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Case law 18 Oct 2021

Contributions of a process feature in a product-by-process claim

This decision relates to a claim directed to monoclonal antibodies in which the process feature “produced from hybridomas” as deposited under R.31 EPC was the only feature allegedly imparting novelty. The main question was whether the reference to the deposited hybridomas gives rise to the specific amino acid sequence and chemical composition of the claimed antibodies. According to the Board, the deposit information does not convey any technical information. Thus, in the absence of these teachings in the patent, the Board concluded that the referred process feature does not impart any identifiable technical feature on the claimed subject-matter.

The relevant claim reads as follows (claim 2 of the main request):

Monoclonal antibody able to recognize 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3, characterised in that it is produced from a hybridoma selected from the group consisting of the hybridomas deposited in the BCCM/LMBP under deposit numbers LMBP 7011 CB, LMBP 7012CB, LMBP 7013CB, LMBP 7204CB and LMBP 7205CB.

Thus, basically, the referred claim relates to monoclonal antibodies which are:

i)  able to recognize 25- hydroxyvitamin D2 and 25-hydroxyvitamin D3, and

ii) produced from a hybridoma selected from the group consisting of the hybridomas deposited in the BCCM/LMBP (…).

The opposition division held that as a consequence of process feature (ii), the claimed antibodies were characterized by a unique amino acid sequence because deposit numbers allow to identify specific hybridomas and each antibody produced by a hybridoma will have a different sequence (heavy and light chains) which renders the antibody unique.

The Board considered that a process feature in a product-by-process claim only contributes to the novelty of a product claim insofar as it gives rise to a distinct and identifiable characteristic of the product (T 179/03, Reasons 3.7 – 3.9). The skilled person following the teaching of the patent must be aware of that characteristic and be able to recognize it in the claimed product (T 412/93 Reasons 33 and T 1120/00 Reasons 7).

Furthermore, with reference to G2/12 the Board asserted that for a product-by-process claim to be allowable it needs to be established that

(a) it is impossible to define the claimed product other than in terms of a process of manufacture and

(b) the claimed product itself meets the patentability requirements of art. 52(1) EPC.

Thus the relevant questions in this case were

  • whether or not the process feature “produced from a hybridoma selected from the group consisting of the hybridomas deposited (...)” gives rise to the specific amino acid sequence and chemical composition of the claimed antibodies and
  • whether the skilled person is made aware of these structural characteristics of the antibodies by the teaching of the patent.
Technical information about the antibodies cannot be inferred by the skilled person from the teaching of the patent.
The Board of Appeal -

According to the Board, the skilled person reading the patent receives the deposit information in relation to the hybridomas. However, this deposit information does not convey any technical information about the chemical composition or molecular structure of the antibodies produced by these hybridomas. The patent does not provide any information  in this respect either (e.g. in the form of sequence listing). For these reasons, the Board concluded that technical information about the antibodies cannot be inferred by the skilled person from the teaching of the patent.

With reference to T 179/03 (Reasons 3.9 – 3.14), the Board asserted that where a process feature is the only feature allegedly conferring novelty to a product, the burden of proof for showing the fact that the process feature results in a distinct and identifiable characteristic of the product (here: antibodies having a certain sequence or chemical composition) is on the patent proprietor and not on the opponent(s).

In view of the above and considering that the patent proprietor has not discharged the burden of proof, the Board concluded that process feature (ii) does not impart any identifiable technical feature on the claimed subject matter. With respect to the functional feature (i), the Board agreed with the opposition division that antibodies able to bind to  25-hydroxyvitamin D2 and 25-hydroxyvitamin D3 were available to the public before the priority date of the patent. New lines of argumentation were submitted by the patent proprietor but not admitted by the Board in the exercise of its discretion under Art. 13(1) RPBA 2007.

In conclusion, the Board was of the opinion that claim 2 of the main request lacks novelty. The case was remitted to the opposition division with the order to maintain the patent on the basis of the auxiliary request 3, which consisted of claim 1 of the main request.

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