Bio-Rad Laboratories, Inc.

Patent Trials and Appeals Board

Apr 26, 2021

IPR2020-00087 (P.T.A.B. Apr. 26, 2021)

Trials@uspto.gov Paper 40
571-272-7822 Date: April 26, 2021

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

10X GENOMINCS, INC.,
Petitioner,
v.
BIO-RAD LABORATORIES, INC.,
Patent Owner.

IPR2020-00087
Patent 9,562,837 B2

Before CHRISTOPHER M. KAISER, KIMBERLY McGRAW, and
ELIZABETH M. ROESEL, Administrative Patent Judges.
McGRAW, Administrative Patent Judge.

JUDGMENT
Final Written Decision
Determining Some Challenged Claims Unpatentable
35 U.S.C. § 318(a)

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I. INTRODUCTION
In this inter partes review, instituted pursuant to 35 U.S.C. § 314,
10X Genomics, Inc. (“Petitioner”) challenges claims 1–4, 7–13, and 19 of
U.S. Patent No. Patent 9,562,837 B2 (Ex. 1001, “the ’837 patent”), owned
by Bio-Rad Laboratories, Inc. (“Patent Owner”). This Final Written
Decision is entered pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
For the reasons discussed below, we determine that Petitioner has shown by
a preponderance of the evidence that claims 1–4, 7, 9–13, and 19 of the ’837
patent are unpatentable but has not shown by a preponderance of the
evidence that claim 8 is unpatentable.
A. Procedural History
Petitioner filed a Petition for inter partes review of claims 1–4, 7–13,
and 19 of the ’837 patent. Paper 2 (“Pet.”). Patent Owner filed a
Preliminary Response. Paper 8. Applying the standard set forth in 35
U.S.C. § 314(a), which requires demonstration of a reasonable likelihood
that Petitioner would prevail with respect to at least one challenged claim,
we instituted an inter partes review of all challenged claims on all asserted
grounds. Paper 9 (“Inst. Dec.”).
Following institution, Patent Owner filed a Patent Owner Response
(Paper 27, “PO Resp.”), Petitioner filed a Reply (Paper 30, “Pet. Reply”),
and Patent Owner filed a Sur-reply (Paper 32, “PO Sur-reply”). An oral
hearing was held on January 27, 2021, and a copy of the hearing transcript
has been entered into the record. Paper 39 (“Tr.”).
B. Real Parties-in-Interest
Petitioner identifies 10X Genomics, Inc. as the real party-in-interest.
Pet. 71. Patent Owner identifies Bio-Rad Laboratories, Inc. as the real
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party-in-interest. Paper 25, 1 (Bio-Rad Laboratories, Inc.’s Updated
Mandatory Notices, “Mandatory Notices”).
C. Related Matters
There are three related proceedings before the Board involving the
parties. IPR2020-00086 also involves the ’837 patent, and IPR2020-00088
and IPR2020-00089 involve related U.S. Patent No. 9,896,722 B2 (“the ’722
patent”), which claims priority to the ’837 patent claims as a continuation-
in-part application. The January 27, 2021, oral hearing transcript pertains to
all four cases. Final written decisions are issued in the three related
proceedings concurrently with this Decision.
The parties also identify Bio-Rad Laboratories, Inc. v. 10X Genomics,
Inc., Case No. 1:18-cv-01679-RGA (D. Del. Oct. 25, 2018) as a related
matter. Pet. 71; Paper 25 (Updated Mandatory Notices), 1.
D. The ’837 Patent
The ’837 patent was issued on an application filed April 2, 2013, and
lists a number of provisional and non-provisional priority applications, the
earliest of which was filed May 11, 2006. Pet. 3; Ex. 1001, codes (22), (60),
(63).1
The ’837 Patent is titled “Systems for Handling Microfluidic
Droplets.” Ex. 1001, code (54). The ’837 patent discloses an assembly that

1 Petitioner argues that the America Invents Act (“AIA”) applies to the ’837
patent because the application that led to the ’837 patent contained new
matter and claims to that new matter with an effective filing date of April 2,
2013. Pet. 5. We do not need to determine whether or not the AIA applies
because on this record, as discussed below, Petitioner’s asserted references
are prior art to the ’837 patent under either the AIA or pre-AIA version of
35 U.S.C § 102.
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includes a droplet formation module and a chamber. Id. at code (57);
3:11–12, 3:36–37, 52:38–39, 53:21–22. The droplet formation module is
configured to form droplets surrounded by an immiscible fluid. Id. at
code (57); 3:12–20, 52:38–48. The chamber is configured to receive
droplets and immiscible fluid and has an outlet configured to receive
substantially only droplets. Id. at code (57), 3:37–48, 53:22–25. According
to the ’837 patent, the assembly is “particularly useful for reducing potential
contamination associated with sample handing.” Id. at 52:27–29.
Figure 38 of the ’837 patent is reproduced below:

Figure 38 shows a microfluidic assembly that includes a droplet formation
module and a chamber. Ex. 1001, 8:22–23, 53:47–48, 53:62–65, 54:34–41.
The droplet formation module includes sample input 801, channel 802, and
oil input 803. Id. at 53:62–65. The assembly includes chamber 804
equipped with outlet 805, which is connected to slide 806, which is in turn
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connected to output nozzle or exit port 807. Id. at 54:34–41, 54:47–57,
54:61–63. The assembly also includes reagent input 808 and coalescence
module 809. Id. at 54:4–6, 54:19–22.
An aqueous sample solution is introduced through sample input 801,
and oil is introduced through oil input 803. Ex. 1001, 53:48–50, 53:59–60.
The oil and aqueous solution meet at a junction in channel 802 such that the
aqueous solution in segmented by the oil, thereby forming droplets. Id.
at 53:60–62. “As the oil containing the droplets moves along the assembly
through the channel 802, the oil and droplets begin to enter the
chamber 804.” Id. at 54:37–39. “Due to the difference in their respective
densities, the oil and droplets separate from each other in the chamber 804.”
Id. at 54:39–41. Droplets exit chamber 804 into outlet 805 “leaving a large
part of the oil behind.” Id. at 54:41–44. Droplets exiting chamber 804
through outlet 805 enter slide 806 and travel though the slide and nozzle
807, which leads to a vessel or container for collecting the droplets. Id.
at 54:51–59.
E. Illustrative Claims
The ’837 patent includes 20 claims. Claim 1 is the sole independent
claim and is reproduced below, with paragraph breaks adjusted and
bracketed numbers added to correspond with Petitioner’s identification of
claim elements:
1. [1.0] An assembly, the assembly comprising:
[1.1] a microchannel in a horizontal plane;
[1.2] at least one droplet formation module comprising a
sample inlet, an immiscible fluid inlet, and a junction, wherein
the junction is located between the sample inlet and the
microchannel and the droplet formation module is configured to
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produce droplets comprising the sample surrounded by the
immiscible fluid; and
[1.3] at least one downstream separation chamber
comprising a droplet receiving chamber inlet and at least one
droplet receiving outlet,
[1.4] wherein the separation chamber is upright to the
microchannel and out of the horizontal plane;
[1.5] wherein the droplet formation module and the
separation chamber are in fluid communication with each other
via the microchannel;
[1.6] and wherein the separation chamber has a wider
cross-section than the microchannel cross-section to accumulate
a plurality of droplets comprising the sample and
[1.7] is of a volume sufficient to separate the plurality of
droplets comprising the sample from the immiscible fluid within
the separation chamber.
Ex. 1001, 88:2–23.
F. Testimonial Evidence
In support of its unpatentability contentions, Petitioner relies on a
Declaration of Richard B. Fair, Ph.D. (Ex. 1008) and a Responsive
Declaration of Richard B. Fair, Ph.D. (Ex. 1072) filed with the Reply.
Patent Owner cross-examined Dr. Fair twice and filed a transcript of the first
deposition as Exhibit 2017 and the second deposition as Ex. 2041.
Patent Owner relies on a declaration of Shelly Anna, Ph.D. Ex. 2016.
Petitioner cross-examined Dr. Anna and filed a transcript of the deposition
as Exhibit 1075.
G. Prior Art and Asserted Grounds
Petitioner asserts that claims 1–4, 7–13, and 19 would have been
unpatentable on the following grounds (Pet. 19–20):
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Claim(s)
Challenged 35 U.S.C. § Reference(s)/Basis
1–4, 10–13, 19 102 Thorsen2
1–4, 7,3 9–13, 19 103 Thorsen
1–2, 4, 7–13, 19 103 Thorsen, Ismagilov 1194
1–2, 4, 7–13, 19 103 Thorsen, Ismagilov 119, Ismagilov 0915

II. ANALYSIS
A. Legal Standards
“In an [inter partes review], the petitioner has the burden from the
onset to show with particularity why the patent it challenges is
unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed.
Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review
petitions to identify “with particularity . . . the evidence that supports the
grounds for the challenge to each claim”)); see also 37 C.F.R. § 42.104(b)
(2019) (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).
A claim is anticipated under 35 U.S.C. § 102 only if “each and every
element as set forth in the claim is found, either expressly or inherently

