Thursday, February 24, 2011

Part of the patent medicine industry regulations

 A Chinese friend asked me out, probably sum up, for your reference:)
the author's experience, is often the most difficult that has been stereotyped by the applicant in accordance with the written format, the description, claims Summary of the book and a lot of tests, materials. because the applicant written on the patent documents do not understand, can only imitate the format, blunt the technical solution of a system divided into these files, fragmented and often contradictory situation occur. This greatly increases the difficulty of understanding the agent, can be used to waste valuable time in advance the date of filing.
, of course, undeniable that there are some applicants familiar with patents, patent documents written in very good condition, Although this level is also a small number of applicants to find agents.
under patent law to implement the provisions of Rule 2, Chinese medicine can only apply for invention patents. patent application process to go through substantive examination . According to Article 53 of the Patent Law Article, the invention patent application to obtain authorization conditions must be met eleven.
relevant laws and regulations are summarized as follows:
Patent Law:
violation of Article V law or social morality or detrimental to public interest inventions, does not grant patents.
Where two or more applicants for the same invention patent, patent granted to person who applied first.
Twenty-two patented inventions and utility models, must possess novelty, inventiveness and practicality.
Novelty means before the filing date, no identical invention or utility model published in domestic and foreign publications However, publicly used in China or in other ways known to the public, nor has any other invention or utility model patent administration department under the State Council an application which records published after the date of filing the patent application document.
Inventiveness means that, with the technology existing before the date of filing, compared to the invention has prominent substantive features and notable progress and that the utility model has substantive features and represents progress.
practical, means that the invention or utility model can be made or used and can produce positive results.
twenty-five pairs of the following, does not grant the patent right:
(a) scientific discoveries;
(b) rules and methods for mental activities ;
(c) the diagnosis and treatment;
(d) animal and plant varieties;
(e) obtained by means of nuclear transformation of material.
of the preceding paragraph (d) producing products listed, granting patent rights in accordance with the provisions of this Law.
Where an application for invention or utility model patent, it shall submit a request, a description and its abstract, and claims and other documents.
The request shall state the name of the invention or utility model, the inventor or designer's name, applicant name, address, and other matters.
instructions on the invention or utility model shall be made clear and complete instructions to technical field technicians to carry it out; when necessary, shall be appended. abstract shall state briefly the invention or utility model technical points.
claims shall be based on the description, explain the scope of the patent protection asked .
第三十一条 an application for a patent for invention or utility model shall be limited to one invention or utility model. belonging to a single inventive concept of two or more inventions or utility models can be used as an application is filed.
An applicant may amend its application for a patent, but the patent for invention or utility model amendment to the application may not go beyond description and the claims recorded in the range of application for a patent on the design changes shall not exceed the original scope of drawings or photographs.
Patent Law Implementing Rules:
referred to the Patent Law Article invention refers to the product, process or improvement of the proposed new technical solution.
Patent Law said utility model refers to the product shape, structure, or a combination thereof, a new technology for practical solutions.
alleged design patent law, refers to the product shape, pattern and color, or a combination and shape, pattern made by the combination of aesthetic feeling and a new design for industrial applications.
Article XIII of the invention can also be granted a patent.
Diershitiao should the invention claims or utility model, the technical features, clearly and concisely the scope of protection is sought.
twenty-one claims shall have an independent claim, can also contain dependent claims.
independent claim shall outline the of an invention or utility model, the technical solution, necessary for the solution of technical problems technical features.
dependent claim shall, by additional technical features, refer to further define the claim.
forty under the present rules Article forty points raised by the case of an application to retain the original filing date, priority, and can keep the priority date, does not go beyond the scope of applications open.
