Trials@uspto.gov
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`Entered: January 18, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`10X GENOMICS, INC.,
`Petitioner,
`
`v.
`
`RAINDANCE TECHNOLOGIES, INC.,
`Patent Owner.
`____________
`
`Case IPR2015-01558
`Patent 8,658,430 B2
`____________
`
`Before MICHAEL P. TIERNEY, Vice Chief Administrative Patent Judge,
`TINA E. HULSE and ELIZABETH M. ROESEL, Administrative Patent
`Judges.
`
`ROESEL, Administrative Patent Judge.
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318 and 37 C.F.R. § 42.73
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`571-272-7822
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` Paper: 46
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`
`Entered: January 18, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`10X GENOMICS, INC.,
`Petitioner,
`
`v.
`
`RAINDANCE TECHNOLOGIES, INC.,
`Patent Owner.
`____________
`
`Case IPR2015-01558
`Patent 8,658,430 B2
`____________
`
`Before MICHAEL P. TIERNEY, Vice Chief Administrative Patent Judge,
`TINA E. HULSE and ELIZABETH M. ROESEL, Administrative Patent
`Judges.
`
`ROESEL, Administrative Patent Judge.
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318 and 37 C.F.R. § 42.73
`
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`IPR2015-01558
`Patent 8,658,430 B2
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`
`In this inter partes review, instituted pursuant to 35 U.S.C. § 314,
`10X Genomics, Inc. (“Petitioner”) challenges the patentability of claims 1–
`17 of U.S. Patent No. 8,658,430 B2 (Ex. 1001, “the ’430 patent”), assigned
`to RainDance Technologies, Inc. (“Patent Owner”).
`We have jurisdiction under 35 U.S.C. § 6. This final written decision
`is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
`For the reasons that follow, we determine that Petitioner has shown by
`a preponderance of the evidence that claims 1–17 of the ’430 patent are
`unpatentable.
`
`I.
`
`BACKGROUND
`A. Procedural History
`On July 8, 2015, Petitioner filed a Petition requesting inter partes
`review of claims 1–17 of ’430 patent. Paper 2 (“Pet.”). On November 2,
`2015, Patent Owner filed a Preliminary Response. Paper 11 (“Prelim.
`Resp.”).
`On January 19, 2016, we instituted inter partes review of claims 1–17.
`Paper 13 (“Institution Decision” or “Dec.”).
`On February 2, 2016, Patent Owner filed a request for rehearing of
`our Institution Decision. Paper 15. On February 24, 2016, we denied
`rehearing. Paper 18 (“Rehearing Decision” or “Rhg. Dec.”)
`On April 25, 2016, Patent Owner filed a Patent Owner Response.
`Paper 21 (“PO Resp.”). On July 14, 2016, Petitioner filed a Reply to Patent
`Owner’s Response. Paper 26 (“Pet. Reply”).
`Petitioner submitted a Declaration of Wilhelm T.S. Huck, Ph.D. with
`the Petition. Ex. 1002. On April 13, 2016, Patent Owner cross-examined
`Dr. Huck and filed a transcript of the deposition testimony as Exhibit 2015.
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`With the Patent Owner Response, Patent Owner submitted a Declaration of
`Todd Squires, Ph.D. (Ex. 2012) and a Declaration of Darren Link, Ph.D.
`(Ex. 2014). Petitioner cross-examined Drs. Squires and Link and filed
`transcripts of the deposition testimony as Exhibit 1030 and Exhibit 1037.
`Petitioner submitted a Second Declaration of Wilhelm T.S. Huck,
`Ph.D. with the Reply. Ex. 1036. On August 23, 2016, Patent Owner again
`cross-examined Dr. Huck and filed a transcript of the deposition testimony
`as Exhibit 2017. On August 31, 2016, Patent Owner filed a Motion for
`Observations on the Cross-Examination of Dr. Huck. Paper 37. On
`September 7, 2016, Petitioner filed a Response to Patent Owner’s Motion for
`Observations on the Cross-Examination of Dr. Huck. Paper 40.
