Friday, 9 April 2010

T 394/06 – Substantiated Doubts Required

[20] It is established case law of the boards of appeal that if an application is objected to for lack of sufficient disclosure, these objections have to be based on serious doubts which are substantiated by verifiable facts (T 19/90).

[21] In its decision, the examining division (ED) has argued that the claimed subject-matter relating to vaccines based on the CASB7439 polypeptide was not sufficiently disclosed in accordance with A 83. There was no evidence derivable from the application or provided by the applicant that the sequences of the application had a therapeutic effect if used to treat a patient suffering from or susceptible to carcinoma, whereby the carcinoma is colon cancer or other colon-associated tumours or diseases. […] 

[22] The board notes that in its argumentation the ED, rather than applying it, has inverted the principle developed in the case law of the boards of appeal whereby it would be required to raise serious doubts which are substantiated by verifiable facts. Already for this reason the argumentation of the ED must fail to substantiate an objection under A 83.

[23] The board notes furthermore that even if the approach taken by the ED were adequate the [applicant’s] arguments […] convincingly show compliance of the application with A 83 in the relevant aspects.

[24] In particular, the [applicant] has shown that there is no reason to doubt that CASB7439, considered to be an intranuclear transcription factor, would not be suitable for producing vaccines for treating carcinoma patients. The [applicant] persuasively argued that in fact intranuclear proteins were constantly turned over in the cell and mechanisms existed which allowed such proteins to be processed and presented in MHC Class I complexes on the surface of cells including tumour cells. This was also true for transcription factors. Also other transcription factors could be used as an immunotherapeutic antigen (D10) and could naturally elicited immune responses in humans (D11 and D12). These data therefore showed that the epitopes contained in these transcription factors were presented to the immune system in an accessible way. Furthermore, document D13 presented data showing that CASB7439 was indeed effective as an immunotherapeutic treatment in a mouse tumour cell challenge model.

[25] All the submissions of the [applicant] therefore support the conclusion that the disclosure of the application is sufficient. On the basis of the facts of this case, there are no serious doubts substantiated by verifiable facts which could justify an objection that the inventions was not sufficiently disclosed.

[26] In view of the above considerations the board is satisfied that the claimed invention complies with the requirements of A 83. 

To read the whole decision, click here.