Claims 3 and 4 of the 466 patent cover a number of other subclasses to include both octasaccharides and hexasaccharides; claim 4 provides a table of allowable amounts.
Suggest you missed my point. '466 says, effectively, there are two gates:
1) A check on fraction-of-all-tetras-together, and on fraction-of-all-octas-together, and on ... (Note that for some reason Momenta is not actually asserting this particular claim)
THEN
2) A check on subfractions of the tetras. (This is the claim they are asserting.)
My question is whether it is possible to, for instance, substitute a different subanalysis for #2. E.g. check on subfractions of the octas instead of the tetras. Do I know that that would be adequate to show a batch meets Lovenox equivalency? No, but I'll bet there is some other kind of subfraction check (not in the patent) that would show equivalency - but it would take substantial time/$ to show that checking that particular subfraction in detail is adequate to show lovenox equivalency and then get FDA acceptance of that method.
PS For any patent attorneys out there - why is it that sometimes the enablement action is in the claim (as it is in claim 8 - where it says what to do with the batch if it passes) and sometimes it is buried in description (as it is for claim 4 - where the claim itself says measure and compare to the table, but then not what to do with the compared batch)?