`An oral hearing was held September 27, 2016. A transcript of the
`hearing was entered in the record. Paper 45 (“Tr.”).
`
`B. Related Proceedings
`The parties identify RainDance Techologies, Inc. v. 10X Genomics,
`Inc., 1:15-cv-00152-RGA (D. Del. Feb. 12, 2015) as a related matter
`involving the ’430 patent. Pet. 51; Paper 19.
`
`C. The ’430 Patent (Ex. 1001)
`The ’430 patent relates to a method for droplet formation. Ex. 1001,
`16:20 (claim 1). As summarized in the Abstract,
`[T]he invention provides methods for manipulating droplet size
`that include forming droplets of aqueous fluid surrounded by an
`immiscible carrier fluid, and manipulating droplet size during
`the forming step by adjusting pressure exerted on the aqueous
`fluid or the carrier fluid.
`Id. (Abstract); id. at 2:28–32 (same). According to the ’430 patent, the
`method can be conducted in microfluidic channels of a microfluidic chip.
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`Id. at 2:45–46, 3:7–8. As explained in the background section of the ’430
`patent, microfluidic devices are useful for performing biological, chemical,
`and diagnostic assays. Id. at 1:26–27. Such devices include a substrate that
`is etched or molded to form channels for carrying one or more sample fluids
`and an immiscible carrier fluid. Id. at 1:27–31.
`An exemplary device for droplet formation is shown in Figures 1
`and 2 of the ’430 patent:
`
`
`
`
`Figures 1 and 2 are drawings showing a device for droplet formation. Id. at
`3:33–34, 4:22–23, 4:28–30. As shown in Figure 1, device 100 includes inlet
`channel 101, outlet channel 102, and carrier fluid channels 103 and 104, all
`four of which meet at junction 105. Id. at 4:23–25. A sample fluid flows
`through inlet channel 101, and a carrier fluid that is immiscible with the
`sample fluid flows through channels 103 and 104. Id. at 4:26–28. Droplets
`are formed at junction 105, where the sample fluid interacts with the carrier
`fluid to form droplets of sample fluid surrounded by immiscible carrier fluid,
`which are received by outlet channel 102. Id. at 4:31–36. According to the
`’430 patent, the sample fluid is typically an aqueous buffer solution, and the
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`carrier fluid can be a non-polar solvent, such as fluorocarbon oil. Id. at
`4:37–46.
`
`D. Illustrative Claim
`Claim 1 of the ’430 patent, the sole independent claim, is reproduced
`below:
`
`1. A method for droplet formation, the method
`comprising the steps of:
`providing a plurality of aqueous fluids each in its own
`aqueous fluid channel in fluid communication with one or more
`immiscible carrier fluid channels;
`forming droplets of aqueous fluid surrounded by an
`immiscible carrier fluid in the aqueous fluid channels;
`applying a same constant pressure to the carrier fluid in
`each of the immiscible carrier fluid channels; and
`adjusting pressure in one or more of the aqueous fluid
`channels, thereby to produce droplets of aqueous fluid in one or
`more outlet fluid channels.
`Ex. 1001, 16:20–31.
`
`E. Petitioner’s Asserted References
`Petitioner’s patentability challenges are based on the following
`references:
`Link et al., US 2008/0014589 A1, published Jan. 17, 2008 (Ex. 1004,
`“Link”); and
`Nam-Trung Nguyen et al., Optical Detection for Droplet Size Control
`in Microfluidic Droplet-Based Analysis Systems, 117 SENSORS AND
`ACTUATORS B 431–36 (2006) (Ex. 1006, “Nguyen”).
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`F. Instituted Grounds
`1. Whether claims 1–7 and 12–17 are unpatentable under 35 U.S.C.
`§ 102 as anticipated by Link;
`2. Whether claims 1–7 and 10–17 are unpatentable under 35 U.S.C.
`§ 103 as obvious over Link; and
`3. Whether claims 8 and 9 are unpatentable under 35 U.S.C. § 103 as
`obvious over Link in view of Nguyen.
