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National Intellectual Property Office: Announcement on Amendments to "Patent Examination Guidelines"

Add time:2021-05-27 15:46:10   Number of views:471  

No. 39

In order to fully implement the spirit of General Secretary Xi Jinping’s important instructions on strengthening the protection of intellectual property rights, deepen the implementation of the "delegation of power, control and service" reform decisions and deployment, and actively respond to the demands of the rapid development of economy and technology for examination rules, and improve the quality and efficiency of patent examination, the Intellectual Property Office It is decided to make amendments to the "Patent Examination Guidelines", which are hereby promulgated and shall come into force on January 15, 2021.

Special announcement.

Intellectual Property Office

December 11, 2020

The Intellectual Property Office decided to make the following amendments to the "Patent Examination Guidelines":

1. Amendments to Section 3.5, Chapter 10, Part Two

Amend Section 3.5 of Chapter 10 of Part Two of the "Patent Examination Guidelines" to read as follows:

3.5 Experimental data about supplementary submission

3.5.1 Principles of review

To determine whether the specification is fully disclosed, the content recorded in the original specification and claims shall prevail.

The examiner shall examine the experimental data supplemented by the applicant in order to satisfy the requirements of Article 22, paragraph 3 and Article 26, paragraph 3 of the Patent Law after the application date. The technical effects proved by the supplementary experimental data should be obtained by those skilled in the relevant technical field from the disclosure of the patent application.

3.5.2 Supplementary experimental data for drug patent applications

In accordance with the examination principles in Section 3.5.1 of this chapter, examples of examination involving drug patent applications are given. ,

2. Amendments to Section 4.2.3 of Chapter 10 of Part Two

In the "Patent Examination Guidelines", Part Two, Chapter 10, Section 4.2.3, "Should be written as performance-limited or use-limited" in the paragraph "It should be written as performance-limited or use-limited", and change "in In some fields, such as alloys, the inherent properties and/or uses of the invention alloys should usually be stated." Amend to "In some fields, such as alloys, the inherent properties and/or uses of the invention alloys should usually be stated. ."

The rest of this section has not been modified.

3. Amendments to Section 5.1, Chapter X, Part Two

Amend item (1) in Section 5.1 of Chapter 10 of Part Two of the "Patent Examination Guidelines" to read as follows:

(1) Where a patent application claims a compound, if the chemical name, molecular formula (or structural formula) and other structural information of the compound are recorded in a comparative document, those skilled in the art will think that the claimed compound has been disclosed , The compound is not novel, unless the applicant can provide evidence to prove that the compound cannot be obtained before the filing date.

If the structural information recorded in a comparative document is not sufficient to determine the structural similarities and differences between the claimed compound and the compound disclosed in the comparative document, but in combination with other information recorded in the comparative document, including physical and chemical parameters, preparation methods and effects After comprehensive consideration of experimental data, etc., those skilled in the technical field have reason to assume that the two are substantially the same, and the claimed compound does not have novelty, unless the applicant can provide evidence to prove that the structure is indeed different.

The rest of this section has not been modified.

4. Amendments to Section 6.1, Chapter X, Part Two

Amend Section 6.1, Chapter 10, Part Two of the "Patent Examination Guidelines" to read as follows:

6.1 Creativity of the compound

(1) To judge the inventiveness of a compound invention, it is necessary to determine the structural difference between the claimed compound and the prior art compound, and to determine the technical problem actually solved by the invention based on the use and/or effect obtained by the structural modification. On this basis, it is judged whether the existing technology as a whole provides technical enlightenment for solving the technical problem through this structural transformation.

It should be noted that if a person skilled in the art can carry out such structural modification to solve the technical problem and obtain the claimed compound only through logical analysis, reasoning or limited experiment on the basis of the existing technology , It is believed that the existing technology has technical inspiration.

(2) The use and/or effect brought about by the structural modification of the compound of the recent prior art by the invention can be to obtain a different use from the known compound, or it can be an improvement in a certain aspect of the effect of the known compound. When judging the inventiveness of a compound, if the change in use and/or the improvement of the effect is unexpected, it reflects that the claimed compound is non-obvious and its inventiveness should be recognized.

(3) It should be noted that when judging the inventive step of a compound invention, if the effect of the claimed technical solution is caused by a known inevitable trend, the technical solution is not inventive. For example, there is an insecticide A-R in the prior art, wherein R is a C1-3 alkyl group, and it has been pointed out that the insecticidal effect increases as the number of C atoms of the alkyl group increases. If the insecticide applied for a certain application is A-C4H9, the insecticidal effect is significantly higher than the insecticidal effect of the prior art. Since the prior art pointed out the inevitable trend of improving the insecticidal effect, the application is not creative.

(4) Examples of creativity judgment

V. Amendments to Section 9.2.1, Chapter 10 of Part Two

The "Patent Examination Guidelines" in Part II, Chapter 10, Section 9.2.1, Item (4), "including the General Microbiology Center (CGMCC) of the China Microbial Culture Collection Management Committee (CGMCC) in Beijing, China, and the China Typical Microbiology Center in Wuhan, China Culture Collection Center (CCTCC)." Amended to "Includes the General Microbiology Center (CGMCC) of the China Microbial Culture Collection Management Committee in Beijing, China, the China Type Culture Collection (CCTCC) in Wuhan, and Guangdong Province in Guangzhou Microbial Culture Collection (GDMCC)."

