T 1644/08 – Hindsight Anticipation

Although there is only one A 54, there are indeed several concepts of novelty, depending on the technical field that is considered. The present decision shows that biotech has its particularities.

The present appeal was filed by the opponent after the Opposition Division had rejected its opposition.

Independent claims 1 and 10 of the main request before the Board read:

1. A DNA construct comprising a DNA sequence encoding an enzyme exhibiting endoglucanase activity, which DNA sequence comprises

a) the DNA sequence shown in SEQ ID No. 8, or the DNA sequence obtainable from the plasmid in Saccharomyces cerevisiae DSM 10081, or

b) an analogue of the DNA sequence shown in SEQ ID No. 8 or the DNA sequence obtainable from the plasmid in Saccharomyces cerevisiae DSM 10081, which

i) has at least 90% identity with the coding region of the DNA sequence shown in SEQ ID No. 8 or the DNA sequence obtainable from the plasmid in Saccharomyces cerevisiae DSM 10081, or

ii) encodes a polypeptide which has at least 90% identity with the polypeptide encoded by a DNA sequence comprising the DNA sequence shown in SEQ ID No. 8 or the DNA sequence obtainable from the plasmid in Saccharomyces cerevisiae DSM 10081.

10. An enzyme exhibiting endoglucanase activity, which enzyme is

a) encoded by a DNA construct according to any of claims 1-4, or

b) at least 90% identical to the amino acid sequence shown in SEQ ID No. 9.

Having found this request to be admissible and to comply with A 123 and A 84, the Board deals with the novelty objections raised by the opponent:

[10] Document D1 discloses the cDNA sequences encoding the (~ 43 kD) endoglucanases from Humicola insolens DSM 1800 and from Fusarium oxysporum DSM 2672 as well as the amino acid sequences of both enzymes […]. Document D1 defines a homologue of these enzymes as

“… a polypeptide encoded by DNA which hybridizes to the same probe as the DNA coding for the endoglucanase enzyme with this amino acid sequence (of the appended Sequence Listing) under certain specified conditions …” […].

In Example 2, it is stated that for screening a cDNA library from Humicola insolens and for cloning a cDNA encoding the endoglucanase “(t)he oligonucleotide probes were made on the basis of amino acid sequences of tryptic fragments of the purified ~ 43 kD endoglucanase” and several probes are disclosed in Table 1 of document D1 […]. Homologous endoglucanases derived from other microorganisms producing cellulolytic enzymes are also contemplated and a list of possible microorganisms is explicitly given in document D1 […].

[11] It is not contested that the specific sequences of the endoglucanases disclosed in document D1 do not fall within the scope of the claims of the main request and that the homologues referred to in that document are disclosed only in a generic form without providing any particular examples thereof. Moreover, there is no mention of Thielavia, let alone of Thielavia terrestris NRRL 8126, as a possible source for cloning these homologous endoglucanases in the list of microorganisms disclosed in document D1.

[12] Nevertheless, the [opponent] argues that, in view of the high (~70%) degree of identity between the enzymes of document D1 and the endoglucanase from Thielavia terrestris NRRL 8126, their amino acid sequences share long stretches of identity […] and probes based on these identity regions will hybridize with a DNA sequence encoding the endoglucanase from Thielavia terrestris NRRL 8126 and with DNA sequences encoding these endoglucanases of document D1. Therefore, the former enzyme falls within the definition of homologues given in document D1 and, in line with decision T 1120/00, these homologues anticipate the endoglucanase of the patent-in-suit […].

[13] The board does not share this view. The presence of stretches of identity between the amino acid sequences of the endoglucanases - and the DNA sequences encoding them - disclosed in document D1 and in the patent-in-suit is not contested. However, the determination of these stretches and the selection of specific oligonucleotide probes within these regions, i.e. the common probes, require hindsight based on the knowledge of the patent-in-suit, namely the amino acid and nucleotide sequences disclosed therein. This is all the more so since, to arrive at subject-matter falling within the scope of the claims - starting from the disclosure of document D1, common probes have to be used in the screening of a cDNA library from Thielavia, and more particularly from the strain used in the patent-in-suit - Thielavia terrestris NRRL 8126, none of them being mentioned in document D1. Thus, the board considers the [opponent’s] arguments, which might be of importance for assessing inventive step, lack of relevance for the assessment of the novelty of the subject-matter claimed in the main request.

[14] Whereas the subject-matter of the main request is directed to the specific amino acid and DNA sequences derived from Thielavia terrestris NRRL 8126 and to an intermediate generalization, namely a limited group of related sequences having at least 90% identity to these specific sequences, the homologues referred to in document D1 represent a broad generalization of the specific sequences disclosed in that document since both the (shared) probe and the hybridization conditions are only broadly defined […]. This situation is completely different from that underlying decision T 1120/00, wherein the claims then under consideration and the disclosure of a prior art document contemplated comparable levels of generalization, in particular, a broad generalization defined in similar terms (“substantially homologous”).

In the board's view, an essential message that this decision seeks to convey is that the same standard must be applied to the disclosure of a patent or a patent application and to that of the prior art (cf. T 1120/00 [15]). In the present case, the intermediate generalization (limited group of related sequences) represents a fair and reasonable extension of the specific sequences disclosed in the patent-in-suit which cannot be compared to the broad generalization made in document D1. This limited group of related sequences is not seen as being clearly, directly and unambiguously anticipated by the broad generalization of document D1.

[15] The main request is thus considered to fulfil the requirements of A 54.

The main request also complied with the requirements of A 56; the patent was maintained on this basis.

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Another decision on novelty in the biotech realm can be found here.