The simultaneous application of G 1/03 and G 2/10 is not an easy topic, to say the least, so it is always interesting to see how the Boards tackle this task.
Claim 1 of the main request before the Board read:
1. An in vitro method of altering the state of differentiation in an embryonic stem cell or population of embryonic stem cells, comprising the step of administering one or more zinc finger proteins (ZFPs) wherein each ZFP has three DNA-binding domainsFl: RSDHLAR (SEQ ID NO: 2),F2: TSGSLTR (SEQ ID NO: 3), andF3: RSDNLAR (SEQ ID NO: 4),which are designed and/or selected to bind to a target site in an endogenous gene which is OCT 3/4, wherein the ZFP alters the state of cellular differentiation, with the proviso that the cell or population of cells is no human embryonic stem cell or population of human embryonic stem cells.
The Board had to examine whether this claim complied with the requirements of A 123(2):
[3] Compared to claim 1 as originally filed, claim 1 of the main request has been restricted to a method of altering the state of differentiation in an embryonic stem cell or population of embryonic stem cells, comprising the step of administering a ZFP characterised by three specific DNA-binding domains which bind to a target site in the oct-3/4 gene, and a disclaimer has been added, excluding human embryonic stem cells.
[4] The claimed subject matter is disclosed in Example 1, describing the role of Oct-3/4 in embryonic stem cells, in combination with examples 2 to 4, demonstrating the effect of a ZFP with the claimed specific DNA binding domains in mouse embryonic stem cells.
[5] By way of a disclaimer, a method using human embryonic stem cells or a population of human embryonic stem cells is excluded from the subject-matter of claim 1. Under A 53(a) EPC in conjunction with R 28(c), European patents shall not be granted in respect of biotechnological invention which concern uses of human embryos for industrial or commercial purposes. According to the decision of the Enlarged Board of Appeal G 1/03 a disclaimer may be allowable to disclaim subject-matter which, under A 52 to A 57, is excluded from patentability for non-technical reasons.
The subject matter remaining in the claim after the introduction of the disclaimer is an in vitro method of altering the state of differentiation in a non-human embryonic stem cell. The claimed method using mouse embryonic stem cells is disclosed in the application as filed […]. The exclusion of human embryonic stem cells does not introduce a new technical teaching nor does it lead to the disclosure of any subject matter going beyond the application as filed. Therefore, the disclaimer also satisfies the condition set out in point 1a of the order of decision G 2/10 (cf. decision T 2464/10).
[6] The board is therefore satisfied that the requirements of A 123(2) are met.
To me (admittedly a non-specialist in this field) this does not sound very convincing. The disclosure of a method using mouse embryonic stem cells does not disclose the method for non-human embryonic stem cells in all its generality, does it? But wouldn’t this have to be disclosed for G 2/10 to be complied with?
Grrr, this disclaimer stuff is not for simple minds like me.
Grrr, this disclaimer stuff is not for simple minds like me.
Should you wish to download the whole decision, just click here.
The file wrapper can be found here.
5 comments:
I share your skepticism. The additional test of G2/10 cannot be "direct and unambiguous disclosure" as usually applied for A.123(2). I wonder if the boards are not simply checking that there is something technically meaningful left in the claim, see the third criteria of T1870/08, point 4.6.7: "it may still be justified to examine whether the remaining subject-matter could plausibly be considered as belonging to the invention as presented in the application. [...] a technical assessment of the original application may show that the amended claim is restricted to such a combination of parameters which the skilled person would never have contemplated as belonging to the invention from a technical point of view, for example because it would not solve the technical problem underlying the original invention".
So: "mouse" is not a direct and unambiguous disclosure of "non-human", but "mouse" shows that the application did not only consider a use in "humans".
I am just guessing here; the whole thing is clear as mud...
This case is an application of G 1/03, and therefore not of G 2/10, so I agree the reference to G 2/10 is odd.
@Roger: maybe I misunderstood you, but as far as I understand the test of G 2/10 is simply the usual test for Art. 123(2), applied to the subject-matter defined by the claim, which is exactly the "subject-matter remaining in the claim after the introduction of the disclaimer". G 2/10 in a way gave a negative answer to the question of how to deal with disclaimers of disclosed subject-matter: no special rules apply.
In this case we have a disclaimer of undisclosed subject-matter (unless the application discloses a restriction to human embryonic stem cells), so the precondition of point 1a of the order of G 2/10 is not fulfilled. In addition, the application does not disclose the "subject-matter remaining in the claim". But all of that is not a problem, since the special regime of G 1/03 applies.
It would be interesting had the application disclosed an optional limitation to human embryonic stem cells, because G 2/10 explicitly states that such cases (of disclaimers excluding disclosed subject-matter) are not dealt with in G 1/03. Would the "special regime" still apply, or would the applicant lose his patent only because of that optional limitation being present?
Ah, I don't think I saw T 1870/08 before. Its catchword:
"The test of G 2/10 also applies to an amendment involving an undisclosed disclaimer by means of which a claim has been rendered new over a European patent application according to Article 54(3) EPC. The examination of the admissibility of the amendment for compliance with Article 123(2) EPC must be made separately for the disclaimer per se and for the subject- matter remaining in the claim (see point 4. of the Reasons)."
Pfff, that would completely negate G 1/03, unless indeed the test of G 2/10 is not the test of Art. 123(2).
If you ask me, the Boards are making a mess of these issues.
There is nothing extraordinary here. I trust that the application experimented on mouse embryonic stem cells but claimed "embryonic stem cells" in general (the most interesting application being, of course, in humans, but that's more expensive and involves a lot more of red tape). So, formally, the disclosure targets more than just "mouse". Neither the examining division nor the Board saw a reason to challenge this generalisation.
G1/03 and G2/10 are two distinct tests, and BOTH must be met independently of each other, which is the case here.
That according to this decision BOTH G 1/03 and G 2/10 must be met is what is extraordinary here, because G 2/10 clearly explains that G 1/03 applies to the situation where the disclaimed subject-matter is not disclosed, while G 2/10 applies to the situation where the disclaimed subject-matter is disclosed. They are distinct tests, applying to distinct situations.
Unfortunately G 2/10, which for the most part is quite clear, contains some very confusing sentences, especially in point 4.7. T 1870/08 does a very interesting job at trying to make sense of this, in the process creating a whole new theory based on what one might call a very thin layer of ice. Personally I don't think it realistic to assume that T 1870/08 is what the EBA had in mind.
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