T 236/08 – Two Much

When you amend an independent claim, think of the trouble the dependent claims may cause …

In the present case, the opponent filed an appeal after the Opposition Division had maintained the patent in amended form.

Claims 1, 2, 7, and 10 of the main request (which was identical to claim 1 as maintained) read:

1. A particulate composition, for therapeutic use, suitable for administration by inhalation, wherein the particles consist of a solid solution comprising a therapeutic agent and a glass-forming carbohydrate and that is capable of stabilising the agent during spray-drying and storage wherein the particles further comprise a physiologically acceptable carboxylate, nitrate, sulfate or bisulfate glass, and wherein the carbohydrate is selected from disaccharides, trisaccharides and oligosaccharides, the corresponding sugar alcohols, polysaccharides and chemically modified carbohydrates.

2. A composition according to claim 1, wherein the carbohydrate is a non-reducing glycoside of a polyhydroxy compound selected from sugar alcohols and other straight chain polyalcohols.

7. A composition according to any preceding claims, wherein the therapeutic agent is a protein or peptide, nucleotide, oligonucleotide or nucleic acid.

10. A composition according to Claim 7, wherein the therapeutic agent is insulin.

The Board agreed with the opponent that this amendment violated A 123(2):

[2.1.1] The feature “suitable for administration by inhalation” in claim 1 of the main request was not present in the claims as originally filed.

On pages 25 and 45 of the description, inhalation is described as a particular way of administration in connection with the use of a specific class of carbohydrates, namely the HDCs (hydrophobically derivatized carbohydrates). In view of the specificity of the embodiments disclosed on pages 25 and 45, these passages cannot serve as a basis for a generalisation to a particulate composition as claimed in claim 1.

The examples also cannot serve as a basis for the feature “suitable for administration by inhalation”, as inhalation does not appear to be the sole or the preferred exemplified way of administration. Inhalation appears to be only one possible alternative among other ways of administration. Indeed, the sole examples showing compositions having inhalation as their purpose are example 2 and its corresponding Figure 1 as well as example 10. The other examples show compositions used for other purposes or having a size which renders them unsuitable for inhalation.

A basis for the feature “suitable for administration by inhalation” can however be found, as part of a list in several parts of the description of the application as originally filed. It appears from the following passages that inhalation is indeed one among several ways of administration disclosed in the description as originally filed:

• on pages 9 and 14 […] the way of administration is presented as being either “mucosal, oral, topical, subcutaneous, intradermal, intramuscular, intravenous and by-inhalation”.

• on page 42 […] suitable delivery methods of guest substances of the present invention include “transdermal, transmucosal, oral, gastrointestinal, subcutaneous, ocular, intramuscular, intravenous and by-inhalation”.

Consequently, the choice of the feature “suitable for administration by inhalation” in claim 1 of the main request has a basis in the application as originally filed and results from a choice among different possible ways of administration.

A further consequence is however that the combination of the subject-matter of claim 1 with the subject-matter of any dependent claim which also results from a selection among different possibilities would constitute an unallowable selection from multiple lists.

[2.1.2] The subject-matter of dependent claim 10 restricts the composition of claim 1 to a composition “wherein the therapeutic agent is insulin”.

Insulin was disclosed in the application as originally filed in original claim 22 and its corresponding part of the description […] which read respectively “wherein the proteins are selected from the group consisting of enzymes, biopharmaceuticals, growth hormones, growth factors, insulin, monoclonal antibodies, interferons, interleukins and cytokines” and “include but are not limited to enzymes, biopharmaceuticals, growth hormones, growth factors, insulin, monoclonal antibodies, interferons, interleukins and cytokines”.

Hence, the subject-matter of dependent claim 10 relates to a singling out from a list of possibilities concerning specifically the use of insulin. Its combination with the subject-matter of claim 1, which results similarly from a selection of possible ways of administration, constitutes a selection from multiple lists and has no basis in the application as originally filed.

[2.1.3] The subject-matter of dependent claim 2 results also from a selection of possibilities, as regards the nature of the carbohydrate.

The feature “non-reducing glycosides of polyhydroxy compounds selected from sugar alcohols, other straight chain polyalcohols” constitutes a singling out from a list of carbohydrates on page 18 […] and original claim 6.

The combination of the subject-matter of dependent claim 2 with the subject-matter of claim 1 of the main request results from a selection from multiple lists and is not disclosed directly and unambiguously in the originally filed application.

[2.1.4] The respondent had not provided any argument to counter the objections raised by the board under A 123(2) in its preliminary opinion. However in the written proceedings, arguments regarding the existence of a support for the feature “suitable for administration by inhalation” on page 5, line 6 to page 6, line were given by the respondent.

The board does not contest that the feature “suitable for administration by inhalation” has a basis in the application as originally filed, although the passage cited by the respondent relates to the background of the invention and not to the invention itself, and does not form a valid basis for this amendment. Inhalation is indeed disclosed […] under “Background of the Invention” and presented in various forms, such as topical, transdermal, subdermal, ballistic forms and implantable therapeutic systems.

Further passages mentioning this way of administration and forming a valid basis for an amendment were cited under point [2.1.1] above.

The board does not contest that the subject-matter of claim 1 alone meets the requirements of A 123(2), since the feature “suitable for administration by inhalation” is a single selection among multiple possibilities.

However, a combination of the subject-matter of claim 1 with the subject-matter of a dependent claim which also results from a selection among different possibilities infringes A 123(2).

[2.1.5] Consequently, the combination of the subject-matter of claim 1 of the main request with at least the subject-matter of dependent claims 2 or 10 constitutes a selection from multiple lists and has no basis in the application as originally filed. Therefore, the main request infringes A 123(2).

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