`
`II.
`DISCUSSION
`A. Claim Construction
`In an inter partes review, claim terms in an unexpired patent are given
`their broadest reasonable interpretation in light of the specification of the
`patent in which they appear. 37 C.F.R. § 42.100(b); Cuozzo Speed Techs.,
`LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016). Under that standard, we
`generally give claim terms their ordinary and customary meaning, as
`understood by a person of ordinary skill in the art in the context of the entire
`disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir.
`2007). We construe claim terms only to the extent necessary to resolve the
`controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361
`(Fed. Cir. 2011) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200
`F.3d 795, 803 (Fed. Cir. 1999)).
`Construction of claims 1–3 is discussed below in connection with
`patentability of those claims over Link. Except for the terms of claims 1–3
`discussed below, we determine that it is not necessary to provide an explicit
`construction of any other claim term for purposes of this decision.
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`B. Person of Ordinary Skill in the Art
`Petitioner describes a person of ordinary skill in the art in July 2011 in
`terms of educational background, experience, and fields of scientific
`knowledge. Pet. 3–4 (citing Ex. 1002 ¶ 12). For example, Petitioner asserts
`that a person of ordinary skill in the art would have had a Ph.D. in
`chemistry, biochemistry, mechanical engineering, or a related discipline,
`with at least two years of experience in using, designing or creating
`microfluidic devices. Id. at 3. Petitioner further asserts that a person of
`ordinary skill in the art would have known how to research the scientific
`literature in fields relating to microfluidics, including fluid dynamics,
`microscale reactions, chemistry, biochemistry, and mechanical engineering,
`and to consult with team members having specialized skills in these fields.
`Id. at 4.
`Patent Owner does not specifically contest Petitioner’s assertions
`regarding the level of ordinary skill in the art.
`We accept Petitioner’s assertions regarding the level of ordinary skill
`in the art, as set forth in the paragraph bridging pages 3 and 4 of the Petition.
`Our finding is supported by Dr. Huck’s testimony (Ex. 1002 ¶ 12), as well as
`the prior art references cited by Petitioner, which reflect the level of skill in
`the art asserted by Petitioner. See, e.g., Ex. 1004 ¶¶ 160, 316 (discussing use
`of aqueous droplets in microfluidic devices as “nanoreactors” for chemical
`and biochemical reactions and assays); Ex. 1006, 2 (discussing principles of
`fluid dynamics relevant to droplet formation in microfluidic devices);
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`Ex. 1009,1 2032 (review article addressing fluid dynamics of microfluidic
`droplets, including for “lab on a chip” applications in which chemical or
`biochemical reactions are performed in droplets). See Okajima v. Bourdeau,
`261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art, itself, can reflect the
`level of skill in the art).
`Based upon their stated qualifications, we consider both Dr. Huck and
`Dr. Squires qualified to opine from the viewpoint of a person of ordinary
`skill in the art regarding the subject matter of the ’430 patent. Ex. 1002
`¶¶ 6–10; Ex. 1003 (Huck CV); Ex. 2012 ¶¶ 6–14; Ex. 2013 (Squires CV).
`
`C. Patentability of Claims 1–7 and 10–17 over Link
`1.
`Link (Ex. 1004)
`Link is incorporated by reference in the ’430 patent, is commonly
`owned with the ’430 patent, and has a common inventor. Ex. 1001, 16:6–
`10; see PO Resp. 16.2 The ’430 patent relies on Link to teach various
`aspects of the claimed invention, including: methods of forming aqueous
`droplets that are surrounded by an immiscible carrier fluid (Ex. 1001, 4:13–
`15); fluidic circuits arranged and controlled to produce an interdigitation of
`droplets of different sizes flowing through a channel (id. at 7:34–37);
`methods for performing polymerase chain reaction (“PCR”) in droplets (id.
