(Examples of methods not considered to be a "method of surgery, therapy or diagnosis of humans")
Example 1: A method for an influenza test by extracting oral mucous membranes with a cotton bud
Example 2: A method for capturing the image of a lung by X-ray irradiation to the chest
Example 3: A method for measuring the body temperature by inserting an electronic ear thermometer into the external ear canal
Example 4: A method for judging the sugar level in urine by dipping a test strip in a collected urine sample, and comparing the color of the test strip with colors on a color chart
Example 5: A method of examining the susceptibility of the examinee to hypertension by determining the type of base on the nth line of the base sequence of the X gene of the examinee and comparing the base with a standard in which when the base type is A the
susceptibility is low, and when the type is G the susceptibility is high
Example 6: A method of preventing uneven smear of jelly for ultrasonography that is spread on the body
(4) Method for treating samples that have been extracted from the human body
A method for treating samples that have been extracted from the human body (e.g., blood, urine, skin, hair, cells, or tissue) or a method for gathering data by analyzing such samples such as the following (i) or (ii) is not considered to be a "method of surgery, therapy, or diagnosis of humans."
(i) Method for the presumption that the samples extracted from the human body are not to be returned to the same body
(ii) Method for the presumption that the samples extracted from the human body
are to be returned to the same body such as any one of the followings (ii-1) to (ii4):
(ii-1) A method for manufacturing a medicinal product (e.g., blood preparation, vaccine, genetically modified preparation and cell medicine) by utilizing raw material collected from a human body
(ii-2) A method for manufacturing a medical material (e.g., an artificial substitute or alternative for a part of the human body, such as an artificial bone, a cultured skin sheet, etc.) by utilizing raw material collected from a human body
(ii-3) A method of manufacturing an intermediate product for a medicinal product or a medical material (e.g. methods for differentiation and induction of the cells, methods for separation and purification of the cells) by utilizing raw material collected from a human body
(ii-4) A method of analyzing a medicinal product or a medical material, or an intermediate product thereof which is manufactured by utilizing raw material collected from a human body
3.2.2 Commercially inapplicable inventions
An invention concerning marketable or tradable subject matter is not considered to be "commercially inapplicable".
For example, a "method of waving hair" can be used for a commercial purpose in the beautician field while being personally used, is not considered to be an "invention applied only for personal use." indicated in 3.1.2 (i). Likewise, a "kit for scientific experiments," which is used in experiments at school, is not considered to be an "invention applicable only for academic or experimental purposes" indicated in 3.1.2 (ii), as it is marketable and tradable.
4. Procedure of Examination for Determining Eligibility for Patent and Industrially Applicability
(1) If the examiner determines that the claimed invention does not fulfill the requirements of the provision of Article 29(1) main paragraph based on the 2. and 3. , the reasons for refusal shall be notified.
The applicant can amend the claims by filing the amendments to be made to the claims and make an argument or clarification by filing the arguments against the notice of reasons for refusal stating that the claimed invention cannot be patentable since it does not satisfy the provision of Article 29(1) main paragraph.
When the examiner comes to be convinced that the claimed invention fulfills the requirements of the provision of Article 29(1) main paragraph by the amendments, argument or clarification, the reasons for refusal are overcome. Otherwise, the examiner shall notify a decision of refusal based on the reasons for refusal stating that the claimed invention cannot be patentable since it does not satisfy the provision of Article 29(1) main paragraph.
(2) The examiner shall explain the specific reasons in determining that the claimed invention cannot be patentable under the provision of Article 29(1) main paragraph in notifying the reasons for refusal or issuing the decision of refusal. It is not appropriate to state only "does not fulfill the requirements for eligibility for a patent," or "does not fulfill the requirements for industrial applicability" etc. since it is difficult for the applicant to make the effectual argument and understand the direction of an amendment for overcoming the reasons for refusal.
