The US Patent and Trademark Office (USPTO) has concluded that recent decisions of the US Supreme Court relating to patents for genes and for diagnostic methods mean that mixtures of ‘naturally-occurring materials’ are not patent-eligible – at least, not unless one or more of the components has been ‘changed’ in some way from its natural state.The USPTO has published an extensive (93-slide) presentation used for examiner training [PDF, 972KB] on the Supreme Court’s interpretation of section 101 of the US patent statute in Mayo Collaborative Services v Prometheus Laboratories, Inc. (2012) and Ass’n for Molecular Pathology v Myriad Genetics, Inc. (2013). In an example to be found on slide no. 55, examiners are told that ‘gunpowder’ would not be eligible for patenting (even if it was not already known) because as ‘a mixture of three naturally occurring materials: potassium nitrate, sulfur and charcoal’ it is ‘not markedly different’ from naturally-occurring materials, ‘because none of the components have been changed.’
This will no doubt come as a surprise to many people, who would not have held any real doubts that gunpowder was ‘invented’ by the Chinese, around the 9th century C.E. Indeed, as the quite well-researched Wikipedia entry on the History of Gunpowder explains, it took a few centuries, and a number of educational accidents, to refine the proportions of gunpowder’s constituent parts to produce maximum explosive effect.
While there is no question that effective gunpowder can be made by combining materials that occur in nature, the resulting combination is not (fortunately) naturally-occurring! There is, to my knowledge at least, nowhere in the natural world at which dangerously flammable reserves of potassium nitrate, sulphur and charcoal can be found just lying around in wait of a serendipitous lightning strike! (Interestingly, however, there is evidence that 17 nuclear fission reactors once formed and operated naturally for around a million years in what is now Gabon, western Africa.)
Conventional wisdom would have it that, in the case of a combination like gunpowder, the prospective invention lies in bringing the components together to create something useful. If the combination is not previously known, and not obvious, then it should be patentable. Apparently, the USPTO no longer believes in this conventional wisdom!
Patent-Eligibility, Mayo and Myriad
Section 101 embodies the ‘threshold question’ of subject matter eligibility, i.e. whether the invention claimed is the kind of thing for which patents may be granted. In Australia, the analogous requirement is that a claimed invention must be for a ‘manner of manufacture’.In the Mayo decision, the Supreme Court held that a method for dosing a medication based on a patient’s metabolite levels after drug administration involved the application of a ‘law of nature’, and therefore was not patent-eligible. In the Myriad decision, the Court held that an isolated DNA molecule having a nucleotide sequence matching that of naturally occurring genes is ineligible because it is a ‘product of nature’.
The new USPTO guidelines for assessing subject-matter eligibility recognise that while section 101 identifies four categories of patentable subject matter – ‘any new and useful process, machine, manufacture, or composition of matter’ – the courts have in turn identified four exclusions, or ‘judicial exceptions’ – abstract ideas, laws of nature (or natural principles), natural phenomena, and natural products.
Contentious subject matter such as business methods and computer-implemented processes are considered for eligibility under the ‘abstract ideas’ exception. It is generally understood that mathematical formulae fall within this exclusion.
‘Laws of nature’ and ‘natural phenomena include natural principles and naturally-occurring relations or correlations, such as the ‘law’ of gravity, the disinfectant qualities of ultraviolet light and the relationship between blood glucose levels and diabetes (slide 20 of the USPTO presentation).
So What’s New in the USPTO Guidelines?
The new exclusion being applied by the USPTO in the wake of the Myriad case are those relating to ‘natural products’. According to slide 26, ‘eligibility requires more that “the hand of man”’. A ‘claimed product must be both non-naturally occurring, and markedly different from naturally occurring products.’The requirement for a marked (or ‘significant’) difference between the natural product and the claimed product is not new. In the 1948 case of Funk Brothers Seed Co. v Kalo Inoculant Co., 333 US 127, the Supreme Court found that claims directed to particular mixtures of bacteria, intended for application to leguminous plants, were not patent-eligible. The bacteria were naturally occurring, but different plants benefited from the presence of different bacteria, while other bacteria would inhibit the beneficial effects.
What Funk Brothers had found and patented was that certain combinations and strains of bacteria could be effective for a range of different plants, while avoiding the inhibiting effect that would normally be expected from the combination.
