After some delay, the US Patent Office (USPTO) has now released its 2014 Interim Guidance on Patent Subject Matter Eligibility, a copy of which can be found here.

A number of examples/scenarios are presented in the guidelines, but they are all based on the well trodden decisions of the Supreme Court and Federal Circuit so they tend to read as a justification for the conclusions previously reached as to subject matter eligibility/ineligibility. However, a supplement to the guidelines, providing examples of how the new analysis is to apply to claims reciting nature-based product can be found here. We recommend a thorough reading of these Examples, as they go some way towards illustrating how the USPTO will likely construe various types of claims (e.g., purified natural products, purified proteins, pharmaceutical compositions, and isolated cell populations). Gun-powder, considered to be patent-ineligible under the previous guidelines, is now considered patent eligible under the new guidelines!

The guidelines are open to written public comment and a public forum for soliciting oral comments is expected around mid-January 2015. See below for details.

The salient features of the guidelines can be summarised as follows:

  • The previous convoluted twelve factor test for assessment of subject matter eligibility has been removed and replaced by a two part analysis which involves:
    • i) determining if the claim is directed to a law of nature, a natural phenomenon, or an abstract idea (so-called “judicial exceptions”) and
    • ii) determining whether any element or combination of elements in the claim is sufficient to amount to significantly more than the judicial exception.

“Significantly more” is to be understood as an improvement to, or an act that effects a transformation or reduction of a particular article to a different state or thing. It also needs to be something more than the application of well-understood, routine and conventional activities.

  • If the claim recites at least one “nature-based product”, it is analysed under i) to determine whether it is “markedly different” from its closest “naturally occurring counterpart in its natural state”. A product will be considered to be markedly different if modified by virtue of structure, function and/or other properties which are not an inherent or innate characteristic of the naturally occurring counterpart. This is a relaxing of the criteria from the previous guidelines which required that the product had to be structurally different from the naturally occurring counterpart. If the nature-based product is determined to be markedly different from the closest naturally occurring counterpart, the claims is directed to eligible subject matter. If the nature-based product is determined not markedly different from the closest naturally occurring counterpart, then the claim must also be analysed under (ii) (AKA the “Mayo” test), the outcome of which will determine the claim’s subject matter eligibility.
  • A claim that recites a nature-based product limitation (whether man made or not) that does not exhibit markedly different characteristics from its naturally occurring counterpart in its natural state is not eligible subject matter. Under this analysis, a claim to an isolated cDNA is considered patent eligible on the basis that an exon-only sequence is considered to rise to the level of a “marked difference” sufficient to meet the second part of the analysis.
  • It is worth noting that claims reciting a combination of “nature-based products” will be analysed by comparing the features of the combination to the “closest naturally occurring counter-part,” However, if there is no naturally occurring counter-part, the analysis does not end there. Rather, the combination is compared to the individual components as found in nature to determine whether the combination is markedly different from the individual components as found in nature. However, the nature-based product examples suggest that the inclusion of an excipient (e.g. preservative or solubilising agent) in a composition comprising an active agent, or enveloping the active agent in a polymeric material would be enough to render the claim patent eligible. Additionally, a demonstration that the components of the composition (whether explicitly or inherently) interact in some way to produce markedly different characteristics from their natural state should render a composition claim patent eligible.
  • While the guidelines address the subject matter eligibility of method of treatment claims, they do not elaborate on the eligibility of diagnostic methods which is a disappointing omission. The guidelines merely address the relevance of the two-part analysis outlined above to the Mayo v Prometheus fact situation. However, the take home message still appears to be that method steps of diagnostic claims will need to involve more than well understood, routine, conventional steps.
  • Claims to isolated antibodies and cells (e.g. stem cell lines) will need to be considered on a fact-by-fact basis. Composition of matter claims to an isolated antibody or cell on its face otherwise identical to one found in nature will be patent ineligible outright (whether man made or not). Antibodies which have been modified (e.g. by mutation) compared to the naturally occurring sequence or which are chimeric or humanised versions of naturally occurring antibodies are considered to be patent eligible. With regard to cells, changes in phenotype resulting from human manipulation may be sufficient to result in markedly different characteristics sufficient for patent eligibility.

Further Information

Any member of the public may submit written comments on the Interim Eligibility Guidance and claim example sets by electronic mail message over the Internet addressed to Electronic comments submitted in plain text are preferred, but also may be submitted in ADOBE® portable document format or MICROSOFT WORD® format. The comments will be available for public inspection here at this Web page. Because comments will be available for public inspection, information that is not desired to be made public, such as an address or a phone number, should not be included in the comments. Comments will be accepted until March 16, 2015.

A public forum will be hosted at the Alexandria campus of the USPTO on 22 January 2015 (5:00 AM – 9:00 AM Australian Eastern Daylight Time (AEDT) to receive public feedback from any interested member of the public. The meeting will also be accessible via WebEx.

The Eligibility Forum will be an opportunity for the Office to provide an overview of the Interim Eligibility Guidance and for participants to present their interpretation of the impact of Supreme Court precedent on the complex legal and technical issues involved in subject matter eligibility analysis during examination by providing oral feedback on the Interim Eligibility Guidance and claim example sets. Individuals will be provided an opportunity to make a presentation, to the extent that time permits.