On April 15, 2025, the U.S. Court of Appeals for the Federal Circuit (“CAFC”) affirmed the Patent Trial and Appeal Board’s (“Board”) decision finding all challenged claims of Sage Products, LLC’s patents anticipated based on prior art, including the ChloraPrep Public Assessment Report (“PAR”) and other references. Sage Prods., LLC v. Stewart, No. 23-1603 (Fed. Cir. Apr. 15, 2025).
Sage Products, LLC (“Sage”) had appealed the Board’s final written decision that found all challenged claims of its U.S. Patent Nos. 10,398,642 and 10,688,067—both entitled “Sterilized Chlorhexidine Article and Method of Sterilizing a Chlorhexidine Article”—unpatentable. The patented invention relates to a sterilized chlorhexidine product in a package, such as an applicator filled with an antiseptic composition for disinfecting skin.
Becton, Dickinson and Co. (“BD”) was the petitioner before the Board and original appellee in the CAFC. It withdrew from the appeal after filing its appellate brief. The U.S. Patent and Trademark Office (“PTO”) intervened under 35 U.S.C. § 143 and stepped in as appellee, relying on BD’s briefing.
The Board relied on four key pieces of prior art in finding Sage’s claims unpatentable, among them the ChloraPrep PAR and regulatory standards. The challenged claims in Sage’s patents all required a “sterilized chlorhexidine product” or a “sterilized chlorhexidine article” comprising a “sterilized chlorhexidine gluconate composition.” The ChloraPrep PAR taught that the ChloraPrep is “a sterile alcoholic antiseptic solution,” “[t]he sterile applicators are individually packaged in an ethyl vinyl acetate film,” and “the applicator is sterile unless seal is broken.” The Board found that the ChloraPrep PAR anticipated Sage’s claims.
The Board explained that the patent’s reference to “sterile” means that “the component or composition has been subjected to a suitable sterilization process such that sterility can be validated.” It also concluded that, based on prior art regulatory standards, a skilled artisan would have understood that the PAR’s references to “sterile” met that construction.
Sage had argued that the ChloraPrep PAR did not use the term “sterile” in the same way as its claims. Specifically, Sage had argued that ChloraPrep PAR’s use of “sterile” stemmed from a mistaken belief—“widely shared in the pertinent community of skilled artisans”—that the antiseptic composition in ChloraPrep was sterile when it was not. But the Board found it “implausible” that a skilled artisan would not know about different regulatory regimes and requirements. It concluded that a skilled artisan would understand that the ChloraPrep PAR’s references to “sterile” items would satisfy the challenged claims’ requirement for “sterilized” items.
Sage renewed its arguments on appeal, but the CAFC affirmed the Board’s decision, concluding that the Board’s anticipation finding was supported by substantial evidence and that the Board did not err in considering industry standards under anticipation. The CAFC explained that an “anticipation analysis is from the perspective” of a skilled artisan, and that a skilled artisan “would have known” the regulatory standards and “would have carried that knowledge with her when examining each of the challenged claims.” Sage also raised “numerous procedural errors” in the Board’s decision and “numerous other arguments.” The CAFC did not find these persuasive, noting that “[m]uch of what Sage complain[ed] about simply repeats, in procedural garb,” its factual challenges.
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