The facts of a legal case
The case has gone through four replies to the review opinions, but the examiner still made a rejection decision, which was revoked after the review request and finally authorized.
After four replies to this application, the claim 1 is as follows:
1, an oral solid pharmaceutical composition, which is characterized by comprising hydrochlorothiazide12.5g, levoamlodipine besylate 2.5g, candesartan cilexetil 8g, microcrystalline cellulose 35g, compressible starch 50g, cross-linked polyvinylpyrrolidone 38g, silicon dioxide10.5g, magnesium stearate/. ..
1) respectively sieve hydrochlorothiazide, candesartan cilexetil and levoamlodipine besylate for later use;
2) respectively drying microcrystalline cellulose, compressible starch, cross-linked polyvinylpyrrolidone, silicon dioxide and magnesium stearate at 70 DEG C for 3 hours, and sieving with a 70-mesh sieve for later use;
3) Weighing the spare levoamlodipine besylate, microcrystalline cellulose, cross-linked polyvinylpyrrolidone, silicon dioxide and magnesium stearate according to the prescription amount, and uniformly mixing by an equal step-by-step method to obtain mixed powder;
4) weighing a specified amount of candesartan cilexetil and hydrochlorothiazide, and uniformly mixing with the mixed powder obtained in step 3) to obtain pharmaceutical composition powder, and sampling for inspection;
5) directly tabletting and coating the obtained pharmaceutical composition powder to obtain a pharmaceutical composition;
Hydrochlorothiazide is a hydrochlorothiazide crystal. In the X-ray powder diffraction pattern measured by Cu-Kα ray, the characteristic peak of hydrochlorothiazide crystal is 4. 1. 、8.2? 、9.8? 、 12. 1? 、 15. 1? 、 16.7? 、 19.3? 、20.0? 、22. 1? 、23.3? 、26.8? Show.
The examiner pointed out that "compressible starch" existed in the preparation step (2) of the components and auxiliary materials of the traditional Chinese medicine composition according to claim 1, but it was not added in the subsequent preparation step. Therefore, the claim 1 does not clearly define the technical scheme to be protected, which does not conform to the provision of Article 26, paragraph 4 of the Patent Law that "the claim shall clearly and concisely define the scope of patent protection". The examiner rejected the application on this ground.
Review request
After receiving the decision to reject the application, the author carefully studied the application and the decision to reject it, and made a request to review the application. He believes that the application is clear and in line with the provisions of Article 26, paragraph 4, of the Patent Law, and requests to cancel the rejection decision. The specific reasons are as follows:
As for the lack of adding "compressible starch" in the preparation step, the applicant thinks that there are only two possibilities, namely, choosing to add it in step (3) or choosing to add it in step (4). In the rejection decision, the third possibility is also pointed out, that is, "it can also mean that the preparation can not contain this ingredient", which the petitioner thinks is not established. As a technician in the technical field to which this application belongs, the ingredients of "compressible starch" have been clearly recorded, and the auxiliary materials of "compressible starch" have also been clearly treated in the preparation step (2) of drying and sieving for later use, so it is necessary to add the auxiliary materials in the following steps. If you don't need to add this auxiliary material, there is absolutely no need to write it in its ingredients, let alone dry and sieve it. Therefore, the requester thinks that this possibility is obviously not based on the knowledge and ability of technicians in their technical fields.
However, as far as this application is concerned, the addition of "compressible starch" can only be added in step (3), and the specific expression is as follows:
The tablets of this application are prepared by direct compression of powder, and in order to mix evenly, this application adopts the equivalent recursive method to mix. For the direct powder tabletting method, the technicians in this field usually mix the main medicine with the auxiliary materials and tabletting, that is, all the auxiliary materials are added together. Especially when the compressible starch is applied to the direct powder tabletting process, the compressible starch is added together with other auxiliary materials, and three comparative documents are provided to prove it. In addition, because the application involves three kinds of main drugs, in order to make the mixture uniform, the application adopts the equal recursive addition method for some main drugs. As for the "equal volume addition method", it is well known to those skilled in the art that when the proportion of components is quite different, the main drug and auxiliary materials can be fully and evenly mixed, and when the content of the main drug is less than 5%, the equal volume addition method is generally adopted. There are three main drugs in this application. According to calculation, the contents of hydrochlorothiazide, levoamlodipine besylate and candesartan cilexetil in the pharmaceutical composition of this application are 8.39%, 1.68% and 5.37% respectively. It can be seen that the content of levoamlodipine besylate is less than 5%. Those skilled in the art will obviously choose to mix the main drug levoamlodipine besylate with the auxiliary materials by equivalent recursive method, and then mix the remaining two main drugs with the obtained mixed powder. Therefore, the requester thinks that it will undoubtedly be chosen by those skilled in the art to join in step (3).
