Qiagen North American Holdings v. Handylab, Inc. ( 2021 )

Case: 20-2249 Document: 54 Page: 1 Filed: 10/29/2021
NOTE: This disposition is nonprecedential.
United States Court of Appeals
for the Federal Circuit
______________________
QIAGEN NORTH AMERICAN HOLDINGS, INC.,
NEUMODX MOLECULAR, INC.,
Appellants
v.
HANDYLAB, INC.,
Appellee
______________________
2020-2249, 2020-2250, 2020-2273, 2020-2276
______________________
Appeals from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in Nos. IPR2019-
00488, IPR2019-00490, IPR2019-01493, IPR2019-01494.
______________________
Decided: October 29, 2021
______________________
PETER M. KOHLHEPP, Carlson, Caspers, Vandenburgh
& Lindquist PA, Minneapolis, MN, argued for all appel-
lants. Appellant Qiagen North American Holdings, Inc.
also represented by GARY J. SPEIER, J. DEREK
VANDENBURGH.
JAMES K. CLELAND, Dickinson Wright PLLC, Ann Ar-
bor, MI, for appellant NeuMoDx Molecular, Inc.
Case: 20-2249 Document: 54 Page: 2 Filed: 10/29/2021
2 QIAGEN NORTH AMERICAN HOLDINGS v. HANDYLAB, INC.
THOMAS SAUNDERS, Wilmer Cutler Pickering Hale and
Dorr LLP, Washington, DC, argued for appellee. Also rep-
resented by HEATHER M. PETRUZZI; OMAR KHAN, New York,
NY; KATHERINE P. KIECKHAFER, Boston, MA.
______________________
Before TARANTO, CLEVENGER, and CHEN, Circuit Judges.
CLEVENGER, Circuit Judge.
Qiagen North American Holdings, Inc. (“Qiagen Hold-
ings”) and NeuMoDx Molecular, Inc. (“NeuMoDx”) (collec-
tively, “Qiagen”) appeal from the Final Written Decisions
of the Patent Trial and Appeal Board (“Board”) holding
that the challenged claims of U.S. Patent No. 7,998,708(“the ’708 Patent”) and U.S. Patent No. 8,323,900 (“the ’900
Patent”) would have been non-obvious. See Qiagen N. Am.
Holdings, Inc. v. HandyLab, Inc., No. IPR2019-00488
(P.T.A.B. July 14, 2020); NeuMoDx Molecular, Inc. v.
HandyLab, Inc., No. IPR2019-01493 (P.T.A.B. July 14,
2020); Qiagen N. Am. Holdings, Inc. v. HandyLab, Inc., No.
IPR2019-00490 (P.T.A.B. July 14, 2020); NeuMoDx Molec-
ular, Inc. v. HandyLab, Inc., No. IPR2019-01494 (P.T.A.B.
July 14, 2020). This appeal focuses specifically on the chal-
lenged independent claims of the two patents. For the rea-
sons set forth below, we affirm.
BACKGROUND
I
HandyLab, Inc. (“HandyLab”) owns the ’708 and ’900
Patents, which are both entitled “Microfluidic System for
Amplifying and Detecting Polynucleotides in Parallel.” The
’900 Patent is a continuation of the ’708 Patent, and the
two share a common specification. Both relate to microflu-
idic devices for detection of nucleotides in biological
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QIAGEN NORTH AMERICAN HOLDINGS v. HANDYLAB, INC. 3
samples. ’708 Patent Abstract. 1 These microfluidic devices
“carry out PCR on nucleotides of interest within microflu-
idic channels, and detect those nucleotides.” Id. col. 2
ll. 10–14. The PCR reactions, which occur on a microfluidic
cartridge, can be performed on a plurality of samples, as
the microfluidic cartridge “has a plurality of PCR reaction
chambers configured to permit thermal cycling of the plu-
rality of samples independently of one another.” Id. col. 2
ll. 28–30; see also id. Abstract.
Independent Claim 1 of the ’708 Patent is representa-
tive and is reproduced below:
1. An apparatus, comprising:
a multi-lane microfluidic cartridge, each lane com-
prising a PCR reaction zone;
a receiving bay configured to receive the microflu-
idic cartridge;
each PCR reaction zone comprising a separately
controllable heat source thermally coupled thereto,
wherein the heat source maintains a substantially
uniform temperature throughout the PCR reaction
zone and thermal cycles the PCR reaction zone to
carry out PCR on a polynucleotide-containing sam-
ple in the PCR reaction zone;
a detector configured to detect the presence of an
amplification product in the respective PCR reac-
tion zone; and
a processor coupled to the detector and the heat
source, configured to control heating of one or more
PCR reaction zones by the heat sources.
