Paper No. 29
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`------------------
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`------------------
`
`ABS GLOBAL, INC.,
`Petitioner,
`
`v.
`
`CYTONOME/ST, LLC,
`Patent Owner.
`
`------------------
`Case No. IPR2017-02162
`Patent No. 9,446,912 B2
`------------------
`
`PETITIONER'S REPLY
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`------------------
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`------------------
`
`ABS GLOBAL, INC.,
`Petitioner,
`
`v.
`
`CYTONOME/ST, LLC,
`Patent Owner.
`
`------------------
`Case No. IPR2017-02162
`Patent No. 9,446,912 B2
`------------------
`
`PETITIONER'S REPLY
`
`
`
`IPR2017-02162
`
`Petitioner's Reply
`
`TABLE OF CONTENTS
`
`I.
`
`II.
`
`INTRODUCTION ........................................................................................... 1
`
`CLAIM CONSTRUCTION ............................................................................ 1
`
`A.
`
`The Preamble Is Not Limiting ............................................................... 1
`
`i.
`
`ii.
`
`The bodies of the challenged claims are structurally complete .. 3
`
`The preamble is not essential to understanding limitations or
`terms in the claim body, and does not serve as an antecedent
`basis to terms in the claim body .................................................. 5
`
`iii.
`
`The preamble was not relied upon during prosecution ............... 7
`
`B.
`
`Patent Owner's Proposed Construction of the Preamble Imports
`Numerous Limitations that Are Not a Part of the Claims ..................... 7
`
`III. THE CLAIMS ARE UNPATENTABLE ...................................................... 11
`
`A. Wada Anticipates Claims 2 and 15 ..................................................... 11
`
`B. Wada Anticipates Claims 20-25 .......................................................... 15
`
`i. Wada Anticipates Claims 20 and 25 ......................................... 15
`
`ii. Wada Anticipates Claim 21 ...................................................... 17
`
`iii. Wada Anticipates Claims 22-23 ............................................... 18
`
`iv. Wada Anticipates Claim 24 ...................................................... 18
`
`C. Wada In Combination with Micronics 2001 Renders Claims 2, 15, and
`20-25 Obvious ..................................................................................... 20
`
`D. Wada In Combination with Nieuwenhuis 2002 Renders Claim 18
`Obvious................................................................................................ 21
`
`IV. CONCLUSION .............................................................................................. 23
`
`
`
`
`
`i
`
`
`
`IPR2017-02162
`
`Petitioner's Reply
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Am. Med. Sys., Inc. v. Biolitec, Inc.,
`618 F.3d 1354 (Fed. Cir. 2010) ............................................................................ 5
`Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc.,
`289 F.3d 801 (Fed. Cir. 2002) ...................................................................... 2, 3, 4
`Howmedica Osteonics Corp. v. Zimmer, Inc.,
`640 F. App’x 951 (Fed. Cir. 2016) ................................................................... 2, 5
`Rowe v. Dror,
`112 F.3d 473 (Fed. Cir. 1997) .............................................................................. 4
`
`
`
`
`ii
`
`
`
`IPR2017-02162
`
`I.
`
`INTRODUCTION
`
`Petitioner's Reply
`
`The Board has already instituted on all claims and all grounds. Paper 11
`
`("Dec."), 24. Patent Owner's primary argument in its Response was already
`
`rejected by the Board, and boils down to whether a statement of intended use in the
`
`preamble of the challenged independent claims is limiting, and further, whether
`
`one clause in it—"suspending a particle in a sheath fluid"—requires a construction
`
`at odds with its plain meaning. This clause is not limiting, and even if it were,
`
`cannot be read as Patent Owner contends. Consequently, the Board correctly found
`
`that Wada anticipates each of the contested claims.
`
`Patent Owner does not dispute any of the Board's findings regarding Wada's
`
`disclosure of the limitations in dependent claims 22 and 23. Patent Owner's
`
`arguments regarding the remaining claims—that Wada does not describe "inlets"
`
`or certain arrangements of the channels used to introduce additional sheath fluid, or
`
`would not have rendered any the claims obvious in combination with Micronics
`
`2001 or Nieuwenhuis 2002—were properly rejected by the Board in its Institution
`
`Decision, and should be rejected again.
