By Yang Hongjun, Niu Weiran, Intellectual Property, King &  Wood Mallesons

Unlike common law system that belongs to case law, China’s legal system is continental law system, subject to the “statute law”.  In the patent granting procedure, only the Patent Law, the Implementing Regulations of the Patent Law and the Guidelines for Patent Examination shall have legal effect in principle.  However, judging from our practical experience, the understanding of the same provision may vary depending on different examiners.  Examiners are inclined to follow the previous examination practice in dealing with issues that are significantly influenced by subjective judgment.  In view of this, proper application of precedents (including reexamination decisions, invalidation decisions and court judgments, etc.) can achieve twice the result with half the effort.

On the other hand, some examiners do not like the fact that the applicant cites precedents, and will think that the applicant is pressuring them with irrelevant cases.  Thus, citation of precedents does not necessarily produce good inner conviction for all examiners, but sometimes has a negative effect.  In practice, patent agents need to consider corresponding strategies based on the comprehensive situation of a case.  We have summed up some experience based on our practice, and share with you here.

1. Role of Guiding Cases

In order to promote unification of standards for application of law, the Supreme People’s Court has devoted itself to the release of guiding cases in recent years, some of which are related to intellectual property.  In addition, in 2019, the Patent Reexamination Board (now the Patent Reexamination and Invalidation Department) of the China National Intellectual Property Administration published a book titled Elaboration of Laws by Cases –Guidelines on Typical Cases of Patent Reexamination and Invalidation, which provides specific cases and explanations for understanding and application of almost each provision the Patent Law.

It would be very effective to cite cases in said book directly if the examiner’s findings were different from those of the guiding cases during the substantive examination.

For example, for the composition invention involving a specific combination of various components, some examiners, in practice, based on separate records of the components themselves in a reference document, determine that the specific combination has been disclosed therein, thereby denying the novelty or inventive step of the invention.

For such a determination, sometimes it is unable to convince the examiner through counter-argument based on the provisions of the Guidelines for Patent Examination.  However, two typical cases are presented in the previously mentioned Elaboration of Laws by Cases, respectively, involving compositions containing a variety of components and compounds with specific structures.  In both cases, it was determined that a piecemeal technical solution further selected from the options disclosed for various components/groups in the prior art was not a solution already disclosed in the prior art.  Listing of these two cases as guiding cases in response to an office action will help the examiners to correct their misunderstanding.

2. Role of Minority Cases

Although it is effective to cite guiding cases, in practice, not many examiners have major misunderstandings in the interpretation of the law and always insist on such major anti-theory.  As a result, there are not many scenarios for the above-mentioned guiding cases.  Many times, applicants hope to be successful in obtaining authorization if the examination practice is not conducive to them.

As an example of an invention involving a new therapeutic use of a known product, the following examination opinion is common for claims such as “the use of compound A in the manufacture of a drug that inhibits the expression of enzyme X.”

“The prior art discloses the use of compound A for treating cancer Y.  In addition, cancer Y is known in the prior art to be one of the diseases that can be treated by inhibiting the expression of enzyme X.  Therefore, the technical solution in Claim 1 is essentially the same as the prior art and does not possess novelty.”

That is, the examiner uses the relationship between “compounds” and “disease categories” as a criterion for novelty, regardless of whether the present invention is concerned with revealing a new therapeutic mechanism.  In practice, a considerable number of examiners have adhered to such an examination opinion, which has even been upheld in many judgements.  This recognition is also difficult to be resolved through amendment.

However, in our practice, some examiners have a looser standard of examination, and make their judgments based on the relationship between “compounds” and “mechanisms” (rather than between “compounds” and “disease categories”).  A reexamination decision documenting such views would be beneficial to similar cases in the substantive examination.  The website of the Patent Reexamination and Invalidation Department allows for the search of past examination decisions through legal provisions and keywords.  In principle, a more recent case would be considered more reflective of the trend of the examination and the trial.  Even minority cases can cause examiners to shake their long-held beliefs and make decisions in the applicant’s favor.

3. Timing of Case Citation

As mentioned earlier, some examiners do not like the practice of citing precedents by applicants, and thus the rash and excessive citation of precedents can sometimes have a negative effect.

From our practical experience, case citation is most effective in situations “where the examiner is likely to misunderstand based on explicit laws and regulations and which are rarely encountered”, but less effective for “common focus issues with more subjective judgment criteria”.

As an example of the former, the Guidelines for Patent Examination stipulates non-therapeutic surgical procedures that cause trauma to living animals are not practical.  However, in some animal model manufacturing methods or biological sample analysis methods, it often involves blood collection, injection and other steps.  The examiner, unfamiliar with the practicability clause, can easily interpret it merely in the literal sense of the relevant provisions of the Guidelines for Patent Examination: the method claim is not practical as long as it contains steps that can cause a wound.  It would be very difficult to disprove such an examination opinion based on the statute itself.  It is better to submit a relevant reexamination decision in response to the first office action (the Patent Reexamination Board has recognized in several decisions that “simple routine injection and blood collection techniques are of little individual dependence, require no special expertise, and can be used in industry”).

Regarding the latter (“common focus issues with more subjective judgment criteria”), inventive step evaluation (especially about technical revelation/motivation) is a typical example thereof.  This is something every examiner encounters almost every day, and each examiner has already developed his or her own point of view.  Moreover, each case is different in its own context and in the context of the prior art, and it is difficult for an examiner or collegial panel to be persuaded by a decision in another case.  At this point, the effect of submitting the decision is not high, but may cause negative effects, and should be treated with caution.

4. Flexible Application of the Result of Substantive Examination

It is generally believed that it would be more effective to cite a decision of a higher examination level.  For example, it might be helpful to cite a reexamination decision in the substantive examination procedure, whereas, in turn, would be difficult for a collegial panel to consider the substantive examination findings of a case if they were cited in the reexamination procedure.

However, in some cases, applicants may consider citing results of multiple substantive examinations to construct “examination practice”, which may be helpful in both the substantive examination procedure and the reexamination procedure.

For example, for inventions that improve the performance of an enzyme by mutation, multiple inventions based on the same inventive concept may involve multiple mutation sites.  Some examiners would think that the same technical features among the mutants’ enzymes are the known enzymes themselves, so there is no unity among the mutants.

“Lack of unity”, while a ground for rejection, is not a ground for invalidation, and in essence, is merely that the examiner thinks that the workload brought by an application is beyond a reasonable scope.  However, on the other hand, if the mutants and various combinations thereof are required to be submitted as separate applications, it will be too heavy a burden on the applicant from an economic point of view.  For similar cases with the unity issue, if the applicant can find, by searching, a number of cases in which “the same application with inventions involving multiple mutation sites has been granted”, and suggests all of them to the examiner, it would help the assertion that “multiple inventions involving multiple mutation sites belong to the same inventive concept, which is a longstanding practice of examination”.

In the reexamination procedure, the collegial panel will also take care to align itself with the longstanding practice of substantive examination.  Therefore, although the substantive examination result of a single case is difficult to be considered by the collegial panel of reexamination, the strategy of constructing “examination practice” through the examination results of multiple cases can also be flexibly used in the reexamination procedure.

In general, in order to reasonably cite precedents, patent agents need not only to be able to grasp the trends and results of the focus cases in a timely manner, but also to understand the nature of a case and consider corresponding strategies according to the comprehensive situation of the case.