T 1196/08 – Romanian Rhapsody

The present decision deals with an interesting case of third party intervention.

The patent proprietor had extended its European patent to Romania. The patent was opposed, but the Opposition Division rejected the opposition (in 2008). The opponent filed an appeal against this decision. In February 2009, a Romanian company (SC Gedeon Richter Romania SA, hereinafter referred to as “SC”) filed a notice of intervention. The patent proprietor had indeed instituted infringement proceedings in Romania on November 26, 2008. The question to be answered by the Board was whether this intervention was admissible or not.

NB: The would-be intervener also requested the Board to refer questions to the Enlarged Board of appeal (EBA) and raised a R 106 objection because the Board had not heard the European Patent Organisation and the State of Romania on the topic to be decided.

*** Translation of the French original ***

[3.1.1] Subject to certain conditions, A 105(1)(a) and R 89 allow a third party to intervene in opposition proceedings after the opposition period has expired, if the party proves that proceedings for infringement of the same patent have been instituted against it.

[3.1.2] In the present case, the declaration of intervention has been filed during the opposition appeal proceedings, which is admissible according to decision G 1/94 of the EBA.

[3.1.3] Moreover, in order for an intervention to be admissible, the infringement proceedings have to be based on the very patent which is the subject of the proceedings at which the intervention is directed (see T 338/89 [4.1.2] and T 446/95 [2.1]).

[3.1.4] Therefore, it is appropriate to first clarify what is the subject of the present European opposition proceedings in application of the European Patent Convention (hereinafter referred to as “Convention”).

A 99(1), first sentence, EPC, provides that within nine months of the publication of the mention of the grant of the European patent in the European Patent Bulletin, any person may give notice to the EPO of opposition to that patent. The Convention defines the notion of “European patent” in A 2(1) EPC 1973, which states that patents granted under the Convention shall be called European patents. According to A 3 EPC 1973, the grant of a European patent may be requested for one or more of the contracting states. Therefore, the opposition proceedings concern a European patent which has been granted for at least one contracting state. However, it is irrelevant for the opposition proceedings if the effects of this patent have been or will be extended. This clearly follows from R 84(1) according to which the opposition proceedings may be continued only at the request of the opponent if the European patent has been surrendered in all the designated contracting states or has lapsed in all those states.

This is why the Board concludes that “the same patent” [French version : ce brevet] within the meaning of A 105(1)(a) is a European patent within the meaning of A 2(1) EPC 1973, i.e. a patent granted under the Convention for one or more of the contracting states, which is, as underlined by the [patent proprietor] a system of law for the grant of patents for invention that is common to the contracting states, pursuant to A 1 EPC 1973. Consequently, the infringement proceedings before national jurisdictions have to be instituted based on a European patent which has been granted under the Convention for at least one contracting state if the conditions of A 105(1)(a) are to be fulfilled.

[3.1.5] In accordance with the evidence filed by the SC company, the infringement proceedings before the Romanian court are based on Romanian patent RO/EP 1108424 which has been obtained by extension of the European patent to Romania.

[3.1.6] The SC company is of the opinion that the Romanian patent resulting from an extension of a European patent has to be considered to be the same patent as a European patent granted under the Convention because the fact that Romania was not party to the EPC at the relevant date only constitutes a difference in view of the legal basis of the effects of the European patent, and not a difference in view of the fact that it is still (encore) a European patent. (NB: The whole sentence is unclear in the French original.)

The Board does not share this opinion, for the following reasons.

[3.1.7] The extension of the effects of European patents to Romania was possible as from October 15, 1996, i.e. the date on which the Agreement between the Government of Romania and the EPO on cooperation in the field of patents (“Cooperation Agreement”) entered into force (see OJ EPO 1994, 746 and 1996, 601).

The Cooperation Agreement is part of the international agreements which the President of the EPO is empowered to conclude subject to the approval of the Administrative Council (A 33(4) EPC 1973). As a bilateral ordinance, the Cooperation Agreement essentially deals – exhaustively and strictly separately from the EPC – with matters pertaining to the integration of extended European applications and protective rights into the national law of the state allowing (autorisant) the extension and their relationship to national applications and rights based on the national Law on industrial property (see, for example, J 14/00 [1.3.2]).

[3.1.8] The extension system provides European patent applicants with a simple and economical means of obtaining patent protection in the states for which a Cooperation Agreement with the EPO has entered into force (states allowing the extension) (see, for instance, “Extension of European patents to Romania”, OJ EPO 1994, 746, (EEPR1), second paragraph, “Extension of European patents to Slovenia”, OJ EPO 1993, 574, (EEPS1) third paragraph, and OJ EPO 1994, 75, (EEPS2), I. Basic principles, second paragraph). Upon request of the applicant and subject to the payment of the prescribed fee, the effects of European patent applications (direct and Euro-PCT applications) and European patents extend to the state allowing the extension, which, however, is not party to the EPC. These effects are the same as those of national applications and national patents (see, for instance, “Extension of European patents to Romania”, OJ EPO 1996, 601, (EEPR2), points 8 and 9, and articles 4 and 5(1) of the Romanian extension ordinance (EO); EEPS2, I. Basic principles, second paragraph, and article 1 of the EO of the Slovenian government, OJ EPO 1994, 80).

As underlined by the [patent proprietor], the extension system may be considered to be an intermediate step for a state before it becomes a party to the Convention. This also follows from the preamble of the Romanian Cooperation Agreement, which stipulates that Romania, whishing to become a party to the EPC, wishes, as an intermediate step, to have a system allowing to extend the effects of a European patent to its territory (extension system).

[3.1.9] Although the extension proceedings essentially correspond to the system provided by the EPC, which is applicable to the states that are party to the Convention, the validity of the extension system is not based on the direct application of the EPC but exclusively on national law inspired by the EPC (see, for instance, EEPR2, point 15; EEPS2, I. Basic principles, second paragraph; J 14/00 [1.2.2]; J 9/04 [1.2.2]; J 2/05 [1.2.2], Singer/Stauder, EPÜ, fifth edition in German, 2010, article 2, point 9). As a consequence, the national law of the state allowing the extension governs the extension proceedings and the legal effects of the extension. As a matter of fact, the legal provisions governing the extension system in Romania, including all the conditions and all the legal effects of the extension, appear in the Romanian EO “Monitorul Oficial al Rômanei, Anul VIII, n° 195, August 21, 1996, 2, 4”, i.e. in an ordinance of the government of the state allowing the extension (see EEPR2, second paragraph).

