(3) the extent to which claim 1 would preclude similar practices which we hold to have been obvious over the practice which is explicitly described in the prior art. a. It appears from the prior art that once upon a time the "art" used natural hCG as the primary source for pharmaceutical application. Apparently, natural hCG is quite stable, at least if we are to believe EPO. According to EPO, some natural hCG products do not need stabilizers, although we note that a "bulking agent" amount of mannitol (now understood to be a stabilizer) is said to have been added to hCG prior to lyophilization. Natural contaminants are said to be a possibility for explaining why natural hCG remained stable after lyophilization. EPO reveals, however, that as more pure hCG came to be, stabilization problems developed. Somewhere along the line hCG in recombinant form [r-hCG] came to exist--all would recognize that r-hCG would be quite pure. Hence, given its purity, it reasonably would have been expected from EPO that r-hCG would need a stabilizer. The PCT application confirms what one skilled in the art would have divined from EPO. According to the PCT application, sucrose is "the solution" to stability problems. To be sure, the PCT application at first blush would appear to be a basis for one skilled in the art to tout sucrose in favor of mannitol, saying that (1) the "most stable formulations" - 16 -Page: Previous 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 NextLast modified: November 3, 2007