Wednesday, July 26, 2017

CAFC in Soft Gel : An incentive to conduct a confirmatory study frequently exists even when one has every reason to expect success

Of interest:

First, Soft Gel contends that the Khan ’786 patent
teaches that it is difficult to dissolve CoQ10 in lemon oil.
But what the Khan ’786 patent states is that CoQ10 is
difficult to dissolve in aqueous solvents, fixed (nonvolatile)
oils, and triglycerides. Khan ’786 patent, col. 1, ll. 46-47,
55-62; id., col. 6, ll. 57-60. Instead of suggesting the use of
those types of solvents with CoQ10, the Khan ’786 patent
teaches the use of an essential (volatile) oil, such as lemon
oil, peppermint oil, or spearmint oil, as a solvent for
CoQ10. Id., col. 5, ll. 60-61; id., col. 6, ll. 27-31; see also
id., col. 6, ll. 43-45. The Khan ’786 patent merely notes
the difficulty of dissolving CoQ10 in many solvents other
than essential oils such as lemon oil.


For those reasons, Soft Gel has failed to discredit the
Board’s finding that the Khan ’786 patent does not teach
away from the inventions of the Soft Gel patents. More
importantly, Soft Gel’s focused attack on the Khan ’786
patent does not undermine the Board’s decision, which is
based on a combination of references. See In re Merck &
Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986) (in the context of
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”).
Read together, the Khan ’786 patent and the Motoyama
reference suggest using the monoterpenes in lemon oil,
peppermint oil, and spearmint oil in conjunction with

Noelle v. Lederman is cited:

In making that argument, Soft Gel applies an incorrect
legal standard for obviousness, requiring “absolute
predictability” rather than “a reasonable expectation of
success.” Noelle v. Lederman, 355 F.3d 1343, 1352 (Fed.
Cir. 2004). It is true that the Khan ’786 patent discloses
lemon oil, not d-limonene. But that does not mean that a
person of skill would not expect d-limonene, the main
constituent of lemon oil
, to work. Dr. Khan may have had
just that expectation in conducting his subsequent research,
in which he investigated whether d-limonene was
responsible for the lemon oil-CoQ10 results. As the Board
correctly noted, “[s]imply because [Dr.] Khan . . . [later]
undertook a study to evaluate limonenes in SNEDDS[]
does not mean that it would not have been obvious [that
limonenes] would have worked to some extent.” A supplemental
study does not imply lack of awareness of the
likely result
; rather, studies are frequently conducted to
confirm what is suspected to be true. An incentive to
conduct a confirmatory study frequently exists even when
one has every reason to expect success. As it happens, Dr.
Khan was successful; his “[r]esults indicated that CoQ[10]
is fairly soluble in [the] monoterpene[] [d]-limonene.”
Palamakula at 78.


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