[3.1.10] As far as the applicability of the EPC is concerned, the provisions of the Convention, of its implementing regulations and of the rules relating to fees of the EPO apply only to the extent to which the national provisions refer to them (see, for instance, article 10 of the Romanian EO and article 10 of the Slovenian EO; EEPR2, point 15; Singer/Stauder, op.cit., article 79, point 40). The wording of the Romanian EO makes it very clear that its references to the provisions of the Convention are exhaustive (see also J 14/00 [1.3.1]) on the subject of the Slovenian EO). According to the Romanian provisions, the only references to the EPC concern the time limits and the means of payment of the extension fee (see article 3 of the Romanian EO and EEPR2, point 15).

[3.1.11] It follows from what has been said that the European patent under consideration extends to the Romanian territory exclusively on the basis of Romanian national law and that, according to article 5(1) of the EO, it has the same effects as a national patent (see also EEPR2, point 9).

However, as explained by the SC company, the European patent under consideration the effects of which extend to Romania is not a national patent granted by the Romanian national office. This legal evaluation is based on the wording of certain provisions of the EO, such as for example articles 5(1), 8, and 9, according to which a distinction is made between a European patent the effect of which extends to Romania and a national patent (see also EEPR2, points 9, 12, and 14). In the present case, the facts, therefore, differ from the facts on which decision T 446/95 was based, so that the latter is not relevant for the present case.

[3.1.12] As for the European patent within the meaning of article 2(1) EPC 1973, it is granted under the Convention by the EPO, for each of the contracting states that are designated pursuant to A 79 EPC 1973. Once it is granted, a European patent has, in each of the contracting states for which it is granted, the effect of a national patent granted by that state (A 2(2) and A 64(1) EPC 1973). It follows that the European patent system, including the effects of a European patent in the contracting states, is based exclusively on the direct application of the EPC.

[3.1.13] Although there are some parallels between the extension system and the European patent system, there are some fundamental differences between those two systems. The extension system, including all the conditions for and all the legal effects of the extension, is exclusively based on the application of national law, unless there are explicit references to the EPC. Moreover, the European patent system and the effects of a European patent in the contracting states are exclusively based on the direct application of the EPC, it being understood that some provisions of the EPC refer to national law. Therefore, it follows from the extension of the effects of a European patent under the national law of the state allowing the extension that the European patent has the effects of a national patent, whereas the designation made pursuant to A 79 EPC 1973 has the consequence that the European patent is granted by the EPO based on the Convention, with effect for the designated contracting states (see Singer/Stauder, op.cit., article 79, point 40). In view of this different legal situation, the Board concludes that a patent extended to the territory of a state allowing the extension is not a European patent within the meaning of A 2(1) EPC 1973. It may well be that the Romanian patent resulting from the extension has its origin in a European patent application and, subsequently, in the European patent granted on the basis of this application in accordance with the Convention, but, even if this were admitted, it follows from the legal situation explained above that the extension and the legal consequences resulting from it are exclusively based on national law. As a consequence, the patent resulting from the extension does not have the legal nature of a European patent within the meaning of A 2(1) EPC 1973.

[3.1.14] According to the Board, as far as the present case is concerned, it follows that Romanian patent RO/EP 1108424, which has been obtained by extension to Romania of the European patent under consideration and which is the subject of the infringement proceedings before the Romanian court, is not a national patent granted in Romania. The Board also concludes that the Romanian patent is exclusively based on national law, i.e. on Romanian law, and not on the Convention. In other words, the Romanian patent is not a patent that has been granted by the EPO for Romania, in application of the Convention. This is why the Board is of the opinion that the Romanian patent is not a European patent within the meaning of A 2(1) EPC 1973. As a consequence, Romanian patent RO/EP 1108424 does not correspond to European patent EP 1108424, which is the subject of the present opposition appeal proceedings. Consequently, the intervention does not satisfy one of the requirements of admissibility enshrined in A 105(1)(a). (see point [3.1.3] above).

[3.1.15] Moreover, the provisions of the Romanian EO do not refer to the provisions of A 105. The references of the Romanian EO to the provisions of the EPC being exhaustive (see point [3.1.10] above), the question of whether A 105 can be applied by analogy does not even arise.

[3.1.16] The SC company invokes the Treaty on European Union (TEU) and the TRIPS (Trade-Related aspects of Intellectual Property rights) Agreement and requests that articles 23 and 49 TEU and articles 41(2) and 49 of the TRIPS Agreement be taken into consideration when the applicability of A 105 is interpreted.

The Convention is a system of law, common to the contracting states, for the grant of patents for invention (A 1 EPC 1973). It constitutes a special agreement within the meaning of article 19 of the Paris Convention for the Protection of Industrial Property and a regional patent treaty within the meaning of article 45 PCT (see the third paragraph of the preamble of the Convention). The Convention does not come under Community law (see EPÜ, Münchner Gemeinschaftskommentar, 1998, article 1, III, 1.a))

The European Patent Organisation is not party to the TRIPS Agreement (see G 1/97 [5a]). However, the provisions of this agreement, very much like decisions of the European and international Court of justice and national decisions, are to be taken into account by the Boards of appeal, which nevertheless are not bound by them (G 2/02 and G 3/02 [8.6]; T 1173/97 [2.2]) However, the EBA has also declared:

“Whereas it is legitimate for the boards of appeal to use the TRIPS Agreement as a means to interpret provisions of the EPC which admit of different interpretations, specific provisions of TRIPS cannot justify ignoring express and unambiguous provisions of the EPC. To do so would usurp the role of the legislator.” (G 2/02 and G 3/02 [8.6])

The Board is of the opinion that these considerations also apply for the TEU.

The Board has explained (see points [3.11-15] above) that the provisions of the Convention as it stands and in particular A 105, as well as the national provisions of the Romanian EO clearly exclude the possibility of intervening in the proceedings based on infringement proceedings concerning a Romanian patent resulting from the extension of a European patent to Romania. Therefore, it is not possible to come to a different conclusion based on the provisions of the TEU or the TRIPS Agreement. On the contrary, it is up to the competent lawmaker to provide the possibility of intervening in such a situation.

[3.1.17] The SC company has also pointed out that it had interest to act against the Romanian patent resulting from the extension because of the proceedings pending before the Romanian court, and in particular in having the nullity proceedings stayed until the outcome of the present appeal proceedings was known. The Board accepts that such an interest to act may exist. However, taking into account the legal situation described above concerning the intervention pursuant to A 105(1)(a), the SC company has to act before the Romanian national legal institutions.

