Appeal No. 2002-0872 Page 5
Application No. 08/470,849
4), Ashkenazi not only teaches a different cell line, but also fails to identify the
conditions used to produce their TNFR1-IgG1 fusion protein in HEK 293 cells. Based
on the evidence of record, it is our opinion that the examiner failed to met his burden of
establishing that the TNFR1-IgG1 preparation of Ashkenazi would be the same or
substantially similar to appellants’ claimed INFR1-IgG1 preparation. Stated differently,
the examiner has not established that despite appellants’ evidence that different cell
lines and culture conditions result in different glycosylation patterns, the Ashkenazi
TNFR1 IgG1 preparation would be expected to be the same or substantially the same
as appellants’ TNFR1 IgG1 preparation.
Furthermore, to the extent the examiner relies on the concept of inherency, we
remind the examiner that “[i]nherency … may not be established by probabilities or
possibilities. The mere fact that a certain thing may result from a given set of
circumstances is not sufficient.” In re Oelrich, 666 F.2d 578, 581, 212 USPQ 323, 326
(CCPA 1981). In our opinion, based on the evidence of record, the examiner failed to
provide sufficient evidence that the culture conditions, and HEK 293 cell line taught by
Ashkenazi would inherently produce a TNFR1-IgG1 protein that is “inherently the same”
as that claimed by appellants.
In addition, we recognize the examiner’s statement (Paper No. 18, page 3),
“[c]laim 24 is objected to as being dependent upon a rejected base claim, but would be
allowable if rewritten in independent form including all of the limitations of the base
claim and any intervening claims.” For emphasis, claim 24 is reproduced below:
24. The human TNFR1-IgG1 preparation of Claim 20 wherein the molar ratio of
sialic acid to protein is of about 5 to 6.
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