`at 9:39–41); techniques for causing droplets to merge (id. at 9:55–58, 10:25–
`27); droplet formation modules arranged and controlled to produce an
`
`1 C. Baroud et al., Dynamics of Microfluidic Droplets, 10 LAB ON A CHIP
`2032–45 (2010).
`2 Link qualifies as prior art to the challenged claims under 35 U.S.C.
`§ 102(b) because its publication date, January 17, 2008, is more than one
`year before the filing date of the earliest application of which the ’430 patent
`claims priority benefit.
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`interdigitation of sample droplets and PCR reagent droplets flowing through
`a channel (id. at 10:7–11); detection modules and methods of detecting
`amplification products in droplets (id. at 12:11–13); droplet sorting (id. at
`14:19–20); methods of releasing contents from the droplets (id. at 12:25–
`27); and microfluidic chips for performing biological, chemical, and
`diagnostic assays (id. at 14:50–52).
`Link discloses microfluidic devices and methods of using such
`devices to generate aqueous phase droplets encapsulated by an inert
`immiscible oil stream. Ex. 1004 ¶ 86. An embodiment of a microfluidic
`device is shown in Link Figure 1, which is reproduced below with
`annotations added by the Board:
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`Figure 1, depicted above, is a schematic illustration of a microfluidic
`device having multiple interacting modules. Ex. 1004 ¶¶ 49, 86. As shown
`in Figure 1, the device has two inlet modules where droplets are formed. Id.
`¶¶ 10, 88, 129, 173, 174. Each inlet module comprises a junction between a
`main channel and a sample inlet channel, such that the sample is introduced
`into the main channel and forms a plurality of droplets. Id. at Fig. 1, ¶¶ 10,
`173, 174. In Figure 1 above, our annotations identify the “main channel,”
`“junction,” and “sample inlet channel,” as described by Link. Id. ¶ 173; see
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`also page 36, infra (addressing Patent Owner’s argument (PO Resp. 40)
`regarding the “main channel” in Link).
`Figures 2–6 of Link illustrate embedded microfluidic nozzles for
`forming sample droplet emulsions on a microfluidic substrate. Id. ¶¶ 50–54,
`131. Link Figures 2A and 4 are essentially the same as Figures 1 and 2 of
`the ’430 patent, which are reproduced above. Link discloses methods for
`forming sample droplets using the devices shown in Figures 2A and 4. Id. at
`¶¶ 130–133, 166, 173. Droplets are formed at a nozzle provided at the
`junction of an aqueous sample fluid channel and one or two oil channels. Id.
`at Figs. 2A, 4, ¶¶ 131, 173.
`
`2.
`
`Independent Claim 1
`First Two Steps
`a.
`There is no dispute that Link discloses a method for droplet formation
`comprising the first two steps of claim 1 of the ’430 patent. See PO Resp.
`18; Pet. Reply 1. We find that these steps are expressly disclosed by Link.
`Our finding is supported, for example, by Link paragraph 10, which
`discloses the following steps:
`(a) providing a microfluidic substrate including at least two
`inlet channels adapted to carry at least two dispersed phase
`sample fluids and at least one main channel adapted to carry at
`least one continuous phase fluid; (b) flowing a first sample fluid
`through a first inlet channel which is in fluid communication
`with the main channel at a junction, wherein the junction
`includes a first fluidic nozzle designed for flow focusing such
`that the first sample fluid forms a plurality of highly uniform,
`monodisperse droplets of a first size in the continuous phase;
`(c) flowing a second sample fluid through a second inlet
`channel which is in fluid communication with the main channel
`at a junction, wherein the junction includes a second fluidic
`nozzle designed for flow focusing such that the second sample
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`fluid forms a plurality of highly uniform, monodisperse droplets
`of a second size in the continuous phase . . .
`Ex. 1004 ¶ 10; see also id. at Fig. 1, claim 1 (same). Link further discloses
`that the “dispersed phase sample fluids” may be aqueous fluids and that the
`“continuous phase fluid” can be an immiscible carrier fluid, such as oil. Id.
