U.S. Patent No. 7,772,209 is directed to administering folic acid and a methylmalonic acid lowering agent before pemetrexed disodium (pages 2-4). The PTAB held that the claims were not obvious over multiple references as none of the references taught using methylmalonic acid lowering agent with the known folic acid to pre-treat (pages 4-5). Evidence supported that elevated levels of methylmalonic acid are correlated only with B12 deficiencies and not folate deficiencies (pages 5-6). Because elevated MMA levels are not predictive of toxicity, but do correlate with vitamin B12 deficiency, the Board credited the testimony that a skilled artisan would have understood that there was no observed correlation between vitamin B12 deficiency and pemetrexed-induced toxicity (page 6). One prior art reference making generalized statement does not overcome the specific teachings relied on by the PTAB (pages 7-8). Statements made to the FDA 5 months after the priority date that the prior art suggested pretreating with both folic acid and the methylmalonic acid lowering agent are informed by what was already invented, so it was proper to decline read the prior art in light of the statement (pages 8-9). Skepticism by the FDA that adding the methylmalonic acid lowering agent would prevent deaths supports the conclusion of non-obviousness (pages 9-10).
Hindsight: Information regarding patentability may come from many sources including statements by the applicant and others made outside of the patent context. It may be beneficial to control, where possible, the statements. Early filing may help limit applicability of statements indicating obviousness. It may be difficult to convince an Examiner, but reliance on specific teachings as a counter to generalized statements may show non-obviousness.