Appeal No. 2002-1296 Page 4
Application No. 08/957,038
media. Recombinant latent TGF-$1 was converted to active form as well.
One major disadvantage of the co-culture system is lack of reproducibility.
Large numbers of BAEC and SMC cell clones need to be screened in
order to develop an effective method. This requires isolation of a number
of cell clones and subsequent laborious testing since the cells, after
several population doublings, need to be replaced. In contrast,
transformed macrophages as used in the present invention are capable of
continuous culture and are readily available for routine analysis.
Another limitation of the co-culture model is the fact that this system fails
to produce active TGF-$1 in the presence of LPS in the tissue culture
medium derived from the water or calf serum. It was reported that LPS
found in the tissue culture medium downregulated the mRNA levels for
TGase II and TGF-$1 in bovine arterial endothelial cells. This creates a
need for testing each batch of tissue culture medium and serum for the
presence of LPS in order to generate active TGF-$1. In contrast, the
present disclosure showed that LPS-induced macrophages expressed
higher levels of TGase II than untreated cells. This may indicate the LPS
induces the activation of TGF-$1 through upregulation of TGase II levels
in macrophages whereas it suppresses the activation of TGF-$1 by
downregulation of TGase II in endothelial cells. It is also apparent that the
method of the present invention is more versatile than the co-culture
system.
Id., pages 23-24 (reference citations omitted).
Discussion
The rejection of claim 15 is premised upon Purchio, Twardzik, ATCC, Adams,
Huber, and Flaumenhaft. In reviewing the matter, it appears that Purchio and Twardzik
in relevant part describe the same work. We note that Purchio is a co-author of the
Twardzik publication and Twardzik is a co-inventor of the Purchio patent. Furthermore,
the specific disclosure of Purchio relied upon by the examiner, i.e., column 64, line 44 -
column 66, line 51, is also reported in Twardzik. Also, the most specific information the
examiner relies upon from Twardzik, i.e., its recognition of "the equivalence of
monocytes and macrophages" (Examiner's Answer, page 5), is also found in Purchio
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