Extreme Caution Needed When Overcoming Inherent Anticipation Rejections
By Robert Dailey
Last week the Federal Circuit affirmed a District Court
finding of inequitable conduct against Cargill in its prosecution of U.S.
Patent Nos. 5,969,169 and 6,201,145. The
case highlights the continuing instability in the Federal Circuit's inequitable
conduct jurisprudence.
At the broadest level, Cargill's patents cover:
A non-hydrogenated canola oil having a polyunsaturated fatty acid content of from about 7% to about 17%, an oleic acid content of about 74% to about 80% and an oxidative stability of from about 35 AOM to about 40 AOM hours in the absence of added antioxidants.
The Examiner initially rejected the claim as being
anticipated by an oil composition disclosed in a European patent. Since the prior art oil had a composition
similar to that of one of Cargill's examples (IMC-30), the Examiner reasoned
that the two oils must also have a similar oxidative stability. Hence, the Examiner's anticipation rejection
rested on the proposition that one can predict the oxidative stability of an
oil simply based on its fatty acid composition (i.e., that fatty acid
composition necessarily determines oxidative stability).
Cargill sought to demonstrate that the Examiner's
scientific proposition is false. This
could have been done through a variety of means. Cargill decided to point to data disclosed in
its own application. Another example
(IMC-29) showed another oil which also had a similar composition to the prior
art oil, but whose oxidative stability differed strikingly from that of
IMC-30. Cargill pointed to IMC-29 for
one specific purpose: to demonstrate that fatty acid composition does not
necessarily determine oxidative stability. The Examiner eventually accepted this argument, and allowed the claims.
All would seem to be well. The inherency rejection was unwarranted, the
applicant pointed out the flaw in the Examiner's scientific logic, and the PTO
allowed the claims. But the Federal
Circuit's analysis went further. Cargill
had done extensive testing on IMC-29. In
some of these tests, chemists had simply refined the oil at the lab bench - a
process that yields oil with a higher oxidative stability than oil refined commercially. Although the data were sketchy, some of the
bench-refined IMC-29 had oxidative stability values comparable to commercially
refined IMC-30.
The Court held that the "reasonable examiner"
might have wanted to have access to the data of these bench tests. Thus, they are material to patentability
under this malleable "reasonable examiner" standard. But would a reasonable examiner find these
data material to patentability? In the
case at bar, the Examiner was making an inherent anticipation rejection, not an
obviousness rejection. Hence, the
applicant would appear to be under no burden to show that IMC-30 is patentably
better than IMC-29. Rather, the
applicant simply needs to show that the Examiner's scientific proposition
regarding composition and oxidative stability is untenable. Cargill did that. In fact, these bench tests appear to bolster
Cargill's inherency argument: two
batches of the same IMC-29 refined in two different ways yielded oils having
very different oxidative stability values.
The case illustrates the continued problems with the
"reasonable examiner" approach for determining materiality. What would a reasonable examiner want? Is candor in responding to the Examiner's
rejections not sufficient? In this
instance, Cargill exercised complete candor in responding to the inherent
anticipation rejection. The situation
would be different if the IMC-29 data in the application had been
doctored. But it wasn't.
What's the moral, then? Be careful when referring to your own data to defeat an inherency rejection! Point to treatises or other scientists' work, or use inventor and/or expert declarations. Or bury the examiner under a weight of case law. Just don't appeal to your own experimental data. Otherwise, the court may hold you responsible for knowing every experiment that any technician ever performed in your client's labs on a given composition.
In short, the Court seems to be saying: "Deal with examiners as lawyers, and not at all as scientists." But is that really what the "reasonable examiner" desires?
Cargill, Inc. v. Canbra Foods, Ltd. (Fed. Cir. 2007).
Additional information regarding this case can be found at Patently-O.
Robert Dailey, Ph.D., is a physical chemist and a third-year law student at the University of North Carolina at Chapel Hill. Dr. Dailey was a member of MBHB's 2006 class of summer associates, and is a regular Patent Docs contributor.
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