Appeal No. 2003-0919 Page 6
Application No. 09/463,097
For the purposes of this appeal, we shall assume arguendo, without deciding,
that Zimmermann describes the methanesulfonic acid addition salt of imatinib within the
meaning of 35 U.S.C. § 102(b). Nonetheless, we agree with applicants that
Zimmermann contains insufficient disclosure to support a finding of anticipation of the
appealed claims which recite a non-hygroscopic or $-crystalline form of the
methanesulfonic acid addition salt of imatinib. In fact, with respect to the particular
polymorphic form recited (non-hygroscopic or $-crystalline form), the examiner
acknowledges that "Zimmermann is silent as to the existence of one or more forms for
its salts." (Paper No. 17, page 7, lines 5 and 6).
The examiner would shift the burden of persuasion to applicants to establish that
the $-crystalline form recited in their claims "cannot be made following routine
conditions." (Paper No. 17, page 9, line 4). Stated another way, the examiner would
place the burden on applicants to establish that the non-hygroscopic or $-crystalline
form of the methanesulfonic acid addition salt of imatinib is not inherently produced
using "routine procedures" disclosed by Zimmermann in column 19. (Paper No. 17,
page 7, lines 4 through 9). This constitutes reversible error.
As stated in applicants' specification:
It has now been surprisingly found that a crystal form may under certain
conditions be found in the methanesulfonate salt of this compound
[imatinib] which is described hereinafter as $-crystal form, and which has
very advantageous properties. [Specification, page 1, third paragraph].
The examiner does not deny that applicants' specification teaches any person
skilled in the art how to make the $-crystalline form of the methanesulfonic acid addition
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