Several Ways for responding to Office Action regarding methods for diagnosis and treatment of diseases
date: 2023-04-03 Yi Qu Read by:

    According to Article 25.3 of the Chinese Patent Law, a method for diagnosis and treatment of diseases shall not be granted for patent right.


Ø  Basic concepts


Diagnostic methods of diseases


    According to Guidelines for Patent Examination, the diagnosis method of disease refers to the processes of identifying, studying, and determining the cause or focus of diseases on living human or animal bodies.


    Where a method involving diagnosis of a disease complies with the following two requirements, it is a diagnosis method and cannot be granted a patent right:

(1) it is practiced on a living human or animal body; and

(2) its direct purpose is to obtain the diagnosis result of a disease or health condition.


    It can be seen that for a method involving diagnosis of a disease, if it is practiced on a living human or animal body and its direct purpose is to obtain the diagnosis result of a disease or health condition, the method shall be considered as a diagnosis method of the disease, regardless whether or not it is used to diagnose the disease of a patient or monitor the physical indicators of a healthy person.


Treatment methods of diseases


    According to the Guidelines for Patent Examination, the treatment method of disease refers to the processes of intercepting, relieving, or eliminating the cause or focus of diseases so that the living human or animal bodies may recover or gain health or relieve pain.


    Treatment methods of diseases include various methods which serve treatment purpose or which are of treatment nature. Prophylactic methods and methods of immunization are regarded as treatment methods of diseases.


    For a method possibly serving both treatment purpose and non-treatment purpose, unless it is clearly stated that the method serves non-treatment purpose, it shall not be granted for patent right.


Ø  Several Ways for Response


    In recent years, with the growing market of medical services and medical products, applications involving related technologies are also increasing. However, as mentioned above, according to Article 25.3 of Chinese Patent Law, methods for diagnosis and for treatment of diseases shall not be granted patent rights. In practice, method claims in an application related to medical treatment are often rejected in view of Article 25.3. In order to obtain a broader scope of protection for the applicant's invention, some possible ways for responding to Office Actions in respect to the methods for diagnosis and for treatment of diseases will be discussed here below.


Arguments


    When receiving the Office Action regarding methods for diagnosis and treatment of diseases, the applicant shall first determine whether the examiner's rejection applied to the method claim is reasonable or not.


    If the applicant believes that the examiner's rejection applied to the method claim is unreasonable and the method claimed in application shall not be considered as a method for diagnosis and treatment of diseases, argument may be made from the following two points to try to convince the examiner that the method should not be regarded as such.


    Firstly, the purpose of the legislation of the Law, which is on one hand for humanitarian considerations and social ethical reasons and on the other hand for practical considerations, may be used as a basis for argument when responding to the Office Action regarding methods for diagnosis and treatment of diseases.


    For example, for a method involving the detection of in vitro samples collected from human body, since some steps in the method involve the puncture process practiced on living human or animal bodies, this method is likely considered as a method for diagnosis and treatment of diseases. In this case, if argument is made from the requirements for determination of Diagnostic methods of diseases as stated above, we will often reach an impasse with the examiner to argue whether the method is practiced on living human or animal bodies. Under such a situation, the applicant may clarify, from the purpose of the legislation of the Law, that although the samples in this method come from living human or animal bodies, the implementation  process will neither violate humanitarian and social ethics, nor involve the individual differences in the sample testing operation and the subjective judgment of doctors, this method can be used in industry, so it is practical, and thus this method shall not be regarded as a method for diagnosis and treatment of diseases.


    Secondly, the direct purpose may be used as another point for argument when responding to Office Action regarding method for diagnosis and treatment of diseases.


    The critical point to determine whether the method should be regarded as the method for diagnosis and treatment of diseases lies in whether the direct purpose of the in vitro sample testing is to obtain the diagnosis result of a disease or health condition. Only when the method is practiced on living human or animal bodies and also its direct purpose is to obtain the diagnosis result of a disease or health condition, can it be regarded as the method for diagnosis and for treatment of diseases.


