explains that
`deflection of diaphragm valve 114 may be carried out by a variety of
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`methods including application of a vacuum or electromagnetic actuators
`and/or piezoelectric actuators coupled to it. Id. at 38:23–27.
`Anderson discloses other embodiments with diaphragm structures as
`well, such as Figures 5A and 5B, not reproduced here. See Ex. 1012, 6:32–
`36. Central chamber 508 is fluidly connected to sample collection chamber
`504, via fluid channel 506. Id. at 45:13–15. The sample collection chamber
`end of fluid channel 506 includes diaphragm 524 for arresting fluid flow. Id.
`at 45:15–17. A fluid sample is typically introduced into the sample
`collection chamber through sealable opening 502 in the body of the device,
`e.g., a valve or a septum. Id. at 45:17–19. Once the sample is introduced
`into the sample collection chamber, it may be drawn into central pumping
`chamber 508 by the operation of pump diaphragm 526. Id. at 45:22–24.
`Opening of sample chamber valve 524 opens fluid channel 506. Id. at
`45:25–26. Subsequent pulling or deflection of pump diaphragm 526 creates
`negative pressure within pumping chamber 508, thereby drawing the sample
`through fluid channel