IP Law Daily PTAB correctly invalidated CoQ10 improved absorption claims for obviousness
Wednesday, July 26, 2017

PTAB correctly invalidated CoQ10 improved absorption claims for obviousness

By Linda O’Brien, J.D., LL.M.

The Patent Trial and Appeal Board correctly concluded that challenged claims in three patents directed to a method for improving the absorption of CoQ10, a coenzyme involved in the production of cellular energy, were unpatentable as obvious, the U.S. Court of Appeals for the Federal Circuit has ruled (Soft Gel Technologies, Inc. v. Jarrow Formulas, Inc., July 26, 2017, Bryson, W.).

Soft Gel is the assignee of three patents: U.S. Patent Nos. 8,124,072 ("the ‘072 patent"), 8,105,583 ("the ‘583 patent"), and 8,147,826 ("the ‘826 patent"). The specifications for the patents describe a method for dissolving a substance referred to as CoQ10 in solvents known as monoterpenes. CoQ10 is a coenzyme that is required for certain metabolic processes and for the production of cellular energy. CoQ10 is sparingly soluble in water and the patents describe the discovery of d-limonene, a monoterpene, as an improved method of delivering increased amounts of bioavailable CoQ10.

In September 2012, Jarrow Formulas requested inter partes examination of the three Soft Gel patents. In each reexamination, the examiner rejected various claims of the patents. On appeal, the Patent Trial and Appeal Board considered five key references: Patent Application Laid-Open Disclosure No. S57-42616 ("Motoyama") which claims an oral formulation of CoQ10 dissolved in an oil; U.S. Patent No. 7,588,786 ("the ‘786 patent") and dissertation ("Nazzal") positing the use of lipids or oils as solvents; the reference "Fenaroli’s Handbook of Flavor Ingredients ("Fenaroli"); and a monograph by the World Health Organization’s International Agency for Research on Cancer ("IARC").

The Board found that the combination of those references suggested the invention claimed in the Soft Gel patents, that a person of skill in the art would have been motivated to combine those references with a reasonable expectation of success, and invalidated numerous claims of the Soft Gel patents on obviousness grounds. Soft Gel appealed.

The Board did not err in its factual finding that d-limonene was the main constituent of lemon oil, the court found. The ‘786 patent and Nazzal teach the use of essential oils, such as lemon oil, in conjunction with CoQ10. The Fenaroli and IARC references together show that lemon oil consists of approximately 88 to 90 percent d-limonene by weight. In addition, another reference in the Journal of Agricultural and Food Chemistry that tested essentials oils other than lemon oil, concluded that limonene was always the main constituent of all oil samples. These references supported the Board’s finding.

Soft Gel’s contention that the ‘786 patent teaches away from dissolving CoQ10 in lemon oil was rejected. The court noted that, although the ‘786 patent notes the difficultly of dissolving CoQ10 in many solvents, it teaches the use of an essential oil, such as lemon, peppermint, or spearmint, as a solvent to make CoQ10 more available to the human body, which was precisely what is claimed in Soft Gel’s patents.

Soft Gel’s argument that a person of ordinary skill in the art would not have had a reasonable expectation of success in combining the references to use d-limonene in Motoyama’s invention also was rejected. According to the court, the ‘786 patent and Nazzal found that the main constituent of lemon oil was d-limonene and that the oil solvent used in Motoyama’s invention included lemon oil. After describing the same formulation disclosed in the ‘786 patent, Nazzal recommended further study of the nature of the interaction between CoQ10 and essential oils. The recommendation of future research along with reading in Motoyama about the role of carvone—a monoterpene found in spearmint and peppermint oil—in dissolving CoQ10, a skilled artisan would have been motivated to combine the two references.

Further, Nazzal suggests testing the interaction of carvone and CoQ10 as well as the interaction of limonene and CoQ10 and Motoyama teaches that carvone successfully dissolves CoQ10. A person of skill would reasonably expect that limonene, like carvone, would successfully dissolve CoQ10. Since the Fenaroli and IARC references make clear that the main constituent in the lemon oil that was the subject of the ‘786 patent was d-limonene, the combination of the ‘786 patent with Motoyama suggests dissolving CoQ10 in d-limonene, the court concluded.

The case is No. 2016-1815.

Attorneys: Devan V. Padmanabhan (Winthrop & Weinstine, PA) for Soft Gel Technologies, Inc. Mark D. Giarratana (McCarter & English, LLP) for Jarrow Formulas, Inc.

Companies: Soft Gel Technologies, Inc.; Jarrow Formulas, Inc.

MainStory: TopStory Patent FedCirNews

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