However, judging from the notice of review opinions received at present, the author thinks that the use of "three-step method" by examiners is sometimes too simple and mechanical. A problem that can't be ignored is that although the technical features distributed in different comparison documents are "combined" together to cover the technical scheme required to be protected; However, for those skilled in this field, is there any enlightenment in the prior art to form such a "combination" so as to solve the technical problems actually solved by the claimed invention? To answer this question objectively, the first problem is to determine what the enlightenment of the existing technology is.
The author wants to talk about his understanding of the enlightenment of the existing technology. The author believes that the enlightenment of the existing technology includes two aspects:
First of all, in the closest prior art, does the claimed invention need to solve any technical problems?
Secondly, is each distinguishing technical feature of the claimed invention relative to the closest prior art disclosed by another (or several) prior art? And the two have the same effect?
In short, the author believes that the enlightenment of existing technology includes the inspiration of "finding technical problems" and the inspiration of "finding technical solutions to technical problems". When judging whether an invention has outstanding substantive characteristics, we should consider both; Both are equally important and should not be biased.
However, in the existing review practice, examiners mostly piece together technical features to cover technical means that need protection, and then evaluate creativity, ignoring the technical problems to be solved whether there are inventions that need protection in the closest existing technology.
Let's discuss the role of "the revelation of finding technical problems" in creative judgment through a specific case.
The patent application number involved is 201310551574.3.
Claim 1 and 2:
1. A celecoxib solid composition with increased dissolution, characterized in that the celecoxib solid composition consists of celecoxib, a dispersion promoter and an alkaline compound, wherein the mass ratio of celecoxib, the dispersion promoter and the alkaline compound is100: 5-95: 0.1-/kloc. The D90 of the solid composition of celecoxib is between 5 and 20. Within m.
2. The celecoxib solid composition according to claim 1, characterized in that the celecoxib solid composition is a powder obtained by co-grinding celecoxib, a dispersion promoter and an alkaline compound.
According to the claim 1, the examiner cited two comparative documents in the first notice of examination opinions, namely, comparative document 1 (CN 10326385A) and comparative document 2 (research progress of methods to improve the dissolution of insoluble drug solid preparations) to evaluate its creativity.
Examiners believe that the reference document 1 discloses a suspension of celecoxib, which consists of at least one drug particle, wherein the effective drug is celecoxib, and the effective average particle size of the particles is 200-3000 nm. The suspension contains at least one surface stabilizer, and the injection can be packaged in the following forms: the particles of the injection are stored in one container in dry powder state, and the solution of the prepared suspension is stored in another container, and the two are mixed into the suspension for injection before injection. The reference document 1 discloses that the preparation greatly improves the solubility and bioavailability of celecoxib.
Therefore, compared with the contents disclosed in the reference document 1, the technical features of the technical scheme claimed in the claim 1 of the present invention are as follows: (1) The former defines the mass ratio of celecoxib, dispersion promoter and alkaline compound and the D90 celecoxib solid composition; (2) The former makes it clear that the solid composition consists of celecoxib, dispersion promoter and alkaline compound; (3) The former confirmed that the solid component of celecoxib increased the dissolution rate.
At the same time, the examiner thinks that the mass ratio in the difference (1) can be determined by the technicians in this field according to the actual needs. On the basis of comparing the document 1 which has already published that "the effective average particle size of particles is 200-3000 nm", the range of D90 is easy for the technicians in this field. As for the difference (2), on the basis that the reference document 1 has disclosed that the dry powder particles of injection can be stored separately from the solution of suspension, it is easy for those skilled in the art to think that all the solid components in the preparation are stored in a container in a dry powder state and then mixed with water for injection before use; As for the difference (3), on the basis of the comparison document 1 "This preparation greatly improves the solubility and bioavailability of celecoxib", it is obvious to those skilled in the art that it has an increased dissolution rate.
Therefore, the examiner thinks that it is obvious that the technical personnel in this field can obtain the technical scheme requested by Claim 1 on the basis of the comparison file 1, so Claim 1 does not meet the provisions of Paragraph 3 of Article 22 of the Patent Law.
Moreover, for Claim 2, the examiner thinks that Reference Document 2 discloses that the dissolution of drugs can be improved by grinding drugs and excipients, granulating and tabletting. When tamarind powder is used as excipient and the ratio of 1:4 is used to grind celecoxib, the dissolution rate of celecoxib is obviously improved. Because the crushing method of airflow crushing combined with high-pressure homogenization adopted in reference document 1 requires higher equipment, and because in order to solve the production cost, on the basis that reference document 2 discloses that the dissolution of drugs such as celecoxib can be improved by adopting the method of * * * simultaneous crushing, it is easy for people skilled in the art to think of replacing the crushing process with the method of * * * simultaneous crushing, and its technical effect can also be expected by people skilled in the art. Therefore, the claim.
