Appeal No. 2006-1335 Page 4
Application No. 09/888,734
when freeze-dried is irrelevant to the behavior of native Factor VIII.”4 Id. In this
regard, appellant points out that Curtis does not teach a freeze-dried preparation
of native Factor VIII as required by appellant’s claimed invention. Brief, page 5.
With reference to the Helgerson and Tuddenham Declarations, appellant asserts
that there are “considerable differences in characteristics and behavior between
native and activated Factor VIII.” Brief, bridging paragraph, pages 6-7. Upon
consideration of the Helgerson Declaration and the Tuddenham Declaration, we
find that both Declarations assert that one of ordinary skill in the art would not
have a reasonable expectation of success in extrapolating the methodology
applied to activated Factor VIII to the native form of Factor VIII. See e.g.,
Tuddenham Declaration, paragraphs 5-6; and Helgerson Declaration, paragraph
3.
In this regard, we note that Helgerson, a co-inventor on the Curtis patent,
declares (paragraph 3), the work related to the Curtis patent was limited to the
activated form of Factor III. According to Helgerson (id.), “[b]ecause the two
protein forms are so different from one another, the attributes of, uses of, and
techniques involving one may not simply extrapolated [sic] to the other.” In our
opinion, this is compelling insight into what a person of ordinary skill in the art
would have gleaned form the disclosure of the Curtis patent.
The examiner attempts to refute the testimony set forth in the Tuddenham
and Helgerson Declarations by asserting (Answer, bridging paragraph, pages 9-
10), “[t]he fact that trehalose can be used to preserve both native and activated
4 We recognize appellant’s argument regarding the preparation of a composition that is stable
without the need for refrigeration. Brief, page 6. There is, however, no specific temperature
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