The inter partes review (IPR) provisions of the Leahy-Smith America Invents Act have been castigated by many for the propensity of the Patent Trial and Appeal Board (PTAB) to find claims challenged in these proceedings to be anticipated or obvious (albeit this outcome has been less frequent for technologies in chemical and life sciences patents).  Perhaps one reason for this less predictable negative outcome in these technologies is the countervailing (to some extent) deference the Federal Circuit has been compelled to give Patent and Trademark Office decisions on factual questions (see Dickinson v. Zurko), and the reliance of anticipation and obviousness rejections on the facts adduced by the parties in IPRs.  These considerations came into play recently in the Federal Circuit's non-precedential opinion in Qiagen North America Holdings Inc. v. Handylab, Inc., affirming the PTAB's Final Written Decision (FWD) finding that the claims challenged in the proceeding were non-obvious.

The IPRs at issue challenged the claims of Handylab's U.S. Patent No. 7,998,708 and U.S. Patent No. 8,323,900, which are directed to microfluidic systems for amplifying polynucleotides in parallel, i.e., a high throughput screening system for performing reactions like the polymerase chain reaction (PCR) on several samples at the same time.  Claim 1 of the '708 patent was reproduced in the opinion as representative of the challenged claims:

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.

Petitioner Qiagen asserted U.S. Patent No. 6,509,186 in asking the PTAB to find the challenged claims obvious.  That reference, according to the opinion, disclosed "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."  Importantly, the Federal Circuit characterized the '186 patent teachings as disclosing a standalone "multi-chamber thermal cycler chip" having thermally isolated chambers.  Qiagen contended that this reference in combination with U.S. Patent Publication No. 2004/0037739 A1 or U.S. Patent Publication No. 2004/0151629 would render the '708 claims obvious, and the '186 patent in combination with the '739 application or U.S. Patent Publication No. 2002/0055,167 would render obvious the challenged claims of the '900 patent.

The Board's claim construction was relevant to its determination, wherein the phrase "multi-lane microfluidic cartridge" was construed to mean "a microfluidic cartridge comprising a plurality of sample lanes, each sample lane comprising a separate sample inlet and microfluidic network."  Under this construction the Board found Petitioner Qiagen had failed to establish obviousness for any of the challenged claims by a preponderance of the evidence on two independent bases.  First, the Board held that the '186 patent did not teach a multilane microfluidic cartridge, because the '186 cartridge was configured having all lanes in fluid communication with a single sample inlet comprising a common reservoir.  None of the other references asserted by Qiagen remedied this deficiency according to the Board's FWD.  The second basis for the Board's non-obviousness determination was that the skilled worker would not have been motivated to combine the prior art references with any reasonable expectation of success, the Petition (in the Board's view) providing only "a single conclusory statement" in this regard.  The Board was convinced by Handylab's expert who testified that developing a microfluidic device as claimed was "a very complex endeavor that presented [numerous] challenges."  Finally, there was an evidentiary dispute wherein the Board refused to consider a Qiagen Exhibit because it was not submitted with the Petition.  This appeal followed.

The Federal Circuit affirmed, in an opinion by Judge Clevenger, joined by Judges Taranto and Chen.  The opinion begins with the Court's determination regarding the Board's conclusion that the skilled worker would not have had a reasonable expectation of success in combining the asserted references to achieve the claimed invention.  The panel found substantial evidence supporting the Board's conclusion; indeed, the Court's finding in this regard was sufficient for the panel not to reach any of the other issues in the appeal.

First, however, the Court considered whether the Board had properly refused to consider the unsubmitted Exhibit (because this decision impacts the scope of the evidence considered by the Board in reaching its conclusion).  Applying an abuse of discretion standard, the panel considered whether Qiagen had satisfied the requirements need to show an abuse of discretion, which according to the opinion only arises if the 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,

citing VidStream LLC v. Twitter, Inc., 981 F.3d 1060, 1064 (Fed. Cir. 2020), quoting Shu-Hui Chen v. Bouchard, 347 F.3d 1299, 1307 (Fed. Cir. 2003).  Under the statutes and regulations governing IPRs, the opinion asserts, a petition must set forth "the evidence that supports the grounds for the challenge to each claim, including [copies of] printed publications that the petitioner relies upon in support of the petition," citing 35 U.S.C. § 312(a)(3), 37 C.F.R. § 42.22(a)(2) and 37 C.F.R. § 42.104(b)(5).  The panel opines that Qiagen could have submitted the absent exhibit but did not, nor did the petition "address the general state of the art of the relevant field" (Qiagen contending it was not necessary).  Under these circumstances the Federal Circuit held that there was no abuse of discretion in the Board refusing to consider the missing exhibit, particularly in view of the "expedited nature" of IPRs operating under a one-year limit for the Board to render a decision, citing Henny Penny Corp. v. Frymaster LLC, 938 F.3d 1324, 1330 (Fed. Cir. 2019), and the PTO's PTAB Consolidated Patent Trial Practice Guide (Nov. 21, 2019).  The panel rejected Qiagen's argument that the Board should have considered the missing exhibit on rebuttal because the exhibit was not relevant to the rebuttal arguments Qiagen made (relating to the asserted published applications) but rather asserted the missing exhibit to address the disclosure of the '186 patent reference.

Having determined that the scope of evidence properly relied upon by the Board in making its non-obviousness determination to be (primarily) each parties' expert witness testimony, the panel held that there was substantial evidence supporting the Board's holding, including 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 [the '186 patent] with a conventional integrated machine such as in [the cited published patent applications]'" with a high expectation of success.'"  The testimony of Qiagen's witness did not remedy this lack of evidence on the point, the Board holding that the expert's testimony was "similarly conclusory" (to be fair, perhaps because by denying entry of the missing exhibit into evidence Qiagen's expert did not have a basis to make such statements in his testimony).  The Board also relied on positive evidence in the form of Handylab's expert, who provided the basis for the Board's determination 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," that basis being inter alia supported by citation to "numerous contemporary publications in the field."  Moreover, the opinion asserts, "Qiagen provide[d] no basis for overruling the Board's credibility determinations."  Coupled with what the panel concluded was "substantial evidence" the Federal Circuit held that the Board's conclusion regarding the complexity of developing microfluidic PCR devices supported the Board's determination that Qiagen had not shown that the skilled worker would have had a reasonable expectation of success for Qiagen to have shown the challenged claims were obvious by a preponderance of the evidence.

Qiagen North America Holdings Inc. v. Handylab, Inc. (Fed. Cir. 2021)
Nonprecedential disposition
Panel: Circuit Judges Taranto, Clevenger, and Chen
Opinion by Circuit Judge Clevenger