Patent Protection of Gene Mutants in China-Part 2

Secondly, as per the limitation of "homology", quote the examiner’s comments of similar patent as "For the mutants defined by "homology", although the formed sequence has certain sequence structure similarity with the original sequence, of course, there are certain differences of sequence structure, and the differences of sequence structure may change the three-dimensional structure of the enzyme, resulting in the change or even loss of its function. Moreover, the specification of this application does not provide an example of amino acid sequence meeting the above conditions and verify its technology effect. Therefore, those skilled in the art cannot expect that all amino acid sequences defined by homology can solve the technical problem to be solved in the application according to the contents fully disclosed in the specification and the prior art. The mutants with open restriction include a large number of mutation sites and different combinations of the sites. The above mutations contain a large number of transaminase mutants whose functions have not been verified, while the specification of this application only verifies the transaminase activity of single point mutants at some sites, some double site and three site combination mutants. Those skilled in the art cannot expect which mutants and their combinations in the above mutations can change the spatial conformation of the protein and affect its function. Moreover, the application does not describe the spatial conformation, functional domain and other information of the enzyme. Therefore, those skilled in the art cannot expect that other mutants other than those verified in the specification of the application still have the function of transaminase and can solve the technical problems to be solved in the application. To sum up, the mutant defined in claim 1 contains the content speculated by the applicant, and its effect is difficult to determine in advance. Therefore, claim 1 is not supported by the description ".

In this case, is the scope of protection finally only the mutant verified by the embodiment in the specification? In fact, it is not absolute. It also depends on the specific contents disclosed in the specification. For example, the five patent invalidation cases filed by Yichang East Sunshine Pharmaceutical Co., Ltd. for the "glucoamylase" series patents owned by Dennisco, the protection of amino acids / nucleotides with mutation sites is involved, and the judgment of the Patent Reexamination Board of the State Intellectual Property Office of which has certain guiding significance. Herein, for CN200880116695.2, the view of the collegiate panel is "When some single point mutations and multiple different combination mutations of these single point mutations have improved performance, it can be reasonably speculated that these single point mutations or combination mutations are related to this performance. Since there are such single point mutations related to performance in the mutation combinations in claims 1, 2 and 3, based on this, the mutation combinations in claims 1, 2 and 3 may also have the same or similar improved performance. The newly combined mutants in claims 1, 2 and 3 can be supported by single mutants and other combined mutants ". Therefore, is it possible to protect a series of combinatorial mutants involving these single point mutations in an open restriction mean as long as it is proved that the single point mutants and several related combinatorial mutations have good performance? As we know, if the specification discloses the relevant research on the spatial conformation and functional domain of the enzyme, the applicant can summarize a reasonable scope based on this, which is "larger range than the mutants verified in the embodiment". However, the current situation is that the research and development of many enterprises are for practical application. Therefore, in the process of mutant research and development, they only need to obtain mutants suitable for industrial production according to their final performance, and there is no need to spend too much manpower and material cost to study the spatial conformation and functional domain of enzyme. In this case, the above cases can give some guidance.

The predictability of the technical effect in the biological field is low, and the experiments can not exhaust all mutation schemes. How to summarize the reasonable scope according to the existing embodiments, or provide what kind of data can support the scope you want to protect, according to the legislative purpose of "matching the protection scope with the technical contribution", it is worthy of serious consideration by the applicant, patent agency and patent examination agency.

Source: en.kangxin.com-Tianyun Jin 

Editor: IPR Daily-Selly