NOTE: This disposition is nonprecedential.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 appellants. Appellant Qiagen North American Holdings, Inc. 

also represented by GARY J. SPEIER, J. DEREK 

VANDENBURGH.

 

 JAMES K. CLELAND, Dickinson Wright PLLC, Ann Arbor, MI, for appellant NeuMoDx Molecular, Inc. 

Case: 20-2249 Document: 54 Page: 1 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 represented 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 Holdings”) and NeuMoDx Molecular, Inc. (“NeuMoDx”) (collectively, “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 Molecular, Inc. v. HandyLab, Inc., No. IPR2019-01494 (P.T.A.B. 

July 14, 2020). This appeal focuses specifically on the challenged independent claims of the two patents. For the reasons 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 microfluidic devices for detection of nucleotides in biological 

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samples. ’708 Patent Abstract.1 These microfluidic devices 

“carry out PCR on nucleotides of interest within microfluidic 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 plurality of samples independently of one another.” Id. col. 2 

ll. 28–30; see also id. Abstract.

Independent Claim 1 of the ’708 Patent is representative and is reproduced below: 

1. An apparatus, comprising:

a multi-lane microfluidic cartridge, each lane comprising a PCR reaction zone;

a receiving bay configured to receive the microfluidic 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 sample in the PCR reaction zone;

a detector configured to detect the presence of an 

amplification product in the respective PCR reaction 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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’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 receiving bays.” ’900 Patent col. 46 ll. 4–20.

The cartridge used in these devices is a “multi-lane microfluidic cartridge,” which contains multiple sample lanes 

and “is configured to accept a number of samples in series 

or in parallel, simultaneously or consecutively.” ’708 Patent col. 13 ll. 21–23; see also id. col. 13 ll. 34–36. The specification 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, according to methods described herein as well as others 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. Patent 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 “multichamber thermal cycler chip,” where each chamber is thermally isolated. Id. col. 8 ll. 46–63; see also id. col. 2 ll. 49–

60. In one embodiment, “unprocessed fluid is stored in common 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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challenged claims of the ’708 and ’900 Patents are unpatentable for obviousness. The Board instituted review 

and consolidated the IPRs by patent.2 Relevant to this appeal, 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 Publication No. 2004/0151629 to Grant Pease, et al. (“Pease”) 

and that the challenged independent claims of the ’900 Patent 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’ arguments, 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 demonstrate by a preponderance of the evidence that the challenged 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 microfluidic cartridges” to mean “microfluidic cartridges each 

comprising a plurality of sample lanes with separate sample inlets and microfluidic networks.” J.A. 59.

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The Board had two independent bases for its conclusion. First, it concluded that “Zou I does not teach a multilane microfluidic unit under the proper claim construction” 

because the reference taught “that all of the lanes are associated with a single sample inlet, namely, common reservoir 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 reasonable 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 microfluidic PCR devices was “a very complex endeavor that presented challenges” on numerous fronts. J.A. 37, 81. The 

Board also declined to consider Qiagen’s Exhibit 1030 because “Petitioner did not submit [it] with the Petition.” J.A. 

37, 80. This appeal followed.

DISCUSSION

Qiagen challenges three aspects of the Board’s decision: (1) the Board’s construction of “multi-lane microfluidic 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 demonstrate 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 reasonable expectation of success. For the reasons below, we 

find that substantial evidence supports the Board’s finding 

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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 declining 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 Exhibit 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 erroneous 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 decision.” 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 replystage filings:

First, they generally require a petitioner to provide 

in the petition itself an understandable explanation of the element-by-element specifics of its unpatentability 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, 

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8 QIAGEN NORTH AMERICAN HOLDINGS v. HANDYLAB, INC.

including” copies of “printed publications that the petitioner relies upon in support of the petition.”

35 U.S.C. § 312(a)(3); see also 37 C.F.R. § 42.22(a)(2) (requiring “[a] full statement of the reasons for the relief requested, 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 Petitions 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 machine,” 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 proceedings, ‘[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 supports 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/documents/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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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 permissible reply evidence and that the Board abused its discretion 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 microfluidic chips with cartridges was unpredictable”; rather, 

the portion of HandyLab’s Response Qiagen sought to rebut 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 accommodate a PCR chip and, further, that Qiagen “d[id] not identify a general teaching from either reference that would 

have applied to Zou I’s chip.” J.A. 2263–64 (HandyLab Response). 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 obviousness challenge was “insufficiently precise and underdeveloped” where the petitioner “did not make out its 

obviousness case in its petition,” which “offered only a conclusory and sweeping allegation,” while the reply argued 

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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 argument 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 material that fairly adds confirmation that the initially presented 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 excluding Exhibit 1030, our analysis on reasonable expectation 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 question of fact that we review for substantial evidence. Intelligent 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 finding.” 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 reasonably have expected to be successful in combining Zou I’s 

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microfluidic chip with a cartridge as taught by NcNeely or 

Pease” or Pourahmadi. J.A. 35, 79. In arriving at its conclusion, 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 reasonable 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 integrated 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 further 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 success.” 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, contamination, design and configuration of a microfluidic network, 

and functionally interfacing the reaction instrument with 

control machinery.” J.A. 37, 81. In arriving at this conclusion, 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 detail 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 testimony that a skilled artisan would expect to combine Zou I’s 

unit “virtually unaltered” into a cartridge system “to be 

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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 testimony. J.A. 38–39, 82. Qiagen provides no basis for overruling the Board’s credibility determinations, and, based on 

the record before us, substantial evidence supports the 

Board’s conclusion regarding the complexity and challenges 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 cartridge,” 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, detecting small volumes of products, and interfacing the reaction 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 regarding 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 preponderance 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

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