T 0005/08 (HIV probes/BIOMERIEUX) 10-11-2010

Main request

Admissibility in the appeal proceedings

1. The main request is considered to be a direct reply to the communication of the board pursuant to Article 15(1) RPBA in which the parties were informed of the board's preliminary, non-binding opinion on the issues to be discussed at the appeal oral proceedings (cf. point IV supra). In that communication, the board discussed the admissibility of the claim requests filed with the appellant's statement of grounds of appeal (a main request and auxiliary requests 1 to 6) and, with reference to the purpose of appeal proceedings and to Article 12(4) RPBA, the board stated that none of these requests had ever been as such in the first instance proceedings.

2. In reply to these observations and in order to have at least one request already considered by the first instance, the appellant filed the main request which is identical to the auxiliary request 6 decided upon by the first instance. The opposition division considered this auxiliary request to fulfil all the requirements of the EPC except for those of Article 56 EPC. The main request is also identical to the auxiliary request 3 filed with the appellant's statement of grounds of appeal except for the absence in the latter of any subject-matter related to the sequence SEQ ID NO: 12. The main request was filed within the time limit set in the board's communication under Article 15(1) RPBA for the parties to file new submissions, i.e. one month before the oral proceedings at the latest.

3. Thus, although the main request at issue was filed at a late stage of the appeal proceedings, it was still within the time limit set by the board considered to be sufficient to allow the parties, in this case the respondents, to prepare themselves appropriately. Moreover, as this main request is identical to the narrowest request decided upon by the opposition division, it was known to the respondents and cannot be seen as a complete surprise to them.

4. The fact that the request introduces subject-matter related to the sequence SEQ ID NO: 12 into the appeal proceedings is considered by the board not to be, in the circumstances of the present case, a disadvantage for the respondents. In the board's view, the absence of any submission or technical information regarding the sequence SEQ ID NO: 12 in the appellant's statement of grounds of appeal can only support the respondent's arguments concerning the alleged lack of evidence for the advantages of the claimed subject-matter, i.e. no demonstration of the alleged advantageous effect over the whole claimed scope, which for the main request includes now the sequence SEQ ID NO: 12.

5. Therefore, the main request is admitted into the appeal proceedings.

Article 100(c) EPC, Article 123(2) EPC

6. Document D1 is a prior art document under Article 54(3) EPC which discloses multiple primer sets for the detection and amplification of nucleic acids from the human immunodeficiency virus (HIV) type 1 and/or type 2. Primer sets are selected from different HIV regions including HIV-1 LTR regions. The oligonucleotides of sequences SEQ ID NO: 2 (30-mer) and 24 (31-mer) - which are identical except for the presence in SEQ ID NO: 24 of an additional (g) nucleotide at 3' position - represent forward primer regions of a HIV-1 LTR region and the oligonucleotide of sequence SEQ ID NO: 4 (23-mer) represents a reverse primer region of a second HIV-1 LTR region (cf. inter alia page 9, lines 6 to 33 of document D1). The first 19 nucleotides of sequences SEQ ID NO: 2 and 24 are identical to the sequence SEQ ID NO: 4 of the patent-in-suit, except for the presence of an "AA" duplet instead of an "AAA" triplet at positions 7 and 8. Thus, the sequences SEQ ID NO: 2 and 24 comprise a fragment of 13 nucleotides (positions 7 to 19) which is identical to a fragment of the sequence SEQ ID NO: 4 of the patent-in-suit (positions 8 to 20). The sequence SEQ ID NO: 4 of document D1 comprises the sequence SEQ ID NO: 1 of the patent-in-suit and has five additional nucleotides at its 5' end. Document D1 explicitly discloses the use of the specific pairs 24/4 and 2/4 as primers for the detection of HIV-1 (cf. page 9, lines 47 to 53 and page 10, Table 1 of document D1). The disclaimer of claims 1 and 2 in the main request ("... with the exception of the oligonucleotide pairs ...", see point VII supra) removes these specific pairs 24/4 and 2/4 of document D1 from the claimed subject-matter.

7. However, the disclosure of document D1 is not limited to the very specific sequences of the oligonucleotide primers disclosed therein. Document D1 explicitly states that, depending upon several considerations, such as the complexity of the targeted sequence, "(g)enerally, the primers used in this invention will have from 12 to 60 nucleotides, and preferably, they have from 16 to 40 nucleotides. More preferably, each primer has from 18 to 35 nucleotides" (cf. page 6, lines 7 to 10 of document D1). And indeed it further states that, apart from the specific sequence of the primers and probes, "(i)t will be apparent to those skilled in the art that additional sequence specific primers and probes can be prepared by, for example, the addition of nucleotides to either the 5' and 3' ends, which nucleotides are complementary or noncomplementary to the target sequence" (cf. page 6, lines 20 to 23 of document D1). The disclosure of document D1 is thus not limited to the specific sequences disclosed therein (specific teaching) but it also contemplates these specific sequences within a more general group of sequences of variable length (generic teaching). The disclaimer of claims 1 and 2 in the main request does not exclude the more generic teaching of document D1 from the claimed subject-matter.