`¶ 86 (creation of “aqueous phase droplets completely encapsulated by an
`inert immiscible oil stream”), ¶ 114 (“the discontinuous phase can be an
`aqueous solution and the continuous phase can a hydrophobic fluid such as
`an oil”); see also Pet. 17–21.
`Link paragraph 10 thus discloses providing a plurality of aqueous
`fluids (“at least two dispersed phase sample fluids”), each in its own aqueous
`fluid channel (“a first inlet channel” and “a second inlet channel”) in fluid
`communication with one or more immiscible carrier fluid channels (“in fluid
`communication with the main channel” which is “adapted to carry at least
`one continuous phase fluid”), and forming droplets of aqueous fluid
`surrounded by an immiscible carrier fluid in the aqueous fluid channels
`(“said first sample fluid forms a plurality of . . . droplets . . . in said
`continuous phase” and “the second sample fluid forms a plurality of . . .
`droplets . . . in the continuous phase”). Ex. 1004 ¶ 10.
`b.
`Pressure Limitations
`The parties’ dispute focuses on the last two steps of claim 1, which we
`refer to as the “pressure limitations” or “pressure steps.” These steps recite:
`applying a same constant pressure to the carrier fluid in
`each of the immiscible carrier fluid channels; and
`adjusting pressure in one or more of the aqueous fluid
`channels, thereby to produce droplets of aqueous fluid in one or
`more outlet fluid channels.
`Ex. 1001, 16:27–32.
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`Parties’ Contentions
`c.
`We instituted review of claims 1–7 and 10–17 based on obviousness
`in view of Link. Dec. 21. As explained in the Institution Decision and the
`Rehearing Decision, the Petition implicitly challenges claim 1 based on
`obviousness. Dec. 17–18, 21; Rhg. Dec. 3–4. More specifically, Petitioner
`cites Link paragraphs 38, 110, 132, 164–166, and 173–174, claim 16, and
`Figures 2A, 2B, and 3 as teaching the pressure limitations of claim 1. Pet.
`21–24 (claim chart). Relying on the testimony of its expert, Petitioner
`contends that the pressure limitations of claim 1 would have been obvious in
`view of Link and would have been arrived at by a person of ordinary skill in
`the art as a matter of routine optimization of a results-effective variable
`(regulating pressure in the aqueous fluid channel or the immiscible carrier
`fluid channel) by selecting from among a finite number of predictable
`options based upon a cost-benefit analysis and design choice. Pet. 21–28,
`37–40, 46–51; Pet. Reply 15–20; Ex. 1002 ¶¶ 42, 106–115; Ex. 1036 ¶¶ 33,
`41, 75–91.
`Patent Owner contends that none of the cited paragraphs of Link
`disclose the pressure limitations of claim 1. PO Resp. 18–39. Patent Owner
`further contends that Petitioner’s analysis ignores the full range of design
`choices, that a cost-benefit analysis would not have led to the pressure
`limitations, that there would have been no reasonable expectation of
`successfully using pressure differences to control droplet size in a multi-
`junction device, and that Link teaches away from using a same constant
`pressure in each of the oil channels. PO Resp. 41–59.
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`Legal Standard for Obviousness
`d.
`A claim is unpatentable for obviousness, if the differences between
`the subject matter sought to be patented 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. 35 U.S.C. § 103(a).
`In applying section 103, we assess the scope and content of the prior art, the
`level of ordinary skill in the relevant art, the differences between the claimed
`invention and the prior art, and whether the claimed invention would have
`been obvious to one of ordinary skill in the art in light of those differences.
`Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
`“[R]ejections on obviousness grounds cannot be sustained by mere
`conclusory statements; instead, there must be some articulated reasoning
`with some rational underpinning to support the legal conclusion of
`obviousness.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007)
`(quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). On the other
`hand, “the analysis need not seek out precise teachings directed to the
`specific subject matter of the challenged claim, for a [factfinder] can take
`account of the inferences and creative steps that a person of ordinary skill in
`the art would employ.” KSR, 550 U.S. at 418.