第 fifty-three thirty of the Patent Law the provisions of eight invention patent application shall be rejected by the substantive examination of the case is:
(a) the application does not meet the conditions of Article II, paragraph;
(b) Application of the Patent Law Article, the provisions of Article Five, or not in conformity with the twenty-two, the first paragraph of Article XIII of the Rules, XX, paragraph one, the provisions of paragraph twenty-one, or the provisions of Article IX of the Patent Law can not obtain a patent right;
(c) the patent application does not meet the third paragraph of Article Six, Paragraph, or the provisions of paragraph 第三十一条;
(d) does not modify the application meet the thirty-third article of the Patent Law, or the divisional application does not comply with the Rules, paragraph forty provisions.

4.3 Diagnosis and treatment of disease
diagnosis and treatment of disease, refers to a living human or animal body for the direct implementation of the object, identification, identify or eliminate the cause or lesions in the process.
out of humanitarian considerations and the reasons for social ethics, doctors in the diagnosis and treatment process should have a choice of various methods and conditions of freedom. In addition, these methods directly to living human or animal body for the implementation of the object, can not industrial use, not a patent law sense of invention. Therefore the diagnosis and treatment can not be patented.
However, for the implementation of disease diagnosis and treatment of equipment or devices, as well as in disease diagnosis and treatment of substance or material used may be granted a patent right belonging to the object.
4.3.1 Diagnosis
diagnostic methods, is to identify, research, and identified the human or animal life or cause lesions in the state process.
4.3.1.1
the invention diagnostic methods are a method of diagnosis-related disease if both of the following two conditions are, however, the diagnosis method can not be patented:
( 1) living human or animal body as an object;
(2) to obtain the diagnosis of disease or health condition as a direct result of the purpose.
If an invention from the point of view is expressed in the form of isolated samples of the object , but the main body of the invention is to obtain the same disease or health condition diagnosis for the direct purpose, the invention still can not be patented.
method of patent protection if the request includes diagnostic procedures, including diagnostic procedures, or has not yet but including the detection procedures under the existing medical knowledge and technology in public the contents of the patent application, as long as said known diagnostic or detection information to direct access to diagnosis of disease or health condition, the method satisfies the above conditions (2).
following methods can not be granted a patent example:
blood pressure measurement, diagnose the troubles of law, adequate diagnostic methods, X-ray diagnostics, ultrasound diagnostics, gastrointestinal imaging diagnostics, endoscopic diagnostics, diagnostic imaging isotope tracer method, infrared non-destructive diagnostics, risk evaluation method, treatment effect prediction method, genetic screening and diagnosis method.
4.3.1.2 invention are not diagnosis
the following types of diagnostic methods is not an example:
(1) the dead body of human or animal autopsy, on the implementation methods;
(2) purpose is not to obtain diagnostic results directly or health status, and just from living human or animal body to obtain information on the results as an intermediate method, or process the information (physical parameters, physiological parameters or other parameters) method;
(3) purpose is not to obtain diagnostic results directly or health status, but only have been away from human or animal body tissues, body fluids or waste for processing or testing to obtain information on the results as an intermediate approach, or method of processing the information.
above (2) and (3) It should be noted that only when the basis of existing medical knowledge and technology in the patent application disclosed the contents of the information obtained from their own can not be directly derived diagnosis of diseases or health conditions, these information can be considered intermediate results .
4.3.2
therapy treatment, is to make a living human or animal body to restore or access to health or reduce the pain, the block to ease or eliminate the cause or lesions in the process.
Treatment methods include the treatment of nature for the purpose of or with the various methods of treatment. immunological methods of disease prevention or as treatment.
for both may include therapeutic purposes, and may include the method of non-therapeutic purposes, it should be clear that the methods for non-therapeutic purposes, or can not be patented.
4.3.2.1 are the following types of treatment method is the invention of
are or should be seen as examples of treatment can not be patented. < br> (1) surgical treatment, drug treatment, psychological therapy.
(2) for the purpose of the treatment of acupuncture, anesthesia, manipulation, massage, Gua Sha, qigong, hypnosis, medicine bath, air bath, sun bath , forest bath and care.
