Brief Introduction on the Latest Amendments of Guidelines for Patent Examination – Lexology

On December 14, 2020, the China National Intellectual Property Administration (short for the CNIPA) issued a notice that listed out the latest amendments of Guidelines for Patent Examination, and informed such amendments will be implemented on January 15, 2021. For understanding such amendments conveniently, this article intends to summarize and introduce the contents concerning the aspects, for example, supplementing experimental dada, novelty of compounds, inventive step of compounds, depositary institution of biological material, definition of monoclonal antibody, inventive step of inventions relating to the field of biology, and the like.

In this amendment, all of the amended contents focus on examination of invention applications in the field of chemistry. For clarification, the contents underlined in black are the expressions after amended, and the contents with strikeout in red are the expressions before amended hereinafter.

I. Amendments concerning supplementing experimental dada

In this amendment, the contents concerning supplemented experimental date in Section 3.5, Chapter 10, Part II of Guidelines for Patent Examination are amended, further clarifying that the purpose of supplementing experimental date is to meet the requirements of Article 26.3 and/or Article 22.3 of the Chinese Patent Law. The amendments are listed as follows.

1. Adding an item of 3.5.1 Principles of Examination, and amending the expression to read as As to the supplemented experimental date provided by the applicant after the filing date for meeting the requirements of Article 26.3 or Article 22.3 of the Patent Law, the examiner shall make examination on them. The technical effects proved by the supplemented experimental date shall be those which can be obtained from the contents disclosed in the patent application by a person skilled in the art.

2. For the fourth amendment to the Chinese Patent Law, Item 3.5.2 Supplemented Experimental Date of Patent Applications of Pharmaceutical Products is added, and the expression of The examination examples for patent applications relating to pharmaceutical products are provided according to the principles of examination of Section 3.5.1 in this chapter. is added.

Accordingly, two examples are added for illustration, and which circumstances may be supplemented experimental data to prove that the description has sufficiently disclosed the invention (Example 1) or prove that the technical solution of claim involves an inventive step (Example 2) are illustrated respectively.

In addition, the following contents are added: when the experimental data are supplemented to prove that the description has sufficiently disclosed of the invention, It is shall be noticed that such supplemented experimental data also shall be made examination when making examination on inventive step. (Example 1), or when the experimental data are supplemented to prove that the technical solution of claim involves an inventive step, It is shall be noticed that here the examiner also needs to make further analysis whether the technical solution claimed in the claims meets the requirements of inventive step combining the supplemented experimental data. (Example 2).

II. Amendments concerning novelty of compound

The contents concerning novelty of compound in Section 5.1, Chapter 10, Part II of Guidelines for Patent Examination are amended, and the specific circumstances that a compound is disclosed and which conditions will be presumed as lack of novelty are defined clearly.

The expression of Item (1) is amended to read as:

(1) For a compound claimed in an application, if it has been referred to the structural information of the compound, i.e. the chemical name, the molecular formula (or structural formula) etc., is disclosed in a reference document so as to enable a person skilled in the art to deem that the compound claimed has been disclosed, it is deduced that the compound does not possess novelty, unless the applicant can provide evidence to verify that the compound is not available before the date of filing. The word "refer to" mentioned above means to define clearly or explain the compound by the chemical name, the molecular formula (or structural formula), the physical/chemical parameter(s) or the manufacturing process (including the raw materials to be used).

If it is insufficient to identify the similarity and difference in structure between the compound claimed and the compound in the reference document, but combining the other information disclosed in this reference document, comprising physical/chemical parameter(s), preparation method, and effect experimental data, etc., and taking consideration comprehensively, a person skilled in the art may deduced, with justified reasons, that the two compounds are identical substantively, the compound claimed does not possess novelty, unless the applicant can provide evidence to verify there are differences in structures.

For example, if the name and the molecular formula (or structure formula) of a compound disclosed in a reference document are difficult to be identified or unclear, but the document discloses the same physical/chemical parameter(s) or any other parameters used to identify the compound as those of the claimed compound of an application, it is deduced that the claimed compound does not possess novelty, unless the applicant can provide evidence to verify that the compound is not available before the date of filing.

If the name, molecular formula (or structure formula) and physical/chemical parameter(s) of a compound disclosed in a reference document are unclear, but the document discloses the same method of preparation as that of the claimed compound of an application, it is deduced that the claimed compound does not possess novelty.

III. Amendments concerning inventive step of compound

The contents concerning inventive step of compound in Section 6.1, Chapter 10, Part II of Guidelines for Patent Examination are amended, the expressions of original Items (1) to (3) are deleted and amended to read as new Item (1) to (3). The aspects that need to be considered when assessing the inventive step of an invention are further figured out, an Item (4) of Examples of Assessment of Inventive Step is newly added and the original examples are incorporated into this item, the expressions of original examples 1-3 are amended, and Examples 4 and 5 are newly added.

The expressions of Items (1)-(4) are amended to read as follows.

