INTRODUCTION

The Patent Trial and Appeal Board (PTAB), hereinafter referred to as “the Board”, of the United States Patent and Trademark Office (USPTO) issued a 'sua sponte' order dated February 24, 2021, that the patent owner’s proposed substitute claims in an on-going post-grant review (PGR) of  US patent 10,143,728 B2 (‘728 patent) may be unpatentable. The Board in its order found that the patent owner, Medy-Tox’s recitation of the trademark “BOTOX®” in the proposed independent claim 19 provides a potential ground of un-patentability.

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BACKGROUND OF THE CASE:

Galderma filed a post-grant review petition challenging the validity of the ’728 patent, which relates to the use of an animal-protein-free botulinum toxin composition in the management of moderate to severe Glabellar frown lines, or face wrinkles. The ’728 patent claimed that the animal-protein-free botulinum toxin composition had a long-lasting effect compared to an animal-protein-containing botulinum toxin composition.

Among other grounds, Galderma contented that the claims of the ‘728 patent are unpatentable due to lack of enablement under 35 U.S.C. § 112 as the specification fails to demonstrate that the inventors were in possession of the full scope of the claims. Based on Galderma’s petition, the Board instituted the PGR.

In response to the Board’s Institution Decision, the Patent Owner filed amendments of the claims of the ’728 patent to address the lack of enablement issues raised in the institution decision. Specifically, the patent owner proposed to amend the claims to limit “animal-protein-free botulinum toxin” to “a serotype A botulinum toxin” composition.

Under the PTAB’s Motion to Amend Pilot Program, the Board provided non-binding preliminary guidance regarding the proposed amended claims. In particular, the Board recognized that the specification of the ‘728 patent contains two examples comparing an animal-protein-free toxin to BOTOX®. However, the Board noted that the two examples of the specification do not consider varying doses and that BOTOX® is not the only animal-derived toxin available. This non-binding preliminary guidance of the Board likely suggests that the patent owner’s proposed amended claims were broader than the support provided in the specification.

In response, the Patent owner filed a revised motion to amend by proposing further restrictions to claims. The amended set of claims specifically replaced the broader “animal-protein-containing botulinum toxin” with the trademark, “BOTOX®”.

THE BOARD’S ORDER

The Board issued the sua sponte order upon receipt of the proposed substitute claims included with Patent Owner’s Revised Motion to Amend. The Board’s order notes that the patent owner’s recitation of a trademark, i.e., BOTOX®, in its claim language could potentially render the claims indefinite. The Board, by citing MPEP § 2173.05(u), noted that the recitation of a trademark, i.e., BOTOX®, in a claim to identify a particular material or product could render the claim indefinite under 35 U.S.C. § 112, second paragraph.

Further, the Board explained that although the circumstances are “rare” in which the Board may itself raise a patentability issue on proposed substitute claims, such circumstances exist here since the issue is “readily identifiable” from the proposed claim amendments.

CONCLUSION

The sua sponte order serves as a reminder that while carrying out claim amendments, the patent practitioners should pay close attention to the relevant MPEP guidance governing patent prosecution.

About the author: Mr. Dhakshina Moorthy, a legal practitioner at Global Patent Filing. In case of any queries please contact/write back to us at support@globalpatentfiling.com.