Due to the special nature of technology, the patent application for invention in the field of Chemistry often requires experimental data to demonstrate the beneficial effects of the invention.
Based on the provisions of 3.4 and 3.5.1 in Chapter 10 of Part II of <GUIDELINES FOR PATENT EXAMINATION>, Chemistry is an experimental science, and a number of inventions in this field need to be verified by experimentation, therefore, the description generally shall include embodiments, in case of an invention of a product, for instance, those which specifically show how to make the product and how to use it. (1) The number of embodiments needed in the description depends on the extent to which the technical features are generalized in the claim, such as the extent of generalization of parallel alternative elements and the range of selected values of data. The number of embodiments needed in a chemical invention varies depending on the nature and the specific fields of technology of the invention. As a general rule, there shall be a sufficient number of embodiments for a person skilled in the art to understand how to carry out the invention and to assess that the invention can be carried out and achieve the effect as expected through the whole of the scope defined by the claims. (2) Whether or not the description is sufficient disclosed is judged on the basis of the disclosure contained in the initial description and claims, for experimental data submitted by the applicant after the application date to meet the requirements of Article 22 (3) (inventiveness) and Article 26 (3) (insufficient disclosure) of the Patent Law, the examiner shall conduct an examination. The technical effect demonstrated by the supplementary experimental data should be able to be obtained by technical personnel in the relevant field from the content disclosed in the patent application.
Based on the above provisions on experimental data in <GUIDELINES FOR PATENT EXAMINATION> and practical experience, we have summarized three common issues related to experimental data that arise in practice for your reference and discussion.
(1) Insufficient number of embodiments or examples, resulting in claims not being supported by the description In an invention patent application for protecting compounds with a certain general formula, as the general formula may cover some substituents, the examiner may issue a supportive opinion in the later examination process. The reason is that the examiner believes that due to the different structures of substituents, the properties of these substituents vary greatly, and not all substituents can produce technical effects that are the same or similar to those of the specific compounds recorded in the embodiments of this application. For example, the substituents of the protected general claims include an aryl group without a heteroatom and a heteroaryl group with a heteroatom, but the embodiments only involve an aryl group without a heteroatom. The examiner generally points out that "Claim 1 contains a large number of compounds with significant structural differences, and those skilled in the art cannot determine that all compounds with a large number of requested protections and significant structural differences from the specific compounds disclosed in this application have the same technical effect as the specific compounds based solely on the specific compounds recorded in the embodiments of this application".
For this, based on the provisions of 5.2.3.1 in Chapter 8 of Part II of <GUIDELINES FOR PATENT EXAMINATION> mentioned above, in the process of responding to the examination opinions in the later stage, if the embodiments and examples of a heteroaryl group containing a heteroatom are added, it is considered an "unacceptable addition", and therefore, the technical solutions that cannot be supported by the description must be removed from the claims. In view of this, the author believes that in the initial stage of writing a new application, the applicant can consider providing as many embodiments and examples as possible that cover substituents with different structures, in order to better support the claims in the description.
(2) The experimental data of the embodiment or example is incorrect, resulting in insufficient disclosure of the description In the process of writing invention patent documents, due to the applicant's error, a certain part of the experimental data recorded in the description is incorrect, leading the examiner to doubt the authenticity of all experimental data in the application documents. For example, in the description of a certain patent application document, the mass spectrometry data of the compound is provided by HPLC-MS: 715.40m/z. However, according to the theoretical molecular weight of the compound of 1036.47, the theoretical mass spectrometry data should be 1035.62m/z. The examiner pointed out in the examination opinion notification that the mass spectrometry data of the compound provided by the applicant is seriously inconsistent with its actual structure, which is not in line with the general understanding in this field. Technical personnel in this field have reasonable reasons to question the authenticity and validity of the experimental data related to this application. In this case, even if the applicant states that the above data was an error at the time of writing and expresses willingness to waive the protection of the compound disclosed in this erroneous embodiment, the examiner does not accept the authenticity and validity of other embodiments and insists on questioning the authenticity and validity of all relevant experimental data in this application.
In view of this, the author suggests that experimental data should be accurately recorded during the new application writing stage, and the experimental data should be double-checked before submitting the new application documents to the Patent Office, so that the description accurately discloses its experimental data and meets the requirements of sufficient disclosure of the description.
(3) The experimental data of the comparative embodiment or example is more effective than the experimental data of the embodiment or example, which raises doubts about the inventiveness of this application In a certain patent application, the comparative example and the example are compared in terms of performance data, but the experimental data of the comparative example is more effective than the experimental data of the example. The examiner pointed out that due to the better experimental data effect of the comparative example compared to the experimental data effect of the example, it is not recognized that the example has unexpected technical effects compared to the comparative example.
In view of this, the author suggests that before submitting a new application, this comparative example can be discarded or some experimental data from other comparative examples can be added, so that the experimental data of the example is more effective than that of the comparative example, so as to avoid being pointed out by the examiner for flaws in the experimental data of the comparative example.
The above are several issues we have encountered regarding experimental data in practice. In the field of Chemistry, experimental data plays a very important role in the process of responding to review comments in the later stage. Therefore, it is necessary to comprehensively verify the quantity, authenticity, and rationality of experimental data to avoid irreparable defects in the process of responding to review comments in the later stage.