`When there is a design need or market pressure to solve a
`problem and there are a finite number of identified, predictable
`solutions, a person of ordinary skill has good reason to pursue
`the known options within his or her technical grasp. If this
`leads to the anticipated success, it is likely the product not of
`innovation but of ordinary skill and common sense.
`Id. at 421.
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`Adjusting Step
`e.
`We find that the final step of claim 1— “adjusting pressure in one or
`more of the aqueous fluid channels, thereby to produce droplets of aqueous
`fluid in one or more outlet fluid channels”—is disclosed by Link (Ex. 1004)
`paragraphs 166, 173, and 174 and Figure 1, when considered as a whole.
`Our finding is supported by Link paragraph 166, which discloses
`“adjusting the pressure on the main and sample inlet channels” in order to
`regulate the size and periodicity of the droplets generated at the inlet
`module. Ex. 1004 ¶ 166. Our finding is also supported by Link paragraph
`173, which discloses formation of droplets at an inlet module comprising a
`junction between the sample inlet channel and the main channel. Id. ¶ 173.
`Further support is found in Link paragraph 174, which describes
`embodiments having “two or more inlet modules,” and Link Figure 1, which
`shows an embodiment having two inlet modules. Id. ¶ 174, Fig. 1.
`There is no dispute that Link’s sample inlet channels are aqueous fluid
`channels, as recited in claim 1. See Ex. 2012 ¶ 74 (describing “sample
`aqueous fluid inlet channel” in Link); see also Ex. 1004 ¶¶ 173, 174 (sample
`aqueous solutions are introduced through sample inlet channel of inlet
`module). Although Link paragraph 166 refers to the “inlet module” in the
`singular, we find that a person of ordinary skill in the art would have
`understood the disclosure of Link paragraph 166 as applicable to each of the
`inlet modules described in paragraph 174 and shown in Link Figure 1. See
`Ex. 1002 ¶ 126 (Link discloses “using a microfluidic device with multiple
`inlet modules” and “that the size of droplets can be controlled by altering the
`pressure at those inlets,” citing paragraph 166).
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`We find that Link’s disclosure of “adjusting the pressure on the . . .
`sample inlet channels” at the inlet module (Ex. 1004 ¶ 166) coupled with
`Link’s disclosure of embodiments having “two or more inlet modules” (id.
`¶ 174) teach one of ordinary skill in the art the adjusting step, i.e., “adjusting
`pressure in one or more of the aqueous fluid channels, thereby to produce
`droplets of aqueous fluid in one or more outlet fluid channels.”
`f.
`Applying Step
`The difference between the method of claim 1 and the method of
`droplet formation disclosed in Link relates to the step of “applying a same
`constant pressure to the carrier fluid in each of the immiscible carrier fluid
`channels.” Ex. 1001, 16:17–28. More specifically, we find that, although
`Link teaches controlling pressures applied to the carrier fluid and aqueous
`fluid channels to regulate droplet size and periodicity (Ex. 1004 ¶ 166), Link
`does not expressly disclose applying a “same constant pressure” to the
`carrier fluid in each of the immiscible carrier fluid channels, as recited in the
`penultimate step of claim 1.
`For the reasons discussed below, we find that the preponderance of
`the evidence supports that a person of ordinary skill in the art would have
`found it obvious to implement Link’s disclosures by applying a same
`constant pressure to the carrier fluid in each of the immiscible carrier fluid
`channels. This step of claim 1 includes two aspects: (1) applying a same
`pressure, and (2) applying a constant pressure. We discuss each aspect
`below.
`
`Same Pressure
`i.
`The parties agree that the phrase, “applying a same constant pressure
`to the carrier fluid in each of the immiscible carrier fluid channels,” requires
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`that the same pressure be applied to all of the immiscible carrier fluid
`channels, e.g., oil channels, in a device. Pet. 11 (“the pressure is distributed
`equally across all channels”); PO Resp. 15 (“same constant pressure”
`requires that “all oil channels in the system have the same pressure applied
`to them”). The parties’ interpretation is consistent with the plain language of
`the claim, which states that the “same . . . pressure” is applied “to the carrier
`fluid in each of the immiscible carrier fluid channels.” We, therefore, adopt
`the parties’ agreed interpretation.
