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Chinese courts examine supplementary experimental data




Lijun Kong and Quan Kang of DEQI analyse a number of cases in which the courts have considered supplementary experimental data

Amendment to guidelines

Regarding the amendment of the Patent Examination Guidelines in 2017, especially the amendment focusing on supplementary experimental data in the field of chemistry, everyone has a different interpretation. Is there any change in the examination principles in this amendment? How does it reflect in specific practice? In fact, Chinese examiners began to examine supplementary experimental data a few years ago, and the amendment to the Patent Examination Guidelines is to unify the written rules with the actual examination principles. Hereinafter, we discuss the examination of supplementary experimental data in the context of several specific cases.

Adjacent is a table contrasting examination before and after the amendment on supplementary experimental data in the Patent Examination Guidelines:

Although this part is stipulated in the chapter of the judgment on the sufficient disclosure of description, the above rules are often applied in other types of actions such as inventiveness. Since the experimental data submitted is not part of the content of the original application, it must be intrinsically linked with the content recorded in the original application. It must be connected to the technical effect.

There should be clear written records and corresponding experimental data in the description for the technical effect proved by the supplementary experimental data.

Since there is no definite contrast between the experimental data that already existed in the original description and the reference documents cited in the substantive examination phase, the applicant sometimes submits comparative experimental data which is intended to prove that the effect of this application is significantly better than that of the reference documents. In this case, the technical effect proved by the comparative experimental data submitted can be concluded from the disclosure of the patent application.

Before amendment After amendment
Whether or not the description is sufficiently disclosed is judged on the basis of the disclosure contained in the initial description and claims.

Any embodiment and experimental data submitted after the date of filing shall not be taken into consideration.
Whether or not the description is sufficiently disclosed is judged on the basis of the disclosure contained in the initial description and claims.

The experimental data submitted after the date of filing shall be examined. The technical effects proved by the supplementary experimental data should be obtained from the disclosure of the patent

Cases concerning supplementary experimental data

Regarding example 1, after further examination, the re-examination board deemed that the synergetic effects proved by the supplementary experimental data had been disclosed by reference 1. The substantive difference between claim 1 and reference 1 was only the difference of arsenic trioxide and sodium meta arsenite, and reference 2 gave the technical inspiration for applying sodium meta arsenite in treating a solid malignant tumour. Finally, a re-examination decision was made to maintain the decision of the rejection.

In this case, if the applicant had been able to provide experimental data to prove that there were substantial differences in the technical effect of arsenic trioxide and sodium meta arsenite, indicating that sodium meta arsenite cannot be conceived from arsenic trioxide by those skilled in the art, it may have been helpful for the argument for inventiveness.


Chinese examiners began to examine supplementary experimental data a few years ago, and the amendment to the Patent Examination Guidelines is to unify the written rules with the actual examination principles


For some cases, such as example 2, the technical effects obtained by the supplementary experimental data could be confirmed by those skilled in the art from the prior art.

In this case, the technical effects did not need to be proved by experimental data, and were known effects for those skilled in the art by looking at prior art. As a result, in the description there could be only written records rather than relevant experimental data, or even no relevant written records. Since no experimental verification is required, the supplementary data in such circumstances will generally not be rejected by the examiner owing to no relevant records in the original description.

However, it was exactly because those skilled in the art could expect the suppleness effect that the supplementary experimental data failed to prove the unexpected technical effect of this application. In the end, the re-examination board judged that this application did not possess inventiveness.

Although such supplementary data was accepted by the examiner, the effects which could be confirmed with prior art were deemed as expected technical effects by the examiner so that the experimental data did not make a substantive contribution to demonstrating inventiveness.

Sometimes, the technical effects proved by the supplementary experimental data can only be established depending on experimental verification.

In these circumstances, the technical effect is neither recorded in the original description nor can it be obtained by those skilled in the art looking at the prior art before the date of filing, or the technical effects are recorded in writing, but there is no corresponding experimental verification.

Since the technical effects must rely on experimental verification being established, the examiner may deem that the effects in the original specification are not sufficiently disclosed in the original description. As a result, even though there is a record in the text about the technical effect in the original description, the supplementary experimental data may not be accepted by the examiner.

Technical effects which can only be confirmed by experiments should be relayed in the disclosure in the original application documents in the examination phase regardless of whether there is a written record or not. If the original application documents do not record the experimental data for corresponding effects or there is no necessary correlation between the data and the written effects, generally the unexpected technical effects cannot be confirmed through the supplementary experimental data. As reconsideration ex post facto, if there is a record of the reaction rate data in the description, the examination will be more beneficial to the applicant.

Example 1

Re-examination decision no 85462

Date of decision: January 22 2015

Claim 1 of this patent application (Application No: CN200980118768.6) sought protection for a kit for the treatment of lung cancer, which consisted of a first composition comprising 1~25 mg/day of sodium meta arsenite and a second composition comprising 3~100mg/m2 of cisplatin.

Reference 1 disclosed a method for treating cancer by arsenic trioxide and a solution for treating a hard tumour by combining arsenic trioxide and other known therapeutic agents. Reference 1 also disclosed that the known therapeutic agents comprised cisplatin and the hard tumour referred to was lung cancer.

