On March 19th, the USPTO released 93 slides as training materials to help Examiners navigate the lengthy ”Guidelines for Subject Matter Eligibility Analysis of Claims Reciting or Involving Laws of Nature,” et al. (A copy of the slides is available at the end of this post.) Although multiple law review articles and blog posts will surely be written about various features of these Guidelines and Training Materials, I would like to focus, fairly briefly I hope, on the two most ambitious, and egregious aspects of these materials.
The first is the unprecedented (literally) expansion of the definition of “natural product” to require that the claimed natural product must be structurally different from the product as it occurs in its natural source, and not simply be functionally changed or improved. See, e.g., slides 48-56. This heightened patent-eligibility requirement appears to have been extracted from Chakrabarty, which described the altered bacterium as having “markedly different characteristics from any found in nature, and one having the potential for significant utility.” However, I don’t see any requirement that the new bacterium be markedly structurally different than its naturally occurring cousins. In Myriad, the isolated genomic DNA was unquestionably structurally different, but the Court based its holding on its opinion that its primary data storing and transmitting properties were unchanged. The Court minimized the import of the structural changes: “Myriad’s claims…[do not] rely in any way on the chemical changes that result from the isolation of a particular section of DNA.”