China | Post-filing data in addressing non-support issues

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Since 2021, it has become common practice in China to use post-filing data to address issues related to inventiveness and sufficient disclosure. However, there is a general perception that the same examination standards may not apply to non-support issues, as there are no specific provisions in the Guidelines for Patent Examination.

Despite this, we have had some success for clients in addressing non-support objections with supplemental data. This article follows another successful case that we shared last year, and we will continue to publish further case studies over the coming weeks. Below is a recent case which provides further insight into utilising post-filing data to address non-support issues.

Case Study: Addressing Non-Support Objections with Supplemental Data

The example application is a China national phase application of a PCT application, which seeks to protect Swiss-type use claims. These claims involve determining the concentration of marker A and the level of phosphorylation of marker B in a sample obtained from a subject to reflect the subject’s susceptibility to compound X.

The Chinese Examiner objected that the term “sample” was too broad and not supported by the description, which only verified the success in reflecting the susceptibility of the subject in one specific sample—an ascitic sample. The Examiner argued that a skilled person could not reasonably determine if such success could be achieved in other samples based on the disclosure of the example application.

While we considered it overly limiting to define the sample as the specific ascitic sample, as implied by the Examiner, we noted that the description mentioned other options for the sample (such as blood, serum, drain fluid, urine, lymph, liquid biopsy samples, etc.).

A strategy worth trying was to define the sample as the most relevant ones mentioned in the description, along with the verified ascitic sample. For samples not experimentally verified in the initial disclosure, supplemental data could be provided to prove the success in reflecting the subject’s susceptibility in these additional samples.

In support of this strategy, arguments could be made that those skilled in the art could reasonably expect success in all these sample options to reflect the subject’s susceptibility to compound X, as these options are recorded in the description. Furthermore, the supplemental data proves the technical effect derived from the description and should be acceptable.

The Applicant made the corresponding amendment and provided the related supplemental data. The Examiner accepted the amendment and finally allowed the example application.

Utilising supplemental data

This case demonstrates that even with a mere mention in the description, it may still be possible to convince the Examiner to accept supplemental data to prove the same technical effect verified in the initial examples. While the less strict attitude towards post-filing data may not generally apply to non-support issues under China patent practice, there might still be some room, on a case-by-case basis, to use supplemental data to fight for a more reasonable protection scope for applicants.

How we can help

Our patent experts in China consistently monitor patent cases and developments to ensure our advice to clients is both strategic and informed. Please reach out to our team at any time.

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