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Summary and Comments on the Latest Revision to Guidelines for Patent Examination

Jiawei CHEN | Jan 10, 2021

 

The revision to the Guidelines for Patent Examination of CNIPA was released in December 2020 and entered into force on January 15, 2021, which mainly clarifies and improves the examination criteria on supplementary experimental data, novelty of compound, and inventive step in the field of compounds and biology. Now we highlight the important contents of this revision as below.

I. Examination criteria on supplementary experimental data have been clarified

On the one hand, it is further clarified that "the experimental data submitted by an applicant after the filing date in order to meet the requirements of Article 22.3 (inventive step) and Article 26.3 (sufficient disclosure) of the Patent Law shall be examined by examiners". On the other hand, "supplementary experimental data of medicament patent application" is added, and two examination examples are provided to illustrate that for those skilled in the art, if the effect of the compound is described in the initial application documents, the experimental data submitted by the applicant in order to prove the sufficient disclosure of description or inventive step of the application shall be examined by examiners.


II. Selection of composition to be function-definition or use-definition has been liberalized

In the past, if there is only one property or use of the composition disclosed in the specification, the composition shall be drafted as the function-defining or use-defining type. In this revision, "shall be" is amended as "usually needs to be", which means that whether the claim needs to be drafted as function-defining or use-defining type should be analyzed in combination with the specific situation.


III. Amendment to novelty of compound

This revision intends to distinguish the following two situations and to clarify the burden of proof.

One is that if the chemical name, molecular formula (or structural formula) and other structural information of the compound are disclosed in a reference document, and the information of the compound are disclosed so sufficiently that a person skilled in the art regards that the compound claimed has been disclosed, then the compound does not possess novelty, unless the applicant can provide evidence to verify that the compound is not available before the filing date.

The other is that if the structural information disclosed in a reference document is not sufficient to identify the structural differences between the compound claimed and that disclosed in the reference document, but after comprehensive consideration of other information disclosed in the reference document, a person skilled in the art has reason to deduce that the both are substantially identical, then the claimed compound does not possess novelty, unless the applicant can provide evidence to verify that there are structural differences.


IV. Amendment to inventive step of compound

This revision intends to guide the examiners, in the judgment of inventive step of a compound, to judge whether or not there exists a technical motivation in the prior art from the perspective of a person skilled in the art, and then draw the conclusion of inventive step. The revised content highlights the internal logical relationship between "unexpected technical effect" and "three-step method", which is an auxiliary factor for the judgment of inventive step.


V. A newly added depository institution of biological material

Guangdong Microbial Culture Collection Center (GDMCC) based in Guangzhou was added as a depository institution for patent procedures. So now there are three depository institutionss including China General Microbiological Culture Collection Center (CGMCC) based in Beijing and China Center for Type Culture Collection (CCTCC) based in Wuhan.


VI. Amendment to claims drafting of a monoclonal antibody

In the past, a claim directed to a monoclonal antibody may be defined by specifying the hybridoma which produces it. In this revision, a claim directed to a monoclonal antibody may be defined by specifying hybridoma which produces it, but also by structural feature.


VII. Amendment to inventive step in the field of biotechnology

The revision has clarified and improved the examination criteria on inventive step of gene, recombinant vector, transformant and monoclonal antibody inventions, and supplemented the examination criteria on inventive step of polypeptide or protein inventions.

(1) Gene
If a protein encoded by a structural gene has a different amino acid sequence and different category or improved function compared with the known protein, and the prior art has not given a technical motivation that the sequence difference can bring about the above function changes, then an invention of a gene encoding the protein 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. 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, in the above two cases, 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 the 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 (Newly added)
If the claimed polypeptide or protein of an invention has a different amino acid sequence and different category or improved function compared with the known polypeptide or protein, and the prior art has not given a technical motivation that the sequence difference can bring about the above function changes, the invention of the polypeptide or protein involves an inventive step.

(3) Recombinant vector
A paragraph is added before the initial content as follows:

If an invention directed to structural modification of the known vector and/or inserted gene has improved the function of the recombinant vector, and the prior art has not given a technical motivation as to apply the above structural modification to improve function, the invention of the recombinant vector involves an inventive step.

(4) Transformant
A paragraph is added before the initial content as follows:

If an invention directed to structural modification of the known host and/or inserted gene has improved the function of the transformant, and the prior art has not given a technical motivation as to apply the above structural modification to improve function, the invention of the transformant involves an inventive step.

(5) Fused cell remains unchanged

(6) Monoclonal antibody
An examination example of inventive step of monoclonal antibody defined by structural feature is added.

If an antigen is known, the monoclonal antibody of the antigen characterized by structural features has an obviously different important sequence of function and use compared with the known monoclonal antibody, and the prior art has not given a technical motivation as to obtain the monoclonal antibody of the above sequence, and the monoclonal antibody can bring beneficial effects, then the invention of that monoclonal antibody involves an inventive step.

Jiawei CHEN



Mr. CHEN graduated from South China Agricultural University with a master degree of Microbiology. He has a command of microorganism experiments, such as aseptic operation and fermentation, and gene cloning, vector construction, protein expression, cell culture and other molecular-biology experiments.

After joining Jiaquan IP, he is mainly engaged in drafting patent application documents and handling office actions in the fields of biochemistry, adhesive, feed, chemical synthesis and detection, sewage disposal, pottery and porcelain, serving for numbers of companies and universities. He, meanwhile, specializes in the practical operation of PPH request.

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