Appeal No. 2006-1335 Page 3
Application No. 09/888,734
The examiner relies on Livesey to make up for the deficiency in Curtis.
According to the examiner, Livesey “provides motivation for lyophilizing ‘native’
Factor VIII in trehalose without albumin by not only claiming a specific
embodiment (claim 17) of lyophilizing Factor VIII[ ]2, but also disclosing [(column
9, lines 16-24)] that trehalose, and not albumin, is one of a number of agents
particularly suited to dry preservation of macromolecules such as proteins.” 3
Answer, page 4.
Based on this evidence, the examiner concludes (Answer, page 5),
the artisan of ordinary skill seeking to preserve the “native” Factor
VIII encompassed by Livesey’s claim 17, recognizing that Factor
VIII is a protein, clearly would have looked to trehalose instead of
albumin, based on Livesey’s disclosure that trehalose is one of a
number of agents particularly suited for protein protection in freeze-
drying procedures, and albumin is not. Additional motivation for
freeze-drying Factor VIII using trehalose in the absence of albumin
would have been derived from the fact that the lone example of
protein freeze-drying of Livesey, Example 5 at columns 23 and 24,
demonstrates that the integrity of a protein containing viral vaccine
is adequately protected by trehalose in buffer with no other
preservative agents.
Appellant does not dispute that Curtis teaches “a method for preparing a
purified and stable activated Factor VIII.” Brief, page 6. Appellant argues,
however, “any teaching regarding how activated Factor VIII might be stabilized
2 For clarity, we note that Livesey’s specification and claim 17, refer to Factor VIII without
reference to whether this blood factor is in its native or activated form. As we understand the
examiner’s argument, the examiner has interpreted this reference to Factor VIII as a generic
reference to both the native and activated forms of Factor VIII.
3 For the reasons that follow, we disagree with the examiner’s interpretation of this disclosure of
Livesey.
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