T 2347/19 - Should have used the lunch break

Key points

•  In this opposition appeal, filed in 2019, three auxiliary requests filed with the Statement of grounds are not admitted under Art. 12(4) RPBA 2007. 
• The Board: " Furthermore, it is apparent from the minutes of the oral proceedings on 17 April 2019 (page 2, penultimate sentence) that, after the rejection of the main request, the appellant-patent proprietor had time during the lunch break to reflect on how to proceed. At that time, the patent proprietor did not make any attempt to overcome the sufficiency objection by filing a new claim request. It instead stated that it wanted to proceed with the then pending auxiliary request 1. " 
• " At the oral proceedings before the board, the appellant-patent proprietor did not submit any argument on this point. Therefore, auxiliary requests 1 to 3 were not admitted into the appeal proceedings pursuant to Article 12(4) RPBA 2007." 
• " A preliminary opinion [of the opposition division] in preparation for the oral proceedings is not binding and may change during the oral proceedings. A change of mind of the opposition division following discussion at the oral proceedings to take up arguments considered not convincing in its preliminary opinion is a possible development in the proceedings and cannot come as a surprise." 
  
  
• The patent concerns a second medical use claim.: "Glucocorticoid (GC) for use in a method of prophylaxis of neurological adverse events caused by the administration of a CD3 binding domain [compound], wherein [detailed features]". 
• "The parties disputed whether the teaching on blinatumomab in the examples of the application as filed could be generalised to any CD3 binding domain." (blinatumomab is an example of a compound/domain that binds CD3; hence, blinatumomab can cause neurological adverse events that are prevented by Glucocorticoid.
• The Board: "The term "CD3 binding domain" encompasses a vast range of substances, including, inter alia, small peptides, antibody constructs and engineered proteins. These substances may exert different biological functions, even with opposite effects. For instance, the CD3-specific antibody OKT3 may both activate or block T-cells in a time-dependent fashion (D31, page 2, second paragraph). As the mechanisms by which blinatumomab causes NAEs and dexamethasone prevents those NAEs were unknown at the filing date and the NAEs could not be univocally attributed to the fact that blinatumomab binds the CD3 receptor, there was no scientific rationale for the skilled person to conclude that dexamethasone could prevent the NAEs caused by any CD3 binding domain within any therapeutic context. 
• Therefore, the subject-matter of claim 1 of the main request is not sufficiently disclosed."
• Auxiliary Request 4 is considered to be allowable. 

EPO 

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

https://www.epo.org/en/boards-of-appeal/decisions/t192347eu1

2. Auxiliary requests 1 to 3 - admittance (Article 12(4) RPBA 2007)

2.1 The appellant-patent proprietor filed auxiliary requests 1 to 3 with its statement of grounds of appeal as new intermediate fall-back positions between the main request and the request held allowable by the opposition division, now auxiliary request 4.

2.2 The patent proprietor (statement of grounds, pages 9 to 12; reply to the appeal, pages 6 and 7) justified the filing of the new auxiliary requests as a reaction to the arguments against sufficiency of disclosure of the main request in the decision under appeal. The opposition division had indicated in its preliminary opinion that the main issue for sufficiency of disclosure was whether the discontinuation of the treatment in the patent examples in which patients had not been pre-treated with dexamethasone was due to the occurrence of NAEs. Other objections raised by the opponents had not been considered persuasive by the opposition division. However, during the oral proceedings, the opposition division concluded that the subject-matter of the main request was not sufficiently disclosed because the effect shown in the patent for a CD19xCD3 bispecific single chain antibody could not be generalised to any CD3 binding domain.

2.3 The board agrees with the appellant-opponent that the appellant-patent proprietor could and should have filed auxiliary requests 1 to 3 in the opposition proceedings.

2.3.1 In its preliminary opinion (page 8, lines 7 and 8), the opposition division did not agree with the opponents that the lack of a causative link between binding the CD3 receptor and the occurrence of NAEs was problematic. At the oral proceedings before the opposition division (minutes, page 2), the parties discussed sufficiency of disclosure in relation to the generalisation of the effect shown in the application as filed for a CD19xCD3 antibody construct. In the decision (point 19.4), the opposition division adopted the opponents' argument that the subject-matter of the main request was not sufficiently disclosed because the effect shown for a CD19xCD3 bispecific single chain antibody could not be extended to any CD3 binding domain.

2.3.2 A preliminary opinion in preparation for the oral proceedings is not binding and may change during the oral proceedings. A change of mind of the opposition division following discussion at the oral proceedings to take up arguments considered not convincing in its preliminary opinion is a possible development in the proceedings and cannot come as a surprise.

Furthermore, it is apparent from the minutes of the oral proceedings on 17 April 2019 (page 2, penultimate sentence) that, after the rejection of the main request, the appellant-patent proprietor had time during the lunch break to reflect on how to proceed. At that time, the patent proprietor did not make any attempt to overcome the sufficiency objection by filing a new claim request. It instead stated that it wanted to proceed with the then pending auxiliary request 1.

2.4 At the oral proceedings before the board, the appellant-patent proprietor did not submit any argument on this point. Therefore, auxiliary requests 1 to 3 were not admitted into the appeal proceedings pursuant to Article 12(4) RPBA 2007.