Receiving a rejection decision is probably not uncommon in a patent attorney’s career. I often hear some colleagues tell the parties after receiving the rejection decision: The examiner of this case has issued a rejection decision, and the possibility of review and withdrawal is relatively small. It is recommended not to review... But from the author’s many years of experience in the industry It seems that rejection is not terrible. As long as we follow the law and follow the "Examination Guidelines", we can refute it with the examiner with reasonable grounds and fully express our views. We may refute it and then withdraw it. In this article, the author will share with you a case of authorization after the rejection decision was revoked.
Facts of the case
This case went through four responses to examination opinions, but the examiner still made a decision to reject it. After a request for review, the rejection decision was revoked and the authorization was finally granted.
After four replies to this application, claim 1 is as follows:
1. An oral solid pharmaceutical composition, characterized in that the pharmaceutical composition The material consists of 12.5g hydrochlorothiazide, 2.5g levamlodipine besylate, 8g candesartan medoxomil, 35g microcrystalline cellulose, 50g compressible starch, 38g cross-linked polyvinylpyrrolidone, 1.5g silicon dioxide and stearin It is made from 1.5g of magnesium phosphate. The preparation method of the pharmaceutical composition is as follows:
1) Sieve hydrochlorothiazide, candesartan medoxomil and levamlodipine besylate respectively and set aside;
2) Bake microcrystalline cellulose, compressible starch, cross-linked polyvinylpyrrolidone, silicon dioxide and magnesium stearate at 70°C for 3 hours respectively, pass through a 70-mesh sieve, and set aside;
3) Weigh the above-mentioned spare, levamlodipine besylate, microcrystalline cellulose, cross-linked polyvinylpyrrolidone, silicon dioxide and magnesium stearate according to the prescription amount, and use equal amounts to Add and mix to obtain a mixed powder;
4) Weigh the prescribed amount of candesartan medoxomil and hydrochlorothiazide, mix with the mixed powder obtained in step 3) to obtain a pharmaceutical composition powder, and take a sample Detection;
5) The obtained pharmaceutical composition powder is directly compressed into tablets and coated to obtain the pharmaceutical composition;
The hydrochlorothiazide is hydrochlorothiazide Crystal, the characteristic peaks in the X-ray powder diffraction pattern of the hydrochlorothiazide crystal measured using Cu-Kα rays at 2θ are 4.1?, 8.2?, 9.8?, 12.1?, 15.1?, 16.7?, 19.3?, 20.0? , 22.1?, 23.3?, 26.8? are displayed.
The examiner pointed out that “compressible starch” exists in the preparation step (2) of drying and sieving the components and excipients of the pharmaceutical composition in claim 1 for later use, but in the subsequent preparation steps It lacks the addition of "compressible starch". Therefore, claim 1 does not clearly define the technical solution for which protection is sought, and is inconsistent with the provisions of Article 26, paragraph 4 of the Patent Law, which states that “the claim shall...clearly and briefly define the scope of patent protection required”. The examiner rejected the application on this basis.
Reexamination request
After receiving the rejection decision of the application, the author carefully studied the application and the rejection decision, filed a review request for the application, and believed that the application was clear and consistent with the requirements. In accordance with the provisions of Article 26, Paragraph 4 of the Patent Law, the petitioner requested to revoke the rejection decision. The specific reasons are as follows:
As for the lack of "compressible starch" in the preparation step, the petitioner believes that there are only two defects. Possible, that is, choose to join in step (3) or choose to join in step (4). The third possibility also pointed out in the rejection decision is that "it can also mean that the preparation does not need this component when preparing the preparation." The petitioner believes that this possibility cannot be established. As a person skilled in the technical field to which this application belongs, the component "compressible starch" has been clearly recorded in the components. In the preparation step (2) of drying and screening the auxiliary materials for use, it is also clear that "compressible starch" is included in the preparation step (2). "If this auxiliary material has been processed accordingly, it must be added in subsequent steps. If there is no need to add this kind of auxiliary material, there is no need to write it in its components, let alone drying and sieving it.
Therefore, the petitioner believes that this possibility is obviously not evaluated based on the knowledge and abilities of those skilled in the technical field.
However, as far as this application is concerned, the addition of "compressible starch" can only be added in step (3). The specific opinions are as follows:
The tablets of this application adopt It is prepared by direct powder compression method, and in order to mix evenly, this application adopts the equal-amount incremental mixing method. For the direct powder compression method, those skilled in the art usually mix the main drug and excipients together and then perform tableting, that is, all the excipients are added together, especially when compressible starch is used in the direct powder compression process. The compressible starch is added together with other auxiliary materials, and three comparative documents are provided to support it. In addition, since the application involves three main drugs, in order to ensure uniform mixing, the application adopts the equal-amount incremental method for some of the main drugs. As for the "equal addition method", it is well known to those skilled in the art that during preparation, when the proportions of the components are very different, the equal amount addition method can be used to fully mix and evenly mix the main drug and auxiliary materials. The equal amount addition method is generally used Used when the main drug content is less than 5%. This application contains three main drugs. After calculation, in the pharmaceutical composition of this application, the content of the main drug hydrochlorothiazide is 8.39, the content of levamlodipine besylate is 1.68, and the content of candesartan cilexetil is 5.37 . It can be seen that the content of the main drug levamlodipine besylate is less than 5. Those skilled in the art will obviously choose to mix the main drug levamlodipine besylate and the excipients in equal amounts, and then mix the remaining two main drugs with the resulting mixed powder. Therefore, the petitioner believes that for those skilled in the art, there is no doubt that they would choose to add in step (3).
