Appeal No. 2002-1545 Page 6
Application No. 08/949,757
expression of significantly different carbohydrate antigens.” Id. The rejection
concludes:
The specification does not describe all of the many combinations of
sugars which comprise rhamnose, glucose, 2-acetamido-2-deoxy
glucose and 2-acetamido-2-deoxy galactose, nor does it provide
how these sugars are related one to another. The structural
arrangement of the components of claimed carbohydrate antigen is
not disclosed. The specification lacks any teaching with the [sic]
respect to the manner in which the various sugars are compiled to
define the surface antigen of Enterococcus. It is clear that the
claimed carbohydrate antigen would react with the polyclonal
antibodies which were induced to the deposited stain [sic] (whole
cell antigen which comprised both protein and carbohydrate
antigens) but it is not clear what the structural orientation of
components are which make up the claimed carbohydrate and
afford Enterococcus its unique carbohydrate characteristics. It is
clear that the molar ratios of the various sugars of the carbohydrate
antigens are taught by the instant invention, but how many, which
sugars, the conformational changes would or could be changed to
afford and produce the many claimed carbohydrate antigens is not
clearly described and no guidance is provided as to how the
various components are inter-related. The specification describes
polyclonal antibodies which bind whole cell antigen of which the
carbohydrate antigen is a part but not with which specific fragments
they bind or with which conformational epitopes they bind are not
taught. Further, the polyclonal antibodies are not a standardized
reagent and therefore are not a recognized standard for defining
the corresponding antigen. Therefore, the written description
requirement [is] not satisfied over the full scope of the claims.
Id. at 6-7.
Turning first to the rejection under 35 U.S.C. § 112, first paragraph, scope
of enablement, “[e]nablement requires that the specification teach those in the
art to make and use the invention without ‘undue experimentation.’ That some
experimentation may be required is not fatal; the issue is whether the amount of
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