2 Ex. 1003, T. Thorsen, Microfluidic Technologies for High-Throughput
Screening Applications (2003) (“Thorsen”).
3 Although Petitioner’s table identifying its asserted grounds states that it is
challenging claim 8 as unpatentable over Thorsen, Petitioner does not
present any argument supporting this challenge. Thus, we do not include
claim 8 in the listing of clams challenged under Thorsen.
4 Ex.1005, Ismagilov et al., US 2006/0094119 A1, pub. May 4, 2006
(“Ismagilov 119”).
5 Ex. 1004, Ismagilov et al., US 7,129,091 B2, issued Oct. 31, 2006
(“Ismagilov 091”).
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described, in a single prior art reference.” Verdegaal Bros. v. Union Oil Co.,
814 F.2d 628, 631 (Fed. Cir. 1987). A claim is unpatentable under
35 U.S.C. § 103 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 to which said subject matter pertains.” KSR Int’l Co.
v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is
resolved on the basis of 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 skill in the art; and
when in evidence (4) objective evidence of nonobviousness, i.e., secondary
considerations. See Graham v. John Deere Co, 383 U.S. 1, 17–18 (1966).
Additionally, the obviousness inquiry typically requires an analysis of
“whether there was an apparent reason to combine the known elements in
the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418 (citing In
re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2016) (requiring “articulated
reasoning with some rational underpinning to support the legal conclusion of
obviousness”)). Furthermore, Petitioner does not satisfy its burden of
proving obviousness by employing “mere conclusory statements,” but “must
instead articulate specific reasoning, based on evidence of record, to support
the legal conclusion of obviousness.” In re Magnum Oil Tools Int’l, Ltd.,
829 F.3d 1364, 1380 (Fed. Cir. 2016).
B. Level of Ordinary Skill in the Art
Relying on Dr. Fair’s testimony, Petitioner asserts that a person of
ordinary skill in the art (“POSA”) would have had “a PhD in chemistry,
biochemistry, mechanical or electrical engineering, or a related discipline
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with one year of experience related to systems for handling microfluidic
droplets,” “a Bachelor of Science in such fields with four years of such
experience,” or an equivalent level of education and practical experience.
Pet. 3; Ex. 1008 ¶ 40. Petitioner and Dr. Fair assert that a “POSA would
have knowledge of scientific literature concerning droplets (including
emulsions), and systems and methods for handling them (including both
their formation and handling downstream of formation), their applications,
and chemistry, components, and reactions that occur within them.” Pet. 3;
Ex. 1008 ¶ 40. In addition, Petitioner and Dr. Fair assert that a “POSA may
have worked on a multidisciplinary team and drawn on his or her own skills
along with certain specialized skills of others; and a chemist, engineer, and
biologist may have been part of the team.” Pet. 3; Ex. 1008 ¶ 40.
Relying on Dr. Anna’s testimony, Patent Owner asserts that a POSA
“would have had at least the equivalent of a Bachelor’s degree in
engineering, physics, or chemistry and two years of academic, research, or
industry experience related to fluid mechanics, fluid dynamics, or
microfluidics.” PO Resp. 16; Ex. 2016 ¶¶ 72–74. In addition, Patent Owner
asserts that “[a]dditional training or study could substitute for work
experience and additional work experience or training could substitute for
formal education.” PO Resp. 16; Ex. 2016 ¶ 72.
Both sides’ declarants represent that their opinions would not change
based on their opponent’s articulation of the level of ordinary skill in the art.
Ex. 1072 ¶ 13; Ex. 2016 ¶ 74.
We find that Patent Owner’s definition of a POSA is consistent with
the scope and content of the ’722 Patent and the asserted prior art. In
addition, we find that Patent Owner’s definition of a POSA is consistent
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with the legal standard for obviousness, which is to be determined from the
viewpoint of a person of ordinary, not extraordinary, skill. Stewart-Warner
Corp. v. City of Pontiac, Mich., 767 F.2d 1563, 1570 (Fed. Cir. 1985)
(section 103 is not concerned with the actual skill of the inventors—whose
skill may be extraordinary—but rather with the level of ordinary skill in the
art).
In contrast, Dr. Fair’s opinion about the level of ordinary skill in the
art is based on his own experience working in the field and “working with
others in this field who consistently had that level of education and/or
experience and worked with a multidisciplinary team.” Ex. 1072 ¶ 10.
Dr. Fair considers himself “an expert in the art of biomedical microfluidics
and related applications, including handling microfluidic droplets.”
Ex. 1008 ¶ 42. We find that Petitioner and Dr. Fair have defined a POSA
based on the level of skill possessed by Dr. Fair and others like him who are
experts in the field. Ex. 1008 ¶¶ 40–42; Ex. 1072 ¶¶ 9, 10. In our view, the
level of skill in the art proposed by Petitioner and Dr. Fair is more akin to
extraordinary, rather than ordinary skill in the art.
For these reasons, we apply Patent Owner’s definition of a POSA.
We also apply a portion of Petitioner’s definition, namely that a POSA
“would have knowledge of scientific literature concerning droplets
(including emulsions), and systems and methods for handling them
(including both their formation and handling downstream of formation),
their applications, and chemistry, components, and reactions that occur
within them.” Pet. 3; Ex. 1008 ¶ 40. This portion is undisputed by Patent
Owner and is consistent with the ’837 patent and the asserted prior art, as
summarized below.
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In any event, our determinations regarding Petitioner’s challenges do
not turn on the differences between Petitioner’s and Patent Owner’s
definitions of a POSA, and our conclusion would be the same under either
party’s definition.
C. Claim Construction
For petitions for inter partes review filed on or after November 13,
2018, such as here, we apply the same claim construction standard that
would be used to construe the claim in a civil action under 35 U.S.C.
§ 282(b), following the standard articulated in Phillips v. AWH Corp.,
415 F.3d 1303 (Fed. Cir. 2005) (en banc). 37 C.F.R. § 42.100(b);
83 Fed. Reg. 51,340, 51,340–41, 51,343 (Oct. 11, 2018). In applying this
standard, we generally give claim terms their ordinary and customary
meaning, as would be 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, 415 F.3d at 1312–13.
Petitioner proposes constructions for the phrases: (1) “sample”
(claim 1); (2) “separation chamber” (claim 1); (3) “droplet receiving outlet”
(claim 1), (4) “coupled” (claims 7, 8); and (5) “polymerase chain reaction”
(claim 13) that are based on Patent Owner’s expected claim constructions in
view of Patent Owner’s infringement contentions in the related district court
action. See Pet. 18–19 (citing Ex. 1026, 9–15, 21–22, 27–29; Ex. 1052, 12–
15).
In the Institution Decision, we addressed three claim terms, namely
“sample,” “separation chamber,” and “droplet receiving outlet,” and we
applied the constructions proposed by Petitioner and relied upon by Patent
Owner in its district court infringement contentions. Inst. Dec. 10–14. In
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the Response, Patent Owner proposes its own constructions for these terms,
as well as the additional terms “coupled” and “polymerase chain reaction
(PCR).” PO Resp. 16–25. In the Reply, Petitioner disputes Patent Owner’s
proposed construction of the term “sample” (Pet. Reply 3–4) and asserts that
the cited art reads on the challenged claims under Patent Owner’s proposed
construction of the remaining terms. See Pet. Reply 2–4 (discussing Patent
Owner’s constructions).
Below we address the terms “sample,” “separation chamber,” and
“droplet receiving outlet.” We determine that no other claim term requires
express construction for purposes of resolving the controversy. See Vivid
Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)
(“only those terms need be construed that are in controversy, and only to the
extent necessary to resolve the controversy”); see also Nidec Motor Corp. v.
Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017)
(applying Vivid Techs. in the context of inter partes review).
1. “sample”
Claim 1 recites a “sample inlet,” a droplet formation module
configured to produce “droplets comprising the sample,” and a separation
chamber . . . to accumulate “a plurality of droplets comprising the sample”
and to separate the “plurality of droplets comprising the sample.” Ex. 1001,
88:4–9, 88:18–23.
Petitioner’s declarant Dr. Fair states that the term “sample” should be
construed to cover “a compound, composition, and/or mixture of interest,
from any suitable source(s).” Ex. 1008 ¶ 73; see also Pet. 18 (citing
Ex. 1008 ¶¶ 72–75).
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Patent Owner responds that a sample is a “fluid containing molecules,
cells, small molecules (organic or inorganic) or particles.” PO Resp. 16; see
also Ex. 1001, 26:48–50 (describing a fluid “containing a sample such as
molecules, cells, small molecules (organic or inorganic) or particles”).
We need not construe the term “sample” as Petitioner has sufficiently
shown that the cited art teaches a “sample” under either party’s proposed
construction and any further construction of this term is not necessary to
resolve any issues in dispute.
2. “separation chamber”
Claim 1 requires the assembly to comprise a “downstream separation
chamber comprising a droplet receiving chamber inlet and at least one
droplet receiving outlet, wherein the separation chamber is upright to the
microchannel and out of the horizontal plane.” Ex. 1001, 88:10–14.
In its Petition, Petitioner contends that “separation chamber” should
be construed as “[b]road enough to encompass an open well.” Pet. 18 (citing
Ex. 1026, 9–12; Ex. 1052, 12–15).
Patent Owner responds “separation chamber” should be construed as a
“chamber sized to accommodate multiple droplets and an immiscible fluid in
separated form.” PO Resp. 18.
Petitioner does not dispute Patent Owner’s construction. See Pet.
Reply 2 (stating Patent Owner’s construction of “separation chamber” is
broad enough to include Thorsen’s incubation chamber and outlet wells).
We find that the Specification supports Patent Owner’s construction
for “separation chamber.” The Specification discloses that partitioned
portions, i.e. droplets, and immiscible fluid flow into a chamber, where the
partitioned portions sink, float, or are displaced from the chamber as a result
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of a difference in density between the partitioned portions and the
immiscible fluid. Ex. 1001, 2:45–50, 3:37–46. Patent Owner’s construction
is further supported by the Specification’s description of a “chamber . . .
configured to receive droplets and an immiscible fluid from the droplet
formation module,” where “the immiscible fluid displaces the droplet from
the chamber into the outlet due to the difference in density.” Id.
at 53:31–37. Patent Owner’s construction is also consistent with the
Specification’s disclosure that “the chamber can include any vessel suitable
for holding droplets, for example, test tubes, vials, beakers, jars, and PCR
tubes.” Id. at 53:44–47.
Accordingly, we adopt Patent Owner’s proposed construction of
“separation chamber” as a “chamber sized to accommodate multiple droplets
and an immiscible fluid in separated form.”
3. “droplet receiving outlet”
Claim 1 recites that the separation chamber comprises “a droplet
receiving chamber inlet and at least one droplet receiving outlet.” Ex. 1001,
88:10–12.
Petitioner and Dr. Fair assert the term “droplet receiving outlet” is
broad enough to “include the opening at the top of an open well.” Pet. 19;
Ex. 1008 ¶ 77 (stating that “[b]ased on Bio-Rad’s infringement contentions,
I understand that Bio-Rad’s interpretation of this term must be broad enough
to include an open well” and citing Ex. 1026, 9–13; Ex. 1052, 12–15).
Patent Owner disagrees that any and all openings at the top of any and
all open wells is a droplet receiving outlet. PO Resp. 22. Instead, Patent
Owner contends that “droplet receiving outlet” should be construed as the
“portion of the separation chamber where droplets are collected.” Id. at 21.
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Petitioner does not dispute Patent Owner’s proposed construction,
stating that Patent Owner’s proposed construction is broad enough to
encompass the asserted art. Pet. Reply 2–3.
We disagree with Petitioner that a droplet receiving outlet
encompasses any opening of at the top of any open well. Petitioner proposes
this construction based on Patent Owner’s “infringement contentions (and its
Complaint) showing [Patent Owner’s] expected claim interpretation.
Pet. 17–18 (citing Ex. 1026; Ex. 1052). Patent Owner’s infringement
contentions and complaint, however, are based on a particular structure as
satisfying the “droplet receiving outlet” limitation and do not purport that a
“droplet receiving outlet” is satisfied by any opening at the top of any open
well. See, e.g., Ex. 1026, 11. Petitioner does not provide any other support
for its proposed construction.
We agree with Patent Owner that a “droplet receiving outlet” should
be construed as the “portion of the separation chamber where droplets are
collected.” The Specification of the ’837 patent discloses that “[t]he
chamber includes an outlet that is positioned to receive substantially only the
partitioned portions of sample.” Ex. 1001, 3:46-48. In addition, the
Specification discloses that the outlet may positioned be “at the top, middle,
or bottom of the chamber” depending on the densities of the partitioned
portions and the immiscible fluid. Id. at 3:48–52. For example, the
Specification states that the outlet is positioned in a top portion of the
chamber if the immiscible fluid is of a greater density than the partitioned
portions, such that the partitioned portions rise in the chamber while the
immiscible fluid sinks and the partitioned portions flow into the outlet. Id. at
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3:52–58. These portions of the Specification show that a “droplet receiving
outlet” can be a portion of the separation chamber.
We find that the Specification also supports Patent Owner’s
interpretation that a “droplet receiving outlet” can include “where droplets
are collected.” For example, the Specification discloses that aqueous
droplets tend to rise when placed in a chamber of fluorinated oil, and
accordingly, “an outlet for collecting the displaced droplets can be
positioned at the top of the chamber.” Ex. 1001, 4:8–12. In another
example, the Specification discloses that aqueous droplets tend to sink when
placed in a chamber of certain mineral oils, and accordingly, “an outlet for
collecting the displaced droplets can be positioned at the bottom of the
chamber.” Id. at 4:12–16. Both of these examples illustrate the role of an
outlet as a structure for collecting droplets.
We find that Patent Owner’s claim construction is supported by the
Specification’s description of Figure 38. The Specification states that “a
chamber 804 equipped with an outlet 805” and “the outlet 805 can be
positioned at an upper portion of the chamber 804 where the rising droplet
will exit the chamber 804 into the outlet 805” or “the outlet 805 [can be]
positioned at a lower portion of the chamber 804.” Ex. 1001, 54:34–35,
54:41–46. When describing the Figure 38 embodiment, the Specification
states that outlet 805 is positioned at the top of chamber 804 to collect
droplets that are displaced by oil flowing into the chamber and that rise to
the top of the chamber. Id. at 59:55–63. These descriptions are consistent
with Patent Owner’s proposed construction for “droplet receiving outlet.”
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For these reasons, we adopt Patent Owner’s proposed construction
that a “droplet receiving outlet” is the “portion of the separation chamber
where droplets are collected.”
D. Overview of the Asserted References
We summarize the relevant disclosures of Petitioner’s asserted
references below.
1. Thorsen (Ex. 1003)
Thorsen is a Ph.D. dissertation. Ex. 1003, 6.6 Petitioner asserts that
Thorsen is prior art to the ’837 patent under § 102(a)(1) and pre-AIA
§ 102(a) and (b) “because it is a printed publication that was available to the
public more than one year before the earliest date of application for the 837
Patent.” Pet. 12–13. Patent Owner does not contest the prior art status of
Thorsen.
Thorsen relates to the design and development of microfluidic devices
for high-throughput screening applications. Ex. 1003, 6, 10. Thorsen
describes the “development of a two-phase microfluidic device,” including
“crossflow-based dynamic formation of picoliter-sized water droplets in a
continuously flowing oil-surfactant stream.” Id. at 10.
In one design described in Chapter 4 (i.e., Thorsen’s “serpentine
channel device”), Thorsen uses a serpentine outlet channel to slow down
droplets in the microfluidic device. Id. at 115 (stating the length and width
of the serpentine outlet channels were varied to create a long outlet path that
served as an incubation chamber for the encapsulated enzyme and substrate).
In another design described in Chapter 3 (i.e., Thorsen’s “incubation

6 We cite to Exhibit 1003 using the page numbers added by Petitioner in the
lower right corner of each page.
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chamber device”), Thorsen replaces the serpentine output channel with a
large, high cavity (i.e., an “incubation chamber”) to slow down droplets in
its microfluidic device. Id. at 99.
a) Chapter 3
Thorsen Chapter 3 discusses microfluidic crossflow as a droplet
formation technology. Ex. 1003, 52. Thorsen reviews the channel
architecture and theory of existing microfluidic crossflow devices, including
those having a serpentine channel to incubate the contents of the droplets.
Id. at 62–89. Thorsen reports that he developed “integrated elastomeric
valves” for gating microfluidic flow and sorting droplets. Id. at 53, 89, 97,
104 (“we successfully demonstrated droplet sorting via elastomeric valves in
the silicone microfluidic devices”).
Thorsen Chapter 3 describes the design and fabrication of
microfluidic device prototypes including a large cavity “incubation
chamber” as follows:
Multilayer soft lithography techniques were used to
fabricate a two-layer Dow Corning Sylgard 184 crossflow device
with integrated valves for droplet sorting. . . . A significant
design modification was added to the device to accommodate
chemical screening reactions where incubations of several
minutes to a few hours are optimal (Figure 3.28A). The
serpentine output channel at the crossflow junction was replaced
with a large (~500 μm) high cavity to slow down the droplets and
create an on-chip incubation chamber (Figure 3.28B). . . . A
control layer of valves was added for sorting droplets at the T-
junction intersection at the end of the chip (Figure 3.28C).
Ex. 1003, 99, 101.
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Figure 3.28 of Thorsen is reproduced below:

