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October 06, 2021


"Wherein the level of β-galactosidase activity comprises between 0.05 and 200 units" is an odd construction. "Comprising" suggests that other levels of activity also fall within the scope of the claim.

Jim: Sometimes claims drafters use "comprising" as a catch-all modifier to indicate some level of "fuzziness" around ranges like this, but certainly (as you point out) there is a danger that the term can be used to find a variety of Section 112 issues depending on how the claims are construed. My understanding (without reviewing the specification or prosecution history) is that this level of activity is de minimis and yet effective in reducing the amount of lactose present in cells producing 2-FL. So any values outside this range would either be ineffective at reducing post-production lactose levels or would reduce the lactose pool in the cells during 2-FL production and thus reduce yield. In either case such embodiments would be disfavored economically and the patent holder might be content to let an infringer be saddled with such an inefficient production method.

Thanks for the comment

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