Traditional Chinese medicine compound is often referred to as a traditional Chinese medicine combination in patents, which is composed of multiple Chinese medicinal herbs and has the characteristics of complex pharmacology and significant therapeutic effects. In recent years, with the implementation of the national intellectual property strategy, the high-risk and high investment characteristics of innovative traditional Chinese medicine research and development have determined the importance of patent protection for pharmaceutical companies. However, at present, although the number of applications for traditional Chinese medicine related patents in China continues to increase, the authorization rate has remained low. By comparing the patent contents related to a large number of traditional Chinese medicine compositions, it can be found that the writing of most patent application documents for traditional Chinese medicine inventions is slightly simple and the content is relatively thin. The applicants are not familiar with the relevant provisions of the Patent Law, and ultimately reject them on the grounds of lack of creativity, resulting in a large number of traditional Chinese medicine compositions being unable to obtain legal protection. Therefore, the professional agents of Beijing Gaowo Intellectual Property will analyze the relevant regulations and specific cases in the patent examination process, and discuss how to improve the creativity of traditional Chinese medicine related patents from the perspective of writing, in order to provide constructive suggestions for the writing of traditional Chinese medicine related patents.
[Case 1]
The invention name is: A traditional Chinese medicine composition for treating lumbar disc herniation and its preparation method (publication number CN112807405A).
Claim 1 of the patent discloses the following content: a traditional Chinese medicine composition, characterized in that the traditional Chinese medicine composition comprises 34 medicinal flavors such as Huangqi, Danggui, Danshen, etc., and specifically provides the weight parts of each medicinal flavor. The instructions state that the efficacy of this traditional Chinese medicine combination is mainly to supplement qi and blood deficiency, supplemented by tonifying kidney qi, relaxing meridians and promoting blood circulation, and relieving pain and dampness. It can effectively treat lumbar disc herniation and protrusion, and has a significant effect on treating lumbar stenosis and deformation. At the same time, the manual also provides the efficacy of each component of the traditional Chinese medicine composition and the relationship between the components. However, in the specific implementation examples of the manual, only three sets of implementation examples and two sets of typical case descriptions were listed, without further detailed experimental explanations.
In this patent, the examiner believes that the components of the traditional Chinese medicine composition recorded in its technical solution are all known medicinal flavors in the field of traditional Chinese medicine, and the efficacy of each medicinal flavor can also be routinely searched. As long as all medicinal flavors with relevant efficacy are combined according to the theory of traditional Chinese medicine Bi Tong disease, a traditional Chinese medicine composition with this effect can be obtained. Although this is not consistent with the understanding of researchers in the field of traditional Chinese medicine, in the field of patent applications, examiners generally conduct strict examination of patent application documents based on the public interest, resulting in such patent applications often being rejected on the grounds that their technical solutions can be obtained through conventional experimental methods.
Gaowo's agent suggests that in response to the examiner's examination approach in the patent examination process related to traditional Chinese medicine compositions, a professional patent layout should be carried out from the early stage of patent writing. In addition to the uniqueness of the technical solution, emphasis should also be placed on providing efficacy data. For example, in [Case 1] patent, only two typical cases were described in conclusive language without further verification of the efficacy of the traditional Chinese medicine composition. In this case, even if the formula of the composition has not been publicly disclosed in existing technology, it is difficult to obtain patent protection, which is also the main reason for the rejection of [Case 1] patent. However, this does not mean that providing the pharmacological experimental data of a traditional Chinese medicine composition patent application alone can grant authorization. It is also necessary to set up corresponding control experiments for the invention points or specific optimization and adjustment schemes of the technical solution. From the perspective of common examination by examiners, avoiding problems such as predictable technical effects requires the assistance of professional agents. Below is a further explanation of the patent case 2 written by Beijing Gaowo Agency.
[Case 2]
The invention name is: A traditional Chinese medicine micro powder composition and its application in chicken ecological breeding mode (public number CN113975310A).
The patent was written by Beijing Gaowo Agency, and claim 1 discloses the following content: a traditional Chinese medicine micro powder composition, comprising the following raw materials: seven medicinal flavors including burdock seed, snake bed seed, Changshan, etc., and specifically providing the weight parts of each medicinal flavor. When writing the patent specification, the agent of Gaowo clearly stated that the traditional Chinese medicine composition has antibacterial, antiviral, and inhibitory effects on the growth of pathogenic microorganisms, and provided the efficacy of each component of the traditional Chinese medicine composition and the relationship between the components. And from a professional perspective, the layout is presented. In the specific implementation examples of the manual, relevant examples of the application of the traditional Chinese medicine composition and corresponding comparative ratios after removing important medicinal components are given, providing targeted comparisons of the effects of the traditional Chinese medicine composition and the corresponding control composition after removing important components in chicken farming mode.
When the examiner conducted substantive examination of the patent, two comparative documents were retrieved. The examiner believes that document 1 (public number CN102716238A) discloses a compound Qinghao health powder, which has the functions of preventing and treating protozoa, bacteria, and viral diseases in chickens, is suitable for basic drive and killing of coccidia, and has the effects of deworming, dysentery prevention, antibacterial, and antiviral. Comparison file 2 (public number CN1778189A) discloses a pure traditional Chinese medicine feed additive for laying hens, which can significantly improve feed conversion rate and egg production rate of laying hens. In order to ensure the health of the chicken flock, technicians in this field have the motivation to add components from comparison document 2 on the basis of comparison document 1, and the components and dosages described in this application are also easily selected by technicians in this field.
During the initial stage of drafting the patent application for Case 2, Gao Wo's agent estimated the examiner's perspective in the later stage of examination and verified the efficacy of the traditional Chinese medicine composition in the patent specification, providing a control experiment of the traditional Chinese medicine composition after removing important components. At the same time, the agent also assisted the applicant in the layout of the experimental plan, designed multiple implementation examples and comparison ratios, and conducted effect comparisons, fully confirming the functional interaction relationship between the components of the traditional Chinese medicine composition after combination. It is not just a simple superposition, but the traditional Chinese medicine composition has significant technical effects, providing a basis for the agent's response to the examination opinions in the later stage. Moreover, during the actual examination of the patent, the agent made a strong defense against the examination opinions issued by the examiner based on the layout and professional knowledge of the previous patent content, confirming that the patent solution achieved efficacy beyond existing technology and convincing the examiner. Therefore, even if there are existing technologies with similar technical solutions to the patent, the examiner ultimately recognized the creativity of the patent and granted patent protection.
Based on this, professional agents suggest that when applying for patents related to traditional Chinese medicine compositions, special attention should be paid to the provision of relevant experimental data and the layout of implementation examples and comparative examples in the specification. Relevant experimental data should be provided to confirm the key research and development/optimization adjustments of the composition, and animal experiments or pharmacology related experiments can also be provided. With the assistance of professional agents, the reasonable layout of patent content should be arranged to obtain patent recognition from the State Intellectual Property Office.
Gaowo Intellectual Property has a large number of professional agents with rich experience in handling patent writing, examination opinion response, and reexamination requests related to traditional Chinese medicine compositions, making patent applications for traditional Chinese medicine compositions no longer difficult to authorize!
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