Ex. 1003, 101. Thorsen Figure 3.28 shows a microfluidic chip design,
including: (A) a schematic of a silicone crossflow device with an incubation
cavity, where black represents the flow layer and grey represents the control
layer; (B) a high resolution image of an actual chip showing a crossflow
junction and an incubation chamber; and (C) a high resolution of a sorting
junction in a chip showing valve structures. Id.
Thorsen describes the steps for fabricating the Sylgard 184 crossflow
devices, stating that after “the two-layer crossflow devices were cured, they
were released from the mold, processed, and sealed channel side down on
the coated coverslips.” Id.
Thorsen describes testing the crossflow devices having an incubation
chamber as follows:
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Droplets were generated in the Sylgard 184 crossflow
devices using mineral oil/1% Span 80 for the continuous phase
and dH2O for the disperse phase. Water and oil st[r]eams were
balanced at the crossflow junction at ~12/15 psi water/oil-
surfactant (w/o-s). Water droplet formation was initiated by
increasing the water pressure to 12.5–13.0 psi. Generated water
droplets entered the “incubation” cavity, where they encountered
a sharp drop in flow velocity (Figure 3.29A). After ~ 1 hour, the
droplets had passed entirely through the cavity and re-entered the
narrow (~60 μm wide) outlet channel, where they flowed toward
the T-junction for valve-based sorting.
Initial sorting was performed by manually switching the
valves while observing the droplets under 20x magnification.
The elastomeric valves were actuated using pressurized air
controlled by an external solenoid valve. When ~13–15 psi of
air pressure was applied to the selected control channel, the
interfacial membrane between the two channel layers
(Figure 3.28C) was deflected down, closing the underlying flow
channel. Manual valve switching rates of several Hz were
carried out without any observable mechanical breakdown. The
valves efficiently sorted the droplets at the T-junction
(Figure 3.29B).
Id. at 102–103.
Figure 3.29 of Thorsen is reproduced below:

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Id. at 103. Thorsen Figure 3.29 shows: (A) water droplets entering the
incubation cavity of a Sylgard 184 device; and (B) sorting of droplets using
elastomeric valves. Id.
Thorsen also describes the development of a fluorescence-activated
droplet sorter using his Sylgard 184 microfluidic chip having a microcavity
and elastomeric valves. Ex. 1003, 104–111. Thorsen discloses that, “[a]s a
functional demonstration of the device, the fluorescence-activated droplet
sorter was used to sort 2–3 μm diameter droplets filled with either green . . .
or red . . . fluorescent dyes.” Id. at 109. Thorsen describes using the
microcavity crossflow device to generate red and green droplets. Id. at 109–
110. Thorsen states: “The formed droplets entered the microcavity, where
they slowed down and formed a mixed cluster of droplets.” Id. at 110.
Thorsen discloses that, to sort the droplets, a detection region was set up
downstream of the microcavity and upstream of a T-junction near the device
outlets. Id. at 110–111. Responsive to fluorescence emission detection, the
valves were actuated to sort the red and green droplets toward the respective
outlet channels. Id. at 110.
Thorsen describes the results of his sorting experiment as follows:
Sorting efficiency was measured both by looking at the PMT
[photomultiplier tube] output values of the output material in the
collection wells. As droplets formed a large aggregate in the
output wells, PMT readings were not especially useful as
neighbor droplets washed out the signal from improperly sorted
droplets. Visual inspection of the output wells was carried under
a 40x objective . . . on an inverted microscope . . . equipped with
a mercury lamp. The wells were rapidly scanned using both
green . . . and red . . . filter sets to look for improperly sorted
droplets. Of the thousands of sorted droplets in each well, only
a small fraction (~1–2%) were of the wrong dye type.
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Id. at 111.
b) Chapter 4
Thorsen Chapter 4 discusses biochemical screening applications for
microfluidic crossflow devices. Ex. 1003, 113. In particular, Thorsen
Chapter 4 describes the development and characterization of a model
enzyme system in reverse vesicles generated by microfluidic crossflow using
a serpentine channel design to act as an incubation chamber for encapsulated
enzyme and substrate. Id. at 114. Thorsen describes the microfluidic
crossflow device for measuring enzyme activity at the single cell level as
follows:
Cells [i.e., Escherichia coli (“E. coli”)] expressing a
recombinant enzyme [i.e., p-nitrobenzyl (pNB) esterase
(“pNB esterase”)] and the appropriate substrate are injected into
separate water channels that meet at the crossflow junction
(Figure 4.1). As soon as the two water streams merge, they are
immediately encapsulated into a droplet in the oil-surfactant
stream. As the droplets flow down the channel toward the outlet,
the substrate is converted to a detectable fluorescent product.
Id. at 114.
Figure 4.1 of Thorsen is reproduced below:

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Id. at 115. Thorsen Figure 4.1 shows a microfluidic channel layout in a
microfluidic crossflow device for single cell catalysis measurements. Id.
Thorsen Chapter 4 describes the preparation and testing of
microfluidic crossflow devices using a serpentine output channel as follows:
Several crossflow patterns were designed with serpentine
outlet channels. The length and width of the channel where the
droplets emerge from the crossflow junction were varied to
create a long outlet path that served as an incubation chamber for
the encapsulated enzyme and substrate. Single-layer devices
were fabricated in Sylgard 184 from the photoresist molds of the
patterns. With a 90 μm wide x 10 μm high output channel ~8 cm
in length, formed droplets required ~20 minutes to reach the
output well. Given adequate spacing between the monodisperse
droplets at the crossflow junction, water droplets in mineral
oil/2% Span 80 (13.0/15.0 psi w/o-s) traveled as a perfectly
coherent stream from the crossflow junction to the outlet well
(Figure 4.2). At higher relative water pressures, the generated
droplets collided in the output channels, forming aggregates.
Ex. 1003, 115.
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Figure 4.2 of Thorsen is reproduced below:

Ex. 1003, 116. Thorsen Figure 4.2 shows a serpentine channel design for a
biochemical screening chip. Id. According to Thorsen, “[m]onodisperse
water droplets in mineral oil/2% Span 80 retain a coherent pattern as they
flow towards the device outlet.” Id.
Thorsen describes cross flow experiments using devices fabricated
from Sylgard 184. Id. at 118. An oil stream was balanced against two
separate aqueous inputs (containing washed E. coli cells and substrate
respectively) as previously described for the two-color droplet sorting
experiment described in Chapter 3. Id. Figure 4.4 of Thorsen is reproduced
below.
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Ex. 1003, 119. Thorsen Figure 4.4 shows E. coli bacteria cells encapsulated
in droplets generated by microfluidic crossflow. Id. Thorsen states that
although the crossflow assay was unreliable, “a few good examples of
catalysis inside the formed droplets were still acquired” as shown in Figure
4.5. Id. Thorsen further states that droplets were visualized for fluorescent
product approximately 10 minutes after encapsulation, after they had flowed
through 4–5 loops of the wide serpentine outlet channel. Id.
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Figure 4.5 of Thorsen is reproduced below.

Ex. 1003, 120. Thorsen Figure 4.5 depicts monodisperse droplets containing
E. coli expressing recombinant pNB esterase and fluorescein diacetate
substrate. Id. at 120. The active E. coli cells took on a bright fluorescent
green coloration as they accumulated fluorescein product during catalysis,
making it easy to visually confirm their presence in droplets. Id. at 119.
2. Ismagilov 091 (Ex. 1004)
Ismagilov 091 is asserted as prior art to the ’837 patent under
35 U.S.C. § 102(a)(2) and pre-AIA § 102(e) as of its May 9, 2003 filing date
and under § 102(a)(1) and pre-AIA § 102(a) as of its December 8, 2005
publication date. Pet. 15–16. Petitioner contends that Ismagilov 091 is prior
art under pre-AIA § 102(b), if the challenged claims are not entitled to their
earliest asserted priority date. Id. at 16.
Patent Owner does not contest the prior art status of Ismagilov 091.
We do not need to address Petitioner’s contention under pre-AIA § 102(b)
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because Patent Owner does not attempt to show a date of invention earlier
than Ismagilov’s 091’s filing date or publication date. We find that
Ismagilov 091 is prior art to the ’837 patent regardless of whether the AIA
applies to the patent.
Ismagilov 091 discloses microfabricated substrates and methods of
conducting reactions in droplets (“plugs”) in a flow of carrier fluid in a
substrate. Ex. 1004, code (57).
Ismagilov 091 discloses that “‘[p]lugs’ . . . are formed in a substrate
when a stream of at least one plug-fluid is introduced into the flow of a
carrier-fluid in which it is substantially immiscible.” Ex. 1004, 9:20–23.
According to Ismagilov 091, the “plugs” may be in the form of “an aqueous
plug-fluid . . . surrounded by a non-polar or hydrophobic fluid such as an
oil.” Id. at 9:39–44. Ismagilov 091 discloses that an “inlet port” is “an area
of a substrate that receives plug-fluids,” and “[t]he inlet port can be in fluid
communication with a channel.” Id. at 8:41–42, 8:46–47. According to
Ismagilov 091, a “channel” includes “microchannels.” Id. at 7:46–48.
Ismagilov 091 discloses that an “outlet port” is “an area of a substrate that
collects or dispenses the plug-fluid, carrier-fluid, plugs or reaction product.”
Id. at 9:5–8.
In a section headed, “Channels and Devices,” Ismagilov 091 discloses
a device that “includes one or more substrates comprising a first channel
comprising an inlet separated from an outlet.” Ex. 1004, 14:20–23.
According to Ismagilov 091,
The device may have one or more outlet ports or inlet ports. Each
of the outlet and inlet ports may also communicate with a well or
reservoir. The inlet and outlet ports may be in fluid
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communication with the channels or reservoirs that they are
connecting or may contain one or more valves.
Id. at 14:36–40. In this section, Ismagilov 091 also discloses that “a plug-
forming region generally comprises a junction between a plug-fluid inlet and
a channel containing the carrier-fluid such that plugs form.” Id. at 14:44–45.
In a section headed, “Fabrication of Channels, Substrates, and
Devices,” Ismagilov 091 discusses methods for fabricating microfluidic
devices, including a polymer casting method. Ex. 1004, 16:1–7, 16:23–41.
According to this method, a negative image of the channels is etched into a
crystalline silicon wafer, and the wafer is used as a mold for casting the
channels from polydimethylsiloxane (PDMS). Id. at 16:23–28. In this
method, the silicon wafer mold is placed in the bottom of a Petri dish,
uncured PDMS is poured onto the mold, and the PDMS then cured and
removed from the mold. Id. at 16:30–35. Ismagilov 091 discloses that
“[h]oles may be cut into the PDMS using, for example, a tool such as a cork
borer or a syringe needle.” Id. at 16:35–36. According to Ismagilov 091,
the PDMS channels are treated with hydrochloric acid to render the surface
hydrophilic. Id. at 16:37–38. Ismagilov 091 discloses that the PDMS
channels can be “placed onto a microscope cover slip (or any other suitable
flat surface), which can be used to form the base/floor or top of the
channels.” Id. at 16:38–41.
Ismagilov 091 also discloses that “[a] substrate containing the
fabricated flow channels and other components is preferably covered and
sealed, preferably with a transparent cover, e.g., thin glass or quartz,
although other clear or opaque cover materials may be used.” Ex. 1004,
16:60–64. According to Ismagilov 091, the substrate can include “[a]
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variety of channels for sample flow” as well as “manifolds (a region
consisting of several channels that lead to or from a common channel).” Id.
at 17:10–11, 17:18–20. Such manifolds can “route[] the flow of solution to
an outlet.” Id. at 17:23–27. Ismagilov 091 discloses that “[t]he outlet can be
adapted for receiving, for example, a segment of tubing or a sample tube,
such as a standard 1.5 ml centrifuge tube. Collection can also be done using
micropipettes.” Id. at 17:27–30.
Figure 3A of Ismagilov 091 is reproduced below.

