Appeal No. 1997-3511
Application No. 08/233,663
relevant to the issues raised by this appeal and particularly to arguments made by
appellants relating to the lyophilization of protein compositions.
While Wang does not specifically relate to factor IX, the remaining references,
relied on by the examiner, are more closely related to this aspect of the claimed subject
matter. For example Zolton, relied on by the examiner as disclosing the use of glycine and
histidine, describes the stabilization of plasma proteins. Since factor IX is a plasma
glycoprotein (Specification, page 1, lines 10-11), this reference would be relevant to the
claimed subject matter. Both Mathews and Bhattacharva describe compositions relating
to factor VIII and describe the incorporation of substances such as calcium chloride,
sugars, buffers, surfactants with this protein for stabilization during isolation and
purification. The examiner has urged that “stabilizers for Factor IX would also be
considered stabilizers for Factor VIII or vice versa . . . .” (Answer, page 6). However, even
where the examiner has shown that each component of the claimed composition has been
combined with a protein, even a closely related protein, there must be a suggestion or
direction to be found in the prior art which would have led one or ordinary skill in the art to
bring all components required by the claim into a single combination. It is not enough that
the individual components have been used in combination with other proteins for various
purposes. As set forth in Ecolochem Inc. V. Southern California Edison, 227 F.3d 1361,
1375, 56 USPQ2d 1065, 1075 (Fed. Cir. 2000) “[a] rejection cannot be predicated on the
mere identification . . . of the individual components of claimed limitations. Rather,
particular findings must be made as to the reason the skilled artisan, with no knowledge of
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