IP Law Daily, PATENT—Fed. Cir.: Invalidation of a patent covering a pediatric vitamin D supplement upheld, (Sep 8, 2026)

By Carolin Dennis, B.Sc., LL.B., LL.M.

The patent owners failed to show that the Patent Trial and Appeal Board (PTAB) abused its discretion.

In a non-precedential disposition, the U.S. Court of Appeals for the Federal Circuit has affirmed the PTAB’s decision to invalidate a pediatric supplement patent finding no abuse of discretion. The Federal Circuit held that substantial evidence supported the PTAB’s conclusion that some claims of the patent covering a pediatric vitamin D supplement were unpatentable (Vieth v. Mom Enterprises, LLC, No. 25-1159 (Fed. Cir. Sep. 2, 2026)).

Elaine Vieth and her husband, Dr. Reinhold W. Vieth (together, Vieths) owned the U.S. Patent No. 9,066,958 (the ’958 patent). The ’958 patent states that a balanced level of vitamin D has long been recognized as essential to health, and that pediatric associations strongly encourage starting vitamin D supplementation from birth onwards. To avoid what it contends are problems in prior art supplementation methods, the ’958 patent describes a composition of vitamin D in medium-chain triglycerides (MCTs) that are applied to an object, such as skin or in the case of an infant to a woman’s nipple or pacifier from which the infant sucks off the composition.

MOM Enterprises, LLC (MOM), the maker of Mommy’s Bliss Baby Organic Vitamin D Drops (Mommy’s Bliss), filed a petition for inter partes review of claims 1 and 3–5 of the ’958 patent citing five prior art references. The petition challenged the claims on three grounds: (1) that claims 1 and 5 are unpatentable as obvious over U. Harder, Wochenbettbetreuung in der Klinik undzu Hause, § 15.9 (Hippokrates Verlag 2003), as translated into English (Harder); H. Wolf, Aktuelle Therapie: Rachitisprophylaxe beim Säugling, Vol. 95, Deutsche Medizinische Wochenschrift, 1530–32 (1970), as translated into English (Wolf); an excerpt from Council of Europe, European Pharmacopoeia 4th ed. Supp. 4.3, 3148–51 (2002) (European Pharmacopoeia); (2) that claim 3 is unpatentable as obvious over these three references in addition to E. M. Blass et al., Suckling- and sucrose-induced analgesia in human newborns, 83 Pain 611–23 (1999) (Blass); and (3) that claim 4 is unpatentable as obvious over Harder, Wolf, European Pharmacopoeia, and L. M. Gartner et al., Prevention of Rickets and Vitamin D Deficiency: New Guidelines for Vitamin D. Intake, 111(4) Pediatrics 908–10 (2003) (Gartner). The PTAB determined that MOM had proven each of the three grounds set forth in the petition and had proven claims 1 and 3–5 to be unpatentable. The Vieths’ appealed.

The Vieths make four main arguments in their appeal. First, the Vieths take issue with the PTAB’s conclusion that Harder inherently discloses the adheres limitation. The Vieths asserted that Harder’s statement that Vigantol® contains only “medium-chain triglycerides (vegetable oil)” does not unambiguously disclose a composition that consists only of vitamin D in MCT, because vegetable oil “generally includes” long-chain triglycerides. In the final written decision, the PTAB found the Vieths had forfeited this argument because it was not included in their Patent Owner Response. However, before the Federal Circuit, the Vieths contended that they argued in their Patent Owner Response that “Harder provides no information regarding the composition of the oil she used – Vigantol®,” and that they properly elaborated on this argument in their Sur-Reply. The Vieths also argued that MOM raised the issue in its Reply brief when MOM argued that Harder disclosed Vigantol® oil as being composed of MCT, omitting reference to “vegetable oil,” and that the PTAB should have considered their Sur-Reply argument demonstrating that MOM had mischaracterized Harder’s disclosure. The Federal Circuit noted that comparing the positions made in the Vieths’ Sur-Reply and in their Patent Owner Response, it is evident that the Vieths did not expand their argument but instead changed their posture from arguing that Harder provided no information regarding the composition of the oil to arguing that Harder taught the composition may include vegetable oil. In addition, the Federal Circuit disagreed to the extent that the Vieths argued that consideration of their Sur-Reply was proper because MOM shifted its obviousness challenge in its Reply brief because the statements the Vieths cited in MOM’s Reply brief closely track statements MOM made in the petition.

