USPTO Enablement Guidelines Post-Amgen

The USPTO Has Issued New Guidelines for Assessing Enablement in View of the Supreme Court Decision in Amgen Inc. v. Sanofi et al.

On January 10, 2024, the United States Patent and Trademark Office (USPTO) published Guidelines for assessing enablement in view of the Supreme Court’s 2023 decision in Amgen Inc. et al. v. Sanofi et al., 143 S. Ct. 1243 (2023) (hereafter Amgen). The Guidelines are intended to guide both Examiners and the public on how to interpret and implement the Amgen opinion. The conclusion is that the USPTO will continue to use the In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988) (hereafter Wands) factors to ascertain whether the amount of experimentation required to enable the full scope of the claimed invention is reasonable. In other words – status quo.

In Amgen, the Supreme Court unanimously held that several of Amgen’s patent claims to a class of antibodies were invalid for lack of enablement. While Amgen’s patents specifically identified 26 amino acid sequences for antibodies that would block or inhibit PCSK9, the Court held that Amgen had not enabled “the entire genus” of antibodies that “bind to specific amino acid residues on PCSK9” and “block PCSK9 from binding to [LDL receptors].” According to the Court, Amgen attempted to claim an entire class of compounds by their function, namely antibodies that bind to the “sweet spot” of PCSK9 thereby inhibiting it from binding to LDL, while only describing 26 amino acid sequences in its specification.

The Federal Circuit had previously identified factors in Wands that can be used to assess whether the specification provides sufficient enablement to make and use the full scope of the claimed invention. While the Supreme Court did not expressly use these Wands factors in Amgen, the Guidelines concluded that they are still “probative of the essential inquiry in determining whether one must engage in more than a reasonable amount of experimentation.”

The Guidelines highlighted several Federal Circuit decisions preceding and following the Amgen decision, showing how the Wands factors were used. Notably, in all of these cases the claims were found to not be enabled. This is where the Guidelines fall short since it instructs the Examiner to apply the Wands factors without giving any examples where antibody claims would in fact be enabled. Therefore, questions still remain as to what amount of disclosure is adequate for enablement under Amgen.

The Design Patent Bar

On November 16, 2023, the United States Patent and Trademark Office (USPTO) announced a rule that will allow individuals with a design background to practice before the USPTO.  Specifically, the rule announces that persons can now sit for the patent bar when they have a bachelor’s, master’s, or doctoral degree in the field of:

However, persons who pass the patent bar with one of these backgrounds will be given limited recognition to prepare and prosecute only design patents. Accordingly, many have deemed this limited recognition to practice in design patents the design patent bar.

A design patent protects the ornamental design for an article of manufacture, which simply means the overall visual appearance of a product. Examples of designs include the ornamental designs of motor vehicles, furniture, clothing/apparel, consumer products, and graphical user interfaces, just to name a few. This differs from a utility patent, which protects the underlying make or use of a process, machine, manufacture, or composition of matter. Due to the design patent bar’s limited recognition, design patent practitioners will not be able to practice before the USPTO concerning utility patent applications. By contrast, persons who sit for the patent bar under the pre-existing rules can practice before the USPTO with regard to both design and utility patents.

The rule is set to go into effect on January 2, 2024. At Thomas | Horstemeyer, we look forward to the expansion of practitioners who can practice design matters before the USPTO.

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