Columbia University v. Illumina, Inc.

Docket No. 2014-1547, -1548, -1550

July 17, 2015


Brief Summary: PTAB decision following IPR regarding obviousness, anticipation and refusal to amend Columbia’s claims as it did not show the same would “establish patentability over the prior art” affirmed.

Summary: This appeal results from PTAB finding following IPR that all challenged claims of Columbia’s US 7,713,698; 8,088,575; and 7,790,869 are anticipated or obvious. The patents relate to sequencing by synthesis (SBS) which uses a removable, label-bearing cap at the 3’-OH group which would block synthesis long enough to detect the label but the label would then be removed to allow synthesis to continue. The system ran into difficulties because the caps were located near the DNA polymerase active site, interfering with its operation. Columbia’s inventors solved the problem by placing an unlabeled removable cap on the 3’-OH group and attaching the label to a cleavable linker attached to the deazapurine base; this system is encompassed by the patents-at-issue. The opinion explains that PTAB factual findings are reviewed for substantial evidence and its legal conclusion de novo. Columbia argued the PTAB did not resolve the conflict regarding the level of skill in the art (i.e., that Illumina’s expert was not a PHOSITA because he had not worked in the area of nucleotide synthesis). The FC panel did not find reversible error with the PTAB’s conduct, finding it “was entitled to weigh the credibility of the witnesses in light of their qualifications.” The FC also agreed with the PTAB that the prior art disclosed labels attached to the base, cleavable tethers and reversibly capped 3’-OH groups prior to the priority date of Columbia’s applications. Columbia argued that “the [PTAB] erred in concluding that a skilled artisan would have combined the prior art” to achieve the claimed invention. The FC opinion explained that while “[t]he obviousness of an invention is not established ‘merely by demonstrating that each of its elements was, independently, known in the prior art”, “a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ” (KSR, US 2007; Star Scientific, FC 2011). Its concluded the review of the prior art as “provid[ing] substantial evidence supporting the PTAB’s finding of motivation to combine” (e.g., “just because better alternatives exist in the prior art does not mean that an inferior combination is inapt for obviousness purposes” (In re Mouttet, FC 2012)). It also explained in FN5 that Columbia’s argument regarding the length of time between the prior art publication and its invention “might appropriately have been raised in support of the secondary consideration of long-felt need” but it was not asserted. Columbia also unsuccessfully challenged the PTAB’s finding of a reasonable expectation in success in combining the prior art. Regarding secondary considerations, the opinion first explained that the development of SBS approaches by Solexa and Amersham before Columbia’s applications were published “weigh[ed] modestly in favor of obviousness” as “simultaneous inventions” (“strong evidence of what constitutes the level of ordinary skill in the art” (Ecolochem, FC 2000)). Assertions of copying by others were also found not to “weigh in favor of nonobviousness.” “Attempted [l]icensing” was found to provide only “modest evidence of nonobviousness” because none of the evidence indicates the subject matter sought to be licensed fell within the claims” of the patents (In re GPAC, FC 1995). Commercial success was not found to favor nonobviousness because “the feature that create[d] the commercial success was known in the prior art” (Ormoc, FC 2006). The evidence of alleged unexpected results was not convincing as it did not relate to the closest prior art (“Unexpected results ‘must be shown to be unexpected compared with the closest prior art. Kao Corp., FC 2006). The panel also agreed with the PTAB that the prior art anticipated certain claims (“when a genus is so limited that a person of ordinary skill in the art can at once envisage each member of this limited class,…a reference describing the genus anticipates every species within the genus” (Abbvie, FC 2014)). Columbia also argued the PTAB denial of its motion to amend its claims was not harmless error but was not deemed improper because Columbia did “not establish patentability over the prior art” by the amendment (Microsoft, FC June 16, 2015). Thus, the PTAB decision was affirmed.

This entry was posted in Anticipation (35 USC 102), Inter Parties Review (IPR), Obviousness. Bookmark the permalink.

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