Biotech Values

[orangeone]

Iwfal, the action phrase about what to do with the batch in claim 8 can be considered a further claim element, that is, claim 8 is a narrower claim than claim 1 which just say analyze. Claim 1 does not require that anything be done with the batch; you infringe by just analyzing it.

Adding the downstream process action phase to make a claim narrower gives you a fall back position in case of non-patentability arguments (harder for an opponent to argue lack of novelty, obviousness, enablement or description).

However there is also another consequence: the action phase turns the claim into a manufacturing process claim.

USC 271(g) provides that products produced ex-US that would be covered by a US method claim constitutes infringement, as long as the product imported is directly made by the patented method and not subsequently substantially transformed.

My guess is that the phrase in claim 8 will be a key part of AMpha's position because they will argue that MNTA just dressed up an "analysis" claim with some wording, and that it is not a real manufacturing process as envisioned by the lawmaker.