Appeal No. 2006-3084 Page 4
Application No. 10/673,860
2-fold higher than ATCC138691, and “AJ12036-derived strains which have
retained this activity, but otherwise might not be identical, i.e. mutants.” The
examiner agrees, but remains of the opinion “that there is not an adequate
description of the mutant strains that are encompassed.” Answer, page 7,
emphasis removed.
The examiner acknowledges that the issue is not “[t]he ability to isolate,
or discover, new mutants of the AJ12036 strain . . . .” Id. Instead, the examiner
contends (id.) that AJ12036 mutants “which retain the ability of the parent strain
to have increased secretion of proteins, therefore, have not been described in
terms of their genetic structure.” Id. According to the examiner, since
[o]ne of skill in the art cannot envision the genetic alterations which
would leave intact this ability to secrete proteins at a higher level
than a wild type strain . . . [o]ne would not be able to envision the
identity of such mutants, since one does not even know the starting
structure, i.e. the genetic sequence or alteration responsible for the
activity of increased secretion in AJ12036, from which mutants are
derived.
Id. We disagree. As the examiner recognizes, methods of making mutants are
known in the art and appellants’ claimed mutants are derived from the deposited
Corynebacterium glutamicum AJ12036 (FERM BP-734). Therefore, the starting
structure, i.e. the genetic sequence or alteration responsible for the activity of
increased secretion, is defined by the deposited microorganism. As appellants
explain (Reply Brief, page 3), “[t]here is no requirement to ‘envision’ the structure
of the mutant since it has been deposited.” As set forth in Enzo Biochem, Inc. v.
Gen-Probe Inc., 323 F.3d 956, 965, 63 USPQ2d 1609, 1614 (Fed. Cir. 2002),
1 According to appellants’ specification (paragraph 27), Corynebacterium glutamicum AJ12036
(FERM BP-734) bacterium “has the capacity of secretory production of heterologous proteins at
least 2-3 fold higher than the parent strain (wild type strain) . . . .”
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