8. The board fails to see any difference between this generic teaching of document D1 and the disclosure of the patent-in-suit in which the specific sequences disclosed therein are also contemplated within a general group of sequences having a variable range of preferred length, such as the 10-50 nucleotides in length indicated in claims 1 and 2 or the 15-26 nucleotides referred to in the patent-in-suit ("... but longer primers may also be employed ...") (cf. page 4, paragraph [0021], in particular lines 19 to 21 of the patent-in-suit). The examples of both document D1 and the patent-in-suit are all performed using only the specific sequences disclosed in these documents and the general information conveyed to the skilled person is the same in both documents.

9. According to the case law of the Boards of Appeal, the same standard is to be applied when considering the disclosure of the patent-in-suit and that of a prior art document (cf. inter alia T 870/02 of 16 September 2004, point 6 of the Reasons, T 1593/05 of 7 November 2007, point 4 of the Reasons and T 1720/06 of 22 April 2008, point 19 of the Reasons). This is also in line with decision T 1120/00 (supra) referred to by the appellant (cf. point X supra). Even though in the context of priority entitlement, the board considered in the latter decision that the information disclosed in the priority documents of the prior art document for carrying out an intermediate and a broad generalization referred to in these documents was the same than that provided by the patent-in-suit in that case and therefore, both generalizations were considered to be entitled to the claimed priority rights (cf. T 1120/00, supra, points 13 to 16 of the Reasons). In line with this case law, the board considers that, for the disclaimer of the main request to restore novelty of claim 1, it is necessary in the present case to exclude also the generic teaching of document D1. In view of this the question of the disclaimer in claim 2 can be left aside.

10. In view of the fact that the disclaimer of claim 1 does not exclude, as required by decisions G 1/03 and G 2/03 (supra), the complete teachings of document D1, the main request is considered not to fulfil the requirements of Article 123(2) EPC as an incomplete disclaimer constitutes added subject-matter which was not originally disclosed.

Auxiliary request

Admissibility in the appeal proceedings

11. Articles 12(2),(4) and 13(1) RPBA are relevant for assessing the admissibility of the auxiliary request. Article 12(2) RPBA requires the statement of grounds of appeal to contain the appellant's complete case. Article 13(1) RPBA leaves to the board's discretion to consider and admit any amendment to a party's case after it has filed its grounds of appeal or a reply thereto. In the exercise of its discretion, account is to be taken of inter alia the current state of the proceedings. Article 12(4) RPBA refers to the power of the board to hold inadmissible requests which could have been presented in the first instance proceedings.

12. The subject-matter of the auxiliary request at issue is directed to a pair of oligonucleotides consisting of a first and a second oligonucleotide consisting, respectively, of the sequences SEQ ID NO: 1 and 5 (cf. point VIII supra). The combination of this pair of oligonucleotides is disclosed in the patent-in-suit and in the application as filed as "a most preferred pair of oligonucleotides according to the invention" (cf. page 6, paragraph [0033] of the patent-in-suit and page 8, lines 5 to 7 of the application as filed) and, accordingly, it is the subject-matter of a dependent claim in the claims as granted (claim 3) and in the original claims of the application as filed (claim 5). However, both in the patent-in-suit and in the application as filed, the pair of oligonucleotides is not directed to the very specific oligonucleotides of sequences SEQ ID NO: 1 and 5 but to general sequences having a total length of 10-50 nucleotides (original and granted claims) - or 10-26 nucleotides (granted claims) - and comprising a fragment of at least 10 nucleotides of these SEQ ID NO: 1 and 5 (original and granted claims).

13. A similar subject-matter is also found in the requests dealt with at the oral proceedings before the first instance and decided upon by the opposition division as well as in several of the claim requests filed by the appellant with its statement of grounds of appeal. However, none of these requests - either in the opposition or in the appeal proceedings - contemplated a pair of oligonucleotides with the first and second oligonucleotides restricted to the very specific oligonucleotides of sequences SEQ ID NO: 1 and 5, respectively. This is all the more surprising since the experimental reports filed by the appellant in the opposition proceedings and with its statement of grounds of appeal contained data derived from such a specific pair of oligonucleotides.

14. Thus, even though the objection of lack of inventive step put forward by the opposition division in the decision under appeal was mainly based on the scope of the claims, in the words of the opposition division "... it is even reasonable to assume that not all the primer pairs ... are effective in amplifying HIV. Hence, the problem is not solved over the whole claimed range and consequently the claim is not inventive over the whole claimed scope ..." (cf. page 13 of the decision under appeal, underlining added by the board), the appellant chose not to file a request specifically directed, and limited to, a pair of oligonucleotides as that claimed in the present auxiliary request which was characterized, both in the patent-in-suit and in the application as filed, as a preferred embodiment of the invention. Nor was such a request filed in the appellant's reply to the board's communication pursuant to Article 15(1) RPBA, even though the pair of oligonucleotides of sequences SEQ ID NO: 1 and 5 was identified in that communication (albeit in the context of Articles 123(2),(3) EPC) and the issue concerning the scope of the claims was also mentioned therein (cf. point IV supra).

