Some time ago I reported on the first decision that implemented the teaching of G 2/10 (here). Well, here is another one. Interesting food for thought.
The appeal was against the refusal of an application by the Examining Division (ED), based on an alleged non-compliance with the requirements of A 123(2).
The main request before the Board was identical to the main request that had been refused by the ED. Claims 1, 10, 11, and 14 of this request read: (emphasis by the Board)
1. A non-human animal comprising a biological tissue, wherein the tissue comprises a cell, the cell expressing one or more proteins comprising a region with anticoagulant activity and a region which can anchor said protein to a cell membrane, wherein the anchor region and anticoagulant region of the protein are derived from different proteins, and wherein the anticoagulant region comprises the sequence of an anticoagulant polypep tide selected from the groups consisting of:i) hirudin, tissue factor pathway inhibitor, tick anticoagulant peptide and protein C activator;ii) functional derivatives, fragments or analogues of i) which retain anticoagulant activity;iii) heparin and antithrombin;iv) functional derivatives and fragments of iii) which retain anticoagulant activity; andv) anticoagulant derivatives of thrombin.10. An organ of the non-human transgenic animal of claim 8 or claim 9.11. A biological tissue comprising a cell, wherein the cell expresses one or more proteins as defined in claim 1, wherein the cell is not produced using a process which involves modifying the germ line genetic identity of human beings or which involves use of a human embryo for industrial or commercial purposes.14. A method of rendering a tissue or organ suitable for transplantation, comprising expressing a protein as defined in claim 1 on the surface of endothelial cells in said tissue or organ, wherein the method does not involve modifying the germ line genetic identity of human beings or use of a human embryo for industrial or commercial purposes.
The applicant argued, inter alia, that by amending claims 11 and 14 to include disclaimers based on the wording of R 28(b) and (c), the only subject-matter which has been disclaimed was that which was excluded from patentability for non-technical reasons.
Compliance with A 123(2)
[2] The question to be answered is whether the subject-matter of each of claims 1 to 15 […] is disclosed in the application as filed. The allowability of the disclaimers of claims 1, 11 and 14, and of the other aspects of the claimed subject-matter will be assessed in succession.
Disclaimers
[3] Each of claims 1, 11 and 14 contains a disclaimer […]. The disclaimer of claim 1 (“non-human”) excludes human beings in order to satisfy A 53(a) while the disclaimers of claims 11 and 14 exclude subject-matter which is not patentable under A 53(b) taken in combination with R 28, paragraphs b) and c).
[4] The three disclaimers which exclude subject-matter not eligible for patent protection and only serve the purpose of removing specific legal obstacles do not contribute to the invention. The “non-human” disclaimer of claim 1, in a self-evident manner, and the disclaimers of claims 11 and 14, for the very reason that they reproduce the specific wording of R 28, do not remove more than is necessary to disclaim subject-matter excluded from patentability for non-technical reasons.
In this respect, the Board disagrees with the conclusion reached by the ED […] that the disclaimers of claims 11 and 14 removed more than was necessary.
[5] As such the disclaimers of the main request, while meeting the criteria as set forth in decision G 1/03 [order], do not change the subject-matter of the application as filed, within the meaning of A 123(2).
[6] In decision G 2/10 […], it was considered that in decision G 1/03 the Enlarged Board of Appeal (EBA) did not provide an exhaustive treatment of when a disclaimer violates A 123(2) and when it does not […]. Applied to the facts of G 2/10, this meant that the EBA did not consider that decision G 1/03 was exhaustive as to the conditions that needed to be fulfilled for an amendment that consisted of the introduction of an undisclosed disclaimer to be regarded as allowable under A 123(2) (see G 2/10 [p. 47, last §]).
[7] The present Board interprets these remarks made in decision G 2/10 as an instruction to the Board to apply the further test developed in this decision, in addition to those set out in G 1/03, in order to carry out a full assessment of whether an undisclosed disclaimer meets the requirements of A 123(2).
[8] The further test to be applied is whether the skilled person would, using common knowledge, regard the remaining claimed subject-matter as explicitly or implicitly, but directly and unambiguously, disclosed in the application as filed (see G 2/10 [4.5.4 (p. 39)]).
[8.1.1] Account being taken of the exclusion associated with the “non-human” disclaimer, claim 1 is directed to any animal, except a human, comprising a biological tissue a cell of which expresses one or more specific chimeric proteins with anticoagulant activity. The animal is referred to in the application as filed without any limitation with the indication that preferably it is a mammal, and more preferably a transgenic pig or a transgenic sheep (see page 7, lines 25 to 28 of the application as filed). The limitation of this general disclosure to non-human animals does not lead to a disclosure of any particular animal. No new technical teaching is introduced. The aforementioned passage in the description as filed provides an explicit support for non-human animals. The preparation of any non-human animal according to claim 1, which includes the introduction into a cell of a genetic construct encoding the desired chimeric anticoagulant protein by gene therapy or as the result of any other method suitable for generating transgenic animals, relies on exactly the same procedure as would be the case for a human (see from line 29 on page 7 to line 11 on page 8 of the application as filed). Thus, regarding the remaining subject-matter of claim 1, the skilled person is not presented in the application as filed with any new disclosure which goes beyond the application as originally filed.