    For example, for methods that only obtain information as an intermediate result from living human or animal bodies, and for methods that only conduct treatment or detection on tissues, body fluids or excreta that have left living human or animal bodies to obtain information as an intermediate result, the applicant may clarify that their immediate purpose is not to obtain the diagnosis result of a disease or health condition, so these methods should not be regarded as the methods for diagnosis and treatment of diseases.


    Specifically, when clarifying that the immediate purpose of this method is not to obtain the diagnosis result of a disease or health condition, the applicant may first explain the specific content of the information obtained by this method, and then clarify that the diagnosis result or health condition cannot be directly obtained from the information according to the medical knowledge in the existing technology and the disclosure of the application, and these information are only intermediate results, thus the direct purpose of the method is not to obtain the diagnosis result of a disease or health condition, and should not be regarded as method for diagnosis and treatment of diseases.


Amendments


    Although we  notice that in the examination procedure of the application, the examiner often very strict on determining whether the method is for diagnosis and treatment of diseases.


    In general, if a method is regarded as the treatment method of diseases, it is difficult to traverse said rejection only by arguments. In our practice, said rejection may be possibly traversed by amending the claims for treatment methods of diseases into the claims for Swiss-type pharmaceutical use.


    As to the application shown below, the rejection applied to the claim is traversed by amending the claim for treatment methods of diseases into the claim for Swiss-type pharmaceutical use.


    Original:  60. A method for determining whether a subject is likely or unlikely to respond to anti-EGFR CAR therapy, the method comprising: contacting cancer cells isolated from a patient with an effective amount of anti EGFR antibodies and mutant EGFR antibodies, and detecting the presence of any antibodies binding to the cancer cells, wherein the presence of antibodies binding to the cancer cells indicates that the subject is likely to respond to the anti EGFR CAR therapy, while the absence of antibodies binding to the cancer cells indicates that the subject is unlikely to respond to anti EGFR CAR therapy.


    Amended: 60. An application of an effective amount of anti EGFR antibodies and mutantEGFR antibodies in the preparation of reagents for determiningA method for determining whether a subject is likely or unlikely to respond to anti-EGFR CAR therapy, the determiningmethod comprising: contacting cancer cells isolated from a patient with antheeffective amount of anti EGFR antibodies and mutant EGFR antibodies, and detecting the presence of any antibodies binding to the cancer cells, wherein the presence of antibodies binding to the cancer cells indicates that the subject is likely to respond to the anti EGFR CAR therapy, while the absence of antibodies binding to the cancer cells indicates that the subject is unlikely to respond to anti EGFR CAR therapy.


    However, if a method is regarded as the diagnostic method of diseases, it is often more difficult to traverse said rejection by arguments or amendments.


    In practice, we encountered some applications in which the method is not explicitly claimed to be practiced on a living human or animal body and is intended solely to obtain the diagnosis result of a disease or health condition, however, if such a is recorded in the specification, it can be challenging to convince the examiner by only argument.


    Under this situation, the applicant may try to make some amendments to claims by deleting or modifying any inappropriate expressions, and revising the method claim as a method that is not practiced on living human or animal bodies. However, sometimes it may be difficult to traverse the rejection by amendments and the outcome may largely depend on whether the contents disclosed in the filing document of the application can be interpreted as having the direct purpose of obtaining the diagnosis result of a disease or health condition.


    Alternatively, as another way for amendments, the applicant may consider rewriting the method claim into a corresponding device claim based on the contents recorded in the specification.


    As for some foreign applications in the medical fields, since Article 25.3 of the Chinese Patent Law may not have been taken into account when written, only one or more sets of method claims and/or EPC2000 recognized medical use claims are claimed when entering the Chinese national phase. Considering that a method claim for diagnosis and treatment of diseases cannot be granted a patent right in China, the applicant may take the opportunity for voluntary amendments to add at least one set of device claims/at least one device claim based on the description and the overall disclosure of the application, before the substantive examination begins, so as to render the at least one set of device claims/at least one device claim to be granted. Finally, the applicant may also consider submitting a divisional application/divisional applications to protect the devices involved in the description and the overall disclosure.


返回顶部图标