Between February and May of this year, IPO, AIPLA and the ABA IP Section have released proposals for amendments to 35 U.S.C. s. 101 to void the Mayo/Alice Rule and to clarify the definition of an “abstract idea” as it relates to patent-eligibility. This is a topic I have followed closely since the March 2004 “Guidance” from the USPTO, particularly with respect to how Mayo, Myriad and Ariosa have made it nearly impossible to get claims allowed to diagnostic methods and to putative “natural products.” While the USPTO has noted that methods of medical treatment are outside of the Mayo/Alice Rule, the major question of how to patent a simple “If A, then B” diagnostic test has remained clouded, particularly since at least some of the Federal Circuit judges and Supreme Court justices believe that discovery of the utility or “correlation” by the inventor of a naturally-occurring relationship cannot provide the additional inventive step beyond the natural law required by Mayo. The “marked difference” requirement promulgated by the PTO to limit patenting natural products is so poorly shaped that drugs in an aqueous carrier are being rejected on the basis that water is a natural product.  Continue reading →