Appeal 2007-0313
Application 10/414,447
precipitate the compound (Specification 2-3), while Bühlmayer used ethyl
acetate (Bühlmayer, col. 49, ll. 50-51). Without more, those skilled in the
art would not have concluded different crystallization solvents and systems
necessarily yield different crystalline forms.
In fact, such a conclusion is counter to Appellants’ own teachings that
any C4-C6 straight or branched chain ketone solvent and any aliphatic
hydrocarbon will suffice (Specification 2, ¶¶ 0009-0010). If the crystal
structure is as sensitive to the crystallization solvent system as suggested,
one would expect more precise teachings regarding that system.
Another concern is that Appellants do not use “consisting of” or even
“consisting essentially of” language to exclude valsartan in other forms.
Thus, their claims include mixtures of crystals, as long as a crystal of the
claimed form is present. It follows that, even if only a trace amount of
Bühlmayer’s crystalline compound is in crystalline Form I or II, Appellants’
claims to these forms would be anticipated. See Smithkline Beecham Corp.
v. Apotex, 403 F.3d 1331, 1339-40, 74 USPQ2d 1398, 1403-04 (Fed. Cir.
2005) (holding that a claim to “Crystalline paroxetine hydrochloride
hemihydrate,” in essence, would cover a single molecule of hemihydrate).
It is the Office’s responsibility to prevent the issuance of invalid
patents. Yet the Office does not have the facilities to determine what form
or admixtures of forms Bühlmayer’s crystalline compound takes. Given the
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