Tuesday, April 07, 2009

CAFC affirms BPAI decision in Kubin: obviousness found

At issue was the question of whether the existence in the prior art of a purified protein,
combined with "routine" cloning methods, renders obvious a claim to a nucleic acid encoding the protein.

The patent applicants in the Kubin case lost for obviousness: For the reasons stated above,
the Board did not err in finding appellants’ claims obvious as a matter of law.

The opinion is by Judge Rader.

The Court of Appeals affirmed the decision of the Board [BPAI] and worked through some
issues of obviousness in biotechnology in the post-KSR world, including a discussion of
the vitality of In re Deuel.

Of the details, the CAFC noted:

More to the point, however, any putative difference in Valiante’s/Sambrook’s and
appellants’ processes does not directly address the obviousness of representative claim
73, which claims a genus of polynucleotides. The difference between Valiante’s and the
application’s techniques might be directly relevant to obviousness in this case if Kubin
and Goodwin had claimed a method of DNA cloning or isolation. But they did not.
Appellants claim a gene sequence. Accordingly, the obviousness inquiry requires this
court to review the Board’s decision that the claimed sequence, not appellants’
unclaimed cloning technique, is obvious in light of the abundant prior art.

The appellants were hoisted on the own petard by the CAFC who noted of appellants'
criticism of prior art:

because they do not provide “any guidance for
the preparation of cell culture that will serve as a useful source of mRNA for the
preparation of a cDNA library,” Appellants’ Br. 34, are diminished by appellants’ own

A “nucleotide sequence” refers to a polynucleotide molecule in the form of
a separate fragment or as a component of a larger nucleic acid construct.
The nucleic acid molecule has been derived from DNA or RNA isolated at
least once in substantially pure form and in a quantity or concentration
enabling identification, manipulation, and recovery of its component
nucleotide sequences by standard biochemical methods (such as those
outlined in Sambrook et al., Molecular Cloning: A Laboratory Manual, 2nd
ed., Cold Spring Harbor Laboratory, Cold Spring Harbor, NY (1989)).
’859 Application at 16-17 (emphasis added). Thus,Kubin and Goodwin cannot
represent to the public that their claimed gene sequence can be derived and isolated by
“standard biochemical methods” discussed in a well-known manual on cloning
techniques, while at the same time discounting the relevance of that very manual to the
obviousness of their claims.

Of inherent properties -->

See, e.g., Gen. Elec. Co. v. Jewel Incandescent Lamp Co., 326 U.S. 242, 249
(1945) (“It is not invention to perceive that the product which others had discovered had
qualities they failed to detect.”); In re Wiseman, 596 F.2d 1019, 1023 (CCPA 1979)
(rejecting the notion that “a structure suggested by the prior art, and, hence,
potentially in the possession of the public, is patentable . . . because it also possesses
an inherent, but hitherto unknown, function which [patentees] claim to have discovered.
This is not the law. A patent on such a structure would remove from the public that
which is in the public domain by virtue of its inclusion in, or obviousness from, the prior

The CAFC discussed the previous case of In re Deuel -->

The instant case also requires this court to consider the Board’s application of
this court’s early assessment of obviousness in the context of classical biotechnological
inventions, specifically In re Deuel, 51 F.3d 1552 (Fed. Cir. 1995). In Deuel, this court
reversed the Board’s conclusion that a prior art reference teaching a method of gene
cloning, together with a reference disclosing a partial amino acid sequence of a protein,
rendered DNA molecules encoding the protein obvious. Id. at 1559. In reversing the
Board, this court in Deuel held that “knowledge of a protein does not give one a
conception of a particular DNA encoding it.” Id. Further, this court stated that “obvious
to try” is an inappropriate test for obviousness.
[T]he existence of a general method of isolating cDNA or DNA molecules is
essentially irrelevant to the question whether the specific molecules
themselves would have been obvious, in the absence of other prior art that
suggests the claimed DNAs. . . . “Obvious to try” has long been held not to
constitute obviousness. A general incentive does not make obvious a
particular result, nor does the existence of techniques by which those efforts
can be carried out.
Id. (internal citations omitted) (emphases added). Thus, this court must examine
Deuel’s effect on the Board’s conclusion that Valiante’s teaching of the NAIL protein,
combined with Valiante’s/Sambrook’s teaching of a method to isolate the gene
sequence that codes for NAIL, renders claim 73 obvious.

