Soft Gel Technologies, Inc. v. Jarrow Formulas, Inc.

Docket No. 2016-1814, -1815, -1051

July 26, 2017

Brief summary: Board decision of obviousness following inter partes reexamination affirmed (e.g., “absolute predictability” not required, no teaching away).

Summary: Soft Gel appealed PTAB inter partes reexamination decision invalidating claims in three related patents (US 8,124,072; 8,105,583; and 8,147,826) relating to a method for dissolving coenzyme Q10 (CoQ10, ubiquinone) in solvents (monoterpenes), as well as a composition, a soft gelatin capsule, and a method for making the soft gelatin capsule. The FC panel opinion explains that the patents note that “at the time of the inventions most solvents that were used to administer CoQ10 in liquid form could dissolve, at most, only about 5 to 10 percent of the CoQ10” and “[f]or that reason, CoQ10 was generally administered in solid form, such as in a tablet or powder” (or “as a suspension, in which the CoQ10 is partially dissolved in a solvent”). These formulations, however, delivered “only a small fraction of the CoQ10” to the bloodstream. According to the patents, monoterpenes (e.g., the claimed d-limonene) were identified as CoQ10 solvents (“about 30 to about 45% of the CoQ10…is solubilized [dissolved] in the monoterpene”). Representative ‘583 claim 1 claims “coenzyme Q-10; a sufficient quantity of d-limonene suitable to solubilize said coenzyme Q-10…with the proviso that said solution is not part of an emulsion, suspension, or elixir.” Representative ‘826 claim 1 claims a method for preparing a soft gel capsule encapsulating that composition. During inter partes reexamination, the examiner rejected the claims in view of “five key references”. The “Motoyama” reference is described as disclosing capsules containing CoQ10 in the monoterpene 1-carvone (found in the spearmint and peppermint oils (“essential oils”) derived from plants), and showing high bioavailability in dogs. The “Khan ‘786 patent” and the “Nazzal” dissertation were described as showing CoQ10/essential oil (peppermint, spearmint, lemon) mixtures that “facilitate[e] absorption by the body” by, e.g., lowering CoQ10’s melting temperature. “Fenaroli” was described as “not[ing] that lemon essential oil has many different components, but ‘contains approximately 90% limonene (by weight).” The fifth reference, a WHO cancer-related document (“IARC”), was described as stating “that limonene is ‘the most frequently occurring natural monoterpene” which “occurs naturally in the d- and l- forms, and that ‘the d form comprises 98-100% of the limonene in most citrus oils.’” The Board concluded “that the combination of those references suggest the invention claimed in the Soft Gel patents” and that one of ordinary skill in the art would have been motivated to combine the same with a reasonable expectation of success. Soft Gel argued in this appeal that the Board erred in finding “that d-limonene is the main constituent of lemon oil”, that the Khan ‘786 patent does not teach away from the claimed invention, and that there would have been a reasonable expectation of success. The FC panel agreed with the Board on each of these points. Regarding the teaching away argument, the FC panel found Khan ‘786 “merely notes the difficulty of dissolving CoQ10 in many solvents other than essential oils”, “teaches the use of essential oils to make CoQ10 more available” (“precisely what is claimed”), and that “lemon oild provided the best performance…not that it behaved in an entirely different manner from the other oils” (“Khan’s focused attack on the Khan ‘786 patent does not undermine the Board’s decision” (In re Merck, FC 1986 (“in the context to teaching away, “[n]on-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references”))). The FC panel also agreed with the Board regarding the reasonable expectation of success since, e.g., Nazzal suggestion of “future research show[ing] that a person of skill in the art would have recognized-and at least one (Nazzal) did recognize-that the monoterpenes limonene and carvone are of interest in the essential oil-CoQ10 mixtures” (“absolute predictability” not required (Noelle, FC 2004)). The fact that the Board’s ‘072 decision “ignored the fact that the claims were amended to recite ‘d-limonene’ instead of ‘limonene’” was found to have “no material effect on its obviousness decision”. The Board decision was therefore affirmed.

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