Wednesday, 20 July 2011

T 578/06 – You Bear The Burden First

The applicant filed an appeal after the Examining Division (ED) had refused its application for lack of inventive step.

The Board saw things in a different light, and made some interesting statements regarding the assessment of inventive step especially in the pharmaceutical field.

[5] The pivotal point to be decided in this appeal is whether or not the subject-matter of claim 1 involves an inventive step.

Closest prior art

[6] For assessing whether or not a claimed invention meets the requirements of A 56, the boards of appeal apply the “problem and solution” approach, which requires as a first step the identification of the closest prior art. In accordance with the established case law of the boards of appeal, the closest prior art is a teaching in a document conceived for the same purpose or aiming at the same objective as the claimed invention and having the most relevant technical features in common, i.e. requiring the minimum of structural modifications to arrive at the claimed invention.

[7] The claimed invention concerns “the use of somatostatin or a somatostatin agonist in the formulation of a pharmaceutical formulation or preparation for the treatment of a human patient in receipt of transplanted isolated pancreatic islet cells, wherein the pharmaceutical composition is administered until the transplanted cells have become established and fully functional, whereby the functional life of the isolated transplanted pancreatic islet cells is extended relative to untreated transplanted isolated pancreatic islet cells”.

[8] Both the appellant and the ED considered the closest prior art to be represented by document D10. Document D10 discloses the administration of a new immunosuppressant (15-deoxyspergualin) to human patients receiving pancreatic islet transplantation to protect the islet cells from host immune assault, thereby sustaining the function of the cells (see abstract). In fact, document D10 is the sole document cited in the examination proceedings which addresses the effect of extending the functional life of transplanted pancreatic islet cells. The board therefore concurs with the appellant and the ED that document D10 represents the closest prior art.

[9] The board also largely concurs with the ED’s formulation of the problem to be solved by the claimed invention. Based on the technical teaching in document D10, and in the absence of any argument for or evidence of an improvement over the teaching in that document, the problem to be solved by the claimed invention is the provision of an alternative means to prolong the functional survival of transplanted pancreatic islet cells in human patients.

Is the problem solved?

[10] In the decision under appeal the ED reasoned […] that the formulated technical problem had not been shown to be solved by the claimed invention and, consequently, that the requirements of A 56 were not met […]. It was argued in essence that the patent application as filed did not comprise experimental data showing the claimed effect. Furthermore, the experimental results in post-published documents D11 and D12 did not reflect those of the required test experiments. The ED concluded that, since in ex parte proceedings it was the applicant who bore the burden of proof for the facts in his favour, it was not credible that the formulated technical problem had been solved.

[11] The application as filed summarises the invention by stating that “[t]he present invention relates to a method of prolonging the survival of transplanted pancreatic cells in a patient” […]. Most of the description relates to somatostatin and its agonists as such, to the synthesis of the latter and to somatostatin receptor binding assays, but it also contains a final part entitled “Survival of Transplanted Pancreatic cells” […] which deals, albeit in a theoretical manner, with syngeneic islet transplantation in rats and human ß-islet xenografts in non-immunocompetent mice and which discloses an experimental methodology to test the ability of somatostatin receptor binding compounds to extend the functional life of transplanted pancreatic islet cells. On the basis of this disclosure the board notes that the application explicitly addresses the effect(s) claimed.

[12] The ED based its negative decision on the fact that neither the application as filed nor post-published documents “illustrated” the use of somatostatin by way of experimental data showing the claimed effect. In relation to the latter, the ED considered that other tests were needed which the applicant had not been able to carry out. The board notes that neither in its decision nor during the prosecution of the application has the ED produced arguments which could discredit the plausibility of the claimed invention. Also the board sees no reasons to doubt the usefulness of somatostatin to attain the claimed effect.

[13] The board notes that the EPC requires no experimental proof for patentability and considers that the disclosure of experimental data or results in the application as filed and/or post-published evidence is not always required to establish that the claimed subject-matter solves the objective technical problem. This is in particular true in the absence of any formulated substantiated doubt as is the case here.

