In recent years due to the increasing attention to the health and cosmetic dental and oral cavity along with social development and improvement of living standards, all kinds of new equipment and methods have emerged one after another in the field of dentistry, and correspondingly, patent applications increased annually in this field from 827 in 2010, to 968 in 2011 and to 1,109 in 2012, which can be divided mainly into four categories: (a) dental surgery such as dental drills, dental forceps and other dental instruments and methods for the correcting dental malocclusion; (b) dental repair methods and dentures; (c) cleaning of teeth and oral cavity such as dental floss, dental cleaning devices; and (d) dental auxiliaries.
China’s Patent Law excludes certain subject matters from patent eligibility. Determination of patentability is often difficult to make in light of the special component of teeth and the extensive subject matters in the field of dentistry. The author intends to make an analysis on the circumstances where patent is denied based on years of examination experience in the field of dentistry.
Ⅱ. A brief introduction to circumstances of denial of patent in the field of dentistry
Mainly two types of dental subject matters are not eligible for patent: (1) methods for diagnosis or for treatment of diseases; and (2) surgical methods of non-treatment.
The reason for patent-ineligibility of diagnosis or treatment methods is for humanitarian, social, and ethical considerations, as well as considerations of China’s current level of technological development, as physicians should be free to choose all kinds of methods in the process of diagnosis and treatment.
Surgical methods refer to the methods of traumatic or invasive treatment such as incision, resection, stitching, and tattooing practiced on living human or animal bodies with the aid of instruments. Such methods are not patent-eligible (188.8.131.52 of China’s 2010 Guidelines for Patent Examination, Guidelines). Surgical methods are either for treatment or non-treatment. A surgical method for curing diseases are treatment method, which is not patent-eligible under Article 25.1 (3) of Patent Law.
Surgical methods for non-treatment purpose do not have practical utilities because such methods are performed on the living human or animal bodies and cannot be industrialized. Article 22 of Patent Law provides that a patent may be granted on an invention or utility model which possesses novelty, inventiveness and practical utility. Likewise, no patent shall be granted on surgical methods for non-treatment purposes for lack of utility (Section 3.2.4, Chapter 5, Part II of Guidelines).
It can be seen from the above that no patent shall be granted on surgical methods regardless of its treatment or non-treatment purposes.
Ⅲ. Case analysis of ineligibility in the field of dental treatment
1. Diagnostic methods for diseases
A diagnostic method refers to a process of identifying, studying or determining the cause or nidus of diseases in a living human or animal body (Section 4.3.1, Chapter 5, Part II of Guidelines). A diagnostic method relating to diagnosis of disease is diagnostic method for diseases, and thus not patent-eligible if it contains the following two elements: one, it targets a living human or animal body; two, it purports to obtain the diagnostic result of a disease or health condition (Section 184.108.40.206, Chapter 5, Part II of Guidelines).
1) Method for diagnosing diseases
Claims:A method for examining oral cavity with appliances, comprising the steps of: generating light with wavelength suitable for diagnosing oral care condition and emitting said light to selected surfaces of teeth in the oral cavity, receiving said light reflected therefrom; treating said light reflected therefrom to determine health condition of the oral cavity and identifying inspected and/or inspected teeth regions; displaying information related to the health condition of the identified oral cavity and those checked and/or unchecked teeth regions to a user.
Analysis:The invention claims a method used to inspect oral cavity with appliances. Firstly, the method is used to inspect the oral cavity of a living human. Secondly, the method is used to identify the health condition of oral cavity through treating the reflected light from the surface of teeth for the immediate purpose of acquiring the health condition of oral cavity. Therefore, such method belongs to methods for the diagnosis of diseases stipulated by Article 25.1 (3) of Patent Law.
Claims:A method for diagnosing orthodontia condition comprising: providing a diagnostic device with diagnostic hardware including at least a digital camera to record multiple images of a tooth and oral cavity; providing a user interface in said device for displaying information to a patient and receiving information therefrom; providing with an electronic circuit inside said device; preprogramming said electronic circuit by statistical data representing a plurality of samples of orthodontia condition; positioning said patient relative to said diagnostic hardware; using the diagnostic hardware to record images of teeth representing actual data of the orthodontia condition and oral cavity; making a comparison between the actual data and the statistical data acquired from said pre-program of said electronic circuit; determining whether orthodontia condition of the patient can be corrected by way of such device; issuing directions from said device to the patient to tell him how to correct orthodontic condition diagnosed by such device.
Analysis:Firstly, by the very theme of the claim “a method for diagnosing orthodontic condition,” it is conclusively a diagnostic method. Secondly, by the contents of the claim, it can be seen that a living human is the direct target of the method which is used to diagnose whether the orthodontia condition can be corrected and a diagnostic result of the teeth and oral cavity condition of the patient can be acquired, that is to say, its immediate purpose is to obtain the diagnostic result of a disease or health condition and therefore it is a method for diagnosing diseases as defined under Article 25.1 (3) of Patent Law.