However, the Court determined that the qualities of the bacteria were naturally-occurring, and that the aggregation of selected strains of bacteria by Funk Brothers was a patent-ineligible application of a natural principle – albeit a principle that had not previously been known. The Court explained that:
The application of this newly discovered natural principle to the problem of packaging of inoculants may well have been an important commercial advance. But once nature's secret of the noninhibitive quality of certain strains of the species of Rhizobium was discovered, the state of the art made the production of a mixed inoculant a simple step. Even though it may have been the product of skill, it certainly was not the product of invention.
Funk Brothers – Ineligible, or Obvious?
The Funk Brothers case was decided under the previous US patent law, which did not make a clear distinction between ‘eligibility’ and ‘invention’ (i.e. what we would now regard as the requirement for nonobviousness under section 103). As can be seen in the above passage, it is not clear whether the Court was concerned that the claimed invention was too obvious to justify a patent or that when the discovery of a natural principle is applied in a trivial manner, then the subject matter is not patent-eligible.However, while the legal principles espoused in Funk Brothers have generally been approached with caution, the Supreme Court seems subsequently to have treated it as having been decided on eligibility rather than obviousness.
A later case, Diamond v Chakrabarty, 447 US 303 (1980), concerned a genetically-modified bacterium. By a slim majority (5-4), the Supreme Court held in Chakrabarty that a ‘live, human-made organism’ is patent-eligible, because it is ‘markedly different’ from the naturally-occurring organism from which it has been derived.
Myriad – A ‘Perfect Storm’ of Ineligibility?
In Myriad this older Supreme Court law has combined to create what the USPTO regards as the new rules for patent-eligibility in relation to naturally-occurring materials. As explained on slide 28 of the training package:- Myriad relies on Chakrabarty and serves as a reminder that Chakrabarty’s markedly different criterion is the eligibility test across all technologies for product claims reciting natural products
- Myriad explains that Funk Brothers’ combination of bacteria was not eligible because the patentee ‘did not alter the bacteria in any way’
Conclusion – The USPTO Must Have This Wrong!
In my opinion, what the USPTO is teaching its examiners simply cannot be right.It is a fundamental principle of the interpretation of patent claims that a claim must be considered as a whole. It may be that each individual element of a combination claim is well-known, however if the combination is novel then the claim is potentially patentable.
This does not mean that any simple, but previously undisclosed, combination of known components will automatically be eligible for patent protection. If each component of the combination merely performs its known function, with nothing new arising from an interaction between the parts, then what you have is what the Australian courts have called a ‘collocation’. Mere collocations are not patent-eligible. A new working relationship between parts is required for a combination of known components to be patent-eligible. I note that this is one way to understand the outcome in Funk Brothers.
But when potassium nitrate, sulphur and charcoal are brought together in suitable proportions, they unquestionably interact in ways that are not known in the natural world!
Of course, they only do so because they are following the ‘laws’ of chemistry, which are themselves the aggregate effect of the more fundamental ‘laws’ of physics. But even a mechanical device, such as a motor, operates by following the laws of physics once the constituent rotors, axles, bearings, gears etc have been brought together in a suitable arrangement by human design. The mere fact that inventions follow the laws of nature does not disqualify them from patentability, otherwise nothing would be patent-eligible!
I understand that the USPTO is inviting public comment on its guidelines, via email to myriad-mayo_2014@uspto.gov. I expect it will receive much strongly-worded feedback!
Before You Go…
Thank you for reading this article to the end – I hope you enjoyed it, and found it useful. Almost every article I post here takes a few hours of my time to research and write, and I have never felt the need to ask for anything in return.
But now – for the first, and perhaps only, time – I am asking for a favour. If you are a patent attorney, examiner, or other professional who is experienced in reading and interpreting patent claims, I could really use your help with my PhD research. My project involves applying artificial intelligence to analyse patent claim scope systematically, with the goal of better understanding how different legal and regulatory choices influence the boundaries of patent protection. But I need data to train my models, and that is where you can potentially assist me. If every qualified person who reads this request could spare just a couple of hours over the next few weeks, I could gather all the data I need.
The task itself is straightforward and web-based – I am asking participants to compare pairs of patent claims and evaluate their relative scope, using an online application that I have designed and implemented over the past few months. No special knowledge is required beyond the ability to read and understand patent claims in technical fields with which you are familiar. You might even find it to be fun!
There is more information on the project website, at claimscopeproject.net. In particular, you can read:
- a detailed description of the study, its goals and benefits; and
- instructions for the use of the online claim comparison application.
Thank you for considering this request!
Mark Summerfield