`
`II. CLAIM CONSTRUCTION
`
`A. The Preamble Is Not Limiting
`Patent Owner falsely claims in its response that "Petitioner acknowledges
`
`that the preamble is indeed limiting in the '912 Patent." POR, 22 n.3. Petitioner did
`
`1
`
`
`
`IPR2017-02162
`
`Petitioner's Reply
`
`no such thing – the Petition repeatedly states the preamble of claims 2 and 15 is not
`
`limiting. See, e.g., Pet., 28 ("Petitioner submits that these preambles are not
`
`limiting…."), 36 n.1 ("Petitioner does not admit that the preamble of claim 2 is
`
`limiting."), 49 n.2 ("Petitioner does not admit that the preamble of claim 15 is
`
`limiting."). Indeed, the Board recognized this dispute in its Institution Decision.
`
`Dec., 7 ("The parties disagree as to whether the preamble of each independent
`
`claim is limiting….").
`
`The preamble of independent claims 2 and 15 is in fact not limiting. It
`
`recites simply "A flow structure for suspending a particle in a sheath fluid…." As
`
`such, it does not "recite[] essential structure or steps" and is not "'necessary to give
`
`life, meaning, and vitality' to the claim[s]." Howmedica Osteonics Corp. v.
`
`Zimmer, Inc., 640 F. App'x 951, 956 (Fed. Cir. 2016). It instead "merely describes
`
`a use or purpose" for claims that otherwise set forth structurally complete
`
`inventions. Howmedica, 640 F. App'x at 956.
`
`Indeed, none of the "guide posts" that the Federal Circuit has set forth for
`
`finding preambles limiting are present here. Catalina Mktg. Int'l, Inc. v.
`
`Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002). First, the bodies of
`
`each of the challenged claims are structurally complete, "such that deletion of the
`
`preamble phrase does not affect the structure or steps of the claimed invention."
`
`Catalina, 289 F.3d at 809. Second, the phrase "[a] flow structure for suspending a
`
`2
`
`
`
`IPR2017-02162
`
`Petitioner's Reply
`
`particle in a sheath fluid" neither serves as antecedent basis for later terms nor is it
`
`essential to understanding limitations or terms in the claim body. Id. at 808.
`
`Finally, Patent Owner did not rely on the preamble during prosecution to
`
`distinguish the claimed invention from the prior art. Id. Therefore, the preamble is
`
`not limiting.
`
`i.
`
`The bodies of the challenged claims are structurally complete
`
`Each challenged claim defines a structurally complete invention without
`
`reliance on the preamble. For example, independent claims 2 and 15 set forth two
`
`structural elements, neither of which rely in any way on the preamble: "a primary
`
`flow channel" and "a sheath fluid distribution system" with at least two "sheath
`
`fluid channel[s]." Claims 15, 18 and 20–25 likewise recite a series of additional
`
`stand-alone structural elements, including "a sample fluid inlet," "a sheath fluid
`
`inlet," and a "third sheath fluid channel."
`
`Nothing in the preamble is needed to understand what these elements define
`
`or how they relate to each other or the claimed "flow structure." The primary
`
`channel is a "flow channel" and is conventionally "configured to convey fluid in a
`
`downstream direction." A flow channel that conveys fluid in a downstream
`
`direction is plainly a component of a flow structure. Ex. 1031 ("Di Carlo") ¶¶14-
`
`17. Moreover, the claimed sheath fluid distribution system includes two "sheath
`
`fluid channels" for "injecting sheath fluid into the primary flow channel." Sheath
`
`3
`
`
`
`IPR2017-02162
`
`Petitioner's Reply
`
`fluid channels that inject sheath fluid into a flow channel are plainly components of
`
`a flow structure. Di Carlo ¶18. Patent Owner cannot seriously contend the phrase
`
`"a flow structure" supplies an essential, missing structural element of the claims—
`
`the body of each claim itself recites the complete, claimed flow structure.
