*AI-generated translation, for reference only.

Keywords: Administrative; Reexamination of Rejection of Invention Patent Application; Inventive Step; Course of Technological Development; Motivation for Improvement; Technical Teaching

Case Facts

Hong Kong [REDACTED] University is the applicant of an invention patent application with Application No. 20088010****.1, entitled "Diagnosing Fetal Chromosomal Aneuploidy Using Genomic Sequencing" (hereinafter the "Application"). The Application uses biological samples from pregnant women (such as maternal plasma) to diagnose fetal chromosomal aneuploidy through massively parallel genomic sequencing; its filing date is July 23, 2008, its priority date is July 23, 2007, and its publication date is September 29, 2010. The Application concerns cutting-edge technical issues in the field of biomedicine, and its inventors include internationally renowned scientists in this field.

On February 5, 2020, the China National Intellectual Property Administration rendered Reexamination Request Examination Decision No. 202160 (hereinafter the "contested decision"), upholding the rejection decision made against the Application by its original examination department, on the ground that Claim 1 of the Application did not possess an inventive step in relation to the combination of Reference Document 1, Reference Document 3, and conventional technical means in the art. The reference documents cited in the contested decision are as follows: Reference Document 1, a patent document with Publication No. US2005/02213****, which discloses a method for performing chromosome karyotype analysis; and Reference Document 3, "Application of the Determination of Cell-free Fetal DNA in Maternal Plasma in Prenatal Diagnosis," published in the Chinese Journal of Obstetrics and Gynecology, July 2006, Vol. 41, No. 7, pp. 492–494, which states that some researchers have found that relatively abundant cell-free fetal DNA exists in the blood circulation of pregnant women.

Hong Kong [REDACTED] University filed a lawsuit with the Beijing Intellectual Property Court, requesting revocation of the contested decision and an order directing the China National Intellectual Property Administration to render a new decision.

On August 14, 2022, the Beijing Intellectual Property Court rendered Administrative Judgment (2020) Jing 73 Xing Chu No. 10465, dismissing the claims of Hong Kong [REDACTED] University. Dissatisfied, Hong Kong [REDACTED] University appealed. On September 26, 2024, the Supreme People's Court rendered Administrative Judgment (2022) SPC IP Admin. Final 811, revoking the contested decision and the first-instance judgment, and ordering the China National Intellectual Property Administration to render a new examination decision on the reexamination request filed by Hong Kong [REDACTED] University with respect to the Application.

Judge's Opinion

The court's effective adjudication held that: in the face of the objective technical problem to be solved, the technical teaching that a person skilled in the art can obtain from the prior art should, in principle, be a concrete and definite technical means, rather than an abstract idea or a general research direction; to find that the prior art gives a concrete teaching merely on the basis of an immature idea or research direction carries the latent risk of hindsight and tends to underestimate the inventive step of an invention-creation. Moreover, if a certain technology was still in an early stage of development before the filing date, then for a person skilled in the art at that stage, because the prior art information available for reference is scarce, the uncertainty is greater, and there is a lack of mature understanding of the technical problem and the technical means, such a person needs to engage in more independent exploration, reflection, and experimentation on their own; and in this process, whether the intellectual contribution they make constitutes creative labor should also be comprehensively considered in light of the state and course of technological development before the filing date. In this case, although Reference Document 3 gives a technical teaching that the level of cell-free fetal DNA in the plasma of pregnant women carrying a fetus with trisomy 21 differs significantly from that of normal samples, since, before the present Application, the general understanding of persons skilled in the art was that the situation of cell-free fetal DNA in maternal plasma was highly complex, with uncertainty existing as to such matters as whether there is a corresponding relationship among the numbers of DNA fragments of the various fetal chromosomes in maternal plasma and whether there is a quantitative relationship between the number of DNA fragments of each fetal chromosome and the number of the same chromosome in fetal cells, Reference Document 3 has not yet given a sufficient technical teaching to motivate a person skilled in the art to choose to apply, in maternal plasma, a detection method substantially identical to that of Reference Document 1 to detect fetal chromosomal aneuploidy and ultimately to be able to obtain the technical solution of the present Application.

Judgment Digest

As to the determination of whether a person skilled in the art has a motivation to improve the prior art, or whether the prior art gives a technical teaching, the state and course of development of the technical field to which the application pertains before the filing date may be comprehensively considered. If, before the filing date, the technology in the field was still in an early stage of development and the understanding of persons skilled in the art regarding the relevant technical problems and technical means was not yet mature, then research and development faced more uncertain factors. Under such circumstances, a finding that a person skilled in the art has a motivation to improve the prior art, or that the prior art gives a technical teaching, should be made with caution.

Related Index

Article 22, Paragraph 3 of the Patent Law of the People's Republic of China (the provision applied in this case is Article 22, Paragraph 3 of the Patent Law of the People's Republic of China that came into force on July 1, 2001)

First Instance: Administrative Judgment (2020) Jing 73 Xing Chu No. 10465 of the Beijing Intellectual Property Court (August 14, 2022)

Second Instance: Administrative Judgment (2022) SPC IP Admin. Final 811 of the Supreme People's Court (September 26, 2024)