`We find that, in view of Link’s disclosure of embodiments having two
`inlet modules (Ex. 1004 ¶¶ 10, 174, Fig. 1) and Link’s disclosure to regulate
`droplet size and periodicity by controlling pressures at the inlet module (id.
`¶ 166), it would have been obvious to a person of ordinary skill in the art to
`apply the same pressure to the carrier fluid at each inlet module.
`The record establishes that there were a finite number of identified,
`predictable ways of applying pressure to the carrier fluid in a device with
`multiple droplet-forming junctions, such as Link Figure 1. There are two
`kinds of evidence on this point: the first concerns the number of pressure
`sources for the carrier fluid channels, and the second concerns the pressures
`applied to each carrier fluid channel.
`Regarding the number of pressure sources, the preponderance of the
`evidence establishes that a person of ordinary skill in the art would have had
`two choices: use separate pressure sources for each of the carrier fluid
`channels or use a common pressure source for all of the carrier fluid
`channels. There is no dispute that the second choice satisfies the “same . . .
`pressure” requirement of claim 1. See PO Resp. 1 (in the ’430 patent, “a
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`common regulator for the flow of oil . . . applies a same constant pressure to
`each of the oil channels across the entire device”).
`Our finding is supported by the testimony of Petitioner’s expert,
`Dr. Huck. Dr. Huck avers that regulating pressure in either the aqueous
`fluid channels or immiscible carrier fluid channels are “the two ways in
`which pressure could be regulated to control droplet size.” Ex. 1002 ¶¶ 111,
`115. In response to questions from Patent Owner as to whether Link
`discloses the same oil syringe for multiple oil lines, Dr. Huck explained that
`a person of ordinary skill in the art “can decide how many syringes he or she
`would use.” Ex. 2015, 196:12–197:3. In his reply declaration, Dr. Huck
`testifies that “a POSA would have been aware of systems in which a single
`carrier fluid source provided carrier fluid for multiple channels.” Ex. 1036
`¶ 41. Dr. Huck’s testimony establishes that the options available for
`applying pressure to the carrier fluid were finite in number and that one
`known option would have been to use a common pressure source for all of
`the carrier fluid channels.
`Our finding is further supported by Patent Owner’s admission and the
`testimony of its expert. Dr. Squires testifies that, “[p]rior to the ’430 patent,
`one way to have a microfluidic system with multiple microfluidic circuits
`. . . would be to use ‘separate pressure regulators for each aqueous stream
`and each carrier fluid stream’ in each fluidic circuit.” Ex. 2012 ¶ 47
`(quoting Ex. 1001, 1:66–67). At the hearing, Patent Owner conceded that a
`person of ordinary skill in the art would have been aware that a multi-
`junction device could be simplified by having one carrier fluid source for all
`of the circuits. Tr. 35:17–24. Taken together, the evidence establishes that
`separate pressure sources for each of the carrier fluid channels or a common
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`pressure source for all of the carrier fluid channels were two known ways of
`applying pressure to the carrier fluid in a multi-junction device.
`As discussed above, there is no dispute that use of a common pressure
`source for carrier fluid satisfies the “same . . . pressure” requirement of
`claim 1. The use of separate pressure sources for each channel also satisfies
`the “same . . . pressure” requirement, provided that each source applies the
`same pressure.
`Regarding the pressures applied to the carrier fluid channels, the
`preponderance of the evidence establishes that a person of ordinary skill in
`the art would have had at least two choices: apply the same pressure to all
`of the carrier fluid channels or apply different pressures to each of the carrier
`fluid channels. Our finding is supported by the undisputed testimony of Dr.
`Huck that, in Link Figure 1, the pressure applied to the four immiscible
`carrier fluid channels “can be the same.” Ex. 2015, 206:18–22; see PO
`Resp. 39 (quoting Dr. Huck’s testimony and citing no contrary evidence).