`
`The remainder of the preamble—"for suspending a particle in a sheath fluid"
`
`– does nothing more than state an intended use of the claimed flow structures. It
`
`adds no structural or functional requirement to the claims not already imposed by
`
`the language in the body of the claims. And, importantly, Patent Owner identifies
`
`no structural effect or feature of the claimed invention that results from the
`
`presence or omission of this preamble phrase. Catalina, 289 F.3d at 808-09 ("a
`
`preamble generally is not limiting when the claim body describes a structurally
`
`complete invention such that deletion of the preamble phrase does not affect the
`
`structure or steps of the claimed invention."). That is logical because, without the
`
`preamble, all of the structural elements in the bodies of the claim remain
`
`structurally complete. "[W]here a patentee defines a structurally complete
`
`invention in the claim body and uses the preamble only to state a purpose or
`
`intended use for the invention, the preamble is not a claim limitation." Rowe v.
`
`Dror, 112 F.3d 473, 478 (Fed. Cir. 1997).
`
`4
`
`
`
`IPR2017-02162
`
`Petitioner's Reply
`
`ii. The preamble is not essential to understanding limitations or
`terms in the claim body, and does not serve as an antecedent
`basis to terms in the claim body
`
`"Suspending a particle" is not fundamental to understanding any of the claim
`
`terms, nor does it give "life and meaning" to them individually or to the claim as a
`
`whole. Patent Owner's many references to instances of the phrase "suspending a
`
`particle" in the specification do not make the preamble limiting. See, e.g.,
`
`Howmedica Osteonics Corp. v. Zimmer, Inc., 640 F. App'x 951, 956 (Fed. Cir.
`
`2016) (preamble "medical implant" not limiting despite specification's "regular
`
`use" of preamble language, including when describing the "invention"). Nor does
`
`Patent Owner's insistence that the purported invention relates to the preamble
`
`language. Am. Med. Sys., Inc. v. Biolitec, Inc., 618 F.3d 1354, 1360 (Fed. Cir.
`
`2010) (preamble not limiting despite recitation in "Field of Invention" section that
`
`"[t]he present invention" relates to preamble language). And the preamble's
`
`indication that the claimed flow structures are suitable for suspending a particle
`
`does nothing more than state an implicit capability of the flow structures that are
`
`present in the flow structures as they are defined in the body of the claims.
`
`Patent Owner's arguments regarding the "life and meaning" of the claims
`
`erroneously presupposes a requirement of a sample—and a requirement that the
`
`sample fluid contains a particle—in all of the claims despite claim language to the
`
`contrary. Claim 2, however, does not even require a sample fluid inlet, let alone
`
`5
`
`
`
`IPR2017-02162
`
`Petitioner's Reply
`
`one for injecting a sample containing a particle. Where the '912 patent claims
`
`require introducing a sample fluid (or require introducing a sample fluid that
`
`includes a particle), the body of the claim specifies a structure—an inlet—that
`
`performs that function. Claim 15, for example, specifies "a sample fluid inlet
`
`provided on a surface of the substrate and configured to receive a sample fluid,"
`
`but does not require that the sample contains a particle. Claim 11 (not challenged
`
`here) goes further, requiring both a structure that includes "a sample fluid inlet in
`
`fluid communication with the primary flow channel" and further requiring that this
`
`sample fluid inlet is used "for injecting a particle into the primary flow channel."
`
`Thus, the bodies of the '912 patent claims make clear that "suspending a particle" is
`
`not fundamental to understanding the claims. Di Carlo ¶¶22-24.
`
`The phrase "suspending a particle" also does not provide any antecedent
`
`basis for the clauses in the body of the claims. As shown by claim 11, when a
`
`claim of the '912 patent requires injecting a particle into the primary flow channel,
`
`the claim says so and provides a structural element to achieve it. Patent Owner
`
`acknowledges that "the body of neither challenged independent claims [sic] even
`
`refers to 'particles.'" POR, 38. Thus, the preamble neither serves as an antecedent
`
`basis, nor is it essential to understanding limitations or terms in the claim body.
