Q1: What are the criterions for judging that a method belongs to diagnostic methods of diseases?
If a method involving diagnosis of a disease meets the following conditions, it shall be deemed to be a diagnostic method:
- It is practiced on a living human or animal body, and
- Its immediate purpose is to obtain the diagnostic result of a disease or health condition.
The following are examples of diagnostic methods excluded from patent protection:
X-ray diagnostic method, ultrasonic diagnostic method, gastrointestinal radiography diagnostic m eth o d , endoscopy diagnostic method, isotope tracing diagnostic method, infrared noninvasive diagnostic method, method of evaluating the risk of suffering from diseases, method of predicting the therapeutic efficacy for diseases, and gene screening diagnostic method.
To avoid rejection as a diagnostic method, for some inventions, it may be feasible to redraft them as a Swiss- type claims, for example, a substance or material in the manufacture of a kit or agent for the diagnosis of a disease. Alternatively, the applicant may argue that the immediate purpose of the method is not to obtain the diagnostic result of a disease or health condition. The following are examples which do not belong to diagnostic methods:
1) Method of pathological anatomy practiced on a dead human or animal body,
2) The immediate purpose only to obtain information from the living human or animal body as an intermediate result rather than to obtain the diagnostic result or health condition, or method of processing such information (e.g., physique and body parameters, physiological parameters, or other parameters), or
3) The immediate purpose is only to treat or test the body tissues, body fluids, or excrements that have been removed from the human or animal body in order to obtain information as an intermediate result rather than to obtain the diagnostic result or health condition, or method of processing such information.
As for the above items 2) and 3), only if the obtained information per se cannot immediately reach the diagnostic result of a disease and health condition, can the information be regarded as an intermediate result.
Particularly, a method of processing medical parameters does not belong to diagnostic methods if the immediate purpose thereof is not to obtain the diagnostic result or health condition. For example, a method of calibrating pressure value for increasing the accuracy of electronic sphygmomanometer, or an imaging method, the immediate purpose of which is to improve the image-forming condition or increase the imaging quality (including eliminating noise and constructed defect, increasing image contrast and resolution, etc.) so as to obtain an improved image and process it.
In the situation that a method has a possibility of being used for diagnosis or treatment of diseases and such a method can be used for non-diagnosis or treatment purpose, a disclaimer may be introduced in a claim to limit the method by "non-diagnosis or treatment purpose".
Q2: What are the criterions for judging that a method belongs to methods for treatment of diseases?
If a method serves treatment purpose or is of treatment nature, it belongs to methods for treatment of diseases. In patent practice, a method of treatment for a disease may often be redrafted as a Swiss-type claim which can be allowable, for example, expressed in the format of "Use of a compound or composition in the manufacture of medicament for the treatment of a disease". Please be advised that a product having the second medical use cannot be protected in a form of a product claim.
The following are some exceptions which can be eligible subject matters:
- Methods of treating dead human or animal bodies, such as methods of anatomy, beautification, antisepsis, or making specimen,
- Method s of purely cosmetic nature which are no invasive to human body or do not produce wounds, including methods of deodorization, protection, decoration or beautification for non-treatment purpose practiced partially on such directly visible parts as skin, hair, nail, and teeth externals; for example, a cosmetic method for preventing the skin from tanning, comprising the use of a sun screener,
- Methods for making a human or animal not in a morbid state feel comfortable or pleased, or methods for supplying oxygen, negative oxygen ions, or moisture under a special condition such as for diving or for shielding from toxic gas; and
- Methods of killing bacteria, viruses, lice, or fleas on a human or animal body (on the skin or in the hair, excluding wounds and infected sites.
Q3: In the field of biotechnology, what types of subject matters are excluded from patent protection?
The following are examples of the subject matters that are excluded from patent protection:
- Invention-creations contrary to social morality, for example, an artificial sexual organ or its substitute not for medical use, a process for modifying the germ line genetic identity of human beings or a human being thus modified, a process for cloning human beings or a cloned human being, use of human embryos for industrial or commercial purposes;
- Embryonic stem cell of human beings;
- Human body at the various stages of its formation and development, including a germ cell, an oosperm, an embryo and an entire human body;
- Inventions-creations where acquisition or use of the genetic resources, on which the development of the invention-creation relies, is not consistent with the provisions of the Chinese laws and administrative regulations,
- A microorganism existing in the nature without the involvement of any artificially induced technical treatment,
- A gene or DNA fragment found in the nature and existing in its nature state, and
- Animal and plant varieties, for example, an embryonic stem cell of an animal, an animal at the various stages of its formation and development, such as a germ cell, an oosperm, and an embryo; a single plant and its reproductive material (such as seed); a transgenic animal or plant, such as a transgenic seed; or a seed treated by a pesticide.
