By Kevin E. Noonan --
The Board of Patent Appeals and Interferences recently got its long awaited opportunity to opine on
the continued validity of the Federal Circuit's In re Deuel decision in light
of the Supreme Court's recent decision in KSR Int'l Co. v. Teleflex Inc. Deuel is widely acknowledged (and decried in
the Patent and Trademark Office) as settling "once and for all" (or
at least until now) that isolation of a nucleic acid encoding a
"known" gene is nonobvious.
The case, Ex parte Kubin, involved an application for
isolated cDNA encoding Natural Killer Cell Activation Inducing Ligand
(abbreviated as NAIL). The Board
affirmed the Examiner's rejection based on prior art including U.S. Patent No.
5,688,690, disclosing the human NAIL gene product (p38), methods for producing
a cDNA encoding p38, a scientific journal article disclosing the nucleotide
sequence of the mouse ortholog, and that old stand-by, the Maniatis cloning
manual (Sambrook et al.). The evidence
from the applicants' specification was that their NAIL cDNA clones were
produced using an expression library screened with a commercially-available
monoclonal antibody against human p38.
The Board correctly noted that the art had progressed
since the time Deuel was decided. Indeed, there are at least the following differences between the factual
situation in Kubin and Deuel:
1. In Kubin, a cell "unambiguously" (see below) expressing the gene was
known; in Deuel, a protein that the prior art taught was expressed in brain was
cloned from placenta.
2. In Kubin, the nucleotide and amino acid sequence of
the mouse ortholog of human NAIL was known; in Deuel, the prior art disclosed
three different brain-specific proteins and a partial amino-terminal amino acid
sequence thereof.
3. In Kubin, the art provided an isolated preparation of
the cognate protein and a monoclonal antibody that binds to the protein; in Deuel, the art
disclosed isolated preparations of three different brain-specific proteins but
no antibodies.
4. In Kubin, the art provided a monoclonal antibody
specific for the gene product of the desired cDNA and thus providing a specific
probe; in Deuel, the probes were a plurality of degenerate oligonucleotides
prepared from the partial amino-terminal amino acid sequences.
5. In Kubin, the art has developed expression cloning
technology and provided an antibody probe specific for the gene product of the
desired clone; in Deuel, the absence of a specific antibody precluded use of
expression cloning technology.
Despite these valid reasons for coming to a different
conclusion in Kubin than the Federal Circuit mandated in Deuel, the Board in
dicta shows that it has still not learned, or refuses to acknowledge the
teachings of In re Deuel. In attempting
to apply the Supreme Court's teachings from KSR, the Board cites the decision's
dicta on the application of the principle of "obvious to try":
When there is motivation 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
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.
KSR Int'l Co. v. Teleflex Inc., 127 S. Ct. 1727, ___, 82
USPQ2d 1385, 1397 (2007). This reasoning is applicable here.
While this is an accurate statement of the Supreme
Court's dicta, the Board misapplies it. The Board goes on to state:
The "problem" facing those in the art was to
isolate NAIL cDNA, and there were a limited number of methodologies available
to do so. The skilled artisan would have had reason to try these methodologies
with the reasonable expectation that at least one would be successful. Thus,
isolating NAIL cDNA was "the product not of innovation but of ordinary
skill and common sense," leading us to conclude NAIL cDNA is not
patentable as it would have been obvious to isolate it.
Thus, the Board continues to conflate whether the method
for making a cDNA such as the NAIL cDNA would be obvious with the obviousness
of the cDNA itself. At least they are
consistent; this is the same mistake that the Board made in Deuel:
The PTO's focus on known methods for potentially
isolating the claimed DNA molecules is also misplaced because the claims at
issue define compounds, not methods. See In re Bell, 991 F.2d 781, 785, 26
USPQ2d 1529, 1532 (Fed. Cir. 1993). In Bell, the PTO asserted a rejection based
upon the combination of a primary reference disclosing a protein (and its
complete amino acid sequence) with a secondary reference describing a general
method of gene cloning. We reversed the rejection, holding in part that
"the PTO's focus on Bell's method is misplaced. Bell does not claim a
method. Bell claims compositions, and the issue is the obviousness of the
claimed compositions, not of the method by which they are made." Id.
