The United States Patent and Trademark Office (USPTO) has recently issued further interim guidance for determining patent eligibility for claims relating to nature-based products and abstract ideas. The interim guidance is accompanied by two sets of examples in which the patentability of a number of different scenarios for nature-based products (including natural products and laws of nature) and abstract ideas is considered.
The interim guidance and accompanying examples are more encouraging for would-be patentees than previous interim guidance from the USPTO, but significant challenges remain in seeking to gain commercially useful protection, particularly in view of the differing and often conflicting requirements in different territories in some technological areas (such as natural products).
The following comments expand on the revised USPTO's approach, but for detailed discussion of the strategic considerations and options for a particular invention, please contact your usual Potter Clarkson representative.
Twin track approach
The USPTO's concern is, in essence, in preventing patent claims from being granted that "tie up" or monopolise a (pre-existing, but possibly unrecognised) "law of nature", "natural phenomenon" or "abstract idea" in such a way that the public would be precluded from using that law of nature, natural phenomenon or abstract idea. If the USPTO concludes that a patent claim would lead to such a monopoly then the claim is considered to be directed to patent-ineligible subject matter and is not allowable.
The USPTO is proposing two ways in which examiners can assess patent eligibility: a "Simplified analysis" approach and a three-step test for more challenging decisions.
The first step is merely the existing assessment of whether the claim is to "a process, machine, manufacture or composition of matter". The focus of the interim guidance is found in Steps 2A and 2B of the analysis.
Step 2A asks whether the claim is "directed to" a law of nature, a natural phenomenon, or an abstract idea" (all classed as "exclusions" from potentially patentable subject matter). The USPTO has explained that "directed to" means that the exclusion is or forms part of the technical features of the invention as defined in the claims, and not merely that the exclusion is involved (as it is clear that the laws of nature, natural phenomenon and abstract ideas at some level underpin the functioning of everything).
As discussed further below, claims including a nature-based product are analysed in Step 2A to identify whether the claim is directed to a "product of nature" (considered as excluded subject matter, either as a natural phenomenon or as a law of nature); or whether the nature-based product in the claim has markedly different characteristics from its naturally occurring counterpart based on structure, function, and/or other properties (in which case it is NOT considered to be excluded subject matter).
If the answer to Step 2A is "Yes", then Step 2B is invoked and this asks whether the claims include additional elements that amount to "significantly more" than the excluded subject matter. "Significantly more" has not been defined clearly by the USPTO, but examples provided by the USPTO of elements which may qualify as "significantly more" include:
Improvements to another technology or field;
Improvements to the functioning of the computer itself (for software claims);
Adding unconventional steps that confine the claim to a particular useful application; and
Limitations beyond linking the exclusion to a particular technology environment.
This will clearly be a hotly-contested assessment with scope for argumentation and potentially significant impact on the likely scope and commercial value of the claim.
The new guidelines include, for the first time, a simplified analysis which allows examiners the flexibility to decide that a claim that involves a nature-based product or abstract idea "when viewed as a whole, clearly does not seek to tie up any judicial exception such that others cannot practice it." Such cases do not need to go through the full three-step test.
This common-sense approach applies to, for example:
Complex manufactured industrial products or processes, such as a robotic arm that operates using mathematical formulae;
Products that do not tie up a nature-based product, such as an artificial hip coated with a naturally occurring mineral; and
Products merely including nature-based components such as phone with an electrical contact made of gold.
As noted above, a further significant difference from previous interim guidance is the concept that nature-based products may be considered as patent-eligible subject matter without having to be considered under Step 2B (and the vaguely defined "significantly more" analysis) by possessing a "markedly different" functional, structural and/or other property. Examples include:
Biological or pharmacological functions;
Chemical and physical functions; and
Structure and form whether chemical, genetic or physical.
The interim guidance and accompanying examples have also clarified that process claims will not be objected to on eligibility grounds for reciting nature-based products, unless the process cannot be distinguished from the natural process (such as "a method of providing an apple").
Examples of eligible nature-based products are:
Compositions of multiple natural products that do not occur together naturally and/or function differently when mixed (e.g. gunpowder, fireworks, a fruit juice drink including a stabiliser); and
Modified natural products (including modified versions of small molecules, proteins, nucleic acid constructs and cells) and modified natural processes as well as the use of such products and processes.
The examples and discussion of abstract ideas (such as business methods, and software inventions) are much less extensive than those provided for natural products. However, the guidance does draw together multiple other pieces of prior guidance on this area from recent months into a single place in order to confirm that abstract idea inventions need to address a technological and/or business problem that has not been previously addressed in a non-technological form.
The examples provided of eligible abstract ideas are all activities that are inextricably linked to a technology (e.g. a computer) and include:
Removing of malicious code from electronic messages;
Generating a composite web page to address a business need;
Digital image processing whereby the image is altered; and
Processing of multiple data points to determine the physical position of a receiver forming part of a GPS system
The guidance from the USPTO is currently interim in nature, and changes are therefore possible in the finalised guidance. However, this guidance provides more information as to what may be considered as patentable subject matter in the United States and, for the first time, explicitly allows for a common sense approach to be applied by the USPTO when examining patent filings that incorporate, as a key element of a broader technical invention, an element that is a nature-based product or abstract idea.
Your usual Potter Clarkson representative will be able to advise further if you have any questions.
The Interim Guidance (December 2014) may be found here; and the examples of nature-based products (December 2014) and abstract ideas (January 2015) found here and here respectively. Interested parties may submit comments to the USPTO on the interim guidance by 16 March 2015: please click here.