[3.1.18] As a consequence, the intervention of company SC, based on the infringement proceedings before the Romanian court based on Romanian patent RO/EP 1108424 resulting from the extension to Romania of the European patent under consideration, is inadmissible because it does not comply with the requirements of A 105(1)(a).

[3.2] A 115, first sentence, provides that in proceedings before the EPO, following the publication of the European patent application, any third party may present observations concerning the patentability of the invention to which the application or patent relates. The documents filed by the SC company concerning the patentability of the invention that is the subject of the patent under consideration are considered to be third party observations pursuant to A 115, first sentence. However, the Board underlines that, pursuant to A 115, second sentence, the SC company is not a party to the proceedings. As to the substance of the case, the letters dated February 24, 2009, December 15, 2009 and October 27, 2010, which are considered to be third party observations pursuant to A 115, do not contain elements that had not been mentioned by the appellant yet.

Referral to the EBA

[4.1] The SC company has asked the Board to refer a question to the EBA in case it would decide that the EO would lead to issuing national patents. According to the SC company, the question of the legal nature of a European patent that has been extended to Romania and the related question of whether an intervention pursuant to A 105 was admissible constitute points of law of fundamental importance.

[4.2] According to A 112(1) EPC 1973, the Board of Appeal shall, during proceedings on a case and either of its own motion or following a request from a party to the appeal, refer any question to the EBA if it considers that a decision is required.

A question involves a “point of law of fundamental importance” within the meaning of A 112(1)(a) if it is relevant in a substantial number of similar cases and is therefore of great interest not only to the parties in the present appeal but to the public at large. (see, for instance, T 271/85). However, a question that involves a point of law of fundamental importance does not necessarily have to be referred to the EBA if the Board itself can answer it without doubt (see, for instance, J 5/81; T 198/88; J 22/95; Case Law, 6th edition 2010, VII.E.14.2). The Board has explained in detail (see points [3.1.7-14] above) why Romanian patent RO/EP 1108424, which has been obtained by extension to Romania of the European patent under consideration, is not a national parent granted in Romania, but a patent that is exclusively based on national law, i.e. on Romanian law, and not on the Convention. The Board has also explained why Romanian patent RO/EP 1108424 is not a European patent within the meaning of A 2(1) EPC 1973 and why the intervention pursuant A 105(1)(a) is, therefore, inadmissible.

[4.3] As mentioned above (see points [3.1.1-18] above), the present Board has no doubts that in the present case the intervention is inadmissible because Romanian patent RO/EP 1108424 does not correspond to European patent EP 11108424, which is the subject of the present opposition appeal proceedings. Consequently, one of the conditions of A 105(1)(a) is not fulfilled. Therefore, there is no point of law of fundamental importance which would have to be clarified by the EBA.

[4.4] These reasons have led the Board to decide that there is no need for referring the questions of the SC company to the EBA.

R 106 objection

[5] The objection raised under R 106 has to be rejected for the following reasons:

A 113(1) EPC 1973 provides that the decisions of the EPO may only be based on grounds or evidence on which the parties concerned have had an opportunity to present their comments. The right to be heard within the meaning of A 113(1) EPC 1973 applies to all proceedings before the EPO and to all parties to the proceedings (Singer/Stauder, op.cit., article 113, 2). Third parties which, according to A 115, second sentence, are not parties to the proceedings, cannot invoke the right to be heard (G 4/88 [2]). Neither the European Patent Organisation nor the State of Romania are parties to the present proceedings under A 107 EPC 1973. Consequently, in the present case, the fact that the Board has not given the European Patent Organisation and the State of Romania the opportunity to file observations does not violate the right to be heard.

A hardly surprising outcome.

On a teleological level, one might add that the possibility of intervening in opposition proceedings is justified by the fact that the fate of the patent can be decisive for the outcome of the infringement proceedings: a revocation of the opposed patent will deprive the infringement proceedings of their very cause. There is no equivalent justification here because even if the European patent is revoked, the Romanian spin-off is not (at least not automatically). It may be found to be valid by a Romanian court. In other words, there is no direct effect of the revocation (or limitation) on the infringement proceedings before the Romanian court.

To read the whole decision (in French) or have a look at the file wrapper, click here.

NB: The decision is also commented on Le blog du droit européen des brevets. 

You can listen to the Romanian rhapsody here.

T 1130/09 – Two Will Do

The applicant appealed against the decision of the Examining Division (ED) to refuse its application based on the finding that the subject-matter lacked novelty.

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

Substrate having a micro-structured surface at least part of which comprises a biocompatible polymer of the following general formula (I)

wherein n goes from 2 to infinity, R1 to R6 are the same or different and represent an alkoxy, an alkylsulfonyl, a dialkylamino, or an aryloxy residue, or a heterocycloalkyl or heteroaryl residue where the hetero atom is nitrogen, and wherein the surface structures have a dimension of between 10 nm and 100 μm.

In what follows the Board answers the question of whether this claim is novel.

*** Translation from the German ***

[3.1] The subject-matter of claim 1 concerns a substrate having a micro-structured surface at least part of which comprises a biocompatible polymer of general formula (I)and wherein the surface structures have a dimension of between 10 nm and 100 μm.

[3.2] In the impugned decision only document D2 was cited in respect of novelty.

Document D2 also discloses a substrate the surface of which is coated with a polyphosphazene according to formula (I) of the application under consideration. The substrate can also be micro-structured […]. The only disclosure concerning structural dimensions […] reads:

“One is not limited by the structural size of the substrate. Therefore, structures of the order of nanometres, microns or even larger or smaller can be manufactured.”

It is true that document D2 does not disclose a specific range defined by specific upper and lower limits, but by referring to structures of the order of nanometres or microns and by referring to the substrates as being micro-structured substrates it defines a range of dimensions that is limited to such microstructures.

The impugned decision invoked the principle of selection inventions by applying the three criteria of decision T 198/84 [7]. This principle is to be applied when a narrow sub-domain is selected from a greater domain.

The description […] of document D2 discloses that the structural dimensions are of the order of microns or nanometres. Thus the specific claimed domain of between 10 nm and 100 μm is a narrow selection, as already mentioned in the impugned decision. Moreover, as there are no exemplary values in D2, this selection has to be considered to be remote from the central embodiments of document D2. Thus the two first criteria of T 198/84 are satisfied.

