[…] Claim 1, in addition to claim 1 as granted, contains a disclaimer in its section b) wherein it is “provided that the cells are not human embryonic stem cells”. In a similar way the subject-matter of claim 25 has been restricted to a method wherein the propagated stem cells are “other than human embryonic stem cells”. [2]
The EBA in its decision G 2/06 has decided that R 28(c) EPC forbids the patenting of claims directed to products which - as described in the respective application - at the filing date could be prepared exclusively by a method which necessarily involved the destruction of human embryos. In the view of the present Board it can be deduced from this decision that methods involving such destruction are also to be regarded as not patentable. [3]
Claim 1 as granted was directed to an apparatus comprising cells within the channels of a matrix. Claim 25 as granted was directed to a method for propagating stem cells. This clearly included embryonic stem cells of human origin. In the passage bridging pages 31 and 32 of the application as published it is stated that embryonic stem cells (ES cells) are obtained from embryos at a very early stage. Since in the application as published the only teaching of how to prepare embryonic stem cells, including human embryonic stem cells, is the use (involving their destruction) of embryos at a very early stage, it is concluded that at the filing date of the application underlying the patent in suit human embryonic stem cells could be prepared exclusively by a method which necessarily involved the destruction of human embryos. This has the result that the invention of claims 1 and 25 as granted falls under the prohibition of A 53(a) EPC taken in combination with R 28(c) EPC (cf. also G 2/06 [29]). [4]
In agreement with decision G 1/03 the amended claims 1 and 25, both containing a disclaimer not removing more than what is necessary to disclaim subject-matter falling under the prohibition of A 53(a) EPC in combination with R 28(c) EPC, meet the requirements of A 123(2) EPC. [7]
The present disclaimers excise unpatentable embodiments involving the destruction of human embryos. This in itself is not problematic under the rules provided by G 1/03 in combination with G 2/06.
But what is strange here is that the disclaimers excise, as far as human stem cells are concerned, all the disclosed embodiments (because all the disclosed embodiments involve the destruction of embryos). Claim 1 as amended therefore covers – among other things – an apparatus comprising human stem cells other than human embryonic stem cells. However, this part of the claimed subject-matter appears to lack sufficiency of disclosure, because “the only teaching of how to prepare […] human embryonic stem cells, is the use (involving their destruction) of embryos at a very early stage.”
But what is strange here is that the disclaimers excise, as far as human stem cells are concerned, all the disclosed embodiments (because all the disclosed embodiments involve the destruction of embryos). Claim 1 as amended therefore covers – among other things – an apparatus comprising human stem cells other than human embryonic stem cells. However, this part of the claimed subject-matter appears to lack sufficiency of disclosure, because “the only teaching of how to prepare […] human embryonic stem cells, is the use (involving their destruction) of embryos at a very early stage.”
Unfortunately, the Board does not address this question. The Opposition Division – to which the case has been remitted - could introduce this new ground, but I doubt it will do so.
The situation is inextricable, since a disclaimer “provided that the cells are not human stem cells” would have been unallowable under G 1/03 because it excises more than the subject-matter that is unpatentable under A 53 (a) EPC.
To read the whole decision, click here.
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