35 U.S.C. § 112
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Supreme Court to Consider Enablement Requirement

The Supreme Court of the United States agreed to consider how much a patent must disclose in order to meet the enablement requirement under 35 U.S.C. § 112. Amgen Inc., et al. v. Sanofi, et al., Case No. 21-757 (Supr. Ct. Nov. 4, 2022) (certiorari granted). The question presented is as follows:

Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to “make and use” the claimed invention, 35 U.S.C. § 112, or whether it must instead enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial time and effort.

Amgen owns two patents that describe antibodies that bind to PCSK9 protein and lower LDL cholesterol levels by blocking PCSK9 from binding to LDL receptors. After a jury determined that Sanofi failed to prove that the asserted claims were invalid for lack of enablement, the district court granted Sanofi’s post-trial motion for invalidity based on lack of enablement. The US Court of Appeals for the Federal Circuit affirmed, finding that the scope of the claims encompassed millions of antibodies and that the patent thus did not meet the enablement requirement because practicing the full scope of the claims would require “undue experimentation.”

The Supreme Court declined to consider the first question presented in Amgen’s petition: whether enablement should be a question of law (under current Federal Circuit precedent) or be designated a question of fact to be decided by a jury. In granting certiorari, the Supreme Court proceeded contrary to the recommendation of the US Solicitor General.




Establishing Indefiniteness Requires More Than Identifying “Unanswered Questions” Part II

Earlier this year, the US Court of Appeals for the Federal Circuit reversed a district court decision for relying on an incorrect standard for indefiniteness. (Nature Simulation Systems Inc. v. Autodesk, Inc). Now, in response to a motion for panel rehearing, the Federal Circuit modified its decision on rehearing deleting language. Nature Simulation Systems Inc. v. Autodesk, Inc., Case No. 20-2257 (Fed. Cir. Oct. 17, 2022) (Lourie, Dyk, Newman JJ.) (Dyk, J., dissenting)

Nature Simulations Systems asserted two patents against Autodesk (one a continuation-in-part of the other), both entitled “Method for Immediate Boolean Operations Using Geometric Facets.” According to the patents, the claimed methods are improvements upon a “Watson” method known in the prior art. The district court concluded that two terms—“searching neighboring triangles of the last triangle pair that holds the last intersection point” and “modified Watson method”—were invalid as indefinite based on “unanswered questions” regarding the scope of the claims posed by Autodesk’s expert. In the first reported decision, the Federal Circuit reversed. The Court held that the “unanswered questions” analysis used an incorrect legal standard, citing the specification as clarifying the scope of the claims and citing case law on deference to US Patent & Trademark Office examiners.

Following rehearing, the Federal Circuit slightly modified its decision in two primary ways but maintained its reversal of the district court’s ruling on indefiniteness.

First, the Federal Circuit added an explanation regarding how the specification answers the questions raised by Autodesk. The Court stated that “the language that the court stated ‘is not contained in the claim language’ is in the specification,” and cited a flowchart and accompanying description in the patent. The Court found fault in Autodesk’s argument because “[t]he claims set forth the metes and bounds of the invention; they are not intended to repeat the detailed operation of the method as described in the specification.”

Second, the Federal Circuit backed away from its previous reliance on deference to the examiner. In its earlier decision, the Court explained that the examiner had issued rejections for indefiniteness but withdrew them after amendments to the claims. The Court then spent a little over a page of the opinion explaining that, as official agency actors experienced in the technology and legal requirements for patentability, patent examiners are entitled to “appropriate deference.” Following rehearing, the Court removed the portion of the opinion addressing examiner deference entirely while maintaining the criticism that the district court gave “no weight to the prosecution history showing the resolution of indefiniteness by adding the designated technologic limitations to the claims.” In support, the Court cited cases holding that claims are construed in light of the specification and file history from the perspective of skilled artisans.

Judge Dyk again dissented, stating that “[t]he fact that a patent examiner introduced the indefinite language does not absolve the claims from the requirements of 35 U.S.C. § 112.” Judge Dyk argued that far from adopting a flawed “unanswered questions” analysis, the district court’s analysis was detailed and [...]

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