(3) for the treatment for the purpose of the use of electricity, magnetism, sound, light, heat and other types of radiation or exposure to humans or animals to stimulate the body's way.
(4) for therapeutic purposes use of coated, frozen, diathermy and other forms of treatment.
(5) for the prevention of disease and the implementation of various immune method.
surgical methods for the implementation and / or drug treatment method using the auxiliary , for example, returning to the same body cells, tissues or organs of the treatment, dialysis method, depth of anesthesia monitoring methods, Oral methods of drug, drug injection practices, drug topical methods.
(7) for the purpose of the treatment of pregnancy, contraception, increase sperm count, fertilization, embryo transfer and other methods.
to treatment for cosmetic purposes, body stretching, weight loss, increased method.
(9) dispose of human or animal body wound, for example, wound disinfection, dressing method.
(10) for the purpose of the treatment of other methods, such as artificial breathing, oxygen method.
be pointed out that, although the use of medication for the disease can not be granted a patent However, the drug itself can be granted a patent. For the medicinal use of substances in the examination of patent applications, the application of this section Section 2.2 of Chapter X and the provisions of Section 4.5.2.
4.3.2.2 does not belong to The invention of the following types of treatment
treatment is not part of the example, the Patent Law shall not be based on Article Five, paragraph (c) refuse to grant the patent.
(1) manufacture of artificial limbs or the method of prosthesis, and for the manufacture of artificial limbs or implants of the implementation of a measurement method. such as a method of making dentures, the method including the production of teeth in the oral cavity of patients die, making dentures in vitro. Although the ultimate aim of the treatment, but the method itself is intended to create a suitable dentures.
(2) through non-surgical way to dispose of animal to change its growth characteristics of livestock production methods. For example, by imposing certain of live sheep electromagnetic fields to promote their growth and improve quality or increase the wool and mutton production methods.
(3) method of slaughtering animals.
(4) For the dead body of human or animal disposal methods adopted. For example anatomy, finishing mortal remains , embalming, make samples of the Method.
(5) pure beauty methods, that is, not involved in the human body does not produce trauma or cosmetic methods, including the skin, hair, nails, teeth, as the external can be the site for the local people implementation, non-therapeutic purposes in the body deodorant, protection, decoration or modification methods.
to make in a non-sick people or animals feel comfortable, happy, or such as diving, anti-virus delivery of oxygen and other special circumstances, the negative oxygen ions and water ways.
(7) to kill human or animal body outside (the skin or hair, but does not include wound and infection sites) of bacteria, viruses, lice, fleas method.
4.3.2.3 Surgery surgical
surgical method is the use of equipment for a living human or animal body cut open implementation, cut, stitching, patterns and other traumatic puncture or interventional treatment or disposal method, this surgical method can not was awarded the patent. However, dead body of human or animal surgical method of implementation, as long as the method does not violate Article V of patent law, the belongs to the object can be granted patent rights.
surgical procedures into the treatment purpose and non-surgical method for therapeutic purposes.
for the purpose of the treatment of surgical methods, a therapeutic method, according to the Patent Law Article Five, paragraph (c) shall not be granted the patent. < br> non-surgical treatment methods of the purpose of the review, Chapter V of this Part apply to the provisions of section 3.2.4.
4.4
animal and plant species of animals and plants is a living object. According to Patent Law twenty-five the first paragraph (d) of this article, animal and plant species can not be patented. patent law does not include animals called human, animal is not mentioned in their synthesis, but only by the intake of natural carbohydrates and protein to maintain its living organisms. patent law called a plant that can make use of photosynthesis to water, carbon dioxide and inorganic salts and other inorganic synthesis of carbohydrates, proteins to survive and move normally does not occur organisms. animal and plant species can be other than patent law protection of the laws and regulations, such as new varieties of plants through the species of animal and plant production methods, can be patented. but production methods mentioned here refers to non-biological methods, not including the production of animal and plant are mainly biological methods.
whether a method method does not belong
invention is the use of so-called micro-organisms of various bacteria, fungi, viruses and other microorganisms to produce a chemical substance (such as antibiotics) or decomposition of a substance such as the invention. microbiological and microbiological methods can be patented. patents on microorganisms examination of the application, the application of this part of the relevant provisions of Chapter X.