However, the third criterion, according to which a technical effect is to be established, cannot be considered in the assessment of novelty, because novelty and inventive step are two distinct requirements of patentability. A technical effect that occurs in the more narrow claimed domain cannot justify the novelty of a domain of values that is novel as such, but can only confirm the novelty of this more narrow claimed domain. However, the question of whether there is a technical effect or not is related to inventive step (see T 1233/05 [4.4], T 230/07 [4.1.6]).

Therefore, the Board is of the opinion that document D2 does not disclose the claimed domain of 10nm to 100 μm and that the subject-matter of original claim 1 is novel over document D2 within the meaning of A 54.

The Board then referred the case back to the ED.

I think this approach is to be approved. It has been criticized in the legal doctrine, for example by Prof. Vigand in the French periodical Propriété Intellectuelle, Décembre 2010, p. 17, in an article dedicated to T 1233/05 (my translation of the French original):

… When the prior art is prior art that is relevant for novelty only (A 54(3) EPC), it is absolutely indispensable to have demanding and precise standards for applying the criterion of novelty.

Therefore, the third condition is necessary because if it is not included, the second applicant, who has not invented anything, can annex considerable portions of the domain claimed by the first applicant.

Thus, if the first [applicant] had covered a domain from 1 to 100, with one example at 80, the subsequent applicants could obtain sub-domains by slices of 10 (from 1 to 10, from 10 to 20, and so on) as long as the first patent has not yet been made accessible to the public. …

With due respect, I do not find this plea very convincing. By abandoning the third criterion, the Board puts an end to mixing novelty and inventive step. In my opinion, the fact that this may lead to regrettable results when the prior art is of the A 54(3) type is more related to the logic behind A 54(3) – which has its flaws – than to selection inventions. In other words, I find it untoward to introduce a dose of inventive step into criteria for novelty assessment in order to mask undesirable side effects of the A 54(3) novelty-only regime.

Should you wish to download the whole decision (in German), just click here.

The file wrapper can be found here.

NB: There was a post on T 230/07 on this blog, plus some interesting comments left by readers.

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.

Obviousness

[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).

T 324/09 – First Or Not?

In EQE papers the question of whether a priority application is a « first application » within the meaning of A 87(4) is often relevant and gives rise to quite tricky situations. In real life, I have not encountered it very often, but the question sometimes arises, as in the present case.

Both opponent I and the patent proprietor filed appeals against the decision of the Opposition Division maintaining the opposed patent in amended form.

Claim 1 as granted read:

A fastener (20) comprising a riveting barrel portion (22), a flange portion (24) which extends radially from the barrel portion generally perpendicular thereto and a fastener portion (26) generally opposite the barrel portion (22), wherein said flange portion includes an outer panel bearing surface (38), characterised in that an annular groove (40) is provided adjacent to and surrounding the barrel portion (22) radially inside the outer annular panel bearing surface (38); in that a plurality of spaced radial ribs (42) bridge said groove (40); and in that said fastener potion (26) comprises a threaded or smooth bore coaxially aligned with said barrel portion (22).

According to the opponent, the priority claim was invalid.

The Board could not agree:

The subject-matter of the invention

[2] The claimed invention relates to a fastener of the self-piercing type. These types of fasteners comprise: “riveting elements” and “pressform elements” as defined in Exhibit 5 which is a datasheet of the “DVS-Deutscher Verband für Schweißen und verwandte Verfahren”.

This document defines a “riveting element” as an element with a portion which is deformed after having been inserted into the object with which it has to be connected by form fit (“Einnietbare Funktionselemente sind gekennzeichnet durch einen Abschnitt, der nach dem Einbringen in das Werkstück umgeformt und mit diesem formschlüssig verbunden ist”). This definition clearly states that a riveting element is characterised by a deformation of a portion of the riveting element itself.

Following this definition it is specified that the form fit can be achieved either by deformation of only a portion of the riveting element or by deformation of both the riveting element and the object with which it has to be connected (“Die Formschlüssigkeit ist entweder durch Umformen des Nietabschnittes allein und/oder durch Umformen der Lochwandumgebung mit dem Nietabschnitt in Kombination erreicht”).

The interpretation of [opponent I] according to which the second part of the definition has to be interpreted in the sense that either the riveting element or the object with which it has to be connected can be deformed, is not correct. The two parts of the definition cited above have to be read in combination. Since the first part specifies the deformation of a portion of the riveting element, the second cannot be construed as giving the alternative of deforming either the riveting element or the other object.

Exhibit 5 goes on to define “pressform elements” as elements which are not deformed when inserted into the element with which they have to be connected (“werden beim Einbringen in das Bauteil nicht umgeformt”). It is the other element which is deformed by pressing it into contact with the pressform element (“Umgeformt wird der Bauteilwerkstoff dessen Lochwandumgebung an die oben genannte Abschnitts bereiche der Funktionselemente angepresst wird.”).

It is evident from the definitions of “riveting element” and “pressform element” that these two elements conceptually represent two fundamentally different ways of connecting a fastener with another object. In one case the fastener is deformed (alone or in combination with the other object), in the other the fastener is not deformed.

Since claim 1 as granted refers to a fastener comprising a riveting barrel portion which according to all embodiments of the patent in suit is deformed (see Figures 9, 11 and 14), the invention clearly belongs to the category of “riveting elements” and not that of “pressform elements”.

Priority

[3] The patent in suit claims the priority of D27 which itself claims the priority of D28. [Opponent I] argues that, since D28 disclosed all features of claim 1 as granted, D27 was not the first filed application referring to the present invention and that the priority was not validly claimed.

D28 discloses in Figures 14 and 16 a fastener comprising shaft 16 which is connected to plate 52 by the deformation of the plate into grooves 20 of the fastener.

There is no disclosure in D28 of any purposive deformation of the shaft in order to connect it with the plate. Moreover, the bulk shape and the thickness of shaft 16 do not suggest any deformation upon insertion into plate 52 either. Therefore, the fastener described in D28 clearly belongs to the pressform element type.

Contrary to the submissions of [opponent I], the passage in column 10, lines 8 to 16, cannot be understood in such a way that the shaft is intended to be deformed, let alone in order to connect the fastener to the plate. This passage merely describes a means to avoid an unintentional minor deformation of shaft (16), due to the deformation of the plate, which results in a restriction of the cross-section of the bore (82).

