T 0754/16 (MICROFLUIDIZED OIL-IN-WATER EMULSIONS AND VACCINE COMPOSITIONS/Zoetis Services LLC) 20-11-2018

1. Remittal of the case to the opposition division based on a substantial procedural violation

1.1 The appellant requested that the case be remitted to the opposition division because it had committed a substantial procedural violation by not not giving the opportunity to comment on the patentability of auxiliary requests 1 to 7 and not admitting auxiliary requests 8 and 9 into the proceedings based on a prima facie examination.

1.2 Right to be heard as regards auxiliary requests 1-7

1.2.1 The Board notes that the minutes of the oral proceedings before the opposition division mention the following:

"7.5. The proceedings were resumed at 18:00 and Ch announced the conclusion of OD that the MR does not meet the requirements of Article 56-100(a) EPC because the claims lack inventive step. A similar reasoning applies to AR1-AR7.

7.6. The partied had no further comments and P asked

for a break to file a new AR."

The opposition division mentions further in its decision:

"3. Since Auxiliary Requests 1-7 have been limited by features already present in D1, they do not seem to provide the claims with inventive step for the same reasons as the Main Request. Therefore, it is considered that Auxiliary Requests 1-7 do not comply with the inventive step requirements of Article 56 EPC.".

It also mentions in the decision the following:

"1. P has not provided substantive arguments in the letter of 22 April 2014 with respect to the inventive step of auxiliary requests 1-7."

1.2.2 It appears therefore explicitly from the minutes that auxiliary requests 1-7 have not been discussed extensively but have indeed been examined as to inventive step during oral proceedings before the opposition division. The opposition division considered that the outcome of the discussion on inventive step for all auxiliary requests 1-7 was the same as for the main request.

More importantly, it is clear from the minutes of the oral proceedings that the appellant did not contest the conclusions of the opposition division as to inventive step of the auxiliary requests 1-7. After the opposition division announced its view, which was not final at this stage, the appellant had, at this moment, an opportunity to provide comments or additional arguments as to inventive step of the auxiliary requests, an opportunity he did not take advantage of. Instead, he only asked for a break in order to file new auxiliary requests.

It appears furthermore from the file hat the patentee did neither provide any comment as to novelty or inventive step regarding auxiliary requests 1-7 in the written opposition proceedings. Only a basis for the amendments brought to these requests was given in the letter accompanying the filing of said auxiliary requests 1-7.

1.2.3 Consequently, the Board is of the view that the appellant's right to be heard in this regard has been met.

1.3 Right to be heard as regards the admission of auxiliary requests 8 and 9 into the opposition proceedings

1.3.1 The appellant filed auxiliary requests 8 and 9 during the oral proceedings before the opposition division, after the opposition division had concluded to the absence of inventive step of the main request and auxiliary requests 1-7. Auxiliary requests 8 and 9 were not admitted in the proceedings by the opposition division because they were considered to be prima facie not allowable.

In its decision, the opposition division mentioned that "in the light of the substance of the new requests, the opposition division notices that indeed, potential issues of added subject-matter and clarity would have to be discussed before assessing inventive step and eventually, compliance with Article 100(b) EPC" and "that at first sight, none of the auxiliary requests appeared to overcome the inventive step objection raised against the previous requests".

The opposition division assumed that it had a discretion not to admit these requests on a prima facie basis and referred to Article 114(2) and Rule 116 EPC. This presupposes, in the first place, that the requests were late filed, which is however not the case.

1.3.2 The opposition division gave in its summons to oral proceedings a positive preliminary opinion as to the main request and auxiliary requests 1-7 as regards Articles 100(b), 54 and 56 EPC. It then reverted its opinion during oral proceedings and came to the conclusion that the main request, as well as auxiliary requests 1-7 lacked inventive step.

