Increased Burden in Drafting "Surviving" and "Useful" Utility Patents in the Life Sciences Industry Extends to Design Patents

Patents are undoubtedly essential to many industries, and in recent years, the decisions regarding patent eligibility, written description, and enablement have certainly shaken up the life sciences industry in particular. There is an increasing burden on patent applicants and patentees to provide complex, lengthy, thoroughly written disclosures to satisfy the rising standards for written description and enablement, as well as the added pressure to draft multiple claims of varying scope.

Although it is well known that design patents can complement utility patents and play an important role in further protecting innovations, oftentimes design patents are overlooked. In contrast to utility patents, design patents protect the ornamental or nonfunctional features of a product – the claim is directed to the design embodied in or applied to the product, not the product itself. Unlike utility patents, design patents have no written description and are limited to one claim.

In a way, perhaps the law behind design patents may be relatively more simple and straightforward, and patent applicants would hope to skip the struggles of the meticulous process of drafting utility patent applications. However, a recent decision for a design patent in the life sciences industry indicates that design patent law is also developing.

Earlier this month, the Federal Circuit (CAFC) issued a decision in In re: SurgiSil, L.L.P. et al., No. 2020-1940 (Oct. 4, 2021). SurgiSil appealed a decision of the Patent Trial and Appeal Board (PTAB) affirming an examiner’s rejection of design patent application No. 29/491,550 (’550 application). The ’550 application claims an “ornamental design for a lip implant” and the application’s figure is shown below:

The examiner rejected the claim of the ’550 application as anticipated by an art tool called a stump, made of “tightly spiral-wound, soft gray paper” which is used “for smoothing and blending large areas of pastel or charcoal.” The “stump” is shown below:

The PTAB took the position that “it is appropriate to ignore the identification of the article of manufacture in the claim language.” However, the court agreed with SurgiSil’s argument that the “stump” could not anticipate the claim, because the stump is a “very different” article of manufacture than a lip implant. The court held that the relevant test for applicable prior art for the claim at issue is limited to the particular “article of manufacture” identified in the claim. Because the claim of the ’550 application identified a lip implant, and the application’s figure depicted a lip implant, the claim is limited to lip implants and does not cover other articles of manufacture.

Therefore, the claim language of a design patent can certainly limit the claim scope to the article manufacture recited in the claim, both when evaluating for an anticipation rejection during prosecution, and at the alternative end, when evaluation for infringement during litigation. This decision highlights the recent trend in both utility patents and design patents alike, that the applicant must take careful considerations when drafting the application. For example, just as clear and sufficient written description must be provided in utility patents, design patents should properly title and identify the article of manufacture. Using a similar strategy as for drafting multiple claims of varying scope in utility patents, design patent applicants should also consider filing multiple, separate design patent applications for the same design, identifying different articles of manufacture and claims, to increase the scope of protection for the design.

The good news for design patents is that unlike for utility patents in the life sciences industry where prosecution has become more challenging and the threat of patents being invalidated based on issues such as lack of written description and enablement has amplified, it may be easier to prosecute a design patent application, and perhaps harder to invalidate a design patent based on prior art, as the prior art must be for the same article of manufacture. Nevertheless, it remains to be seen how this decision influences how design patents are claimed in the future, and how the USPTO reacts to these changes.