We today reaffirm the principle, stated in Bell, that the
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. . . . There must, however, still be prior art that suggests the claimed
compound in order for a prima facie case of obviousness to be made out; as we
have already indicated, that prior art was lacking here with respect to claims
5 and 7. Thus, even if, as the examiner stated, the existence of general
cloning techniques, coupled with knowledge of a protein's structure, might have
provided motivation to prepare a cDNA or made it obvious to prepare a cDNA,
that does not necessarily make obvious a particular claimed cDNA. "Obvious
to try" has long been held not to constitute obviousness. In re O'Farrell,
853 F.2d 894, 903, 7 USPQ2d 1673, 1680-81 (Fed. Cir. 1988). A general incentive
does not make obvious a particular result, nor does the existence of techniques
by which those efforts can be carried out. Thus, Maniatis's teachings, even in
combination with Bohlen, fail to suggest the claimed invention.
This analysis has not been overturned by KSR (see "Trying to Understand What's Not Obvious about What's 'Obvious to Try'"). The problem with the Board's analysis is that
KSR requires a "finite number of identified, predictable solutions"
which does not apply to nucleic acids (and which was the basis for the Federal
Circuit's decisions in In re Deuel and In re Bell). The Board continues to conflate the
obviousness of a method for isolating a cDNA with obviousness of the cDNA
isolated. Insofar as the applicants were
claiming a method of isolating the cDNA, it may be obvious. But that isn't what they are claiming, and
there is nothing in KSR that mandates the result provided by the Board. And KSR does not stand for the proposition that the
"finite number of solutions" is that the invention either will work,
or it won't.
An important factor discounted by the Board comes from
the disclosure of the Mathew reference, relating to the isolation of the
mouse ortholog of the human NAIL cDNA. As urged by the applicants, the Mathew reference showed the results of
Northern blot experiments (for detecting mRNA expression of NAIL) from human
cells and tissues; these results
indicated that NAIL expression could not be detected in the immune cell types
that applicants used for cloning the human NAIL cDNA. The Board thus ignored evidence in the art
that reduced the likelihood that the human NAIL cDNA could be isolated using
the methods disclosed in the Sambrook reference, since the art taught that
human cells that actually expressed the NAIL cDNA did not do so. KSR did not negate the impact of affirmative
evidence that would teach away from an invention, or would teach the skilled
worker than an invention would not work.
There is some good news in the decision regarding the
requirements for enablement under § 112, first paragraph. The Board now recognizes that merely routine
experimentation is required to enable the full scope of applicants' claims,
which recited nucleic acids encoding proteins at least 80% identical to the
disclosed amino acid sequence of the claimed human NAIL protein. Thus, claims having scope broader than the
exact amino acid or nucleotide sequence disclosed should not be rejected under
the enablement requirement of 35 U.S.C. § 112, first paragraph. With regard to the written description
requirement, on the other hand, the Board affirmed the Examiner's determination
that the application failed to satisfy the written description requirement due to the lack of any disclosure of which residues could be changed or any
structure/function relationships that would inform the skilled worker about
which residues could (and which should not) be changed.
This first foray in the Patent and Trademark Office's
application of the rubrics of KSR to patentability of nucleic acid sequences is
not really a surprise, in view of the animus with which the examining corps
continues to hold the decision (see, e.g., Kintisch, "Patent Experts Hope High Court Will Clarify What's Obvious," Science 314:1230-31). However, and fortunately, the multiple factual
distinctions between the Kubin case and In re Deuel should limit the applicability
of the decision.
Ex parte Kubin (B.P.A.I. 2007)
Precedential opinion
Panel: Chief Administrative Patent Judge Fleming and Administrative Patent Judges Gron, Scheiner, Grimes, and Linck
Opinion by Administrative Patent Judge Linck
Patent Docs would like to thank Patently-O for bringing
this decision to their attention; additional information regarding this case can be found at Patently-O.