T 1836/10 – You Can’t Exclude The Absent

This is an examination appeal.

Claim 1 of the main request before the Board read (in English translation):

Method for obtaining pluripotent embryonic stem cells in an embryo-preserving (embryonenerhaltend) way, wherein

(a) a channel is opened in the zona pelucida of fixed blastocysts;

(b) a suitable instrument for mobilising cells is led through the trophectoderm until the inner cell mass and some stem cells of the inner cell mass are mobilised by means of this instrument; and

(c) the mobilised stem cells are aspirated;

wherein the viability of the blastocysts is not affected by the performance of steps (a)-(c),

provided that the cells obtained are not used for industrial or commercial purposes if the blastocyst is a human blastocyst. (my emphasis)

*** Translation of the German original ***

[3] When refusing the application, the Examining Division (ED) based [its decision] on A 53(a) in connection with R 28(c) according to which uses of human embryos for industrial or commercial purposes are excluded from patentability. The ED stated that the application inter alia mentions human embryos as starting material for carrying out the claimed method. Thus the subject-matter of the claims encompassed the commercial use of human embryos without any apparent direct benefit for the embryo itself, which is excluded from patentability. According to the ED, the fact that in the claimed method – unlike in other methods known from the prior art – the embryo was not destroyed was irrelevant for this assessment.

[4] By introducing the “negative” feature “… provided that the cells obtained are not used for industrial or commercial purposes if the blastocyst is a human blastocyst” the appellant tries to take account of the objection under A 53(a) in connection with R 28(c). It is undisputed that the added negative feature cannot be derived from the application as filed. However, the appellant bases the amendment of claim 1 on decisions G 1/03 and G 2/03 of the Enlarged Board (EBA), according to which the introduction of an undisclosed negative feature, a so-called “disclaimer”, into a claim may be allowable if the disclaimer excludes (ausklammert) subject-matter which, under A 52 to A 57, is excluded from patentability for non-technical reasons (see G 1/03 [2.4]).

[5] When it is to be decided whether in the present case the introduction of the disclaimer into claim 1 is allowable in view of A 123(2), it is relevant whether the added disclaimer limits the scope of the claims of the patent by excluding subject-matter which, under A 53(a) in connection with R 28(c), is excluded from patentability. In order to answer this question it is necessary to interpret the subject-matter of claim 1 before the introduction of the disclaimer and the subject-matter defined by the disclaimer.

Interpretation of claim 1 without the disclaimer

[6] If the disclaimer is ignored, claim 1 is directed to a method for obtaining pluripotent embryonic stem cells characterised by the method steps (a) to (c), wherein the viability of the blastocysts is not affected by the performance of those steps […]. The starting material for obtaining embryonic stem cells used in the method are blastocysts, i.e. embryos that are about 4 to 7 days old, that already expose some differentiation into an inner cell mass, from which the fetus develops later on, and the trophectoderm, from which extra-embryonic tissues develop […]. The blastocysts may have their origin in a domesticated animal or a primate, e.g. a human being […].

[7] According to the invention the pluripotent embryonic stem cells are aspirated from the inner cell mass of the blastocysts by means of a suitable instrument. [The operator] penetrates into the inner cell mass of the blastocysts, mobilises stem cells and then aspirates them According to the claim the stem cells are to be obtained in an “embryo-preserving” way, i.e. any damage of the blastocyst embryo is to be avoided in order not to affect its viability.

[8] The “product” of the claimed method are pluripotent embryonic stem cells. The claim does not – explicitly or implicitly – disclose for which purposes these stem cells are to be used later on. In paragraph [0018] of the application as published it is explained that the stem cells obtained according to the invention may be used in pharmaceutics and medicine or veterinary medicine, respectively. The replacement or regeneration of a damaged or missing tissue or organ of a human or animal patient is mentioned as a preferred use. However, as the disclosed possible future uses of the stem cells obtained are not to be considered as an additional method step or as a further technical feature of the claimed method, but only as “subjective intentions”, the use of the product of the method, i.e. of the embryonic stem cells , is not relevant for the definition of the claimed subject-matter (see the explanations of the EBA regarding A 64(2) in decision G 2/88 [5, second paragraph]).

Interpretation of the disclaimer

[9] In case the blastocyst used for obtaining the embryonic stem cells according to the claim is a human blastocyst, the disclaimer that has been introduced into claim 1 excludes that the stem cells obtained are used for industrial or commercial purposes. Thus the disclaimer excludes a future use […] of the stem cells. As explained above, this use cannot be considered to be a step of the claimed method because the latter is terminated when the stem cells are obtained.

[10] As the disclaimer tries to exclude from claim 1 something that is not encompassed by this claim, the claimed subject-matter is not limited by the introduction of the disclaimer at all. As far as the claim without the disclaimer is concerned, the Board is of the opinion – as was the ED – that it encompasses subject-matter that violates A 53(a) in connection with R 28(c) because the use of human embryos as a starting material in a method for obtaining embryonic stem cells that is to be used commercially, constitutes a “use … for industrial or commercial purposes” within the meaning of R 28(c) (see also the judgment of the CJEU of October 18, 2011, in case C-34/10 on the interpretation of Article 6(2)(c) of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, in particular point 3 of the order)

“3. Article 6(2)(c) of Directive 98/44 excludes an invention from patentability where the technical teaching which is the subject-matter of the patent application requires the prior destruction of human embryos or their use as base material, whatever the stage at which that takes place and even if the description of the technical teaching claimed does not refer to the use of human embryos.”

[11] In its decisions G 1/03 and G 2/03 the EBA has explained that an applicant may not arbitrarily amend its claims and that a disclaimer that may be required ought not to exclude more that is necessary to exclude the subject-matter that is excluded from patentability for non-technical reasons. Otherwise a disclaimer is to be considered unallowable in view of A 123(2). The Board is of the opinion that this applies mutatis mutandis to a disclaimer trying to exclude subject-matter that is not encompassed by the claim at all. The amendment of claim by means of such a disclaimer does not serve the intended purpose and is, therefore, unallowable in view of A 123(2). Moreover the claim amended by the introduction of the disclaimer does not comply with the requirement of clarity pursuant to A 84.

[12] Consequently, the Board is of the opinion that the amendment of claim 1 violates A 123(2).

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