`
`6
`
`
`
`IPR2017-02162
`
`Petitioner's Reply
`
`iii. The preamble was not relied upon during prosecution
`
`Patent Owner did not rely on the preamble during prosecution to distinguish
`
`the claimed invention from the prior art. See generally Ex. 1002. This is not
`
`surprising because, as noted in the Petition, numerous prior art references disclose
`
`flow structures for suspending particles in sheath fluid. Pet., 36 n.1, 49 n.2. Indeed,
`
`as admitted by Drs. Gilbert and Bunner—named inventors of the '912 patent with
`
`at least ordinary skill in the art—flow structures for suspending particles in sheath
`
`fluid have been in the prior art for decades. Ex. 1026, Gilbert Tr. at 145:5-13
`
`(focusing in three dimensions goes back to the 1970s); Ex. 1027, Bunner Tr. at
`
`208:3-7 ("Q. So, in your mind, [your claimed method of surrounding a particle on
`
`at least two sides by a sheath fluid], can be practiced even by sheath flow devices
`
`that were developed in the 1950's, right? A. Possibly."); accord Ex. 2007 at 166:6-
`
`167:4 (stating that "[h]ydrodynamic focusing has been used for upwards of 50
`
`years in the field" for flow cytometry applications). For all of these reasons, the
`
`preamble is not limiting.
`
`B.
`
`Patent Owner's Proposed Construction of the Preamble Imports
`Numerous Limitations that Are Not a Part of the Claims
`
`Patent Owner's proposed construction of the preamble—"placing a particle
`
`in smooth laminar sheath fluid flow"—should be rejected as a textbook example of
`
`improper importation of limitations that are not a part of the claim. See Dec., 13.
`
`The effect of importing these limitations here—which would have to be done in
`7
`
`
`
`IPR2017-02162
`
`Petitioner's Reply
`
`conjunction with finding the preamble limiting—would be to add to the
`
`independent claims structural elements that are incapable of being defined. For
`
`example, the phrase "placing a particle in smooth laminar sheath fluid flow" does
`
`not identify a structural element of the claimed flow channels that would achieve
`
`this purpose. Claim 2, for example, does not specify any structural element for
`
`injecting a particle, or even a sample inlet. Patent Owner does not attempt to
`
`explain which structure of claim 2 would "plac[e] a particle in smooth laminar
`
`fluid flow." Additional structural limitations not present in the body of the claims
`
`would thus need to be imported, but Patent Owner identifies none in its proposed
`
`construction.
`
`Patent Owner also does not identify a coherent evidentiary basis for its
`
`proposed new claim limitations. The word "smooth" does not appear anywhere in
`
`the intrinsic record, nor is it found in Patent Owner's expert's declaration. In fact,
`
`Patent Owner's expert proposes a different interpretation for the phrase altogether.
`
`See Ex. 2008 ("suspending a particle" means "placing the particle in a laminar-
`
`flowing sheath fluid flow such that the sheath fluid and particle flow in a 'sheath
`
`flow' arrangement."). But each of these proposals ignores that, where Patent Owner
`
`wanted to refer to a "sheath flow" structure—for example, in the preamble of the
`
`first patent in this family, U.S. Patent No. 7,311,476—the preamble recited "a
`
`sheath flow structure." Ex. 1032, cls. 1, 25, 27. Nothing in the '912 claims requires
`
`8
`
`
`
`IPR2017-02162
`
`Petitioner's Reply
`
`a laminar sheath fluid flow and a skilled person thus would not understand the
`
`claims to require it. Di Carlo ¶19-21.
`
`Patent Owner's discussion of the specification is equally unavailing because
`
`it repeatedly conflates "suspending a particle" with using sheath flow to suspend a
`
`sample containing particles. See, e.g., POR, 6 ("the sample containing the particle
`
`is pinched and enveloped by the surrounding 'sheath fluid'"); id. ("the
`
`particles…remain contained within the sample fluid). Although the claims do not
`
`require "sheath flow," Patent Owner attempts to use "sheath flow" to justify its
`
`interpretation. But even Patent Owner acknowledges that "[s]heath flow is an
`
`arrangement in which an internal center fluid"—not a particle—"flows in a
`
`separate laminar layers from an outer laminar-flowing sheath fluid layer." POR, 7;
`
`see also id. ("…[s]heath flow is useful because it can…prevent particles in the
`
`center fluid, which is surrounded by the sheath fluid, from touching the sides of
`
`the flow channel"); id. ("cells in the center fluid" are protected by the sheath
`
`fluid). This defect pervades Patent Owner's analysis. See id., 8-13; Di Carlo ¶¶25-
`
`26.