Ismagilov 091 Figure 3A shows a photograph (right side) and a schematic
diagram (left side) depicting a stream of plugs formed from an aqueous
plug-fluid and an oil (carrier-fluid) in curved serpentine channels. Ex. 1004,
4:6–10, 18:24–26, Fig. 3A. According to Ismagilov 091, the carrier-fluid is
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introduced into inlet port 300 of a substrate, and three aqueous plug-fluids
are introduced in separate inlet ports 301, 302, and 303. Id. at 18:31–33.
Ismagilov 091 discloses that “[p]lug-fluids may comprise a solvent
and optionally, a reactant” and that “[s]uitable carrier-fluids include oils,
preferably fluorinated oils.” Ex. 1004, 20:10–11, 20:37–38. According to
Ismagilov 091, “[t]he carrier-fluid or plug-fluid, or both may contain
additives, such as agents that reduce surface tensions (e.g., surfactants).” Id.
at 20:45–47.
3. Ismagilov 119 (Ex. 1005)
Ismagilov 119 is asserted as prior art to the ’837 patent under
35 U.S.C. § 102(a)(2) and pre-AIA § 102(e) as of its March 16, 2005 filing
date and under § 102(a)(1) and pre-AIA § 102(a) as of its May 4, 2006
publication date. Pet. 16–17. Patent Owner does not contest the prior art
status of Ismagilov 119. We find that Ismagilov 119 is prior art to the ’837
patent regardless of whether the AIA applies to the patent.
Ismagilov 119 incorporates Ismagilov 091 by reference. Ex. 1005,
¶ 30. Like Ismagilov 091, Ismagilov 119 also discloses a microfluidic
system and refers to droplets as “plugs.” Id. ¶ 22, Fig. 13b (showing
“aqueous droplets, or plugs” being formed at the junction between “channel
a” through which an aqueous stream is pumped and “channel b” though
which a carrier fluid is pumped).
Ismagilov 119 discloses that “the use of fluorinated carrier fluid can
provide protection of plugs and control of the surface chemistry.” Ex. 1005
¶ 9. Ismagilov 119 discloses that, if centrifugation is used as a force for
bringing two plugs into contact, then “preferably the carrier fluids and the
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plug fluids have different densities, as is the case when aqueous plug fluids
and fluorinated carrier fluids are used.” Id. ¶ 14.
Ismagilov 119 discloses that “it is desirable add a surfactant into the
carrier fluid . . . to control the surface tension and the wetting properties of
the carrier fluid.” Ex. 1005 ¶ 94. For example, Ismagilov 119 discloses
“perfluorooctanol as the surfactant when fluorinated fluids were used as
carrier fluids.” Id. According to Ismagilov 119, “fluorous-soluble
surfactants can be used to control non-specific protein adsorption at a
fluorinated carrier-aqueous interface.” Id. Ismagilov 119 provides an
example of a fluorous-soluble surfactant that “arranges itself at the
fluorinated carrier-aqueous interface during plug formation and presents a
monolayer of oligoethylene glycol groups.” Id.
E. Asserted Anticipation of Claims 1–4, 10–13, and 19 by Thorsen
Petitioner contends that Thorsen anticipates claim 1 in three ways:
(1) the disclosure in Chapter 3 of a microfluidic incubation chamber device
(Thorsen’s “incubation chamber system”); (2) the disclosure in Chapter 4 of
a microfluidic serpentine channel outlet device (Thorsen’s “serpentine
channel system”); and (3) the teachings of Chapter 4 applied to the system of
Chapter 3. See, e.g., Pet. 19–21, 27–28. Regarding the third way, Petitioner
contends a POSA would have understood that Chapter 4’s teaching of a cell
screening assay applies to the incubation chamber system described in
Chapter 3 system and “read the teachings in both chapters as describing a
single system and operation.” Id. at 20.
For the reasons discussed below, we find Petitioner has shown that
claims 1–3, 10–13, and 19 are anticipated by Thorsen’s incubation chamber
system disclosed in Chapter 3, alone or in combination with the teachings of
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Thorsen Chapter 4 pertaining to a sample, and we find Petitioner has shown
that the subject matter of dependent claim 4 would have been obvious in
view of Thorsen’s disclosure of outlet wells having an open top. In view of
these findings, we do not reach Petitioner’s contention that claims 1–4, 10–
13, and 19 are anticipated by Thorsen’s serpentine channel system in
Chapter 4 alone.
1. Claim 1
a) [1.0] An assembly, the assembly comprising:
Petitioner contends, and Patent Owner does not dispute, that
Thorsen’s incubation chamber system, as described in Chapter 3 and shown
in Figures 3.28 and 3.29, constitutes an assembly as recited in the preamble.
Pet. 27–28 (citing Ex. 1003, 10, 99, 101–103, 109–111, 115; Ex. 1008 ¶ 95).
We are persuaded by Petitioner’s undisputed contentions and find that
Thorsen’s microfluidic incubation chamber device is an assembly and
discloses the preamble of claim 1.7
b) [1.1] a microchannel in a horizontal plane;
Petitioner contends, and Patent Owner does not dispute, that
Thorsen’s incubation chamber system has a microchannel in a horizontal
plane as required by claim element 1.1. Pet. 28–30 (citing, inter alia, Ex.
1003, Fig. 3.28). We have reviewed and agree with Petitioner’s undisputed
contentions. For example, we find that Thorsen’s incubation chamber
system, as shown in Figure 3.28, includes a microchannel located between

7 Because we find that Thorsen discloses the subject matter recited in the
preamble of claim 1, we need not, and do not, determine if the preamble
should be construed as limiting.
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the crossflow junction and the incubation chamber. Ex. 1003, Fig. 3.28;
Pet. 28.
We also agree with Petitioner’s undisputed contention that Thorsen’s
microchannel is in a horizontal plane. For example, Petitioner persuasively
shows that a coverslip is used to close the channels. Pet. 29–30. We are
persuaded by Petitioner’s contention that because the glass coverslip is
placed horizontally, Thorsen’s microchannels, which are closed by and
parallel to the glass coverslip, are similarly horizontal and in a horizontal
plane. Id. (citing Ex. 1003, 96–97, 103, Figs. 3.28, 3.29, 4.2, 4.4, 4.5; Ex.
1006 ¶¶ 31, 100).
Therefore, we determine Petitioner has persuasively shown that
Thorsen’s description of its incubation chamber system discloses a
microchannel as required by claim element 1.1.
c) [1.2] at least one droplet formation module
comprising a sample inlet, an immiscible fluid inlet, and
a junction, wherein the junction is located between the
sample inlet and the microchannel and the droplet
formation module is configured to produce droplets
comprising the sample surrounded by the immiscible
fluid;
Petitioner contends that Thorsen discloses the limitations of claim
element 1.2, relying on the combined disclosures of Chapters 3 and 4.
Pet. 30–37.
Addressing the structural limitations of claim element 1.2, Petitioner
contends Thorsen’s crossflow junction––which is used in Thorsen’s
microfluidic devices having an either incubation chamber system as
disclosed in Chapter 3 or the serpentine channel system disclosed in Chapter
4––is a droplet formation module as required by claim element 1.2. See,
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e.g., Pet. 31–32. Petitioner states Thorsen’s Figure 3.28A shown below left,
with an annotated excerpt shown below right, depicts the cross flow junction
used in an incubation chamber system. Pet. 31–32.

