Monday, November 01, 2021

Qiagen loses PCR case at the CAFC

Aiagen lost its appeal at the CAFC

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.

The tecnology

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.”

Of evidentiary issues

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).


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 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

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)).


Post a Comment

<< Home