6.2. Signification de "comprenant (notamment)", "consistant (essentiellement)", "contenant"

Catchword: 

1. There is no provision stipulating that examples within the meaning of Rule 42(1)(e) EPC should not be in the form of claim-like clauses, i.e. in the form of one or more independent clauses followed by a number of clauses referring to previous clauses, at the end of or in another part of the description. There is no justification for deleting such examples just because they were drafted as claim-like clauses. They are to be treated like any other part of the description and thus, inter alia, must support the claims (Article 84 EPC). (Reasons 3.4 and 3.5)  2. It is a general and overarching objective, and as such also a "requirement" of the Convention, that authorities, courts and the public interpreting the claims at a later stage should, as far as possible, arrive at the same understanding of the claimed subject-matter as the EPO bodies deciding on the patentability of the same subject-matter. The only tool for achieving this objective is the patent specification as the expression of a unitary legal title. The description, as an integral part of the patent specification, should therefore also serve this overriding objective, i.e. it should provide a common understanding and interpretation of the claims. If the description contains subject-matter which manifestly impedes a common understanding, it is legitimate to insist on its removal under Articles 84 and 94(3) EPC and Rules 42, 48 and 71(1) EPC. (Reasons 5.5.3)  3. The board approves the practice where instead of a direct removal, i.e. the deletion of the subject-matter not covered by the claims, a "removal" by way of an appropriate statement is made, leaving the technical disclosure unaffected. (Reasons 5.7.2)  4. A referral to the Enlarged Board of Appeal whose sole purpose is to correct the Guidelines and which is not necessary either for ensuring a uniform case law within the boards or for the board's decision is not admissible. Such a referral could be perceived as an attempt to encroach on the President's powers under Article 10(2)(a) EPC. (Reasons 8.2.2)

Résumé

In T 147/22 the respondent (opponent) raised several clarity objections, which were mainly directed to the expression "consisting essentially of" and to the fact that the ingredients cited in claim 1 were associated with a function.

On the first aspect, the board noted that the expression "consisting essentially of" limited the ingredients in the composition of claim 1 to those defined in components (a) to (d), although further non-active ingredients could be present provided they did not materially affect the chemical stability of TAS-102. The respondent had argued that the expression "consisting essentially of" rendered claim 1 unclear because the skilled person would not know which were the compounds that did not impair the stability of TAS-102 in the composition, and the patent did not contain any information in that respect. According to the board, however, the nature and amount of those additional ingredients was strongly limited by the condition that they must not impair TAS-102 stability. Furthermore, the skilled person confronted with a composition containing components (a) to (d) and additional ingredients could easily determine whether or not the additional ingredients impair TAS-102 stability. Testing the chemical stability of active compounds in a composition was standard practice in the field of pharmaceutical formulations. Such tests were illustrated in Test Examples 1 to 5 of the patent for the particular case of TAS-102. Therefore, the skilled person could easily determine by standard comparative tests whether or not a given composition consisted essentially of components (a) to (d).

With regard to the functional definition of the ingredients in claim 1, the board held that the criterion for assessing whether a compound had the function assigned to it was the function (or functions) that the skilled person would assign to that compound in the context of a given formulation. Contrary to the respondent's view, the formulator's intention was irrelevant in that respect. It was undisputed that the functional features "excipient", "disintegrating agent", "binder", "lubricant", "flavouring agent", "colourant" and "taste-masking agent" were standard in the technical field of pharmaceutical formulations. The skilled person would have no difficulty in determining whether a given formulation ingredient fulfils one or more of these functions on the basis of common general knowledge. These were functional features which were generally allowed if the invention could not be defined more precisely without unduly restricting the scope of the invention. Furthermore, in the present case, the main ingredients were not solely defined by functional features. They were further limited by structural features: for instance, the excipient according to component (b) was selected from lactose, sucrose, mannitol and erythritol. In view of common general knowledge and the structural limitations of the functional features, the board considered that the definition of the ingredients in claim 1 was not unclear.

The respondent's objection was based on the possibility that an ingredient fulfilled more than one function and, depending on its function, the amount of the compound in the composition could vary. For instance, polyvinyl alcohol was generally known to be a binder and a lubricant. If it was considered a binder, it could be present in an amount of 0.001 to 5% by mass while it could not be present if it was considered a lubricant.