2. Manual
third paragraph of the Patent Law and Patent Law Article Six Rules for the Implementation of Article XVIII, respectively, the substance of the statement and write mode makes provision.
2.1 specification shall meet the requirements of the Patent Law
third paragraph of Article Six provides instructions on the invention or utility model shall be made clear and complete description of the technical field of the technical staff to achieve prevail.
instructions to the invention or utility model, a clear, complete instructions, technical field should be reached to achieve the degree of technical staff. In other words, the description shall meet the full disclosure requirements of the invention or utility model. < br> on the .
(1) subject-specific. The description shall proceed from the existing technology, a clear reflection of the invention or utility model you want to do and how to do it, so that technical field of technology can accurately understand the invention or utility New for the protection of the topic. In other words, a description of the invention or utility model shall be resolved by technical problems and solve their technical problems with technical solutions, and to compare the existing technology of the invention or utility model, the beneficial effects. the technology issues, technical programs and should be mutually beneficial effects of adaptation, with no contradictory or circumstances associated.
(2) statements accurate. description shall use the invention or utility model technical field of technical terms. specification of the representation should be accurate invention or utility model to express the technical content, not vague or ambiguous, so that technical field of the technical staff is not clear, correct understanding of the invention or utility model.
2.1.2 full complete description shall
including the understanding of the invention or utility model, all the necessary technical content.
a complete description shall include the following contents:
(1) to help understand the lack of invention or utility model can not be content. For example, the relevant technical field, background description of the state of technology and time specifications, drawings and other drawings that.
(2) determine the invention or utility model is novel, creative and practical requirements of the content. For example, the invention or utility model to solve the technical problems to solve their technical problems and technical solutions used in the invention or utility model, the beneficial effects.
(3) the invention or utility model the desired content. For example, to resolve the invention or utility model technical issues with the concrete implementation of the technical solution approach.
to overcome the prejudices of the invention or utility model, a description also should explain why the invention or utility model to overcome the prejudices and biases of new technical solutions between differences and prejudices to overcome the technical means used.
should be pointed out that any technical field of the technical staff can not be directly from the existing technology, the only relevant content to come, are described in the specification should be.
2.1.3 to achieve
technical field of technology can achieve, is the technical field of the technical staff in accordance with the instructions recorded in the content, we can realize that the invention or utility model technical solutions to solve their technical problems and produce the desired technical effect.
instructions should be clearly recorded in the invention or utility model technical solutions, detailed description of the invention or utility model, the specific method, a complete understanding and realization of public for invention or utility model essential technical content, to the technical field of the technical staff to achieve the degree of invention or utility model. inspector has reasonable grounds to doubt if the invention or utility model does not meet the requirements of full disclosure, you should ask the applicant for clarification.
the following conditions due to lack of technical means to solve the technical problems have been considered impossible:
(1) give only the task instructions and / or ideas, or just show a desire and / or results, but not given any of the technical field of the technical staff to implement the technical means;
(2) instructions given in the technical means, but the technical field of the technical staff, it is ambiguous which means, according to the instructions written The content can not be specific implementation;
(3) instructions given in the technical means, but the technical field of the technical staff and can not be solved by the means of the invention or utility model to solve technical problems;
(4) Application the theme of a number of technical means to constitute the grounds of the technical program, for which a technical means, technical field of the technical staff in accordance with the instructions recorded in the content and can not be achieved;
(5) specific instructions given in the technical program, but did not give experimental evidence, they must rely on the program to confirm result can be established. For example, for the invention of new uses of known compounds, usually, you need the instructions given in the experimental evidence to substantiate its use as described in and the effect will not be able to achieve the requirements can be achieved.
