Appeal No. 2005-2739 Page 6
Application No. 09/966,893
cells” (id., pages 5-6), “since this process, like the protein component of the invention,
was also well known in the art” (id., page 6).
The examiner has not explained why these teachings would not have conveyed
with reasonable clarity to one of skill in the art that appellants were in possession of a
genus of enzymes implicated in a host of lysosomal storage disorders. The examiner’s
conclusory assertion that the working examples are not representative of a larger genus
is insufficient to meet the examiner’s “initial burden [to] present[ ] evidence or reasons
why persons skilled in the art would not recognize in the disclosure a description of the
invention defined by the claims” (Wertheim, 541 F.2d at 263, 191 USPQ at 97).
The rejection of claims 8-13 as lacking adequate written descriptive support under
35 U.S.C. § 112, first paragraph, is reversed.
Scope of Enablement
Claims 8-13 stand rejected under 35 U.S.C. § 112, first paragraph, “because the
specification, while being enabling for [a] composition comprising a protective
protein/cathepsin A (PPCA) protein useful for treating galactosialidosis, does not
reasonably provide enablement for any other embodiment” (Examiner’s Answer, page 6).
“[A] specification disclosure which contains a teaching of the manner and process
of making and using the invention in terms which correspond in scope to those used in
describing and defining the subject matter sought to be patented must be taken as in
compliance with the enabling requirement of the first paragraph unless there is reason to
doubt the objective truth of the statements contained therein which must be relied on for
enabling support.” In re Marzocchi, 439 F.2d 220, 2223, 169 USPQ 367, 369 (CCPA
1971) (emphasis original). “[I]t is incumbent upon the Patent Office . . . to explain why it
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