Having read through AMRN's 8,293,727 prosecution documents and Judge Du's conclusions, I actually think the most sensible line of argument puts Du in a tenuous position/favors AMRN.
The patent examiner, in explaining the allowances of claims, said that while reducing trigs using EPA was prima facie obvious given prior art, the patent will be granted due to unexpected Apo-B reduction and long felt unmet need for a trig drug that doesn't raise LDL-C.
Judge Du establishes that not raising LDL-C was prima facie obvious. However it should be noted that Mori and Hayashi were DIRECTLY considered by the examiner. In fact, an entire chart of trials was presented by AMRN to the examiner, with some showing no stat sig increase in LDL-C and some yes. Rather than getting mired in endless statistical decision fatigue, the examiner decided that unmet need was the most relevant lens to view LDL-C. So basically, the examiner was well aware LDL-C neutrality existed in prior art but opted for an alternative perspective: long felt unmet need. Prima facie obvious is somewhat moot then in regards to overuling the examiner on LDL-C, especially if the cited prior art was already considered.
The other card Du tried to play was Apo-B was not unexpected, but we all know what happened there.
In short, pursuing prima facie obvious for LDL-C neutrality doesn't contradict the reasons for allowance. The examiner knew about LDL-C neutral results, but granted anyway due to unmet need (which Du agreed existed). Taking away Apo-B being unexpected would contradict the reasons for allowance, but Du erred very clearly on that point.
And of course, pursuing prima facie obvious for reducing trigs with EPA is moot since the PTO already agrees on that point, but granted the patents for Apo-B reduction being unexpected and no LDL-C increase being unmet need.
From a federal judge's view, an overruling of the PTO is going to be eye-catching. But he or she wont see a smoking gun that shows the PTO erred.