NB: The passage in column 10, lines 8 to 16 reads (in English translation):

“On the bottom side of element 10 of the middle bore 82 there is a portion 86 the diameter of which is extended. This portion primarily serves to avoid that a deformation of the shaft portion 16 of the nut element leads to a narrowing of the opening section (Durchgangsfläche) of the bore 82 as a result of the plastic deformation of the sheet piece into the zones 20 and the recess 28, which narrowing would hinder the bearing part (Lagerteil) from being introduced into element 10.”

The argumentation of [opponent I] according to which shaft 16 was suitable to be deformed and hence represented a riveting element cannot be followed either. The question to be answered is not only whether shaft 16 is suitable to be used as a riveting portion, but whether - more importantly - it was designed and intended to be deformed and hence used as a riveting part in D28. Since, as stated above, shaft 16 was explicitly not intended to be deformed, it does not represent a riveting portion.

Since D28 does not disclose all features of claim 1 of the patent in suit, D27 represents the first filing of the invention according to the patent in suit.

Hence its priority is validly claimed.

The Board then found the claim to be inventive and rejected the opposition.

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

T 1129/09 – Be Exhaustive

When you appeal against the decision of an Examining Divison (ED) to refuse your application, be sure to address all the objections raised. Otherwise, you might end up as the applicant in the present case.

The relevant procedural facts are exposed in the decision.

[1] In section 3.1 of its last communication dated 30 January 2009 the ED informed the [applicant] that “[i]f the applicant is interested in a speedy appealable decision, he can ask for a “decision according to the state of the file” and withdraw his request for oral proceedings (OPs). Then the ED will issue a decision of a standard form referring to the previous communications (see Guidelines C-VI, 4.5) this decision is appealable like any decision announced after an OPs”.

[2] With its fax of 2 March 2009 the [applicant] withdrew its request for OPs and requested a decision to be “rendered according to the state of the file”.

[3] In the resultant decision of standard form, reference is merely made to the communications of the ED dated 27 April 2007, 28 January 2008 and 30 January 2009.

[4] The first communication only made a novelty objection based on D1, which after reply of the [applicant] was subsequently withdrawn. In the second communication an objection for lack of clarity (definition by the result to be achieved) and lack of sufficiency was raised. In the reply thereto the [applicant] traverses these objections by reference to the examples in the description.

In the last communication again an objection for lack of clarity is raised, this time for absence of features in the main claim which are essential for solving the problem posed (section 2.2.1), as well as a further elaboration of the sufficiency objection already made (section 2.2). The earlier objection for lack of clarity is apparently dropped as it is not repeated nor referred to. In section 2.3 an objection of lack of inventive step is raised (A 56), based on the object to be achieved by the invention, as seen by the ED.

[5] With its appeal the [applicant] filed amended claims requests and supplied the statement of grounds of appeal in respect of novelty and inventive step of the subject-matter of claim 1 of each of these requests.

[6] In its communication the Board observed that the appeal appeared to concern only the issues of novelty and inventive step in respect of the newly filed claims, but not the other issues (A 83 and A 84) of the decision under appeal. The amendments to claim 1 of the main and the auxiliary request neither seemed to address these issues. Regarding the possible inadmissibility of the appeal the Board referred also to decision T 844/05.

[7] In its letters of 4 and 17 February 2011 the [applicant] did not address the issue of admissibility of the appeal as raised by the Board, other than by asking that the appeal be “permitted” and by supplying arguments, now regarding sufficiency of disclosure and clarity of the claims.

[8] During the OPs before the Board the discussion therefore concentrated on the admissibility of the appeal and focused on the content of the ED’s last communication, the [applicant’s] statement of grounds of appeal and the amended claims filed with the appeal.

[9] A 108, third sentence, provides that

“[w]ithin four months of notification of the decision, a statement setting out the grounds of appeal shall be filed in accordance with the Implementing Regulations”.

Pursuant to R 99(2),

“[i]n the statement of grounds of appeal the [applicant] shall indicate the reasons for setting aside the decision impugned, or the extent to which it is to be amended, and the facts and evidence on which the appeal is based”.

[10] Under the established case law the grounds for appeal should specify the legal or factual reasons on which the case for setting aside the decision is based. If the [applicant] submits that the decision under appeal is incorrect, the statement setting out the grounds of appeal must enable the Board to understand immediately why the decision is alleged to be incorrect and on what facts the [applicant] bases its arguments, without first having to make investigations of its own (see T 220/83 [4], followed by numerous decisions, such as T 809/06 [2] and T 844/05 [1]).

[11] As it is the statement of grounds of appeal which has to fulfil by itself these requirements the supplying of reasons regarding grounds of the impugned decision, for the first time with the letter of 4 February 2011, outside of the applicable time-limit cannot remedy the deficiency that they have not been supplied with the statement of grounds.

[12] The admissibility of the appeal therefore depends in the present case on whether the letter of 29 April 2009, together with the two sets of claims and description page 6 annexed to said letter, can be regarded as a valid statement of grounds of appeal.

[12.1] It is therefore to be examined whether the impugned decision is based in substance only on inventive step. If that is not the case, it must be apparent from the arguments presented in the statement of grounds and/or from the attached amended claims that the reasons for refusal based on lack of sufficiency (A 83) and lack of essential features (clarity/support, A 84) are implicitly addressed or that at least the amended claims clearly overcome them. The Board is of the opinion that this requirement is not met in the present case, for the following reasons.

[12.2] The communication of 28 January 2008 already contains a very brief objection under A 83 that the skilled person only receives vague indications on how to achieve a plastic which is highly stretched and on how the geometry allows a uniform repartition of the forces.

In the communication of 30 January 2009 this objection is expanded in that explanation is considered lacking in the patent as to how a further reduction in wall thickness and weight of the bottom is achieved (for arriving at a weight ratio of more than 4:1 for the wall: bottom, as claimed) while at the same time maintaining/improving the mechanical properties of the container.

Both are clear objections under A 83, insufficiency of disclosure.

In the latter communication, based on the same deficiencies as the information contained in the patent, an objection for lack of essential features in claim 1, to define the invention, was made. It is consistent case law of the Boards of Appeal that such an objection is one for lack of clarity/support, see Case Law, 6th edition 2010, Chapter II.B.1.1.4.

[12.3] The [applicant’s] statement of grounds of appeal does not contain any arguments regarding the lack of sufficiency (A 83) or the lack of essential features (clarity/support, A 84) but only arguments in respect of lack of novelty and inventive step. This fact was not disputed by the [applicant].

The [applicant] was also not in a position to identify any part of the two sets of claims and amended description page 6 annexed to said letter which related to these objections and clearly overcame them.

