Ex Parte Kubin: Overcoming the Deuel

Ex Parte Kubin (BPAI 2007) (Precedential)

Kubin’s patent claims are directed to a cDNA molecule (NAIL) that serves as an NK cell surface marker. During examination, the examiner found them obvious. On appeal to the Board of Patent Appeals and Interferences (BPAI or Board), the applicant constructed an argument based on In re Deuel (Fed. Cir. 1995), that its cDNA claims cannot be “made obvious by mere knowledge of a desired protein sequence and methods for generating the DNA that encodes that protein.” (Quoting Deuel). 

The Board, however, affirmed the rejection, finding the claims invalid because the cDNA structure would have been “obvious to try.”  This case likely eviscerates any strength still remaining in Deuel.

[T]he Supreme Court recently cast doubt on the viability of Deuel to the extent the Federal Circuit rejected an “obvious to try” test. Under KSR, it’s now apparent “obvious to try” may be an appropriate test in more situations than we previously contemplated. . . .

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.

Kubin’s claims were also challenged on enablement and written description because they claimed only 80% identity with the described DNA sequence.

On enablement, the Board noted a parallel from its obvious to try analysis. Although there are certainly caveats, the Board appears to have held that a compound that is obvious to try is necessarily enabled because it would not require undue experimentation to make and use the invention.

The amount of experimentation to practice the full scope of the claimed invention might have been extensive, but it would have been routine. The techniques necessary to do so were well known to those skilled in the art.

Written Description: On the other hand, the Board found that “appellants did not describe the invention [] sufficiently to show they had possession of the claimed genus of nucleic acids.”

Rejections affirmed on obviousness and written description.

Notes:  

  • This is one of two precedential BPAI opinions for 2007.
  • The application appears to be owned by Immunex, a company now owned by Amgen after a $17B purchase.

16 thoughts on “Ex Parte Kubin: Overcoming the Deuel

  1. 16

    Kevin,

    I think you are misperceiving the political situation here. KSR was a slap on the wrist by the Supreme Court, essentially putting the Federal Circuit on probation. But if it means anything, it means that Deuel’s per-se non-obviousness rule cannot possibly survive unscathed.

    Let us imagine what would happen if the Federal Circuit wrote an opinion reaffirming Deuel and rejecting KSR’s language as “dicta”. First, in the next few months the Supreme Court is going to be inundated with petitions from private parties in other cases, all screaming that the Federal Circuit is ignoring KSR. Those petitions normally would go nowhere because private parties have no credibility. Next, a petition comes from the solicitor-general, signed by the PTO, saying that the Federal Circuit has held chemical compounds to be per se non-obvious. That petition will have credibility–regardless of what people on this blog think of the PTO management, the Supreme Court trusts them to know good patent policy, right now probably more than it trusts the Federal Circuit. All of a sudden the Federal Circuit is staring down the barrel of a summary reversal, a bunch of GVRs, and being labeled the next Ninth Circuit. The Federal Circuit judges don’t need that. And if Khan-Alza-Dystar is any guide, they are not going to wage a scorched earth campaign to save Deuel.

  2. 15

    The problem is that In re Kubin came right before the Federal Circuit Takeda case wherein the court applied In re Deuel (they didn”t overrule or ignore it). Admittedly, Takeda involved small molecules, however, I think its logic could have easily been applied to the facts of Kubin.

  3. 14

    The problem is that In re Kubin came right before the Federal Circuit Takeda case wherein the court applied In re Deuel (they didn”t overrule or ignore it). Admittedly, Takeda involved small molecules, however, I think its logic could have easily been applied to the facts of Kubin.

  4. 13

    The problem is that In re Kubin came right before the Federal Circuit Takeda case wherein the court applied In re Deuel (they didn”t overrule or ignore it). Admittedly, Takeda involved small molecules, however, I think its logic could have easily been applied to the facts of Kubin.

  5. 12

    The problem is that In re Kubin came right before the Federal Circuit Takeda case wherein the court applied In re Deuel (they didn”t overrule or ignore it). Admittedly, Takeda involved small molecules, however, I think its logic could have easily been applied to the facts of Kubin.