`
`When referring to a suspension of particles, rather than a sample fluid in
`
`sheath flow, the specification uses "suspending" according the Board's preliminary
`
`interpretation. See, e.g., Ex. 1001, 1:35-40 (stating that sheath fluid "may envelop
`
`and pinch a sample fluid containing a number of particles" that are "suspended
`
`9
`
`
`
`IPR2017-02162
`
`Petitioner's Reply
`
`therein"), 10:1-2 (particles in the sample were suspended in "[a] 10:1 dilution" of
`
`"sample" fluid); Di Carlo ¶27. Claims in related U.S. Patent No. 8,529,161 also
`
`track the Board's interpretation. See Ex. 1033, cl. 1 (specifying "a sample having
`
`one or more particles suspended in a suspension medium"). And this interpretation
`
`is consistent with usage in the prior art. Di Carlo ¶26 (noting that Wada states that
`
`a "cell suspension is flowed through the channel" prior to introduction of sheath
`
`fluid); Ex. 1006, 20:56–57.
`
`To the extent the Board finds that its preliminary interpretation of
`
`"suspending a particle" (Dec. 8) both inapt and that the phrase requires
`
`interpretation—and it need not engage in this exercise whatsoever because the
`
`preamble is not limiting—"surrounding a particle in sheath fluid" would be the
`
`broadest reasonable interpretation. This interpretation is consistent with the
`
`descriptions of the functioning of the invention in the specification, which uses this
`
`language to describe the relationship of a particle to the sheath fluid. See, e.g., Ex.
`
`1001, 2:47-62 (stating that when "suspending a particle in a sheath fluid," the
`
`"particle [is] surrounded by the sheath fluid on at least one side"), 3:5-13 (stating
`
`that a "particle" is "suspend[ed]" in a "method of surrounding a particle on at least
`
`two sides by a sheath fluid"), 6:22-38 (stating that "particles are surrounded by
`
`sheath fluid" to create a "suspension of the sample particles"); Di Carlo ¶28.
`
`10
`
`
`
`IPR2017-02162
`
`Petitioner's Reply
`
`Patent Owner's expert, Dr. Kapur, identifies nothing amiss with this
`
`approach. Dr. Kapur confusingly reads the phrase "surrounding a particle in a
`
`sheath fluid" in a vacuum to suggest that it "could include any system in which a
`
`particle is placed in a sheath fluid, even one in which the fluids are not flowing."
`
`Ex. 2008 ¶27 (emphasis added). That, however, cannot be correct. The body of
`
`every challenged claim specifies "a primary flow channel," which is "configured to
`
`convey fluid in a downstream direction," as well as a sheath fluid distribution
`
`system for "injecting sheath fluid into the primary flow channel." Fluids are clearly
`
`flowing in the claimed flow structure without reading a requirement of flowing
`
`into the preamble. Indeed, the specification uses the same language to describe a
`
`system in which sheath fluid is flowing. Ex. 1001, 3:15-23 (referring to
`
`"surrounding a particle on at least two sides by a sheath fluid" using "sheath fluid
`
`conveyed through the primary sheath flow channel"); Di Carlo ¶¶29-32.
`
`III. THE CLAIMS ARE UNPATENTABLE
`
`A. Wada Anticipates Claims 2 and 15
`The Board properly determined that Wada anticipates claims 2 and 15.
`
`Patent Owner now offers only two theories to contend that Wada does not describe
`
`every element of independent claims 2 and 15, both of which are flawed and
`
`should be rejected.
