As a patent agent, the creative three-step method is simply a familiar daily compulsory course! When it comes to the three-step method, what must immediately appear in each agent's mind is "to judge whether the claimed invention is obvious relative to the existing technology, usually according to the following three steps: (1) to determine the closest existing technology ... (2) to determine the different technical characteristics of the invention and the technical problems that the invention actually needs to solve ... (3) to judge whether the claimed invention is obvious to the technology in this field.
The deepest feeling in practice is that in the process of judging whether the third step of the three-step method is obvious, it is often necessary to consider whether the invention has achieved unexpected technical effects. If there is such an effect, it will be much easier in the process of creative argumentation. However, in the process of review, examiners often find comparative documents with the same technical field, similar technical schemes and similar technical effects through retrieval. At this point, the examiner often thinks that the difference between this application and the comparison document and the "technical effect" brought by this difference are "obvious". What should I do?
Next, let's look at a case:
The application program
The application relates to an omeprazole enteric-coated capsule, which comprises capsule shell and omeprazole pellets contained in capsule shell. The pellets consist of a pellet core, an alkali layer, an isolation layer, an enteric-coated layer and an outer layer in turn from inside to outside, and the specific composition, dosage and preparation method of each layer are defined.
* * Comparison file 1 **
The reference file 1 discloses an omeprazole enteric-coated capsule, and specifically discloses the following technical information:
Preparation of (1) moth pill: weighing 7.0kg of omeprazole, 8.86 kg of starch/kloc-0, 7.0 kg of dextrin, 2.28 kg of sucrose/kloc-0, 3.08kg of sodium carbonate and 945kg of sodium carboxymethyl cellulose respectively, and sieve with 80 mesh sieve; Dissolve 2.8 kg of sucrose with 8.4 kg of purified water, add 224 g of sodium carbonate, and stir evenly to make a solution; Mixing omeprazole, starch, dextrin, sodium carboxymethyl cellulose, remaining sucrose and sodium carbonate in a mixer; Put the dry powder into the centrifugal studio of LBZ- 1000 centrifugal fluidized coating granulator, spray the solution evenly on the dry powder by a spray gun to make pellets, and take the pellets between 18-24 mesh as qualified mother pellets; Drying the mother pill with hot air at 40-50 DEG C for 3 hours; The qualified mother pill is about 45kg.
(2) Coating of isolation layer: weighing 3.6kg of hydroxypropyl methylcellulose, 0.72kg of talcum powder, 0.54 kg of PEG-6000 and 32.4kg of purified water to prepare an isolation layer coating solution, coating the prepared 45kg pellets with isolation layer in LBL-200 fluidized bed granulating and coating machine, and controlling the temperature of the coating material at 35-45℃; The coating process takes about 2.5 hours, and the coated pellets pass through the 16 mesh sieve.
(3) enteric coating: 42.0kg Kollicoat Mae 30DP, 1.26kg of triethyl citrate, 1.4kg of titanium dioxide, 4.4kg of talcum powder and 42kg of purified water are weighed to prepare an enteric coating solution, and the pellets are coated with an isolation layer continuously, and the temperature of the coating material is controlled at 35-40 DEG C.. The coating process takes about 9 hours, and the coated pellets pass through the 16 mesh sieve.
(4) Pellet filling: check the content of omeprazole in pellets, and calculate the filling weight of pellets according to 20mg/ pellet; Using NJP- 1200-A hard capsule filling machine, the pellets were filled into No.2 hard capsule, and the filled capsule was polished.
The reference document 1 also discloses the release rate and acid resistance effect of three capsule samples. At 1 month, the release rates were 9 1.2%, 90.5% and 9 1.5% respectively, and the acid resistance was 94.5%, 94.8% and 95.0% respectively. At 6 months, the release rates were.
The examiner thinks that the difference between the claim 1 of this application and the reference document 1 is that the claim 1 also includes an outer layer, while the outermost layer of the reference document 1 is an enteric layer, and the mass ratio of each layer in the pellet prescription is also different from inside to outside; (2) The raw materials and dosage of each layer are slightly different, and the preparation methods are also different.
In view of the above differences, the examiner thinks that under the technical enlightenment that sodium carbonate in the mother pill disclosed in the reference document 1 is divided into two parts, one part is coated after being mixed with sucrose solution, and the other part is left in the pill core, the technicians in this field can easily think of adjusting the raw materials and dosage in the so-called "alkali layer", and it is easy to replace sodium carbonate with ordinary sodium phosphate (such as sodium dihydrogen phosphate), while the others are based on the so-called pill core and alkali layer. As well as the choice of auxiliary materials and their dosage in the coating of isolation layer and enteric layer, are all easily realized by ordinary technical knowledge by technicians in the field according to the teaching of the comparison document 1. Under the condition of determining the proportion, according to the conventional steps and limited tests, the preparation method required by claim 1 can be obtained, and the effect is predictable. After two OA replies, the examiner rejected the application.