The rest of this section has not been modified.

VI. Amendments to Section 9.3.1.7, Chapter 10, Part Two

Amend Section 9.3.1.7, Chapter 10, Part Two of the "Patent Examination Guidelines" to:

9.3.1.7 Monoclonal antibodies

The claims for a monoclonal antibody can be defined by structural features or by the hybridoma that produces it.

7. Amendments to Section 9.4.2, Chapter 10 of Part Two

(1) Three new paragraphs are added under the title of Inventiveness, Chapter 10, Section 9.4.2 of the "Patent Examination Guidelines", the content is as follows:

To judge the inventiveness of an invention in the field of biotechnology, it is also necessary to judge whether the invention has outstanding substantive features and significant progress. In the judgment process, it is necessary to determine the distinguishing features between the invention and the close prior art according to the specific limitations of different protection subjects, and then determine the technical problem actually solved by the invention based on the technical effect that the distinguishing feature can achieve in the invention, and then judge Whether the prior art provides technical enlightenment as a whole, and based on this, whether the invention is obvious relative to the prior art.

Inventions and creations in the field of biotechnology involve different levels of protection topics such as biological macromolecules, cells, and individual microorganisms. In the ways to characterize these protection themes, in addition to common methods such as structure and composition, they also include special methods such as the deposit number of biological materials. Inventive judgments need to consider the structural differences between the invention and the prior art, the distance between the kinship, and the predictability of technical effects.

In the following, some specific situations in the inventive judgment of different protection themes in this field are shown.

(2) The "Patent Examination Guidelines" Part Two, Chapter 10, Section 9.4.2.1, Item (1) is amended to:

(1) Gene

If a protein encoded by a structural gene has a different amino acid sequence and a different type or improved performance compared to a known protein, and the prior art does not provide the technical enlightenment that the sequence difference brings about the above-mentioned performance changes, Then the gene invention encoding the protein is creative.

If the amino acid sequence of a certain protein is known, the invention of the gene encoding the protein is not inventive. If a protein is known but its amino acid sequence is unknown, as long as those skilled in the art can easily determine its amino acid sequence when the application is filed, the gene invention encoding the protein is not inventive. However, in the above two cases, if the gene has a specific base sequence, and compared with other genes encoding the protein with a different base sequence, it has an effect that those skilled in the art would not expect, then The invention of genes is creative.

If the structural gene claimed by an invention is a naturally available mutant structural gene of a known structural gene, and the claimed structural gene and the known structural gene are derived from the same species, they also have the same properties and functions , The invention is not creative.

(3) Add the peptide or protein item (2) to Section 9.4.2.1, Chapter 10, Part Two of the "Patent Examination Guidelines", with the content as follows:

(2) Peptides or proteins

If the polypeptide or protein claimed by the invention is different from the known polypeptide or protein in amino acid sequence, and has different types or improved properties, and the prior art does not provide the technical enlightenment of the above-mentioned performance changes caused by the sequence difference , The invention of the polypeptide or protein is creative.

(4) Amend "(2) Recombinant vector" in Section 9.4.2.1 of Chapter 10 of Part Two of the "Patent Examination Guidelines" to "(3) Recombinant vector", and insert a paragraph before the original content, with the following content:

If the invention aims at the structural modification of known vectors and/or inserted genes to improve the performance of the recombinant vector, and the prior art does not provide technical enlightenment for improving the performance of the above-mentioned structural modification, the invention of the recombinant vector is inventive.

(5) Amend "(3) Transformation" in Section 9.4.2.1, Chapter 10, Part Two of the "Patent Examination Guidelines" to "(4) Transformation", and insert a paragraph before the original content, with the content as follows:

If the invention aims at the structural modification of a known host and/or inserted gene to improve the performance of the transformant, and the prior art does not provide technical enlightenment for using the above-mentioned structural modification to improve the performance, the invention of the transformant is inventive.

(6) Amend "(4) Fusion Cells" in Section 9.4.2.1, Chapter 10, Part Two of the "Patent Examination Guidelines" to "(5) Fusion Cells".

(7) Amend "(5) Monoclonal Antibody" in Section 9.4.2.1, Chapter 10, Part Two of the "Patent Examination Guidelines" to "(6) Monoclonal Antibody", and amend the content as a whole to:

If the antigen is known, the monoclonal antibody of the antigen characterized by structural features is obviously different from the known monoclonal antibody in the key sequence determining the function and purpose, and the prior art does not provide the monoclonal antibody that obtains the above sequence If the monoclonal antibody can produce beneficial technical effects, the invention of the monoclonal antibody is creative.

If the antigen is known, and it is clear that the antigen is immunogenic (for example, if the polyclonal antibody of the antigen is known or the antigen is a macromolecular polypeptide, it can be known that the antigen is obviously immunogenic), then The invention of monoclonal antibodies limited only by this antigen does not have an inventive step. However, if the invention is further limited by the hybridoma secreting the monoclonal antibody of the antigen, and thus produces unexpected effects, the invention of the monoclonal antibody is inventive.

The rest of this section has not been modified.

This decision will take effect on January 15, 2021.

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