T 784/06 – Mental Interaction?

The main request before the Board comprised the following method claim:

1. A method of determining the genotype at a locus within genetic material obtained from a biological sample, the method comprising:

A. reacting the material at the locus to produce a first reaction value indicative of the presence of a given allele at the locus;

B. forming a data set including the first reaction value;

C. establishing a distribution set of probability distributions, including at least one distribution, associating hypothetical reaction values with corresponding probabilities for each genotype of interest at the locus;

D. applying the first reaction value to each pertinent probability distribution to determine a measure of the conditional probability of each genotype of interest at the locus, and

E. determining the genotype based on the data obtained from step (D).

Inventive step

[2] Claim 1 is directed to a five-step method of determining the genotype at a locus within genetic material obtained from a biological sample. In step A the material is reacted to produce a first reaction value. In steps B to E each the following mental activities are performed based on the application of mathematical methods: 

(i) forming a data set (step B ),

(ii) establishing a distribution set of probability distributions (step C ),

(iii) applying the first reaction value to each pertinent probability distribution (step D) and

(iv) determining the genotype based on the data obtained from step D (step E).

Thus, the claimed method is defined as a mix of technical and “non-technical” features, the latter, particularly steps C and D, being argued by the patentee to be core features of the invention.

[3] Such a method is to be considered an invention within the meaning of A 52(1) (see decision T 641/00 [4]), which, to be patentable, should inter alia satisfy the requirement of inventive step, being reminded in this respect that A 52(2) does not exclude from patentability any subject-matter or activity having technical character, even if it is related to the items listed in this provision, including mathematic methods, since, according to A 52(3), these items are only excluded “as such” (see decision T 154/04 [5(C)].

[4] It is established case law that non-technical features, such as mental activities, are not to be ignored in assessing inventive step, insofar as they interact with the technical subject-matter of the claim for solving a technical problem and thereby contribute to the technical character of the claimed subject-matter.

This principle was laid down in decision T 208/84 [16], re-affirmed in decision T 154/04 [8(G)] and recently confirmed in opinion G 3/08 [10.7.1, 10.13.2 (citing T 154/04), and 12.2.2]).

It is in conformity with decisions T 931/95 [8], T 641/00 [6], T 258/03 [5.3] and T 531/03 [2.5] which stipulate that for the assessment of inventive step account should be taken of only those features which contribute to the technical character of the claimed subject-matter.

[5] Thus, for assessing inventive step of the method of claim 1, the first and fundamental question to be answered is whether, also in the light of the description […], the mental activities of steps B to E interact with the technical activity of step A so as to yield a tangible technical result.

This question is answered positively by appellant 1 which sees in the data treatment the key for the determination of the genotype of the biological sample.

Appellant II answers negatively as in its view the data treatment steps are too general to provide any technical contribution beyond a trivial one.

[6] It is observed that steps B to C in claim 1 are indeed very generally formulated […]. The description of the patent specification is in this respect no more generous than the claims in terms of information.

In fact, the section entitled “Summary of the Invention” […] is no more that a mere repetition of the claims and an outline of the flow of data treatment with no concrete details.

As regards the [part of the] description […] with appendix A […] and the drawings, which are under the heading “Detailed Description of Specific Embodiments”, they concern an unspecified embodiment wherein the data treatment is carried out using computer processing employing a computer software called “GetGenos”. This section does not provide a truly useful example of how to proceed within the framework of the outlined method. In fact, the mathematic reasoning starting from an actual experimental value determined according to step A and ending with the determination of a precise genotype according to step E is not described in detail. Moreover, it fails to supply a reasonably complete and sufficient description of the software “GetGenos” especially developed by the inventors to produce GBA data, some aspects of the processing of which are discussed […].

This deficiency is remedied neither by the mathematic formulae referred to […] nor by the mere code lines written in C language contained in Appendix A […], which are said […] to serve the purpose of generating probability distributions. No informational content can be attributed to the constants, variables and functions mentioned therein.

[7] The above observations are seen as relevant here within the framework of the discussion on inventive step in that the stated deficiencies deprive the skilled reader of the information he/she needs to understand how to proceed from the first reaction value collected in step A through steps B, C and D to the determination on a probabilistic basis of the genotype of step E.

Under these circumstances, no interaction can be established between the technical activity of step A with the mental activities of steps B to E leading to a tangible technical result, as required by the case law.

The features of steps B to El which pertain to a general manner of analysing the data, are thus to be ignored in assessing inventive step, which assessment can therefore rely on a reasoning focusing only on the technical features of step A.

[8] A method of determining the genotype at a locus within genetic material obtained from a biological sample as featured in step A of the method according to claim 1, i.e. comprising reacting the material at the locus to produce a first reaction value indicative of the presence of a given allele at the locus, is known from the prior art, as represented, for example, by documents D7 and Dl3 on file.

[9] In document D7, a method for apo E genotyping is disclosed. Namely, the three-allelic polymorphism of the apolipoprotein E (apo E) gene in a population of six individuals is ana1ysed.b~c ombining PCR amplification with a simple solid-phase step reaction to detect the variable nucleotides in two given loci of the apo E gene with radioactive labels. After completion of the detecting step reaction, the radioactivity resulting from the incorporated radioactive isotopes is measured, giving a reaction value indicative for each locus of the presence of a given allele.

[10] In document D13, a method for determining the genotype of an organism at a given genetic locus is disclosed, which comprises obtaining from the organism a sample containing genomic DNA and carrying out assays using genetic bit analysis (GBA), i.e. the method especially referred to in the patent […], to produce a colorimetric value that is indicative of the presence of a specific allele at a given locus. Example 6 […] describes the method in relation to genotyping at a given human or equine locus.

[11] Thus, if the inventive step involved in the method of claim 1 has to be evaluated merely on the basis of the contribution offered by the general and broad wording of step A, the manifest conclusion is that there is no inventive step involved therein.

Therefore, the main request does not satisfy the requirements of A 56 and, as such, cannot form the basis for the maintenance of the patent in an amended form.

The Board finally revoked the patent.

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