Determination of Whether a Claim Can Be Supported by the Specification

Judgment Gist

In determining whether a claim can be supported by the specification, consideration should be given to whether a person skilled in the art can reasonably be convinced that the technical solution of the claim is able to solve the technical problem that the invention seeks to solve and does not exceed the scope of the inventor's technical contribution. So-called reasonable conviction generally means that a person skilled in the art, based on the content disclosed in the specification and using conventional experimental or analytical methods rather than broad theoretical conjecture, is able to reasonably generalize the scope of protection of the claim from the content disclosed in the specification.

Keywords

Administrative; invalidation of invention patent right; claim being supported by the specification; inventor's technical contribution; reasonable conviction

Basic Facts

A certain German company is the patentee of the invention patent numbered 20141014****.X and titled "Method and nucleic acids for the analysis of cell proliferative disorders." On 30 November 2018, a certain Jiangsu Wei company filed a request for invalidation against this patent right. The basis of examination in this case was the claims submitted by the German company on 25 February 2019, comprising a total of 28 claims.

The China National Intellectual Property Administration, on 10 July 2019, rendered Invalidation Request Examination Decision No. 40815, holding that claims 1-3, 6-9, 12-17, and 20-28 of the patent, as well as the technical solutions in claims 4, 5, 10, 11, 18, and 19 involving "the biological sample is selected from body fluid, urine, plasma, serum, whole blood, isolated blood cells, and cells isolated from blood" and involving "the cancer is hepatocellular carcinoma," could not be supported by the specification; and maintaining as valid the technical solutions in claims 4, 5, 10, 11, 18, and 19 involving "the biological sample is selected from cell lines, histological sections, tissue biopsies, paraffin-embedded tissue, feces, colonic effluent, and combinations thereof" and "the cancer is colorectal cancer."

The German company brought suit before the Beijing Intellectual Property Court, requesting that the challenged decision be set aside. The first-instance court dismissed its claims on 24 December 2021. Dissatisfied, the German company appealed. On 24 April 2024, the Supreme People's Court rendered an administrative judgment dismissing the appeal and upholding the original judgment.

Judgment Opinion

The court's effective judgment held: Article 26, paragraph 4 of the Patent Law provides: "The claims shall be based on the specification and shall define, in a clear and concise manner, the scope of the patent protection sought." Whether a claim can be supported by the specification should be judged comprehensively from the perspective of a person skilled in the art, based on the overall situation of the prior art in the field, the content disclosed in the specification, and the content defined by the claim. If a person skilled in the art, based on the content disclosed in the specification and the overall situation of the prior art, can reasonably be convinced that the technical solution for which protection is sought by the claim is able to solve the technical problem that the invention seeks to solve, and does not exceed the scope of the technical contribution made by the inventor, then the claim should be deemed capable of being supported by the specification. That a person skilled in the art can reasonably be convinced means that, based on the content disclosed in the specification, a person skilled in the art, using conventional experimental or analytical methods rather than broad theoretical conjecture, can extend the content disclosed in the specification to the scope of protection of the claim.

The German company argued that the evidence it submitted was sufficient to prove that detecting tumors through blood testing was a relatively common line of thought in the field, and therefore a person skilled in the art would not doubt that the DNA content of blood tumors is extremely low and difficult to detect; blood testing was a reasonable inference by a person skilled in the art based on tissue testing.

The court analyzed as follows:

First, multiple pieces of journal-article evidence show that, even after the priority date of the patent, conducting cancer screening by means of blood testing was still at the stage of scientific exploration, and there was as yet no settled conclusion that it could serve as a kit-based test. The evidence submitted shows that, for cancers of different primary sites, whether blood testing can be adopted needs to be proven through research.

Second, although means of blood-based detection of circulating DNA did indeed exist in the prior art, for different cancers the sources of ct-DNA in blood differ, so it cannot be concluded that conventional technical means would necessarily be able to carry out detection through blood or other test kits.

Third, the patent concerns the use, in the preparation of a test kit, of a device for determining the methylation level of the Septin9 gene or of the Septin9 sequence of the genome; the content disclosed in the specification should be sufficient to prove that its technical solution of detection via blood or other means in a test kit is able to achieve that use, rather than reaching a conclusion based on the broad teachings of academic papers around the earliest priority date or based on the general attention to and demand for blood testing in the field. The specification of the patent does not disclose experimental data verifying the Septin9 methylation level in blood based on colorectal cancer positive cases, nor does it disclose a specific technical solution for achieving that use using a blood test kit.

Finally, the China National Intellectual Property Administration reached, on the basis of the fundamental cognition of a person skilled in the art at the earliest priority date, the conclusion that the DNA content of blood tumors is extremely low and difficult to detect. By the same reasoning, the detection of other non-tissue samples can also lead to the same conclusion as blood testing. The findings of the challenged decision are not improper.

Associated Index

Article 26, paragraph 4 of the Patent Law of the People's Republic of China (the version applicable in this case is Article 26, paragraph 4 of the Patent Law of the People's Republic of China that came into force on 1 July 2001)

Source: Intellectual Property Court of the Supreme People's Court, 2026-09-17. Original: https://ipc.court.gov.cn/zh-cn/news/view-6073.html