United States: Obviousness Does Not Require Absolute Predictability

Last Updated: September 4 2017
Article by Wen Li

Addressing the issue of obviousness, the US Court of Appeals for the Federal Circuit affirmed three inter partes re-examination decisions of the Patent Trial and Appeal Board (PTAB) invalidating numerous claims in each of three related patents. Soft Gel Tech., Inc. v. Jarrow Formulas, Inc., Case Nos. 16-1814; -1815; 17-1051 (Fed. Cir., July 26, 2017) (Bryson, J).

Jarrow requested inter partes re-examinations of three related Soft Gel patents. The patents relate to compositions comprising a solution of CoQ10 dissolved in d-limonene, which belongs to the family of monoterpene. The US Patent and Trademark Office ordered re-examinations of all three patents, and the examiner rejected various claims of the patents in each re-examination. On appeal, the PTAB invalidated numerous claims in each of the three patents for being obvious over the combination of five references.

In particular, the PTAB found that (1) a prior art reference (Motoyama) discloses that CoQ10 is highly soluble in carvone, which is a monoterpene found in spearmint oil and peppermint oil; (2) other prior art references (Khan and Nazzal) teach using peppermint oil, spearmint oil and lemon oil with CoQ10; and (3) according to other prior art (IARC and Fenaroli), d-limonene is the main component of lemon oil. The PTAB determined that combination of the references suggests the claimed composition. The PTAB also found that a skilled artisan would have been motivated to combine the references and would have had a reasonable expectation of success in doing so. Soft Gel appealed.

On appeal, Soft Gel raised issues with three factual PTAB findings—namely, that d-limonene is the main component of lemon oil, that Khan does not teach away from the claimed invention, and that a skilled artisan would have had a reasonable expectation of success for combining the references.

The Federal Circuit explained that the record (including the IARC and Fenaroli references) supports the finding that d-limonene is the major component of lemon oil. Regarding a reference introduced by Soft Gel to challenge that finding, the Court concluded that the reference actually supported the PTAB finding.

The Federal Circuit also sustained the PTAB's ruling that Khan does not teach away from dissolving CoQ10 in lemon oil. The Court explained that Soft Gel mischaracterized Khan in contending that Khan teaches difficulties associated with dissolving CoQ10 in lemon oil. The Court also rejected as immaterial Soft Gel's contention that Khan only disclosed melting, and not dissolving, CoQ10 in the presence of an essential oil. Because Khan discloses using essential oils to make CoQ10 more available to the body, the Court reasoned that it resolved the same problem as the claims at issue. Finally, notwithstanding Soft Gel's attempt to draw a contrast between lemon oil and peppermint oil/spearmint oil, the Federal Circuit concluded that Khan showed the best results being associated with lemon oil. The Federal Circuit noted that the PTAB's obviousness conclusions were not undermined by Soft Gel's attack on Khan because the decisions were based on a combination of references.

Finally, the Federal Circuit explained that Soft Gel urged an incorrect legal standard for obviousness, one that required "absolute predictability" rather than "a reasonable expectation of success." Soft Gel relied on a follow-up study conducted by Dr. Khan on the use of d- and l-limonene as evidence that it would not have been obvious that the earlier results from lemon oil are attributable to d-limonene. The Court noted that a supplemental study on the use of limonene does not imply lack of awareness of the likely results. Rather, subsequent studies are frequently conducted to confirm a reasonable expectation.

Obviousness Does Not Require Absolute Predictability

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