The CAFC wrote -->

Insofar as Deuel implies the obviousness inquiry cannot consider
that the combination of the claim’s constituent elements was “obvious to try,” the
Supreme Court in KSR unambiguously discredited that holding. In fact, the Supreme
Court expressly invoked Deuel as a source of the discredited “obvious to try” doctrine.
The KSR Court reviewed this court’s rejection, based on Deuel, of evidence showing
that a particular combination of prior art elements was obvious because it would have
been obvious to one of ordinary skill in the art to attempt such a combination:
The only declaration offered by KSR—a declaration by its Vice President
of Design Engineering, Larry Willemsen—did not go to the ultimate issue
of motivation to combine prior art, i.e. whether one of ordinary skill in the
art would have been motivated to attach an electronic control to the
support bracket of the assembly disclosed by Asano. Mr. Willemsen did
state that an electronic control “could have been” mounted on the support
bracket of a pedal assembly. (Willemsen Decl. at P33, 36, 39.) Such
testimony is not sufficient to support a finding of obviousness, however.
See, e.g., In re Deuel, 51 F.3d 1552, 1559 (Fed. Cir. 1995) (“‘Obvious to
try’ has long been held not to constitute obviousness.”).
Teleflex, Inc. v. KSR Int’l Co., 119 F. App’x 282, 289 (Fed. Cir. 2005). The Supreme
Court repudiated as “error” the Deuel restriction on the ability of a skilled artisan to
combine elements within the scope of the prior art:

The same constricted analysis led the Court of Appeals to conclude, in
error, that a patent claim cannot be proved obvious merely by showing
that the combination of elements was “obvious to try.” When there is a
design need or market pressure to solve a problem and there are a finite
number of identified, predictable solutions, a person of ordinary skill has
good reason to pursue the known options within his or her technical grasp.
If this leads to the anticipated success, it is likely the product not of
innovation but of ordinary skill and common sense. In that instance the
fact that a combination was obvious to try might show that it was obvious
under § 103.

The CAFC invoked O'Farrell-->

The Supreme Court’s admonition against a formalistic approach to obviousness
in this context actually resurrects this court’s own wisdom in In re O’Farrell, which
predates the Deuel decision by some seven years. This court in O’Farrell cautioned
that “obvious to try” is an incantation whose meaning is often misunderstood:
It is true that this court and its predecessors have repeatedly emphasized
that “obvious to try” is not the standard under § 103. However, the
meaning of this maxim is sometimes lost. Any invention that would in fact
have been obvious under § 103 would also have been, in a sense,
obvious to try. The question is: when is an invention that was obvious to
try nevertheless nonobvious?
In re O’Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988). To differentiate between proper and
improper applications of “obvious to try,” this court outlined two classes of situations
where “obvious to try” is erroneously equated with obviousness under § 103. In the first
class of cases,
what would have been “obvious to try” would have been to vary all
parameters or try each of numerous possible choices until one possibly
arrived at a successful result, where the prior art gave either no indication
of which parameters were critical or no direction as to which of many
possible choices is likely to be successful.

The punchline:

In such circumstances, where a defendant merely throws metaphorical darts at a
board filled with combinatorial prior art possibilities, courts should not succumb to
hindsight claims of obviousness. The inverse of this proposition is succinctly
encapsulated by the Supreme Court’s statement in KSR that where a skilled artisan
merely pursues “known options” from a “finite number of identified, predictable
solutions,” obviousness under § 103 arises. 550 U.S. at 421.

As to the Kubin case -->

KSR and O’Farrell directly implicate the instant case. Appellants’ claim 73
recites a genus of isolated nucleic acid molecules encoding the NAIL protein. As found
by the Board, the Valiante reference discloses the very protein of appellants’ interest –
”p38” as per Valiante. Board Decision at 4.

The record shows
that the prior art teaches a protein of interest, a motivation to isolate the gene coding for
that protein, and illustrative instructions to use a monoclonal antibody specific to the
protein for cloning this gene. Therefore, the claimed invention is “the product not of
innovation but of ordinary skill and common sense.” KSR, 550 U.S. at 421. Or stated in
the familiar terms of this court’s longstanding case law, the record shows that a skilled
artisan would have had a resoundingly “reasonable expectation of success” in deriving
the claimed invention in light of the teachings of the prior art. See O’Farrell, 853 F.2d at

See previous IPBiz post -->


As a footnote, the ALJ who wrote Kubin falls into the Duffy category
of "unconstitutionally appointed" judges. Does anyone remember that fracas?

Patent Docs wrote:

("I may not know how to define what's obvious but I know it when I see it," to paraphrase Justice Powell in another context).

IPBiz observes the following from wikipedia: The most famous opinion from Jacobellis, however, was Justice Potter Stewart's concurrence, holding that the Constitution protected all obscenity except "hard-core pornography." Stewart wrote, "I shall not today attempt further to define the kinds of material I understand to be embraced within that shorthand description; and perhaps I could never succeed in intelligibly doing so. But I know it when I see it, and the motion picture involved in this case is not that." The movie in question was "The Lovers."


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