4. Determining the disclosure of the relevant prior art
T 438/19 × View decision
Catchword:
The following questions are referred to the Enlarged Board of Appeal for decision:
1. Is a product put on the market before the date of filing of a European patent application to be excluded from the state of the art within the meaning of Article 54(2) EPC for the sole reason that its composition or internal structure could not be analysed and reproduced without undue burden by the skilled person before that date? 2. If the answer to question 1 is no, is technical information about said product which was made available to the public before the filing date (e.g. by publication of technical brochure, non-patent or patent literature) state of the art within the meaning of Article 54(2) EPC, irrespective of whether the composition or internal structure of the product could be analysed and reproduced without undue burden by the skilled person before that date? 3. If the answer to question 1 is yes or the answer to question 2 is no, which criteria are to be applied in order to determine whether or not the composition or internal structure of the product could be analysed and reproduced without undue burden within the meaning of opinion G 1/92? In particular, is it required that the composition and internal structure of the product be fully analysable and identically reproducible?
T 939/22 × View decision
Abstract
In T 939/22 claim 1 of the main request was directed to "(a( vaccine comprising a recombinant nonpathogenic Marek's Disease Virus (rMDVnp) comprising a first nucleic acid (…) and wherein the rMDVnp is a recombinant herpesvirus of turkeys (rHVT)." The construction of rMDVnp was relevant for assessing novelty over D8.
The definition of rMDVnp in the description (page 7, lines 19 to 20 of the patent in suit) stated that the term rMDVnp referred to a rMDVnp that included heterologous nucleotide sequences (i.e. sequences from pathogens other than MDV). In other words, the definition in the description equated the term rMDVnp to a specific recombinant vector with inserts of nucleotide sequences encoding proteins from other pathogens. According to the board, this definition could not change the common understanding of the terms of art rMDVnp and rHVT as used in claim 1 nor was this definition consistent with how a skilled person would understand the claim. Indeed, the skilled person would understand the terms rMDVnp and rHVT as used in claim 1 to refer to the genome of a viral vector stemming from a non-pathogenic strain of an MDV serotype. No further limitations were implied by the terms rMDVnp and rHVT. The skilled person would not understand the term rHVT to exclude viral vectors in which a specific region of the genome of HVT (which is MDV serotype 3, i.e. MDV3) has been replaced by the corresponding region of a different MDV serotype, as is the case for novel avian herpesvirus (NAHV). Of course, claim 1 further required that nucleotide sequences of at least two specified pathogens other than MDV, i.e. Newcastle disease virus (NDV) and infectious laryngotracheitis virus (ILTV), be inserted into the rMDVnp/rHVT vector. Hence, the claim was directed to a construct formed by the rMDVnp/rHVT vector and inserts of nucleotide sequences from other pathogens.
The board held that the exclusion of viral constructs comprising nucleotide sequences from different MDV serotypes from the term MDVnp (page 7, lines 14 to 17 of the patent in suit) was in line with how the skilled person would understand the term MDVnp, as it did not include recombinant viral constructs but referred only to the naturally occurring viruses. Claim 1, however, was specifically directed to a vaccine comprising a recombinant non-pathogenic MDV (rMDVnp), specifically rHVT. Even if the definition of MDVnp in the description were intended to include rMDVnp in a way that excluded chimeric viruses, this could not change the skilled person's understanding of the terms rMDVnp and rHVT.
In the board's view, excluding chimeric viruses from the claimed subject-matter appeared contradictory for the following reasons. The term chimeric virus, as understood by the skilled person, related to a specific type of recombinant virus that contains genetic material from different viruses within a single viral genome construct. This typically implied that the resulting viral construct exhibits characteristics derived from each of the parental viruses. Accordingly, inserting nucleotide sequences of NDV and ILTV into the rHVT vector as claimed resulted in a chimeric virus. Therefore, chimeric viruses could not be excluded from the subject-matter of claim 1, let alone a (recombinant) NAHV that included nucleotide sequences from NDV and ILTV.
The board also noted that, due to the comprising language, claim 1 did not exclude that the rMDVnp could be engineered to comprise additional nucleic acid inserts encoding antigens of pathogens other than NDV and ILTV.
It was clear from the wording and structure of claims 3, 4, 9 and 11 that the inventors of D8 had envisaged both (i) a multivalent vaccine that was a mixture of different NAHV constructs, each encoding a separate foreign gene (claim 19), and (ii) a multivalent vaccine based on a single NAHV construct encoding a plurality of foreign genes (claim 11, to which vaccine claim 18 refers). A multivalent vaccine encoding more than one heterologous antigen was furthermore addressed in several passages of the description. D8 provided detailed instructions on how to prepare the recombinant chimeric virus and clear protocols on how to test them for their suitability as vaccines. Thus, sufficient information was provided to enable the skilled person to produce and test a composition suitable as a multivalent vaccine as defined in claim 18 of D8.
In addition, it was credible that a recombinant MDV comprising more than one insert from two different heterologous viruses in the non-essential US2 site, encoding thus one additional foreign antigen to those tested in Examples 1 to 3 of D8, could be prepared and would provide protection by preventing or reducing the severity of a disease caused by at least one of the viruses whose antigens were encoded by the recombinant MDV construct.
