In re Kubin (Fed. Cir. 2009), 08-1184.pdf (Opinion by Judge Rader)
In a much anticipated biotech case, the Federal Circuit has affirmed a BPAI obviousness decision and in the process expanded the court's obvious to try jurisprudence. The Kubin opinion found that the Supreme Court's KSR decision overturned In re Deuel and its admonition against an "obvious to try" test for obviousness.
To be clear, Kubin does not hold that an invention that was "obvious to try" was necessarily obvious under Section 103(a). Going forward, however, the question in this long-running debate will be "when is an invention that was obvious to try nevertheless nonobvious?" (quoting In re O’Farrell, 853 F.2d 894 (Fed. Cir. 1988).
Kubin revives the O'Farrell analysis of obvious to try and carves-out two factual situations where obvious-to-try analysis should not apply.
(1) Throwing darts versus a finite number of Identified, predictable known options:
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.
(2) Exploring new technology versus improving known and predictable technology:
[An] impermissible “obvious to try” situations occurs where 'what was “obvious to try” was to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it.' (Quoting O'Farrell).
Again, KSR affirmed the logical inverse of this statement by stating that § 103 bars patentability unless “the improvement is more than the predictable use of prior art elements according to their established functions.”
Application: In this case, the court finds that neither of the O'Farrell exceptions apply. The invention is old-school biotech: isolating and sequencing a human gene that encodes for a protein. People do this in high school now, and the application explicitly states that the DNA and Protein sequence may be obtained through "conventional methodologies known to one of skill in the art." Likewise, the protein in question had already been identified and the prior art suggested that the protein plays an role in human immune response.
KSR moves to Non-Predictable Arts: Biotech has traditionally been thought of as unpredictable. Here, Judge Rader may have dismantled the art-level distinction in holding that KSR applies to the unpredictable arts. The issue rather is if the particular invention in question was predictable.
Therefore this court cannot deem irrelevant the ease and predictability of cloning the gene that codes for that protein. This court cannot, in the face of KSR, cling to formalistic rules for obviousness, customize its legal tests for specific scientific fields in ways that deem entire classes of prior art teachings irrelevant, or discount the significant abilities of artisans of ordinary skill in an advanced area of art.
- Kevin Noonan provides an important critique of the case - focusing primarily on the court's mishandling of the factual issues. [Link].
- I should note here that the PTO is well ahead of the Federal Circuit. MPEP 2141 indicates that being "obvious to try" is a proper rationale to "to support a conclusion of obviousness." The big book does hint that such an application would only be proper if the "trying" means "choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success."
- This case makes clear that the level of enablement of the prior art is very important to any obviousness conclusion. That result is in contrast to the recent Gleave case that found anticipation absent known utility.