To make the subject matter patentable, (1) as to inventions-creations relying on genetic resources, the applicant should indicate the direct and original source of such genetic resources in the application documents, and if necessary, submit evidence proving that the acquisition of the genetic resources is consistent with the provisions of the Chinese laws and administrative regulations; (2) as to microorganism, if it is isolated from pure culture and has particular industrial use, it constitutes a patentable subject matter; and (3) as to gene or DNA fragment, if it is isolated or extracted for the first time from the nature, its base sequence is unknown in the prior art and can be definitely characterized with industrial application, it constitutes a patentable subject matter. In addition, a somatic cell, a tissue and an organ of an animal (except an embryo) do not belong to ineligible subject matters; and if a cell, a tissue and an organ of a plant cannot differentiate and develop into an entire plant, they do not belong to ineligible subject matters.
Q4: Business method - eligible subject matter or not?
In the most recent change of the Guidelines for Examination, a business method can be an eligible subject matter provided that it includes technical features therein. In other words, combination of a business method with technical feature(s) in one technical solution of a claim is important for making it patentable.
A method in relation to a trading interactive system may be patentable through a solution of combining both business model and technical features together. Such a solution can realize the purpose of the invention for customers to complete a trade by a POS terminal and a POS platform by a Mobile terminal.
A method for trading, characterized in that it includes:
- A POS terminal reading card information from a trade card,
- The POS terminal sending the card information to a Mobile terminal X which creates a communication with the POS terminal, and the Mobile terminal X further sending the information to a POS sever platform, and receiving a verification result returned from the POS platform by the Mobile terminal X; upon passing the verification, then performing step C,
- The POS terminal sending the trade information received to the Mobile terminal X, and the Mobile terminal X further sending the information to the POS sever platform, completing the trade, and receiving a trade result from the POS platform by the Mobile terminal X.
This solution relates to the field of payoff by means of E-commerce, and specifically refers to a method for completing a trade by POS trading system. Although the subject matter of 'method for trading' refers to a business model, its solution comprises a series of technical features, such as 'a POS terminal reading card information', 'a Mobile terminal X creates a communication with the POS terminal', and 'interaction of the Mobile terminal and the POS platform'. By using the technical means, the business model can make the trade to succeed, so as to improve the user experience, thus it cannot be excluded from patent protection. It is still worth noticing that a pure business method as rules and methods for mental activities cannot be granted a patent right.
Q5: Computer program - eligible subject matter or not?
Though computer languages and computer programs per se as rules and methods for metal activities cannot be granted a patent right, an invention relating to computer program may be patentable if the invention satisfies relevant drafting requirement e.g., claiming for a device which includes the improvement of the software, the combination of hardware and software (including expressed in a way of 'media + computer program flow'). As for an invention of method relating to computer program, it needs to be drafted in the way of program modules in claims.
For the solution of 'media + computer program flow', the claim can be drafted in the form of the followings:
1) 'A computer readable storage media, wherein a computer program (instructions) stored thereon, characterized in that the computer program (instruction) performed by a processor realizes the following steps……',
2) 'A computer readable storage media, wherein a computer program (instructions) stored thereon, characterized in that the computer program (instruction) performed by a processor realizes the steps of said method as mentioned in claim X'.
Existing mobile computing devices, e. g. , portable computer, mobile telephone, etc. , usually use small- storage-capacity flash memory card as storage medium due to its size and the requirement of portability, hence, the mobile computing devices cannot process multimedia data which need large storage capacity due to storage capacity limits, and multimedia technology cannot be applied in mobile computing devices. The invention provides a method of enlarging storage capacity of mobile computing devices using virtual device file systems, so that mobile computing devices can use large storage space on servers for local applications.
A method for enlarging storage capacity of mobile computing devices using virtual device file systems characterized in that it includes the following steps:
- building up a virtual device file system module on a mobile computing device, and hanging it on the operating systems of the mobile device,
- providing virtual storage space to applications on the mobile computing device through the virtual device file system module, and sending read/write request on the virtual storage space to the remote server through network,
- converting read/write request from the mobile computing device to read/write request on local storage devices on the remote server, and
- sending read/write result back to the mobile computing device through network.
The technical problem solved is how to increase effective storage capacity of mobile computing devices, e. g., portable computers. It is solved by the method of internal operating performance of mobile computing devices with improvement through execution of computer programs. Therefore, what it reflects is to build up virtual storage space on local computers through virtual device file system module and convert access to local storage devices into access to storage devices on servers. Such a method includes the technical means and brings the technical effect, which makes the invention patentable.
