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Application Of Supplementary Test Data In Chinese Patent Prosecution – Patent


Experiments, tests and their results are very important aspects
in the process of research and development, and are also important
aspects in patents that protect the achievements of the research
and development, especially in the fields of experimental science
such as chemistry and biology. However, during actual patent
prosecution, due to various reasons, the patent application may not
be able to include all experiments and tests performed during
development of the invention at the beginning. In some cases, the
lack of experiments and tests (usually referred to as
“examples” in patent documents) may lead to rejections
during examination of patents. Fortunately, in current Chinese patent practice, it is possible to
provide supplementary test data during examination in order to
overcome related rejections. In this article, specific conditions
are discussed where supplementary test data may be applied to
overcome rejections during examination of patents.

Relevant regulations in Chinese
Patent Law on supplementary test data

There are several explanations in the Guidelines for Patent
Examination which can be considered as a legal basis for providing
supplementary test data during patent prosecution. In the
Guidelines for Patent Examination, it is mentioned that for
supplementary test data filed after the application date in order
to meet the requirements of Article 22.3 (regarding inventiveness)
and 26.3 (regarding sufficient disclosure), the examiner should
consider the data during examination, and the technical effects
proved by the supplementary test data should be the ones which can
be obtained by a person skilled in the art from the disclosure of
the application.

In this regard, the Guidelines for Patent Examination gives two
examples as follows to further explain the regulation above:

Example 1: The claims set forth compound A, and the description
sets forth the preparation examples of compound A, the hypotensive
effect of compound A, and the experimental method for determining
the hypotensive activity, but does not set forth the result data.
The applicant submits supplementary data on the hypotensive effect
of compound A in order to demonstrate sufficient disclosure of the
description. For person skilled in the art, the hypotensive effect
of compound A has been disclosed in the original application, and
the technical effect proved by supplementary data can be obtained
from the disclosure of the application documents. Note that the
supplementary data should also be considered in the examination of
inventiveness.

Example 2: The claims set forth compound of general formula I.
The description sets forth compound of general formula I and its
preparation method, the preparation examples of several specific
compounds A and B of general formula I, and the antitumor effect of
general formula I, the experimental methods for the determination
of antitumor activity and the result data. The experimental results
record that IC50 values of the example compounds for tumor cells
are in the range of 10-100 nm. To demonstrate the inventiveness of
the claims, the applicant submitted comparative experimental data
showing an IC50 value of 15nM for compound A and 87nM for compound
of reference document 1. For a person skilled in the art, compound
A and its antitumor effect are disclosed in the original
application, and the technical effects demonstrated by
supplementary data can be obtained from the application documents.
Kindly note that the examiner still needs to further analyze
whether the technical solution of the claim meets the requirements
for inventiveness in combination with the supplementary data.

According to the explanations and examples above, it can be seen
that the Guidelines for Patent Examination supports application of
supplementary test data for overcoming rejections under certain
conditions. These conditions will be discussed in detail
hereinafter.

Specific rejections that may be
overcome by applying supplementary test data

1) Insufficient disclosure

As mentioned in Example 1 above, when the examiner rejects an
application for not disclosing test data demonstrating the
technical effect of the invention, i.e., insufficient disclosure,
it may be helpful to overcome the rejection by filing supplementary
test data demonstrating the technical effect. In this case, the
technical effect demonstrated by supplementary data must be
obtained from the original application. Also, the experimental
methods for obtaining the supplementary test data should be
disclosed in the original application. We understand that the
R&D cycle for some technical fields such as medication can be
very long, and the time for performing experiments may delay the
time for applying patents. In this case, it may be possible to file
a patent application without test data demonstrating the technical
effect, and file supplementary test data during examination of the
application. This kind of strategy may expedite filing of patent
application, but there is also a potential risk that the examiner
will not accept the supplementary test data.

2) Lack of inventiveness

As mentioned in Example 2 above, supplementary test data may be
used to demonstrate inventiveness of the application over
references cited by the examiner. A direct way of doing so is to
take the reference documents as comparative examples, and providing
test data showing the present invention leads to better results
compared to the reference documents. Another approach is to provide
test data showing that the present invention achieves unexpected
effects in view of the prior art. For example, an application sets
forth a specific crystal form of a compound, and the examiner cites
a document disclosing the compound but not its crystal form to
reject the inventiveness of the application. In this case, if the
applicant can provide test data showing unexpected effects of the
specific crystal form of the present invention, it may be helpful
to overcome the rejection. Note that as mentioned above, the
technical effect demonstrated by supplementary data must be
obtained from the original application.

3) Lack of support from description

Although not mentioned above, supplementary test data may also
be used to overcome lack of support rejection. One of the most
common situations for lack of support is the general formula
compounds. For example, the claims set forth a compound of a
general formula, and the examples of the application only provide
test data for a few specific compounds. In this case, the examiner
may deem the general formula not supported by the description. To
overcome this kind of rejection, it may be helpful to provide test
data showing that some other compounds of the general formula have
similar properties or achieve similar effects. However, as
mentioned in the Guidelines for Patent Examination, the test data
filed after the application date is not allowed to be added into
the description. Therefore, it is possible that the examiner does
not accept the supplementary test data in this case.

To conclude, application of supplementary test data may be
helpful in overcoming rejections during examination of patent
application, thus providing the applicants more ways to facilitate
granting of the patent application, and more flexible strategy of
scheduling filing of patent application and performing experiments.
After all, according to the Guidelines for Patent Examination, the
key point for filing supplementary test data is that the technical
effects proved by the supplementary test data should be the ones
which can be obtained by a person skilled in the art from the
disclosure of the application. In addition, in actual patent
practice, the examiner will determine whether to accept the
supplementary test data or not on various aspects, such as
disclosure of the original application, effects proved by the
supplementary data, etc., and the practice of different examiners
may vary. Therefore, although supplementary data may be filed after
the application, providing all necessary experiments and tests in
the original description is still the best choice for preparing
application documents.

The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.



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