Thorsen’s Figure 3.28A illustrating Thorsen’s cross flow junction is
depicted above left and an annotated excerpt of the cross flow junction
shown in Figure 3.28A is depicted above right. Pet. 31–32.
Petitioner states, and we find, that Thorsen’s crossflow junction
depicted in Figure 3.28A is a “droplet formation module” comprising a
“sample inlet” (the channels annotated in green), an “immiscible fluid inlet”
(the channel annotated in orange containing an immiscible oil), and a
“junction” (the red cross flow junction where the orange and green channels
intersect), wherein the “junction” is located between the “sample inlet” (the
channels annotated in green) and the “microchannel” (the microchannel
annotated in blue) that leads to the incubation chamber (black dot). Pet. 31–
32; Ex. 1003, Fig. 3.28.
Turning to the recitation of a “sample” in claim element 1.2,
Petitioner states that Thorsen discloses using the cross flow junction in both
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the incubation chamber system and the serpentine outlet channel system, and
that the incubation chamber system is a modification of the serpentine
channel system designed for chemical screening reactions that require
additional time beyond the time provided by the serpentine output channel
system. Pet. 32, 35 (citing Ex. 1003, 3.28, 3.29, 4.1, 4.2, 99–103, 109–111,
114–116). Petitioner points to Thorsen’s description of the incubation
chamber device as a modification of its serpentine channel device wherein
the “serpentine output channel at the crossflow junction was replaced with a
large (~500 μm) high cavity to slow down the droplets and create an on-chip
incubation chamber (Figure 3.28B).” Pet. 35; Ex. 1003, 99.
Petitioner also asserts that Thorsen discloses that its devices are
intended for “chemical screening” that includes screening of a sample, such
as compound, composition, and/or mixture of interest from any suitable
source. Pet. 34 (citing Ex. 1003, 10, 21, 26; Ex. 1008 ¶¶ 106–109).
Petitioner asserts that Chapter 3 of Thorsen discloses using the cross
flow junction incubation chamber system to form aqueous droplets
surrounded by immiscible oil fluid at the junction (Pet. 33 (citing Ex. 1003,
62, 73–74)) as well as to sort aqueous droplets containing either “green
(fluorescein) or red (R-phycoerythrin) fluorescent dyes” (Pet. 36–37 (citing
Ex. 1003, 109–12).
Petitioner further asserts that Thorsen Chapter 4 describes using the
same cross flow junction in connection with the serpentine output channel
system to produce aqueous droplets comprising a sample (e.g.,
cells/enzymes of interest and a reagent (substrate)) for a chemical screening
assay to measure enzyme activity at the single cell level. Pet. 35–36 (citing
Ex. 1003, 114–120, Figs. 4.1, 4.2, 4.4, 4.5).
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Patent Owner responds that Thorsen does not disclose the subject
matter of clam element 1.2, asserting that Thorsen does not disclose using a
“sample” under either party’s construction of the term, and therefore the
“sample” limitations are missing from Thorsen’s disclosure. PO Resp. 26.
Patent Owner asserts that, although the red or green dyes may be used to
indicate the presence of certain bacteria or antibodies, they are not
“samples” themselves, within the meaning of the ’837 claims. Id. at 27
(citing Ex. 2016 ¶ 121). Patent Owner further contends Thorsen does not
disclose using cells or enzymes as samples because the experiments
disclosed in Chapter 4 using cells/enzymes reported problems with the
adhesion of cells to the channel walls. Id. at 26. Patent Owner points to
Thorsen’s statement of problems with “flow balance,” “cell adhesions to
PDMS” and “substrate autohyrdrolysis [sic].” Id. at 10 (citing Ex. 1003,
120–127; Ex. 2016 ¶¶ 36–40). Patent Owner also points to Thorsen’s
statements that “[w]orking on the development of a microfluidic crossflow
assay emphasized the difficult dynamic integration process between
biochemical and micromechanical systems” and “that the problems he
experienced ultimately ‘plagued the assays’ and that ‘further research in this
area’ was needed.” Id. at 10–11 (quoting Ex. 1003, 127).
Patent Owner similarly contends that a POSA would not understand
Thorsen to disclose use of the incubation chamber disclosed in Chapter 3 to
perform chemical screening because the channel walls of Thorsen’s
incubation chamber system were made from the same material as the
serpentine channel system and “Thorsen reported problems with the
adhesion of cells to the channel walls in his only attempt to use an actual
sample, i.e., his use of pNB esterase in the serpentine channel system of
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Chapter 4).” PO Resp. 26 (citing Ex. 2016 ¶ 120); see also id. at 47–48
(asserting Thorsen’s Chapters 3 and 4 do not describe a single system and
that even they do describe a single system, the system is not enabled).
We have reviewed the parties’ evidence and arguments and determine
Petitioner has shown persuasively that Thorsen discloses the subject matter
recited in claim limitation 1.2, notwithstanding Patent Owner’s arguments to
the contrary.
We disagree with Patent Owner’s argument that because Thorsen does
not disclose the successful use of a sample in Thorsen’s incubation chamber
system, that Thorsen does not disclose a sample inlet, for two reasons.
First, claim 1 is directed to an “assembly” comprising a “droplet
formation module [that] is configured to produce droplets comprising the
sample.” Ex. 1001, 88:2–9. Thus, although claim 1 recites a “sample,” the
“sample” is not an element of the claimed assembly, but rather is merely a
material “worked upon” by the assembly. See In re Otto, 312 F.2d 937, 939
(CCPA 1963) (“inclusion of the material or article worked upon by a
structure being claimed does not impart patentability to the claims”). The
recitation of a “sample” in the context of claim 1 is analogous to the
recitation of “hair” in the context of Otto’s claimed hair curlers and does not
impart patentability to the claim. See id. at 937–38, 939.
Second, even if claim 1 requires a sample, we find that Thorsen
discloses using a sample in its incubation chamber system. For example, we
determine that Petitioner has shown persuasively that the green (fluorescein)
and red (R-phycoerythrin) fluorescent dyes disclosed in Thorsen Chapter 3
are “samples” under either party’s definition of the term sample. Patent
Owner contends that although “fluorescein and R-phycoerythrin complexes
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may be used to indicate the presence of certain bacteria or antibodies, they
are not ‘samples’ themselves within the meaning of the ’837 claims.” PO
Resp. 27 (citing Ex. 2016 ¶ 121). We disagree with Patent Owner. The
green and red fluorescent dyes are each compounds of interest and thus
satisfy Petitioner’s definition of “sample” (i.e., “a sample, such as a
compound, composition, and/or mixture of interest, from any suitable
source”). The droplets containing the dyes are also a fluid containing
molecules and thus satisfy Patent Owner’s definition of “sample” (i.e., fluid
containing “molecules, cells, small molecules (organic or inorganic) or
particles”).
We also agree with Petitioner that Thorsen’s microfluidic devices,
including Thorsen’s incubation chamber system disclosed in Chapter 3, were
intended as a general platform that could be used with samples (e.g.,
molecules, DNA, enzymes or other proteins, or cells). Pet. 40–41 (citing
Ex. 1003, 21, 104); see also Ex. 1003, 104 (stating “given the small volume
of individual droplets” that are can be sorted using the elastomeric valves in
its microfluidic device, that to fluorescence was proposed as a system for
“applications such as single-cell assays of enzymatic activity or
protein/protein interactions”).
We further agree that a POSA would understand that Thorsen’s
incubation chamber system is not limited to using only the materials used in
the disclosed experiments (i.e., water and oil or the red and green fluorescent
dyes). Thorsen’s Chapter 3 states that the incubation chamber is a design
modification “to accommodate chemical screening reactions where
incubation of several minutes to a few hours are optimal (Figure 3.28A)”
(Ex. 1003, 99), thus indicating that the incubation chamber is intended for
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use with chemical screening reactions and samples besides that used in the
disclosed experiments. We agree with Petitioner that a POSA would
understand this statement to expressly disclose use of samples in screening
reactions where incubation intended to be used with this system is not
limited to water droplets in oil or to only samples having green and red
fluorescent dyes. Pet. 33–34.
We also agree with Petitioner that Thorsen discloses use of samples
comprising E. coli cells and pNB esterase enzymes in the experiments
disclosed in Chapter 4. We disagree with Patent Owner’s argument that the
E. coli cells and pNB esterase enzyme are not disclosed as “samples”
because Thorsen reported problems “with the adhesion of cells to the
channel walls” in the experiments involving “use of pNB esterase in the
serpentine channel system of Chapter 4.” PO Resp. 26–27; see also id. at
48–50 (Patent Owner’s non-enablement argument).
Although Thorsen identifies problems with the crossflow assay
described in Chapter 4 and states the assay was unreliable due to the
problems that “quickly made the fabricated devices non-functional” (see
Ex. 1003, 119), Thorsen also states that, in spite of the problems, a “few
good examples of catalysis inside the formed droplets were still acquired”
(Ex. 1003, 120). As such, even though Thorsen identifies issues with cell
adhesion in the crossflow assay of Chapter 4, Thorsen also discloses
successful results using the assay. See Celeritas Techs. v. Rockwell Int’l
Corp., 150 F.3d 1354, 1361 (Fed. Cir. 1998) (stating a “reference is no less
anticipatory if, after disclosing the invention, the reference then disparages
it”).
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In particular, Thorsen describes an experiment in which it was
possible to visualize droplets containing E. coli bacterial cells for fluorescent
product for approximately 10 minutes after encapsulation after they had
flowed through 4–5 loops of the wide serpentine output channel. Ex. 1003,
119. Thorsen further explains that the “active cells took on a bright
fluorescent green coloration as they accumulated fluorescein product during
catalysis, making it easy to visually confirm their presence in droplets under
a 60x/1.4 NA oil immersion objective.” Id. Additionally, Thorsen provides
photographs of E. coli bacterial cells successfully encapsulated in droplets
that were generated by microfluidic crossflow (Ex. 1003, Fig. 4.4) as well as
images of monodisperse droplets containing E. coli expressing recombinant
pNB esterase and fluorescein diacetate substrate, thus illustrating “a few
good examples of catalysis inside the formed droplets” (Ex. 1003, 119,
Fig. 4.5). As such, Thorsen discloses the successful use of its serpentine
channel system using E. coli cells and pNB esterase enzymes as samples,
and we disagree with Patent Owner that Thorsen does not enable the use of
cells (i.e., E. coli) and enzymes (i.e., pNB esterase) as samples.
Therefore, we determine that Petitioner has sufficiently shown that
Thorsen discloses the subject matter recited in claim element 1.2.
d) [1.3] at least one downstream separation chamber
comprising a droplet receiving chamber inlet and at least
one droplet receiving outlet
Petitioner contends that Thorsen’s incubation chamber device satisfies
the limitations of claim element 1.3. Pet. 45–48. Petitioner asserts the
incubation chamber of Thorsen’s microfluidic incubation chamber device
disclosed in Chapter 3 is a separation chamber as required by claim element
1.3. Pet. 46–47. Petitioner asserts that the incubation chamber is a
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“separation chamber” that has both a “droplet receiving chamber inlet” and a
“droplet receiving outlet.” Pet. 45–46. In particular, Petitioner asserts that
the microchannel that delivers the droplets formed at the Crossflow Junction
to the incubation chamber, and which is shown in Figures 3.28A, 3.28B and
3.29A, is a “droplet receiving chamber inlet.” Pet. 46–47 (citing Ex. 1003,
101, Figs. 3.28A, 3.28B). Petitioner further asserts that the microchannel
shown in Figure 3.28C through which droplets exit the incubation chamber
is a “droplet receiving outlet” as required by claim element 1.3. Pet. 47
(citing Ex. 1003, 101, Fig. 3.28C).
Patent Owner opposes, asserting that Thorsen’s incubation chamber is
not a separation chamber and that Thorsen’s incubation chamber does not
have a droplet receiving outlet.
We have reviewed the parties’ arguments and evidence and determine
Petitioner has shown persuasively that Thorsen’s microfluidic incubation
chamber device discloses the subject matter recited in claim element 1.3.
As noted above, we adopt Patent Owner’s proposed construction of
“separation chamber” as a “chamber sized to accommodate multiple droplets
and an immiscible fluid in separated form.” Petitioner’s evidence shows
persuasively that Thorsen’s incubation chamber accommodates multiple
droplets and an immiscible fluid in separated form and, therefore, that
Thorsen’s incubation chamber is a separation chamber under our
construction of the term. For example, Petitioner points to Figure 3.29A of
Thorsen, which depicts multiple droplets in mineral oil entering and
accumulating in Thorsen’s incubation chamber. Pet. 46–47; Ex. 1003,
Fig. 3.29A; see also Ex. 1003, 99 (stating that Thorsen’s incubation chamber
has a “large (~500 µm) high cavity”), 110 (stating “thousands” of red and
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green droplets were formed and that the formed droplets entered the
microcavity, where they slowed down and formed a mixed cluster of
droplets).
Patent Owner presents a number of arguments as to why Thorsen’s
incubation chamber is not a separation chamber. PO Resp. 29–31. In
particular, Patent Owner argues that (1) Thorsen “does not expressly discuss
separating droplets from the immiscible fluid inside the incubation chamber”
(id. at 29); (2) Thorsen’s incubation chamber is designed to slow the
movement of droplets and oil and is not designed to separate droplets for
collection (id. at 30); (3) the flow of droplets and oil into the chamber is the
same as the flow out of the chamber (id.); (4) the purpose of a “separation
chamber” of the ’837 patent is to separate droplets so they can be collected
at a “droplet receiving outlet” and such collection cannot occur in Thorsen’s
incubation chamber (id. at 31); (5) Figure 3.29 depicts droplets in multiple
layers, not all of which are resting on the bottom of the incubation chamber
(id.); (6) if an oil was used that had the same density as water, the aqueous
droplets would stay dispersed in the oil and not sink to the bottom. (id.).
We disagree with these arguments because they do not refute that
Thorsen’s incubation chamber is “sufficiently sized to accommodate
multiple droplets and an immiscible fluid in separated form.” Whether
Thorsen’s incubation chamber was designed to separate droplets for
collection, or whether droplets would not settle in the chamber if a different
oil were used, is not the correct test. Patent Owner’s construction for
separation chamber, which we adopt here, does not require actual separation
or collection in the chamber. Moreover, even if separation were required,
Petitioner shows persuasively that Thorsen discloses separation because
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Figure 3.29 depicts multiple droplets accumulating on the floor of Thorsen’s
incubation chamber. Patent Owner’s argument that Figure 3.29 depicts
droplets in multiple layers, not all of which are resting on the bottom of the
incubation chamber supports, rather than refutes, Petitioner’s position
because it admits that at least some of the droplets did rest (settle) on the
bottom of the chamber.
Therefore, we agree with Petitioner that Thorsen’s incubation
chamber is a separation chamber as recited in claim 1.
We also agree with Petitioner that Thorsen’s incubation chamber has
both a droplet receiving inlet and a droplet receiving outlet. Petitioner
shows that Thorsen’s incubation chamber has a microchannel that deposits
droplets into the chamber (a droplet receiving inlet) and a microchannel
through which droplets leave the incubation chamber (a droplet receiving
outlet). See, e.g., Ex. 1003, Fig. 3.28A (illustrating microchannels entering
and leaving the incubation chamber).
We disagree with Patent Owner’s argument that Thorsen does not
disclose an incubation chamber having a droplet receiving outlet. Patent
Owner first argues Thorsen does not disclose a droplet receiving outlet
because there is “no evidence in the record as to whether droplets approach
and exit the incubation chamber one at time, collect as a group and exit the
incubation chamber multiple droplets at a time or something in between.”
PO Resp. 37–38 (citing Ex. 2016 ¶¶ 143–150). We disagree with this
argument because Thorsen discloses droplets leaving the incubation
chamber through the micrcochannel. For example, in describing use of the
incubation chamber system to sort droplets containing red or green dyes,
Thorsen states that the droplets containing the red or green fluorescent dyes
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“entered the microcavity, where they slowed down and formed a mixed
cluster of droplets,” then describes “a single droplet or small cluster of
droplets leaving the microcavity” and then states that the droplets collect in
the output wells. Ex. 1003, 110–111. As such, Thorsen discloses droplets
leaving the incubation chamber.
Patent Owner also argues that it is impossible for a POSA to collect
droplets before they exit the incubation chamber because it would be
impossible to collect droplets without also collecting oil. PO Resp. 38–39.
We disagree with this argument because there is no restriction in claim 1 that
prevents the collection of oil at the droplet receiving outlet. Indeed, the ’837
patent describes outlet 805, which is shown in Figure 38, as positioned
where the rising droplets will exit chamber 804 into outlet 805 and “leav[e] a
large part of the oil behind.” Ex. 1001, 54:41–44. Because the Specification
states that a “large part of the oil” is left behind, it can be presumed that at
least part of the oil exits chamber 804 into outlet 805 with the droplets. Id.
Third, Patent Owner contends that it would be impossible to collect
droplets at all in Thorsen’s incubation chamber if the system used an oil that
was more dense than water because only oil would leave chamber and the
water droplets would rise to the top of the incubation chamber. PO Resp. 39
(citing Ex. 2017, 86:15–87:15; Ex. 2016 ¶ 146). We disagree with this
argument because it ignores Thorsen’s disclosure of using mineral oil, which
is less dense than water droplets. See, e.g., Ex. 1003, 102, 109; Ex. 1008 ¶
51.
Fourth, Patent Owner contends that Thorsen does not disclose a
droplet receiving outlet because Dr. Fair testified during his deposition that
his opinion regarding the “droplet receiving outlet” is based on a
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misunderstanding of Figure 3.29A. PO Resp. 39–41 (citing Ex. 2016
¶¶ 147–148; Ex. 2017, 132:21–133:16).
We disagree with this argument. Although Dr. Fair did mistakenly
state during his deposition that Figure 3.29A depicted a droplet receiving
outlet, as opposed to droplet receiving inlet, Dr. Fair corrected later his
misstatement. See Ex. 2017, 167:9–169:1. Dr. Fair’s misstatement during a
deposition, which was later corrected, does not negate his declaration
testimony in which he correctly identifies the microchannel shown in Figure
3.29A as the channel through which droplets enter the incubation chamber
(i.e., a droplet receiving inlet) and identifies the microchannel through which
droplets leave the incubation chamber as a droplet receiving outlet. See
Ex. 1008 ¶¶ 125–128.
Thus, for the foregoing reasons, Petitioner has sufficiently shown that
Thorsen’s disclosure of its microfluidic incubation chamber device discloses
the limitations of claim element 1.3.
e) [1.4] wherein the separation chamber is upright to
the microchannel and out of the horizontal plane;
Petitioner contends, and Patent Owner does not dispute, that
Thorsen’s incubation chamber is a separation chamber that is upright to the
microchannel and out of the horizontal plane. Pet. 51–52 (citing Ex. 1003,
35, 63, 99, 102–103, Fig. 3.29, Fig. 4.1); see also PO Resp. 44–46 (asserting
that Thorsen’s outlet wells do not satisfy the limitations of clam element 1.4,
but not making a corresponding argument regarding Thorsen’s incubation
chamber).
We agree with Petitioner’s undisputed contentions. For example, we
agree that because Thorsen’ incubation cavity is approximately 500 µm high
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(Ex. 1003, 99), which is taller than any of the microchannel dimensions
disclosed in Thorsen (see, e.g., Ex. 1003, 35, 63, 103 (disclosing
microchannel dimensions 100 µm or smaller)), that Thorsen’s incubation
chamber necessarily extends out of the horizontal plane of the