`
`11
`
`
`
`IPR2017-02162
`
`Petitioner's Reply
`
`Patent Owner's first argument is that, when used to sort a sample containing
`
`two different kinds of particles, the flow structures disclosed in Wada allegedly
`
`disrupt the laminar flow in the second region. For the reasons discussed above in
`
`Section II, the claims do not require laminar flow and the Board may reject this
`
`argument on this basis alone. Moreover, the device in Wada's Figure 22 does not
`
`disrupt the laminar flow in the second sheath fluid introduction region. That is
`
`because the two regions in Figure 22 have the same structure and function in the
`
`identical manner – each uses microchannels to introduce sheath fluid into the
`
`primary flow channel in a particular direction or directions, which produces a
`
`laminar flow. Di Carlo ¶¶33-45; Wada, 13:1-16, 8:61-9:26, 23:21-24.
`
`More specifically, Wada applies the same "hydrodynamic flow 2202" to the
`
`selected particles (represented by black circles) through each of the two focusing
`
`microchannels in the series. E.g., Pet., 35, 42-45. The sheath fluid microchannel in
`
`the second region is the same size, shape and proportion, and is depicted in Figure
`
`22 as introducing the same "hydrodynamic flow 2202" to force particles away from
`
`the boundaries of the primary flow channel as each of the sheath fluid
`
`microchannels in the first region. Wada, 13:1-16, Fig. 22; Di Carlo ¶¶35-37. By
`
`doing so, each region maintains laminar flow wherein the introduced sheath fluid
`
`surrounds the fluid layer containing the particles. Di Carlo ¶38-45; Wada, 11:34-
`
`13:33, 23:19-24.
`
`12
`
`
`
`IPR2017-02162
`
`Petitioner's Reply
`
`Patent Owner's expert also incorrectly portrayed how Wada's Figure 22
`
`device functions, asserting, inter alia, that it mixes the sample and sheath flows
`
`within the second region of Figure 22. Ex. 2008 ¶¶33-34. That is simply incorrect –
`
`the two flows only mix when combined much further downstream in the collection
`
`wells (2212) not upstream at the second sheath fluid introduction region where
`
`laminar flow is maintained. Di Carlo ¶38. Moreover, as Wada itself plainly
`
`illustrates, the second region introduces a sheath fluid layer to move the entire
`
`particle stream toward one side of the primary flow channel or the other so that
`
`particles flow into one collection channel or the other. Di Carlo ¶38.
`
`In Wada's microscale devices, each particle follows a fluid streamline and
`
`does not move from one streamline to the other. The particles are thus not
`
`"disrupted" or "de-suspended" when additional sheath fluid is introduced. Di Carlo
`
`¶39-40. Rather, in Figure 22, particles "follow the sample fluid streamlines,"
`
`meaning that "[p]articles will follow the streamline that they're on as they move
`
`through the device" rather than changing from one streamline to another. Ex. 2007,
`
`171:3-172:7; Di Carlo ¶40. This is true both for microfluidic devices generally, and
`
`for the device shown in Wada Figure 22. Ex. 2007, 170:25-171:23; Di Carlo ¶40.
`
`Specifically, in Figure 22, the particles "will follow…fluid streamlines in the
`
`first sheath fluid introduction region" and "in the second sheath fluid introduction
`
`region." Ex. 2007, 171:14-23. Contrary to Patent Owner's argument, particles are
`
`13
`
`
`
`IPR2017-02162
`
`Petitioner's Reply
`
`not moved out of their streamlines in the second sheath fluid introduction region.
`
`As Dr. Di Carlo testified, "That's not how fluid physics work. The particles follow
`
`the fluid streamlines. If you inject additional fluid, it just deflects the fluid
`
`streamlines with the particles in a new direction." Ex. 2007, 172:4-7; Di Carlo ¶¶
`
`41-45. The defect in Patent Owner's position is further illustrated by a single
`
`example: "if you had a series of particles that were the same color, you would have
`
`the same channel on for a period of time as well and continuously focusing those
`
`same color particles in one direction." Ex. 2007, 132:19-22. Every one of these
`
`particles would thus remain in laminar flow. All of the sheath fluid microchannels
`
`in Figure 22 thus introduce sheath fluid in a manner that maintains laminar flow
`
`and does not cause mixing. Di Carlo ¶¶41-45.
