Judge Connolly issued an interesting opinion this week granting summary judgment of invalidity as to the three patents-in-suit under § 101, despite competing expert testimony regarding conventionality.
A 101 Motion Denied
Similar to Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377 (Fed. Cir. 2015), the patents at issue in CareDx, Inc. v. Natera, Inc., C.A. No. 19-567 (CFC) (CJB), D.I. 183 (D. Del. Sept. 28, 2021) were directed to detecting a natural phenomenon -- here cfDNA in blood that signified a likely transplant rejection. The dispute between the parties thus largely focused on step two of the Alice framework and whether the method described in the patent was merely the application of well-known and conventional techniques.
The statement of undisputed material facts defendants submitted with their motion stated that "[n]either the written description nor the claims of the Patents disclose nonconventional techniques," citing to statements in the specification as well as an expert declaration. Plaintiff responded by disputing the fact, submitting its own expert declaration. Based on this apparent dispute, Judge Connolly initially denied the motion and Defendants moved for an interlocutory appeal.
Like a Phoenix, It Rises
In an interesting twist, Judge Connolly denied the motion to certify the issue for interlocutory appeal but decided to reconsider the underlying summary judgement motion, in light of some caselaw cited in the certification briefing. An evidentiary hearing was held with testimony from the competing experts and just this week Judge Connolly issued his new opinion granting the motion for summary judgment.
Patentee Held to Statements in Specification
The particular issue that caught his eye was the question of whether a patentee could use extrinsic evidence, like the plaintiffs' expert testimony here, to overcome statements in the specification that certain claim elements were well-known or conventional. As described in the opinion, the plaintiff had argued that:
[T]he "specification['s] admi[ssion] that the claimed techniques are routine and conventional appears verbatim in myriad patents and patent applications covering different technologies that are not limited to DNA sequencing applications," and it insists that "[i]t would be unfair to read this widely repeated passage in biotech patents referencing generic publications about biochemistry basics to be some sort of supposed voluntary confession that there is no inventive concept in the specification"
CareDx, Inc. v. Natera, Inc., C.A. No. 19-567 (CFC) (CJB), D.I. 183 at 16 (D. Del. Sept. 28, 2021) (quoting plaintiffs' answering SJ brief).
Judge Connolly rejected this argument "out of hand," noting:
[T]here is a reason why patentees frequently represent to the PTO that techniques recited in their patents are conventional. Section 112 of the Patent Act requires that the specification provide sufficient explanation of the claimed invention to enable an artisan of ordinary skill to make and use the invention. To avoid or overcome an objection by the PTO that the requested patent lacks adequate detail to satisfy§ 112, patent applicants will often expressly represent that recited techniques are conventional. Having done that here, CareDx cannot now avoid the consequences that flow from its representation. Indeed, it would be unfair to Defendants to let it do so.
Id. at 28
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