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March 08, 2021

Comments

Call this a "random" observation: one thing about the claim seemed a little odd to me. It starts by claiming a conjugate of FVIII and "one or more biocompatible polymers"—i.e., there potentially are multiple polymers. However, all the remaining language in the claim uses the singular when talking about a polymer. It is "the" polymer; the polymer "comprises"; and the polymer "is" attached at the B-domain. That makes it a little confusing. Does it mean that actually just one PEG is ever attached, or can there be instances of attaching more than one polymer? If the latter, are they all the same—i.e., all PEG—or are they actually different types of the claimed polymers?

Dear Hard:

Keeping in mind that indefinite articles like "a" or "an" are usually construed to mean "one or more" (unless there is a reason not to), and "comprising" means "what is recited and other things," we have "an" isolated polypeptide conjugate comprising "a" functional factor VIII polypeptide. The "biocompatible polymer(s)" are recited as "one or more," so that there can be more than one of these. The rest of the claim is limited to functional factor VIII polypeptide comprising a particular amino acid sequence (SEQ ID NO: 4) or an allelic variant thereof, and is further limited to having "a" (one or more) B-domain. Then the biocompatible polymer comprises polyalkylene oxide (PEG being a specific embodiment of this broader genus) that is covalently attached to the functional factor VIII polypeptide at the B-domain. This latter is what is necessary to distinguish over the prior art, where PEGylation of Factor VIII was, according to the opinion, randomly distributed. So the claim contemplates possibly more than one PEGylation provided that 1) at least one is in the B domain; and 2) it isn't randomly distributed in the Factor VIII protein.

How many and where PEGylation occurs is bounded by the prior art, the prosecution history, and the teachings in the specification. Baxalta tried to get the claim limited to conjugation at cysteine residues (because their conjugation was at lysine residue(s), I suppose) and the court wouldn't limit the claims to these embodiments.

Thanks for the comment

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