Appeal No. 2001-1905 Page 5
Application No. 08/245,827
treated’ in vivo.” The examiner, however, fails to address appellant’s argument
(Brief, page 6), with reference to page 7, lines 3-8 of the specification, that:
The specification provides adequate teaching and guidance
regarding the medical conditions being treated. For example, the
specification states that
Such patients will include those discussed above
which are susceptible to, or suffer from, strokes,
anoxia and certain degenerative diseases. They will
also include those patients which have no symptoms
but are found to have abnormally high levels of
glutamate or related compounds in the CNS…
The examiner finds (Answer, page 6) that the in vitro examples provided
in the specification “would not reasonably be extrapolated by the skilled artisan
to knowing how to use glutathione to effectively treat any patient, as claimed in
vivo….” However, we remind the examiner as set forth in In re Strahilevitz, 668
F.2d 1229, 1232, 212 USPQ 561, 563 (CCPA 1982), working examples are not
required to satisfy section 112, first paragraph. Nevertheless, in support of his
position, the examiner finds that “glutathione does not cross the blood brain
barrier.” See Answer, pages 6, 7 and 11. However, as appellant points out
(Brief, page 12) the examiner’s “assertion is entirely based on the [e]xaminer’s
own speculation and is not supported by any evidence and/or scientific reports.”
In relying on what they assert to be general knowledge to negate patentability
examiner’s must articulate that knowledge and place it of record. Failure to do
so is not consistent with either effective administrative procedure or effective
judicial review, examiners cannot rely on conclusory statements, but must set
forth the rationale on which they rely. Cf. In re Lee, 277 F.3d 1338, 1343-1344,
61 USPQ2d 1430, 1433-1434 (Fed. Cir. 2002).
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