Specific Issues in the Fields of Chemicals, Bio-technology, and Pharmaceuticals
Q6: Can a set of relevant inventions be included in one application?
According to the local practice, it is allowable to put some relevant inventions in the same patent application if satisfying the unity requirements. In general, a product, its preparation method, use of the product, and the apparatus specifically used for preparing the product can be included in one application.
Specifically, for a set of different compounds, it can be included in one application, with the proviso that they meet the following standards:
(1) All alternative compounds possess a common property or activity;
(2) All alternative compounds possess a common structure, which constitutes the distinguishing feature between the compounds and those in the prior art, and is essential to the common property of activity of the compounds of general formula; or under the circumstances that they do not have a common structure, all of the alternative elements belong to the same class of compounds recognized in the technical field to which the invention pertains.
The above principle may also be applicable for the relevant inventions of compositions.
As for an intermediate and a final product, they need to meet the following two conditions for combining in one application.
(1) The intermediate and the final product have the same basic structure unit, or their chemical structures are technically closely related, and the basic structure unit of the intermediate is incorporated into the final product;
(2) The final product is prepared or separated directly from the intermediate.
As to several processes for preparing the same final product from the different intermediates, if these different intermediates possess the same basic structure unit, these processes may be claimed in one application.
Q7: Which technical information should be included in the description?
(1) As for the invention of a chemical product
The description should describe the identification, preparation and use of the chemical product.
If the chemical product is a compound, said identification includes its chemical name and chemical structure by which those skilled in the art can identify the compound. Chemical/ physical property parameters which are necessary for the identification of the compound should also be described in the description (for example, molecular weight and the distribution of molecular weight of a polymer). When the compounds are of a general formula, at least several specific compounds in the scope defined by such a formula shall meet the aforesaid requirements.
If the chemical product is a composition, besides its components, the description should describe the chemical and/or physical state of each component, the selection of each component, the range of content of each component and its effect on the property of the composition.
At least one preparation method of the chemical product should be described, including the raw materials, procedures and conditions. A specially adapted equipment if used for carrying out the method should also be indicated.
Usage and/or use effect of the chemical product should be disclosed. For a new pharmaceutical compound or pharmaceutical composition, not only its specific medical use or pharmacological action, but also its effective amount and the method for using it need to be described.
(2) As for the invention of a chemical process
Regardless of a process for preparing a substance or any other process, the raw materials, procedures and processing conditions adopted in the process may also need to be described. Where necessary, the effect of the process on the property of the aimed substance should be described so as to enable those skilled in the art can solve the problem the invention intends to solve.
(3) As for the invention of use of a chemical product
The description should describe the chemical product to be used, the method for using the product and the effect to be achieved. As for a new use of a known compound, experimental evidence may generally be required to validate the new use and effects thereof.
In addition, concerning the above (1)-(3), as for property parameter to show the result of the invention, the method used to measure it needs to be specified when various measuring methods in the prior art yield different results. If it is a specific method, it shall be explained to enable those skilled in the art to carry it out.
Q8: How to obtain relatively broad scope of claim protection?
Claims are generalized from the description, and often, from one or more embodiments or examples as set forth in the description. If those skilled in the art can reasonably predict that all the equivalents or obvious variants of the embodiments would have the same properties or uses, it is allowed to generalize the claim to cover all the equivalents or obvious variants. Thus, to obtain relatively broad scope, it is recommended that features mentioned in the claims, especially those in independent claims, be described in detail and provided with sufficient options.
Chemistry is an experimental science, and most inventions in this field need to be verified by experimentation. Thus, it is generally required that the description may include some examples as well as experimental data when necessary. The number of examples may be determined in accordance with the nature of the invention, the specific technical field, the state of the prior art, and the claimed scope of protection. The description may give only one example if the example is sufficient to support the claims, however, for a board scope of protection of the claim, more than one example may be needed.
Where the improvement involves a numerical range, the description shall usually give examples for the values near the both ends (preferably the both end values), and, where the range is broad, at least one example for an intermediate value. As for a claim of compounds with a general formula, whether it can be supported by the description is generally examined based on the preparation examples and working examples.
If a new compound is claimed, it is generally allowed to claim its salt though not exemplified in examples, with the proviso that the compound is supported by the description and there is no reason to doubt the formation of the salt or the same effect as the compound. On the contrary, it would be not be easy for solvate, prodrug, metabolite, and other compounding form (such as ester or N-oxide) of the compound to be considered as being supported by the description without their working examples. If a crystal form of a compound is claimed, it generally shall refer to the crystal form proven as having been prepared in the description.
