Updated USPTO guidance for biotech claims

On May 5 2016 the US Patent and Trademark Office (USPTO) published an update to its existing guidelines on patent-eligible subject matter under 35 USC §101. With respect to the life sciences and biotechnology industry, the guidelines included four new examples that demonstrate how the Alice/Mayo two-part test is applied to diagnostic methods and nature-based products. These examples provide helpful guidance to the life sciences industries, with relatively specific examples of claims that fall on either side of the patent-eligibility line.

The test for determining whether patent claims are patentable subject matter has two steps. First, the court determines whether the claims at issue are directed to a patent-ineligible concept (eg, a law of nature or a natural phenomenon). If so, the court then considers the elements of each claim both individually and as an ordered combination to determine whether the additional elements transform the nature of the claim into "something more" than the judicial exception itself.

Diagnostic methods
Example 29 is directed to the diagnosis and treatment of a hypothetical disease called 'julitis' by detecting a newly identified protein marker. The USPTO gave the following examples of claims that included patentable subject matter:

• A method of detecting a newly discovered protein biomarker (provided that the steps do not recite or describe a recognised judicial exception).
• A method of diagnosing a disease by detecting a newly discovered protein biomarker (provided that the claim recites the novel use of agents – eg, non-human antibodies to detect a human protein).
• A method of diagnosing a disease by detecting a newly discovered protein biomarker (provided that the claim recites the use of agents that are not "well-understood, routine and conventional" at the time – eg, newly identified antibodies).
• An individualised method of diagnosing and treating a disease encompassing detecting a newly discovered protein biomarker (while the claim recites a law of nature and/or abstract idea and the detection step is recited at a high level of generality, the administration component of a non-conventional agent in Step (d) provides "something more" than the judicial exception itself).
• A second individualised method of diagnosing and treating a disease encompassing detecting a newly discovered protein biomarker (while the claim recites a law of nature and/or abstract idea and the treatment recited is conventional for the disease at the time, the administration component in Step (d) provides "something more" than the exception(s) itself as the combination of elements add meaningful limits on the use of the exception).
• A method of treating a disease (provided that the claimed steps do not recite or describe a recognised judicial exception per se, but instead focus on the process of practically applying the product of nature).

The following is given as an example of a patent-ineligible claim: a method of diagnosing a disease by detecting a newly discovered protein biomarker (the claim encompasses a law of nature and/or abstract idea judicial exceptions and the detection steps are recited at a high level of generality, using routine and conventional antibody detection techniques, thereby providing nothing that is "significantly more" than the exception itself).

Example 31 relates to screening for gene alterations (ie, genetic biomarkers), and is modelled on the claims of Myriad’s US Patent 5,753,441. Five exemplary claims are included, where four are indicated to be "eligible" and one is said to be "ineligible". The four patent-eligible claim examples were variations on screening methods for detecting genetic biomarkers and were patent-eligible as reciting a technique that was not "well-understood, routine and conventional". The patent-ineligible claim example was a screening method directed to "comparing" sequences where the comparison of two pieces of information is recited at a high level of generality such that it could be deemed a mental process. This claim mirrors the claim invalidated in Myriad.

Nature-based products
Example 28 is directed to a newly developed hypothetical vaccine. It illustrates the application of the "markedly different characteristics" and "significantly more" analyses to nature-based composition claims. Six examples of eligible' claims are provided:

• A vaccine comprising an attenuated virus (the composition has markedly different structural and functional characteristics than its naturally occurring counterpart – ie, a mutated nucleic acid sequence and reduced virulence).
• A vaccine comprising an inactivated virus (the composition has markedly different structural and functional characteristics – ie, chemically modified nucleic acids and inability to replicate).
• A vaccine comprising a peptide and a pharmaceutically acceptable carrier selected from the group consisting of a cream, emulsion, gel, liposome, nanoparticle or ointment (the composition has markedly different structural and functional characteristics than the naturally occurring counterparts of the components of the composition).
• A vaccine comprising a peptide and an adjuvant, alone or in combination with a carrier (the mixture has a changed functional property from its naturally occurring components – ie, greatly enhanced immunogenicity).
• A vaccine delivery device comprising a peptide-coated microneedle array (the device incorporates "an unconventional limitation that confines the exception to a particular useful application of the exception" – ie, coated microneedle arrays).

The following is given as an example of an ineligible claim: a vaccine comprising a peptide and a pharmaceutically acceptable carrier (the composition components – it, peptide and  water as the "pharmaceutically acceptable carrier" under the broadest reasonable interpretation‑do not have markedly different structural and functional characteristics than their naturally occurring counterparts).

Example 30 is directed to a hypothetical dietary sweetener. The exemplary eligible claims are as follows:

• A sweetener comprising percentages of a sap component, water and a compound (the composition has markedly different functional characteristics (ie, taste) than the naturally occurring counterparts of the elements of the composition).
• A sweetener comprising percentages of a sap component, water or juice and pectin (the composition has markedly different structural and functional characteristics than the naturally occurring counterparts).
• A sweetener comprising sap component particles of a specified size (the composition has markedly different functional characteristics than the naturally occurring counterparts of the elements of the composition – ie, specific particle size distribution resulting in increased dissolution).
• An altered time release sweetener formulation (the composition has markedly different functional characteristics (ie, altered time release properties) than the naturally occurring counterparts of the elements of the composition).

The patent-ineligible claim examples are directed to a sweetener comprising a sap component and water. The claims fell within the ambit of the judicial exception as the sweetener elements (ie, sap) do not have markedly different structural and/or functional characteristics than their naturally occurring counterparts.

The examples included in this most recent USPTO update offer additional specific guidance and clarification to patent applicants and their attorneys and have been welcomed by those in the life sciences industry. In particular, the update indicates that when drafted properly, diagnostic methods can still be deemed patentable subject matter.