Columbia University v. Illumina, Inc.
Docket No. 2019-2302-5, -2452 (IPR2019-00291, -00318, -00322, -00385, -00797) (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/19-2302.OPINION.2-1-2021_1726127.pdf)
LOURIE, O’MALLEY, REYNA
February 1, 2021 (Non-Precedential)
Brief Summary: IPR obviousness decisions affirmed (e.g., no teaching away). Summary: Columbia appealed two IPR final written decisions (FWDs) holding claims 1 of US 9,718,852; 9,719,139; 9,708,358; 9,725,480; and claims 1-2 of US 9,868,985 directed to nucleotide analogs and methods for using those for DNA sequencing (“sequencing-by-synthesis” (SBS)) unpatentable as obvious in view of combinations of the Tsien, Prober, Metzker, and Dower references. “This appeal centers on one aspect of the claims: the use of a capping group that is ‘small,’ and not a ‘ketone group,’ ‘a methoxy group, or an ester group’”, which Columbia is required “in order to ‘work for SBS’” (“an ‘allyl capping group’ is small, and is not ketone, methoxy, or ester”). The FWDs “found that Tsien discloses the use of allyl capping groups” that is not “negated” by “Metzker’s experiment” which “a person of ordinary skill would have understood…could be further improved by ‘increasing [nucleotide] concentration or reaction time’”. Administrative Patent Judge Worth dissented, “believing that ‘Metzker’s experiment would have discouraged a person from pursuing an allyl nucleotide.” The FC panel reviewed the Board’s legal determinations de novo (obviousness conclusions) and the underlying factual findings for substantial evidence (“[w]hat the prior art teaches”, motivation, teaching away, reasonable expectation of success) (In re Elsner, FC 2004; In re Gartside, FC 2000; Consol. Edison, US 1938). Columbia argued the Board erred in finding a motivation “to pursue an allyl capping group for use with SBS” and a reasonable expectation of success (e.g., “the Board’s error stemmed from is ‘misapprehension’ of Metzker’s experiment”, POSA would have been “discouraged…from using an allyl capping group because SBS requires efficient incorporation of nucleotides”). The FC panel disagreed, concluding that “Columbia has not demonstrated that there was any…clear discouragement” from the allyl capping group (“it confirms rather than negates Tsien’s teachings”) (Univ. of Md. Biotech. Inst., FC 2017 (“Teaching away requires ‘clear discouragement’ from implementing a technical feature.”); In re Ethicon, FC 2017). The FC panel explained that “while it may be true that Metzker and other scientists ultimately chose to research alternative capping group, ‘just because alternatives exist…does not mean that an inferior alternative ‘is inapt for obviousness purposes’” (In re Mouttet, FC 2012). The FC panel also agreed with the Board’s finding of a reasonable expectation of success (e.g., POSA “would have understood how to improve incorporation efficiency”, “Columbia’s patents provide further evidence” and “cite Metzker without mentioning concerns regarding the use of allyl capping groups” (PharmaStem, FC 2007 (“Admissions in the specification regarding the prior art are binding on the patentee for purposes of a later inquiry into obviousness.”)) and that Columbia’s argument regarding priority dates considered in a previous reexamination unconvincing. The FC panel also explained that the Board “was not obliged to discuss every argument that Columbia raised.” The Board’s obviousness decisions were therefore affirmed.