Federal Circuit affirms Board decision finding chromosomal abnormality testing claims lack written description affirmed

Stephen Quake, et al. v. Yuk-Ming Dennis Lo, et al.

Docket Nos. 2018-1779, -1780, -1782
Reyna, Chen, Hughes
July 10, 2019

Brief Summary: Board finding of no WD of chromosomal abnormality testing claims affirmed.

Summary: Quake appealed Board decision finding four claims to methods for identifying chromosomal abnormalities (fetal aneuploidy) using “random” massively parallel sequencing of DNA in cell-free fetal DNA (cff-DNA) (“meaning that all of the DNA in a sample is sequenced, as opposed to sequencing specific, targeted sequences”) invalid for lack of written description (WD, section 112). Quake’s US 8,008,018 is involved in an interference with Lo’s applications to determine who first invented the random MPS method, during which proceeding the Board made the finding of insufficient WD. This issue was previously addressed by the Board and FC to correct the Board’s prior errors, but the Board again found the claims invalid for lack of WD (note: Biogen, FC 2015 held that the FC “has exclusive appellate jurisdiction over Board decisions”)). The Board concluded that the ‘018 specification “describes some of the elements” but “does not tie the elements together”, “explain how to use the data…to determine fetal aneuploidy”, or “suggest[] to a skilled artisan to adjust for chromosome size when doing the comparison claimed in step D” (a “necessary” step). Quake appealed both the Board’s WD decision and its decision not to enter evidence from district court (DC) proceedings. The FC panel explained the inventor must “convey with reasonable clarity…that…he or she was in possession of the invention” (Centocor, FC 2011 (“not a ‘mere wish or plan’”), and is “particularly important when, as here, claims are added later during prosecution in response to development by others” (Agilent, FC 2009) (e.g., “the first time Quake tried to cover random MPS…was after the publication of Lo’s patent application”). The FC panel also explained that “ipsis verbis disclosure is not necessary” to satisfy the WD requirement (Fujikawa, FC 1996; In re Ruschig, CCPA 1967 (“mark[ing] blaze marks on…trees’ to ‘find[] one’s way through the woods’ of a specification such that a skilled artisan would be able to follow that trail and understand what the inventors had invented”)). But the FC panel agreed with the Board’s WD decision “given the specification’s repeated discussion of targeted sequencing, a bare citation to” a reference relating to MPS, “and use of the phrase ‘about 30 bp of random sequence”, summarized as “a highly elliptical, cryptic way to communicate possession of a second method of sequencing” (e.g., “at most…faint ‘blaze marks’”, “only expressly describes detection of target sequences”). The FC panel rejected Quake’s arguments regarding whether step D was sufficiently disclosed (e.g., “conducting statistical analysis on random MPS data was known and predictable”, “unclaimed limitations…did not need to be described”, normalizing chromosomal size “more of an enablement issue”, “need to normalize random MPS results was known…and therefore not necessary to describe”, burden of proof not shifted from Lo to Quake). The FC panel also found no error with the Board’s decision not to enter evidence from the DC proceeding (Redline, FC 2015; Ultratec, FC 2017).

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