Note: This is part 2 of tonight's Ariad-fest. Part 1 is below.
The Ariad reexamination itself makes for entertaining reading, if you have a sufficiently geeky worldview, which I do. I was incorrect in my first look at this the other night, when I thought that the rejections were largely on means-plus-function grounds. All of the claim rejections are based on 35 U.S.C. 102, which is good ol' prior art, and 35 U.S.C. 103, which is obviousness. If something has been publicly described, you can't patent it. The bulk of the document is a case-by-case recitation of the various publications which anticipated the patent's claims or rendered them obvious.
By my count, there are fifty-three of them cited. Since the patent's claims are written in the pounding, repetitive, unbalanced-washing-machine style favored by many attorneys, most of these citations turn around and invalidate great swaths of them, over and over. Not only are there the expected papers from the primary literature, but various textbooks and reference handbooks (the PDR, Goodman and Gilman) make an appearance as well.
The actions and literature descriptions of the mechanisms of cyclosporin, glucocorticoids, various antibiotics, and many other substances are adduced. My favorite section is on pages 46-49, on the effect of substances such as resveratrol, found in grapes and in red wine. (More on resveratrol here and here). The examiner cites the King James Bible as invalidating prior art, along with several more conventional citations, and points out that:
"In short, any time someone, over the last several hundred or thousand years, drank even a moderate amount of red wine with food containing significant fats (e.g., the typical French diet) they were reducing NF-kB acitivity (and concomitant NF-kB mediated gene expression) that had been induced by the fat content in the food."
And as the official Manual of Patent Examining Procedure makes clear, something old doesn't become patentable just because you've finally discovered the scientific reason for its effects. If the use or property you're trying to claim is inherent in the prior art, it's unpatentable. As long as the inherent characteristic necessarily flows from the prior art, and is not just one of many other possibilities, the claim can be rejected. Once this happens, the burden of proof is on the applicant to show that there's a difference that isn't obvious. That will be Ariad's only recourse at the USPTO, which is why they're also going outside and petitioning the US District Court.
From my perspective, they're not going to have an easy time of it. The rejection of the NF-kB claims seems pretty comprehensive, and it's hard for me to think of arguments that would refute enough of the examiner's contentions to matter. Left unspoken in the office action is the clear inference that the original patent should never have been granted in the first place, which is what I thought back in 2002. Looking back, that post seems downright psychic, if I do say so myself.