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Computer implemented inventions in biotechnology and healthcare at the EPO

Keltie LLP

K2 IP Limited

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dna-1811955_1920IPcopy recently attended an EPO presentation from the EPO’s Bioinformatics team on the subject of computer implemented inventions (CII) in biotech and healthcare and how to go about patenting such inventions.

This author works in Keltie’s software team and so is familiar with CII related inventions. Bioinformatics inventions however can sit somewhere between the biotech and software disciplines and so this presentation provided a handy insight for attorneys from either field into the subject area.

CIIs have a couple of “hurdles” to overcome – the exclusion from patentability under Art 52 EPC and inventive step under Art 56 EPC.

The first hurdle requires a patent claim to be analysed feature-by-feature to determine whether the claimed elements of the invention fall within one of the excluded areas of the EPC. At this stage claims are assessed independently from prior art and each feature is taken in isolation. If at least one feature of the claim is technical then the Art 52 EPC requirement is met. In practice, this requirement is met with relative ease by reciting a computer, a memory or some other tangible technical feature (a “computer implemented step” or “measuring step”).

The EPO then move on to the second hurdle which is more difficult to overcome. The claims of a CII application need to meet novelty and inventive step requirements as for all other applications and as far as the novelty assessment is concerned all features (technical and non-technical) are taken into account.

For inventive step, the problem-solution approach is used. For mixed-type inventions (involving a mixture of technical and non-technical features) all features that contribute to the technical character of the invention are taken into account. It is important to note that even features that, when taken in isolation, are regarded as non-technical are taken into account as long as, in the context of the invention, they contribute to producing a technical effect serving a technical purpose and thereby contribute to the technical character of the invention.

The clear presence of a technical purpose either explicitly or implicitly in the claims of a CII claim is important.

Examples of technical purposes include: computer-implemented algorithms for determining a specific technical parameter; determining relationships in the context of a solution to a technical problem (e.g. phylogenetic trees used for vaccine selection); providing information for a technical task a user has to master (e.g. display of information enabling identification of experimental errors); specific medical purposes not requiring further interpretation (e.g. diagnosis of a disease); deriving body temperature of a subject from an ear temperature detector; providing a genotype estimate based on an analysis of DNA samples (as well as providing a confidence interval for the estimate to quantify reliability), configuration of medical equipment, updating software on medical equipment, context aware user interfaces, tele-medical control of medical devices.

For inventions involving medical treatment there will usually be a technical purpose where the treatment, or recommendation related to treatment, aims to achieve objectively measurable or determinable amelioration. In other words, the measurement/determination needs to be independent of the evaluating person and needs to be verifiably linked to the outcome. Examples of medical treatment include: treatment of a pathological condition, determination of treatment parameters and improvement of posture for medical (as opposed to aesthetic) reasons.

Examples of non technical purposes include: mathematical algorithms which only lead to abstract data; the processing of data without an adequate technical purpose; cognitive data structures which aren’t used for the solution of a technical problem; presenting information in a visually attractive way.

Inventions involving administrative methods within the healthcare environment are unlikely to serve a technical purpose (e.g. billing workflows, determining adherence to a workflow, maintaining hospital staff schedule).

So, as long as a feature serves a technical purpose in the context of the claim it can make a claim inventive even if it is non-technical when taken in isolation (G-VII, 5.4). A pitfall for overcoming the second hurdle may occur when a claim is insufficiently detailed – the presence of a mathematical method which serves a technical purpose may not be enough if the claim is not functionally limited to that technical purpose. In other words if essential steps are left vague or omitted then they will not be taken into account when assessing inventive step (even if the information is present in the main body of the specification).

An example of the first hurdle/second hurdle analysis was provided with respect to T2050/07. Claim 1 from that case is reproduced below and is marked up to indicate the technical purpose, the technical features that overcome the first hurdle and the features which contribute to overcoming the second hurdle (these features were what the Board assessed to distinguish the claim over the prior art):

“1. A method of analyzing a DNA sample that contains genetic material from at least two individuals to determine a probability distribution of genotype likelihood or weight in the sample, comprising the steps:

(a) amplifying the DNA sample to produce an amplification product comprising DNA fragments, wherein each allele at a locus is amplified to generate relative amounts of DNA fragments of the alleles that are proportional to the relative amounts of template DNA from the alleles in the DNA sample, and wherein the amplification product produces a signal comprising signal peaks from each allele the amounts of which are proportional to the relative amounts of the alleles;

(b) detecting signal peak amounts in the signal and quantifying the amounts using quantifying means that include a computing device with memory to produce DNA length and concentration estimates from the sample;

(c) resolving the estimates into one or more component genotypes using automated resolving means, said resolution into one or more genotypes including solving the coupled linear equations d = G.w+e for the relevant loci (i), individuals (j) and alleles (k), in which d is a column vector which describes the peak quantitation data of a DNA sample from the signal, G is a matrix that represents the genotypes in the DNA sample, with a column j giving the alleles for individual j, w is a weight column vector that represents relative proportions of template DNA in the sample and e is an error vector, wherein the solution includes calculation of data variance σ2 from the linear model d = G.w+e together with the global minimal solution Pd = Gw0, where Pd is the perpendicular projection point which is the closest point to d in mixture space C(G) and w0 is the minimum weight vector, using linear regression methods, and calculating a probability distribution of the data assuming a normal distribution and that the error is unbiased, so that E(e) = 0, but has a dispersion D[e] =σ2V in which V is the covariance matrix of the data; and

(d) determining, using the probability distribution of the data, a probability distribution of genotype likelihood or weight in the DNA sample

It was noted by the Board that the distinguishing features were (i) a modification of a linear equation ‘p=G x w’ in D6 to d=G.w+e in the invention (i.e. the presence of an error vector modelling measurement error) and (ii) the calculation of a data variance σ2 from the linear model together with the global minimal solution “Pd=Gw0

Taken in isolation the distinguishing features were non technical but within the context of the invention they contribute to producing a technical effect serving a technical purpose.

In general it was also noted during the talk that a technical purpose may be present where there is an objective measurement, where a result has a technical meaning in the context of steps to be taken (e.g. display of diagnosis/treatment recommendation) or where data processing steps have an inherent technical effect regardless of the meaning/use of the data.

Mark Richardson 21 November 2019


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