Further Study Does Not Undermine Reasonable Expectation of Success; ‘Absolute Predictability’ is Not Required

Soft Gel Techs., Inc. v. Jarrow Formulas, Inc., (Fed. Cir. July 26, 2017) (Before Prost, C.J., Bryson, and Hughes, J.) (Opinion for the court, Bryson, J.)

Soft Gel appealed from three inter partes reexaminations, where the Board invalidated three Soft Gel patents for obviousness. The patents concerned a method for dissolving CoQ10 and encapsulating the solution. CoQ10 is an essential enzyme for all human tissues and organs. CoQ10 is poorly soluble in water and prior art solvents used to administer CoQ10 could dissolve at most 5-10% of the enzyme. To solve this problem, the patents describe dissolving CoQ10 in a class of monoterpenes known as limonene, specifically, d-limonene. Unlike water, monoterpenes can dissolve a significant amount of CoQ10, which can then be encapsulated.

The Board found Soft Gel’s three patents invalid for obviousness, based on five references. Motoyama described dissolving CoQ10 in the monoterpene 1-carvone, found in spearmint and peppermint oils, and encapsulating the solution. Khan and Nazzal taught dissolving CoQ10 in peppermint, spearmint, or lemon oil instead of water. Fenaroli noted that lemon oil contains approximately 90% limonene by weight. The IARC reference taught that limonene, in particular, d-limonene, is the most frequently occurring monoterpene and is the predominant limonene in lemon oil. Based on these references, the Board found that: (1) Motoyama teaches dissolving CoQ10 in carvone and then encapsulating the solution, (2) Khan and Nazzal teach the use of essential oils with CoQ10, and (3) Fenaroli and IARC teach that d-limonene is the most common monoterpene in lemon oil. This combination of references taught the claimed invention: using d-limonene to dissolve CoQ10 and encapsulating the solution.

Soft Gel made three arguments on appeal. First, Soft Gel challenged the Board’s finding that d-limonene is the main constituent of lemon oil, pointing to a reference that tested different lemon oil species, and one of the samples contained only 38.1% d-limonene. The Court noted that the limonene content ranged from a minimum of 38.1% to a maximum of 95.8% in 19 tested samples. This supported the Board’s finding that d-limonene is the main constituent of lemon oil.

Second, Soft Gel argued that Khan teaches away from dissolving CoQ10 in lemon oil because it teaches that it is difficult to dissolve CoQ10 in certain solvents. The Court disagreed, noting that Khan teaches that it is difficult to dissolve CoQ10 in aqueous solutions like water and many solvents but is more soluble in essential oils like lemon oil.

Finally, Soft Gel argued that a person of ordinary skill would not have any reasonable expectation of success in combining the references to obtain the claimed invention, because Motoyama, Khan, and Nazzal do not expressly mention d-limonene. However, Soft Gel ignored that the main constituent of lemon oil is d-limonene, and Nazzal specifically recommended studying the interaction between CoQ10 and essential oils like lemon oil. Soft Gel cited a second and later article by Khan evaluating the use of l- and d-limonene, arguing that because Khan conducted “follow up” research, it must not have been obvious that lemon oil contained d-limonene and d-limonene would be effective in dissolving CoQ10. The Court rejected this argument because the legal standard for obviousness does not require “absolute predictability,” only “a reasonable expectation of success.” Undertaking further study “does not imply lack of awareness of the likely result; rather, studies are frequently conducted to confirm what is suspected to be true.” Additionally, an “incentive to conduct a confirmatory study frequently exists even when one has every reason to expect success.” The Court found that a person of ordinary skill would have a reasonable expectation of success in using d-limonene to obtain the claimed invention and affirmed the Board’s decision finding the patents invalid for obviousness.

A reasonable expectation of success in combining references to obtain the claimed invention does not require absolute certainty or predictability. As a result, an invention is not non-obvious simply because persons of ordinary skill in the art continues to study aspects of the claimed invention after an initial disclosure. Rather, conducting additional or follow-up studies can be strong evidence that success is expected or likely.

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