[12.4] The [applicant] argued that even if sections 2.2 and 2.2.1 of the last communication of the ED were to be seen as objections under A 83 and A 84, due to the fact that said sections also refer to comparisons between the subject-matter of claim 1 and the disclosure of D1 and/or D2, the [applicant] was led to believe that the only issue at stake was a lack of inventive step and that by filing, together with the corresponding arguments, new sets of claims overcoming in its opinion this ground an admissible appeal had been filed.

[12.5] The Board cannot follow said argument for the following reasons:

[12.5.1] In the first place, both for sufficiency of disclosure as well as for lack of clarity/support, there is an arguable case for taking account of the features by which the claimed invention distinguishes itself from the prior art, being D1 or D2. These are the features which are important for the invention, as it is the invention as claimed which needs to be sufficiently disclosed, if not in the claim, then with the help of the description and the general technical knowledge of the skilled person, see T 1011/01 and T 226/85 cited in Case Law of the BoA, Chapter II.A.1.

The same applies even more for distinguishing features, essential to the invention so as to comply with the requirement of clarity in/support for the claims, see Case Law of the BoA, Chapter II.B.4.2, in particular T 1055/92 cited therein.

[12.5.2] In the second place the [applicant] should have made its position on the issue clear, by at least submitting that lack of sufficiency and lack of clarity/support have nothing to do with the “distinguishing features”, or that by filing arguments and amended claims as a response to the issue of inventive step it assumed that it automatically responded also to the objections raised under A 83 and A 84. Both are not the case.

[13] The [applicant] argued further that according to the case law of the Boards of Appeal by filing an amended set of claims the [applicant] does not need to address every single objection of the impugned decision and that therefore in the present case it did not need to address the objections concerning lack of sufficiency of disclosure (A 83) and lack of clarity/support (A 84) explicitly.

The Board cannot follow said argument for the following reasons:

[13.1] The Board establishes that, other than this general statement, the [applicant] did not put forward any supporting case law. Also the present Board is not aware of any case law supporting such a general statement. In the present case, without arguments directed to the amended features when compared with the objections under A 83 and A 84, it would require anyway that the Board performs further investigations on its own to examine the possibility whether the amended claims evidently address these issues, which goes, in the present case, beyond its duties, see point [10] above.

[13.2] The cases cited in the Case Law of the Boards of Appeal of the EPO, 6th edition 2010, Chapter VII.E.7.6.2 d in this respect relate to either submitting claims which already had been accepted before by the department of first instance (T 729/90), clearly overcome a novelty objection by adding to the claim a novel feature (T 105/87) or clearly put the established lack of inventive step into question (T 563/91). None of these situations apply here.

[13.3] Even if the Board had examined the nature of the amendments in the new sets of claims, it would not have been evident that they also overcome the objections based on insufficiency of disclosure and on lack of clarity/support:

[14] The amendments concern the hemispherical shape of the feet and the tangentially shaped connection of the feet to the hemispherical bottom. The objections related however to the wall/bottom weight ratio being at least 4 and to the question whether the invention was sufficiently claimed and described insofar as the wall-thickness/weight of the container’s bottom was reduced, while maintaining, or even improving, at the same time the mechanical properties of the container. The feature of the wall/bottom weight ratio being at least 4 has remained, however, unchanged in claim 1 and the application does not give any indications that the “substantially hemispherical” shape of the feet or their connection to the hemispherical bottom, address the issue of the weight reduction, let alone in connection with the mechanical properties. Finally, the present case does not fall within the other exceptions, listed in Chapter VII.E.7.6.2 of the Case Law of the Boards of Appeal of the EPO, to the principle that the statement of grounds should be complete.

[15] It follows from the above that the statement of grounds of appeal, read together with its annexes, does not enable the Board to understand immediately why the decision is alleged to be incorrect as regards the findings of lack of sufficiency of disclosure (A 83) and lack of essential features in claim 1 (clarity/support, A 84). This would have been necessary because these grounds constitute a sufficient basis for the refusal of the application. It was therefore not sufficient to only make submissions in relation to A 56, which is a further ground on the basis of which the present application was refused, independently of the two other grounds.

In conclusion, the [applicant] did not file any submission that can be regarded as a sufficient statement of grounds of appeal within the meaning of A 108, third sentence.

Therefore the appeal is inadmissible.

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

Oldies But Goldies – Deleting Claimed Features

This week we had a decision citing T 331/87, so I thought it would be appropriate to have a closer look at this important decision itself.

The decision dealt with an appeal of the patent proprietor against the decision of the Opposition Division (OD) to maintain the patent in amended form.

Claim 1 as granted differs from Claim 1 as filed in the following way (deleted parts in red, additions in blue):

The Board agrees with the patent proprietor that the opposition should have been rejected.

[2] Claim 1 as granted differs mainly from Claim 1 as originally filed by omitting the feature “... laser cutting head carried by the main frame” and replacing it by the feature “... laser cutting head (17) carried in fixed horizontal relationship to the frame (12)”. It is the excision of the feature concerning the attachment of the cutting head to the frame, which was considered by the impugned decision to contravene A 123(2), because it allegedly extended the subject-matter of the application of the European patent beyond the content of this application as filed.

[3] For the determination whether an amendment of a claim does or does not extend beyond the subject-matter of the application as filed, it is necessary to examine if the overall change in the content of the application originating from this amendment (whether by way of addition, alteration or excision) results in the skilled person being presented with information which is not directly and unambiguously derivable from that previously presented by the application, even when account is taken of matter which is implicit to a person skilled in the art in what has been expressly mentioned (Guidelines, Part C, Chapter VI, No. 5.4). In other words, it is to examine whether the claim as amended is supported by the description as filed.

[4] In the decision T 260/85 [12 and headnote][…] the Board of Appeal 3.5.1 came to the conclusion that

“it is not permissible to delete from a claim a feature which the application as originally filed consistently presents as being an essential feature of the invention, since this would constitute a violation of A 123(2)”.

In that case the application as originally filed contained no express or implied disclosure that a certain feature (“air space”) could be omitted. On the contrary, the reasons for its presence were repeatedly emphasised in the specification. It would not have been possible to recognise the possibility of omitting the feature in question from the application (point [8]). It could be recognised from the facts that the necessity for the feature was associated with a web of statements and explanations in the specification, and that its removal would have required amendments to adjust the disclosure and some of the other features in the case.