microchannels.
Therefore, we find Petitioner has persuasively shown that Thorsen
discloses the subject matter of claim element 1.4.
f) [1.5] wherein the droplet formation module and
the separation chamber are in fluid communication with
each other via the microchannel;
Petitioner asserts that Thorsen discloses the subject matter recited in
claim element 1.5 because Thorsen discloses a microchannel providing fluid
communication between the Crossflow Junction (droplet formation module)
and the Incubation Chamber (separation chamber). Pet. 55. Other than its
arguments regarding “separation chamber,” which we address above, Patent
Owner does not dispute Petitioner’s contentions.
We have reviewed the parties contentions and agree with Petitioner
that Thorsen discloses the subject matter recited in claim element 1.5. For
example, we find that Thorsen’s Figure 3.28 discloses a cross flow junction
(droplet formation module) that is in fluid communication with the
incubation chamber (separation chamber) via the channel that runs from the
junction to the incubation chamber (a microchannel) and thus discloses the
subject matter recited in claim element 1.5. Ex. 1003, Fig. 3.28, 98–103.
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g) [1.6] and wherein the separation chamber has a
wider cross-section than the microchannel cross-section
to accumulate a plurality of droplets comprising the
sample and
Petitioner contends that Thorsen’s microfluidic incubation chamber
device discloses the limitations of claim element 1.6. Pet. 55–56 (citing Ex.
1003, 99, 103, 109–111, Figs. 3.28, 3.29). Other than its arguments
regarding “separation chamber,” which we address above, Patent Owner
does not dispute Petitioner’s contention.
We agree with Petitioner’s contention and find that Thorsen discloses
the subject matter recited in claim element 1.6. For example, we find that
the high resolution images of an actual chip in Figures 3.28 and 3.29 of
Thorsen each show an incubation chamber (“separation chamber”) having a
wider cross section than the microchannel cross section. Ex. 1003,
Figs. 3.28, 3.29. We also find that Figure 3.29 of Thorsen depicts a plurality
of droplets accumulating in the separation chamber. Ex. 1003, Fig. 3.29.
We also find that Thorsen discloses that “thousands” of droplets containing
red or green fluorescent dyes entered the incubation cavity where they
slowed down and formed a mixed cluster of droplets. Ex. 1003, 109–111.
Thus, Petitioner has persuasively shown that Thorsen discloses the
subject matter of claim element 1.6
h) [1.7] is of a volume sufficient to separate the
plurality of droplets comprising the sample from the
immiscible fluid within the separation chamber.
Petitioner asserts Thorsen discloses the limitations of claim element
1.7 by disclosing an incubation chamber of sufficient volume that the
droplets can move and sink relative to the less dense mineral oil phase.
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Pet. 57 (citing Ex. 1003, 76, 80–84, 100–103, 119, Figs. 3.28, 3.29; Ex.
1008 ¶ 154).
Other than asserting Thorsen does not disclose a separation chamber,
which we address above, Patent Owner does not dispute Petitioner’s
contention. PO Resp. 46.
We agree with Petitioner’s contentions and find that Thorsen discloses
the subject matter recited in claim element 1.7. For example, we find that
Thorsen discloses that the incubation chamber has a volume of 1 µm, while
the droplets have a volume of only ~30pL. Ex. 1003, 76, 100–103, 119, Fig.
3.29. We are persuaded by Dr. Fair’s testimony that a POSA would
understand that, given these volumes, Thorsen’s incubation chamber is of a
sufficient volume to allow the droplets to separate. Ex. 1008 ¶ 154.
i) Conclusion
For the foregoing reasons, we Petitioner has sufficiently shown that
Thorsen discloses all of the limitations of claim 1. Accordingly, we
conclude that Petitioner has shown by a preponderance of the evidence that
claim 1 is anticipated by Thorsen.
2. Claim 2
Claim 2 recites the “assembly of claim 1, wherein an aqueous fluid
from the sample inlet is segmented with an immiscible fluid from the
immiscible fluid inlet at the junction.” Ex. 1001, 88:24–26.
Petitioner contends that Thorsen’s crossflow junction, which is used
in both Thorsen’s incubation chamber system and serpentine channel
system, discloses the limitations of claim 2. Pet. 60 (citing Ex. 1003, 70–76,
102, 103, 109–111, 114–120, Figs. 3.5–3.9, 3.11, 3.12, 3.14, 3.15, 3.28,
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3.29, 4.1, 4.2). Patent Owner does not separately argue the patentability of
claim 2.
We have reviewed, and are persuaded by, Petitioner’s contentions and
find that Thorsen’s cross flow junction as depicted in Thorsen Figure 3.28,
which is used in both Thorsen’s incubation chamber system and serpentine
channel system, produces droplets, as shown in Figure 3.29, by segmenting
aqueous fluid from the sample inlet with an immiscible fluid from the
immiscible fluid inlet. See, e.g., Ex. 1003, 102 (describing production of
aqueous droplets in mineral oil depicted in Figure 3.29), Fig. 3.28; see also
id. at 114–116 (describing the production of droplets using the cross flow
junction in the serpentine chamber device described in Chapter 4); Figs. 4.1,
4.2 (depicting Thorsen’s cross flow junction in connection with the
serpentine channel system).
3. Claim 3
Claim 3 recites the “assembly of claim 1, wherein the at least one
droplet receiving outlet is located on the lower portion of the separation
chamber.”
Petitioner contends that Thorsen’s incubation chamber device
disclosed in Chapter 3 satisfies the limitations of claim 3. Pet. 60 (citing Pet.
45–48).
Other than contending the microchannel through which droplets leave
the incubation chamber is not a droplet receiving outlet, which we address
above, Patent Owner does not dispute Petitioner’s contentions. See
generally PO Resp.
We agree with Petitioner’s contentions and determine Thorsen
discloses the subject matter recited in claim 3. For example, we agree that
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Thorsen discloses a microchannel that receives droplets out of the separation
chamber and that this microchannel is a droplet receiving outlet. We also
agree with Petitioner’s contention that this microchannel is located on the
lower portion of the incubation chamber (separation chamber). Thorsen
states that after the cross flow device (i.e., the microchannel incubation
chamber device) was released from a mold, that it was “sealed channel side
down on the coated coverslips” (Ex. 1003, 102), thus demonstrating that the
microchannel is located on the lower portion of the incubation chamber. See
also Ex. 1003, Fig. 3.29A (depicting a photograph of the incubation chamber
and microchannel viewed through an inverted microscope).
Therefore, we find that Thorsen‘s incubation chamber system
discloses the limitations recited in claim 3 and therefore Petitioner has
shown by a preponderance of the evidence that Thorsen anticipates claim 3.
4. Claim 4
Claim 4 recites the “assembly of claim 1, wherein the at least one
droplet receiving outlet is located on the upper portion of the separation
chamber.”
Petitioner contends that claim 4 is anticipated by Thorsen’s disclosure
of an outlet well having an opening at the top of the well. Pet. 61. Petitioner
makes no argument that Thorsen’s incubation chamber has a droplet
receiving outlet located on its upper portion. For purposes of Petitioner’s
anticipation ground, we do not reach Petitioner’s contention that Thorsen’s
outlet wells have a “droplet receiving outlet,” as recited in claims 1 and 4.
Instead, we address this aspect of claims 1 and 4 below in the context of
Petitioner’s obviousness ground. See, e.g., Boston Sci. Scimed, Inc. v. Cook
Grp. Inc., Nos. 2019-1594, -1604, -1605, 2020 WL 2071962, at *4
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(Fed. Cir. Apr. 30, 2020) (non-precedential) (recognizing that the “Board
need not address issues that are not necessary to the resolution of the
proceeding” and, thus, agreeing that the Board has “discretion to decline to
decide additional instituted grounds once the petitioner has prevailed on all
its challenged claims”).
5. Claim 10
Claim 10 recites the “assembly of claim 1, wherein the droplet
receiving outlet receives substantially one or more droplets.”
Petitioner asserts, inter alia, that Thorsen discloses that the incubation
chamber receives thousands of droplets and has a droplet receiving outlet
that receives substantially one or more droplets. Pet. 66 (citing Ex. 1003,
102–103, 109–111, Figs. 3.29). Patent Owner does not separately argue the
patentability of claim 10. See generally PO Resp.
We agree with Petitioner’s contentions and determine Thorsen
discloses the subject matter recited in claim 10. For example, we agree that
Thorsen discloses a droplet receiving outlet that receives substantially one or
more droplets by describing the use of Thorsen’s incubation chamber system
to sort droplets containing red or green dyes. Ex. 1003, 110–111. Thorsen
states that droplets containing the red or green fluorescent dyes “entered the
microcavity, where they slowed down and formed a mixed cluster of
droplets,” then describes “a single droplet or small cluster of droplets
leaving the microcavity” where they later collect in the output wells. Ex.
1003, 110–111.
Therefore, we find that Thorsen‘s incubation chamber system
discloses the limitations recited in claim 10 and therefore Petitioner has
shown by a preponderance of the evidence that Thorsen anticipates claim 10.
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6. Claim 11
Claim 11 recites the “assembly of claim 1 further comprising a
reagent inlet, wherein the reagent inlet is in fluid communication with the
junction or the microchannel.”
Petitioner asserts that Thorsen’s cross flow junction discloses a
reagent inlet that is in fluid communication with the junction or the
microchannel. Pet. 67 (citing Pet. 30–37; Ex. 1003, 99–103, 114–118,
Figs. 3.28–3.29, 4.1, 4.2). Patent Owner does not separately argue the
patentability of claim 11. See generally PO Resp.
We agree with Petitioner’s contentions. For example, Figures 3.8 and
4.1 each depict a cross flow junction having two inlets for adding sample
and reagents. See, e.g., Ex. 1003, Fig. 4.1 (identifying one input for
cells/eznymes (sample) and the other input for substrate (reagent). These
figures also show that the reagent inlet is in fluid communication with the
junction or microchannel.
Therefore, we find that Thorsen‘s incubation chamber system
discloses the limitations recited in claim 11 and therefore Petitioner has
shown by a preponderance of the evidence that Thorsen anticipates claim 11.
7. Claims 12 and 13
Claim 12 recites the “assembly of claim 11, wherein the reagent inlet
introduces one or more amplification reagents to the junction or the
microchannel.” Claim 13 recites the “assembly of claim 12, wherein the one
or more amplification reagents are for a polymerase chain reaction.”
Petitioner asserts Thorsen discloses the subject matter recited in claims 12
and 13. Pet. 67–69 (citing Ex. 1003, 52, 130).
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Patent Owner does not separately argue the patentability of claims 12
and 13. See generally PO Resp.
We have reviewed and agree with Petitioner’s evidence and argument.
For example, we agree that Thorsen describes use of microfluidic systems
for biological applications including PCR reactions and describes
microfluidic assay systems having a cross flow junction with a reagent inlet
for use with those same applications. See, e.g., Ex. 1003, 52, 103, Figs.
3.28, 4.1. We agree with Petitioner’s contentions, supported by the
persuasive unrebutted testimony of Dr. Fair, that a POSA would be familiar
with amplification reagents for use in PCR. Pet. 67; Ex. 1008 ¶ 182.
Thus, we determine Petitioner has shown that Thorsen discloses the
limitations recited in claims 12 and 13 and therefore has shown by a
preponderance of the evidence that claims 12 and 13 are unpatentable under
35 U.S.C. § 102 as anticipated by Thorsen.
8. Claim 19
Claim 19 recites the “assembly of claim 1, further comprising a
sorting module to direct the flow of droplets, wherein the sorting module is
located between the droplet formation module and the separation chamber.”
Petitioner asserts that the serpentine channel microfluidic device
discloses this limitation because this device uses valves to sort droplets to
direct the flow of droplets to a particular outlet well. Pet. 69–70 (citing
Ex. 1003, 99–103, 106–112, Figs. 3.28–3.29, 4.2). Patent Owner does not
present any particularized argument directed to this claim. See generally
PO Resp.
We have reviewed and we agree with Petitioner’s contentions. We
agree that Thorsen shows a valve sorting module that is located between the
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crossflow junction (the droplet formation module) and the outlet well.
Ex. 1003, 99–103, 106–112, Figs. 3.28–3.29, 4.2. Thorsen further discloses
using this droplet sorting module to sort “thousands” of red from green
fluorescent droplets with 98–99% accuracy. Id. at 109–111.
Thus, we determine Petitioner has shown that Thorsen discloses the
limitations recited in claim 19 and therefore has shown by a preponderance
of the evidence that claim 19 is unpatentable under 35 U.S.C. § 102 as
anticipated by Thorsen.
9. Conclusion
For the foregoing reasons, Petitioner has shown by a preponderance of
the evidence that claims 1–3, 10–13, and 19 are unpatentable under 35
U.S.C. § 102 as anticipated by Thorsen. As discussed above, we do not
reach Petitioner’s contention that claim 4 is anticipated by Thorsen.
F. Asserted Obviousness of Claims 1–4, 7, 9–13, and 19 over
Thorsen
Petitioner contends that claims 1–4, 7, 9–13, and 19 would have been
obvious under 35 U.S.C. § 103(a) over Thorsen.
Having already determined that Petitioner establishes by a
preponderance of the evidence that claims 2, 3, 10–13, and 19 are
anticipated by Thorsen, we do not address Petitioner’s additional grounds
challenging these claims as obvious over Thorsen. See SAS Inst. Inc. v.
Iancu, 138 S. Ct. 1348, 1359 (2018) (holding a petitioner “is entitled to a
final written decision addressing all of the claims it has challenged”); Boston
Sci. Scimed, 809 F. App’x at 990 (“We agree that the Board need not address
[alternative grounds] that are not necessary to the resolution of the
proceeding.”).
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For the reasons stated below, we determine that Petitioner has shown
by a preponderance of the evidence that claims 1, 4, 7, and 9 would have
been obvious over Thorsen.
1. Claim 1
Petitioner contends that claim 1 would have been obvious in view of
Thorsen’s disclosure of an incubation chamber system and a serpentine
channel system, both of which have outlet wells, where the outlet well
corresponds to a “separation chamber” and the open top of the outlet well
corresponds to a “droplet receiving outlet” under Patent Owner’s claim
constructions. Pet. 47–48; see also id. at 19, 27–59 (Petitioner’s
obviousness contentions for claim 1 based on Thorsen alone). Patent Owner
opposes.
For the reasons below, we agree with Petitioner notwithstanding
Patent Owner’s arguments to the contrary.
Turning first to claim element 1.3, we agree with Petitioner that
Thorsen’s outlet wells are a separation chamber under Patent Owner’s
proposed construction of that term, i.e., “chamber sized to accommodate
multiple droplets and an immiscible fluid in separated form,” which we
adopt. We are persuaded by Petitioner’s arguments and evidence that
Thorsen’s outlet well are sized to accommodate multiple droplets and an
immiscible fluid as Thorsen teaches collecting aqueous droplets surrounded
by immiscible mineral oil in its outlet well. Pet. 48 (citing Ex. 1003, 110–
111). For example, we find that Thorsen discloses collecting thousands of
droplets comprising either red or green fluorescent dye in its outlet wells.
See, e.g., Ex. 1003, 110–111. We also agree with Petitioner’s argument and
evidence that, because Thorsen’s aqueous water droplets are more dense
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than the mineral oil, the droplets will sink to the bottom of the outlet well,
and therefore Thorsen discloses that the droplets and immiscible fluid are in
separated form. See Section II.E.1.d. above.
Patent Owner responds that the outlet wells are not separation
chambers because Thorsen does not expressly disclose that the droplets may
sink to the bottom of the outlet well and that if an oil was used that has the
same density as water, the droplets would not sink to the bottom of the well.
PO Resp. 33. We disagree with Patent Owner’s argument because it ignores
Thorsen’s disclosure of using mineral oil, which is less dense that water, in
its microfluidic devices, including the serpentine channel device. See, e.g.,
Ex. 1003, 115; Ex. 1008 ¶ 51.
We also disagree with Patent Owner’s argument that Petitioner’s
expert, Dr. Fair, testified that he did not assert that Thorsen’s outlet wells
were separation chambers. PO Resp. 32–33 (citing Ex. 2017, 80:19–81:22).
We agree with Petitioner that Dr. Fair’s testimony during this part of his
deposition was directed to opinions of a separation chamber under a claim
construction of separation chamber that is not asserted in the present
proceeding. Pet. Reply 8 (citing Ex. 2017, 77:2–5, 77:11–14). Dr. Fair
testifies in his declaration that Thorsen’s outlet wells are separation
chambers under the construction of this term asserted in the present
proceeding. See, e.g., Ex. 1008 ¶¶ 129–130.
Therefore, we find that Thorsen’s outlet well is a separation chamber
as recited in claim 1.
We also agree with Petitioner’s evidence and argument that Thorsen’s
outlet wells teach or suggest the separation chamber limitations recited in
claim elements 1.3–1.7.
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57
More particularly, we agree with Petitioner’s contention that
Thorsen’s outlet wells have a “droplet receiving chamber inlet” as required
by claim element 1.3, which Patent Owner does not dispute, because
Thorsen states that the droplets formed at Thorsen’s crossflow junction will
travel to the outlet well through a microchannel. Pet. 47–48 (citing
Ex. 1003, 114–116, Figs. 4.1, 4.2). We agree with Petitioner and find
Thorsen teaches a droplet receiving inlet (the end of the microchannel that
enters the outlet well and delivers droplets form the crossflow junction) as
required by claim element 1.3.
We also agree with Petitioner’s assertions that the outlet wells are
upright to the microchannels as required by claim element 1.4 and have a
wider cross section to accumulate a plurality of droplets comprising the
sample as required by claim element 1.6. Pet. 52–53, 56. We disagree with
Patent Owner’s arguments that Thorsen does not disclose the dimensions or
designs of Thorsen’s outlet wells and therefore do not disclose the subject
matter recited in these limitations. PO Resp. 33–37.
For example, we are persuaded by Petitioner’s argument that
Thorsen’s outlet wells were fabricated by punching through multiple layers
of the microchip (i.e., the thick upper layer of PDMS and the thin lower
layer of PDMS), whereas the main channel is only patterned only along the
thin bottom layer. Pet. Reply 14–19; Ex. 1003, 98–102, Fig. 3.27. Patent
Owner admits that Thorsen fabricated the openings (i.e., outlet wells) in the
devices by punching holes in the microchip itself at the channel ends, as was
standard practice at the time. PO Resp. 2. Patent Owner asserts that the
punch used to fabricate the outlet wells is 585 µm, which is larger than the
dimensions of the microchannels disclosed in Thorsen, each of which are
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under 100 µm. PO Sur-reply 11; see also Ex. 1003, 31 (stating holes were
punched with a 585 µm steel punch at channel ends), 115, Fig. 4.1
(identifying microchannel of 90 µm output channel connected to outlet
well). Thus, according to Patent Owner’s own contentions, the outlet well
was formed by punching through the microfluidic device layers at the
channel ends using a punch that is wider than the microchannels, we find the
outlet wells are upright to the microchannel as required by claim element 1.4
and have a wider cross-section than the microchannel as required by claim
element 1.6. Ex. 1003, 98–102, Figs. 3.27, 4.2; Pet. Reply 14–19.
We also agree with Petitioner’s contentions that Thorsen teaches that
its outlet wells are “of volume sufficient to separate the plurality of droplets
comprising the sample from the immiscible fluid within the separation
chamber” as required by claim element 1.7 for the same reasons we find
Thorsen’s outlet wells are a separation chamber (i.e., a “chamber sized to
accommodate multiple droplets and an immiscible fluid in separated form”).
We are also persuaded by Petitioner’s argument, supported by Dr.
Fair’s testimony, that it would have been obvious to remove collected
droplets from Thorsen’s outlet wells using a micropipette. Pet. 48 (citing
Ex. 1008, 130, 136).
For example, we also persuaded by Petitioner’s argument, supported
by Dr. Fair’s testimony, that a POSA “would know that the purpose of
screening is often to collect the positive results for further use (e.g., by
