Athena Diagnostics, Inc. v. Mayo Collaborative Services d/b/a Mayo Medical Laboratories (15-cv-40075).

Judge Talwani granted Mayo 2019s motion to dismiss Athena Diagnostics 2019 complaint, finding the claims of U.S. Patent No. 7,267,820 encompassed unpatentable subject matter. The patent is directed to diagnosing Myasthenia Gravis, an autoimmune disorder by detecting IgG autoantibodies. The inventors had discovered that some sufferers of the disease had IgG antibodies that attack a receptor, known as MuSK, on muscles, resulting in muscular weakness, and developed a diagnosis method whereby a radio-labelled version of the receptor, known as 125I-Musk, is introduced to a sample of bodily fluid to attach to MuSK antibodies. The fluid is immunoprecipitated, and the presence of the radioactive label indicates the person has the disease. In the face of Mayo 2019s Alice motion, Athena argued that the claims were not directed to a law of nature, but instead utilize the man-made 125I-Musk to form a complex with MuSK antibodies that do not occur in nature. Judge Talwani agreed that the complex was not naturally-occurring, but found that this did not transform the subject matter to a patent eligible concept 2013 the patent was not directed to the 125I-Musk-antibody complex, but to the interaction of the 125I-Musk and antibodies present in fluid, which is a naturally-occurring interaction. She analogized the facts with those of Mayo, in which while it 201ctook human action (the administration of a thiopurine drug) to trigger the desired reaction, the reaction itself happened apart from any human action. 201d Judge Talwani determined that in Mayo, a man-made substance was administered to a person and the by-product of the metabolization of that substance was observed, just as here.

Having determined that the patent was directed to a law of nature, Judge Talwani next determined that the claims did not include an inventive concept beyond the law of nature that would nevertheless make them patent-eligible, relying on statements in the patent specification that 201ciodination and immunoprecipitation are standard techniques in the art. 201d Athena argued that, while the iodination (radio-labelling) and immunoprecipitation processes were known at the time of invention, they were not well understood or routine when applied to complex molecules like proteins. The Court, citing the written description requirements of 35 US.C. 112, found that the specification lacked any such statements, and that Athena 2019s argument was contradicted by the specification.

In analyzing both the first and second steps of the Alice test, Judge Talwani relied on language in the specification that the purpose of the patent was for diagnosing neurotransmission or developmental disorders related to MuSK, finding that, on its face, the patent claims a process for detecting antibodies, not for creating the 125I-Musk. Because the antibodies occur naturally, it did not matter that 125I-Musk is not itself naturally occurring.