Takeaway: The Board has confirmed that it may allow joinder of additional grounds by the same party, as it has routinely done so in the past.

In its Final Written Decision, the Board determined that Petitioner had demonstrated by a preponderance of the evidence that claims 1, 2, 4, 5, 8, 19, 20, 24, and 25 of the ’540 patent were unpatentable under 35 U.S.C. § 102(b). However, the Board determined that Petitioner had not met its burden of showing by a preponderance of the evidence that claims 3, 12, 13, 15, 18, 21, and 22 were unpatentable under 35 US.C. § 103(a).  The Board denied Patent Owner’s Motion to Amend, as well.

After trial was instituted in IPR2012-00022, Petitioner filed a Petition for inter partes review of claims 3, 8, 12, 13, 15, and 18 of the ’540 patent in IPR2013-00250, as well as a Motion for Joinder requesting the joinder of IPR2013-00250 with IPR2012-00022.  The Board then instituted trial with respect to each of the claims challenged in IPR2013-00250 and joined that proceeding with IPR2012-00022.  Accordingly, inter partes review proceeding, as joined, challenged the patentability of claims 1-5, 8, 12, 13, 15, 18-22, 24, and 25 of the ‘540 patent.

In parallel, claims 1, 2, 4, 5, 8, 19-22, 24, and 25 of the ’540 patent were held to be invalid in Ariosa Diagnostics v. Sequenom, Civ. No. 12-00132-SI (N.D. Cal.), in which the district court granted summary judgment because it found that these claims were directed to patent-ineligible subject matter under 35 U.S.C. § 101.  Patent Owner appealed this decision U.S. Court of Appeals for the Federal Circuit.

The ’540 patent relates to non-invasive “prenatal diagnosis by detecting foetal nucleic acids in serum or plasma from a maternal blood sample.” The Board declined to address the anticipation challenge to claims 1-5, 12, 13, 15, 18-22, 24, and 25 under 35 U.S.C. § 102(a) based on Lo, and the obviousness challenge to claim 8 under 35 U.S.C. based on the combination of Lo and Simpson, because at oral argument Petitioner stated that it was no longer pursuing these challenges.

The Board next addressed Patent Owner’s argument that Petitioner lacked standing under 35 U.S.C. § 315 because Petitioner had filed a civil action challenging the validity of the ’540 patent prior to filing its Petition in IPR2012-00022. The parts of 35 U.S.C. § 315 relevant to this issue include § 315(a)(1), which states that “[a]n inter partes review may not be instituted if, before the date on which the petition for such a review is filed, the petitioner or real party in interest filed a civil action challenging the validity of a claim of the patent” and § 315(a)(3), which states that “[a] counterclaim challenging the validity of a claim of a patent does not constitute a civil action challenging the validity of a claim of a patent for purposes of this subsection.”

In this case, Petitioner had filed a declaratory judgment action against the exclusive licensee of the ’540 patent seeking a declaration that the ’540 patent was not infringed; the exclusive licensee counterclaimed for infringement; and Petitioner “answered by raising the affirmative defense of invalidity of the ’540 patent.” The Board concluded that Petitioner had standing to file IPR2012-00022 because “the statute clearly defines which civil actions, when filed, bar a party from filing an inter partes review—civil actions challenging the validity of a patent” and because “[a] civil action for a declaratory judgment of non-infringement is not a civil action challenging the validity of a patent.”  The Board went on to conclude that “asserting an affirmative defense of invalidity is treated differently than a counterclaim for invalidity, and thus for the purposes of § 315(a)(1) cannot be considered a filing of a civil action for invalidity.”

Patent Owner had also argued that this IPR2012-00022 was time-barred under 35 U.S.C. § 315(b) because Petitioner had accepted service of a complaint alleging infringement of the ’540 patent more than one year before the Petition filing date for joined proceeding IPR2013-00250. The Board, however, disagreed, citing Macauto U.S.A. v. BOS GMBH & KG, Case IPR2012-00004 (PTAB January 24, 2013), for the proposition that the time bar under 35 U.S.C. § 315(b) does not apply where the complaint of infringement was voluntarily dismissed without prejudice.”

Patent Owner had further argued that joinder was not appropriate in this case because the joinder statute, 35 U.S.C. § 315(c), only allows the joinder of parties and does not allow the joinder of issues. The Board disagreed, noting that the Board has routinely allowed joinder of additional grounds by the same party.

The Board next addressed claim construction for the recited term “detecting,” and then provided its patentability analysis. As for the inherency-based anticipation challenge to claims 1, 2, 4, 5, 8, 19, 20, 24, and 25, the Board found that Kazakov anticipated each of these claims under  35 U.S.C. § 102(b).  Regarding the obviousness challenge to claims 1, 2, 4, 5, 19-22, 24, and 25 based on the combination of Simpson, Schallhammer, and Kazakov (note: Schallhammer was effectively dropped as a reference from this combination because Petitioner had ceased to rely on Schallhammer in arguing this challenge, which the Board did not apparently mind since it considered Schallhammer to be cumulative to Simpson and Kazakov), the Board concluded that Petitioner had not demonstrated by a preponderance of the evidence that these claims would have been obvious in view of Simpson and Kazakov.  With respect to the obviousness challenge to claims 3, 12, 13, 15, and 18 based on the combination of Simpson, Schallhammer, Kazakov, and Bianchi, the Board found that Bianchi did not remedy the deficiencies of the combination of Simpson and Kazakov noted above.

Patent Owner had filed a Contingent Motion to Amend, presenting two sets of possible replacement claims. The Board denied this Motion, stating that “in a case such as this, where the claims have been determined to be invalid by a district court, we decline to enter an amendment to claims where the patent owner did not explain how the proposed amendments addressed the district court’s concerns regarding the validity of the claims.”

The Board addressed other issues in its Decision, including Patent Owner’s Motion to Exclude Evidence. In this connection, the Board denied the Motion to Exclude Evidence to the extent it sought to exclude certain exhibits, and dismissed the Motion to Exclude as moot as to the extent it sought the exclusion of other exhibits.

Ariosa Diagnostics v. Isis Innovation Limited, IPR2012-00022
Paper 166: Final Written Decision 
Dated: September 2, 2014 
Patent: 6,258,540 
Before: Lora M. Green, Francisco C. Prats, and Jeffrey B. Robertson 
Written by: Green
Related Proceedings: Ariosa Diagnostics v. Sequenom, Civ. No. 12-00132-SI (N.D. Cal.); Ariosa Diagnostics, Inc. v. Sequenom, Inc., Appeal Nos. 14-1139, 14-1142, and 14-1144; IPR2013-00250