T 2276/22 (DECELLULARIZED HUMAN AMNIOTIC FLUID PREPARATION HAVING LONG-TERM STABILITY/MAM Holdings of West Florida L.L.C.) 09-10-2024

1. Overview of the examination proceedings

1.1 In the international preliminary report on patentability (IPRP) dated 30 May 2018 and 6 September 2018, documents D1-D4 were identified, while in the context of inventive step, only D1 was specifically mentioned.

1.2 The communication of the examining division (ED) under Article 94(3) EPC, dated 6 April 2020, raised issues solely under Article 54 EPC over D1-D3 and Article 84 EPC. The communication did not mention D4 at all.

1.3 The applicant's response, dated 14 July 2020, addressed issues under Article 54 EPC over documents D1-D3, as well as under Article 84 EPC.

1.4 A summons to oral proceedings before the ED was issued on 9 July 2021, focussing primarily on an objection of lack of novelty pursuant to Art 54 EPC over D1, dealing only very briefly and generally with inventive step in Section 1.3 thereof: "It is finally noted, in case the composition of claim 1 is rendered novel by showing that the product of the present invention differs from the ones of the prior art, an inventive step is presently not acknowledged. Even when considering the storage at 2-8°C it is at present not seen which advantages could be derived from the product obtained. The two examples given by the invention concern the process for preparing sterile filtered amniotic fluid but do not show any advantage for the product per se or in terms of it medical applications.".

Only D1 was mentioned in the summons and D4 was not mentioned.

1.5 The patent applicant replied to the summons on 20 December 2012 in particular by filing new auxiliary requests, and addressing the issues raised on novelty and inventive step.

1.6 During a telephone consultation between the primary examiner and the patent applicant on 2 February 2022 (as reported in the EPO communication of 4 February 2022), issues of Articles 123(2) EPC and 54 EPC were primarily discussed, and those issues maintained. D1 remained as the primary reference and was the only document discussed in the context of novelty. Inventive step was also discussed as reported: "All objections raised during the summons and concerning inventive step are not overcome (Art. 56 EPC). In particular D1 ([041]-[042]), D3 (page 8 [021]) and D4 (page 10 l. 11-15) were shortly discussed as well as figure 1 of the originally filed application was briefly discussed".

1.7 With a letter dated 8 February 2022, the patent applicant filed auxiliary requests 3-7. The letter addressed issues pursuant Article 123(2) EPC as well as novelty and inventive step over D1.

1.8 During a second telephone consultation between the primary examiner and the patent applicant on 9 February 2022 (as reported in the EPO communication of 16 February 2022), the day before the appointed oral proceedings, the applicant's representative was informed that "none of the requests on file appeared to comply with the EPC".

1.9 At the oral proceedings, the claims of auxiliary request 1, corresponding to the main request on file in the appeal proceedings, were admitted, and found to satisfy the requirements of Articles 123(2) and 54 EPC over D1, D3 and D4. However, the claims were considered to lack an inventive step. The new auxiliary request 2 was also found to lack inventive step, while the chair announced also that the ED was of the opinion that auxiliary requests 3 to 9 also did not fulfil the requirements of Articles 123(2) and 56 EPC.

In the minutes of the oral proceedings, only document D1 has been mentioned as having been discussed as closest prior art in combination with D4 (see points 9.1 and 9.2 of the minutes).

1.10 The decision of the ED mentioned that the patent applicant used D1 as closest prior art with regard to the assessment of inventive step of the auxiliary request 1 (corresponding to the main request in the appeal proceedings), but that the ED considered that D4 was more appropriate as closest state of the art; hence, the ED made a problem-solution approach starting from D4 in its decision (see point 15.3 of the decision). The ED concluded that the claimed subject-matter was not inventive over D4 combined with D1.

The same conclusion applied to auxiliary request 2 filed during the oral proceedings when starting from D4 which was preferred over D1 as closest state of the art (cf. point 16 of the decision).

Auxiliary requests 3 to 9 were neither considered to meet the requirements of Article 56 EPC. The ED argued that same reasons discussed above apply mutatis mutandis but did not add any further argument or comment (see point 18.1 of the decision).

