Published 09/08/2017 by CIONCA - Staff
On July 26, 2017, a decision was made by the United States Court of Appeals for the Federal Circuit (“Federal Circuit”) in Soft Gel Technologies, Inc. v. Jarrow Formulas, Inc. Soft Gels—in a sequence of a parent patent, a continuation, and a continuation-in-part patent for (1) a soft gel capsule, (2) a solubilized coenzyme Q-10, and (3) a method for preparing a soft gel capsule. After it was established that the Q-10 coenzyme was beneficial to the human body, Soft Gels saw “a need in the art for an improved methodology to deliver increased amount[s] of bioavailable CoQ-10 to an individual in need thereof.” Therefore, Soft Gels created an oil mixture solvent containing d-limonene and gel capsule for the coenzyme. In 2012, Jarrow Formulas, Inc. requested an inter partes reexamination of all three patents. Reexaminations of all three were ordered, and the assigned examiner issued rejections for each set of claims based on grounds of obviousness.
With five key prior art references to consider, the Patent Trial and Appeal Board (PTAB, Board) rejected a number of Soft Gel’s patent claims. The first reference was to Patent Application of Motoyama (“Motoyama”). Motoyama claims “an oral formulation containing CoQ10 dissolved in an oil.” This patent application makes evident that the bioavailability of the coenzyme to the bloodstream significantly increases when mixed with an essential oil and ingested orally with a capsule. The next two references—another patent and a dissertation—express the observation that CoQ10 has poor solubility in aqueous solvents, leading to the idea of mingling the coenzyme with an oil mixture solvent instead prior to introducing it to the body. The fourth reference the Board relied upon, Fenaroli’s Handbook of Flavor Ingredients, “notes that lemon essential oil has many different components, but ‘contains approximately 90% limonene.’” The fifth and final reference the Board considered was Some Naturally Occurring Substances: Food Items and Constituents, Heterocyclic Aromatic Amines and Mycotoxins (1993), “a monograph…[stating] that limonene is ‘the most frequently occurring natural monoterpene.’” Overall, the Board found that Soft Gel’s claimed patents were simply a reconstruction of the prior art. Furthermore, the Board also concluded that “a person of skill in the art would have been motivated to combine those references and would have had a reasonable expectation of success in doing so.” A number of Soft Gel’s patent claims were rejected upon this reexamination. Soft Gel appealed to the Federal Circuit.
First, Soft Gel sought to “[challenge] the Board’s factual finding that d-limonene is the main constituent of lemon oil.” Soft Gel attempted to refer to an experiment that yielded a sample of lemon oil species that only contained 38.1% limonene content. However, this was only one of nineteen samples, and the limonene content among samples varied from 38.1% to 95.8%. Therefore, this reference did not help in supporting Soft Gel’s contention . Second, Soft Gel argued that the second reference used against them only addressed the melting of CoQ10 from a solid to a liquid, only concerning itself with state of matter rather than dissolving the coenzyme in essential oils. However, the Federal Circuit decided that the patent referenced “teaches the use of essential oils to make CoQ10 more available to the body, which is precisely what is claimed in the Soft Gels patents.” Third, Soft Gel tried to make a distinction between lemon oil and peppermint and spearmint oils by citing an experiment in which essential oil performance was tested when combined with the coenzyme and emulsifiers. Although lemon oil caused the CoQ10 to re-melt, it simply performed better than the spearmint and peppermint oils, which does not imply that it “behaved in an entirely different manner.”
For the aforementioned reasons, the Federal Circuit affirmed the Board’s decision.
This case is another example of instances when a combination of prior art elements is novel, yet not patentable because the combination would have been obvious to a person of ordinary skills in the art (POSITA) at the time the application for patent was filed. Particularly in this case the combination was obvious because “a person of skill in the art would have been motivated to combine those references and would have had a reasonable expectation of success in doing so.”
Full Soft Gel Technologies, Inc. v. Jarrow Formulas, Inc.decision can be found here: http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/16-1814.Opinion.7-24-2017.1.PDF
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