Experiments, tests and their results are very important aspects in the process of research and development, and are also important aspects in patents that protect the achievements of the research and development, especially in the fields of experimental science such as chemistry and biology. However, during actual patent prosecution, due to various reasons, the patent application may not be able to include all experiments and tests performed during development of the invention at the beginning. In some cases, the lack of experiments and tests (usually referred to as “examples” in patent documents) may lead to rejections during examination of patents. Fortunately, in current Chinese patent practice, it is possible to provide supplementary test data during examination in order to overcome related rejections. In this article, specific conditions are discussed where supplementary test data may be applied to overcome rejections during examination of patents.
Relevant regulations in Chinese Patent Law on supplementary test data
There are several explanations in the Guidelines for Patent Examination which can be considered as a legal basis for providing supplementary test data during patent prosecution. In the Guidelines for Patent Examination, it is mentioned that for supplementary test data filed after the application date in order to meet the requirements of Article 22.3 (regarding inventiveness) and 26.3 (regarding sufficient disclosure), the examiner should consider the data during examination, and the technical effects proved by the supplementary test data should be the ones which can be obtained by a person skilled in the art from the disclosure of the application.
In this regard, the Guidelines for Patent Examination gives two examples as follows to further explain the regulation above:
Example 1: The claims set forth compound A, and the description sets forth the preparation examples of compound A, the hypotensive effect of compound A, and the experimental method for determining the hypotensive activity, but does not set forth the result data. The applicant submits supplementary data on the hypotensive effect of compound A in order to demonstrate sufficient disclosure of the description. For person skilled in the art, the hypotensive effect of compound A has been disclosed in the original application, and the technical effect proved by supplementary data can be obtained from the disclosure of the application documents. Note that the supplementary data should also be considered in the examination of inventiveness.
Example 2: The claims set forth compound of general formula I. The description sets forth compound of general formula I and its preparation method, the preparation examples of several specific compounds A and B of general formula I, and the antitumor effect of general formula I, the experimental methods for the determination of antitumor activity and the result data. The experimental results record that IC50 values of the example compounds for tumor cells are in the range of 10-100 nm. To demonstrate the inventiveness of the claims, the applicant submitted comparative experimental data showing an IC50 value of 15nM for compound A and 87nM for compound of reference document 1. For a person skilled in the art, compound A and its antitumor effect are disclosed in the original application, and the technical effects demonstrated by supplementary data can be obtained from the application documents. Kindly note that the examiner still needs to further analyze whether the technical solution of the claim meets the requirements for inventiveness in combination with the supplementary data.
According to the explanations and examples above, it can be seen that the Guidelines for Patent Examination supports application of supplementary test data for overcoming rejections under certain conditions. These conditions will be discussed in detail hereinafter.
Specific rejections that may be overcome by applying supplementary test data
1) Insufficient disclosure
As mentioned in Example 1 above, when the examiner rejects an application for not disclosing test data demonstrating the technical effect of the invention, i.e., insufficient disclosure, it may be helpful to overcome the rejection by filing supplementary test data demonstrating the technical effect. In this case, the technical effect demonstrated by supplementary data must be obtained from the original application. Also, the experimental methods for obtaining the supplementary test data should be disclosed in the original application. We understand that the R&D cycle for some technical fields such as medication can be very long, and the time for performing experiments may delay the time for applying patents. In this case, it may be possible to file a patent application without test data demonstrating the technical effect, and file supplementary test data during examination of the application. This kind of strategy may expedite filing of patent application, but there is also a potential risk that the examiner will not accept the supplementary test data.
2) Lack of inventiveness
As mentioned in Example 2 above, supplementary test data may be used to demonstrate inventiveness of the application over references cited by the examiner. A direct way of doing so is to take the reference documents as comparative examples, and providing test data showing the present invention leads to better results compared to the reference documents. Another approach is to provide test data showing that the present invention achieves unexpected effects in view of the prior art. For example, an application sets forth a specific crystal form of a compound, and the examiner cites a document disclosing the compound but not its crystal form to reject the inventiveness of the application. In this case, if the applicant can provide test data showing unexpected effects of the specific crystal form of the present invention, it may be helpful to overcome the rejection. Note that as mentioned above, the technical effect demonstrated by supplementary data must be obtained from the original application.
3) Lack of support from description
Although not mentioned above, supplementary test data may also be used to overcome lack of support rejection. One of the most common situations for lack of support is the general formula compounds. For example, the claims set forth a compound of a general formula, and the examples of the application only provide test data for a few specific compounds. In this case, the examiner may deem the general formula not supported by the description. To overcome this kind of rejection, it may be helpful to provide test data showing that some other compounds of the general formula have similar properties or achieve similar effects. However, as mentioned in the Guidelines for Patent Examination, the test data filed after the application date is not allowed to be added into the description. Therefore, it is possible that the examiner does not accept the supplementary test data in this case.
To conclude, application of supplementary test data may be helpful in overcoming rejections during examination of patent application, thus providing the applicants more ways to facilitate granting of the patent application, and more flexible strategy of scheduling filing of patent application and performing experiments. After all, according to the Guidelines for Patent Examination, the key point for filing supplementary test data is that the technical effects proved by the supplementary test data should be the ones which can be obtained by a person skilled in the art from the disclosure of the application. In addition, in actual patent practice, the examiner will determine whether to accept the supplementary test data or not on various aspects, such as disclosure of the original application, effects proved by the supplementary data, etc., and the practice of different examiners may vary. Therefore, although supplementary data may be filed after the application, providing all necessary experiments and tests in the original description is still the best choice for preparing application documents.