“[A]n invention can often be the recognition of a problem itself.” This may be especially evident where the problem has persisted for a long time without being recognized. Such a “considerable time lapse suggests instead that [an obviousness rejection] only traverses the obstacles to this inventive enterprise with a resort to hindsight.”
Background / Facts: The patent on appeal here from an obviousness rejection on reexamination by the PTO concerns pharmaceutical compositions for the topical treatment of certain skin conditions, e.g., psoriasis. The prior art discloses that psoriasis is commonly treated through a combination treatment of: (1) a vitamin D analog and (2) a corticosteroid. However, physicians tended to prescribe it as a two-drug regimen that required patients to apply one drug in the morning and another at night because a combined dosage did not seem to be as effective. This two-drug regimen generated patient compliance issues, but over the course of a decade had remained the only viable dosing option. After recognizing that the problem was due to a storage stability issue where the two drugs would break each other down over time, the patentee began testing formulations that combined vitamin D analogs and corticosteroids into a single regimen, ultimately arriving at the claimed invention. Nevertheless, the PTO found the combination to be obvious to try.
Issue(s): Whether, in the words of the Board of Appeals at the PTO, “a skilled worker familiar with a wide range of possible ingredients to incorporate into a composition comprising a steroid and vitamin D analog” would have arrived at the patent’s claimed invention.
Holding(s): No. “The inventors of the … patent recognized and solved a problem with the storage stability of certain formulations – a problem that the prior art did not recognize and a problem that was not solved for over a decade. … [A]n invention can often be the recognition of a problem itself. … Here, the prior art either discouraged combining vitamin D analogs and corticosteroids in a single formulation, or attempted the combination without recognizing or solving the storage stability problems associated with the combination.” In several places, the court chastised the PTO for a “hindsight-guided” analysis. “By brushing aside the storage stability issue, the Board erred by collapsing the obviousness analysis into a hindsight-guided combination of elements.” The court criticized in particular the age of the references being combined in an allegedly obvious manner, noting that “combining [the cited art] and vitamin D to address the side effects of a steroid treatment is only straightforward in hindsight. [The cited art] was publicly available in the prior art for twenty-two years before the … patent was filed, yet there is no evidence that anyone sought to improve [it] with vitamin D.”