Interference No. 104,843 Paper 51
Kundu v. Ragunathan Page 8
embodiment [2001 at 8], but Kundu does not say so. PLURONIC® F127 is also listed as
a preferred wetting agent [2001 at 10].
[16.7] Manufacturing reproducibility. Alpharma produced a large (159.4 kg) batch to determine
reproducibility of a variant (one-pot) manufacturing process using docusate sodium
[0030]. A one-pot method of making is discussed in Kundu’s specification [2001 at 16-
17 and 22-23].
[16.8] Placebo testing. Alpharma produced 500 kg batches of "placebo" [0029]. Alpharma’s
placebo was the formulation without the active ingredient. The purpose of these batches
was to test the manufacturing process and optimize mixer speed [2003, ¶34]. Kundu
discloses high and low shear mixing generally in its specification [2001 at 16], but does
not appear to provide any insights gleaned from this testing.
[16.9] Preservative tests. Alpharma prepared docusate sodium and MYRJ® 52 formulations to
test the preservative effectiveness [0029] & [0032]. Kundu discloses the use of
antimicrobial agents and preservatives, particularly sodium benzoate, in its specification
[2001 at 14].
[16.10] Clinical testing. In the second half of 1999, Alpharma conducted clinical testing of
docusate sodium formulations with different floc sizes and prepared a final report [0040].
According to Dr. Capella [2003, ¶45], this study suggested that the two-pot method was
most suitable for further clinical analysis (Paper 31 at 19). Kundu discloses that the two-
pot formulation "was particularly well suited for further clinical evaluation" [2001 at 24].
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