Thank you for your brief note. Please elaborate if you can.
I do believe you that that there is no absolute requirement to prove something works (37 CFR 1.91 - I think an examiner may ask for a working model or a prototype though if they doubt feasibility ) - more specifically to this case I think a patent examiner that is aware that the FDA is a specifically considering whether or not a potency assay component has been validated or not (as I believe the examiner in the US would be in this case) is unlikely to patent an assay that the FDA has so far failed to validate I'd submit. That would be to put blockages in front of others that could make similar things work it seems to me.
What I know for a fact is that in the current patent application as disclosed under google patents with respect to the US PTO (I've said how to obtain that already) -there are no claims remaining that the US PTO is currently being asked to consider involving the IL2 aspect of the potency assay - those claims are shown as cancelled.
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