Thus, filing auxiliary requests 8 and 9 was a direct response to the opposition division's change of opinion. Under Rule 116(2) EPC, requests filed after the final date set for making written submissions, can only then not be admitted if the patent proprietor had been notified of the grounds prejudicing the maintenance of the patent. This was clearly not the case. Neither does Article 114(2) EPC provide a basis for disregarding these requests, since, firstly, it does not apply to late filed requests in the form of amended claims, but only to late filed facts and arguments (see Bühler in Singer/Stauder, Europäisches Patentübereinkommen, 7. Auflage 2016, Artikel 114, point 52). Secondly, the auxiliary requests were filed in due time, as a direct and immediate response to the opposition division's changed opinion and since the proprietor had no earlier opportunity to react thereto.

The situation is comparable to the one underlying decision T 273/04. In this case, the opposition division came to a completely new conclusion during the oral proceedings. Hence, the patent proprietor was faced with a new situation to which he had the right to react, in particular by amending his requests. Such requests could not be considered to be late, since they were caused by the new and unexpected procedural development of the case to which the patent proprietor had no previous opportunity to react. According to T 273/04 a prima facie examination was only allowed if the requests are filed too late. Since this was not the case, a refusal based on a prima facie examination was not justified.

Consequently, by not admitting auxiliary requests 8 and 9, the opposition division committed a procedural violation.

1.3.3 However, this procedural violation cannot justify a remittal. According to Article 11 RPBA, the Board shall remit a case to the department of first instance if fundamental deficiencies are apparent in the first instance proceedings, unless special reasons present themselves for doing otherwise. In the present case, the fundamental deficiencies only concern auxiliary requests 8 and 9, but not the higher ranking requests (including the the request for the patent as granted) which are still maintained by the appellant. A remittal based on the auxiliary requests, including auxiliary requests 1 to 7, is not justified because there is no link with the procedural violation.

The procedural violation does not justify the reimbursement of the appeal fee either. Under Rule 103(1)(a) EPC, the appeal fee shall be reimbursed if such reimbursement is equitable. For the reimbursement of the appeal fee to be equitable, there must be a causal link between the substantive procedural violation and the filing of the appeal (see Case Law of the Boards of Appeal, 8**(th) edition 2016, IV.E.8.6). Since the appellant still pursues his main request, as well as auxiliary request 1 to 7, the appellant would have had to file the appeal in any case and it was not the procedural violation which forced him to file the appeal. The appellant submitted that he might not have filed an appeal if the auxiliary requests had been admitted. However, in order to decide whether the reimbursement of the appeal fee is equitable, the procedural situation as it stands has to be looked at. The appellant requests that the decision on the main request as well as auxiliary requests 1 to 7 be reviewed by the Board of Appeal. For this, he had to file the appeal, irrespective of the decision on auxiliary requests 8 and 9.

1.3.4 In view of the above, the Board notes that the opposition division committed the procedural violation, but it does not justify a remittal to the opposition division or a refund of the appeal fee.

2. Admission of D38 into the proceedings

D38 has been submitted by the appellant with the statement of grounds of appeal and is cited by the appellant in the frame of the discussion on inventive step. The filing of this document constitutes therefore an answer to the decision of the opposition division, and the Board does not see any reason not to admit it into the proceedings (Article 12(4) RPBA).

3. Admission of D4a, D14a, D51-D56, and D57

According to the appellant D57 has been filed in response to the respondent's arguments or documents and to some arguments of the Board in its communication.

D4a, D14a, D51-D56, were filed by respondent 02 in response to the documents or arguments filed by the appellant.

The Board considers these documents as a response to the parties' documents or arguments filed during the appeal proceedings. The Board exerts its discretionary power and admits all documents into the proceedings (Articles 13(2) and 13(3) RPBA).

4. Main request- Novelty

4.1 Claim 1 of the main request relates to a "submicron microfluidized oil-in-water emulsion" and is therefore in the form of a "product by process" claim, namely an emulsion obtainable by microfluidization. According to the case law of the Boards of Appeal, such a feature can only distinguish it from known products if differences in the method of manufacture actually lead to differences in the product itself.

4.2 D1 was mentioned as novelty-destroying by respondents 01 and 02.

4.3 D1 discloses inter alia in examples 3, 4 or 6 a submicron oil-in-water emulsion comprising a surfactant and mineral oil which is passed through an homogenizer.

According to the calculation of respondent 02, as demonstrated in documents D31 and D32, the mean particle size of the particles obtained in examples 4 and 6, as shown in Figure 1, is about 0.340 mym. This was not contested by the appellant.