[5] Nevertheless it is also apparent that in other, perhaps less complicated technical situations, the omission of a feature and thereby the broadening of the scope of the claim may be permissible provided the skilled person could recognise that the problem solving effect could still be obtained without it (e.g. T 151/84 - 3.4.1). As to the critical question of essentiality in this respect, this is a matter of given feasibility of removal or replacement, as well as the manner of disclosure by the applicant.

[6] It is the view of the Board that the replacement or removal of a feature from a claim may not violate A 123(2) provided the skilled person would directly and unambiguously recognise that (1) the feature was not explained as essential in the disclosure, (2) it is not, as such, indispensable for the function of the invention in the light of the technical problem it serves to solve, and (3) the replacement or removal requires no real modification of other features to compensate for the change (following T 260/85). The feature in question may be inessential even if it was incidentally but consistently presented in combination with other features of the invention. Any replacement by another feature must, of course, be examined for support in the usual manner (cf. Guidelines, Part C, Chapter VI, No. 5.4) with regard to added matter.

[7] It is therefore necessary to examine whether the person skilled in the art reading the application as filed would consider the feature “carried by the main frame” in respect of the cutting head as essential or not to the function of the machine as described in the application.

[7.1] From US-A-4 063 059 being the prior art coming closest to the subject-matter of Claim 1 it is known to equip an automatic machine tool punch press with a plasma-arc torch which is able to cut large and/or irregularly shaped holes in the workpiece to be treated. Such cutting torches have the disadvantage that they cause relatively large kirfs, ragged edges and large heat distort areas adjacent to the cut […].

[7.2] It is also generally known to utilise laser beam cutting machines for cutting large holes in workpieces without the aforementioned disadvantages. In addition laser beam cutting machines can be used as devices which permit surface marking of workpieces of a precisely predetermined position. However, as the laser beam generators are highly sensitive to shocks and vibrations such laser beam cutting machines are not yet combined in operation with a machine tool punch press which is subjected to pounding vibrations during punching operations […].

[7.3] According to the application as filed

“it would represent a major advance in the art of machine tools to provide a single machine tool capable of high speed, high accuracy workpiece punching, cutting and surface marking wherein all functions are controllable from a central automatic control and wherein workpiece movement is accomplished by a single mechanism so as to eliminate the necessity of workpiece handling between operations”.

During the oral proceedings the [patent proprietor] explained that the term “single” machine tool would stand for a unit consisting of individual devices being controlled from one central control. This interpretation corresponds to the object of the invention as specified in the application as filed […]:

“to provide a combined automatic turret punching machine tool and automatic laser cutting tool wherein both the punching tool and the cutting tool share a common control and a common workpiece movement system”.

[7.4] Having in mind this problem and knowing the advantages and disadvantages of a laser beam cutting machine […] it is clear to the person skilled in the art that for the solution of the problem it is necessary

• to position the laser beam generator independently from the machine tool punch press,
• to position the laser cutting head in a fixed horizontal relationship to the punch tools, and
• to provide control means for alternatively controlling.

Only when these conditions are fulfilled, is the laser beam generator not affected by the jarring vibratory operation of the machine tool punch press and the laser cutting head can share the automatic control and the workpiece movement assembly of the machine tool punch press.

[7.5] From this it results, without being mentioned expressis verbis in the application as filed, that the embodiment of the invention as described in the original application, namely the cutting head being mounted to the mainframe or being carried by the main frame, only represents an advantageous embodiment of the invention.

The disclosure never emphasised the strict necessity of this particular solution. Specific embodiment is not indispensable to the function of the invention.

The removal of this from Claim 1 does not require any modification of the other features of the invention.

Only the requirement for horizontal fixing in relation to the frame enters in lieu of the excised feature itself. Therefore, the excision of the feature “carried by the main frame” by replacing it by a feature being essential to the solution of the above-mentioned problem does not contravene A 123(2).

[8] Since novelty and inventive step have never been disputed by the [opponent], there is no need to give in this decision reasons in detail.

[9] Consequently, the Grounds for Opposition mentioned in A 100 do not prejudice the maintenance of the patent unamended.

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

T 641/11 – Don’t Know You

The present decision is a good reminder of the provisions governing authorisations.

The European patent under consideration was refused by a decision of the Examining Division (ED). The decision was notified to the authorized professional representative, Mr H., having his place of business in Germany.

A notice of appeal was filed and the appeal fee was paid by Mr L., a new professional representative having his place of business in the United Kingdom. The new and the previous representative were not members of the same association. Neither was an authorization filed for the new representative nor was the EPO notified by the previous representative that his authorization had terminated before the appeal was filed.

With communication dated February 23, 2011, the EPO informed the new representative that, according to R 152(1) in conjunction with Article 1(2) of the Decision of the President of the EPO dated 12 July 2007 on the filing of authorizations (OJ EPO 2007, L.1), an authorization in his favour had to be filed within a period of two months from the notification of the communication. Otherwise any procedural steps taken by him would be deemed not to have taken place.

On March 21, 2011, the new representative withdrew the appeal and requested refund of the appeal fee. No authorization was filed by him within the time limit referred to above.

With letter dated April 1, 2011, the previous representative laid down representation. Consequently, the new representative was informed by the EPO that he was recorded in the Register of European patents as professional representative for the patent application.

[1] According to R 152(8) a representative shall be deemed to be authorized until the termination of his authorization has been communicated to the EPO. The previous representative, Mr H., was therefore authorized until 1 April 2011 when he laid down representation.

[2] The new representative, on the other hand, did not file an authorization of the applicant when he had been requested by the EPO to do so. The legal consequence is that, according to R 152(6), any procedural steps taken by him before 1 April 2011 are deemed not to have been taken. Consequently, the notice of appeal filed by him on 19 January 2011 is deemed not to have been filed. The same is true for the withdrawal of the appeal. Since the appeal fee was therefore paid without reason it is to be reimbursed.

[3] On 1 April 2011, i.e. on the date when the previous representative laid down representation, the change of representatives has taken effect due to Article 1(2) of the Decision of the President of the EPO dated 12 July 2007 referred to above. Thus, according to R 130, the present decision is to be notified to the new representative.

I guess this could be used by a company that is not quite sure whether to appeal or not and that needs to buy some time (e.g., if the Opposition Division has maintained the opposed patent in amended form and the patentee will only file an appeal if the opponent does so). If the appeal is filed by a non-authorised representative who is not in the same association as the representative acting so far, then there is a two-month window starting with the notification during which the authorisation can be filed, so that the appeal is validly filed. If the company comes to the conclusion that the appeal should not be filed, then it just has to wait, and the appeal fee will be reimbursed.

