Appeal No. 2001-0987
Application 09/169,109
On consideration of the record, including the above -listed materials, we reverse
the examiner’s rejections.
DISCUSSION
The question here is whether the combined disclosures of Villani and Sims
support a conclusion of obviousness of claims 1 through 8, which recite the crystalline
polymorph form 2 of loratadine having a unique x-ray powder diffraction pattern and
infrared spectrum. We answer that question in the negative.
Villani discloses polymorph form 1 of loratadine, but does not disclose or suggest
that loratadine may assume distinct, crystalline polymorphic forms having different
physical properties. Nor does Villani teach a person having ordinary skill in the art how
to make polymorph form 2 of loratadine.
The Sims reference does not cure the deficiencies of Villani. Sims discloses a
list of 16 non-sedating antihistamines, including loratadine, useful in combination
therapy (Sims, page 8, lines 3 through 6). After listing those antihistamines, Sims refers
to “a pharmaceutically acceptable salt, hydrate, or polymorph thereof” (id., lines 6 and
7). That reference to pharmaceutically acceptable salts, hydrates, or polymorphs,
however, does not teach a person having ordinary skill in the art that loratadine may
assume distinct, crystalline polymorphic forms having different physical properties.
Rather, it appears that the above-quoted language constitutes boilerplate; and that Sims
refers generally to pharmaceutically acceptable salts, hydrates, or polymorphs of any
one of 16 non-sedating antihistamines without specifically suggesting that loratadine is
capable of existing in the form of distinct crystalline polymorphs. On this point, we
disagree with the examiner’s finding that “Sims expressly teaches that loratadine may
be in the form of polymorphs” (Examiner’s Answer, page 3, lines 10 and 11). Nor does
Sims teach a person having ordinary skill in the art how to make polymorph form 2 of
loratadine.
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