I. Background and Release Mechanism of the Case Selections

On August 22, 2024, the Patent Reexamination and Invalidation Department of the China National Intellectual Property Administration (hereinafter referred to as the "Department") released the 2024 Selections of Key Points in Typical Patent Reexamination and Invalidation Decisions (hereinafter referred to as the "Selections"). This Selections lists 59 representative cases from those concluded by the Department in 2024, summarizing them into 72 key decision points. It aims to centrally interpret the application of law in patent reexamination and invalidation cases and showcases the latest trends in patent examination across various technical fields.

A review of the release history of the typical cases reveals a core trend: a shift "from comprehensive volumes to precise focus, and from print to digital acceleration." In 2018, the Department launched its first case collection, Case Studies on Patent Reexamination and Invalidation, and its 2022 sequel covered cases from 2018 to 2021, both were print editions. Starting in 2023, the Department moved to a digital format with the release of the Selection of Key Points in Typical Patent Reexamination and Invalidation Cases (2023). This transition has significantly improved timeliness and accessibility, providing the industry with more immediate guidance on examination standards.

II. Interpretation of Core Examination Standards from Typical Cases

(A) General Examination Standards

1. Standards for Evidence Examination

The Selection provides guidance on determining prior art/prior design for publication disclosure, use disclosure, and internet disclosure. 

For publication disclosure, quality standards for registered drugs in specific units such as the Drug Administration or Drug Testing Institute are generally not considered public disclosures under the Patent Law, as access is restricted to specific personnel; for drug inserts with multiple versions, a sales receipt showing only the drug name and sale date cannot prove the publication date of a specific version.

For use disclosure, the publication date of sold products can be determined through e-commerce transaction snapshots or payment records for metered products; even if a product is located in a specially managed place, it still constitutes a public disclosure by use if it is in a position where the public can directly observe it.

For internet disclosure, the Selection clarifies that the upload time of technical standard proposals from the International Telecommunication Union (ITU) is considered the publication date, and for webpage archives from the Internet Archive, the publication date of an image is determined by the date field in the image's URL.

The Selection also clarifies the examination standards for the admissibility and probative force of evidence. Regarding admissibility and probative force, unilateral test reports will be examined to see if sampling and testing methods comply with national or industry standards; for unilaterally commissioned expert opinions, the probative force will not be recognized if there are defects in the submitted samples or the testing process; testimony from interested witnesses can serve as part of a chain of evidence if corroborated by other evidence. 

Regarding the standard of proof, a use disclosure should be supported by a chain of evidence that establishes a "high probability." If the petitioner has met their burden of proof and the patentee merely raises doubts without providing counter-evidence, the probative force of the petitioner's evidence will not be negated.

2. Standards for Novelty/Inventive Step Examination

In the examination of novelty, the Selection clarifies the standards for determining the content disclosed by the prior art. First, the "separate comparison" principle is applied flexibly. For example, if a prior art document discloses the code name of a commercially available chemical product, uniquely determining its structure and composition, but does not disclose its specific physical or chemical performance parameters, other evidence can be introduced to confirm those parameters. As another example, when using a patent document as a reference, the content of its cited document that is closely related to the patent document can be considered as part of the disclosure of the reference. Second, the standard for content disclosed by video evidence is strict, requiring that technical features be "directly and unambiguously determined" from video evidence. 

Finally, the Selection clarifies a key procedure: a PCT international application that has entered the Chinese national phase can be used as a "conflicting application" for assessing novelty.

In the evaluation of inventive step, the examination practice is deepened around the "three-step approach" (determining the closest prior art → determining the distinguishing features → assessing for obviousness). First, when determining distinguishing features,

an"overall perspective" is emphasized; multiple features that cooperate to achieve a specific function should not be considered in isolation. Different "application scenarios" can also be a source of inventive step. Second, when assessing for obviousness, the key is to

analyze whether the role played by the distinguishing feature or the technical problem it solves in the reference document is the same as in the present invention. Examiners will consider cross-field technical inspiration, meaning a person skilled in the art would be

motivated to look for solutions in similar or related technical fields. Finally, the Selection clarifies the impact of the technical effects described in the description on the conclusion of the "three-step approach": if a technical solution is deemed obvious, other technical

effects described in the description are not sufficient to overturn this conclusion, as long as those effects would have been foreseeable to a person skilled in the art after combining the prior art.

3. Standards for Support by the Description

The core principle is that the scope of protection of the claims should be commensurate with the technical contribution disclosed in the description. The assessment of whether a claim can be supported by the description should be based on the "technical problem the invention is intended to solve," but not the "technical problem the invention actually solves" as determined during the assessment of inventive step. 

Reasonable generalization in the claims is permissible, provided the description offers sufficient technical guidance for a person skilled in the art to expect that the generalized technical solutions can solve the intended technical problem. For claims defined by functional or effect-based features, the patent description should sufficiently disclose how to achieve that function or effect.