collecting the positive droplets from the outlet well by micropipette and
transferring them to a sample test tube for subsequent use).” Pet. 21–22;
Ex. 1008 ¶¶ 83–84.
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Patent Owner argues there is no evidence that a micropipette would be
used with Thorsen’s outlet well because there is no evidence that the
opening in Thorsen’s outlet well would be wide enough to accommodate a
micropipette. See, e.g., PO Resp. 41–44; see also id. at 46 (citing Ex. 2016
¶¶ 154–157). In particular, Patent Owner contends Dr. Fair testifies that the
smallest micropipette is 1 mm (1000 µm), which is much larger than the
dimensions of the wells described in Thorsen. PO Resp. 43–44; see also id.
at 46 (stating there is no evidence Thorsen’s outlet well is large enough to
insert a micropipette).
Petitioner responds that, to the extent Thorsen does not expressly
disclose an outlet well large enough to accommodate a micropipette, it
would have been well within the knowledge and skill of a POSA to produce
an outlet well that would accommodate a micropipette tip, such as by using a
commercially available 2 mm or 4 mm cork borer, or Thorsen’s disclosed
~5 mm punch. Pet. Reply 24–25 (citing Ex. 2016 ¶¶ 30–31; Ex. 1004, 44;
Ex. 1006 ¶ 196 (identifying 2mm diameter wells); Ex. 1076, 2, 4–5
(identifying 4mm reservoir holes); see also Ex. 2016 ¶ 69 (stating that
Exhibit 2033 describes techniques “common at the time” to “punch a hole
through the PDMS at the end of channels”).
We agree with Petitioner that it would have been obvious to a POSA
to transfer the droplets collected in Thorsen’s outlet wells and move them
into a vessel such as a PCR tube or test tube using a micropipette. See, e.g.,
Pet. 58–59 (citing Ex. 1008 ¶¶ 130, 156); see also Ex. 1008 ¶¶ 129–130,
155–156 (stating using a pipette to remove droplets from an open well was
routine and well known). Petitioner provides persuasive argument and
evidence, supported by the persuasive testimony of Dr. Fair that, after
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sorting droplets in a chemical screening reaction, a POSA would have
collected the sorted droplets for further use or additional processing.
Pet. 58; Ex. 1008 ¶ 156.
We are also persuaded by Petitioner’s argument that Thorsen
discloses that his fluorescence-based droplet sorter was only 98–99%
accurate on a first pass, and that this disclosure would have provided
additional motivation to a POSA to collect Thorsen’s sorted droplets by
micropipette for another round of additional sorting or other processing.
Pet. 58–59 (citing Ex. 1003, 109–111; Ex. 1008 ¶ 156). We are persuaded
by Dr. Fair’s testimony that a POSA would have collected the sorted
droplets for additional processing. Ex. 1008 ¶ 156.
Patent Owner does not direct us to persuasive evidence rebutting
Dr. Fair’s testimony that using a pipette to remove droplets from an open
well, such as Thorsen’s open wells, would have been routine and well-
known to a person of ordinary skill in the art. Ex. 1008 ¶¶ 129, 130, 155,
156. Although Patent Owner directs us to paragraphs 151 and 152 of
Dr. Anna’s testimony (PO Resp. 42–44 (citing Ex. 2016 ¶¶ 151, 152)),
neither paragraph (nor the related paragraph 153) refutes Dr. Fair’s
testimony regarding what was known in the art about the use of
micropipettes to collect droplets from the open wells of a microfluidic
device.
Therefore, to the extent Thorsen does not expressly disclose an outlet
well (separation chamber) having an opening that large enough to
accommodate a micropipette tip (droplet receiving outlet), we agree with
Petitioner that it would have been obvious to a POSA to modify the outlet
well of Thorsen to provide an outlet well large enough to accommodate a
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micropipette tip in order to allow the collection of droplets that contain the
desired (screened for) product for further use. Pet. Reply 22–25 (citing
Pet. 48–54; Ex. 1008 ¶¶ 83, 108, 129–136). We are persuaded by
Petitioner’s argument that Thorsen discloses sorting (physically separating)
droplets and that it would have been obvious to use a micropipette to collect
and transfer the sorted droplets, as a “standard industry way” of moving
solutions containing multiple droplets from wells. Pet. 47–48, 57–58, 68–
69; Ex. 1008 ¶¶ 85, 106, 162; Pet. Reply 22–25; id. at 23 n.5 (citing
Ex. 2017, 42:21–43:4, 140:21–142:2).
We also find that Petitioner shows persuasively that Thorsen teaches
the remaining limitations of claim 1 in connection with either the incubation
chamber system or the serpentine channel system, both of which have outlet
wells. Thorsen’s incubation chamber system teaches the limitations of 1.1
(“a microchannel in a horizontal plane) and 1.2 (“at least one drople
formation module . . .”) for the same reasons as discussed in
Section II.E.1.a–c above.
In addition, we agree with Petitioner’s undisputed contentions that
Thorsen’s serpentine channel system has a microchannel (the serpentine
outlet channel) in a horizontal plane. Pet. 29–30 (citing Ex. 1003, 114–116,
Figs. 4.1, 4.2). We further agree that Thorsen uses a coverslip to cover the
channels of Thorsen’s microfluidic devices, and that because the glass
coverslip is placed horizontally, Thorsen’s microchannels, which are closed
by and parallel to the glass coverslip, are similarly horizontal and in a
horizontal plane. Id. (citing Ex. 1003, 96–97, 103, Figs. 3.28, 3.29, 4.2, 4.4,
4.5; Ex. 1006 ¶¶ 31, 100).
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We also agree with Petitioner’s contentions that the cross-flow
junction of Thorsen’s serpentine channel system satisfies the limitations of
claim element 1.2 for the same reasons set forth above. As described above,
we agree with Petitioner that Thorsen’s cross-flow junction teaches the
subject matter recited in claim elements 1.2 and that the cross-flow junction
is used in both Thorsen’s serpentine channel system and Thorsen’s
incubation chamber system.
Therefore, we find that Thorsen teaches or suggests all of the subject
matter recited in claim 1.
2. Claim 4
Claim 4 recites the “assembly of claim 1, wherein the at least one
droplet receiving outlet is located on the upper portion of the separation
chamber.” Petitioner asserts that Thorsen teaches the subject matter recited
in claim 4 for the same reasons described in connection with claim
limitations 1.3–1.7. Pet. 61.
We agree with Petitioner that Thorsen teaches the subject matter of
clam 4. For example, we agree that the top of Thorsen’s outlet wells, which
as described above is a droplet receiving outlet, is located on the upper
portion of the separation chamber (outlet well). Pet. 61. Thus, we find that
Thorsen teaches the subject matter recited in claim 4.
3. Claims 7 and 9
Claim 7 recites the “assembly of claim 1, wherein the droplet
receiving outlet is coupled to a vessel.” Claim 9 recites the “assembly of
claim 7, wherein the vessel is a PCR tube or a test tube.”
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Petitioner asserts that Thorsen renders obvious the additional
limitations of these dependent claims. Pet. 62–66 (citing Ex. 1008 ¶¶ 108,
130, 167–171).
Petitioner asserts that Thorsen’s outlet well (droplet receiving outlet)
is “coupled” to a vessel if the droplets can be moved from the outlet well to
a test tube strip or other vessel. Pet. 62–63 (citing Ex. 1026, 21–22).
Petitioner asserts that it would have been obvious to collect the sorted
droplets from the outlet wells for further use or additional processing. Id.
(citing Ex. 1008 ¶¶ 108, 169).
Patent Owner does not dispute that the transfer of droplets from the
outlet to a vessel using a pipette may constitute “coupling.” See, e.g., PO
Resp. 55–57. Rather, Patent Owner contends that Thorsen does not teach
the subject matter of claims 7 and 9 for the same reason a POSA would not
have been motivated to collect droplets using a micropipette. PO Resp. 55.
As noted above in Section II.F.1., we agree with Petitioner that it
would have been obvious to collect droplets from the top of Thorsen’s outlet
wells using a micropipette and transfer the droplets to another vessel, such as
a PCR or test tube. Thus, we agree that Petitioner has sufficiently shown
that Thorsen teaches or suggests the subject matter recited in claims 7 and 9.
4. Secondary Considerations
Patent Owner contends that secondary considerations, including long-
felt need, commercial success, praise, and acquiescence and licensing weigh
in favor of a finding of nonobviousness of the ’837 patent claims. PO
Resp. 57–63.
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a) Presumption of Nexus
Patent Owner asserts that its “ddPCR™ platform . . . practices the
’837 patent.” PO Resp. 57–58. As support for this assertion, Patent Owner
relies on a statement that “[t]he Bio-Rad Digital PCR Systems and/or their
use is covered by claims of U.S. patents,” including the ’837 patent and
eight other patents. Id. at 57 (citing Ex. 2018 (Patent Owner’s standard
terms and conditions of sale)). Patent Owner also asserts that “[t]he patented
features from the ‘837 patent are repeatedly referenced in Bio-Rad’s
instruction manuals and are critical to the Bio-Rad products’ workflows.”
Id. (citing Exs. 2010, 2011). Dr. Anna directs us to portions of these
manuals that instruct users how to transfer droplets out of the separation
chamber of a cartridge. Ex. 2016 ¶ 204 (citing Ex. 2010, 18; Ex. 2011, 18).
Based on these assertions, Patent Owner contends that “the secondary
considerations . . . related to Bio-Rad’s products have a direct nexus to the
claims of the ‘837 Patent.” PO Resp. 57.
“In order to accord substantial weight to secondary considerations in
an obviousness analysis, the evidence of secondary considerations must have
a nexus to the claims, i.e., there must be a legally and factually sufficient
connection between the evidence and the patented invention.” Fox Factory,
Inc. v. SRAM, LLC, 944 F.3d 1366, 1373 (Fed. Cir. 2019) (internal quotes
omitted); see also Lectrosonics, Inc. v. Zaxcom, Inc., Case IPR2018-01129,
Paper 33 at 32 (PTAB Jan. 24, 2020) (precedential) (“For objective indicia
of nonobviousness to be accorded substantial weight, its proponent must
establish a nexus between the evidence and the merits of the claimed
invention.”). There is a rebuttable presumption of nexus “when the patentee
shows that the asserted objective evidence is tied to a specific product and
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that product ‘embodies the claimed features, and is coextensive with them.’”
Fox Factory, 944 F.3d at 1373 (citations omitted); Lectrosonics, Paper 33
at 32.
Patent Owner does not present an analysis demonstrating that its
products are coextensive (or nearly coextensive) with the challenged claims
of the ’837 patent. At best, Dr. Anna directs us to instructions for
transferring droplets from outlet wells to a PCR plate. Ex. 2016 ¶ 204
(citing Ex. 2010, 18; Ex. 2011, 18). Even if these instructions were
sufficient to establish that Patent Owner’s products have a “separation
chamber” and a “droplet receiving outlet,” there are numerous other claim
limitations that are not addressed by Patent Owner’s evidence of nexus.
Although Patent Owner relies on its standard terms and conditions listing the
’837 patent among eight other patents (PO Resp. 57 (citing Ex. 2018)), a
simple patent listing is not enough to show coextensiveness or nexus.
Accordingly, Patent Owner has not shown that its products are
entitled to a presumption of nexus.
b) Patent Owner’s Acquisition of ’837 Patent
Patent Owner asserts that “Bio-Rad acquired RainDance and all of its
intellectual property in January 2017, including the ’837 patent,
demonstrating the value that has been placed on the protected features of the
’837 patent.” PO Resp. 57 (citing Ex. 2014 (press report titled, “Bio-Rad to
Acquire RainDance Technologies”)). Patent Owner does not present
arguments or evidence as to the value that was ascribed to the ’837 patent or
the technology covered by the challenged claims in the context of Patent
Owner’s acquisition of RainDance. Accordingly, we are not persuaded that
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Patent Owner has shown a nexus for this asserted secondary considerations
evidence.
c) Long-Felt Need
Patent Owner asserts that “RainDance’s patented droplet system,
which included features embodied in the ‘837 patent, fundamentally
enhances the way researchers and scientists study cell-based and cell-free
biomarkers in cancer, infectious disease, and inherited disorders.” PO
Resp. 58 (citing Ex. 2016 ¶ 205).
According to Patent Owner, its ddPCR™ platform was heralded as a
breakthrough that greatly advanced the capabilities of PCR and was rapidly
adopted in the industry and led to an explosion of research. PO Resp. 59
(citing Exs. 2001–2004). Based on this evidence, Patent Owner contends
that “[t]he inventions of the ‘837 patent fulfilled a long-term need for a
means of isolating sample from the surrounding environment for further
analysis using microfluidic droplets by means of the claimed separation
chamber.” Id. at 60.
“A finding that a presumption of nexus is inappropriate does not end
the inquiry into secondary considerations.” Fox Factory, 944 F.3d at 1375;
Lectrosonics, Paper 33 at 33. “To the contrary, the patent owner is still
afforded an opportunity to prove nexus by showing that the evidence of
secondary considerations is the ‘direct result of the unique characteristics of
the claimed invention.’” Fox Factory, 944 F.3d at 1373–74 (quoting In re
Huang, 100 F.3d 135, 140 (Fed. Cir. 1996)); Lectrosonics, Paper 33 at 33.
Patentee must show a “nexus to the merits of the claimed invention,”
meaning “some aspect of the claim not already in the prior art.”
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Lectrosonics, Paper 33 at 33 (quoting In re Kao, 639 F.3d 1057, 1068–69
(Fed. Cir. 2011)).
We determine that Patent Owner has not demonstrated a nexus
between the evidence relied upon to show long-felt need and the merits of
the claimed invention. Patent Owner asserts that the evidence touts its
ddPCR™ platform as “an easy-to-use alternative to the existing technology”
that enabled researchers to publish numerous studies and “to detect rare
targets with a level of precision that was just not possible with previous
technologies.” PO Resp. 55–56 (citing Exs. 2001–2004). Patent Owner
makes no attempt to show a nexus between the technology discussed in
Exhibits 2001 to 2004 and the features recited in the challenged claims of
the ’837 patent.
d) Commercial Success
Patent Owner contends that its products that embody the ’837 patent
have been a commercial success, with the inventions disclosed in the ’837
patent contributing to this success and representing “a significant
improvement on the prior art that greatly advanced the capability of PCR
and NGS [Next Generation Sequencing].” PO Resp. 60 (citing
Exs. 2006–2009; Ex. 2016 ¶ 210).
Patent Owner also contends that Petitioner’s “products embodying the
invention have been a commercial success.” PO Resp. 631 (citing and
quoting Ex. 2012 (discussing number of instruments sold in total and to “top
research institutions” and “global pharmaceutical companies” and associated
revenue increases as of December 31, 2018 and June 30, 2019)).
For the reasons discussed above, Patent Owner has not shown that its
products are entitled to a presumption of nexus. Nor has Patent Owner
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shown a nexus between the merits of the claimed invention and the evidence
relied upon to show commercial success of its products or Petitioner’s
products. Although Patent Owner relies on Exhibits 2005 to 2009 and 2012,
it does not show a nexus between this evidence and the unique features of
the challenged claims.
e) Praise by Others
Patent Owner asserts that its ddPCR™ products have received
“repeated accolades for their contributions to the field” and that its
“ddSEQ™ system has also received wide acclaim.” PO Resp. 62–63 (citing
Exs. 2005–2009). According to Patent Owner, “prior to its acquisition by
Bio-Rad, Raindance received praise from the industry for its own systems
that incorporated the patented features of the ‘837 patent.” Id. at 62 (citing
Ex. 2016 ¶ 216). Petitioner asserts that both Patent Owner’s and Petitioner’s
products “have received praise because of their turn-key, easy-to-use
workflows.” Id. at 63 (citing Ex. 2013).
For the reasons discussed above, Patent Owner has not shown that its
products are entitled to a presumption of nexus. Nor has Patent Owner
shown a nexus between the merits of the claimed invention and the evidence
relied upon to show industry praise of Patent Owner’s products,
RainDance’s products, or Petitioner’s products. Although Patent Owner
relies on Exhibits 2005–2009, 2013, and 2023–2026, it does not show a
nexus between this evidence and the unique features of the challenged
claims. Furthermore, although Patent Owner discusses advantages of the
patented inventions (PO Resp. 62–63), Patent Owner does not show that
these advantages are the reasons Patent Owner’s and Petitioner’s products
have received praise. Nor does Patent Owner show that the evidence of
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industry praise or other asserted secondary considerations is tied to the novel
features of the claimed invention or the claimed combination as a whole.
WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1331 (Fed. Cir. 2016);
Lectrosonics, Paper 33 at 33.
5. Conclusion
As discussed above, we find that Thorsen teaches or suggests the
subject matter of claims 1, 4, 7, and 9. We have considered all of Patent
Owner’s evidence of nonobviousness and find it unpersuasive. Accordingly,
we balance Petitioner’s strong evidence of obviousness against Patent
Owner’s alleged objective evidence of nonobviousness, we determine that a
preponderance of the evidence supports Petitioner’s position that claims 1, 4,
7, and 9 are unpatentable under 35 U.S.C. § 103 over Thorsen.
G. Asserted Obviousness of Claims 1, 2, 4, 7–13, 19 over Thorsen
and the Ismagilov References.
Petitioner contends claims 1, 2, 4, 7–13, 19 would have been obvious
over the combined teachings of (1) Thorsen 092 and Ismagilov 119 alone,
which incorporates Ismagilov 091 by reference, or over the combined
teachings of (2) Thorsen, Ismagilov 119 and Ismagilov 091. See, e.g., Pet.
19–20.
Having already determined that Petitioner establishes by a
preponderance of the evidence that claims 1, 2, 4, 7, 9–13, 19 are
unpatentable, we do not address Petitioner’s additional grounds challenging
these claims over the combined teachings of Thorsen, Ismagilov 119 or over
Thorsen, Ismaagilov 119, and Ismagilov 091.
For the reasons below, we find that Petitioner has not established by a
preponderance of the evidence that claim 8 would have been obvious over
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combined teachings of (1) Thorsen 092 and Ismagilov 119 alone, which
incorporates Ismagilov 091 by reference, or over the combined teachings of
(2) Thorsen, Ismagilov 119 and Ismagilov 091.
1. Claim 8
Claim 8 recites the “assembly of claim 7, wherein the droplet
receiving outlet is sealably coupled to a vessel.” Petitioner asserts claim 8 is
unpatentable over either Thorsen and Ismagilov 119 over Thorsen,
Ismagilov 119 and Ismagilov 091. Pet. 65–66. In particular, Petitioner
asserts that it would have been obvious to modify Thorsen’s outlet wells so
that they are adapted for receiving a standard 1.5 ml centrifuge tube in view
of the teachings of Ismagilov 091. Pet. 66 (citing Ex. 1004, 17:27–29).
Petitioner also asserts that it would have been obvious that a vessel, such as
centrifuge tube, could be substituted in place of an outlet well and thus such
substitution is nothing more than combining known element according to
known methods to yield predicable results. Pet. 63 (citing Ex. 1008 ¶ 170).
Petitioner further asserts that an outlet that has been adapted to receive a
centrifuge tube would seal the tube, or that it would have been obvious to do
so. Pet. 66 (citing Ex. 1008 ¶¶ 174–175; Ex. 1005 ¶¶ 32–34, 191–195).
We determine that Petitioner’s contentions are insufficient to show
that claim 8 would have been obvious over Thorsen in combination with the
Ismagilov references. Petitioner relies upon Thorsen’s outlet well for
teaching the separation chamber having a droplet receiving outlet. Petitioner
does not provide any evidence or argument, however, as to how the
modified devices, in which a centrifuge tube replaces the outlet well, or the
outlet well is adapted to receive a centrifuge tube, would satisfy the
separation chamber or droplet receiving outlet limitations of claim 1.
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Therefore, Petitioner has not sufficiently shown that the combination of
Thorsen and the Ismagilov references would have rendered obvious the
subject matter of clam 8 and, thus, has not shown by a preponderance of the
evidence that claim 8 is unpatentable over either Thorsen and Ismagilov 119
or over Thorsen, Ismagilov 119 and Ismagilov 091.
III. CONCLUSION8
For the foregoing reasons, we determine that Petitioner has shown by
a preponderance of the evidence that claims 1–2, 4, 7, 9–13, and 19 are
unpatentable but has not shown that claim 8 is unpatentable.

