In re: Ikeda Food Research Co., Ltd.

Docket No. 2017-2624

January 29, 2019

Brief summary: Board decision affirming the rejection of claims directed to method for measuring blood glucose using a biosensor as obvious due to inherent disclosure by the prior art affirmed.

Summary: Ikeda appealed Board decision affirming the rejection of its claims directed to method for measuring blood glucose using a biosensor as obvious. The claimed biosensor includes “an enzymatic reaction layer” on an electrode comprising an enzyme (flavin compound-binding glucose dehydrogenase (FAD-GDH)) with glucose sensing ability (“enzymatic activity”) “wherein enzymatic activity to maltose in the enzymatic reaction layer is 5% or less relative to the enzymatic activity to glucose”. The claims were rejected in view of the “Senior” reference describing a glucose sensor using a different FAD-GDH enzyme and the “Yugawa patents” that also describe a biosensor using electrodes and GDH and “PQQ-GDH” in a “reaction layer” (“employing the FAD-GDH enzyme preparation described in Senior with the biosensor described in the Yugawa patents would have rendered the Challenged Claims obvious”). The FC panel reviewed the Board’s “factual findings for substantial evidence and its legal conclusions de novo” (Redline Detection FC 2015; In re NuVasive, FC 2016 (“more than a mere scintilla of evidence”); Elbit, FC 2018 (“PTAB decision to favor one conclusion over another is the epitome of a decision that must be sustained upon review for substantial evidence”)). The Board’s obviousness underlying findings of facts were reviewed in view of the Graham factors (US 1966), secondary considerations (In re Cyclobenzaprine, FC 2012 (“‘a feasible solution to the long-standing problem’ supports a finding of long-felt need”), and whether there was a motivation to combine the prior art with a reasonable expectation of success (Univ. Cal., FC 2018). The FC panel explained that while “inherency may supply a missing claim limitation in an obviousness analysis”, “the limitation at issue necessarily must be present[] or the natural result of the combination of elements explicitly disclosed by the prior art” (PAR Pharm., FC 2014), and that “the [US]PTO can require an applicant to prove that the subject matter shown to be in the prior art does not possess the characteristic relied upon” (Southwire, FC 2017; In re Spada, FC 1990). The USPTO found that “even though Senior did not expressly disclose the low-maltose activity limitation”, “Senior’s disclosed enzyme preparation inherently contains the same enzyme specificity for glucose relative to maltose”. Ikeda contested this point but not “that each of the other limitations are taught by” Senior and Yugawa. But the FC panel found the Board’s conclusions to be supported by substantial evidence since, e.g., the enzymes have “the same ‘E.C’’ classification number…even though each FAD-GDH enzyme is produced from a different microorganism” and “it was reasonable for the PTAB to conclude” the enzyme preparations have “identical enzymatic activity, which necessarily includes having the same substrate specificity”, and “Ikeda did not present evidence of testing any of the enzyme preparations found in the prior art” (Butamax, FC 2014; In re Spada, FC 1990). The FC panel also found no error with the Board’s conclusion that “Ikeda’s expert testimony” regarding long-felt need “did not have any substantive relevance”. Thus, the Board decision was affirmed.

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