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Ariosa Diagnostics v. The Board of Trustees of the Leland Stanford Junior University. (IPR2013-00308, Paper No. 40, November 19, 2014)
In a recent inter partes review (IPR), the Patent and Trial Appeals Board (PTAB) found that while only some of the grounds of unpatentability were sufficient to meet the “preponderance of the evidence standard” for determining claims unpatentable, all of the claims reviewed were found to be unpatentable. In its decision, the PTAB construed multiple claim terms using the Broadest Reasonable Interpretation (BRI) before determining that all of the claims were unpatentable as being either anticipated or obvious in view of the cited references. Ariosa at 37.
I the IPR, five grounds of unpatentability were asserted against U.S. Patent No. 8,296,076 (“the ‘076 patent”) based on five asserted prior art references. In its decision, the PTAB reproduced claims 1-3 and 9 as illustrative of the claimed subject matter of the ‘076 patent. Id. at 5 and 6. Specifically, the ‘076 patent “‘relates to the field of molecular diagnostics, and more particularly to the field of prenatal genetic diagnosis.’” Id. at 3. The ‘076 patent provides a method for sequencing a mixture of DNA, including maternal and fetal DNA, and to provide sequence tags for the DNA to detect aneuploidy of the fetus. Id. at 3 and 4.
During the IPR, the PTAB was required to construe multiple terms of the claims of the ‘076 patent. The PTAB cited several cases in support of its construction of the claims under the BRI standard. Specifically, the PTAB discussed that “[c]laim terms…are given their ordinary and customary meaning,” “[i]f an inventor acts as his or her own lexicographer, the definition must be set forth in the specification with…deliberateness,” exclusion of a preferred embodiment “is rarely, if ever correct,” and “[u]nder the doctrine of claim differentiation, dependent claims are presumed to be of narrower scope than the independent claims from which they depend.” Id. at 7 and 8 (internal citations omitted).
“Sequencing Predefined Sequences”
While some of the claim terms were construed without the explicit request of either the petitioner or the patent owner, the PTAB agreed with most of the petitioner’s constructions of disputed claims. For example, Claim 1 recites the term “sequencing predefined sequences” to obtain sequence tags and assign the sequence tags to a specific predefined subsequence. In attempting to limit “predefined” to target sequencing, the patent owner contended that “predefined” excluded random sequencing, because “predefined” “refers to preselecting the nucleic acids to be sequenced prior to sequencing them.” Id. at 9. However, the ‘076 patent discloses preferred and exemplary embodiments of the invention, all of which include the use of random shotgun sequencing. Id. at 10. The PTAB determined that nowhere in the specification of the ‘076 patent was the sequencing limited to only preselected sequences, but instead the specification included both predefined sequences and random shotgun sequencing. Id. at 12.
Furthermore, the PTAB discussed that claim differentiation supported its conclusions. For example, claim 9, which depends from claim 2, which in turn depends from claim 1, recites that “said sequencing comprises selectively sequencing nucleic acid molecules comprising the predefined sequences.” Id. The PTAB recognized that claim differentiation is more of a rebuttable presumption than a rule, but found that the patent owner provided no evidence with which to rebut the “presumption.” Id. at 12 and 13. Thus, the PTAB determined that “sequencing predefined sequences” included both random shotgun sequencing and sequencing by hybridization. Id. at 13.
Although claim 1 does not include the term “polymorphism-independent,” the patent owner argued that the PTAB should construe the ‘076 patent to limit the claims “to detect fetal aneuploidies that are polymorphism-independent.” Id. at 14. However, the patent owner provided no reasoning for this interpretation. Accordingly, the PTAB determined that the broadest reasonable interpretation of the claims encompassed a method for testing both polymorphism dependent and independent distribution of a chromosome. Id. at 14 and 15.
The PTAB’s broad, but reasonable, interpretation of the claim terms in the ’076 patent was significant in its determination that the claims were unpatentable.
For example, the Lo reference discloses sequence tags which are used to allow for identification of chromosomal gains or losses. Id. at 20. The PTAB refused to limit the “sequencing predefined sequences” to only predefined subsequences. Id. Thus, the PTAB determined that, while Lo does not specifically disclose subsequences which were assigned to a specific region (i.e., predefined subsequences), the sequence tags of Lo identified certain chromosomes and were used to in the sequencing of the DNA sequences. Id. at 20 and 21. Thus, the PTAB’s broad construction of the term “sequencing predefined sequences” resulted in the PTAB finding that Lo disclosed this term of claim 1 of the ‘076 patent.
The PTAB’s interpretation of “polymorphism independent” was beneficial to the patent owner in its analysis of the combination of Quake and Kapur to find claim 1 prima facie obvious. Specifically, Kapur discloses a method of genotyping by a single nucleotide polymorphism (“SNP”). Id. at 31. However, the ‘076 patent discloses a sequencing by hybridization and a SNP array does not contain all of the possible combinations of nucleotides. Id. Thus, the PTAB determined that claim 1 was not obvious over Quake and Kapur.
Petitioner’s Arguments Legally Deficient
One interesting argument made by the patent owner was that the petitioner’s expert testimony was “legally deficient and does not reflect a proper anticipation or obviousness analysis.” Id. at 16. The patent owner argued that the testimony of petitioner’s experts was deficient because the experts could not “identify a distinction between obviousness and anticipation.” Id. The PTAB, however, noted that it is at the Board’s discretion to “assign the appropriate weight to be accorded to the testimonial evidence of [the experts],” and refused to dismiss the expert testimony completely. Id. at 17. In relying on only one paragraph of the expert testimony, the PTAB stated that it (the PTAB) was “well-positioned to determine and assign appropriate weight to evidence presented.” Id. at 36. Thus, the PTAB, , guided by the its expertise, did not completely exclude the expert testimony, but instead used a small portion in its unpatentability analysis.
This decision provides some insight into the PTAB’s application of the BRI standard when reviewing a biotechnology patent. Throughout the IPR, the PTAB was unwilling to limit the claim terms in a manner inconsistent with the specification and the exemplary embodiments and experiments. The PTAB further used both claim differentiation and ordinary meanings of the claim terms to broadly, but reasonably, construe the claims, finding that claims 1-13, on similar or different grounds, were unpatentable. Id. at 37. Furthermore, the PTAB is unlikely to provide narrow claim interpretations of terms unless the terms are specifically limited in the specification. We are anxiously waiting for the Federal Circuit to decide whether or not the BRI standard is the appropriate standard for a PTAB trial in Versata Development Group v. SAP America.