3. Determination on Industrial Applicability Requirements
The subject of determination on the industrial applicability requirements is a claimed invention.
When a claimed invention is considered as any of (i) to (iii) in 3.1 , an examiner shall determine that the claimed invention does not comply with the industrial applicability requirements.
When there are two or more claims in the claims, an examiner shall make examination of the industrial applicability requirements for each claim.
Here, the word "industry" is interpreted in a broad sense, including manufacturing, mining, agriculture, fishery, transportation, telecommunications, etc.
3.1 List of industrially inapplicable inventions
An invention considered as any one of (i) to (iii) shown below does not comply with the industrial applicability requirements.
(i) Inventions of methods of surgery, therapy or diagnosis of humans (see 3.1.1)
(ii) Commercially inapplicable inventions (see 3.1.2)
(iii) Obviously impracticable inventions (see 3.1.3)
3.1.1 Inventions of methods of surgery, therapy or diagnosis of humans
Methods of surgery therapy or diagnosis of humans have been termed
"medical activity" and are normally practiced by medical doctors (including those who are directed by medical doctors, hereinafter referred to as "medical doctors").
A method considered as any one of (i) to (iii) shown below is considered as an "invention of methods of surgery, therapy or diagnosis of humans".
(i) Methods of surgery of humans (see (1))
(ii) Methods of therapy of humans (see (2))
(iii) Methods of diagnosis of humans (see (3))
The following methods of (a) and (b) are included in "inventions of methods of surgery, therapy or diagnosis of humans".
(a) Methods for contraception or delivery
(b) Methods for processing samples that have been extracted from a human body (e.g., a method of dialyzing blood) or analyzing the samples during the process on the presumption that the samples are to be returned to the same body for therapy (except for the methods described in 3.2.1(4)b)
Even if methods of surgery, therapy or diagnosis are practiced on animals in general, unless it is clear that the methods practiced on humans are explicitly excluded, the methods are deemed as being "inventions of methods of surgery, therapy or diagnosis of humans".
(1) Methods of surgery of humans
Methods of surgery of humans include the following:
(i) Methods for surgical treatment (such as incision, excision, centesis, injection and implant)
(ii) Methods of using (e.g., inserting, moving, maintaining, operating and extracting) a medical device (e.g., a catheter or an endoscope) inside the human body (excluding inside the mouth, inside the external nostril, and inside the external ear canal)
(iii) Preparatory treatment for surgery (e.g., anesthetic treatment for surgery and method of disinfecting skin before injection)
Cosmetic methods having surgical operations whose purpose is not therapeutic or diagnostic are also considered methods of surgery of humans.
(2) Methods of therapy of humans
Methods of therapy of humans include the followings:
(i) Methods of administrating medicine or giving physical treatment to a patient for curing or restraining a disease
(ii) Methods of implanting substitute organs such as artificial internal organs or artificial limbs
(iii) Methods of preventing a disease (e.g., methods of preventing tooth decay or influenza)
Methods of treatment for the maintenance of physical health (e.g., methods of massage or shiatsu therapy) are also considered to be methods of preventing a disease.
(iv) Preparatory treatment for therapy (e.g., method for arranging electrodes for electrical therapy)
(v) Supplemental methods for improving treatment effects (e.g., rehabilitation methods)
(vi) Methods for nursing associated with treatment (e.g., methods to prevent bedsores)
(3) Methods of diagnosis of humans
Methods of diagnosis of humans include methods of judging for the medical purposes the physical condition of a human body as indicated in (i) or (ii) below:
(i) Physical condition of a human body such as conditions of diseases and physical health or the mental condition of a human body
(ii) Prescription or treatment/surgery plans based on the above (i)
Example: Methods of judging whether the patient has had a stroke by observing an image obtained by an MRI scan.
3.1.2 Commercially inapplicable inventions
An invention which corresponds to the invention indicated in (i) or (ii) below is considered to be a "commercially inapplicable invention".
(i) An invention applied only for personal use (for example, a method of smoking)
(ii) An invention applied only for academic or experimental purposes
3.1.3 Obviously impracticable inventions
An invention which cannot be practically implemented is not considered to be an "obviously impracticable invention" even if it works in theory.
Example: A method for preventing an increase in ultraviolet rays associated with the destruction of the ozone layer by covering the whole earth's surface with an ultraviolet ray-absorbing plastic film.
3.2 Types of industrially applicable inventions
In principle, an invention which does not correspond to any one of (i) to (iii) in 3.1 is considered to be an industrially applicable invention. Inventions not considered to be a "method of surgery, therapy, or diagnosis of humans" and a "commercially inapplicable invention" include the following:
3.2.1 Types of methods not considered to be a "method of surgery, therapy or diagnosis of humans"
(1) Product such as medical device or medicine
A medical device or a medicine is a product, and is not considered to be a "method of surgery, therapy, or diagnosis of humans." A product combining them is also not considered to be a "method of surgery, therapy, or diagnosis of humans."
(2) Method for controlling the operation of a medical device (Note)
A method for controlling the operation of a medical device is not considered to be a "method of surgery, therapy, or diagnosis of humans" as long as the function of the medical device itself is represented as a method. The "method for controlling the operation of the medical device" here may include not only a method for controlling the internal operation of the medical device but also a functional or systematic operation provided to the medical device itself, such as the moving, opening, and/or closing of an incising means in accordance with an operating signal, the emission and/or receiving of a radioactive ray, an electromagnetic wave, a sound wave, or the like.
(Note) A method including any one of the following steps (i) or (ii) is not considered to be a "method for controlling the operation of a medical device."
(i) An action of a medical doctor (for example, a step where a medical doctor operates a device in order to provide medical treatment in accordance with a symptom)
(ii) A step with an influence on the human body by a device (for example, the incision or excision of a specific site of patient’s body by a device or the irradiation of radiation, electromagnetic wave or sound wave by a device)
(3) Method for gathering various kinds of information from the human body by measuring structures and functions of organs in the human body
The methods indicated in (i) or (ii) below, which are intended to collect various types of data about a human body by measuring structures or functions of organs in the human body, is not considered to be a "method of diagnosis of humans".
(i) Method of extracting samples and data from the human body, or methods of analyzing, e.g., comparing such samples and data with standards, by utilizing samples and data extracted from the human body (see the following Example 1 to Example 5).
(ii) Preparatory treatment for measuring structures or functions of various organs of the human body (see the following case 6)
Except the case where it includes the step indicated in (a) or (b) below of judging for medical purposes.
(a) Physical condition of a human body such as conditions of diseases and physical health or the mental condition of a human body
(b) Prescription or treatment or surgery plans based on the conditions of (a)
Also, even if corresponding to such method, the methods that include steps corresponding to methods of surgery or therapy of humans are deemed to be "methods of surgery or therapy of humans."