2. Substantial procedural violation

2.1 In the present case, the Board notes that D4 had never been cited as possible closest prior art for the assessment of inventive step by the ED in the written proceedings. There is no further trace of a possible discussion on this point during the telephonic consultations or during the oral proceedings before the ED, even less on a complete problem-solution approach based on D4 as closest state of the art.

There is neither any trace of a problem-solution approach over any document in any of the communication dated 6 April 2020 or 9 July 2021, even less in the minutes of the telephonic consultations.

Consequently, an assessment on inventive step on the subject-matter of auxiliary request 1, corresponding to the main request on file in the appeal proceedings, over D4 and accompanied by a problem-solution approach appears for the first time in the decision of the ED. The same conclusion applies for auxiliary requests 2-9.

Moreover, with regard to auxiliary requests 3-9, the decision of the ED simply mentions the following: "These request are considered not to meet the requirements of Art. 56 EPC. The same reasons discussed above under item 14.3 and 15 apply mutatis mutandis". The decision does however not explain why the amendments carried out in these auxiliary requests should have no incidence with regard to the assessment of inventive step.

2.2 Even though the appellant has not challenged the ED's decision on the grounds of a substantial procedural violation, the Board is entitled to examine whether or not any such violation occurred during the examination proceedings (see for instance decision T 405/12, point 3 of the Reasons; CLB, ibid., III.B.2.1.). The Board considers in particular it inappropriate to start an examination on facts and requests which have never been discussed during the examination phase and which constitute a new case in the appeal proceedings, in particular in view of the large number of requests.

2.3 Under Article 113(1) EPC the decisions of the European Patent Office may only be based on grounds or evidence on which the parties concerned have had an opportunity to present their comments.

In the context of the examining procedure, Article 113(1) EPC is intended to ensure that before a decision refusing the application is issued, the applicant has been clearly informed of the essential legal and factual reasons on which the finding of non-compliance with the requirements of the EPC is based, so that he knows in advance the reasons as to why the application may be refused and has the opportunity to comment on this reasoning. According to the established case law of the Boards of Appeal, the term "grounds or evidence" in Article 113(1) EPC should not be narrowly interpreted, so that the word "grounds" does not refer merely to a ground of objection to the application in the narrow sense of a requirement of the EPC, but refers to the essential reasoning, both legal and factual, which leads to the refusal of the application (see for instance T 186/02, point 2.5 of the Reasons; T 305/14, point 2.3 of the Reasons; Case Law of the Boards of Appeal (CLB), 10th edition, July 2022, III.B.2.3.2.). Although it is not required to provide the parties in advance with all foreseeable arguments in favour of or against a request (see CLB, ibid., III.B.2.3.1.), in the present case the assessment of inventive step starting from D4 as closest prior art constitutes a fundamental reason for the decision under appeal and represents therefore a "ground" under Article 113(1) EPC.

Since an assessment on inventive step over D4 accompanied by a problem-solution approach appears as an essential point of the decision that was presented for the first time in the decision of the ED, and since that has never been mentioned or discussed in any step of the examination proceedings, it results that the applicant's right to be heard enshrined in Article 113(1) EPC has been infringed.

2.4 The Board also considers that the decision under appeal was insufficiently reasoned in the sense of Rule 111(2) EPC, which constitutes a further fundamental procedural deficiency (see CLB, ibid., V.A.9.4.4.b)). Pursuant to Rule 111(2), first sentence, EPC, decisions which may be appealed must be reasoned. According to established case law, a decision must set out the essential factual and legal considerations justifying the decision taken in a logical chain of reasoning. Furthermore, the conclusions drawn from the facts and evidence must be clearly set out. The reasoning should enable the parties and, in the case of an appeal the Board, to understand whether the decision is justified or not (see CLB, ibid., III.K.3.4.1).

This is not the case here, as explained above, since the decision does not explain why the substantial amendments carried out in auxiliary requests 3-9 should have no incidence with regard to the assessment of inventive step.

2.5 For the reimbursement of the appeal fee to be equitable (see Rule 103(1)(a) EPC), there has to be not only a substantial procedural violation but also a causal link between this procedural violation and the necessity to file the appeal. In this case, there is such causal link since the appeal is based on a request which was refused for lack of inventive step.

Consequently, the Board decides to remit the case to the ED (Article 111(1), second sentence, EPC and Article 11 RPBA) and to reimburse the appeal fee (Rule 103(1)(a) EPC).