T 1285/13 - Article 57

Key points 

• "The examining division decided that the requests before it not only lacked an inventive step but also industrial applicability. The examining division decided that the indication of achievable objectives given in the application did not go beyond speculation and vague general statements. Therefore, no defined industrial application was considered to be disclosed. 
• The Board states that " the issue of Article 57 EPC is closely related to the question whether or not the technical problem underlying the invention has been credibly solved. As shown in points 13 to 23 above, the board is convinced that the priority application plausibly discloses a role for miR-1 in the regulation of physiological processes." . The Board therefore finds that the claim meets the requirement of Article 57 EPC.

T 1285/13 -  link

V. Claim 1 of the main request reads as follows:

"1. An isolated nucleic acid molecule having a length of from 18 to 25 nucleotides comprising a nucleotide sequence which has an identity of at least 90% to a sequence shown in SEQ ID NO 58 (miR-1) or a complement thereof."

Reasons for the Decision

Article 57 EPC
30. The examining division decided that the requests before it not only lacked an inventive step but also industrial applicability. The examining division decided that the indication of achievable objectives given in the application did not go beyond speculation and vague general statements. Therefore, no defined industrial application was considered to be disclosed.

31. The issue of Article 57 EPC is closely related to the question whether or not the technical problem underlying the invention has been credibly solved. As shown in points 13 to 23 above, the board is convinced that the priority application plausibly discloses a role for miR-1 in the regulation of physiological processes. The application predicts a role in developmental timing by mediating sequence specific repression of RNA translation (page 1, lines 20-22). This prediction is supported by the data of example 1, Table 1 and Figure 1a) which show expression of miR-1 in a developmental stage specific manner in Drosophila. This function is confirmed by later published document D10 which shows that miR-1 influences cardiac development. The priority application provides also evidence of a conserved function across different species and of tissue specific expression.

32. Lin-4 and let-7, the two stRNAs disclosed in the prior art, were both known as regulators of developmental timing (cf. document D1). It is on this basis that the role of miR-1 as a developmental regulator was assigned. Neither the prior art nor the post-published documents provide any evidence for a different function. The role as a regulatory molecule of developmental timing is specific enough to be of immediate concrete benefit in the sense of point 6 of the reasons of decision T 898/05 of 7 July 2006. At the least miR-1 may be used for the staging of development in Drosophila. Furthermore, in view of its presence in various species it may be used for the modulation of development which is of importance to industry in view of developmental dysfunctions such as cancer (cf. page 5, lines 18 to 20 of the priority application).

33. The main request therefore meets the requirements of Article 57 EPC.