But as you need a second attorney, it might be cheaper for the company to file an appeal and to withdraw it later on if the appeal is not useful.

Should you wish to download the whole decision, just click here.

The file wrapper can be found here.

T 777/08 – Crystals Are A Girl’s Best Friends

This appeal was directed against the decision of the Opposition Division (OD) to revoke the patent.

Claim 3 of the main request (and claim 1 of the auxiliary request) read:

Crystalline Form IV atorvastatin (i.e. [R-(R,R*)]-2-(4-fluorophenyl)-ß,δ-dhihydroxy-5(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid hemi calcium salt)hydrate characterised by the following X-ray powder diffraction pattern expressed in terms of the 2θ, d-spacings, and relative intensities with a relative intensity of >15% measured using CuKα radiation:

The Board dismissed the appeal because it found this claim to lack inventive step.

[5.1] [… C]laim 3 of the main request and claim 1 of the auxiliary request are identical and relate to form IV of crystalline atorvastatin hydrate.

The board considers, in agreement with the [patent proprietor], that the amorphous form of atorvastatin, as obtained according to the processes of documents D1 and D2, represents the closest state of the art.

The [patent proprietor] defined the problem to be solved in view of this prior art as lying in the provision of atorvastatin in a form having improved filterability and drying characteristics.

The solution as defined in claim 3 of the main request and claim 1 of the auxiliary request relates to a specific polymorph of atorvastatin.

Having regard to the experimental results reported in document D25, which demonstrate shorter filtration and drying times for form IV compared to the amorphous form, the board is satisfied that this problem has been solved.

[5.2] It remains to be investigated whether the proposed solution would have been obvious to the skilled person in the light of the prior art and the relevant common general knowledge.

The skilled person in the field of pharmaceutical drug development would have been aware of the common general knowledge as reflected by documents D10, D27 and D28.

It is noted in this context that the [patent proprietor] has disputed that document D10 forms part of the state of the art within the meaning of A 54(2). This document was printed in the July 1995 issue of the journal “Pharmaceutical Research”, that is, in the same month as the present priority date of 17 July 1995. Although the exact day on which it was made available to the public could not be established, it is noted that document D10 is a review article, which is, by definition, an account of the common general knowledge and the state of the art prior to its own publication date. As will be explained in more detail below, this is corroborated by the disclosures of documents D27 and D28. Hence, the board considers document D10 to provide a legitimate basis for evidence of the common general knowledge of the skilled person at the priority date of the patent in suit (cf. T 1110/03 [2]).

From his common general knowledge, the skilled person would firstly be aware of the fact that instances of polymorphism are commonplace in molecules of interest for the pharmaceutical industry, as can, for instance, be inferred from the following passage of document D28 […]:

“Polymorphs have crystal lattices which differ in the ways in which the same molecule is bound in the unit cell. The differences may reflect different ways of packing molecules in the cell, or conformational changes, which can be large. Hydrogen-bonding will be involved for most molecules of interest to the pharmaceutical industry.”

The skilled person would also have known it to be advisable to screen for polymorphs early on in the drug development process, as explained in document D28 […] (cf. also document D10 […]):

“In giving each development candidate the best chance of progressing, it seems better to search for polymorphs rather than to leave their appearance to time and chance with the consequent disruption.”

Indeed, the skilled person would also have been aware of regulatory requirements to provide information on the occurrence of polymorphic, hydrated, or amorphous forms of a drug substance (cf. document D10 […]). Moreover, he would be familiar with routine methods for screening for polymorphs by crystallisation from a range of different solvents under different conditions (cf. document D28 […]; document D10 […]).

It follows from the above that, at the priority date of the patent in suit, it belonged to the routine tasks of the skilled person involved in the field of drug development to screen for solid-state forms of a drug substance. For the sake of completeness, the board therefore wishes to note that, in the absence of any technical prejudice, which has not been alleged by the [patent proprietor], the mere provision of a crystalline form of a known pharmaceutically active compound cannot be regarded as involving an inventive step (contrary to the statement in the patent in suit, paragraph [0011]).

However, in the present appeal proceedings, as outlined above under point [5.1], the [patent proprietor] relied in support of the presence of an inventive step on the improved filterability and drying characteristics of form IV atorvastatin hydrate compared to the amorphous form.

It must therefore be decided whether there was an incentive for the skilled person to arrive at the present solution in the expectation of achieving these improved characteristics.

As pointed out by the [patent proprietor], amorphous forms are generally known to be more soluble and have greater bioavailability than their crystalline counterparts. However, several disadvantages can also generally be expected for the amorphous form, namely, with respect to chemical and physical instability (see document D27 […], document D10 […], section entitled “Amorphous Forms”).

In addition, the following is stated in document D28 […]:

“Crystalline products are generally the easiest to isolate, purify, dry and, in a batch process, handle and formulate.”

Thus, in view of his general knowledge, as reflected in this excerpt from document D28, the skilled person, starting from the amorphous form of a pharmaceutically active compound as closest prior art, would have a clear expectation that a crystalline form thereof would provide a solution to the problem as defined under point [5.1] above. Although this might not be true of every crystalline form obtained (cf. document D28 […]), it was nevertheless obvious to try this avenue with a reasonable expectation of success without involving any inventive ingenuity.

The board cannot accept the [patent proprietor’s] contention that the skilled person would be dissuaded from attempting to obtain a crystalline form by the prospect of a potential loss of solubility and bioavailability when compared to the amorphous form. On the contrary, the skilled person would regard this as being a matter of trade-off between the expected advantages and disadvantages of these two classes of solid-state forms, as outlined above.

The [patent proprietor] further argued that the presence of an inventive step was supported by the fact that a specific polymorph was being claimed rather than crystalline forms in general. The board does not deny that there may be other options for solving the problem posed (see e.g. patent in suit, paragraph [0036]). However, an arbitrary selection from a group of equally suitable candidates cannot be viewed as involving an inventive step.

[5.3] Therefore, the subject-matter of claim 3 of the main request and claim 1 of the auxiliary request represents an obvious solution to the problem posed and does not involve an inventive step.

Since a decision can only be taken on a request as a whole, none of the further claims need be examined.

Consequently, the [patent proprietor’s] main and auxiliary requests are rejected for lack of inventive step of claims 3 and 1, respectively.

Should you wish to download the whole decision, just click here.

The file wrapper can be found here.

My friend Laurent has provided a nice summary here.

NB: Apparently this decision was found worthy of being published in the OJ EPO. Don’t ask me why.