Claims:A method of detecting the early caries patients comprising: a selective optical detection probes used for early detecting caries lesions and using optical device combining probe to detect caries.
Analysis:Caries lesions and using preamble shows that it claims a detecting method, an analysis of its essence shows that such method is used to detect the patient’s teeth. That is to say, it is with the living human as its purpose. It is used to diagnose the early caries by way of detecting the reflected light from the teeth that is lighted by irradiating wavelength. Since caries is a kind of disease, it is directly for the purpose of acquiring the diagnostic result of a disease. Therefore, such method belongs to methods for the diagnosis of diseases stipulated by Article 25.1 (3) of Patent Law and no patent shall be granted to it.
2) Method not for diagnosing diseases
Claims:A colorimetric method for displaying categories of colors of teeth by irradiating light onto a surface of a tooth and collecting said light reflected from said surface for comparison with selected tooth color classification standard.
Analysis:According t o the description, the said colorimetric method of teeth is used for dental treatment, dental restorations, tooth whitening and denture manufacture. The colorimetric result is used to restore teeth by selecting the same or similar restoration materials. Although the object of the colorimetric method of teeth is living human or animal bodies and treatment is its ultimate purpose, its immediate purpose is only for the determination of the teeth color and no diagnostic result can be acquired from such method. Therefore, it is not a method for diagnosing diseases and is patentable.
2. Method involving treatment of diseases
A method for treatment of diseases 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. (Section 4.3.2, Chapter 5 of the Guidelines)
1) Method that is clearly for treatment of diseases
There are a considerable number of applications of method in the field of dental treatment. The nature of its being treatment method can be seen from its preamble, such as “a microwave treatment method for pulpitis,” “an application of double acid derivative or its salt in periodontitis treatment.” Both pulpitis and periodontitis are diseases. The treatment of these is obviously 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. Therefore, such are the types of methods for diagnosing diseases as defined under Article 25.1 (3) of Patent Law and no patent shall be granted.
2) Surgical method for treatment purposes
Dental method applications, including surgical methods, take up a considerable proportion in the field of dental treatment. Such applications should be examined to see whether they are for the purpose of treatment or not. Method of surgery with treatment as its purpose should not be granted a patent according to Article 25.1 (3) of Patent Law because it belongs to methods for the treatment of disease.
Claims:A method of dental prosthetics comprising the steps of molding a bite and making a false tooth, wherein a false tooth (1) is connected by a steel wire (2) being a U-shaped structure threading a plurality of false teeth; opening a slot at an end of each good tooth (4); embedding two end heads of said steel wire (2) in said slots of said good teeth (4) at the left and right ends, said end head of the steel wire (2) being horizontal or inclined; filling adhesive (3) in said slots; adhering said false teeth (1) to said good teeth (4) at the seam by using said adhesive (3); grinding and polishing to finish said process of inserting said false teeth.
Analysis:The claim seeks for the protection of a method of dental prosthetics, including slot opening operation of good teeth. The process belongs to methods of surgery. By dental prosthetics, the lost teeth can be supplemented so that the living human or animal bodies may recover or gain health or relieve pain. Therefore, such is a surgical method for the purpose of treatment and is therefore not patent-eligible.
3) Method of cosmetic nature having treatment purpose/effect
Recent years have witnessed increasing applications of patents for cosmetic dentistry. Attention should be paid to whether it is a method for the treatment of disease or not. If the method of cosmetic nature has treatment purpose or effect and such purpose or effect cannot be separated from its cosmetic effect, it should be ascertained as a method for the treatment of disease. Take the method of removing dental plaque for example. Such method has a cosmetic effect of improving the appearance of teeth and a treatment effect of preventing dental caries and periodontal disease that is inevitably resulted from the removing of dental plaque. Therefore, such method has the treatment effect that can not be separated from its cosmetic effect and it is a method for the treatment of disease.
4) Method that are not for treatment
Whether a method is for treatment should be ascertained by whether its direct purpose is for treatment of disease on the basis of the essence of the claim. Take the method of dentures manufacture for example. Such method is used to make teeth molds and manufacture dentures outside the patient. Although its ultimate purpose is treatment, its own purpose is to manufacture appropriate dentures for the patient. Furthermore, the test method for the manufacturing of dentures is not for the purpose of treatment. Therefore, it is not a method for the treatment of disease.
Methods of purely cosmetic nature, i.e., methods of cosmetic nature which are not invasive to human body or do not produce wounds, including methods of protection, decoration, or beautification for non-treatment purpose. For example, a method used to have decorative diamond adhered to teeth is a kind of method of purely cosmetic nature. And therefore, it is not a method for treatment.
3. Surgical methods for non-treatment purpose
The surgical methods mentioned above are methods of treatment and not patent-eligible. Likewise, a patent shall not be granted on a surgical method involving non-treatment purpose because it has no practical utility as defined under Article 22 (4) of Patent Law.
