pharmaceutically acceptable carrier. Thus, Bergeron discloses a composition comprising a
compound of formula 1 (see Table 1, compounds 33 and 34) in a pharmaceutically acceptable carrier
(sterile water).
The question remains, however, as to whether Bergeron teaches a composition comprising an
amount of compound 33 or 34 that would meet the requirements of appellant’s claimed invention?
While appellant’s specification does not explicitly define the phrase “an effective amount”, appellant
discloses (page 11, lines 12-15), “[p]harmaceutical compositions according to the invention can, for
example, … contain from approximately 0.05 g to approximately 10.0 g, and preferably from
approximately 0.3 g to approximately 1.0 g, of active ingredient.”[4] While Bergeron does not teach
the amount of the compound in the composition, it appears, absent evidence to the contrary that the
composition of claim 1 is identical or substantially identical to the composition disclosed by
Bergeron as useful in the determination of IC50 values. Appellant’s burden under
the circumstances presented herein was described in In re Best, 562 F.2d 1252,
1255, 195 USPQ 430, 433-434 (CCPA 1977) as follows:
Where, as here, the claimed and prior art products are identical or substantially
identical, or are produced by identical or substantially identical processes, the PTO can
require an applicant to prove that the prior art products do not necessarily or inherently
possess the characteristics of his claimed product.… Whether the rejection is based on
`inherency' under 35 U.S.C. ' 102, on `prima facie obviousness' under 35 U.S.C. ' 103,
jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by
the PTO's inability to manufacture products or to obtain and compare prior art products
[footnote omitted].
We find no evidence on this record that the composition of Bergeron does not necessarily or
inherently possess the characteristics of appellant’s claimed composition. Accordingly, we affirm the
rejection of claim 1 under 35 U.S.C.
§ 102(b) as anticipated by Bergeron. Claims 2-7 fall together with claim 1. However, since our basis
for affirming the rejection differs from the examiner’s, we designate the affirmance as a new ground
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