Tuesday, 5 January 2010

T 18/09 – Clones Are Not Books

Today we will see that T 18/09 contains some intriguing statements on novelty.

[...] Documents D22 and D24 have been cited by the respondent as novelty-destroying documents. They disclose the nucleic acid sequences of clones 129696 (GenBank Accession R16882) and 115371 (GenBank Accession T87299) of the IMAGE Consortium at the Lawrence Livermore National Laboratory in Livermore, California.

It is undisputed that the IMAGE clones were freely available to researchers anywhere in the world and Invitrogen Corporation was a known distributor of them. The two documents in question report partial EST (Expressed Sequence Tag) sequences of human origin which are completely uncharacterised und not annotated. Evidence on file comparing these partial sequences with the Neutrokine-α sequence of the patent-in-suit (SEQ ID NO:1) as well as the putative amino acid sequences encoded by these clones and that of Neutrokine-α (SEQ ID NO:2) shows that clone 129696 encodes amino acid residues 208 to 285 of SEQ ID NO:2 and that clone 115371 encodes amino acid residues 211 to 285 of SEQ ID NO:2.

However, the nucleic acid sequence of these clones have several undetermined nucleotides and nucleotides different from those reported for Neutrokine-α, as well as sequence frameshifts when compared to the nucleic acid sequence of Neutrokine-α. Thus, the sequences of the IMAGE clones actually given in documents D22 or D24 do not anticipate the claimed subject-matter. [10]

Nevertheless, the respondent relied on the declaration of Dr Kikly D84 who, thinking that the said clones actually contained more cDNA sequence than is represented in the documents, ordered the two clones from Invitrogen Corporation and sequenced them. She reports that the longest open reading frame (out of six possible ORFs) of clones 129696 and 115371 actually encodes residues 68 to 285 (i.e. over 75% of the full-length Neutrokine-α polypeptide) and 59 to 285 of SEQ ID NO:2 (100% of the extracellular domain of Neutrokine-α) respectively.

Based on these findings and with reference to decision G 1/92, the respondent argued that the IMAGE clones themselves anticipated the claimed subject-matter because they were commercially available, they could therefore be analysed and their analysis would have shown that they contained a nucleic acid molecule which comprised a polynucleotide sequence encoding the same residues 73 to 285 of SEQ ID NO:2, i.e. the extracellular domain of the Neutrokine-α polypeptide. [11]

The board, however, does not consider the clones of the IMAGE Consortium to have made “available to the public” in the sense of decision G 1/92 the subject-matter in question. Whereas the product referred to in that decision was a commercially accessible and reproducible product that had been “made available to the public” by a particular prior art use (the purpose thereof being thus fully known), the clones of the IMAGE Consortium of documents D22 and D24 were two clones with no assigned role which were physically present in a collection of about 540,000 clones and were available therefrom. The respondent retrieved them by using the knowledge of the Neutrokine-α sequence of the patent-in-suit in its search query. As a matter of fact, documents D22 and D24 contain no information whatsoever that could have drawn the skilled person’s attention to them as clones possibly related to a member of the human TNF superfamily and thus motivate him/her to investigate them among all the available clones of the IMAGE collection.

Although, as argued by the respondent, these two IMAGE clones were assigned specific identification numbers which showed that they were physically individualized and could be ordered and analysed by anyone who so wished, there was nothing in the art that could have led the skilled person in a straightforward manner to these identification numbers and thereby to retrieve the corresponding IMAGE clones. The two specific clones were accessible to the public only as an integral part of the complete clone collection of the IMAGE Consortium. Thus, no comparison is possible with the situation underlying the rationale of G 1/92. [12]

Whereas the location of an indexed book in a library hints at the contents of that book and thereby allows its retrieval by interrogation of that library through a direct mental procedure (cf. T 301/87), the position of an IMAGE clone in a particular well on a specific plate, i.e. the identification number of an IMAGE clone, does not provide any indexed information on the nature or the properties of that clone so as to render it accessible to the public by a similar interrogation. Under these circumstances, their mere existence in a large collection of clones can by no means be seen as a form of implicit disclosure of anything falling under the scope of the present claims. [13]

In the board’s view, this conclusion is in line with the normal practice of the EPO to consider the deposition of a strain or a plasmid that contains a recombinant sequence as disclosing only the whole strain or plasmid in toto but not the details or component parts within these entities, i.e. the recombinant sequence. The specific recombinant sequence as such, “the elements which are recognised as essential later on”, is not made available and directly disclosed by the mere deposition of a strain or plasmid containing that sequence (cf. T 301/87). [14]

Thus, the claimed subject-matter is considered to fulfil the requirements of A 54. [15] 

Being ignorant in the field of biotechnology, I should perhaps remain silent, but I have to say that I am somewhat surprised by the reasoning of the Board. The clones were available, obtaining the recombinant sequence was straightforward for a specialist, but still the sequence is not deemed to be disclosed. It sounds a little bit like a departure from “absolute novelty”, and certainly from the logic of G 1/92 (even taking into account T 952/92): the motivation of the skilled person appears to have crept into the novelty assessment. If my understanding is correct - I am open to correction -  this might open up a gap between novelty in the mechanical (and even chemical) field and novelty in biotech. It may well be that this approach is justified by the very complex nature of the subject-matter under consideration, but even then I think it would have been appropriate for the legislator (or at least the Enlarged Board) to take the necessary steps. 

What do the specialists think ? Any comment ?

To read the whole decision, click here.