How to Tackle Issues Concerning Lack of Support in a Patent Application for a Biological or Chemical Invention
Author: Phoebe Xi
As stipulated in Article 26.4 of the Chinese Patent Law, the claims shall be supported by the description and shall define the extent of the patent protection sought for in a clear and concise manner. This article aims to adapt the scope of the right acquired by a patentee to the contribution made by the patentee.
From our patent prosecution practice in China, we find that Chinese examiners have extremely stringent requirements to determine whether the scope of protection defined by claims can be supported by the specification. This can result in queries by applicants from the US and Europe when their applications come under substantive examination during the Chinese national phase. Many patent agents handling foreign cases, especially agents in biological and chemical fields, must have always received their clients' doubt like this: even though the protection scope of the pending claims of a patent application filed in China is the same as or even smaller than the counterpart granted in another country, why the application under examination in China, instead of being patented directly, gets into the situation that the claims are required to be further defined and narrowed.
In light of this practice in China, Chang Tsi & Partners has prepared advice on the skills needed to successfully draft a new application and respond to an Office Action in the biological & chemical field.
Drafting of a Patent Application
1. Quantity and Quality of Examples
Generally, experimental data are used to show advantageous effects of a biological or chemical invention, and such experimental data are often recited in the form of effect embodiment (effect example) in the application documents.
When an examiner raises the issue related to lack of support, he/she usually makes a comment that, based on the examples recited in the present application, not every technical solution to be protected in the claim can be expected to produce the technical effect depicted in the examples, and the protection scope thereof thus cannot be supported by the specification.
As can be seen from the above, the quantity of examples is of importance. This does not mean that it must be better to recite more examples, however. The truth is that typical examples, namely examples of high quality, can provide more support. For instance, with regard to substituents in a compound of a general formula, only if one of the substituents selected from a group consisting of H, alkyl, alkoxy, and halogen is proved to have the unexpected technical effects as stated in the application, can an examiner admit the protection of the other substituents. Thus, it is unnecessary for the applicant to prepare examples of the other substituents. Nevertheless, if an applicant desires the further protection of substituents of other types, e.g. -COO-, the applicant should provide an example to show that the compound comprising -COO- can bring about the recited, unexpected technical effects as well. Furthermore, as commonly known in the art, -CO-, -NH-, or -CH2-, as a bioisostere of -COO-, has physical and chemical properties similar to -COO- in general and thus can be protected also.
2. The Inventive Principle or Mechanism, the Product or Process Features, and the Technical Problem to Be Solved
To fully support the protection scope of claims, the specification should contain a detailed description of the technical solution or the technical effects of the invention, such as the inventive principle or mechanism, the product or process features, and the technical problem to be solved. With these details, the claims can be better supported.
For instance, if the inventive principle or mechanism can be clearly stated in the specification, then even with limited examples in the specification, a person skilled in the art, based on the principle or mechanism, can still unambiguously determine that all of the technical solutions within the scope of the invention can achieve the technical effects and solve the technical problem in the invention, and the claims can be supported by the specification.
1. Complementary Experimental Data
An applicant can also submit complementary experimental data to obtain a wider scope of protection.
The Draft Revision to the Guidelines for Patent Examination, 2017, states that with respect to experimental data submitted after the date of filing, the examiner shall conduct an examination of the data; the technical effects, as demonstrated by such complementary experimental data, shall be concluded by a person skilled in the art from the disclosure of the patent application.
First, it should be noted that complementary experimental data are submitted by the way of evidence submission, rather than through a replacement sheet of the amended specification.
Second, for issues related to lack of support, whether the claimed technical effects within the overall scope of the claims can be achieved need to be determined based on the recordation of the inventive mechanism in the original specification, even based on prior art if necessary. For instance, in terms of an application only containing examples towards one end of the claimed scope, or an application only providing some specific compounds comprising a minority of a particular group of a general formula, the applicant is usually required to explain what technical effects the inventive mechanism or the common groups in the formula can achieve, and to take account of the general knowledge in the prior art, if necessary, to indicate that it can be expected by a person skilled in the art to realize the invention within the overall scope. On this basis, the applicant can additionally provide the examiner with some complementary experimental data for his/her consideration.
2. Whether and How to Make Arguments
With respect to the issues concerning lack of support as raised by an examiner in the substantive examination stage, one should first take the applicant's desire into consideration, which is to obtain patent rights as soon as possible or to define a scope of protection as wide as possible. Furthermore, one should offer a response of the highest performance to cost ratio when the client has not strongly indicated either of the above desires.
For instance, regarding technical features similar to, e.g. an antibody comprising an amino acid sequence..., in a claim, an examiner tends to hold that the statement containing the word "comprise/comprising" is open-ended, thereby causing the claim to cover a great number of technical solutions, and other technical solutions apart from the one having been demonstrated by the examples may not bring about the technical effects as expected in the application documents. Thus, he/she may be of the opinion that the scope of protection of the claim cannot be supported by the specification. In such situations, one should directly advise the applicant to replace the defective expression with one that is close-ended.
What is required is that a person skilled in the art can unambiguously determine that other technical solutions, except those having been proved in the examples, can also produce the unexpected technical effects of the invention according to the inventive principle or mechanism, product or process features or the technical problem to be solved as recited in the examples, together with the general knowledge in the art, even if the examples are limited in number. In the event of the aforesaid situation, it is not advisable to limit the scope of protection of the claims to the examples. Instead, one is advised to provide reasons and documentation to carry out one or more rounds of discussion with the examiner, in order to obtain a wider scope of protection. Sometimes, it is more like a "bargain" between the examiner and the patent agent.
In addition, there is a common idea that an invention which opens up a whole new field of technology is entitled to more generality in the claims than one that is concerned with advances in a known technology. Thus, claims can be reasonably generalized within the disclosure of the specification.
At last, as for a technical solution that fails to be protected in the original application, the applicant is advised to file a divisional application.