2 Dec 2016

T 1581/12 - Only limits, thus disclosed

Key points


  • The pending claim is based on two SEQ ID NOs from lists, and an amino acid length taken from a list of lengths. Does this involve added subject-matter under the two lists principle?
  • The Board finds it does not. " The case law referred to by appellant II is exclusively concerned with a combination of specific members from two, fully independent lists. []  However, the present situation, with a list with amino acid sequences and a list with fragment lengths, is different. " "The disclosure of an amino acid sequence, although inherently, makes available all possible fragments of this sequence, []. [] The board does not see that the list of fragment lengths is actually independent from the list of amino acid sequences disclosed in the parent application. The combination of the value "20 or more consecutive amino acids" with the amino acid sequences SEQ ID NOs 4, 6, therefore only limits the original disclosure in the parent application. This limitation does not provide any new information and does not create new subject-matter." 




EPO T 1581/12 - link


6. With reference to the case law of the Boards of Appeal concerning a selection from two lists, appellant II has argued that there is no basis in the parent application for a combination of the sequences SEQ ID NO 4, 6 and a length of "20 or more consecutive amino acids" for fragments derived from these amino acid sequences and comprising an epitope (cf. point XI supra).

[Argument of appellant II: (point XI: )In the parent application, sequences SEQ ID NO 4, 6 were disclosed as members of a list of several hundreds of sequences. Likewise, the fragment length indicated in claim 1 was disclosed in the parent application within a list of a plethora of lengths to be selected "depending on the particular sequence". Nothing in the parent application could be seen as a basis for singling out the combination of claim 1. Claim 1 required a further selection of those fragments having a functional feature (epitope; accessible to the immune system). All this was not in line with the case law established by the Boards of Appeal with regard to the selection of combinations from two or more lists (see, inter alia, T 583/09 and T 2134/10, supra). Indeed, this was the reason given in T 583/09 (supra) for not allowing a combination of a specific SEQ ID NO with a fragment length, independently whether or not the fragment was characterized by a functional feature. In the present case the question whether the list of SEQ ID NOs and the list of fragment lengths were independent was irrelevant because the combination present in claim 1 resulted from a selection that was neither disclosed nor derivable from the parent application.] 
7. The case law referred to by appellant II is exclusively concerned with a combination of specific members from two, fully independent lists. In these decisions the competent boards come to the conclusion that, in the absence of a clear pointer to such a combination, it is not possible to associate one member of one list with another member of the other list. Such combination is considered to create new subject-matter. However, the present situation, with a list with amino acid sequences and a list with fragment lengths, is different. The disclosure of an amino acid sequence, although inherently, makes available all possible fragments of this sequence, starting from the shortest peptide with only two consecutive residues up to a peptide having the full-length of the amino acid sequence minus one residue. As stated by appellant I (cf. point X supra), the longer fragments always comprise all shorter fragments, and the full-length sequence comprises all possible fragments. Indeed, the values of the fragment length disclosed in the parent application would be understood by a skilled person to apply to each and every member of the list of disclosed amino acid sequences (SEQ ID NOs), wherein the upper length of these fragments varies "depending on the particular sequence" (cf. page 6, first full paragraph of the parent application). The board does not see that the list of fragment lengths is actually independent from the list of amino acid sequences disclosed in the parent application. The combination of the value "20 or more consecutive amino acids" with the amino acid sequences SEQ ID NOs 4, 6, therefore only limits the orignal disclosure in the parent application. This limitation does not provide any new information and does not create new subject-matter.
8. Likewise, the requirement that the claimed fragments comprise an epitope does not create new subject-matter but also amounts to a limitation concerning the preferred fragments disclosed in the parent application (cf. page 6, first full paragraph, last sentence of the parent application). Indeed, the term "epitope" is understood in the here relevant technical field to define the ability of a peptide, polypeptide or protein to raise antibodies. There is no requirement in the claims that these epitopes have to be protective, neutralizing or that they must have any other property. It is also known in the art that peptides of 8-10 residues may already comprise a linear epitope and that even shorter peptides, when associated with appropriate carrier proteins (haptens), may also have this ability. Therefore, fragments of "20 or more consecutive amino acids from SEQ ID NO 4 and 6" may certainly comprise an epitope and no additional selection is required which would result in the combination of subject-matter not disclosed in the parent application.
9. Contrary to the present case, the protein fragments claimed in the case underlying the decision T 583/09 were always defined by a functional feature ("wherein the fragment has the ability to: i) bind to hyaluronic acid; or ii) bind to extracellular matrix") (cf. T 583/09, supra, page 3, lines 1-4 and page 10, point 4 of the Reasons). In that case this board, in a different composition, considered that there was no disclosure in the application as filed linking fragments of each one of the disclosed lengths with said functional feature. In the present case, no such functional feature is required for the claimed fragments and, therefore, the situations underlying both cases are different.
10. If at all, the present case seems to have some similarity to the case underlying decision T 2134/10 (supra). In that case this board, in a different composition, acknowledged a basis in the application as filed for a combination of a specific amino acid sequence with a particular fragment length, wherein the fragments also comprised an antigenic epitope. This combination was considered not to be a combination of features belonging to different lists. A similar decision was taken for a combination of a specific amino acid sequence with a particular degree of identity. The board considered such a combination to be only "a limitation ... among all the degrees specified" (cf. T 2134/10, supra, page 13, point 11 of the Reasons).
11. Thus, the main request fulfils the requirements of Article 76(1) EPC.

No comments:

Post a Comment

Do not use hyperlinks in comment text or user name. Comments are welcome, even though they are strictly moderated (no politics). Moderation can take some time (I don't get emails about comments to be approved).