(1) When assessing the inventive step of an invention of compound, the differences in structure between the claimed compound and the compound in the latest prior art need to be determined, and the technical problem that is actually solved by the invention on the basis of the obtained use and/or effect of the improvement in structure is determined, on this basis, whether or not there exists such a technical motivation in the prior art by applying such improvement in structure to solve the technical problem.

It is shall be noticed that if the person skilled in the art can carry out such improvement in structure to solve the technical problem just by logical analysis, inference, or limited experimentation on the basis of the prior art, to obtain the claimed compound, there exists such a technical motivation in the prior art.

(1) When a compound is novel, not similar in structure to a known compound, and has a certain use or effect, the examiner may deem it to involve an inventive step without requiring that it shall have an unexpected use or effect.

(2) The use and/or effect brought by the improvement in structure of the invention to the compound of the prior art may be the different use obtained from the known compound, may also be the improvement to the effect in certain aspect of the known compound. When assessing the inventive step of a compound, if the modification of use and/or the improvement to the effect is/are unexpected, then it reflects that the claimed compound is non-obvious, and the inventive step thereof shall be identified.

(2) For a compound that is similar in structure to a known compound, it must have unexpected use or effect. The said unexpected use or effect may be a use different from that of the known compound, the substantive progress or improvement of a known effect of a known compound, or a use or effect which is not clear in the common general knowledge or cannot be deduced from the common general knowledge.

(3) It shall be noted that when assessing inventive step of an invention of compound, if the effect of the claimed technical solution is caused by something known and inevitable, the technical solution does not involve an inventive step. For example, an insecticide A-R is in the prior art, wherein, R is C1-3 alkyl. It has been pointed out in the prior art that the effectiveness of insecticide is improved with the increase of the number of atom in the alkyl. If the insecticide in an application is A-C4H9, the effectiveness has been obviously improved compared with the prior art. The application does not involve an inventive step because it has been pointed out in the prior art that the improved effectiveness of the insecticide is inevitable.

(3) Whether two compounds are similar in structure has relation to the technical field of the compounds, the examiner shall apply different criteria to different technical fields. The following are some examples:

(4) Examples of Assessment of Inventive Step

[Example 1]

(Omitting).

IV. Amendments concerning depositary institutions of the biological material

The contents concerning depositary institutions of the biological material in Section 9.2.1, Chapter 10, Part II of Guidelines for Patent Examination are amended, a depositary institution of Guangdong Microbial Culture Collection Center (GDMCC) based in Guangzhou is newly added, except the two depositary institutions of the Center for General Microorganism of the Administration Committee of the China Microbiological Culture Collection (CGMCC) based in Beijing and the China Center for Type Culture Collection (CCTCC) based in Wuhan.

V. Amendments concerning the definitions of Monoclonal Antibody

For the fast development of the sequencing technique, the contents concerning monoclonal antibody in Section 9.3.1.7, Chapter 10, Part II of Guidelines for Patent Examination are amended. The contents of monoclonal antibody defined by structural feature are newly added, on the basis of maintaining the contents of monoclonal antibody defined by specifying hybridoma which produces it. The original example is amended, the example of monoclonal antibody that is defined by structural features, such as amino acid sequences of CDRs of heavy chain variable region and light chain variable region, etc. is newly added, and then the definition methods of monoclonal antibody are enriched.

The amended expression is read as A claim directed to a monoclonal antibody may be defined by structural features, also by specifying hybridoma which produces it.

[For Example]

(1) A monoclonal antibody against antigen A, which contains amino acid sequences of VHCDR1, VHCDR2 and VHCDR3 shown as SEQ ID NOs:1-3, and amino acid sequences of VLCDR1, VLCDR2 and VLCDR3 shown as SEQ ID NOs:4-6.

(2) A monoclonal antibody against antigen A, produced by a hybridoma having CGMCC Deposit No. xxx.

VI. Amendments concerning inventive step of field of biology

For keeping consistency of criterion for assessment concerning inventive step of compound in Section 6.1, Chapter 10, Part II of Guidelines for Patent Examination, the contents of inventive step concerning field of biology in Section 9.4.2, Chapter 10, Part II of Guidelines for Patent Examination are amended, the expressions concerning three-step assessment on inventive step concerning field of biology are added under the title of inventive step in Section 9.4.2.

The contents are newly added to read as When assessing on inventive step of an invention in field of biology, it also needs to assess whether the invention has prominent substantive features and represents a notable progress or not. During the assessment, the distinguishing features of the invention from those of the latest prior art need to be determined, on the basis of the specific limitations on the different subject matter, the technical problem actually solved by the invention are determined, on the basis of the technical effect of the distinguishing features, and then whether or not there exists such a technical motivation in the prior art as a whole is determined, and thus whether or not the claimed invention is non-obvious in respect of the prior art is determined on the basis above-mentioned.

The inventions-creations in field of biology relate to the subject matter of biomacromolecule, cell, or microorganism, etc., with different level. In the methods for characterizing such subject matter, except the common method of structures and components, etc., some specific methods like the accession number of the deposit of a biological material are also included. In determining the inventive step of an invention, the following factors need to be taken into account: the differences in structure, the proximity of the genetic relationship, and the predictability of the technical effect between the invention and the prior art.