However, in the process of careful analysis and comparison of document 1, the author found that:
The reference document 1 clearly points out that "however, it is difficult to reduce the particle size of celecoxib to less than 5 microns by conventional drug crushing methods, and it is even more impossible to effectively control the particle size ..." In order to solve the above problems, the reference document 1 "uses airflow crushing to pretreat celecoxib, so that the raw material of celecoxib is changed from needle-like to granular micro-powder, which reduces the adsorption of celecoxib and improves its fluidity. Subsequently, celecoxib after airflow pulverization was blended into suspension for high-pressure homogenization by adding surface stabilizer, and then celecoxib was prepared into nano-suspension through high-pressure homogenization. "
It can be seen that the technical enlightenment given by the reference document 1 is: "It is difficult to reduce the particle size of celecoxib to less than 5 microns by conventional drug crushing methods, and it is even more difficult to effectively control the particle size. Therefore, when preparing celecoxib nano-suspension, it is necessary to pretreat celecoxib by airflow pulverization to change the raw material of celecoxib from needle-like to granular micro-powder, then add surface stabilizer to prepare celecoxib after airflow pulverization into suspension that can be used for high-pressure homogenization, and then use high-pressure homogenization to further reduce the particle size of celecoxib. "
However, "* * * grinding" in Reference Document 2 only grinds drugs and excipients together, which obviously belongs to the "conventional drug grinding method" mentioned in Reference Document 1. Therefore, under the technical enlightenment of the comparison document 1 "It is difficult to reduce the particles of celecoxib to below 5 microns by conventional drug crushing methods", people in the field will never think of adopting the "* * *" conventional drug crushing method to reduce the particles of celecoxib. Moreover, the ultimate goal of reference document 1 is to provide a long-acting nano-release injection. Obviously, there is no technical enlightenment from the combination of reference document 1 and reference document 2 in "* * * grinding". Replacing the grinding process of reference document 1 with the grinding method of reference document 2 will not only make the technical effect of reference document 1 even more serious, it will be difficult to achieve the technical effect that reference document 1 could have achieved.
So it finally comes down to the enlightenment of the existing technology. The author has reason to think that after reading the closest existing technology (reference document 1), the technicians in this field have no motivation to improve the technical scheme of reference document 1 (using * * * simultaneous grinding instead of grinding process) and further solve the dissolution problem on the basis of ensuring to solve the original problems of reference document 1.
In other words, the prior art not only does not give the technical enlightenment of applying the technical features disclosed in reference file 2 to the nearest prior art (reference file 1) to solve the defects existing in reference file 1; Moreover, on the contrary, the technical instruction obtained by the technicians in this field is that the comparison file 1 cannot be combined with the comparison file 2, because the combination of the two will not solve the technical problems of the comparison file 1, let alone replace the technical means of the comparison file 1 to obtain better technical effects.
After analyzing this, the author merged claim 2 with claim 1 in a reply, and submitted the revised claim and opinion statement. The examiner adopted the author's opinion, and only pointed out some other formal defects in the second review opinion, and the author authorized it after modification.
Here, the author wants to further talk about the understanding of "three-step method" in combination with this application.
Patent Examination Guide (20 10), Part II, Chapter 4, 3.2. 1. 1, judging creativity in three steps: (1) determining the closest existing technology; (two) to determine the significant technical characteristics of the invention and the technical problems actually solved by the invention; (3) Judge whether the claimed invention is obvious to the technical personnel in this field. ..
Regarding the creativity of claim 1 in this application, the author's disagreement mainly lies in his understanding of the second step and the third step.
(1) For the second step, when determining the distinguishing technical features of the invention and the technical problems actually solved by the invention, the Review Guide stipulates: "In the review, the technical problems actually solved by the invention should be objectively analyzed and determined. Therefore, firstly, the distinguishing features of the claimed invention should be analyzed by comparing with the closest prior art, and then the technical problems actually solved by the invention should be determined according to the technical effects achieved by the distinguishing features. In this sense, the technical problem actually solved by the invention refers to the technical task of improving the closest existing technology to obtain better technical effects. "
(2) For the third step of "judging whether the claimed invention is obvious to the technicians in this field", the Review Guide stipulates that it is necessary to judge whether the claimed invention is obvious to the technicians in this field from the closest existing technology and the technical problems actually solved by the invention. In the process of judgment, it is necessary to determine whether there is some technical enlightenment in the existing technology as a whole, that is, whether the above-mentioned distinguishing features are given in the existing technology to solve its existing technical problems (that is, the technical problems actually solved by the invention), which will give the technicians in this field the motivation to improve the recent existing technology and obtain invention protection when faced with technical problems.
Specifically, according to the claim 1 of the present invention, from the technical problems to be solved in the comparison document 1, it is completely impossible to solve the dissolution problem (both technical effects cannot be achieved at the same time, and one technical effect must be sacrificed). Therefore, it is impossible for a person skilled in the art to obtain the technical means of claim 1 by changing the technical scheme of reference document 1.
The author thinks that when judging whether an invention has outstanding substantive characteristics, we should fully consider the enlightenment of existing technology, including the enlightenment of putting forward technical problems and the enlightenment of putting forward technical solutions, and the two should not be neglected. Otherwise, it will be unfair to many inventions that are not authorized because of creativity.