Moreover, examples 7 and 8 of D1 disclose vaccine compositions made from the emulsion of example 4, and comprising one or more antigens. For instance, in example 7 the emulsion comprised 5% oil-lecithin adjuvant, namely 0.5 % of lecithin and 4.5% of oil, with 2% of surfactants in the vaccine compositions.

The Board notes that the microfluidization process involved in the preparation of the claimed submicron emulsion of claim 1 of the main request remains vaguely and broadly defined, without any restriction as to the microfluidization parameters and conditions. It is therefore not credible that such a generally defined process may systematically lead to a structural difference between the claimed emulsion and an emulsion as disclosed in D1, in particular as regards the uniformity and polydispersibility of the emulsions, as it was argued by the appellant.

In this context, Figure 1 of D1 shows the uniform and undispersed particle size of the submicron emulsions obtained in D1 in examples 4 or 6. The size distribution of the emulsion shown in Figure 1 of D1 appears in particular to be similar to the size distribution of the emulsion shown in Figures 10A and 10B of the contested patent, corresponding to the compositions prepared with a specific microfluidization pressure of 4.500 PSI in example 20 of the contested patent. In addition, the teaching of said example 20 does not appear to be a mistake, as argued by the appellant. There are indeed no reasons to question the teaching of example 20, as regards the operating pressure; the use of such pressures for making microemulsions is confirmed in the specification of the contested patent in paragraph [0069] and in documents D59 or D6 (see D509, par. [0066] and D6, col. 8, l. 38-41).

Figure 1 of D1 presents therefore a direct comparison between the emulsions of D1 and emulsions obtainable by a process of microfluidization, and shows undeniably and explicitly the absence of any difference with the claimed submicron emulsions.

It appears therefore impossible to conclude to the existence of a difference between the submicron emulsions disclosed in D1 and the submicron emulsions as claimed in claim 1 of the main request. Claim 1 of the main requests lack therefore novelty over D1.

4.4 The Board could in particular not follow the arguments of the appellant that a microfluidization process confers inevitably technical differences to the claimed emulsions. To support its argumentation, the appellant relied on some examples of the patent, and on documents D38, D57 and D4.

4.4.1 According to the appellant, examples 5, 6, 8-10 of the patent provide a comparison between the prior art compositions and compositions according to the invention. The Board notes however that these examples provide a comparison between microfluidized compositions with a size around 0.1 mym and homogenized compositions having a size of around 1 mym in Example 5, or between compositions for which there is no information about the size of the emulsion droplets; it is therefore not possible to see in said examples a comparison with the emulsions of D1 with a mean droplet size of 0.340 mym.

Moreover, some of the emulsions as in example 6 have been prepared under specific microfluidization conditions, with in particular an operating pressure of 10.000 +/- 500 PSI (cf. example 3 of the contested patent), a specific feature which is not a characteristic of claim 1 of the main request.

Hence, the Board does not see how said examples could provide a comparison with the emulsions of D1.

4.4.2 D38 compares emulsions produced by homogenization during 3-5 minutes with emulsions made by microfluidization with 1 pass at 10k PSI and 3 passes at 18k PSI. D38 mentions that "microfluidization decreased particle size versus homogenization" and that "multiple passes increase the uniformity of the particle size distribution" (see point 7.). This document therefore clearly shows that a microfluidization process, processed under specific conditions, might provide an emulsion presenting a different uniformity and polydispersity than an emulsion obtainable by homogenization.

As argued by respondent 01, the homogenized compositions disclosed in D38 do however not correspond to the compositions disclosed in D1, which renders impossible in any case a valid comparison.

Moreover, the subject-matter of claim 1 of the main request is not restricted by any specific processing condition, such as the operating pressures and the number of passes used in D38.

