A problem to be solved that forms the basis of a reason to combine the prior art must be known in the art or derived directly from the prior art to avoid the impropriety of hindsight bias. Here, for example, the problem of solubility to be solved by the proposed combination of prior art references was found to be improperly derived from the challenged claims themselves because the prior art made no mention of limited solubility. “Defining the problem in terms of its solution reveals improper hindsight in the selection of the prior art relevant to obviousness.” This would be a good case to consult and cite in response to an asserted motivation to combine that has no basis in the prior art or general understanding.
Background / Facts: The patents on appeal here from inter partes review proceedings at the PTO are directed to a controlled-release oral dosage form of a soluble drug and a method of use thereof. The prior art references cited by the petitioner in an assertion of obviousness both teach controlled-release profiles of formulations that are similar to each other and have overlapping drug-to-polymer ratios. However, the prior art makes no mention of limited solubility and only depicts drug release profiles up to seven hours.
Issue(s): Whether the petitioner improperly used hindsight by defining the problem to be solved by the proposed combination of prior art references with a recitation of the challenged claims.
Holding(s): Yes. “[T]o the extent that [the petitioner] relies on the problem to be solved to supply the reason to combine the prior art, it failed to demonstrate to the Board that the problem was known in the art or that [its] formulation of the problem was derived directly from the prior art, rather than from the challenged claims. The Board therefore did not err in finding that [the petitioner] improperly relied on hindsight in formulating the problem to be solved. [] ‘Defining the problem in terms of its solution reveals improper hindsight in the selection of the prior art relevant to obviousness.’” Moreover, in light of “the large number of formulation considerations in play when designing a drug formulation” and the lack of explanation concerning modification “without affecting the other desired properties,” there is nothing to establish that the proposed modification “would have been reasonably expected to lead to a dosage form that satisfies the other limitations of the challenged claims.”