In the chemistry and medicine related field with low predictability, it is generally difficult to anticipate or predict whether an invention can be implemented or what technical effects an invention can achieve. Therefore, experimental data are generally required in the original disclosure to demonstrate enablement and technical effect of the invention. Generally, the experimental data provided in the original disclosure would be presumed to be true based on the principal of good faith. If the experimental data have obvious defects, however, the authenticity of them would be questioned.
Several recent cases show that the Patent Reexamination Board's (PRB) begins to pay increasing attention to authenticity of the experimental data disclosed in the original disclosure, especially when patentability of an invention is based on an unexpected technical effect. If the experimental data serving as a basis for the unexpected technical effect are identical with substantively different formulations or compositions, or are contrary to common sense without reasonable explanations, the authenticity of the data may be questioned and rejected. As a result, the invention would not be considered to achieve an unexpected technical effect.
In this case, the PRB was skeptical with the experimental data in the original disclosure and investigated the experimental data in other related applications from the same applicant. The PRB concluded based on investigations that the experimental data used for demonstrating synergic effect in the original disclosure were not reliable, and finally upheld the rejection decision for its lacking of an inventive step in the reexamination decision.
Specifically, the invention involved in this reexamination decision related to an emulsion for mask comprising a Chinese medicine of bletilla striata as an active ingredient, Nisin and 3-iodo-2-propynyl butylcarbamate (IPBC) as antiseptic agents, and other conventional components such as a humectant all in specific amounts. The petitioner argued for inventive step of the invention mainly based on a synergic effect resulting from the combination use of Nisin with IPBC illustrated in the working examples.
When investigating the reexamination request of the above invention, the PRB found another eight applications filed by the same applicant at nearly the same time. In all of these eight applications, working examples were implemented using different active ingredients and auxiliaries in different amounts. However, the experimental results obtained in these eight applications were identical to the results given in the invention at issue. Therefore, the PRB questioned authenticity of the experimental data, because completely identical experiment results obtained in a series of nine applications using different parameters did not comply with general rules of scientific experiment. As a result, the PRB did not accept or take the claimed synergic effect into consideration when evaluating inventive step. The PRB evaluated the inventive step based on the common effect predictable from the prior art, and finally rejected the invention for its lacking of an inventive step.
In this case, the PRB questioned the comparative results between a working example and a comparative example because the result was contrary to common sense and no reasonable explanation was provided. The PRB finally upheld the rejection decision for lacking of an inventive step in the reexamination decision.
Specifically, the invention involved in this reexamination decision related to a flame retarder comprising a polymer having a specific molecular weight and a specific amount of sulfonic acid group. The petitioner argued for inventive step of the invention mainly based on an unexpected technical effect of achieving excellent flame retardancy with a small amount of sulfonic acid group. The unexpected technical effect had been demonstrated by a comparison between a working example and a comparative example, while it was well known in the art that the flame retardancy was enhanced by the increasing amount of the sulfonic acid group.
The PRB questioned the experimental results of comparison for the following reasons. It was well known in the art that the higher amount of sulfonic acid group would result in improved flame retardancy. Although the flame retardant polymer in the comparative example had a greater more amount of sulfonic acid group than that in the working example, the flame retardancy in the former was significantly lower than the latter. Such a comparison result was obviously contrary to the common sense in the art. Thus, the authenticity of the comparison result between the comparative example and the working example was compromised. Besides, although the petitioner offered explanation in combination with evidence that the improved flame retardancy might be resulted from improved compatibility and dispersibility, the claimed evidence could not serve as an effective basis for determining the technical effect of the invention. Further, although the petitioner explained that the deteriorated flame retardancy might be resulted from an increased molecular weight, this explanation was not reasonable enough because identical level of flame retardancy was reported in two different examples with substantially the same amounts of sulfonic acid and significantly different molecular weights. Therefore, the arguments and the evidence provided by the petitioner were not reliable enough to support its intent, and it is contrary to the common sense in the art. As a result, the PRB did not accept the alleged unexpected technical effect, and finally rejected the invention for lacking of an inventive step.
Although both of the cases are finally rejected by the PRB, the rationale is somewhat different. The case A reflects application of the increasingly emphasized principle of good faith in patent examination practice. In the case B, however, the rejection could have been avoided if an additional study had been carried out to find out the factor(s) working synergistically with the lower amount of sulfonic acid group and such factor(s) had been disclosed in the original specification. In summary, more attention are needed to pay on preparing experimental data in applications of chemistry and medicine related field.