Reference 2 disclosed a pharmaceutical composition comprising a meta arsenite salt for treating malignant tumours, and specifically for treating solid malignant tumours.

In the observation, the re-examination petitioner provided in-vivo and in-vitro experimental data to demonstrate the synergetic effects of the combination of sodium meta arsenite and cisplatin in treating lung cancer and also enclosed the statement and research results from Dr Sujiong Kim, a technical expert, who compared the treatment of sodium meta arsenite, cisplatin, arsenite and cisplatin on H292 lung cancer cells and PC14E6 adenocarcinoma cells.

As to the supplementary in-vivo and in-vitro experimental data supplied by the re-examination petitioner, the re-examination board deemed that the original description recorded the data of in-vitro synergetic effects, and the technical effects proved by the supplementary data were just the synergetic effects of both in-vivo and in-vitro. Thus, the supplementary data was accepted and the inventiveness examination could be continued.


Example 2

Re-examination decision no 78652

Date of decision: November 25 2014

The claim 1 of this patent application (Application No: CN201010606129.9) sought protection for a cosmetic composition comprising 2.5wt%~10wt% of one or more volatile linear alkanes and one or more cationic surfactants, wherein the weight ratio of the amount of volatile linear alkanes to the amount of cationic surfactants was in the range of 0.5~1.2. The distinguished feature between claim 1 and reference 1 was the difference of the weight ratios of volatile linear alkanes to cationic surfactants. The ratio in reference 1 was 1.4 and the ratio in this application was 0.5~1.2.

The applicant supplemented the experimental data of the comparison test to state the inventiveness. The experimental data of the comparison test showed better suppleness obtained by the composition of this application compared with the control group of reference 1.

In this regard, the re-examination board deemed that the suppleness effect in the supplementary experimental data of comparison test was due to the different content of cationic surfactants. Although this description did not record any experiment for testing the suppleness of this composition, those skilled in the art could expect that cationic surfactants have an impact on the suppleness of hair conditioner. Thus, the re-examination board accepted the supplementary experimental data.


Example 3

(2016) Administrative appeal case no 1878 of the Supreme People's Court

Date of judgment: September 27 2016

The claim 1 of the patent application (Application No: CN200580023071.2) sought protection for a method for producing the compound represented by the following formula (III) and its salts thereof, which included reacting the compound represented by the following formula (I) and its salts thereof with the compound represented by the following formula (II) in the presence of a palladium compound, a copper compound, a phosphorus compound and an alkali. The copper compound was used in an amount of 0.001 to 0.2 mole per mole of the compound represented by formula (I). The palladium compound was palladium acetate, palladium chloride or palladium hydroxide. The copper compound was cuprous bromide, cuprous iodide, cuprous chloride or cuprous acetate.

The distinguishing features between reference 1 and claim 1 were as follows: (1) the copper compound was added in the method of claim 1 and the types and amounts of copper compound were specifically limited, but no copper compound was added to the reaction of reference 1; (2) the compound represented by the formula (II) of claim 1 was an aryl or heteroaryl boronic acid derivative more specifically defined than that in reference 1. Reference 2 gave the technical inspiration for applying copper compounds and cuprous compounds as co-catalysts in this kind of reaction.

The patent applicant submitted supplementary experimental data after the date of filing to demonstrate that the technical solution of claim 1 turned out to have a higher reaction rate and less by-products.

The opinion of the Supreme People's Court was as follows: the technical effect of higher reaction rate proved by the supplementary experimental data was not recorded in the original application documents, and there was no necessary link between the speed of the reaction rate and the rate of yield. The description of the patent application involved only recorded high yield, which could not conclude a high reaction rate. Thus, the supplementary experimental data was not accepted.


Conclusion

The technical effects proved by the supplementary experimental data that can be accepted by the examiner must be obtained from the original description, and the supplementary experimental data can only play a reinforcing role. In the event that the effects have not been recorded in the original application documents, and cannot be conceived by those skilled in the art in combination with the prior art, the supplementary experimental data will not be accepted. Through the above provisions, an improper scope of protection and damage to the interests of the public caused by random supplementary experimental data are avoided.

Kong Lijun
  Kong Lijun is a patent attorney at DEQI IP Law Corporation and has practised IP law for 11 years. She is authorised to represent in the IP Court. She obtained a PhD degree in biophysics from Tsinghua University, a master’s degree in biochemistry and molecular biology from the Academy of Military Medical Sciences and a bachelor’s degree in biochemistry from Jilin University.

Lijun Kong focuses on the preparation and prosecution of patent applications. She also has experience in patent re-examination, invalidation, patent analysis and infringement. She is a member of the All China Patent Agents Association.

Kang Quan
  Kang Quan is a patent attorney at DEQI IP Law Corporation and has practised IP law for 14 years. She is authorised to represent in the IP Court. She earned a bachelor’s degree in mechanical engineering and automation and a master’s degree in mechanism and automation engineering from Beijing Institute of Technology.

She focuses on drafting and prosecuting patent applications, re-examinations and invalidations. She was named a Beijing Outstanding Patent Attorney in 2015, and was elected as a teacher at Capital Patent Agency Teacher Library. She is a member of the All China Patent Agents Association.


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