Claims:A method for testing canine orthodontic tooth movement, comprising the steps of: designing a first correction device; and installing said device and moving a target teeth by force; said installing and forcing including general anesthesia of an experimental dog, cleaning surface of its teeth and having a wet insulation of said surface, adhesion of zinc polycarboxylate cement to cast crown on a corresponding tooth of said dog, passing of an end of stainless steel wire through a square hole of square hole-like protrusions on said movement cast metal crown, connecting the other end of said stainless steel wire through a square hole of a “square hole Buccal tube” projections on an anchorage tooth cast metal crown wherein said stainless steel wire being passed; possible necessary bending of stainless steel wire for preventing its ends from dropping off; using nickel-titanium extension spring as power source after the completion of adhesion in order to move the target teeth.
Analysis:The claim seeks for the protection of a method for canine experimental orthodontic tooth movement. Such experimental method is practiced on living canine body, including anesthesia, moving teeth by force and other steps of surgery. Treatment is not its immediate purpose. Therefore, it is a method of surgery having nontreatment purpose. It has no practical applicability because it can not be used in industry and no patent shall be granted to it.
Claims:A method for cleaning pulp wherein an abutment of a sucking head under negative pressure on sucking point for suction of pulp.
Analysis:The claim seeks for the protection of a method for cleaning the pulp. Such method is practiced on living human or animal bodies, including the operation of using sucking head with negative pressure to suck pulp. It is a method of surgery having non-treatment purpose. And therefore, it has no practical applicability because it can not be used in industry.
Claims:A method for dental implantation orthotopic bone graft with a hollow drill, comprising the steps of, grafting autologous chip bone wherein a part with fewer local bone defects being selected at the same time of preparing an implantation bed in a dental implantation region, a hollow drill being adopted for gradually deepening for drilling the chip bones from shallow to deep after the positioning, the depth of the drilling down of each time is 0.4 to 0.6mm, so a plurality of cortical bones and cancellous bones capable of being obtained by a plurality of times.
Analysis:The claim seeks for the protection of method for dental implantation orthotopic bone graft by way of hollow drill. Such method is practiced on living human or animal bodies, including the use of hollow drill to drill chip bones to obtain cortical bones and cancellous bones. It is a method of surgery having nontreatment purpose. And therefore, it has no practical applicability because it cannot be used in industry.
Ⅳ. Claims drafting and amendment prospects during examination
The author finds in her examination experience that some applications claim methods for the diagnosis or for treatment of diseases, but the true intentions of the applicants are not seeking for the protection of such methods for the diagnosis or for the treatment of diseases. However, such claims are not patent-eligible because they fall within the domain of methods for the diagnosis or for the treatment of diseases due to the defect in drafting written descriptions and claims. Therefore, attention should be paid to the drafting format in the stage of claims drafting for patent application. Firstly, the preamble should not be in the form of methods for the diagnosis or for the treatment of diseases. Take “a method for dealing with pictures based on the early diagnosis of caries” for example. The preamble itself contains diagnosis of disease (early diagnosis of caries). Change it into “a method for dealing with pictures” and such error can be corrected. Secondly, if there is a method in the claim, there should be no step or conclusion for diagnosis or treatment, and no step of surgical method included. For example, there should be no step for surgical treatment of normal teeth in the claim for dentures manufacturing methods. It should be emphasized that if an application has been already filed for patent, any amendment to it should satisfy the requirements of Article 33 of Patent Law that such amendment may not exceed the scope specified in the original written descriptions and claims.
For method including the purpose of treatment and non-treatment, if its non-treatment purpose can be clearly separated from its treatment purpose, a modification by disclaimer may be adopted. Fox example, an addition of “non-treatment purpose” in the claim for limitation can exclude treatment purpose so that the rest subject having only non-treatment purpose can become a patentable subject. However, it is possible that such two purposes of the method in the claim seeking for protection are inseparable. Another example is that if the step of treatment is inevitably contained in the method, the effect of such step implementation determines that the method has a nature of treatment. Under such circumstance, the foregoing amendment by disclaimer can not be adopted.
For the pharmaceutical applications in the field of dental treatment, Section 4.5.2, Chapter 10, Part II of Guidelines provides that since a medicament and a method for the manufacture thereof are patentable according to the Patent Law, it shall not be contrary to Article 25.1 (3) if an application for the medical use of a substance adopts pharmaceutical claim or use claim in the form of method for preparing a pharmaceutical. For example, “the application of double acid derivative or its salt for the treatment of periodontitis” can be changed into “the application of double acid derivative or its salt in the medicament manufacturing for the treatment of periodontitis,” and such method will not fall within the scope of method for the treatment of diseases.
It should notice that whether the method belongs to the non-patentable object under China’s Patent Law when dealing with the patent application for dentistry method. Making such a determination, it is necessary to start from the essence of the claims, make a combination of the recording of the description when necessary and an analysis on whether living human or animal bodies is the immediate practicing object of the method seeking for protection or not and whether its immediate purpose is to obtain the diagnostic result of a disease or health condition or not. For those applications for patent possibly involving no-grant-of-patent subject, the applicant should write and modify the claim in appropriate way and does his best so that the claim will not fall within the scope of no-grant-of-patent object.
(Translated by Yuan Renhui)