6. Interpretation of claims
6.2. Meaning of "comprising (substantially)", "consisting (essentially) of", "containing"
This section has been updated to reflect case law and legislative changes up to 31 December 2023. For the previous version of this section please refer to the "Case Law of the Boards of Appeal", 10th edition (PDF). |
In T 759/91 and T 522/91 the claims contained the expression "comprising substantially". The board was of the opinion that this term lacked clear, explicit boundaries and its scope needed interpretation. While in everyday language the word "comprise" might have both the meaning "include" or "comprehend" and "consist of", in drafting patent claims legal certainty normally required it to be interpreted by the broader meaning "include" or "comprehend". The word "substantially" imposed a restriction on the word "comprising" in the sense that "to a large extent only that is comprised which is specified". The boundaries of the term "comprising substantially" were therefore to be drawn where the essential characteristics of the specified subject-matter ceased. The scope of the term "comprising substantially" was therefore interpreted as being identical to that of "consisting essentially of". However, in view of the unequivocal character of the words "consisting of" as compared to "comprising", the expression "consisting essentially of" was to be given preference. See also T 1730/09, T 274/16.
In T 405/00 the board considered that, according to the language conventional for patent claims in the field of chemistry, the wording "composition comprising a persalt" defined exclusively the mandatory presence of at least one of the specific chemical compounds belonging to the group of persalts.
In T 1023/02 the board stated that a claim using "comprising" language should generally not be construed as covering subject-matter which included further steps of a nature that would manifestly counteract the specified technical purpose of the step(s) recited in the claim.
In T 1599/06 the board likewise had to interpret the term "comprising". It emphasised that the meaning of terms in a patent claim has to be determined from the point of view of the skilled person, who reads the claim in the context of the application and against the background of his/her common general knowledge. The claim was directed to a vaccinating agent comprising at least one specific purified and isolated protein of Mycobacterium tuberculosis. The examining division had interpreted the term "comprising" broadly and held that the claimed subject-matter lacked novelty in relation to a partially purified protein fraction which, in their view, contained inter alia the specified proteins. In the board's view, however, the skilled person would derive from the application as a whole the information that the specific characteristic of the vaccinating agents according to the invention was their generation from isolated and purified Mycobacterium tuberculosis proteins. Therefore, the skilled person would have considered that the definition in claim 1 covered vaccinating agents that, firstly, were constituted from isolated and purified proteins as mentioned in the claims and, secondly, contained those proteins as their main constituents.
In T 1771/06 a claim specifically referred with closed language to the characterising part (GBSS gene fragment in the antisense direction) of the gene construct and, in an attempt to generalise, left open other structural elements necessary to operate the system ("comprising a fragment ... which codes for ...., said fragment consisting of a nucleotide sequence selected from ... SEQ ID No: ..."). According to the board this was not an unusual claim formulation. The board did not accept the appellant's argument that the scope of the claim extended to gene constructs which comprised any DNA in addition to the GBSS gene fragments. The skilled person would certainly take into account the fact that the gene construct was made for the purpose of introducing the GBSS DNA fragment into the potato cells and integrating it into the genome. Accordingly, the gene construct would be thought to contain all necessary DNA elements for these steps to take place.
In T 390/08 the board held that the definition of a composition as "consisting of" compulsory and optional components met the requirements of Art. 84 EPC, as such a composition defined a "closed" composition from which elements other than those mentioned were excluded. See also T 1190/01, T 1998/07.
In T 2027/13 the claimed composition was defined by an open formulation (in view of the word "comprising"), which already implied the presence not only of the optional excipients, but also of any additional pharmaceutically acceptable components (including impurities) and even of further release controlling agents, and the expression "consisting essentially of", which referred to a single ingredient of the composition. As the usual reading of this expression did not make sense in the case in hand, the skilled person reading the claim was at a loss as to the possible limitation introduced by the expression.
In decision T 711/90 the board confirmed the assumption in the case law that the substitution of the term "consists of" for "contains" in a claim raised the question of clarity of the claim. When, as in the claim in question, the glass consisted of components denoted (i), (ii) and (iii), the presence of any additional component was excluded and, therefore, the proportions of the components (i), (ii) and (iii) expressed in percentages should have added up to 100 mole % for each claimed composition. Regarding Art. 123(2) EPC, see chapter II.E.1.15. "Comprises", "consists of", "consists essentially of", "contains".
- T 438/22
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)
- T 147/22
Abstract
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.