[14] The boards of appeal have indeed dealt with cases where, in the context of the assessment of inventive step, there could only be an invention if the application made it at least plausible that its teaching did indeed solve the problem it purported to solve and in which to establish plausibility the disclosure of experimental results in a patent application, or, under certain circumstances, by post-published evidence, was considered necessary (see decision T 716/08 [14-16] for a summary of the case law).

[15] The board re-emphasises in this context however that this case law considers the establishment of plausibility only relevant when examining inventive step if the case at hand allows the substantiation of doubts about the suitability of the claimed invention to solve the technical problem addressed and when it is thus far from straightforward that the claimed invention solves the formulated problem. This is all the more clear from decisions where an inventive step was in fact denied because the formulated problem was not considered to have been solved. By way of example the board refers to the following two decisions:

[15.1] In T 893/02 [12] […] the board agreed […] with the appellants that the technical effect of inducing immunoprotection against melanoma would “probably not be expected” by the skilled person since the prior art taught that gp75 was not a protein present at the surface of melanoma cells and that anti-gp75 auto-antibodies are only very rarely found in the sera of melanoma patients.

[15.2] In T 1329/04 […] the same board, albeit in a different composition, dealt with the situation where allegedly a new member (GDF-9) of the TGF-ß superfamily had been described. However, the board noted in point [7] of the reasons for the decision that GDF-9 as disclosed did not exhibit the most striking structural feature which served to establish whether or not a polypeptide belonged to the TGF-ß superfamily: namely the presence of seven cysteine residues with their characteristic spacing. Any change in the TGF-ß characterising pattern of cysteins and their invariant spacing was expected to have significant repercussions on the function of any TGF-ß family member.

In point [8] of the reasons for the decision the board noted moreover that GDF-9 was also far from fulfilling the homology criterion as its sequence was stated to be significantly divergent from those of other family members. The board concluded […] that these findings lead to the conclusion that GDF-9 could “not be clearly and unambiguously identified” as a member of the TGF-ß superfamily by only using a “structural approach”.

[16] In the present case, the appellant has argued, based mainly on the disclosure in post-published document D11, that the administration of somatostatin or its analogs to a transplanted patient induced a ß-cell rest in the transplanted islet cells which resulted in the inhibition of the glucose-induced endocrine function of those cells, thereby rendering the transplanted cells less liable to an attack by the host immune system. Furthermore, the administration of somatostatin or its analogs to a transplanted patient resulted in a reduced energy requirement of the transplanted islet cells. Both the above actions of somatostatin administration extended the functional life of transplanted islet cells as compared to non-treated transplanted cells.

[17] The board has established in point [12] above that it has no reason to doubt the usefulness of somatostatin for the claimed effect. Under these circumstances, post-published evidence may be taken into account.

Document D11 concludes indeed […] that the use of somatostatin analogs could be envisaged in cases where a decrease in ß-cell function could contribute to reduce antigen expression and thus diminish an immune assault against these cells as was the case following islet transplantation.

Furthermore, post-published documents D13 and D14 demonstrate that the treatment of a recipient of an islet graft with a compound that blocks glucose-induced insulin secretion (diazoxide) improves the islet cell transplant function, by preventing desensitisation of the cells upon transplantation […]. A compound shown to be capable of blocking glucose-induced insulin secretion in vitro was somatostatin […].

Further evidence that somatostatin (analogs) can mimic the effects of diazoxide in vivo comes from post-published document D12 which discloses that both diazoxide and octreotide, being a somatostatin analog, are capable of inducing ß-cell rest […].

[18] The board accepts that the data referred to in this post-published literature do not constitute an explicit proof of the claimed effects. Nevertheless, they at the least constitute proof that the claimed effects are plausible. In this context also the argument of the ED that survival of transplanted islet cells might not only depend on their insulin production cannot weaken the finding on plausibility.

[19] In view of the above considerations, the board considers that it is plausible that the technical problem is solved by the claimed subject-matter.