2.2 specification writing manner and order
Regulations under the Patent Law, the provisions of Article XVIII, the invention or utility model patent application for invention or utility description shall The new name, the name should be consistent with the name of the request. The description shall include the following components:
(a) the technical field: specifying the claimed technical solution belongs to the technical field;
(b) Background art: indicating the understanding of the invention or utility model, searching and examination of useful background technologies; possible, citing the documents reflecting such art;
(c) the content of the invention or utility model: the invention or utility New technical problems to be solved, and solving the technical problems with technical solutions, and control of existing technology of the invention or utility model, the beneficial effect;
(d) description of figures: manual contains drawings, the various pieces of drawings briefly explain;
(e) the specific method: describing in detail the applicant that the invention or utility model approach; necessary, examples; contains drawings, a description of the control drawings.
specification of the invention or utility model shall be in accordance with the above-mentioned manner and order, and each part shall be preceded by the title, unless the nature of the invention or utility model, or order by other means can be more economical presentation and a more accurate understanding of the invention or utility model.
invention or utility model shall be standardized terms, the statement clearly, and not to use > patent application contains one or more nucleotide or amino acid sequences, the description shall contain the required sequence tables. The sequence table should be used as part of a separate statement submitted with the written instructions consecutive page numbers, and in accordance with the requirements of the Patent Office submit the sequence listing in machine-readable copy of the form.
the following manner and order to the itemized details.
2.2.1 Name
invention or utility model should be clear, concise, written in the manual Home body part above the center position.
invention or utility model shall be written in accordance with the following requirements:
(1) specification of the invention or utility model, the name and the name of the request should be consistent, the general shall not exceed 25 words, exceptional circumstances, for example, some applications in chemistry, you can allow up to 40 characters;
(2) general technical field using technical terms, preferably in the International Patent Classification technical terms, no non-technical terms;
(3) clear, concise, comprehensive picture of the claimed invention or utility model, the theme and type (product or method) in order to facilitate the classification of patent applications, such as a zipper zipper containing products and manufacturing methods of the two applications for the invention, its name should be written in the Do not use commercial advertising.
2.2.2 technology
technical invention or utility model protection is sought should be the area of invention or utility model program or direct application of their respective specific technology, rather than the upper or adjacent areas of technology, nor is the invention or utility model itself. the specific technical areas are often associated with the invention or utility model in the international patent classification may be divided into the location of the minimum. For example, the invention of a cantilever on the excavator, The improvement is that technology in the background section of a rectangular cantilever to elliptical cross section. in their respective technical field can be written, area), but not written, types of oval cross-section of the excavator boom useful background technology, and cited as reflecting such files. In particular, the invention or utility model cited included the claims requirements of an independent right technical features of the preamble portion of the existing technical documents, that is, with the invention or utility model cited the closest prior patent application file. specification documents cited in patent documents can also be a generic document, such as journals, magazines, manuals and books. cited patent documents, at least to indicate the country of patent documents , open number, preferably including open date; cited non-patent documents, to specify the title and details of these source files.
In addition, the background art section of the manual, but also objectively pointed out that the technical problems in the background and shortcomings, however, is limited by the invention or utility model involves the technical program to solve the problems and shortcomings. Where possible, the description of problems and shortcomings of the existence of such causes and to solve these problems have difficulties. < br> cited document should also meet the following requirements:
(1) cited documents should be open publication, in addition to paper forms, but also includes other forms of electronic publications.
(2) the non-patent documents cited and foreign patent documents should be in the open day before the filing date of this application; patent documents cited in the China Open at not later than the date of this application open.
(3) citation of foreign patents or non-patent documents, should be documents cited in the original text when posted or released, the language used in documents indicating the source cited, and related information, if necessary, given the Chinese translation, and translation placed in brackets.
meet these requirements if the cited document, the that this application instructions cited in the records of the contents of the file. But the way they achieve this citation full disclosure requirements of the invention or utility model, see Section 2.2.6 of this chapter.
