Appeal 2007-0313
Application 10/414,447
for believing that the products of the applicant and the prior art are the same,
the applicant has the burden of showing that they are not”).
The crystalline compound disclosed by Bühlmayer has the same
chemical formula as that Appellants are trying to claim. And it’s in
crystalline form.2 It’s also useful for exactly the same purpose as that
disclosed by Appellants, i.e., to inhibit the action of angiotensin II on its
receptors (e.g., Specification 1; Bühlmayer, col. 6, ll. 30-33).
In my view, there is insufficient evidence to suggest that Bühlmayer’s
crystalline form is different than Appellants’ Forms I and II. The difference
in melting points, relied upon by the majority (see supra p. 7), is not
convincing. As one skilled in the art would have known, small differences
in melting points provide scant information and should be viewed critically.
This is particularly true when, like here, there is no evidence they were
obtained under the same conditions, such as rate of heating and sample size,
or even method (for example, DSC versus capillary tube). Further, melting
points are notoriously sensitive to impurities. In this case, the purity of
Appellants’ crystals varies, exhibiting a range of color from “white to off-
white.” (Specification 4-5, ¶¶ 0030 & 0044.) Such impurities could explain,
or at least partially explain, their lower melting point.
The majority also relies on differences between how the products
were isolated (see supra p. 7). Appellants prepared their products by
dissolving valsartan in a ketone and adding an aliphatic hydrocarbon to
2 While Appellants describe a “Reference Example,” that example is clearly
not Bühlmayer’s, as it is “amorphous” (Spec. 8) rather than “crystalline”
(Bühlmayer, col. 49, l. 51). Notably, Appellants do not disclose a melting
point for their “Reference Example.”
12
Page: Previous 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Next
Last modified: September 9, 2013