In a recent decision from the District of Massachusetts, Judge Indira Talwani denied a motion to dismiss a patent suit under Rule 12(b)(6) for failure to state a claim due to patent ineligibility under 35 U.S.C. § 101 . In their motion, defendants Mayo Collaborative Services LLC and Mayo Clinic (collectively “Defendants”) argued that the patent asserted by Athena Diagnostics, Inc., Isis Innovation Limited, and Max-Planck-Gesellshaft zur Forderung der Wissenschaften e.V. (collectively “Plaintiffs”), was invalid under 35 U.S.C. § 101 “because the claimed method applies routine and conventional techniques to a law of nature.”

The patent, U.S. Patent No. 7,267,820, titled “Neurotransmission Disorders,” is directed to the diagnosis of a form of Myasthenia Gravis, an autoimmune disorder that negatively impacts muscle strength. The patent claims a method for diagnosis in which a radioactive material – ¹²⁵I – is adhered to muscle specific tyrosine kinase (“MuSK”), a receptor located on the surface of neuromuscular junctions. As claimed in the patent, this combination of substances is then brought into contact with a sample of bodily fluid and used to detect the presence of MuSK antibodies, which, if present, would indicate the presence of the disease in the test subject.

In their motion, Defendants argued that under the two-step analysis for determining patent-eligibility under Section 101, as outlined in Alice Corp. Pty. Ltd. v. CLS Bank Int’l., 134 S. Ct. 2347 (2014) (“Alice”) and Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012) (“Mayo”), the ’820 patent should be deemed invalid.

The two-part test for validity under section 101, as articulated in Alice, first requires a determination of whether the claims at issue are directed to a patent-ineligible concept, such as a law of nature, natural phenomenon, or an abstract idea. Next, if the concept is patent ineligible, the court then must determine whether the claim features an “inventive concept” that sufficiently transforms the ineligible concept into an eligible one. Defendants argued that the method claimed in the ’820 patent is merely a law of nature and applies standard diagnostic techniques to that law. In opposition, Plaintiffs argued the ’820 patent “is not directed at a law of nature because the patent requires the production and use of the ¹²⁵I-MuSK combination,” which is not naturally occurring, and that the application of known techniques to a non-naturally occurring substances makes the claimed subject matter patent eligible.

In applying the first part of the aforementioned two-step test, the Court found that, even though the ¹²⁵I-MuSK combination is manmade, use of the manmade molecule did not transform the claims at issue such to convey patent-eligiblity. Rather, the Court determined, “[t]he focus of the claims of the invention is the interaction of the ¹²⁵I-MUSK and the bodily fluid, an interaction which is naturally occurring.”  In determining the claims directed to a law of nature, the Court heavily analogized the subject matter of the ’820 patent to those invalidated by the Supreme Court in Mayo and Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1372 (Fed. Cir. 2015), cert. denied, 136 S. Ct. 2511 (2016).

The Court then turned to the second part of the Alice test and the search for an “inventive concept.”  The Court noted that, although Defendants cited portions of the patent specification that, in Defendants’ view, “show that the methods described in the patent are commonly used by researchers in the field” (Order at 10), the Court ultimately held that it was unable to determine, at the motion to dismiss stage, whether the patented method uses merely standard techniques in the art or sufficiently inventive techniques to be considered patentable. Thus, the Court ultimately denied Defendants’ motion, noting that, “[w]hile it may later be established that the Plaintiff’s process is not deserving of patent protection because the techniques are standard in the art and therefore fail to provide an inventive concept, the court cannot resolve these factual determinations at the motion to dismiss stage.”

The case is Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, C.A. No. 15-cv-40075-IT (D. Mass.).