The remaining subject-matter test applied to claims 11 and 14
[8.1.2] The preparation of a cell which expresses one or more chimeric anticoagulant proteins, as referred to in claim 11, basically relies on the introduction of a construct encoding such a protein. It is disclosed in the application as filed only in general terms. It may or not involve a transfection (see page 7, lines 5 to 15, and page 8, lines 5 to 11, of the application as filed). The remaining subject-matter of claim 11 is limited to the situation where the cell is produced using a process which does not involve either modifying the germ line genetic identity of human beings or using a human embryo for industrial or commercial purposes.
[9] A method of rendering a tissue or organ suitable for transplantation which comprises expressing a chimeric anticoagulant protein on the surface of endothelial cells of said tissue or organ, as referred to in claim 14, is disclosed in the application as filed only in general terms (see page 7, lines 12 to 15 of the application as filed). The remaining subject-matter of claim 14 is limited to the situation where the method involves no modification of the germ line genetic identity of human beings or use of a human embryo for industrial or commercial purposes.
[10] The limitation imposed by the disclaimers of claims 11 and 14 serves the sole purpose of removing specific subject-matter not eligible for patent protection pursuant to A 53(b) in combination with R 28(b) and (c). It has no bearing on the remaining subject-matter in that no new technical teaching is introduced and it leads neither to a disclosure directed to any particular animal nor to an intermediate generalisation that is not explicitly or implicitly disclosed in the application as filed.
[11] Thus, it follows from the above, that the disclaimers of claims 1, 11 and 14 of the main request meet the requirements set out in point 1a of the Order of decision G 2/10. Accordingly, these claims satisfy A 123(2).
The Board then found the remaining amendments to comply with A 123(2) and remitted the case to the ED for further prosecution.
NB: The Board also provided a headnote:
Remaining subject matter test of G 2/10 applied. The EBA in G 2/10 did not consider that G 1/03 provided an exhaustive treatment of the conditions under which an undisclosed disclaimer was to be allowable. In addition to the requirements set out in G 1/03, G 2/10 developed the further test of whether the skilled person would, using common general knowledge, regard the remaining claimed subject matter as explicitly or implicitly, but directly and unambiguously, disclosed in the application as filed.
Mmmm … As far as I can see, G 1/03 allowed disclaimers cutting out undisclosed subject-matter – which, from a purist point of view, appear to be violations of A 123(2) – in very particular circumstances. G 2/10, as I understand it, states that under more general conditions, the only thing that matters is that what is claimed in the end complies with A 123(2). Combining these two and stating that G 2/10 has added criteria to G 1/03 does not sound right to me. I think these two decisions should not be mixed, because they address different situations (and I am not even sure that they are 100% compatible). But then, I may be wrong. What do you think?
Should you wish to download the whole decision, click here.
The file wrapper can be found here.
4 comments:
I agree with you. G 1/03 relates to undisclosed disclaimers and G 2/10 realtes to disclaiming disclosed subject-matter. May be the the Human as an animal was disclosed in the patent application and, therefore, both decisions could apply.
I tend also to agree with Oliver. In G2/10 the EBA explains in length (reasons 3.3 - 3.9) why G1/03 "relates to the case in which neither the disclaimer not the subject matter excluded by it...has a basis in the application as filed" (point 3.3) and does not deal with the case where this subject matter has basis in the application as filed.
My impression is that G1/03 defines criteria which make a claim amended with a disclaimer which would normally offend Art. 123(2), allowable. It defines an exceptional situation.
G2/10 goes more to the core of the Art. 123(2) requirements; its starting point is the fact that the disclaimed subject matter has basis in the application. I would think that from this point on, there is no more relation with G1/03.
I agree with Oliver, as
- G2/10 is (to my understanding) a mere application of A123(2): the remaining features, after a disclosed disclaimer, shall be disclosed in the application as filed,
- G1/03 is an exception to A123(2) as the remaining features cannot be disclosed in the application as filed, since the disclaimer is undisclosed.
I agree that the headnote of T2464/10 is not convincing...
How the EboA did say at the end of G2/10 that:
The wording the Enlarged Board chose in the starting line of answer 2, reading "a disclaimer may be allowable", indicates that with the criteria set up in
answer 2 the Enlarged Board did indeed not intend to give a complete definition of when an undisclosed disclaimer violates Article 123(2) EPC and when it does
not.
Hence, in that decision it was not decided that, the requirements of answer 2 being fulfilled, an undisclosed disclaimer would be always allowable under Article 123(2) EPC.
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