1 Citations to the common specification are to the
’708 Patent.
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4 QIAGEN NORTH AMERICAN HOLDINGS v. HANDYLAB, INC.
’708 Patent col. 46 ll. 5–22. The independent claims of the
’900 Patent track those of the ’708 Patent, with the main
difference being that the former recites “a plurality of
multi-lane microfluidic cartridges” and “a plurality of re-
ceiving bays.” ’900 Patent col. 46 ll. 4–20.
The cartridge used in these devices is a “multi-lane mi-
crofluidic cartridge,” which contains multiple sample lanes
and “is configured to accept a number of samples in series
or in parallel, simultaneously or consecutively.” ’708 Pa-
tent col. 13 ll. 21–23; see also id. col. 13 ll. 34–36. The spec-
ification sets forth the structure of the sample lane:
A sample lane is an independently controllable set
of elements by which a sample can be analyzed, ac-
cording to methods described herein as well as oth-
ers known in the art. A sample lane comprises at
least a sample inlet, and a microfluidic network
having one or more microfluidic components, as
further described herein.
Id. col. 12 l. 66–col. 13 l. 4.
The main prior art reference at issue here is U.S. Pa-
tent No. 6,509,186 to Quanbo Zou, et al. (“Zou I”), which
discloses “a thermal cycler which permits simultaneous
treatment of multiple individual samples in independent
thermal protocols, so as to implement large numbers of
DNA experiments simultaneously in a short time.” Zou I
Abstract. Specifically, Zou I discloses a standalone “multi-
chamber thermal cycler chip,” where each chamber is ther-
mally isolated. Id. col. 8 ll. 46–63; see also id. col. 2 ll. 49–
60. In one embodiment, “unprocessed fluid is stored in com-
mon reservoir 7 and is directed to chamber 11 through
fluid-bearing channel 31.” Id. col. 4 ll. 30–32.
II
Qiagen Holdings and NeuMoDx each filed petitions for
inter partes review of claims 1–33 of the ’708 Patent and
claims 1–22 of the ’900 Patent, asserting that the
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QIAGEN NORTH AMERICAN HOLDINGS v. HANDYLAB, INC. 5
challenged claims of the ’708 and ’900 Patents are un-
patentable for obviousness. The Board instituted review
and consolidated the IPRs by patent. 2 Relevant to this ap-
peal, Qiagen argued that the challenged independent
claims of the ’708 Patent would have been obvious in view
of Zou I and U.S. Patent Publication No. 2004/0037739 A1
to Michael McNeely, et al. (“McNeely”) or U.S. Patent Pub-
lication No. 2004/0151629 to Grant Pease, et al. (“Pease”)
and that the challenged independent claims of the ’900 Pa-
tent would have been obvious in view of Zou I and McNeely
or U.S. Patent Publication No. 2002/0055,167 to Farzad
Pourahmadi, et al. (“Pourahmadi”). The parties’ argu-
ments, and the Board’s Final Written Decision, largely
track across the two consolidated IPRs, so we discuss them
together below.
In its Final Written Decision for IPR2019-00488, the
Board construed the claim term “multi-lane microfluidic
cartridge” to mean “a microfluidic cartridge comprising a
plurality of sample lanes, each sample lane comprising a
separate sample inlet and microfluidic network.” J.A. 17. 3
Turning to the merits of Qiagen’s obviousness argument,
the Board then determined that Qiagen failed to demon-
strate by a preponderance of the evidence that the chal-
lenged independent claims were obvious over the
combination of Zou I and McNeely, Pease, or Pourahmadi.
J.A. 39–40, 83.
2 IPR2019-01493 was consolidated with IPR2019-
00488, and IPR2019-01494 was consolidated with
IPR2019-00490.
3 In its Final Written Decision for IPR2019-00490,
the Board likewise construed the term “multi-lane micro-
fluidic cartridges” to mean “microfluidic cartridges each
comprising a plurality of sample lanes with separate sam-
ple inlets and microfluidic networks.” J.A. 59.
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6 QIAGEN NORTH AMERICAN HOLDINGS v. HANDYLAB, INC.
The Board had two independent bases for its conclu-
sion. First, it concluded that “Zou I does not teach a multi-
lane microfluidic unit under the proper claim construction”
because the reference taught “that all of the lanes are as-
sociated with a single sample inlet, namely, common reser-
voir 7.” J.A. 28, 70. The Board further concluded that this
deficiency in Zou I was not remedied by any of the other
three references. J.A. 32, 75. Second, the Board held that
Qiagen failed to demonstrate that a POSA would have been
motivated to combine the prior art references with a rea-
sonable expectation of success in doing so. J.A. 39, 83. In
particular, the Board noted that Qiagen’s Petitions offered
only a single conclusory statement regarding the POSA’s
alleged reasonable expectation of success and that Qiagen’s
expert offered only conclusory statements on this issue.