2.2.4 the content of the invention or utility model < br> This section should be clear and objectively stated the following:
(1) to solve the technical problems
invention or utility model, the technical problems to be solved, is the invention or utility model to solve the existing technology technical problems exist. invention or utility model patent application recorded in the technical solution should be able to solve these technical problems.
invention or utility model to solve the technical problems should be written in accordance with the following requirements:
exists for the existing technology defects or deficiencies;
(ii) with a positive, objective and concise language as a base of an invention or utility model to solve the technical problems can further explain the technical effect.
the invention or utility New technical problems to be solved not by the description of advertising and advertising style.
description of an application for a patent for invention or utility model can be listed by one or more to solve technical problems, but should also be described in the specification to address these technical problems technical solutions. When an application contains a number of invention or utility model, the manual lists a number of technical issues should be solved both with a general inventive concept related.
(2) technical program < br> an application for a patent for invention or utility model is the core recorded in the description of its technical solution.
Patent Law Implementing Rules first paragraph of Article XVIII (c) said solution of the invention or utility model The technical problem is the technical solution adopted clear and complete description of the invention or utility model to solve the technical problems of the technical solution adopted by the technical features. In this part of the technical program, or at least should reflect all the necessary technical features include an independent claim technical solutions, but also give additional technical features include additional technology solutions to further improve.
instructions should be recorded in the technical program and the corresponding claims are limited to technical solutions consistent presentation.
general Under the first part of the technical program manual independent claim shall state the technical program, the term shall be the language of independent claims, or the same as the corresponding to the invention or utility model, the sum in the form of technical features necessary to clarify its essence, if necessary, describes the necessary technical characteristics of the total effect of the invention or utility model, the relationship between.
then, through the invention or utility model, a description of additional technical features, reflecting the further improvement of its dependent claims technical solutions.
If an application has a number of inventions or utility models should explain the invention or utility model for each technical solution.
(3) beneficial effects of
instructions should be clear and objective of the invention or utility new in comparison with the existing technology has beneficial effects.
beneficial effect is the composition of the invention or utility model by the technical features is brought, or is bound by the technical characteristics described in the technical effect produced.
beneficial effect of the invention is to determine whether the consumption, raw materials, process savings, process, operation, control, ease of use, environmental pollution control or cure, and useful performance reflected the emergence of other aspects.
beneficial effects can be achieved by structural features of the invention or utility model, the the combination of analysis and theoretical explanation, or by listing the manner of experimental data shows that not only the assertion of the invention or utility model has a beneficial effect.
, however, that no matter which way the beneficial effects, should be with the existing technology comparison, that the invention or utility model, the difference with existing technology.
mechanical, electrical field of the invention or utility model, the beneficial effects, in some cases, the invention or utility model can be combined with the structural characteristics and mode of action explanation. However, the chemistry of the invention, in most cases, this approach is not appropriate to the beneficial effects of the invention, but rather to illustrate by means of experimental data.
desirable for the present there is no measurement methods have to rely on human senses to judge, for example, taste, smell, statistical methods can be used to explain the experimental results that the beneficial effects.
experimental data on the beneficial effects of reference, should be given the necessary experimental conditions and methods .
2.2.5 Description of the Drawings
manual contains drawings shall bear the names of various pieces of drawings, plans, and the contents of a brief description of the icon. In the case of many parts, allowing with the way the list of component parts of the drawings, a list of specific instructions.
more than one photo, it should be drawing on all photos to explain.
example, an invention known as energy-saving devices device side view;
Figure 3 is shown in Figure 2 A to the view;
Figure 4 in Figure 1 along the BB line sectional view.
2.2.6 mode of carrying out the invention or utility
The specific implementation of the new preferred way to an important part of the specification, which for full disclosure, understanding and implementation of the invention or utility model ...

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