4.11. Reproducibility of the content of the disclosure
According to the established case law a disclosure destroys novelty only if the teaching it contains is reproducible, i.e. can be carried out by the skilled person (T 1437/07, T 1457/09). Subject-matter described in a document can only be regarded as having been made available to the public, and therefore as comprised in the state of the art pursuant to Art. 54(1) EPC, if the information given therein to the skilled person is sufficient to enable him, at the relevant date of the document, to practise the technical teaching which is the subject of the document, taking into account also the general knowledge at that time in the field to be expected of him (see T 26/85, T 206/83, T 491/99, T 719/12).
In T 206/83 (OJ 1987, 5), in particular, it was found that a document did not effectively disclose a chemical compound, even though it stated the structure and the steps by which it was produced, if the skilled person was unable to find out from the document or on the basis of his common general knowledge how to obtain the required starting materials or intermediates. Information which could only be obtained after a comprehensive search was not to be regarded as part of the common general knowledge. This need for an enabling disclosure was also in conformity with the principle expressed in Art. 83 EPC 1973 for patent applications which had, accordingly, to "disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art". The requirements as to the sufficiency of the disclosure were, therefore, identical in all these instances.
In T 719/12 neither party contested that document (1) disclosed the compound methyl-2-(α-thenoyl)-ethylamine by name. The board held that document (1) alone did not make the compound available to the public, since the specific attempts to prepare it which were described in that document had failed. Therefore, the board concluded that it had not been made available to the public, as no method for its preparation had been available at the publication date of the prior art.
For selection inventions the requirement of a reproducible disclosure also plays a significant role. In T 26/85 (OJ 1990, 22) the ranges of a certain parameter as defined in the claim fell within the broader ranges stated for the same parameter in a prior art document. The board considered that a realistic approach, when assessing the novelty of the invention under examination over the prior art in a case where overlapping ranges of a certain parameter existed, would be to consider whether the person skilled in the art would, in the light of the technical facts, seriously contemplate applying the technical teachings of the prior art document in the range of overlap; if it could be fairly assumed that this would be the case, it had to be concluded that no novelty existed. Such was not the case in the matter under consideration, since there existed in the prior art a reasoned statement clearly dissuading the person skilled in the art from using the range under a certain value, and the range of overlaps was under this value; the claimed range was therefore considered novel (see also T 255/91).
In T 447/92 the board held that the cited document did not disclose when or how far a movable piece in the claimed invention (an air circuit breaker) moved, or the way in which it worked to prevent the spring-back of a lever. No relative movement was described or shown in the drawings and it was a matter of conjecture as to the manner in which the relevant parts co-operated. The board found that it might have been obvious to a skilled person that the notch could co-operate with the shaft in the manner defined in the claims of the patent in suit, but that this only meant that the disclosure took him close enough to do the rest himself. It did not mean that the document took the skilled person all the way to the present invention. Thus, the features of the air circuit breaker according to claim 1 of the application were not unambiguously derivable from the drawings of an earlier European patent application.
In T 310/88 the board of appeal had to consider a discrepancy between what actually happened in practice when carrying out a technical teaching in a prior document according to the letter of its description, and what this prior document said would happen. The board held that the invention was novel over the prior document because the latter did not contain a sufficiently clear teaching for that conclusion not to be reached (see T 23/90).
In T 491/99 the board held that an earlier patent, which used terminology which at first sight was suggestive of the product invention claimed, was not in fact a prejudicial disclosure if a skilled person could actually only make the product in question later, from the process and machine described for the first time in the European patent in suit.
In T 1437/07 the board pointed out that a disclosure in a prior art document is novelty-destroying only if the teaching it contains is reproducible. This need for an enabling disclosure is in conformity with the principle expressed in Art. 83 EPC. Thus, the requirements of sufficiency of disclosure are identical for a prior art document and a patent. The board followed the principles developed by the case law in the framework of the evaluation of the requirements of Art. 83 EPC in the case of a medical use, i.e. that the skilled person should not only be able to carry out the teaching of the prior art document, but it should also be credible that the effect at issue – here, relief of pain – has been achieved (see also T 491/08).
In T 578/12 the appellant contested that claim 1 of the main request was not new in view of prior art document D1, an Australian patent application; its main argument was that D1 had no drawings or any description of a detailed embodiment of any dispensing machine and could not be regarded as an enabling disclosure. The board noted inter alia that the fact that D1 did not contain any figures did not hinder the skilled person from understanding the described method or from carrying it out. The decision in this case gives an example of a detailed set of reasons for the outcome of examining features disclosed by a prior-art document.
In T 1457/09 claim 4 was drafted as a second medical use claim. In the decision under appeal the opposition division held that the subject-matter of the corresponding claim was anticipated by the intermediate document (D1). The opposition division considered that both documents (D1) and (D1a, the priority document of D1) disclosed pharmaceutical compositions comprising the peptide RMFPNAPYL and their use as a cancer vaccine. The board found that for the requirement of reproducibility to be considered as fulfilled in relation to a medical use it is necessary that the disclosure in the prior-art document is such as to make it credible that the therapeutic effect on which the disclosed treatment relies can be achieved (T 609/02). The board held that in the case at issue a prior art document was novelty-destroying only if it disclosed not only the product referred to in the claim – here RMFPNAPYL – for the claimed therapeutic application – here treatment of cancer – but also that the claimed product was indeed suitable for the claimed therapeutic application. The board concluded that the experimental results disclosed in document (D1a) were not sufficient to make it credible that the RMFPNAPYL peptide was suitable for the treatment of cancer. Therefore document (D1) did not destroy the novelty of the subject-matter of claim 4.