USPTO’s Proposed Changes to Terminal Disclaimers

Earlier this month, the USPTO issued a notice of proposed rulemaking (NPRM) to add a new requirement to terminal disclaimers to overcome nonstatutory double patenting rejections. Specifically, if the proposed rule were to be adopted, filing of a terminal disclaimer would obligate the applicant to agree that the patent would become unenforceable if any claim in any other patent linked by a terminal disclaimer were held to be invalid or unpatentable over the prior art. The rule would only apply to terminal disclaimers filed on or after the effective date of any final rule. Comments must be submitted by July 9, 2024, to ensure consideration.

If passed, the rule would potentially have some interesting consequences for clients with respect to their continuation practice because a continuation application would only be as enforceable as the weakest claim in the family.  Accused infringers could, for example, defend themselves against a patent infringement lawsuit by attempting to invalidate a broader claim in a related, but unasserted, patent.  Accordingly, broadening continuations could be riskier to pursue if there are plans to assert any of the patents in the patent family.

The net benefit of this rule appears to be in favor of accused patent infringers, to the detriment of patent applicants.  However, we have been advising our clients on how they could minimize the overall impact of this revised terminal disclaimer rule if it were to be implemented.

USPTO Proposed Fee Increases for 2025

The USPTO has announced its Notice of Proposed Rulemaking (NPRM) for raising fees in 2025.  The NPRM retains most of the fee adjustments that were first proposed in 2023, with only a few changes made in response to input from the Patent Public Advisory Committee (PPAC).  The fees are significant and can greatly impact some patent filing and prosecution strategies.  The changes in the USPTO fees are briefly described below.

Examples of Significantly Higher Fees

Examples of New Fees That Could Impact Filing and Prosecution Strategies

The NPRM does respond to feedback provided by the PPAC in 2023, but the fee increases generally remain unchanged.  Although the USPTO is required to accept and respond to properly submitted comments from various stakeholders through the Federal eRulemaking Portal by June 3, 2024, we would expect that the USPTO is unlikely to make any significant changes given the minimal changes that were made in response to feedback from the PPAC.

The new and increased fees are likely to impact patent filing and prosecution strategies for all of our clients.  However, different clients will be impacted in different ways.  We invite all of our clients to arrange for a discussion with us on how to reduce or minimize the impact of the increased and new fees on their budgets.

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.

  • Recent Comments

    No comments to show.