Reexamination Notice
In response to the reexamination request, the Patent Reexamination Board issued a reexamination notice, stating in the reexamination notice: The components and excipients of the pharmaceutical composition of claim 1 "Compressible starch" exists in the preparation step 2) of drying and sieving for later use, but the addition of "compressible starch" is missing in the subsequent preparation steps. Those skilled in the art cannot determine whether it is added in the preparation step. "Compressible starch" cannot be determined in which step the "compressible starch" is added, that is, the description of "compressible starch" in claim 1 has inconsistencies in the context. Therefore, claim 1 does not clearly define the technical solution sought for protection and is inconsistent with the provisions of Article 26, paragraph 4, of the Patent Law.
In addition, the Patent Reexamination Board further pointed out in response to the reexamination requester’s opinion: the scope of protection requested by the claims shall be subject to the scope recorded in the claims, and the current claim 1 is not limited to step 3) Adding compressible starch to the application, the reexamination petitioner's statement of opinion is inconsistent with the scope of the current claims. In the absence of amendments to the claims, there are still contextual inconsistencies. Therefore, the reexamination petitioner’s statement of opinion is not enough to overcome the unclear defect of claim 1.
Reexamination Reply
Usually after receiving the reexamination notice, many agents think that there is basically no chance of withdrawing the objection. However, is there really no prospect of revoking the authorization for this application? Doesn’t the Patent Reexamination Board recognize the content of the reexamination petitioner’s opinion at all? Just give up? It would be a big mistake to think so.
After carefully studying the reexamination notice, the author believes that according to the reexamination notice, "the reexamination committee believes that the current claim 1 is not limited to adding compressible starch in step 3), and the reexamination petitioner's opinion The statement is inconsistent with the scope of the current claims, and there are still contextual inconsistencies in the claims without modification." It can be seen that the Patent Reexamination Board accepted the reexamination requester's statement of opinion, but only believed that in the case of no modification of the claims, , there are still inconsistencies in the context, and the statement of opinions is inconsistent with the scope of the current claims. As long as the claim is modified to limit the addition of compressible starch in step 3), the unclear defect of claim 1 can be overcome. This is the enlightening opinion given by the reexamination committee.
Based on the above analysis, when the author responded to the reexamination notice, he modified claim 1, that is, in step 3) of claim 1, the “microcrystalline cellulose, cross-linked polyethylene Add "compressible starch" between "pyrrolidone".
And made a statement of opinions on this. First of all, the petitioner fully stated that the above modifications are in compliance with the relevant provisions of the Patent Law and the Examination Guidelines, and believed that it was recorded in step 3) of claim 1. The addition of "compressible starch" between "microcrystalline cellulose and cross-linked polyvinylpyrrolidone" does not exceed the scope recorded in the original instructions, and can be undoubtedly derived from the instructions. The specific opinions are as follows:
The description part of the application specifically records two dosage forms of the oral solid pharmaceutical composition, one is a tablet and the other is a capsule, and the preparation of these two dosage forms is provided respectively. Method, from the preparation methods of these two dosage forms, we can see that the only difference between the preparation methods of the two dosage forms is that in the preparation of capsules, after obtaining the mixed powder, a wet granulation step and the main drug candesartan are added. The timing of adding esters is different. As for excipients, it can be seen from the capsule preparation method that all excipients including "compressible starch" are dried and sieved in step 2), and are all in step 3. ) added in. For the preparation method of tablets, the excipients used are exactly the same as those used for capsules. All excipients are dried and sieved in step 2), and other excipients except "compressible starch" They are all added in step 3). As for the lack of "compressible starch" added in preparation step 3), it is obviously caused by the petitioner's mistake when writing. In this regard, the petitioner sincerely requests the review committee understood, and allowed to be added to step 3) to overcome this apparent formal flaw.
Secondly, the petitioner insisted on the statement of opinions in the reexamination request and believed that based on the knowledge and ability of technical personnel in the technical field, it can be determined without doubt that "compressible starch" is in added in step 3).
Withdrawal of the authorization
The reexamination committee accepted the petitioner’s statement of opinion, revoked the rejection decision, and received the notification of granting the invention patent right shortly after.
Summary
When a patent attorney receives a rejection decision, he should not despair or give up. He should carefully analyze the application involved and the rejection decision, and follow the "Examination Guidelines" in accordance with the law. Refuting with the reviewer with reason and evidence, fully expressing our point of view. Many times you will find that the more you write, the more reasonable you feel. After refuting, you will really withdraw your refutation.