Next, the Vieths argued that the PTAB failed to properly apply the construction of the adheres limitation. The Vieths asserted (a) that the PTAB failed to address whether the prior art teaches the non-coating element of the adheres claim limitation and instead only looked to whether the non-dripping element was met; and (b) that the PTAB improperly disregarded the role of the object in the adheres limitation and wrongly concluded that the specification identifies only viscosity and triglyceride chain length as impacting adherence.

The Federal Circuit noted that the finding that Harder inherently discloses, or in the alternative teaches, the non-coating element of the adheres limitation was supported by substantial evidence in the form of expert testimony and Harder itself. In the final written decision, the PTAB found that the argument regarding the role of the object was not sufficiently developed in any brief such that it could ascertain the basis of the argument. The Federal Circuit noted that in their Reply, the Vieths did not dispute this other than to argue that they were citing the specification’s use of nipples and pacifiers to rebut the PTAB’s overly narrow finding that adherence is dictated solely by viscosity and triglyceride chain length. Therefore, the Federal Circuit found no abuse of discretion in the PTAB’s determination that the Vieths had forfeited this argument. Furthermore, the PTAB’s finding that the ’958 specification identifies only viscosity and triglyceride chain length as impacting adherence was supported by substantial evidence in the form of expert testimony, and the ’958 specification itself. Thus, even if the Vieths had made this argument before the PTAB, it was not persuasive.

Further, the Vieths contested the PTAB’s finding of obviousness with respect to dependent claim 3, asserting that Blass is non-analogous prior art to the ’958 patent because Blass’s “field of endeavor” does not relate to the same industry as that of the ’958 patent claims. In the final written decision, the PTAB noted that the Vieths first made the argument that Blass “is in an entirely different field” in their Sur-Reply brief and thus, the Vieths had forfeited any argument that Blass is non-analogous art. The Federal Circuit found that the Vieths point to no place in the record where they argued to the PTAB that, despite being in a different field of endeavor, Blass is not reasonably pertinent to the problem the inventors of the ’958 patent were involved. Thus, the Federal Circuit found no abuse of discretion in the PTAB’s finding that the Vieths forfeited this argument.

Lastly, the Vieths contended that the PTAB erred when it found there was no nexus between the Vieths’ secondary indicia evidence and the claims of the ’958 patent. The Federal Circuit noted that the PTAB’s determination that Baby Ddrops and Mommy’s Bliss are not “coextensive” with the claims was supported by substantial evidence that is the packaging of the two products, which each set forth alternative methods of use that were specifically identified as prior art in the patent specification and that do not use the claimed method. The Federal Circuit also found that the PTAB reasonably found that the Vieths had not established a nexus in fact for its evidence of commercial success or industry praise as they failed to establish that their evidence of commercial success or their evidence of industry praise was tied to the method of the claims. As for copying, the PTAB reasonably determined that the Vieths’ evidence was weak because they did not show how MOM arrived at its product instructions, and there was no evidence of intentional copying of Baby Ddrops. Moreover, even if the PTAB assumed that MOM had copied Baby Ddrops, the record as a whole did not demonstrate non-obviousness. Thus, even if the PTAB erred in its copying analysis, there was no reason to disturb the obviousness conclusion.

Accordingly, the PTAB’s decision was affirmed.

The Case is No. 2025-1159.

Judge: Schall, A.

Attorneys: Alan Anderson (Alan Anderson Law Firm LLC) for Elaine Vieth, and Reinhold W. Vieth. Lauren Ann Degnan (Fish & Richardson PC) for MOM Enterprises, LLC.

Companies: MOM Enterprises, LLC

Cases: Patent FedCirNews