Additionally, the Selection clarifies the examination standards for claims containing parameters. For claims defined by a parameter formula, if the generalized scope includes parameter values that clearly cannot solve the technical problem, and the description fails to provide effective guidance on selecting appropriate parameters, the claim is not supported by the description. Typically, for claims in the field of optical lenses containing parameter relationships, if the parameter relationship reflects a commonly pursued system performance (e.g., miniaturization), the description should disclose the technical means to achieve that goal, rather than just providing a few examples with specific values; if the parameter relationship is a design constraint, the overall technical meaning of the parameter relationship and its correspondence with the technical effect will be considered, and for uncommon and broad parameter ranges, the description needs to provide examples near both end values and at least one intermediate value to support the generalized

scope.

4. Standards for Priority Examination

The Selection explains the rules for determining priority involving cited patent documents.First, if a cited document in the background part of a patent document meets the relevant requirements of the Patent Examination Guidelines, the content of the cited document can be deemed to be recorded in the patent description.

Second, in determining "inventions of the same subject matter," if a person skilled in the art can understand the technical field, the technical problem to be solved, the technical solution, and the expected technical effect from the overall content of the priority document and its cited documents, and these four aspects are identical to those of the later application, then the applications are deemed to be of the same subject matter, and the later application can enjoy the priority of the earlier application.

(B) Examination Standards for Special Technical Fields: Focusing on High-Value Areas

1. Biotechnology and Pharmaceutical Field

In the biotechnology and pharmaceutical field, the examination standards reflect a control over the substance of innovation, experimental data, and field-specific principles.

First, the Selection clarifies the determination of technical inspiration for combination drug inventions and medical use inventions. Vague references in the prior art, such as "can be used in combination with other drugs" or a broad list of unverified indications, are insufficient to provide a clear technical inspiration for specific combination therapies or medical uses.

Second, the Selection explains the impact of supplementary experimental data on the assessment of inventive step. The core standard for whether the effect proven by supplementary experimental data can be used in the assessment of inventive step is whether the effect can be derived from the content disclosed in the patent, i.e., whether there is a close correlation between the effect proven by the supplementary data and the effect disclosed in the patent document.

Finally, the standards for inventive step for specific inventions are refined. For drug compound polymorphs, due to the common motivation for polymorph screening, inventiveness depends on producing an "unexpected technical effect," and the more conventional the means of obtaining the polymorph, the higher the requirement for the effect. For traditional Chinese medicine compositions, the examination follows the intrinsic logic of "treatment based on syndrome differentiation" and the principles of herb compatibility. For medical uses defined by physiological indicators, the core of the examination is whether the physiological indicator has practical clinical guidance value and has a substantial impact on the scope of protection.

2. Artificial Intelligence (AI) Field

In the AI field, the examination standards reflect how to grasp the influence of application scenario characteristics on the algorithm or model during the assessment of inventive step.

In scenarios utilizing AI for human-computer interaction, the assessment of inventive step should consider whether the "specific object, application scenario, and training purpose" have a substantial impact on the technical solution. If these specific factors lead to the model being significantly different from the prior art in terms of training data, methods, and objectives, and the prior art does not provide inspiration for modifying the model for that training purpose, then the solution involves an inventive step.

When applying an AI algorithm or model to different scenarios, the inventive step depends on whether the characteristics of the application scenario cause substantial adjustments or changes to the algorithm or model. This change is reflected in significant differences in training data, input/output data, and model selection, and ultimately solves a different technical problem than the prior art.

3. Telecommunications and Semiconductor Fields

The Selection explains the determination of motivation to combine solutions in different versions/releases of communication standards during the assessment of inventive step in the telecommunications field. The key lies in the specific application scenarios and the technical problems solved by the different versions of the communication standards. If a distinguishing feature is used in different scenarios to solve different technical problems across standard versions, then the reference document cannot be considered to provide technical inspiration for introducing that distinguishing feature.

The Selection also establishes two key examination standards for the protection of integrated circuit layout designs. First, it clarifies the legal meaning of "otherwise distributing for commercial purposes" in the context of "commercial exploitation" as stipulated in the Regulations on the Protection of Integrated Circuit Layout Designs. "Otherwise distributing for commercial purposes" should be understood as an act equivalent to "importing" and "selling," and should not include preparatory acts where no actual provision has occurred, such as offering for sale or similar acts. Second, it provides trial guidance on the judgment of the originality of an integrated circuit layout design. In assessing originality, the right holder's own prior layout designs are also within the scope of comparative layout-designs. A subsequent layout design should have "substantial differences" from the prior design, and these differences should not be "conventional designs" recognized in the field.

III. Conclusion

The Selection, using the typical reexamination and invalidation cases of 2024 as a vehicle, systematically sorts out the patent law issues in patent reexamination and invalidation procedure, comprehensively reflecting the latest practical orientation of the CNIPA.

These typical cases involve strategic emerging industries such as biotechnology, AI, high-end communications, and semiconductors. The legal issues in these fields are novel and complex, and thus the Selection is able to provide rapid and clear examination guidance for

cutting-edge technologies and new business models.