Subject matter eligibility: interpreting the USPTO guidelines

The new examination guidelines do not carry the weight of law, and it is not likely that their more extreme aspects will withstand judicial scrutiny, but practitioners need to keep tabs on court decisions, says Courtenay C. Brinckerhoff.

In March 4, 2014, the US Patent and Trademark Office (USPTO) published examination guidelines designed to aid examiners in applying the principles of recent Supreme Court decisions addressing when inventions relating to laws of nature, natural phenomena, and natural products are eligible for patenting under 35 USC §101.

While the guidelines respond directly to Molecular Pathology v Myriad Genetics, Inc, 133 SCt 2107 (2013), and Mayo Collaborative Services v Prometheus Laboratories, Inc, 132 SCt 1289 (2012), they also draw from older Supreme Court decisions, such as Diamond v Chakrabarty, 447 US 303 (1980), and Funk Brothers Seed Co v Kalo Inoculant Co, 333 US  127, 131 (1948), and reach subject matter far beyond the ‘isolated DNA’ at issue in Myriad and the personalised medicine methods at issue in Prometheus.

Indeed, many have criticised the guidelines for broadening the exceptions to patent eligibility and threatening to discourage investment and innovation in biotechnology, pharmaceuticals, and personalised medicine.