T 0899/18 - Rat embryonic stem cell

Key points

•  This might be a run-of-the-mill biotech opposition case.
• Claim 1 is directed to: " A rat embryonic stem cell characterized by having the following properties (a)-(j):   [...] (c) having an embryoid body forming ability, (d) expressing SSEA (Stage-Specific Embryonic Antigen)-1 and SSEA-4, (e) having the same number of chromosomes as does a normal rat cell, (f) capable of being subcultured and holding the undifferentiated state, (g) having in vitro pluripotency, (h) having the potential to differentiate into cells of the three embryonic germ lineages, (i) having teratoma formation ability, and (j) having an ability to produce a chimeric rat." 
• Claim 2 is directed to " A method of producing a rat embryonic stem cell " 
• Claim 5 is the product-by-process claim: " A rat embryonic stem cell obtained by the method according to any one of claims 2 to 4." 
• Claim 13 is: " Use of a rat embryonic stem cell of claim 1 or 5 in the production of a genetically modified rat." 
• Claim 14 is: " A method of producing a genetically modified rat, which comprises the following steps (X)-(Z): (X) introducing a desired gene into the rat embryonic stem cell of claim 1 or 5, (Y) preparing an oocyte for transplantation comprising the rat embryonic stem cell into which the gene was introduced, (Z) transferring the oocyte for transplantation into a pseudopregnant female rat to produce an offspring rat.
• Claim 15 is: " A genetically modified rat produced by the production method of claim 14." 
• The opponent appeals only on the ground of insufficient disclosure.
• " The methods and results disclosed in the patent are confirmed by the experimental evidence in document (2), which was produced and submitted by the respondents after the publication date of the application on which the present patent was granted. While the appellant argued that the probative value of document (2) was highly suspect, he did not put forward any persuasive arguments to support his allegation. 
• " In the light of the experimental results provided in the examples of the patent, there is no doubt that chimeric rats produced by the methods taught in the patent are genetically modified, in particular by insertion of the GFP gene into the cell genome in most tissues, including testis (see Figure 24 of the patent). No experimental evidence to the contrary has been submitted by the appellant." 
• The Board: " the evidence in documents (1) and (3) does not discharge the appellant's burden of proof, nor supports his objection of lack of sufficient disclosure of the claimed rat embryonic stem cells." 
• Application filing date 2005.

• EPO 

The link to the decision is provided after the jump.

https://www.epo.org/law-practice/case-law-appeals/recent/t180899eu1.html