When a patent application in the field of genetic engineering contains a claim referring to a nucleotide sequence and there are slight differences between the sequence of the application and the sequence of the priority document, is the priority claim invalid? Not necessarily - it depends on what, precisely, is being claimed.
The appeal was against the decision of the Examining Division (ED) to refuse the patent application under consideration, because it did not comply with A 123(2) and because the subject-matter was not novel.
When examining the requests before it, the Board came to the conclusion that the objections under A 123(2) did not apply any more. It then dealt with the novelty objection.
[5] With regard to the second auxiliary request the examining division decided that the subject-matter of its claims 1, 3 and 5 was not novel over the disclosure in document D2. The document was considered as prior art pursuant to A 54(2) because the claims could enjoy priority only from the fourth priority document. This was so because the nucleotide sequence of the BRCA2 gene referred to in the claims of the second auxiliary request, i.e. SEQ ID No. 1, was only identical to that disclosed in the fourth, but not to that disclosed in the third priority document.
[6] Present claim 1 of the main request relates to “[a] method for determining variation in the open reading frame (ORF) defined by SEQ ID No. 1 which comprises determining in a tissue sample of a subject a frameshift mutation in said ORF, wherein said mutation causes protein truncation ...”.
Present claim 3 of the main request relates to “[a] method for diagnosing a lesion in a human subject for neoplasia which comprises determining in a tissue sample from said lesion a frameshift mutation in the open reading frame (ORF) defined by SEQ ID No. 1 wherein said mutation causes protein truncation and is indicative of neoplasia ...”.
[7] Thus, in other words, the methods of claims 1 and 3 require determination of the open reading frame of the BRCA2 gene from the tissue sample and its comparison with the open reading frame “defined by SEQ ID No. 1” as the “reference” open reading frame.
Consequently, the “open reading frame defined by SEQ ID No. 1” and not “SEQ ID No. 1” is a feature of the claimed methods.
[8] Establishing a “reading frame” is a way of breaking a nucleotide sequence into portions of three nucleotides called triplets or codons. The “open reading frame” is the one that contains a start and a stop codon in the same frame. Also, it is the one supposed to be translated into a protein. Each three-nucleotide codon is translated into one amino acid.
[9] Hence, for determining any reading frame of a nucleotide sequence, including an “open reading frame”, knowing the actual sequence of nucleotides, i.e. the kind of nucleotide at a given position, is not necessary.
[10] The nucleotide sequence according to SEQ ID No. 1 as disclosed in the third priority document differs from that disclosed in the application in the kind of nucleotide at positions 2014, 4553, 4815, 5782-5789, 5841, 5972 and 8716. These alterations neither affect the length of the sequence to be translated nor the codon which “opens” the reading frame, i.e. the start codon. Therefore, despite the variations in the sequence, the open reading frame defined by SEQ ID No. 1 according to the third priority document and the application as filed remains the same.
Thus, the feature at issue here, i.e. the “open reading frame defined by SEQ ID No. 1” is disclosed in the third priority document.
[11] Consequently, in the board’s view, the non-identity of the nucleotide sequence disclosed in SEQ ID No. 1 according to the third priority document and the application as filed is not a reason for denying the third priority date for the subject-matter of the present claims 1 to 3 and accordingly is also not a reason for considering document D2 as prior art pursuant to A 54(2).
Therefore, the ED’s objections of lack of novelty and inventive step are not tenable.
[12] The finding in point 11 above, first half-sentence, is in line with the reasoning in two decisions issued after the decision under appeal was taken, i.e. decision T 80/05 [37] and T 666/05 [40].
Also in the cases underlying these decisions the claims related to diagnostic methods involving the determination of frameshift mutations, the “reference open reading frame” was defined in relation to a specific sequence and the issue of the entitlement to priority arose because in both cases only the fifth priority document disclosed a sequence exactly corresponding to that referred to in the claims.
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