CAFC Finds Most Patent Owner Arguments Forfeited in Vitamin D Baby Drops Appeal from PTAB

Yesterday, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued a ruling in Vieth v. MOM Enterprises, LLC affirming the Patent Trial and Appeal Board’s (PTAB) invalidation of Elaine and Dr. Reinhold Veith’s patent claims to methods of administering vitamin D to human beings. The Federal Circuit agreed that most of the claim construction and prior art arguments raised by the Vieths on appeal were forfeited for not being properly developed in the proceedings below, and also dismissed the Vieths’ contentions that they had established nexus between industry praise for its products and the challenged method claims.

Patent Owner Response Fails to Allege Composition of Prior Art Vitamin D Droplets

MOM Enterprises, which makes Mommy’s Bliss Baby Organic Vitamin D Drops, filed a petition for inter partes review (IPR) challenging several claims from U.S. Patent No. 9066958, Vitamin D Compositions and Methods of Administration to a Human Being. Independent claim 1 of the ‘958 patent claims a method of administering nutritional or therapeutic amounts of vitamin D by applying one drop of a vitamin D composition that adheres to the exterior surface of an object, and then having the human suck or lick the composition directly from the object. Finding that the prior art disclosed administering vitamin D within the claimed composition range to infants by coating a spoon or pacifier, the PTAB invalidated the Vieths’ patent claims for obviousness.

On appeal, the Vieths challenged the PTAB’s finding that a 2003 German textbook on midwifery care (“Harder”) inherently discloses the claim limitation “wherein said drop adheres to the surface of said object.” The PTAB found that Harder inherently taught this “adheres” limitation because it disclosed a composition consisting only of vitamin D in medium-chain triglycerides (MCT) that necessarily adheres to objects in the way claimed by the ‘958 patent. Even if not inherently disclosed, the PTAB found the “adheres” limitation suggested by Harder’s disclosure of delivering vitamin D in an MCT composition by placing a drop on the tip of a spoon for an infant to lick off.

The Vieths contended that Harder improperly stated that Vigantol, a prescription medication including vitamin D, contains only MCT because the vegetable oil contained within the Vigantol composition generally includes long-chain triglycerides (LCT). However, the patent owner response filed by the Vieths during IPR only stated that Harder provides no information regarding the composition of the Vigantol oil. According to the CAFC, the LCT argument contained within the Vieths’ sur-reply was a change in position, not an expansion of their previous argument, because the previous response contained no information about the vegetable oil alleged to be in the composition. As a result, there was no abuse of discretion in the PTAB finding this argument forfeited.

Noninfringing Uses on Product Labels Prevents Nexus From Secondary Considerations

The Vieths also challenged the PTAB’s construction of the “adheres” limitation for failing to address whether both the non-coating and non-dripping elements of that limitation were present in the prior art. Acknowledging that the non-coating element requires that the drop be removed efficiently for an effective dose, the Federal Circuit noted that the PTAB explicitly disagreed that efficient removal of the drop would be prevented if the drop were to roll into the bowl of the spoon. The appellate court held the PTAB’s finding supported by substantial evidence, including expert testimony on the spoon delivery method, and agreed with the PTAB that the Vieths did not sufficiently develop their argument that the Board ignored the object requirement of the “adheres” limitation when it found that the specification of the ‘958 patent teaches that MCT necessarily adheres to all objects.

As well, the Federal Circuit agreed that the Vieths had forfeited their challenge to a 1999 study on pacifier-induced pain reduction in newborns (“Blass”) as non-analogous prior art in an entirely different field, as this argument was also first raised in the patent owners’ sur-reply. The CAFC also affirmed the PTAB’s finding that a skilled artisan would be motivated to combine Blass with Harder’s method by replacing the spoon in Harder with the pacifier taught by Blass as the pacifier was more likely to produce a sucking response in infants, thus ensuring better vitamin D delivery.

Finally, the CAFC nixed the Vieths’ argument that they were presumed to an entitlement of nexus on their secondary considerations of nonobviousness by proving that MOM’s Mommy’s Bliss or Baby Ddrops, a product sold by Ddrops Company which licenses the ‘958 patent, embodied and were coextensive with the ‘958 patent’s claimed features. The appellate court found that both Mommy’s Bliss and Baby Ddrops contained labels setting forth non-infringing uses that taught mixing the claimed substance with milk instead of water. That alternative method of use specifically identified as prior art by the ‘958 patent’s specification meant that both products were not coextensive with the patent’s claims. Further, the CAFC agreed that the Vieths did not establish that their evidence of commercial success or industry praise for Baby Ddrops were tied to the patented method, and that there was no long-felt but unmet need owing to the minimal differences between the prior art and the claimed invention.

Considering the Vieths’ remaining arguments unpersuasive, the Federal Circuit affirmed the PTAB’s final written decision.