Hereinafter, some specific situations in determining the inventive step for different subject matter in the present field are listed.

Furthermore, the contents in Section 9.4.2.1, Chapter 10, Part II of Guidelines for Patent Examination are amended.

The expressions in determining the inventive step of an invention in original Items (1) to (4) in Section 9.4.2.1 Inventions Relating to Genetic Engineering are amended into the determination method of three-step assessment on inventive step, it means that having unexpected effect is an assistant condition not a necessary condition. Item (2) Polypeptide and protein is newly added, and some of the expressions and serial numbers of original Item (1) Gene, (2) Recombinant vector, (3) Transformant, (4) Fused cell, and (5) Monoclonal antibody are amended.

The amendments are as follows.

9.4.2.1 Inventions Relating to Genetic Engineering

(1) Gene

Where a protein encoded by structural gene has different amino acid sequence and has different type of or improved function, comparing with the known protein, and the prior art fails to give a technical motivation that the difference of sequence brings out the modification of the function, the invention of said gene encoding said protein involves an inventive step.

If the amino acid sequence of a protein is known, the invention of said gene encoding said protein does not involve an inventive step. If a protein is known, but its amino acid sequence is not, an invention of a gene encoding the protein does not involve an inventive step if a person skilled in the art can readily determine the amino acid sequence at the time of filing. However, under the two situations above, when the gene has a specific base sequence and has technical effects compared with other genes having a different base sequence encoding said protein, which a person skilled in the art cannot expect, the invention of said gene involves an inventive step.

If the amino acid sequence of a protein is known, an invention of a gene encoding the protein does not involve an inventive step. However, if the gene has a particular base sequence and has technical effects compared with other genes having a different base sequence encoding said protein, which a person skilled in the art cannot expect, the invention of said gene involves an inventive step.

If the claimed structural gene of an invention is the naturally obtainable mutant of a known structural gene and that the claimed gene is derived from the same species as that of the known structural gene and has the same properties and functions as those of the known structural gene, then the invention does not involve an inventive step.

(2) Polypeptide or protein

If the claimed polypeptide or protein of an invention has difference in amino acid sequences from the known polypeptide or protein and has different type of or improved function, and the prior art fails to give a technical motivation that the difference of sequence brings out the modification of the function, the invention of said polypeptide or protein involves an inventive step.

(23) Recombinant vector

If an invention achieves an improvement on the property of a recombinant vector by modification in structure to the known vector and/or inserted gene, and the prior art fails to give a technical motivation that the property is improved by applying such modification in structure, the invention of the recombinant vector involves an inventive step.

If both a vector and an inserted gene are known, an invention of a recombinant vector obtained by a combination of the two usually does not involve an inventive step. However, if an invention of a recombinant vector with a specific combination of them can produce unexpected technical effects compared with the prior art, the invention involves an inventive step.

(34) Transformant

If an invention achieves an improvement on the property of a transformant by modification in structure to the known host and/or inserted gene, and the prior art fails to give a technical motivation that the property is improved by applying such modification in structure, the invention of the transformant involves an inventive step.

If both a host and an inserted gene are known, an invention of a transformant obtained by a combination of them generally does not involve an inventive step. However, if an invention of a transformant obtained from a specific combination of them can produce unexpected technical effects compared with the prior art, it involves an inventive step.

(45) Fused cell

If parent cells are known, an invention of a fused cell produced by fusing the parent cells does not involve an inventive step. However, if the fused cell has an unexpected technical effects compared with the prior at, the invention of the fused cell involves an inventive step.

(56) Monoclonal antibody

If an antigen is known, a monoclonal antibody of the antigen characterized by features in structure is remarkably different from those of the known monoclonal antibody on the key sequence listing that determines its function and use, the prior art fails to give a technical motivation of obtaining the monoclonal antibody with the sequence listing, and the monoclonal antibody can produce advantageous technical effect, the invention of the monoclonal antibody involves an inventive step.

If an antigen is known and it is clearly known that the antigen has immunogenicity (for example, said antigen clearly has immunogenicity because a polyclonal antibody of the antigen is known or the antigen is a polypeptide with a large molecular weight), the invention of a monoclonal antibody of only defined by the antigen does not involve an inventive step. However, if the invention is further defined by other features the hybridoma which produces the monoclonal antibody, and hence has unexpected technical effects, the invention of that monoclonal antibody involves an inventive step.

The above contents focus on introduction of the amendments of Guidelines for Patent Examination. In particular, the follows are further figured out that: (1) the purpose for supplemented experimental date lies in meeting the requirements of Article 26.3 and/or Article 22.3 of the Chinese Patent Law, (2) the specific circumstances that a compound is disclosed and which conditions will be presumed as lack of novelty, and (3) the aspects that need to be considered when assessing the inventive step of an invention. The following contents are newly added: (1) the definition on a monoclonal antibody by structural features and the example, and (2) the expressions concerning three-step assessment on inventive step concerning field of biology. The author wishes it would be helpful to the applicants by such brief instruction as mentioned above.

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Brief Introduction on the Latest Amendments of Guidelines for Patent Examination - Lexology