By Kevin E. Noonan —

The Federal Circuit heard oral argument for In re Kubin last week, and a very hot bench (Judge Rader presiding, joined by Judges Linn and Friedman) sharply challenged the positions of both Kubin and the Patent Office.  While it is foolish to attempt to read the tea leaves of judicial intention when listening to oral argument, the questions from the bench point out once again that obviousness remains a legal issue intimately dependent on the underlying facts (and misapprehension of those facts).

Judge Rader immediately raised the "obvious to try" issue with Barbara Rudolph, representing Kubin.  After letting Ms. Rudolph get about 80 words into her presentation, Judge Rader asked her "If I use the O'Farrell standard of a reasonable expectation of success, don't I come out with the office?" which, he reminded her, preceded In re Deuel and thus would be controlling precedent.  She reminded the Court that the O'Farrell standard for "obvious to try" sets forth two situations where what is obvious to try is not obvious.  One of these is when all possible parameters are varied with no direction from the art on which parameter to vary or how.  That was the situation here, according to Ms. Rudolph. 

Judge Friedman then gave counsel the opportunity to take a breath and set forth some background information, asking for a brief synopsis of what the patent applicants were trying to do.  She responded by explaining the underlying immunology of natural killer (NK) cells.  In response to renewed questioning from Judge Rader, that the prior art Valiante reference "taught p38 which is NAIL" (the subject matter of the Kubin application was a cDNA encoding human NAIL), she reminded the Court that what Valiante disclosed was "a band on a gel," i.e., that the Valiante patent disclosed an antibody immunologically reactive to p38, and therefore, that Valiante did not disclose purified p38, but merely its detection on a Western blot (where it would be expected to be in the presence of a multiplicity of other proteins).

At this point the Court went off the factual rails a bit.  Judge Rader asked:

From which Judge Rader came to the conclusion that:

Frankly, no.  Ms. Rudolph reminded the Court that Kubin was claiming a cDNA and the prior art taught the p38 protein, and that Kubin's claim was not to the entirety of the NAIL sequence but just to a fragment of it.  This led the Court to what seemed to be a greater misunderstanding of the underlying facts:

This colloquy seems to indicate that the Court is at least receptive to the Patent Office position that the cloning methods were "routine."  But this ignores, of course, the critical factual distinctions between the prophetic example from the prior art Valiante patent and what Kubin actually did.  Ms. Rudolph tried to get the Court back on track:

Judge Rader seemed to continue to miss Ms. Rudolph's point that what was deficient in the art were not cloning methods, but a source for preparing a cDNA library:

As anyone familiar with the underlying science will recognize, you don't "get the library out of Sambrook."  You get generic cloning methods from Sambrook, but the predicate for using these methods is having a biological source, a cell or tissue, that expressed the protein encoded by a cDNA of interest, from which source Sambrook can be used to prepare a library.  It is ironic that one of the classic scientific limitations of gene cloning was ignorance of the source of such important cDNAs like blood clotting Factor VIII.

Judge Linn commented that, on the one hand, the Matthew reference "troubled" him as a teaching away, but also said he thought that example 12 of the Valiante reference was "of consequence" to the obviousness question.  In response to Judge Linn's question about the significance of Example 12 being a prophetic example, Ms. Rudolph responded that while its prophetic nature "didn't matter," looking at the evidence as a whole showed there was no reasonable expectation of success that practicing Example 12 would result in Kubin's invention.

Judge Rader continued to emphasize the existence of the antibody probe, combined with using "the Sambrook libraries," and then (voila!) "you find the sequence."  Ms. Rudolph responded succinctly:  "Probe it in what?  . . .  [Y]ou need a starting material from which to probe.  And if you have a NK cell library, that's not going to produce p38 or sufficient amounts [of it]."  Judge Rader then asserted that "Valiante had already produced p38," to which Ms. Rudolph reminded the Court that had been done for the protein and not for the cDNA.  Specifically, she correctly asserted that "you need a starting cell library that will have a sufficient amount of that particular gene that will produce that particular protein."  Unfazed, Judge Rader responded:

Ms. Rudolph made one more attempt to clarify the issue:

Janet Gongola, Associate Solicitor for the Office of the Solicitor, argued for the Patent Office.  Judge Rader started her off with Deuel, asking her the converse of his O'Farrell question to Kubin's counsel.  She distinguished Deuel based on the statement in Deuel that:

A unique argument to anyone with a memory of the In re Bell / In re Deuel dyad of cases and the Federal Circuit's clear holding (followed de facto by the Patent Office ever since) overruling the same arguments the Office now makes against Kubin's claims.  Judge Rader persisted, asking Ms. Gongola to "distinguish the rule of Deuel, which says general methodologies are irrelevant.  [And if so,] you lose Sambrook, and if you don't have Sambrook, you can't have the libraries [and] you can't use example 12 to get to Kubin."  Her response:

Judge Linn then asked her about the statements by Kubin's counsel that Valiante did not show a library.  Ms. Gongola responded:

There are, of course, two errors of fact and one of law in this argument.  The first is that neither the Matthew reference nor the Valiante reference taught that mouse 2B4 was the murine homolog of human NAIL.  That understanding was evident only when Kubin succeeded in cloning NAIL cDNA and compared it to the mouse 2B4 reference.  Second, the reason that Matthew could use substantially the same method that Valiante prophetically taught for cloning the murine p38-encoding gene is that mouse NK cells make sufficient 2B4 mRNA that a conventional murine cDNA library will be capable of producing cDNA clones encoding the sought-after gene.  Kubin (and Matthew) show that this isn't the case for human NK cells.  Ms. Gongola, and the Board, continue to base their obviousness argument on the obviousness of the cloning methods — "People knew how to clone" — but as Judge Lourie realized in Deuel, that isn't the standard:

And KSR does nothing to change that.

Interestingly, in view of the professed desire of the Office to have the Federal Circuit overturn
Deuel, Ms. Gongola did not assert any deficiencies in Deuel per se occasioned by the Supreme Court's KSR decision:

She also asserted, in response to Judge Linn's comment that KSR involved simple mechanical technology, that the Supreme Court in KSR envisioned that its principles would be applicable across other technologies.  Ms. Gongola based this assessment on dicta in KSR that the application of such principles to other technologies might not be as easy as it had been for the Court in KSR.  She also cited the Federal Circuit's Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd. decision as one "that helps us in this case," again asserting the "facts" before the Court in Kubin.  The Federal Circuit's decision in finding Takeda's claims non-obvious was based on the "hundreds of [related] compounds" in the prior art and the failure of the art to teach "compound b" as a desirable compound.  Here, according to Ms. Gongola:

Both Kubin and amici had the opportunity to argue in their briefs the factual distinctions and misapplication of the facts in the Board's obviousness analysis.  However, unless one of the judges or their clerks digs down far enough to understand the limitations of the art, and the hindsight recognition that mouse 2B4 and NAIL are homologs, the Court may need to defer to the Office's factual findings under Dickinson v. Zurko.  And Ms. Gongola's protestations that the Office does not seek to overturn Deuel should preclude a sea change in Patent Office examination even if the court upholds the Kubin rejection. 

A decision is expected (but not guaranteed) within 90 days.