The Board of Trustees of the Leland Stanford Junior University (“Stanford”) v. The Chinese University of Hong Kong

Docket No. 2015-2011

June 27, 2017

Brief Summary: Board interference decision of no written description vacated and remanded because, e.g., it erred in relying on “conclusions about the Roche 454 platform to conclude that Illumia teaches only targeted sequencing”, failed “to explain the meaning of key sentences and phrases in the specification’s discussion of the sequencing process”, and did not “compare these statements to the claim limitations.”

Summary: Stanford appealed the results of three interference proceedings in which all of its claims relating to cell-free fetal DNA (“cff-DNA”) testing methods for detecting fetal aneuploidies (in which a fetus has an abnormally high number of chromosomes such as in Down’s and Turner’s syndromes) were found to be unpatentable for lack of written description (“WD”) (No. 105,920 (Stanford’s Ser. No. 12/393,833 and US 8,008,018 (a CON of US 7,888,017) vs. CHUK’s Ser. No. 13/070,275); and 105,923 / 105,924 (Stanford’s 12/393,833)). The ‘920 decision was issued separately by the Board but referred to by the FC panel “for clarity” (“our decision applies to the Board’s findings in all three interferences”). Stanford’s (“Quake’s”) original claims were directed to “target sequences” and “measuring the presence of different target sequences”. CHUK claimed that “in 2011, [Stanford] realized that CHUK had claimed the ‘random sequencing’ method”, “cancelled all pending claims”, and “added…claims…that, for the first time, explicitly cover random” massively parallel sequencing (“MPS”) methods. The Board found Stanford’s “specification disclosed ‘targeted’ rather than ‘random’ sequencing, and the specification would not have indicated to one of ordinary skill in the art that Quake was in possession of the claimed random MPS method” (“the facts do not indicate that those of ordinary skill in the art would have understood the inventors had put these pieces [disclosed in the specification] together into a complete method”). The Board relied in large part on the testimony of Dr. Gabriel, finding “Dr. Gabriel’s statement that the Illumina platform referenced in the specification could be used for both random and targeted sequencing was not a reference to random MPS….” The case was originally heard in a ND CA but was transferred to the FC in view of Biogen (FC 2015 (interferences declared after Sept. 15, 2012 can only be appealed to the FC)). The FC opinion first rejected Stanford’s Biogen-related argument, stating “Biogen is the law of this circuit and we, as a panel, will not revisit it.” The FC panel also found “Stanford’s attempt to include evidence elicited during [the DC] proceedings is inappropriate” since “the activities in the [DC] are a nullity when the [DC] lacks subject matter jurisdiction” (Rurgas AG, US 1999) and “[o]ur precedent makes clear that our review of a Board interference decision must be confined to the ‘four corners’ of the record before the Board” (In re Gartside, FC 2000; 35 USC § 144 (2012)).

Regarding the written description issue (“the heart of Stanford’s appeal”), the FC panel explained that it reviews the Board’s legal conclusions de novo (In re Elsner, FC 2004) and it factual findings for substantial evidence (In re Gartside, FC 2000). It also explained that written description is found “when ‘the essence of the original disclosure’ conveys the necessary information-‘regardless of how it’ conveys such information, and even when the disclosure’s ‘words [a]re open to different interpretations” (In re Wright, FC 1989; In re Ruschig, CCPA 1967 (“disclosure should ‘provide sufficient ‘blaze marks’ to guide a reader”)). The FC panel found the Board erred in relying on “conclusions about the Roche 454 platform to conclude that Illumia teaches only targeted sequencing” and “frames its finding in terms of an erroneous premise: the Board’s task was to determine whether the ‘018 patent’s written description discloses random MPS sequencing…not whether the description does not preclude targeted MPS sequencing.” It also found the Board failed “to explain the meaning of key sentences and phrases in the specification’s discussion of the sequencing process” and “compare these statements to the claim limitations.” Thus, citing In re Nuvasive (FC 2016) and Ariosa (FC 2015), the FC panel vacated the interference decision and remanded it for reconsideration. The FC panel also suggested the Board should consider “the record evidence as to pre-filing date art-related facts on Illumina products” and “any post-filing date publications contain[ing] art-related facts on random MPS sequencing of Illumina products existing on the filing date” (In re Hogan, CCPA 1977 (“use of ‘later publications as evidence of the state of the art existing on the filing date”)).

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