The extrapolation of the specific emulsion characteristics of the emulsions obtained in D38 by specific process conditions to the emulsions obtained by microfluidization as broadly defined in the claims is furthermore also not possible, since the specification of the contested patent shows in particular that its is possible to obtain an emulsion as claimed, namely having a mean droplet size of less than 0.5 mym under conditions different than those used in D38, i.e. by a microfluidization at 4.500 PSI, which is much less than the 10.000 and 18.000 PSI used in D38, as shown in example 20 and Figure 1 of the specification. Said emulsion of example 20 has a size uniformity and polydispersity which does not present any difference to those disclosed in D1 (see the patent, Figures 10A and 10B and D1, Figure 1)

4.4.3 As to the appellant's argument that a skilled person would exclusively use microfluidizing processing conditions as disclosed in D4, which is a user guide for the specific Microfluidics® microfluidizer, it can also not be followed. This argument was in particular given in D57 (see points 40-54).

First, this specific device is not the only one which can be used for the preparation of the claimed emulsions, in view of the lists of devices disclosed in paragraphs [0067] or [0087] of the specification.

Secondly, the user guide D4 states that emulsions should be passed in Y type devices, by using 10.000 to 15.000 PSI and multiple passes (see page 6 of D4). These specific conditions are, however, not given in the description of the contested patent, are not claimed and remain only general instructions. This is confirmed by the further mention in the same passage of D4 which mentions in particular that "overprocessing may cause droplet size to increase" and "try lower pressure and/or less passes".

There is also some evidence on file that operating pressures other than those given in D4 may be used to provide emulsions according to the claimed invention.

As shown in D38, the appellant obtained emulsions according to the invention with a pressure of 18.000 PSI and 3 passes, which is much higher than the operating pressure indicated in D4. The contested patent also teaches in paragraph [0069] and example 20 that a lower pressure of 4.500 PSI +/- 500 also provides emulsions according to the invention. Documents D59 and D6, which were mentioned by the appellant, also disclose an operating pressure of respectively 2.5000-40.000 in an undefined microfluidizer and 5.000-30.000 in a specific model 110Y microfluidizer for preparing submicron vaccine emulsions (see D509, par. [0066] and D6, col. 8, l. 38-41). All these disclosures show that the skilled person has a large palette of processing conditions other than those given in D4.

4.4.4 As to the argument of the appellant that the type of microfluidizer covered by the feature "microfluidized" in claim 1 is the specific 110Y from Microfluidics, it is contradicted by the description which gives several equivalent microfluidizers, such as the Gaulin or the Minilab devices (see paragraphs [0067] and [0087]).

Document D33a mentioned by the appellant does furthermore not make a particular distinction between homogenizers and microfluidizers and mentions specifically that "a microfluidizer is an example of a homogenizer" (see page 239).

4.4.5 More generally, the assessment of novelty of a claim relating to a product obtained by a process cannot be restricted to the assessment of embodiments covered by the claim presenting indeed a distinguishing technical feature over the product of the prior art. The discussion and evaluation of the product-by-process claim must also be extended to alternative embodiments covered by the claims which cannot be distinguished form the prior art product. It is indeed sufficient that one of said alternative cannot be differentiated from the prior art product to conclude to a lack of novelty of the product-by-process claim over the prior art product.

4.5 Consequently, claim 1 of the main request lacks novelty over D1, and the main request does not meet the requirements of Article 54 EPC.

5. Auxiliary requests 1-3

The appellant did not contest that D1 disclosed all features added in the independent product claims of auxiliary requests 1-3.

5.1 Auxiliary request 1 - Novelty

Claim 1 has been restricted as to the amounts of mineral oil, and by the specification of the amount and presence of lecithin as surfactant, as well as the size range of the mean oil droplet size comprised between 0.1 mym to 0.5 mym. As shown above under point 4.3, all these features were also present in D1.

Consequently, claim 1 of auxiliary request 1 lacks novelty over D1, and auxiliary request 1 does not meet the requirements of Article 54 EPC.

5.2 Auxiliary request 2 - Novelty

Independent product claim 3 has been restricted to a vaccine composition wherein said antigen is dispersed in said emulsion. These amendments have no impact on the conclusion reached as regards novelty over D1, since also present in the disclosure of D1, which shows in examples 7 and 8 vaccine compositions comprising one or more antigens.

Consequently, claim 3 of auxiliary request 2 lacks novelty over D1, and auxiliary request 2 does not meet the requirements of Article 54 EPC.