`
`Patent Owner's second argument is that, when used to "suspend," Figure 1A
`
`of Wada discloses only a primary sheath fluid introduction region. Importantly,
`
`Patent Owner does not dispute that Figure 1A of Wada discloses "suspending" a
`
`particle, or a "primary flow channel," or a sheath fluid distribution system with "a
`
`first sheath fluid introduction region." POR, 36. Patent Owner's sole dispute is that
`
`Figure 1A does not depict "a second sheath fluid introduction region." The Board
`
`has already rejected this argument, properly recognizing that Patent Owner ignores
`
`Wada's disclosure that the embodiment depicted in Figure 1A may be configured
`
`to focus particles "by using a series of offset focusing microchannels to achieve
`
`14
`
`
`
`IPR2017-02162
`
`Petitioner's Reply
`
`focusing by serial introduction of fluids from the offset channels," rather than the
`
`single pair of opposing microchannels shown in Figure 1A. Pet., 33, 34, 42, 44
`
`(quoting Wada at 9:13-17) (emphasis added).
`
`Perhaps acknowledging how tenuous these arguments are, Patent Owner's
`
`chief complaint regarding claim 15 appears to be that the figures in Wada do not
`
`explicitly depict in the Figures the inlets used to supply fluid to the depicted sheath
`
`fluid and sample channels. But, as the Board recognized, Wada discloses to a
`
`skilled person that "all" of its devices—including the device shown schematically
`
`in Figure 22—have inlets. Dec., 15. That these inlets are not drawn on the picture
`
`in Figure 22 does not erase Wada's clear disclosure of them. Moreover, Patent
`
`Owner's complaint is belied by its own specification. The '912 patent makes clear
`
`that an "inlet…may comprise a channel." Ex. 1001, 4:60-61. Wada Figure 22
`
`plainly shows a sample channel and sheath fluid channels, and thus discloses
`
`inlets.
`
`Thus, Patent Owner's argument should be rejected and claims 2 and 15
`
`should be held unpatentable as anticipated by Wada.
`
`B. Wada Anticipates Claims 20-25
`i. Wada Anticipates Claims 20 and 25
`
`Patent Owner's argument that Wada does not disclose "injecting sheath fluid
`
`into the primary flow channel" in a direction "transverse to a major plane of the
`
`15
`
`
`
`IPR2017-02162
`
`Petitioner's Reply
`
`substrate" (claim 21) or in a "thickness direction" (claim 25) is not supported by
`
`expert testimony or Wada's disclosure. Patent Owner cannot seriously contend that
`
`injecting sheath fluid in such directions would render these claims patentable over
`
`Wada. Wada explains that its focusing steps include horizontally and/or vertically
`
`focusing by introducing a fluid flow. Pet., 37, 58-59, 65-66. As such, Wada
`
`anticipates claims 20 and 25.
`
`Patent Owner objects that Wada's disclosure of "focusing" in various
`
`dimensions appears in an earlier section of the specification than the discussion of
`
`Figure 22, but does not explain what difference that makes. The order of the three
`
`sections confirms that focusing is used in Figure 22. The first section, titled
`
`"Laminar Flow Vertical Focusing of Cells and Other Particles in Microscale
`
`Systems," explains focusing in one dimension. The second section, "Focusing
`
`Cells Horizontally in a Microchannel," explains focusing in the other dimension.
`
`Figure 22 appears in the third section, "Use of Focusing to Sort Particles," which
`
`describes the use of focusing in one or both dimensions for sorting particles. Wada
`
`at 11:34-13:34; Ex. 2007, 159:15-161:5. Wada's description of Figure 22
`
`specifically refers back to this third section, stating "Fig. 22 schematically
`
`illustrates one particle sorting configuration utilizing these methods." Wada at
`
`13:1-2. And, as Dr. Di Carlo testified, a skilled person reading the description of
`
`Figure 22 would understand it "to say that you could introduce sheath fluid
`
`16
`
`
`
`IPR2017-02162
`
`Petitioner's Reply
`
`horizontally and vertically." Ex. 2007, 162:13-23; see also Ex. 2007, 162:4-12
`
`("[A] skilled person would look at Fig. 22 and the disclosures in the same section
`
`of the Wada specification and interpret…that you could focus horizontally or
`
`vertically"); Ex. 2007, 126:18-20 ("[A]s discussed in Wada, you can have
`
`vertically intersecting channels that inject sheath fluid vertically as well.").