J.A. 36, 38, 80, 82. In contrast, the Board viewed
HandyLab’s evidence, including the testimony of its expert,
as credibly demonstrating that the development of micro-
fluidic PCR devices was “a very complex endeavor that pre-
sented challenges” on numerous fronts. J.A. 37, 81. The
Board also declined to consider Qiagen’s Exhibit 1030 be-
cause “Petitioner did not submit [it] with the Petition.” J.A.
37, 80. This appeal followed.
DISCUSSION
Qiagen challenges three aspects of the Board’s deci-
sion: (1) the Board’s construction of “multi-lane microflu-
idic cartridge,” (2) the Board’s determination that Zou I
failed to disclose a “multi-lane” microfluidic cartridge, and
(3) the Board’s determination that Qiagen failed to demon-
strate motivation to combine with a reasonable expectation
of success. We have jurisdiction to decide the appeal under
28 U.S.C. § 1295(a)(4)(A).
Our analysis begins with the Board’s decision on rea-
sonable expectation of success. For the reasons below, we
find that substantial evidence supports the Board’s finding
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QIAGEN NORTH AMERICAN HOLDINGS v. HANDYLAB, INC. 7
of no reasonable expectation of success, and thus we affirm
without reaching the other issues raised on appeal.
I
Because Qiagen contends that the Board erred in de-
clining to consider Exhibit 1030, our review of the Board’s
finding of no reasonable expectation of success begins with
the scope of the evidence considered by the Board.
We review the Board’s evidentiary rulings for abuse of
discretion, VidStream LLC v. Twitter, Inc., 981 F.3d 1060,
1064 (Fed. Cir. 2020), and we disagree with Qiagen that
the Board abused its discretion in declining to consider Ex-
hibit 1030. Per the standard, we only disturb the Board’s
evidentiary rulings if the Board’s decision: “(1) is clearly
unreasonable, arbitrary, or fanciful; (2) is based on an er-
roneous conclusion of law; (3) rests on clearly erroneous
fact findings; or (4) follows from a record that contains no
evidence on which the Board could rationally base its deci-
sion.” Id. (quoting Shu-Hui Chen v. Bouchard, 347 F.3d
1299, 1307 (Fed. Cir. 2003)).
The statutes and regulations governing IPRs set forth
the required contents of petition-stage filings and of reply-
stage filings:
First, they generally require a petitioner to provide
in the petition itself an understandable explana-
tion of the element-by-element specifics of its un-
patentability contentions, identifying supporting
parts of the relied-on prior art. Second, reinforcing
that requirement for what must be in the petition
is a regulatory limit on permissible reply material.
AMC Multi-Cinema, Inc. v. Fall Line Pats., LLC, No. 2021-
1051, 2021 WL 4470062, at *5 (Fed. Cir. Sept. 30, 2021)
(internal citations omitted; emphasis in original).
Relevant here, a petition must set forth “the evidence
that supports the grounds for the challenge to each claim,
Case: 20-2249 Document: 54 Page: 8 Filed: 10/29/2021
8 QIAGEN NORTH AMERICAN HOLDINGS v. HANDYLAB, INC.
including” copies of “printed publications that the peti-
tioner relies upon in support of the petition.”
35 U.S.C. § 312(a)(3); see also 37 C.F.R. § 42.22(a)(2) (re-
quiring “[a] full statement of the reasons for the relief re-
quested, including a detailed explanation of the
significance of the evidence including material facts, and
the governing law, rules, and precedent”); 37 C.F.R.
§ 42.104(b)(5) (stating that a petition must set forth “[t]he
exhibit number of the supporting evidence relied upon to
support the challenge and the relevance of the evidence to
the challenge raised, including identifying specific portions
of the evidence that support the challenge”).
Qiagen could have submitted Exhibit 1030 in its Peti-
tions to support its contention that a skilled artisan would
have had “a high expectation of success” in combining the
PCR unit of Zou I with “a conventional integrated ma-
chine,” but it did not. J.A. 435–36. As Qiagen tacitly
acknowledged, its Petitions did not address the general
state of the art of the relevant field. See J.A. 4962 (Qiagen
Reply, stating that “[t]he Petition did not need to address
in granular detail each purported general ‘challenge’ in the
field”); J.A. 4998 (same). In this case, the Board acted
within its discretion in disregarding Exhibit 1030, and we
see no reason to overturn its decision. See Henny Penny
Corp. v. Frymaster LLC, 938 F.3d 1324, 1330 (Fed. Cir.
