Appeal No. 2002-1545 Page 7
Application No. 08/949,757
experimentation required is not ‘undue.’” In re Vaeck, 947 F.2d 488, 495, 20
USPQ2d 1438, 1444 (Fed. Cir. 1991) (citation omitted, emphasis in original).
“Whether undue experimentation is needed is not a single, simple factual
determination, but rather is a conclusion reached by weighing many factual
considerations.” In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed.
Cir. 1988). The factual considerations discussed in Wands are: (1) the quantity
of experimentation necessary to practice the invention, (2) the amount of
direction or guidance presented, (3) the presence or absence of working
examples, (4) the nature of the invention, (5) the state of the prior art, (6) the
relative skill of those in the art, (7) the predictability or unpredictability of the art,
and (8) the breadth of the claims. Id.
At best, the examiner has focused upon one factor, the amount of
direction or guidance presented, to the exclusion of the others. Thus, the
examiner has failed to set forth a prima facie case that the specification fails to
enable the full scope of the claims. Moreover, as noted by appellants:
The present specification provides the ATCC number for a
deposited strain (ATCC 202013) which carries an antigen as
claimed in present claim 1. The specification further provides, on
page 17, details of cell fermentation, and on pages 18-20, a
detailed description of how the fermented and harvested cells of
this strain can be treated in order to extract the recited antigen.
The specification then sets forth details of the steps used to isolate
and purify the antigen. On pages 20 and 21, applicants provide the
sugar composition of the isolated antigen, including the identity and
molar ratio of four sugars contained in the antigen, and biochemical
and H1-NMR analyses of the antigen.
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