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Cedars Sinai v. Quest Diagnostic

Representative Claim(s)

  1. A system for diagnosing irritable bowel syndrome, comprising: an isolated biological sample from a subject desiring diagnosis regarding irritable bowel syndrome (IBS); and an assay for detecting in the biological sample, a level of an anti-vinculin antibody.

Posture:

Motion to Dismiss based on inevitable finding of non-patentable subject matter

Exception Category: Law of Nature

“Quest argues that the Asserted Claims are invalid under § 101 because they ‘are directed to a single natural phenomenon: the correlation between the presence of antivinculin antibodies and IBS.’ … Quest argues, ‘[t]he Federal Circuit has found substantively identical claims invalid under § 101.’ Quest also argues that the Asserted Claims represent a ‘sweeping preemption of the natural phenomenon,’ as Claims 3 and 9 ‘preempt all means for detecting the natural phenomenon of elevated vinculin in IBS patients.’ Quest argues that Claims 4 and 10 fare no better because ‘the recitation of ELISA to detect anti-vinculin is not sufficiently novel or specific to transform the natural phenomenon into a patent eligible application thereof.’ ”

“The Asserted Claims in this matter appear initially to be highly analogous to the claims invalidated by the Federal Circuit in Cleveland Clinic. The Asserted Claims essentially recite the combination of an assay for detecting an anti-vinculin antibody and a biological sample ‘from a subject desiring diagnosis’ of IBS. The crux of the claims thus relies on the fact that there is a correlation between IBS and a subject’s levels of anti-vinculin antibody. In other words, the claims are directed to systems for observing the law of nature that anti-vinculin antibody correlates to IBS.”

“The fact that the correlation between vinculin and IBS was not known before Cedars-Sinai’s discovery is also irrelevant. As a law of nature, this correlation has always existed. Simply because Cedars-Sinai was the first to discover it, i.e., make a “breakthrough” in the field, does not change its inherent character as a law of nature. For this reason, any attempt by Cedars-Sinai to distinguish Cleveland Clinic based on the argument that the correlation between MPO and cardiovascular health was already known before Cleveland Clinic’s patent issued is also unpersuasive. As stated, ‘groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry.’ Accordingly, the Asserted Claims are directed to a law of nature under Mayo/Alice Step One.”

Significantly More: Not Decided

“At the first hearing …, Cedars-Sinai again initially appeared to be focusing the bulk of its argument on the idea that the claim term ‘an assay’ referred to ‘a vinculinbased assay’ that uses manufactured vinculin. However, over the course of oral argument, Cedars-Sinai began adding further emphasis to an argument that the Asserted Claims recite an inventive concept because vinculinbased assays were purportedly not well-understood, routine, or conventional at the time of filing of the ’884 Patent.”

“The parties’ arguments in briefing and at oral argument, however, lead the Court to conclude that expedited claim construction and expedited claim construction discovery as to the claim term ‘an assay’ would be beneficial before the Court reaches a determination as to patentability under Section 101.”