Thursday, 28 April 2011

T 1834/09 – Missing? Not Quite

Can the absence of experimental data in the priority document make the priority claim invalid? That is the question the Board had to deal with in the present case.

The applicant lodged an appeal against the decision of the Examining Division (ED) refusing its application. 

In its summons to oral proceedings, the Board expressed the view that the claimed subject-matter was not new inter alia over document D4, which was prior art under A 54(3). 

According to the applicant, document D4 was not entitled to rely on its earliest priority date for two reasons. 

First, for an invention relating to newly identified members of a protein family which was known to have a highly divergent range of biological activities, such as the TNRF superfamily to which the polypeptide of document D4 belonged, it was necessary to provide in the priority document a credible disclosure of an exploitable specific function or activity. This position was supported by decisions T 81/87 and T 77/97. The earliest priority document of document D4 failed to disclose such a function.

Second, the failure to identify a specific function or activity of a protein in a previous application in a scientifically credible manner had the consequence that it was not possible to take advantage of the priority of that application as it did not disclose the industrial applicability of the protein as required by A 57. 

Since it was not entitled to its earliest priority date, document D4 was not relevant for the novelty assessment of the claimed polypeptide. 

The Board sees things differently :

[1] Claim 1 is directed to any polypeptide characterised by having about 80% amino acid sequence identity with the native sequence Apo-2DcR polypeptide comprising amino acid residues 1 to 259 of Figure 1A as represented in SEQ ID NO:1. This sequence identity is the sole essential feature which is required for a polypeptide to fall within the scope of the claim. Claim 1 encompasses a polypeptide consisting of the sequence SEQ ID NO:1. 

[2] The ED, finding that document D4 disclosed that particular polypeptide, concluded that claim 1 was not new. D4, which is a Euro-PCT application published after the international filing date of the application at issue, claims the priority dates of 14 January 1997 and 7 August 1997. It was cited under A 54(3). 

[3] The appellant has argued that document D4 and its earliest priority document (application US 60/035,496 filed on 14 January 1997) did not describe the ‘same invention’, as a specific function of the polypeptide disclosed has been identified only in document D4. Therefore, document D4 was not entitled to claim priority from its earliest priority document. As the application at issue was entitled to its priority date of 28 June 1997, document D4 did not belong to the state of the art for the novelty assessment of the subject-matter of claim 1. 

[4] The legal standard to be applied when assessing whether a claim is entitled to a priority date pursuant to A 87(1) is given by decision G 2/98 in the answer to the point of law referred to the Enlarged Board of Appeal which reads:
“The requirement for claiming priority of “the same invention”, referred to in A 87(1), means that priority of a previous application in respect of a claim of a European patent application in accordance with A 88 is to be acknowledged only if the skilled person can derive the subject-matter of the claim directly and unambiguously, using common general knowledge from the previous application as a whole”. 
[5] The respective descriptions of document D4 and its earliest priority document (application US 60/035,496) are very similar, insofar as the polypeptide in question (denoted “TRID” in document D4 and “TNFR-5” in the priority document) and all aspects related thereto, including its preparation and its therapeutical uses, are concerned. The descriptions differ insofar as three experimental examples (Example 4 showing the tissue distribution of TRID mRNA expression, Example 5 showing that the extracellular domain of TRID binds the cytotoxic ligand-TRAIL and blocks TRAIL-induced apoptosis, and Example 6 showing that TRID protects cells from TRAIL-induced apostosis) have been added in document D4. 

[6] The earliest priority document of document D4 teaches that the TRID/TNRF-5 polypeptide is capable of interacting with a TNF-family ligand, i.e. a potent inducer of apoptosis, a function which qualifies said polypeptide as an appropriate compound for the treatment of immune system-related disorders associated with increased apoptosis or the inhibition of apoptosis […]. 

[7] It has to be decided whether this teaching, which is not supported by experimental data, amounts to a credible disclosure rather than a pure speculation. 

[8] A significant statement in this respect can be found on page 4, lines 20 to 24, of the earliest priority document. There, it is stated that the TNFR-5 polypeptide shares sequence homology with other TNF receptors and that it shows the highest degree of sequence homology with the translation product for the human mRNA for nerve growth factor receptor, including multiple conserved cysteine rich domains. 

[9] According to a well established principle in the field of biology, an identified DNA sequence and the putative encoded protein are assigned to a known protein family or superfamily on the basis of sequence comparison - such as by degree of homology, the presence of highly conserved domains, motifs and/or signatures. Thus, once an unambiguous consensus sequence has been defined, the skilled person is prepared to accept that a peptide belongs to the family/superfamily, and performs the same or similar biological function(s) as the other members thereof, if it exhibits this consensus sequence. 

[10] The board takes the view that the sequence homology disclosed in the earliest priority document of document D4 has to be considered as being a strong and reliable indication that the TNRF-5 polypeptide is capable of interacting with a member of the TNF ligand family. This is regarded as being a clear sign that the TNRF-5 polypeptide is useful in the treatment of a number of immune system-related disorders associated with increased apoptosis or the inhibition of apoptosis and is, therefore, susceptible of industrial application. 

[11] Appellant’s argument that such prediction of a biological function or property based solely on sequence analysis and on the mere presence of a particular domain or motif in a polypeptide sequence cannot reasonably be made in case of the TNFR superfamily has not been substantiated by any sort of written evidence, and is to be considered as an unproven allegation only. 

[12] Based on the evidence on file, the board does not agree that the earliest priority document (US 60/035,496) and document D4 do not describe the ‘same invention’ in that only the latter discloses a specific function of the polypeptide in question. 

[13] The two decisions cited by the appellant in support of its position that document D4 was not entitled to its earliest priority date are not relevant for the present case as they were concerned with different technical situations. In decision T 77/97 the competent board had to decide whether claims referring to compounds not explicitly described in the priority document were entitled to the priority date, and in the case underlying decision T 81/87 the decisive question to be answered was whether the priority documents disclosed all the ‘critical’ features of the claimed invention. 

[14] The board concludes that the ‘same invention’ (in accordance with decision G 2/98) is described in document D4 and its earliest priority document. Therefore, document D4 is entitled to the priority date of 14 January 1997 pursuant to A 87(1) and, as such, is part of the state of the art according to A 54(3). 

[15] The sequence of the TRID polypeptide (identically contained as SEQ ID NO:2 in both document D4 and its earliest priority document) and the sequence of the Apo-2DcR polypeptide (see SEQ ID NO:1 of the application at issue) are identical. This fact is not contested by the appellant. 

[16] Therefore, a particular embodiment of claim 1 is explicitly disclosed in document D4. Thus, the subject-matter of claim 1 lacks novelty and the main request does not comply with the requirements of A 54. 

I understand that if the priority document had been merely speculative, its disclosure of the polypeptide would not have been sufficient to serve as basis for a valid priority claim. This is because the priority document has to disclose the ‘same invention’ and not merely the same subject-matter.

Should you wish to download the whole decision, click here

The file wrapper can be found here.