`
`ii. Wada Anticipates Claim 21
`
`Patent Owner does not dispute that the phrase "symmetrically
`
`introduced…with respect to a centerline of the primary flow channel" in claim 21
`
`means "introduced from opposite sides of the primary flow channel with respect to
`
`a centerline of the primary flow channel." POR, 40. Patent Owner's Response
`
`argues that this claim should be interpreted to require that the sheath fluid flow
`
`rates in these two sheath fluid channels must be the same. But flow rates are
`
`irrelevant to whether the sheath fluid in Wada is "introduced from opposite sides of
`
`the primary flow channel with respect to a centerline of the primary flow channel."
`
`Claim 21 does not refer to flow rates. Claim 21 refers to the direction in which the
`
`sheath fluid is introduced into the primary flow channel: "from opposite sides of
`
`the primary flow channel with respect to a centerline of the primary flow channel."
`
`Patent Owner does not dispute that Figure 22 of Wada discloses introducing sheath
`
`fluid in the manner specified by the claim.
`
`17
`
`
`
`IPR2017-02162
`
`Petitioner's Reply
`
`Moreover, as discussed above in Section III.A, Wada's disclosure is not
`
`limited to a particle-sorting purpose or particular flow rates. As Dr. Di Carlo
`
`testified, and explained in his report, the structural elements of Figure 22 support
`
`injecting sheath fluid simultaneously and at the same flow rate through two
`
`consecutive pairs of sheath fluid channels to provide additional focusing. Ex. 2007,
`
`123:21-124:2; Ex. 1003 ¶¶226-236; Di Carlo ¶¶46-48; Wada, 13:6-10 (describing
`
`use of opposing microchannels for "simultaneously introducing hydrodynamic
`
`flow 2202 from both microchannels to focus cells" into the center of the channel),
`
`8:56-9:22 (discussing introduction of sheath fluid through opposing microchannels
`
`for focusing a particle stream into the center of the channel), 13:1-16 (introducing
`
`hydrodynamic flows of sheath fluid through "at least two sets of opposing
`
`microchannels for focusing"). Claim 21 should therefore be held unpatentable as
`
`anticipated by Wada.
`
`iii. Wada Anticipates Claims 22-23
`
`Patent Owner does not dispute that Wada discloses the limitations of claims
`
`22 and 23, and these claims should be held unpatentable for the same reasons that
`
`independent claim 15 should be held unpatentable.
`
`iv. Wada Anticipates Claim 24
`
`As with claim 15, Patent Owner's argument regarding claim 24 hinges on
`
`whether the figures in Wada depict the inlets used to supply fluid to the depicted
`
`18
`
`
`
`IPR2017-02162
`
`Petitioner's Reply
`
`sheath fluid channels. Wada discloses to a skilled person that its devices—which
`
`includes the device shown schematically in Figure 22—have inlets. Pet., 52-53
`
`(citing, e.g., Wada at 25:20-23, 26:11-32). That the entrances to these channels are
`
`not drawn on the picture in Figure 22 does not erase Wada's clear disclosure of
`
`inlets. And Wada further discloses that a common inlet can be used to supply
`
`sheath fluid to the sheath fluid channels. Pet., 64 (citing Wada at 26:25-29).
`
`Patent Owner complains that no explanation is provided regarding "how the
`
`downstream channels would be configured to wrap around the device and meet at a
`
`common inlet in view of the upstream channels and sample channel." POR, 53. But
`
`Petitioner explained with regard to claim 23—from which claim 24 depends—that
`
`these channels are located in the same substrate layer: the bottom surface. Pet. 64.
`
`And Patent Owner did not dispute that Wada discloses these limitations in claim
`
`23. Moreover, Petitioner explained with regard to claim 15, from which claim 24
`
`indirectly depends, that Wada discloses to a skilled person that each "sheath fluid
`
`inlet" and "sample fluid inlet" is located on and extends "through the top surface
`
`into the interior portion of the device," so as to be "in communication with…the
`
`channels" formed in the bottom surface. Pet. 57. Because the sample and sheath
`
`fluid inlets are located on the same surface, and together are not on the s
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