5.3 Auxiliary request 3 - Novelty

Independent claim 1 of auxiliary request 3 is identical to claim 3 of auxiliary request 2. Consequently, claim 1 of auxiliary request 3 lacks novelty over D1, and auxiliary request 3 does not meet the requirements of Article 54 EPC.

6. Auxiliary request 4 - Remittal to the opposition division

6.1 When dealing with auxiliary requests 1-7, the opposition division mentioned in its decision that "since auxiliary requests 1-7 have been limited by features already present in D1, they do not seem to provide the claims with inventive step for the same reasons as the main request". Said decision on the auxiliary requests is limited to inventive step and does not give any further details what the limiting feature(s) of the auxiliary requests were and where to find them in document D1.

Moreover, the decision taken by the opposition division on auxiliary requests 1-7 as regards inventive step over D1 was based on a false postulate, namely that the difference of the claimed invention related to a "microfluidized" oil-in-water emulsion.

In view of these facts, it appears that the decision of the opposition division does not hold good and, with regard to the reasoning concerning auxiliary requests 1-7, is unacceptably incomplete and deficient.

6.2 In the Board's view, a remittal on the basis of auxiliary request 1 would have been a response to this decision.

It is however immediately obvious that the independent product claims of auxiliary requests 1-3 did not present any new features, and this was also not contested by the appellant during the oral proceedings before the Board of Appeal. The Board considers therefore that a remittal based of any of auxiliary requests 1-3 as unjustified.

6.3 However, the objections of lack of novelty of auxiliary request 4 were contested by the appellant during the oral proceedings before the Board, while the respondents were of the opinion that auxiliary request 4 was also not novel either over document D1 or document D13, and in addition, involved problems with Articles 84 and 123(2) EPC.

As stated above, the Board could not identify from the decision of the opposition division where the new feature "immunostimulatory molecule" was disclosed in D1. The decision does not mention why and how auxiliary request 4 differed from D1 and where to find a basis in D1 for the added feature of the independent product claim of said requests.

The decision of the opposition division does also not deal with the grounds of lack of disclosure under Article 100(b) EPC raised by the respondents and the objections as to lack of clarity raised by respondent 02 against auxiliary request 4 already during the opposition proceedings (cf. letter of opponent 02 of 15 December 2015).

6.4 Hence, the Board finds itself discussing the novelty of a request, rejected for lack of inventive step based on a difference that has not been recognized by the Board, and on the basis of an amendment in claim 1 of auxiliary request 4 of a feature that has not been identified by the opposition division in D1.

The Board is also confronted with a situation where, even if it recognized the novelty of auxiliary request 4 on the basis of arguments never discussed during the opposition proceedings, the assessment of inventive step would be based on a different technical feature, namely the "immunostimulatory molecule", and the Board would still have to deal with points which have not been the basis of the decision, namely Articles 100(b) EPC, 84 EPC and 123(2) EPC.

This situation also applies also to any of the further auxiliary requests 5-7 which also comprise new technical features in their independent claim.

6.5 It is not the duty of the Boards of Appeal to consider and decide upon questions raised for the first time during the appeal proceedings. Instead, the main purpose of appeal proceedings is to give the losing party the opportunity to challenge the decision of the Opposition Division (cf. G 9/91, loc. cit., point 18 of the Reasons).

In the present case, the Board considers it therefore appropriate to exercise its power conferred on it by Article 111(1) EPC to remit the case to the Opposition Division for further prosecution on the basis of the claims according to auxiliary request 4, because the Board does not have a proper basis for a review of the decision, due to the insufficient reasoning of the opposition division.

Respondent 2 pointed out that the case was already 16 years old. The Board notes however that the case was in fact 14 years old, among which 12 years before the first instance. Taking this into account and also considering the opposition division's poor reasoning in its decision, this case should therefore be dealt with preferentially.

In view of Article 114(1) EPC, it will be the task of the opposition division to examine auxiliary request 4 and to decide on the grounds of opposition raised, namely novelty and inventive step under Articles 100(a) EPC, disclosure of the claimed invention under Article 100(b) EPC, as well as Article 84 EPC and Article 123(2) EPC.