In an administrative appeal case, the Supreme People's Court (SPC) held that when assessing inventiveness, where a given certain technology was still in its early stages of development before the filing date, a person skilled in the art at that time would have had little prior art to draw upon and would have faced greater uncertainty. Lacking a mature understanding of the relevant technical problems and solutions, such a person would have been compelled to engage in more independent exploration, original thinking, and extensive experimentation. Under these circumstances, whether their intellectual contribution qualifies as inventiveness should be evaluated in light of the state and course of technological development before the filing date.
The case involved a reexamniation decision on a rejected invention patent application. The facts are briefly summarized as follows.
University A filed an invention patent application titled "Diagnosing Fetal Chromosomal Aneuploidy Using Genome Sequencing," referred to as "the disputed application." The application proposed a method for diagnosing fetal chromosomal aneuploidy using a biological sample from a pregnant woman, such as maternal plasma, through large scale parallel genome sequencing.
The China National Intellectual Property Administration (CNIPA) issued a reexamination decision upholding the earlier rejection of the disputed application. The decision found that claim 1 of the disputed application lacked inventiveness in view of the combination of Reference 1, Reference 3, and conventional technical means in the field. The relevant References are as follows. Reference 1 is a patent publication, which disclosed a method for performing chromosome karyotype analysis. Reference 3 is an article titled "Application of Cell Free Fetal DNA Detection in Maternal Plasma in Prenatal Diagnosis," published in the Chinese Journal of Obstetrics and Gynecology in July 2006, which stated that researchers had discovered relatively abundant cell free fetal DNA circulating in maternal plasma.
University A filed a lawsuit with the first instance court, requesting that the reexamination decision be annulled and that the CNIPA be ordered to issue a new decision.
The first instance court dismissed the lawsuit. The court found that Reference 1 disclosed a method for detecting aneuploidy in a sample containing fetal chromosomes, and that its detection method was essentially the same as that of the disputed application, including parallel sequencing of randomly fragmented sample DNA. A person skilled in the art would have been motivated to use the method of Reference 1 to detect differences in the DNA described in Reference 3, thereby achieving the diagnostic purpose. The court also found that there was teaching to analyze differences between test samples and control samples using the method of Reference 1, and to select statistically significant differences as the basis for diagnosis. A person skilled in the art would have had a reasonable expectation of success, and the approach fell within conventional statistical methods and conventional technical means in the field.
University A appealed the first instance decision. The SPC issued an administrative judgment annulling the reexamination decision and the first instance judgment, and ordered the CNIPA to issue a new reexamination decision on University A's request.
In its final judgment, the Supreme People's Court stated that the key issue in the second instance was whether claim 1 of the disputed application possessed inventiveness. The core dispute revolved around whether Reference 3 provided a technical teaching regarding a certain distinguishing technical feature.
The SPC held that, in addressing the objective technical problem to be solved, the technical teaching that a person skilled in the art could derive from the prior art should generally be a specific and concrete technical means, rather than an abstract idea or a general research direction. Finding that the prior art provided a concrete teaching based merely on an undeveloped idea or research direction risks hindsight bias and tends to undervalue the inventiveness of a creation. Furthermore, if a certain technology was still in its early stages of development before the filing date, a person skilled in the art at that time would have had little prior art to rely on and would have faced greater uncertainty. Such a person would have lacked mature understanding of the technical problems and means, and would have needed to engage in more independent exploration, thinking, and experimentation. Under these circumstances, whether their intellectual contribution qualifies as inventiveness should be evaluated in light of the state and course of technological development before the filing date.
In this case, although Reference 3 provided a technical teaching that the level of cell free fetal DNA in maternal plasma of a woman carrying a trisomy 21 fetus was significantly different from that in normal samples, there was considerable uncertainty before the filing date of the disputed application. Before the disputed application, the general understanding of a person skilled in the art was that the situation of cell free fetal DNA in maternal plasma was very complex. There was uncertainty about whether the quantities of DNA fragments of different fetal chromosomes in maternal plasma corresponded to each other, and whether there was a quantitative relationship between the number of DNA fragments of each fetal chromosome and the number of corresponding chromosomes in fetal cells. Therefore, Reference 3 did not provide a sufficient technical teaching to motivate a person skilled in the art to apply a detection method substantially the same as that described in Reference 1 to maternal plasma for detecting fetal chromosomal aneuploidy, and ultimately to arrive at the technical solution of the disputed application.
This final judgment clarifies the logic for determining technical teaching in patent inventiveness assessment. It rejects the substitution of abstract concepts and early stage research directions for specific and concrete technical teachings, and effectively prevents hindsight bias from improperly diminishing the inventiveness of a creation. By grounding its analysis in the actual development history of the field and fully respecting the technical uncertainty that existed before the filing date, the SPC objectively affirmed the inventor's creative contribution. This judgment not only accurately applies the rules for assessing inventiveness but also reflects the judiciary's careful protection of original innovation. It provides important judicial guidance for patent validation and innovation incentives in high tech fields.
(2022) Zui Gao Fa Zhi Xing Zhong No. 811
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