Clarity on "in the treatment of..." vs. "for the treatment of..."
I'm wondering if I could get some clarity on using the terminology of "in the treatment of..." vs. "for the treatment of...". Our indication says "for the treatment of" and we've included a first-and-only claim that has the full indication nested. So, it's something like "The first and only ______ ... for the treatment of...(the whole indication)". The indication is not quite verbatim, it has an (on-label) adjective added (e.g., "moderate") that wasn't present at that point in the PM indication (though it is mentioned later in the PM indication in the same context).
We've gotten some feedback from PAAB saying that we need to change "for" to "in" and we are unsure where exactly the problem lies. Is the problem the added adjective ("moderate") which renders the indication portion of the claim not completely verbatim, or is the problem that we cannot nest the full indication (with "for") within other claims (i.e., "The first and only _____" is the problem).
Thanks in advance for any help!
Jennifer Carroll last edited by
This sounds like a specific question about a specific file and issue. It would be best addressed by discussing the specifics of the request with the reviewer of the file, in the context of the actual claim and indication, particularly since there are additional considerations for exclusivity claims.
As a general principle, claims with the phrase “…indicated for…” require the verbatim indication, whereas non-verbatim/truncated indication claims may appear as “…indicated in…”. A “first and only” claim like that described, would appear to be an indication comparison and therefore require the copy “indicated in/for”.