T 0299/12 - Consisting essentially of

Key points

• In this case, the Board finds added matter in replacing "comprising"  with "consisting essentially of".
• " The board cannot agree with the [proprietor's] view in this respect and notes that the [proprietor's] arguments rely on a preliminary selection of the examples that contain only testosterone, oleic acid, ethanol, isopropanol, propylene glycol, carbomer, water and, optionally, cross-linking agents and preservatives, a selection that would result in a very limited number of embodiments, namely formulation [...] and the formulation of example 9. The selection, however, would leave out of the scope of claim 1 typical compositions lacking any of the ingredients now considered essential by claim 1 (e.g. formulations A and B of example 1 and the formulations of examples 3-4) []. But, more importantly, all of the selected examples on which claim 1 would be based appear to contain triethanolamine (i.e. a cross-linking agent), thereby suggesting that, for the particular combination of components (a) to (e) and water defined in present claim 1, triethanolamine would be an essential feature. Hence, even though the passage on page 7, lines 15-24, generally mentions cross-linking agents as being optional ingredients, the teaching of the application as filed for the particular combination of ingredients now in claim 1 (i.e. testosterone, oleic acid, ethanol, isopropanol, propylene glycol, carbomer and water) is that cross-linking agents, in particular triethanolamine, are essential. [] In conclusion, at least for the reason that claim 1 defines triethanolamine as being optional rather than essential, it encompasses subject-matter which extends beyond the content of both the application and the parent application as originally filed."

EPO T 0299/12 - link

Main request

3. Added subject-matter (Article 100(c) EPC in combination with Articles 76(1) and 123(2) EPC)

3.1 The description of the application as originally filed essentially corresponds to the text of the parent application as filed, wherein the claims of the parent application were designated in the present application as clauses. The discussion below relating to the application as originally filed (Article 123(2) EPC) therefore applies mutatis mutandis to the parent application as filed (Article 76(1) EPC).

3.2 In its arguments on added subject-matter, the respondent started from the composition defined by the combination of clauses 1 and 2 in the application as filed, which would establish the essential components of present claim 1, i.e. components (a) to (e). Starting from that composition, the board observes that claim 1 of the main request contains restrictions on three main aspects: firstly, claim 1 restricts the number of possible components present in the composition by the expression "consists essentially of", which limits said components to (a) to (e), water and, optionally, preservatives and cross-linking agents; secondly, the claim restricts the nature of the components (a), (c), (d) and (e) to be specifically testosterone, ethanol/isopropanol, propylene glycol and carbomer, respectively; and thirdly, the claim introduces a restriction on the concentration of the essential components (a) to (e).

The board is of the opinion that the introduction in claim 1 of said first restriction, i.e. the expression "consists essentially of", already results in the addition of subject-matter in the sense of Articles 76(1) and 123(2) EPC, for the reasons explained below.

3.3 The respondent submitted that the wording "consists essentially of", which was not explicitly mentioned in the application as filed, would be supported by the combination of clauses 1 and 2 with the passage on page 7, lines 15-24, of the application as filed, whereby the clauses would establish the essential components (a) to (e), and the passage would limit the optional ingredients to cross-linking agents and preservatives. In addition, in the light of formulation 545 in table 2, the formulations in examples 5, 8 and 9 and the typical manufacturing process detailed in the passage bridging pages 18 and 19 of the application as filed, the skilled person would necessarily understand that testosterone, ethanol, isopropanol, propylene glycol and carbomer would be essential components, while cross-linking agents, such as triethanolamine, and preservatives, such as butylated hydroxytoluene, would be merely optional.

The board cannot agree with the respondent's view in this respect and notes that the respondent's arguments rely on a preliminary selection of the examples that contain only testosterone, oleic acid, ethanol, isopropanol, propylene glycol, carbomer, water and, optionally, cross-linking agents and preservatives, a selection that would result in a very limited number of embodiments, namely formulation 545 of table 2, composition K of table 3, formulation DAA-97-601 of table 4, the formulations of example 8, and the formulation of example 9. The selection, however, would leave out of the scope of claim 1 typical compositions lacking any of the ingredients now considered essential by claim 1 (e.g. formulations A and B of example 1 and the formulations of examples 3-4) and compositions containing ingredients excluded from present claim 1, such as further irritation-reducing agents (e.g. formulations J and L of table 3; and formulations DAA-97-602 and DAA-97-600 of table 4). But, more importantly, all of the selected examples on which claim 1 would be based appear to contain triethanolamine (i.e. a cross-linking agent), thereby suggesting that, for the particular combination of components (a) to (e) and water defined in present claim 1, triethanolamine would be an essential feature. Hence, even though the passage on page 7, lines 15-24, generally mentions cross-linking agents as being optional ingredients, the teaching of the application as filed for the particular combination of ingredients now in claim 1 (i.e. testosterone, oleic acid, ethanol, isopropanol, propylene glycol, carbomer and water) is that cross-linking agents, in particular triethanolamine, are essential.

3.4 In conclusion, at least for the reason that claim 1 defines triethanolamine as being optional rather than essential, it encompasses subject-matter which extends beyond the content of both the application and the parent application as originally filed.