IV. ORDER
In consideration of the foregoing, it is hereby:
ORDERED that claims 1–2, 4, 7, 9–13, and 19 of U.S. Patent No.
9,562,837 B2 have been shown to be unpatentable;
ORDERED that claim 8 of U.S. Patent No. 9,562,837 B2 has not been
shown to be unpatentable; and
FURTHER ORDERED that, because this is a final written decision,
parties to this proceeding seeking judicial review of the decision must
comply with the notice and service requirements of 37 C.F.R. § 90.2.

8 Should Patent Owner wish to pursue amendment of the challenged claims
in a reissue or reexamination proceeding subsequent to the issuance of this
decision, we draw Patent Owner’s attention to the April 2019 Notice
Regarding Options for Amendments by Patent Owner Through Reissue or
Reexamination During a Pending AIA Trial Proceeding. See 84 Fed. Reg.
16,654 (Apr. 22, 2019). If Patent Owner chooses to file a reissue application
or a request for reexamination of the challenged patent, we remind Patent
Owner of its continuing obligation to notify the Board of any such related
matters in updated mandatory notices. See 37 C.F.R. § 42.8(a)(3), (b)(2).
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In summary:

9 As noted above, we do not reach Petitioner’s challenge of claim 4 as
anticipated under § 102 by Thorsen.
10 As noted above, we do not reach Petitioner’s challenge of claims 2, 3, 10–
13, and 19 as unpatentable under § 103 over Thorsen.
11 As noted above, we do not reach Petitioner’s challenge of claims 1–2, 4, 7,
9–13, 19 as unpatentable over the combined teachings of Thorsen and
Ismagilov 119.
12 As noted above, we do not reach Petitioner’s challenge of claims 1–2, 4, 7,
9–13, 19 as unpatentable over Thorsen, Ismagilov 119, and Ismagilov 091.
Claims
35
U.S.
C. §
Reference(s)/Basis
Claims
Shown
Unpatent
able
Claims
Not shown
Unpatentable
1–4, 10–13, 19 102 Thorsen9 1–3, 10–13, 19

1–4, 7, 9–13, 19 103 Thorsen10 1, 4, 7, 9
1–2, 4, 7–13, 19 103 Thorsen, Ismagilov 11911
8
1–2, 4, 7–13, 19 103
Thorsen,
Ismagilov 119,
Ismagilov 09112
8
Overall Outcome 1–2, 4, 7,
9–13, 19
8
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FOR PETITIONER:
Samantha Jameson
Gina Cremona
Matthew D. Powers
Azra Hadzimehmedovic
Robert L. Gerrity
TENSEGRITY LAW GROUP LLP
samantha.jameson@tensegritylawgroup.com
gina.cremona@tensegritylawgroup.com
matthew.powers@tensegritylawgroup.com
azra@tensegritylawgroup.com
robert.gerrity@tensegritylawgroup.com
FOR PATENT OWNER:
David Bilsker
Kevin Johnson
Anne Toker
QUINN EMANUEL URQUHART & SULLIVAN LLP
davidbilsker@quinnemanuel.com
kevinjohnson@quinnemanuel.com
annetoker@quinnemanuel.com