[20] In the present case, the ED further considered, as a basis for requiring experimental proof that it was credible that the formulated technical problem had been solved by using any of the claimed compounds, that it was the applicant, in ex parte proceedings, who bore the burden of proof for the facts in his favour.

[21] It is an accepted principle in proceedings before the EPO that he who raises an objection has the burden of proof for it, i.e. evidence, facts or any other sort of substantiation must be provided to support the objection. In the board’s view it follows firstly that in examination proceedings, as far as issues relating to patentability requirements are concerned, the burden of proof cannot lie initially with the applicant. It follows, secondly, that if an ED raises an objection, it must appropriately be substantiated.

In the present case, the ED failed to provide such substantiation (see point [12] above). Thus, the board is not convinced by the ED’s argument […], which is, in the context of the present case, understood to mean that in ex parte proceedings the burden of proof is on the appellant even without a substantiated objection by the ED.

[22] In fact, the ED’s proposition as referred to in point 20, above, seems to originate from the EPO publication “Case Law of the Boards of Appeal of the EPO” and is still present in its 6th Edition (English version) published in 2010 in the paragraph bridging pages 564 and 565.

The board notes however that the cited passage exemplifies the proposition by reference to cases holding that a document cited by an ED does not form part of the state of the art (decision T 160/92), that the conditions laid down in A 123 have been met (decision T 383/88), or that a limitation of the claims is admissible (decision T 2/81).

Furthermore, the passage continues by observing, in the context of sufficiency of disclosure, that the applicant is obliged to provide evidence of the skilled person’s relevant knowledge if there is reason to believe the disclosure may not cover all the subject-matter claimed (decision T 82/07).

The board notes that all the procedural situations referred to in this passage are those where, in response to a substantiated objection from the ED, the applicant was required to support his/her contention. Consequently, also the passage (apparently) relied on by the ED does not support its view that in ex parte proceedings the applicant has the burden of proof for facts in his favour. It therefore appears that the proposition cited by the ED has been taken out of its context.

[23] In view of the above considerations the board is satisfied that the claimed invention should be considered to solve the formulated technical problem in accordance with the requirements developed in the case law of the boards of appeal.


[24] The ED stated in the reasons for its decision that, provided the applicant had been able to show that the effect of prolonging the survival of transplanted isolated islet cells by the use of somatostatin or its agonists, the application might possibly have been recognised as making an inventive contribution to the art. The board takes from this that the fact that the formulated technical problem had allegedly not been proved to be solved was the only reason for the ED to refuse the application.

In view of this positive votum of the ED and in absence of any reason for deciding differently, the board therefore accepts that the invention as claimed involves an inventive step as required by A 56.

To read the whole decision, click here. The file wrapper can be found here.

Laurent Teyssèdre has a nice summary on his blog (here).


Anonymous said...

I guess, I read already better decisions: it's a rare one, where the BoA deals with plausibility in a medical use claim under Art 56 and not Art 83 (eg T1079/08). Further, plausibility should be assessed with the knowledge at the date of filing.

Anonymous said...

Anonymous - I agree. But this BoA has a habit of deadling with medical use claims under A56 rather than A83

(see T 716/08 – Does It Work?)

Myshkin said...

It is disappointing that the Board does not explain why it deviates as in T 716/08 from case law such as G 1/03 (which would have forced the Board to refer a question to the EBA if I'm not mistaken). Surely it must be aware of the deviation, or do Boards not communicate?

I am also not convinced that it is not in the first place on the applicant to show or at least argue some degree of plausibility that a particular technical effect is achieved compared to the closest prior art. In my view this would not conflict with the ED's duty to substantiate a finding of lack of inventive step, since such reasoning can be based on a very general problem formulation. The applicant could then argue against this objection by showing that a particular effect is (plausibly) achieved, forcing the ED to adapt the problem formulation (or substantiate why the effect is not achieved). Of course in practice the ED will usually assist the applicant in formulating effects (Art. 114(1)), but this does not make it the ED's burden to show that an effect is not achieved when nothing suggests that the effect is plausible.