Ariosa Diagnostics, Inc. et al. v. Sequenom, Inc.


Docket No. 2014-1139, 2014-1144

REYNA, LINN (C), WALLACH
June 12, 2015

Update:  Petition for Rehearing en banc denied 12/2/15; Cert. denied 6/27/16

Brief Summary: Method claims for amplifying and detecting fetal DNA in maternal serum or plasma deemed patent ineligible under Mayo (natural phenomena coupled to routine, conventional methods…no transformation of “the nature of the claim”).

Summary: Sequenom appealed DC grant of SJ because the asserted claims of US 6,258,540 are not directed to patent eligible subject matter and are therefore invalid under 35 U.S.C. § 101. Representative independent claim 1 claims: “A method for detecting a paternally inherited nucleic acid of fetal origin performed on maternal serum or plasma sample from a pregnant female, which method comprises amplifying a paternally inherited nucleic acid from the serum or plasma sample and detecting the presence or a paternally inherited nucleic acid of fetal origin in the sample.” Claims 24 and 25 were also reproduced for comparison; each adds some additional details to the claimed methods. The opinion explains that “[t]he remaining claims explain how the method of detection occurs or how it can be used” (e.g., PCR amplification, detection via a sequence specific probe). The defendants make and sell non-invasive tests use for prenatal diagnosis of certain conditions. Before the ‘540 inventors made their discovery, it was not known that fetal DNA (cell-free fetal DNA, or “cffDNA”) could be detected in material tissue, which was routinely discarded. However, the DC found cffDNA to be a natural phenomena, “the steps of amplifying and detecting were well-understood, routine, or conventional” at the time the patent application was filed (1997), and that “the claimed processes posed a risk of prempting a natural phenomenon.” The FC reviews the question of whether a claim is invalid under 35 U.S.C. § 101 de novo. The opinion explained that under Alice (US 2014) and Mayo (US 2012), it must first be determined whether the claims at issue are directed to a patent ineligible concept and then, if yes, whether the additional elements of the claim “transform the nature of the claim” into a patent-eligible application (“a search for an ‘inventive concept’…sufficient to ensure that the patent in practice amounts to substantially more than a patent upon the [ineligible concept] itself.”) The panel noted that “[m]ethod claims are generally eligible subject matter” but concluded that, here, “[t]he method…begins and ends with a natural phenomenon” (i.e., cffDNA) and “are directed to matter that is naturally occurring” (the first step in the Mayo analysis). The second step in the Mayo analysis requires “more than simply stating the law of nature while adding the words ‘apply it’”. The panel concluded the preparation steps of the ‘540 claims “amount[] to a general instruction to doctors to apply routine, conventional techniques when seeking to detect cffDNA” and “is not new and useful” (although “the discovery of the presence of cffDNA in maternal plasma or serum” was acknowledged to be new and useful). The detecting steps were found to be “similarly well-understood, routine, and conventional”. Accordingly, the claims were found to be patent-ineligible and invalid. The opinion also addressed the issue of preemption (are all practical uses of the phenomenon preempted by the claims? “[P]atent claims should not prevent the use of basic building blocks of technology-abstract ideas, naturally occurring phenomena, and natural laws.”). The panel explained that “[w]hile preemption may signal patent ineligibile subject matter, the absence of complete preemption does not demonstrate patent eligibility” (e.g., alternative uses of cffDNA outside the scope of the claims). The panel declined to “draw distinctions among natural phenomena based on whether or not they will interfere significantly with innovation in other fields now or in the future” (“The Supreme Court cases…have not distinguished among different laws of nature or natural phenomena according to whether or not the principles they embody are sufficiently narrow.”) While the panel did “not disagree” that the concept discovered “is a positive and valuable contribution to the field”, it explained that “even such valuable contributions can fall short of statutory patentable subject matter”. The DC decision was therefore affirmed. Judge Linn’s interesting concurring opinion joined the court “only because I am bound by the sweeping language of the test set out in Mayo”. Otherwise, Judge Linn “see[s] no reason, in policy or statute, why this breakthrough invention should be deemed patent ineligible.”

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