Appeal No. 2005-2739 Page 5
Application No. 09/966,893
specification satisfies the requirement is a question of fact, which must be resolved on a
case-by case basis (Vas-Cath, 935 F.2d at 1562-63, 19 USPQ2d at 1116), and it is 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” (In re Wertheim, 541 F.2d 257, 263, 191 USPQ 90, 97 (CCPA 1976)).
“Applicants have some flexibility in the ‘mode selected for compliance’ with the
written description requirement” (University of Rochester, 358 F.3d at 928, 69 USPQ2d
at 1896), and it is well settled that actual reduction to practice is not necessary to satisfy
the requirement (id. at 926, 69 USPQ2d at 1894). Finally, the court has made it clear
that other factors, including the level of skill in the art, are relevant to whether a
description satisfies § 112. See Capon v. Eshhar, 418 F.3d 1349, 1358-59, 76 USPQ2d
1078, 1085 (Fed. Cir. 2005) (“[T]he determination of what is needed to support generic
claims to biological subject matter depends on a variety of factors, such as the existing
knowledge in the particular field, the extent and content of the prior art, the maturity of
the science or technology, the predictability of the aspect at issue, and other
considerations appropriate to the subject matter.”).
Appellants point out that the claims “encompass only those proteins useful for
treating lysosomal storage disorders [ ] other than Fabry disease” and “[a]
comprehensive list of such proteins is provided in Table 1 of the specification” (Appeal
Brief, page 7), together with “references to scientific literature and/or Genbank accession
numbers disclosing the structure (amino acid sequence) of these proteins” (id., page 5).
Appellants argue that “[t]his structural information can be used to create nucleic acid
vectors for the expression of these proteins in any desired cell type, including insect
Page: Previous 1 2 3 4 5 6 7 8 9 10 11 Next
Last modified: November 3, 2007