2019) (“Because of the expedited nature of IPR proceed-
ings, ‘[i]t is of the utmost importance that petitioners in the
IPR proceedings adhere to the requirement that the initial
petition identify with particularity the evidence that sup-
ports the grounds for the challenge to each claim.’” (quoting
Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821
F.3d 1359, 1369 (Fed. Cir. 2016))); see also USPTO, PTAB
Consolidated Patent Trial Practice Guide (Nov. 21, 2019),
available at https://www.uspto.gov/sites/default/files/docu-
ments/tpgnov.pdf, at 73 (“Petitioner may not submit new
evidence or argument in reply that it could have presented
earlier, e.g.[,] to make out a prima facie case of
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QIAGEN NORTH AMERICAN HOLDINGS v. HANDYLAB, INC. 9
unpatentability.”); id. at 74 (“While replies and sur-replies
can help crystalize issues for decision, a reply or sur-reply
that raises a new issue or belatedly presents evidence may
not be considered.”).
Qiagen contends that Exhibit 1030 constitutes permis-
sible reply evidence and that the Board abused its discre-
tion by excluding it. We disagree that the Board erred.
Qiagen did not use Exhibit 1030, as it claims, to rebut a
general argument from HandyLab “that interfacing micro-
fluidic chips with cartridges was unpredictable”; rather,
the portion of HandyLab’s Response Qiagen sought to re-
but was specific to McNeely and Pease. See J.A. 4962–63
(Qiagen Reply); J.A. 2263–64 (HandyLab Response). In
particular, HandyLab argued that neither McNeely nor
Pease suggest that the disclosed cartridges can accommo-
date a PCR chip and, further, that Qiagen “d[id] not iden-
tify a general teaching from either reference that would
have applied to Zou I’s chip.” J.A. 2263–64 (HandyLab Re-
sponse). In its Reply, Qiagen specifically discussed
McNeely and Pease, then cited new evidence (Exhibit 1030)
to argue much more broadly that “using a microfluidic PCR
chip like Zou I with a cartridge was routine and predictable
by March 2006.” J.A. 4963 (Qiagen Reply). But “[a] reply
may only respond to arguments raised in the corresponding
opposition, patent owner preliminary response, patent
owner response, or decision on institution.”
37 C.F.R. § 42.23.
We have “applied those rules [governing filing content
in IPRs] in a number of decisions that restrict use of certain
reply material in forming the record.” AMC, 2021 WL
4470062, at *6 (collecting cases); see also Wasica Fin.
GmbH v. Cont’l Auto. Sys., Inc., 853 F.3d 1272, 1285–87
(Fed. Cir. 2017) (affirming Board’s ruling that an obvious-
ness challenge was “insufficiently precise and underdevel-
oped” where the petitioner “did not make out its
obviousness case in its petition,” which “offered only a con-
clusory and sweeping allegation,” while the reply argued
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10 QIAGEN NORTH AMERICAN HOLDINGS v. HANDYLAB, INC.
that a relevant artisan would have looked to a different
passage and would have modified the prior art). The Board
reasonably concluded that this case presents no exception.
This is not an instance where the later-submitted material
(Exhibit 1030) can be tied to a non-conclusory assertion in
the original Petition: As noted above, Exhibit 1030 was
only submitted with Qiagen’s Reply, not with the original
Petition, and Qiagen’s Petition did not include any argu-
ment or evidence that using a microfluidic PCR chip with
a cartridge was routine and predictable as of the priority
date. Cf. AMC, 2021 WL 4470062, at *6 (“[W]e have made
clear that if the petition asserts that a claim requirement
is met, provides a reason that the assertion is true, and
cites evidentiary support for that reason, then reply mate-
rial that fairly adds confirmation that the initially pre-
sented material does in fact support the assertion is not
prohibited new material, but a proper part of the record.”
(collecting cases)).
Because the Board did not abuse its discretion by ex-
cluding Exhibit 1030, our analysis on reasonable expecta-
tion of success centers on the evidence considered by the
Board—primarily, the testimony of the parties’ experts.
II
Whether a skilled artisan would have had a reasonable
expectation of success in combining the prior art is a ques-
tion of fact that we review for substantial evidence. Intelli-
gent Bio-Sys., 821 F.3d at 1366. A factual finding is
supported by substantial evidence “if a reasonable mind
might accept the evidence as sufficient to support the find-
ing.” HP Inc. v. MPHJ Tech. Invs., LLC, 817 F.3d 1339,
1343–44 (Fed. Cir. 2016) (citing Consol. Edison Co. v.