The applicant transferred the case to our company, and the author requested to review this rejection decision. In the re-examination request, the author thinks that the basic sodium salt is divided into two parts in the preparation process of the pill core of this application and the mother pill of the reference document 1. One part is mixed with omeprazole to make dry powder, and the other part is mixed with water to make solution, which is sprayed on the dry powder with a spray gun. The main pill in the comparison document 1 is actually equivalent to the pill core of this application, excluding the alkali layer of this application. The reference document 1 does not give the enlightenment that "sodium carbonate can be used in two parts" and "the setting of alkali layer" can solve the problem that "sodium carbonate cannot be released and destroyed within 2 hours after oral administration, but it can be fully and timely released within 2 hours", and the prior art does not give any teaching on this. Furthermore, combined with the test results of this application, it shows that the claim 1 of this application solves the problem that it will not be released and destroyed within 2 hours after oral administration, and it can be completely released in time after 2 hours, with better stability.
In the process of examination, the collegial panel adopted the author's opinion. First of all, the collegiate bench thinks that compared with the reference document 1, the technical scheme of this application actually solves the problems of insufficient release and poor stability of the existing omeprazole enteric-coated capsules after oral administration. According to the record in the comparison document 1, the technical problem to be solved is the product quality and safety production risk caused by using plasticizer diethyl phthalate and ethanol in the existing prescription, so a scheme to solve this technical problem by replacing the enteric coating material is put forward. It can be seen that the comparison file 1 is different from the technical problems to be solved in this application.
Secondly, the collegiate panel thinks that the reference document 1 does not disclose the alkali layer structure coated outside the pill core described in the claim 1 of this application, nor does it disclose or imply that adding the alkali layer structure can solve the release and stability problems, nor does the reference document 1 give any explanation on other distinguishing features. Therefore, on the basis of the comparison document 1, the technicians in this field have no motivation to increase the alkali layer structure of pellets, nor can they obviously obtain the technical scheme required by claim 1. According to the comparative test recorded in the specification of this application, it can be seen that the technical scheme of adding alkali layer structure in this application has achieved the effect of improving the release rate, that is, dissolution rate and acid resistance. Therefore, this application is creative compared with the reference document 1.
Final results
The application was patented.
Summarize the above cases.
In the actual trial stage of the above cases, the recorded technical features and the technical effects brought by different technical features were "unfortunately" considered as "obvious" by the examiner. However, what made this case finally authorized?
Careful readers can easily find that in the process of examining a case, the collegial panel is most concerned about whether there is enlightenment in the existing technology, so that technicians in this field can apply this distinguishing feature to the nearest existing technology to solve its technical problems. In the case, the collegial panel held that the comparison document 1 did not solve the problems of insufficient release and poor stability of omeprazole after oral administration.
The above cases also give some enlightenment to patent writing and reply to examination opinions:
When writing an application, the most important thing is to find out the innovation points of the application relative to the existing technology, and list the appropriate technical effects on this basis. We should not reduce the technical effect we should have because we are afraid of being mentioned in the comparison document. When writing, it will be very helpful to search for relevant existing technologies. Understanding the prior art can more specifically highlight the technical advantages of the present invention. After all, there is a saying that "know yourself and know yourself, and fight every battle"!
When replying to the review opinions, we should carefully analyze the review opinions and find out the relationship between the "distinguishing technical characteristics" and "technical effects" evaluated by the examiner.
With the rapid development of science and technology today, examiners may not always be at the forefront of scientific development in this field. Therefore, many examiners' opinions are not necessarily accurate, for example, the identification of different technical characteristics is not accurate enough, and their opinions are not conclusive. They just put forward their own opinions (or guesses), hoping that the applicant will clarify and explain his invention, so as to identify whether his review opinions are correct.
The patent agent should make full use of this opportunity, communicate with the applicant as much as possible, fully understand the technical advantages of this application, fully show it to the examiner, and reasonably analyze whether the existing technology has "enlightenment" to obtain the technical scheme required by this application.
Patent agents should also face up to the examiner's "wise after the event" opinion, which is human nature. After all, the examiner will make a judgment after seeing the invention, and it is not easy to make an objective judgment completely from the perspective of an uncreative "technical person in this field". In this case, it should be fully explained to make the examiner aware of the creativity of the invention.
In addition, in view of the examiner's opinion that "it belongs to common sense/common technical means" and "it can be obtained through limited experiments", we can also consider providing some common sense and some evidence to supplement the experimental data to prove that the existing technology cannot "inspire" the technicians in this field to obtain this application.
Of course, in the trial stage, the patent agent also needs to make appropriate amendments to the claims when necessary. At this time, we should pay attention to the principle of estoppel, that is, if the patentee restricts the scope of the claim (such as restrictive modification or interpretation) in order to meet the statutory authorization requirements in the process of patent examination and approval (including the examination process of patent application or the procedure of invalidation, objection and retrial after patent authorization), then when claiming the patent right, the content abandoned through this restriction shall not be included in the patent right.