There was an interesting oral order from Judge Burke last week in Natera, Inc. v. CareDX, Inc., C.A. No. 20-38 (D. Del. Apr. 28, 2023). Defendant apparently asserted a large number of § 112 defenses based on lack of enablement or written description. The Court held that the defendant had to narrow it's defenses.
The parties further disputed whether the parties should count § 112 arguments by limitation or by claim. The Court held that they should be counted by claim limitation, not by claim:
With respect to the parties' dispute as to whether an argument that a claim is invalid under section 112 based on a particular claim limitation counts as one argument (or instead whether a single argument should be "claim 1 is not enabled"), (D.I. 186 at 3), the former shall count as one argument. In the Court's view, an assertion that "claim 1 is not enabled" constitutes a defense, while an assertion that "claim 1 is not enabled because of limitation x" constitutes an argument in support of that defense that will rely on particular pieces of evidence (evidence that might differ from the evidence that would support an assertion that "claim 1 is not enabled because of limitation y"). (See, e.g., id., ex. G at 44-47 (Defendant asserting in its Final Invalidity Contentions that claim 1 of the '180 patent is invalid under Section 112, paragraph 1 because the specification lacks an adequate written description, and providing seven arguments based on different claim limitations demonstrating why that is so); see also Fraunhofer-Gesellschaft Zur Forderung der angewandten Forschung e.V. v. Sirius XM Radio Inc., Civil Action No. 17-184-JFB-SRF, D.I. 634 (D. Del. Feb. 14, 2023) ("[I]f Defendant argues that one or more claims are invalid under one or more of the requirements of [Section] 112 based on a particular claim limitation, that shall count as a single argument.")).
That makes sense, since enablement and written description of each claim limitation is really a separate argument. With that in mind, the Court also held that challenging the same limitation in multiple claims is a single argument, not multiple arguments:
To the extent that Plaintiff proposes that the same argument for a particular claim limitation applied to multiple claims should count as separate arguments per claim, (D.I. 186 at 2), that proposal is REJECTED. If Defendant asserts that "claim 1 is not enabled because of limitation x" and Defendant makes the same argument as to other claims that have that same limitation x, that would count as one argument, even if it is made as to multiple different claims. See Fraunhofer, D.I. 634 ("If other claims have the same limitation that comprises the basis for the given invalidity argument under [Section] 112, that shall not count as an additional [Section] 112 argument."). Defendant would be making the same argument for multiple claims, so it does not make sense to count those as different arguments.
This may seem like minutia, but it could become important quickly if you are in a case involving a high number of § 112 arguments.
If you enjoyed this post, consider subscribing to receive free e-mail updates about new posts.