15. It was only at the beginning of the oral proceedings before the board that the appellant filed - as its second auxiliary request - a request which intended to limit the claimed subject-matter to the specific pair of oligonucleotides consisting of a first and a second oligonucleotide of the sequences SEQ ID NO: 1 and 5, respectively. However, this auxiliary request presented several deficiencies which required the appellant to necessarily introduce further amendments and modifications. In all, five different versions of the auxiliary request were submitted at the oral proceedings before the board, each time replacing the previously submitted version. Except for the last version, all other versions of the auxiliary request were withdrawn before the board decided on their admissibility (cf. Annexes I to V of the minutes of the oral proceedings before the board) (cf. point VI supra).

16. There is no doubt that the auxiliary request is a very late filed request. No convincing reasons have been provided by the appellant to justify its filing at this very late stage of the proceedings. Indeed and in view of the above mentioned facts, the board considers that such a request limited to a preferred embodiment of the invention could well have been filed at an earlier stage of the appeal or the opposition proceedings, either with the appellant's statement of grounds of appeal - so as to have a complete case as required by Article 12(2) RPBA, in reply to the board's communication pursuant to Article 15(1) RPBA, or even at first instance in order to overcome the objection of the opposition division regarding the breadth of the claims (Article 12(4) RPBA). The appellant's choice not to file such a request deprived the respondents of the opportunity for preparing and presenting their case appropriately and it certainly did not contribute to the procedural economy of the present case.

17. This situation is further aggravated by the fact that the present auxiliary request, as such, has not been directly put forward by the appellant itself but it is the final result of a lengthy discussion between the respondents, the appellant and the board that took place at the oral proceedings and occasioned the introduction of several amendments, modifications and changes, in several different versions of a first filed auxiliary request (cf. points VI and 15 supra). This chain of events is not in line with the function of an appeal proceedings as established in the case law of the Boards of Appeal, namely to give a judicial decision upon the correctness of a separate earlier decision taken by a department of the European Patent Office (cf. "Case Law of the Boards of Appeal of the EPO", 6th edition 2010, VII.E.1, page 821). As repeatedly stated in the case law, it is not the purpose of an appeal proceedings to give the patent proprietor the opportunity to recast its claims as it sees fit and to have all its requests admitted into the appeal proceedings - a principle mirrored in Articles 12(4) and 13 RPBA (cf. inter alia decision T 361/08 of 3 December 2009, point 14 of the Reasons).

18. As for the appellant's argument that the auxiliary request represents the appellant's last chance to save the patent (cf. point X supra), the board considers this argument inappropriate to justify, in the present case, the very late filing of the auxiliary request and the complete chain of events or the history of its prosecution as cited above. It has also been clearly established by the Boards of Appeal that there is no absolute right for a patentee to such a last chance. On the contrary, the admissibility of a late filed request is always a matter of the board's discretion (cf. inter alia T 446/00 of 3 July 2003, point 3.3 of the Reasons). Although not part of the present appeal proceedings, the fact that a divisional application is still pending before the first instance speaks also against the appellant's argument (cf. "Case Law", 6th edition 2010, VII.E.16.5.5, page 903).

19. In view of the complete chain of events cited above and the particular circumstances of the present case, it is the board's conviction that not even the principle of procedural economy can assist the appellant's request to have its late filed auxiliary request admitted into the appeal proceedings. First, the appellant's auxiliary request is not clearly and directly allowable but requires further examination as to the substantive requirements of the EPC, at least for those of Article 56 EPC. Second, the conduct of the appellant during the oral proceedings, in particular the filing, modification and replacement of a fairly large number of auxiliary requests in a short time, is not seen as being in accordance with a party's obligation to take care not to act in a manner detrimental to the efficient conduct of oral proceedings (cf. "Case Law", 6th edition 2010, VII.E.16.5.4, page 902). This is all the more important specially in those cases, as in the present one, in which a decision taken by the board in appeal proceedings might be of relevance for pending divisional applications and for possible subsequent litigations before national courts. In these cases, the respondents should be given at least an opportunity to prepare and present their case appropriately. This was not so in the present case. Reasons of procedural economy cannot, in principle, override the actual purpose of an appeal proceedings or excuse an appellant from complying with the basic requirements of these proceedings, such as an early filing of amendments and an efficient conduct at oral proceedings.

20. In view of the foregoing considerations, the state of the appeal proceedings and the complete prosecution history of the present auxiliary request, the board, in the exercise of its discretion under Article 13(1) RPBA, decides not to admit the auxiliary request into the appeal proceedings.