`Accordingly, we find that the “same . . . pressure” aspect of the
`“applying” step represents one of a finite number of identified ways of
`applying pressure to the carrier fluid in a multi-junction device, such as
`shown in Link Figure 1. As further discussed below, a person of ordinary
`skill in the art would have had a reason to choose this option, and it would
`have led to predictable results.
`Constant Pressure
`ii.
`We find that, based on Link’s disclosures regarding pressure-driven
`pumps or syringes for driving carrier fluid flows into multiple channels
`(Ex. 1004 ¶¶ 38, 164, 166, claim 16) and controlling pressures at the inlet
`module to regulate droplet size and periodicity (id. ¶ 166), it would have
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`been obvious to a person of ordinary skill in the art to apply a constant
`pressure to the carrier fluid.
`The record establishes that there were a finite number of identified,
`predictable ways of controlling the pressures applied to the carrier fluid and
`aqueous fluid in order to regulate the size and periodicity of the droplets at
`the inlet module. A person of ordinary skill in the art could have
`implemented Link’s paragraph 166 teaching by: (1) keeping the carrier fluid
`pressure constant and adjusting the aqueous fluid pressure; (2) keeping the
`aqueous fluid pressure constant and adjusting the carrier fluid pressure; or
`(3) adjusting both the carrier fluid pressure and the aqueous fluid pressure.
`Ex. 1004 ¶ 166; Ex. 1002 ¶¶ 111, 115 (regulating the pressure in either the
`aqueous fluid channels or immiscible carrier fluid channels are “the two
`ways in which pressure could be regulated to control droplet size”); Ex.
`1036 ¶ 33 (identifying three options listed above). We identified these
`options in our Institution Decision. Dec. 11. After considering the full
`record developed during trial, we see no reason to deviate from our prior
`finding.
`We find that Link teaches applying a constant pressure to the carrier
`fluid by disclosing pressure-driven pumps or syringes for driving carrier
`fluid flows into multiple channels. Ex. 1004 ¶¶ 38, 164, 166, claim 16. Our
`finding is supported by the express disclosures of Link, id., as well as the
`expert testimony.
`Link discloses that both the dispersed phase (i.e., aqueous) fluid and
`the continuous phase (i.e., carrier) fluid can be “pressure driven” (id. ¶ 38,
`claim 16), and that “pressure drive[n] flow control, e.g., utilizing valves and
`pumps” can be used “to manipulate the flow . . . into one or more channels
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`of a microfluidic device” (id. ¶ 164). The expert testimony demonstrates
`that this pressure driven flow, as disclosed by Link, is correctly understood
`as the application of a constant pressure. Dr. Squires explains that one
`“class of well-known pressure-driven flows in microfluidics, employs
`pressure sources . . . which impose a specified pressure P to the fluid, upon
`which the fluid flows with flow rate Q.” Ex. 2012 ¶ 43. As noted by Dr.
`Huck (Ex. 1036 ¶¶ 13, 32, 60), Dr. Squires’ testimony acknowledges that
`constant pressure regulators were known in the art for driving the flow of
`carrier fluid in microfluidics. Ex. 2012 ¶ 43. The opinions of Dr. Huck and
`Dr. Squires are consistent with Exhibit 1005, which discloses “pressure-
`driven pumping for microfluidic applications,” including a pump capable of
`generating constant pressures on the oil and water channels for droplet
`formation. Ex. 1005,3 Title, Abstract, 046501-5, Fig. 3(d), 046501-9.
`Link also discloses “pressurized syringes” for feeding into the main
`and sample inlet channels, i.e., the carrier fluid (oil) channels and aqueous
`fluid channels. Ex. 1004 ¶ 166; see also id. ¶¶ 56, 139 (disclosing “oil
`syringes”). Dr. Huck explains that these pressurized syringes can be either
`positive displacement (i.e., constant flow rate) or pressure-controlled (i.e.,
`constant pressure
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