Review notice
In response to this reexamination request, the Patent Reexamination Board issued a notice of reexamination, in which it was pointed out that "compressible starch" existed in the preparation step 2) of drying and sieving the components and auxiliary materials of the Chinese medicinal composition in claim 1, but it was not added in the subsequent preparation step, and the technicians in this field could not determine whether to add "compressible starch" in the preparation step or in which step. Therefore, Claim 1 does not clearly define the technical scheme for protection, which is not in conformity with Article 26.4 of the Patent Law.
In addition, the Patent Re-examination Board further pointed out that the scope of protection of the claim is subject to its recorded scope, and the current claim 1 does not limit the addition of compressible starch in step 3). The opinion statement of the reexamination claimant is inconsistent with the record scope of the current claim, and there is still a contextual inconsistency in the case that the claim has not been amended. Therefore, the opinion statement of the reexamination requester is not enough to overcome the unclear defect of claim 1.
Review reply
Usually, after receiving the notice of review, many agents think it is basically impossible to withdraw the rebuttal. However, is there really no prospect of revoking the application authorization? Does the Patent Reexamination Board not recognize the contents of the applicant's opinion statement? You can only give up? If you think so, you are all wet.
After carefully studying the notice of re-examination, the author thinks that according to the notice of re-examination, "the re-examination board thinks that the current claim 1 is not limited to adding compressible starch in step 3), but the statement of the applicant for re-examination is inconsistent with the scope recorded in the current claim, and there is still a context inconsistency in the case that the claim has not been modified", and it is known that the Patent Re-examination Board accepted the statement of the applicant for re-examination, but only thinks that there is still a context inconsistency in the case that the claim has not been modified. As long as the claim is modified to limit the addition of compressible starch in step 3), the defect of unclear claim 1 can be overcome, which is an enlightening opinion given by the re-examination Committee.
Based on the above analysis, the author revised the claim 1 when replying to the reexamination notice, that is, the "compressible starch" was added between the "microcrystalline cellulose and crosslinked polyvinylpyrrolidone" recorded in step 3) of the claim 1.
And expressed their opinions. 1. The applicant fully declares that the above amendments comply with the relevant provisions of the Patent Law and the examination guidelines, and thinks that adding "compressible starch" between "microcrystalline cellulose and cross-linked polyvinylpyrrolidone" described in claim 1 step 3) is not beyond the scope recorded in the original specification, and can be obtained without doubt from the specification. The specific opinions are as follows:
In the description part of this application, two dosage forms of oral solid pharmaceutical composition are specifically recorded, one is tablet and the other is capsule, and the preparation methods of these two dosage forms are provided respectively. As can be seen from the preparation methods of the two dosage forms, the difference between the two dosage forms is that in the preparation of capsules, wet granulation is added after the mixed powder is obtained, and the addition time of the main drug candesartan cilexetil is different. As for excipients, it can be seen from the preparation method of capsules that all excipients including "compressible starch" are dried and sieved in step 2) and added in step 3). As for the preparation method of tablets, the excipients used are exactly the same as those used in capsules. All excipients are also dried and sieved in step 2), and other excipients except "compressible starch" are also added in step 3). As for the lack of "compressible starch" in the preparation step 3), it is obviously caused by the written error of the requester, and the requester hereby implores the reexamination board.
Secondly, the requester insists on the opinion statement in the reexamination request, and thinks that based on the knowledge and ability of technicians in this technical field, it can be undoubtedly determined that "compressible starch" was added in step 3).
Withdrawal authorization
The Reexamination Committee accepted the applicant's opinion statement, revoked the rejection decision, and soon received the notice of granting the invention patent right.
summary
The patent agent should not despair and give up when receiving the rejection decision. He should carefully analyze the application involved and reject the decision, refute with the examiner according to the law and the review guide, and fully show our views. Many times you will find that the more you write, the more justified you feel, and you will really refute it.