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April 08, 2020


"wherein the preparation comprises a pH between about 3.0 and about 4.0"

That wording makes it sound like pH is a component that is present in a drug formulation, rather than a property of that formulation. That may be insufficient to bring the claim down under 112, but it's still sloppy claim drafting.

@Atari Man
With respect, it doesn't seem that ambiguous, confusing, or sloppy to me. Especially given the constraints of claim drafting with a "comprises" transition, the meaning of the term seems pretty straightforward.

Also, a quick and dirty search in Google Patents turns up a fair number of similarly drafted examples, at least some of which originate from reputable patentees. That said, pharma is not in my wheelhouse, so I'm not familiar with the drafting best practices, if any, for this type of claim. I'm curious if you happen to know of any best practices, or have any thoughts on what a better drafting approach would be here.

Dear Atari:

Semantically, "has" would read better than "comprises," or even "is characterized by."

But in view of hardreaders' comment, maybe defendant didn't see the advantage of making this argument.

Thanks for the comment.

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