Monday, 31 January 2011

T 206/08 - Unexplored Fields

One of the more delicate questions for patent drafters is how many examples have to be disclosed in order for the invention to be sufficiently disclosed. Obviously, this depends on the breadth of the claimed subject-matter and on the relevant skilled person. In the mechanical realm, very often one exemplary embodiment will be enough, but in the field of chemistry more than that may be required.

The present appeal is from the decision of the Opposition Division (OD) to revoke the opposed patent.

Claim 1 of the main request before the Board (which was also the first auxiliary request before the OD) read:
1. A detergent composition comprising a protease and from 0.00018% to 0.06% pure enzyme by weight of total composition of:
(a) α-amylase characterized by having a specific activity at least 25% higher than the specific activity of Termamyl® at a temperature range of 25°C to 55°C and at a pH value in the range of 8 to 10, measured by the Phadebas® α-amylase activity assay comprising diluting said α- amylase in 50 mM Britton-Robinson buffer, adding 1 ml of this α-amylase solution to 5 ml 50 mM Britton-Robinson buffer containing one Phadebas® tablet suspended therein and measuring the absorbance at 620 nm after 10 or 15 minutes of incubation (testing time) in the range of 0.2 to 2.0 absorbance units; and/or;
(b) α-amylase according (a) comprising the amino sequence shown in SEQ ID No. 1 or an α-amylase being at least 80% identical with the amino acid sequence shown in SEQ ID No.1 and/or;
(c) α-amylase according (a) comprising the amino sequence shown in SEQ ID No.2 or an α-amylase being at least 80% identical with the amino acid sequence shown in SEQ ID No.2 and/or;
(d) α-amylase according (a) comprising the following amino sequence in the N-terminal: His-His-Asn-Gly-Thr-Asn-Gly-Thr-Met-Met-Gln- Tyr-Phe-Glu-Trp-Tyr-Leu-Pro-Asn-Asp (SEQ ID No.3) or an α-amylase being at least 80% identical with the amino acid sequence shown (SEQ ID No.3) in the N-terminal and/or;
(e) α-amylase according (a-d) wherein the α- amylase is obtained from an alkalophilic Bacillus species and/or
(f) α-amylase according to (e) wherein the amylase is obtained from any of the strains NCIB 12289, NCIB 12512, NCIB 12513 and DSM 935 and/or;
(h) Variant of a parent α-amylase, which parent α- amylase (i) has one of the amino acid sequences shown in SEQ ID No. 1 , ID No.2 or ID No.4 respectively, or (ii) displays at least 80% identity with one or more of said amino acid sequences, in which variants: (i) at least one amino acid residue of said parent α-amylase has been deleted; and/or (ii) at least one amino acid residue of said parent α-amylase has been replaced by a different amino acid residue; and/or (iii) at least one amino acid residue has been inserted relative to said parent α-amylase; said variant having an α-amylase activity and exhibiting at least one of the following properties relative to said parent α-amylase: increased thermostability, increased stability towards oxidation, reduced Ca ion dependency, increased stability and/or a-amylolytic activity at neutral to relatively high pH values, increased a-amylolytic activity at relatively high temperature and increase or decrease of the isoelectric point (pI) so as to better match the pI value for α-amylase variant to the pH of the medium.
The Board raises a sufficiency problem.

[3.1] This claim […] defines detergent compositions containing protease and a defined amount of α-amylases (AA). In particular, the claimed compositions may comprise any AA that displays a superior amylolytic activity in the PAA assay as defined in feature “(a)” (due to the option “and/or” at the end of this feature).

[3.2] According to the established jurisprudence of the Boards of Appeal the requirement for sufficient disclosure should be objected to by rendering credible that there exist serious doubts, substantiated by verifiable facts, that the disclosure provided is insufficient for carrying out the invention.

It is also established jurisprudence of the Boards of Appeal that, even though a reasonable number of trial and error experiments is permissible, there must be available adequate instructions in the specification or on the basis of common general knowledge which would lead the skilled person necessarily and directly towards success through the evaluation of initial failures or through an acceptable statistical expectation rate in the case of random experiments (see Case Law of the BoA of the EPO, 6th edition 2010, point II.A.4.2).

[3.3] In the present case, the definition of the AAs suitable for preparing the claimed detergent compositions only in terms of the superior activity to be verified as described in feature “(a)” extends the area in which the skilled person should possibly search further suitable AAs to all naturally occurring or engineered amylolytic enzymes.

On the other hand, the patent in suit just discloses (also via the reference to documents D1 and D2) only a few examples of the AAs complying with feature “(a)” all manifestly similar in their structure, in particular at the N-terminal.

Under these circumstances, the fact brought forward by the [opponents], and undisputed by the [patent proprietor], that there exist many other sorts of AAs whose structures can be completely different from those of the AAs exemplified in the patent in suit, renders evident that the person skilled in the art enters a totally unexplored field when searching for further embodiments of the claimed subject-matter among the AAs substantially different from the few exemplified in the patent in suit.

Accordingly, he cannot have any particular expectation of success when randomly attempting the PAA assay among these AAs. Alternatively, the skilled person is obliged to start a complete research program in the hope of finding any criteria (e.g. as to which other segments of amino acid sequence, in addition to those present in the sequences already specified in claim 1, are more frequently associated with the required superior enzymatic activity) for selectively limiting the group of AAs in which to search.

Hence, the Board concludes that the skilled person is very likely to face a large amount of experimental work, before being able to realize embodiments of the claimed detergent composition based on AAs substantially different from the few exemplified.

[3.4] Therefore, the Board finds that the subject-matter of claim 1 is not sufficiently disclosed and, thus, that the Appellant’s main request is not allowable in view of A 83.

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