Sunday, October 28, 2007

PAR v. Roxane on enablement under 35 USC 112

Further to the IPBiz discussion of enablement in the context of the re-exam of WARF stem cell patents (for example, here, one has a CAFC case on enablement, Pharmaceutical Resources and PAR v. Roxane, originating in D NJ. The judgment of D NJ was affirmed.

Judge Moore cited Ormco v. Aligned for the proposition that a patent claim is presumed enabled unless proven otherwise by clear and convincing evidence. Moore cited Liebel-Flarsheim, 481 F.3d 1371 for "beware of what one asks for." Moore also cited Liebel for the proposition that the full scope of the claims must be enabled.

The decision got into the concept of inoperative embodiments, citing Atlas Powder, 750 F.2d 1569 (tho Graver Tank - I could have been cited).

Judge Moore cited to In re Wands, 858 F.2d 731, 737 for the "Wands factors" on enablement. If one has broad claims in an unpredictable art, there is a high burden that the patent disclosure must meet. Judge Moore also talked about the impact of a large number of inoperative combinations, citing to Atlas Powder, 750 F.2d 1569.

On the facts, PAR's specification had three working examples. Judge Moore concluded that these three working examples did NOT provide an enabling disclosure commensurate with the entire scope of the claims.

Remember the new URL for the CAFC:


Blogger David Woycechowsky said...

Moore also cited Liebel for the proposition that the full scope of the claims must be enabled.

I have never understood this. The simple objection is that this would prevent a patent from ever covering later arising embodiment, which would directly contradict some precedents, and indirectly contradict Festo and its foresseability test.

The more fundamental, philosophical objection is that one can pretty much always make an inoperative embodiment within the scope of any claim. For example, if one claims "an iron paper weight", then you could make the paper weight to heavy to be lifted without a crane and therefore inoperative. If one was worried about that inoperative embodiment and instead claimed "an iron paper weight weighing less than a pound" then embodiments with razor sharp edges would be considered inoperative. If one responded by claiming "an iron paperweigh weighing less than a pound and without sharp edges" then that would still not cover embodiments that are so hot that they are molten. And so on and so on. You can play that game with any claim. There are always inoperative embodiments, at least in theory. The full scope of any claim is never enabled. Never has been. never will be.

Of course, the trick in In Re Fisher (?) using the concept of "commensaurateness" is one answer to these objections, but I would argue that that legal standard is empty of substance and makes results impossible to predict.

8:03 AM  

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