  6. 11

    The factual distinction with Deuel may be correct, but falls down if In re Bell is considered. In that case, which Deuel was a second try by the PTO, the entire amino acid sequence of the protein was in the prior art. The real problem with these decisions is that they are contrary to prior binding precedent of the Federal Circuit and the Supreme Court. First, the decisions contradict the holdings in the Durden line of cases that there are no per se rules of obviousness. Second, the Bell/Deuel “rule” violates the Supreme Court’s holding in Graham that the inquiry under 103 is based in part on the *factual* level of ordinary skill in the prior art. The Federal Circuit is not at liberty to overrule the Supreme Court and convert a time-dependent factual inquiry into an immutable rule of law. Then there is the plain wording of the statute itself: “…would have been obvious at the time the invention was made to a person having ordinary skill in the art ….” No 3-judge panel of the Federal Circuit can simply trump what the Supreme Court held 103 to require. I think most of the judges on the Federal Circuit appreciate this and if given the chance a different panel would decline to follow Bell/Deuel (or the court en banc would overrule), particularly considering their recent record at the Supreme Court.

  7. 10

    In response to comment that 80% identity is too low to satisfy written description, in an article I recently published I surveyed all Lilly-type written description rejections decided by the BPAI that I could find. Six involved percent identity claims similar to the Kubin claim, and in all six cases the board reversed the examiner’s rejection, including cases where the percent identity was as low as 50% or 70%. The board seems to be swayed by applicants who can provide some examples of functional variants, or some sort of structure-function teaching, which might be where Kubin fell down. If you’re interested, the full article is available on SSRN at link to papers.ssrn.com.

  8. 8

    And so written description continues its march to the most insidious doctrine in the patent laws. I’m thinking of a claim construction in my mind – can you guess it? can you guess it? – wrong – sorry, you didn’t “written description” what I was thinking (actually what I was thinking was what would have a posita would have been thinking).

  9. 7

    Dennis: I don’t mean to suggest that we can ignore the latest salvo by the Board. I just think (and even moreso having digested the opinion a little) that they are still using the predictability of the method to assess the obviousness of the product of the method. This is the logic that the CAFC expressly rejected in Deuel, and I don’t think KSR changes that – it may be obvious to try to clone a gene, but was it obvious to obtain THIS gene? The facts here are much better to the BPAI’s position than in Deuel, but a fly in the BPAI ointment is that the art (Matthews) taught that human NAIL mRNA was not expressed in the cell type used to isolate the cDNA for human NAIL. This is more than a teaching away – it increases the unpredictability factor, since you can’t isolate something if you don’t know where it is. And it makes the case factually closer to Deuel, where a cDNA encoding a protein that the prior art taught was specifically expressed in brain was actually isolated from placenta.

  10. 6

    80% identity is pretty low and probably not going to fly. If the % identity was higher, this would have probably helped…

  11. 5

    I’m wondering if Immunex: (a) Appealed directly to the CAFC OR (b) Opted for a trial de novo in front of the District Court in Wash. D.C.?

    Which of these two obvious paths do you think they took?

    (Or are you savvy enough to know that I’m messing with your head by offering you something known as a false choice menu?)

  12. 4

    “And, moreso affirms that biotech is still unpredictable.”

    That’s nice, I suppose. The bigger issue for practitioners and their clients is that “unpredictability” in the most common sorts of biotech cases seems to be a less compelling reason for finding a claim non-obvious these days.

  13. 3

    Kevin, Thanks for the comments. You are right that the Board factually distinguishes Deuel. And, moreso affirms that biotech is still unpredictable. However, the decision also attacks Deuel in a way that cannot be ignored.

  14. 2

    It helps to read the opinion. The distinction with Deuel is factual: unlike in Deuel, the art disclosed a mouse homolog as well as an antibody that cross-reacted with the human protein. Unlike in Deuel, where there was no known other species homolog and the amount of information on the protein sequence was limited, here there was a great deal more information. And, as the case states, the increased level of skill in the art, under these limited circumstances, makes Deuel irrelevant, not overturned.

  15. 1

    Well, the PTO has been itching to overturn Deuel for more than 10 years (in a Science article before KSR came down and Examiner was still complaining about it), but there is a world of difference between isolating a new gene and producing an electronic switch in a gas pedal. Let’s hope the CAFC gets a chance to review this; KSR may provide convenient dicta for the Board to crib in sustaining the rejection, but it shouldn’t pass muster if appealed.

Comments are closed.