35 U.S.C. § 112 Archives

PTO Continues to Wave Wands in Assessing Enablement

by Christopher M. Bruno | Jan 18, 2024 | Patents

In light of the 2023 Supreme Court of the United States decision in Amgen Inc. v. Sanofi, the US Patent & Trademark Office (PTO) published guidelines for PTO employees to use, regardless of technology, to ascertain compliance with the enablement requirement under 35 U.S.C. § 112. (89 Fed. Reg. 1563 (Jan. 10, 2024).) Unsurprising to those familiar with the Amgen decision, the PTO hewed closely to existing practice.

The PTO collected the Supreme Court’s clarifications regarding the relationship between the enablement requirement and an amount of experimentation, namely that although particular disclosure of all embodiments is not required, claims are not enabled if they require more than reasonable experimentation. Regarding the “reasonable experimentation” requirement, the PTO explained that consistent with several post-Amgen US Court of Appeals for the Federal Circuit opinions, it would continue to apply the factors that the Federal Circuit announced in its 1988 In re Wands decision.

Although the PTO intends to continue to rely on pre-Amgen Federal Circuit Wands analyses as instructive, it found particular persuasive force since the Federal Circuit’s decision was affirmed by the Supreme Court in Amgen. There, according to the guidance, the Federal Circuit concluded that the genus claims were not enabled because of the amount of experimentation required to test whether antibodies satisfied certain functional limitations. Thus, because “the scope of the claims was far broader in functional diversity than the disclosed examples, … [and] the invention was in an unpredictable field of science with respect to satisfying the full scope of the functional limitations, … there was not adequate guidance in the specification.”

The PTO also noted that the Federal Circuit’s 2023 Baxalta v. Genentech decision, like Amgen, found claims directed to antibodies that contained certain functional limitations to be invalid. There, the Court, like the PTO, detected no appreciable difference between the reasonable experimentation standard as articulated in Wands and the standard as set forth in Amgen. The guidance canvassed other post-Amgen enablement decisions, all of which the PTO read to support continued reliance on Wands.

Practice Note: Although the PTO says that it will continue to apply the Wands factors as it has before, the Amgen decision may, as a practical matter, make establishing enablement of functional limitations more difficult. Whether examiners—especially those in life sciences technology areas—change the course of their review post-Amgen remains to be seen.

Supreme Court to Consider Enablement Requirement

by Amol Parikh | Nov 10, 2022 | Cert Alert, Patents

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

by Art Dykhuis | Oct 27, 2022 | Patents

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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