The board disagreed. The fact that polyvinyl alcohol was known to be a binder and a lubricant did not render the claim unclear. If polyvinyl alcohol was present in the composition, it necessarily played the role of a binder, even if it also fulfilled the function of a lubricant. Therefore, it should be counted as a binder that may be present in an amount of 0.001 to 5% by mass in the composition. Considering arbitrarily that polyvinyl alcohol could function exclusively as a lubricant and that therefore its presence would render the composition different from the one in claim 1 would be unrealistic. Certainly this was not how the skilled person would read the claim.

Moreover, the board stated that the fact that "excipient" was a very broad term did not mean that it was unclear. "Excipient" was a standard term in pharmaceutical formulations.

Résumé

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.

Résumé

In T 2103/22 the board, in order to assess compliance with the requirements of Art. 123(2) EPC, had to first determine the subject-matter effectively defined by claim 1 of the main request. In particular, the board interpreted the meaning of the following terms as well as the meaning of their combination:

a) "said polyester resin is a blended polyester resin which is a blend of a lowly crystalline polyester resin and a highly crystalline polyester resin at a weight ratio of 90:10 to 10:90 (…)"

b) "a layer of a polyester resin which comprises an ethylene terephthalate unit formed on at least one surface of the metal sheet".

The respondent (opponent) adhered to the conclusion of the opposition division which had been reached considering that "is" in term a) was to be read as "comprises", which meant that any other component different from the ones specifically mentioned in said claim 1 could be present in the blended polyester resin. The board disagreed and stated that, although it was correct that the normal rule of claim construction was that the terms used in a claim should be given their broadest technically sensible meaning, the literal reading of this passage defined that "said polyester resin" consisted of the lowly crystalline and highly crystalline polyester resins further defined in claim 1 of the main request, in the given weight ratio. In that regard, the board noted that, according to established case law (Case Law of the Boards of Appeal, 10th ed. 2022, II.A.6.2), the term "consists of" meant that the definition of "said polyester resin" was given in a "closed" manner, i.e. it excluded the presence of any other components other than the ones specifically defined (in the case at issue the lowly and highly crystalline polyester resins).

On b), the board found that the term "a layer of a polyester resin" defined, according to its literal reading, that the polyester therein mentioned, i.e. "which comprises an ethylene terephthalate unit", was the main component of the layer. However, this wording neither imposed that the polyester resin was the sole component of the layer, nor that it was the sole resin possibly present in the layer. The board further held that the reference to "unit" in that passage made it clear that the term "which" made reference to the polyester resin and not to the layer. This, in the board's view, would also be the logical reading of the claim made by the skilled person, considering that the term "which" usually makes reference to the word directly preceding it.

As the subject-matter of claim 1 of the main request was defined by the combination of terms a) and b), the board also determined the meaning of the combination of these two terms. It held that the polyester resin specified in the term "a layer of a polyester resin" was identical to the "said polyester resin" further defined in claim 1, i.e. it consisted of a blend of only the lowly and highly crystalline polyester resins.

Taking into account the further definitions of the lowly and highly crystalline polyester resins in claim 1, the board concluded that both of them were "a polyester resin that comprises an ethylene terephthalate unit". Therefore, the term "which comprises an ethylene terephthalate unit" of claim 1 of the main request was in fact redundant (i.e. not further limiting). Contrary to the view of the opposition division, the definitions of the highly and the lowly crystalline polyester resins further imposed that said terephthalate unit had to be present in majority since, otherwise, the resin would not be a "polyethylene terephthalate" anymore.

To determine whether the requirements of Art. 123(2) EPC were met, the board assessed if the deletion of the term "chiefly" from claim 1 of the application as filed resulted in added-matter. It saw no reason to deviate from the literal sense of the term "chiefly", which was that the polyester resin of the layer so defined should principally comprise an ethylene terephthalate unit not as the sole component but as the most important component of the polyester.

According to the board, adopting for the relevant passages of the application as filed the same reading as the one outlined for the corresponding passages of claim 1 of the main request, the term "which chiefly comprises an ethylene terephthalate unit" could only be held to be redundant (i.e. not further limiting) in view of the other features defining the valid support in the application as filed for the claimed subject-matter. Therefore, the presence or not in claim 1 of the main request of the terms "which chiefly comprises an ethylene terephthalate unit" or "chiefly" contained therein, did not lead to added-matter pursuant to Art. 123(2) EPC.