The PTAB’s final written decision in Ariosa Diagnostics, Inc. v. Illumina, Inc., IPR2014-01093, should serve as a reminder to Petitioners challenging claims under 35 U.S.C. § 102(e) – take care to establish that your reference is prior art. 

Claims 1-22 of U.S. Patent No. 7,955,794 relate to methods directed to multiplexing amplification and/or genotyping reactions of target nucleic acid sequences.  The patent is also the basis of the co-pending district court case, Illumina, Inc. v. Ariosa Diagnostics, Inc., Case No. 3:14-cv-01921 (N.D. Cal), wherein Illumina alleges that Ariosa’s Harmony™ Prenatal Test infringes the claims of the ‘794 patent.  The PTAB instituted IPR of each claim on a single ground – alleged anticipation under 35 U.S.C. § 102 in view of Fan, U.S. Patent Application Publication No. 2002/0172946.

The PTAB held that the Petitioner did not meet its burden to demonstrate that the challenged claims are unpatentable, focusing on Petitioner’s failure to prove that Fan was available as prior art.  Fan published after the earliest claimed priority date of the ‘794 patent, but claimed priority to a U.S. provisional application pre-dating the ‘794 patent’s claimed priority date.  The IPR petition noted the filing date of Fan’s underlying U.S. provisional application, and identified allegedly anticipatory disclosure in that U.S. provisional application (incorporated in Fan by reference).  The Patent Owner argued that, despite the alleged shared disclosure, the Petitioner failed to establish that the ‘794 patent was entitled to the U.S. provisional application filing date and, thus, did not meet its burden of proving that Fan was prior art.

In siding with the Patent Owner, the PTAB relied heavily on the Federal Circuit’s decision in Dynamic Drinkware, LLC. v. National Graphics, Inc., 800 F.3d 1375 (Fed. Cir. 2015).  We previously reported on that decision here.  In Dynamic Drinkware, the Federal Circuit distinguished between two burdens: the burden of production and the burden of persuasion.  The Petitioner bears the burden of persuasion to prove unpatentability by a preponderance of the evidence.  The burden of production, however, shifts between the parties.  To prevail on a Section 102(e) challenge that relies on the benefit of a filing date of an earlier application, it is the Petitioner’s burden to prove (1) that the reference patent publication is entitled to the benefit of the earlier filing date by showing support for the reference patent publication claims in the parent application, and (2) that the anticipatory disclosure of the reference patent is shared by the parent application.

Petitioners should not forget to lay the foundation for the prior art challenge in the original petition by affirmatively demonstrating that the references are, in fact, prior art to the asserted claims.

Here, the Petitioner argued that it made a prima facie showing that Fan is prior art by noting the filing date of the underlying provisional application and arguing that Fan anticipated the challenged claims.  According to the Petitioner, such a showing was sufficient to shift the burden of production to the Patent Owner.  The PTAB disagreed.  The original petition did not specify the subsection of Section 102 under which Fan was prior art, instead stating that Section 102(a), (b), and/or (e) applied.  As Petitioner never explicitly stated that Fan was prior art under Section 102(e), nor otherwise argued that the ‘794 patent could not claim entitlement to earlier applications, the burden of production did not shift to the Patent Owner.  Additionally, the Petitioner did not demonstrate that the claims of Fan were fully supported by the underlying provisional application in compliance with 35 U.S.C. § 112—yet another reason Petitioner failed to demonstrate Fan qualified as prior art under Section 102(e).

Petitioner also argued that Dynamic Drinkware is not applicable because the reference at issue in that case was a patent (prior art under Section 102(e)(2)), whereas Fan is a published U.S. patent application (prior art under Section 102(e)(1)).  The PTAB again sided with the Patent Owner and held that Dynamic Drinkware applies to both patents and published applications.  The court in Dynamic Drinkware relied upon 35 U.S.C. § 119(e)(1) in concluding that one challenging a patent’s validity must establish that the reference-patent claims are supported by the disclosure in the reference-patent’s provisional application.  According to the PTAB, no persuasive authority was presented demonstrating that the court’s application of 35 U.S.C. § 119(e)(1) applied only to patents.

The Petitioner filed a request for rehearing, arguing that the application of Dynamic Drinkware to published applications is new law inconsistent with prior authority.  Additionally, Ariosa argues that it did not have sufficient opportunity to establish that the ‘795 patent is supported by the underlying provisional application. Not surprisingly, the Patent Owner opposed the request.

Stay tuned to PTABWatch for updates regarding Ariosa’s request for rehearing and the PTAB’s application of Dynamic Drinkware.  In the meantime, cautious Petitioners will lay the foundation for a prior art challenge based on Section 102(e) art – whether issued patent or published application – by affirmatively demonstrating that the claims of the reference patent publication are fully supported by the earlier patent application and entitled to the priority date.