Court Opinion

ID: 5132258
Source: CourtListenerOpinion
Date Created: 2021-12-07 00:02:23.158028+00
Date Added: 2024-06-11T08:23:29.066249
License: Public Domain

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        NOTE: This disposition is nonprecedential.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,
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 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