NLRB, 305 U.S. 197, 229 (1938)).
The Board concluded, after “[h]aving considered the
complete trial record,” that Qiagen “failed to establish by a
preponderance of the evidence that a POSA would reason-
ably have expected to be successful in combining Zou I’s
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QIAGEN NORTH AMERICAN HOLDINGS v. HANDYLAB, INC. 11
microfluidic chip with a cartridge as taught by NcNeely or
Pease” or Pourahmadi. J.A. 35, 79. In arriving at its con-
clusion, the Board reviewed the parties’ submissions as
well as testimony by their experts. The Board found that
Qiagen’s Petitions contained only “a single reference to rea-
sonable expectation of success, in a conclusory statement
that ‘a POSA would have been motivated to combine the
multiplexing PCR unit of Zou I with a conventional inte-
grated machine such as in McNeely or Pease’” or
Pourahmadi, “‘with a high expectation of success.’” J.A. 36,
80; see also J.A. 435–36 (Qiagen Petition). The Board fur-
ther found the declaration of Qiagen’s expert, Dr. Bruce
Gale, to be “similarly conclusory as to how Zou I and
McNeely or Pease” or Pourahmadi “could be combined” and
that it “does not elaborate on reasonable expectation of suc-
cess.” J.A. 36, 80; see also J.A. 558–65 (Gale Decl., ¶¶ 117–
27). Substantial evidence supports these findings.
Moreover, the Board agreed with HandyLab that “the
development of microfluidic PCR devices was not routine
and predictable by March 2006, but rather a very complex
endeavor that presented challenges with regard to uniform
heating, detection of small volume reactions, contamina-
tion, design and configuration of a microfluidic network,
and functionally interfacing the reaction instrument with
control machinery.” J.A. 37, 81. In arriving at this conclu-
sion, the Board expressly credited the declaration of
HandyLab’s expert, Dr. Allen Northrup, in which Dr.
Northrup “provide[d] factual support . . . with reference to
numerous contemporaneous publications in the field.” J.A.
37; see also J.A. 81. Indeed, Dr. Northrup discussed in de-
tail the “host of specific technical difficulties” presented by
the development of microfluidic PCR devices, including the
particular challenges identified above. J.A. 3499–505
(Northrup Decl., ¶¶ 33–42); J.A. 3790–98 (Northrup Decl.,
¶¶ 771–86). In contrast, the Board viewed Dr. Gale’s testi-
mony that a skilled artisan would expect to combine Zou I’s
unit “virtually unaltered” into a cartridge system “to be
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12 QIAGEN NORTH AMERICAN HOLDINGS v. HANDYLAB, INC.
conclusory and not supported by the evidence of record.”
J.A. 38, 82. The Board further noted that this testimony
was “inconsistent” with other portions of Dr. Gale’s testi-
mony. J.A. 38–39, 82. Qiagen provides no basis for overrul-
ing the Board’s credibility determinations, and, based on
the record before us, substantial evidence supports the
Board’s conclusion regarding the complexity and chal-
lenges in developing microfluidic PCR devices.
Qiagen argues that the Board’s findings with respect to
the challenges presented by “contamination” and “design
and configuration of a microfluidic network” are predicated
on the Board’s reading of Zou I, which is in turn predicated
on the Board’s construction of “multi-lane microfluidic car-
tridge,” with which Qiagen disagrees. Even if we were to
agree with Qiagen on these two points, they are insufficient
to overcome the substantial evidence standard in light of
the evidence considered by the Board—including evidence
regarding the challenges of providing uniform heating, de-
tecting small volumes of products, and interfacing the re-
action instrument with control machinery. J.A. 3499–501,
3503–05, 3790–98 (Northrup Decl., ¶¶ 34–36, 39–42, 771–
86). Further, some of this evidence was unrefuted; the
Board additionally found that Dr. Gale “d[id] not address
the evidence supporting Dr. Northrup’s testimony regard-
ing the complexities of connecting PCR microfluidic chips
to heat sources or detection mechanisms.” J.A. 39; see also
J.A. 83.
CONCLUSION
For the reasons stated above, we affirm the Board’s
conclusion that Qiagen failed to demonstrate by a prepon-
derance of the evidence that the challenged independent
claims of the ’708 and ’900 Patents are unpatentable for
obviousness in view of Zou I and McNeely, Pease, or
Pourahmadi.
AFFIRMED