To obtain a relatively broad scope of the claims, it is recommended that the description sufficiently provide examples or data when necessary to the extent that those skilled in the art can be convinced of the claimed effect of the invention. Also, evidence of the background technology can be used in support of the generalized scope of the claimed invention.
The compounds of a general formula are claimed, which define group G in the general formula as "alkyl, alkoxy or aryl". In the examples, group G is exemplified as methyl and phenyl.
Since "alkoxy" is not exemplified in the examples, it would generally be questioned as lacking support by the description. Moreover, alkyl and aryl are each exemplified by only one specific group, restriction by proper number of carbon atoms in the claim might be required, depending on the application case. In the event that the description failed to recite a suitable subclass of alkyl and aryl, the limited examples might lead the protection of group G narrowed. It is recommended that the different preferable values of the groups be described in the description for suitable amendments in response to the examiner's objections.
A synergistic composition as claimed comprising component A and component B is claimed. It defines that component A is a known compound A1, and component B can be selected from known compounds B1, B2, B3 or B4. The examples only show a composition comprising A1 and B1 and a composition comprising A1 and B2.
Compositions in which component B is compound B1 or B2 in the claim are supported by the description. As synergistic effect could be unpredictable, for compound B3 and B4, the related embodiments to prove such effect might be necessary for supporting the whole claim. In this situation, other factors or evidence need also be considered, such as similarity of B1, B2, B3 and B4 or the mechanism of resulting in synergistic effect. Lack of examples for compound B3 and B4 might result in narrowed scope of the claimed invention.
Q9: How to use supplementary data after the filing date?
In the previous practice, supplementary data after the filing date cannot be used for supporting sufficient disclosure of an invention if the examiner raises objections in this regard. Supplementary data are mostly used for proving inventiveness of the claimed invention. By such experimental data, advantageous effect achieved by the invention over the closest prior art, which may be difficult to determine without relevant comparison, can be clearly demonstrated. In the most recent change of the Guidelines for Examination, a door opens for the post- filing data in the situation of insufficient disclosure of the description in a patent application.
Thus, with respect to the issues of insufficient disclosure, claim support and/or inventiveness of the claimed invention, filing supplementary data may be used as a way to obviate the related objections raised by the examiner. For the issue of insufficient disclosure, the examiner should examine the supplementary data provided after the filing date instead of absolute rejection as the previous practice. Attention needs to be paid that the substantive standards of sufficient disclosure have not been changed, and the examiner still needs to look at original disclosure in relation with the supplemented data to make judgment. As for the supplementary data for the issues of claim support and inventiveness, no change is involved in the new rule of the Guidelines.
Nevertheless, making use of filing supplementary data, it is required that the technical effect proven by them can be obtainable by those skilled in the art in relation with and on the basis of the disclosure of the original application.
Q10: What features are excluded from Swiss type claims?
Swiss type claim is commonly used for protecting a second medical use of a known compound. However, it cannot be understood as directly protecting a method of using the compound for treating disease. Accordingly, examination of this type of claim is conducted on the use itself, without consideration of the process of treating diseases. As for a Swiss type claim comprising features relating to using method, such as the object, mode, route, usage amount, and interval of administration, such features may not necessarily be deemed as defining the pharmaceutical use per se.
In particular, dosage regimen are generally closely related to the doctor's treatment plan, but not necessarily related to the preparation of the medicine itself. Thus, the difference merely present in dosage regimen might not enable the claim to be patentable. Nevertheless, if difference in administration led to difference in the use, such as in the form of the medicine, the difference might render the claim patentable.
Q11: How to protect nucleotide /amino sequence?
As for nucleotide/amino sequence, it is generally considered that difference in nucleotide sequence may lead to change or loss of function of the nucleotide molecule, and small change of amino sequence may lead to great change of its spatial configuration, and in turn lead to change of its function. Thus, based on an exemplified sequence, it would be difficult to expect that another sequence having high homology with the exemplified sequence could also have the same function. In practice, the claimed sequences having even very high homology with those exemplified in examples may also be considered as lacking support by the description. Therefore, to get relatively broad scope of sequences to be protected may, it is recommended that more sequences may be exemplified in the examples in the application.
Designs for the Protection of Products
Q12: Can GUI be eligible for design protection in China?
"GUI" is the abbreviation of "Graphic User Interface". It is a type of interface that allows user to interact with electronic devices through graphical icons and visual indicators. GUI can be protected in China since May 1, 2014 in the form of GUI embodied in articles/products. The following illustrates GUI protection.
-Product with GUI of an operation system
(Mobile Phone with GUI)
-Product with GUI of software
(Mobile Phone with GUI)
-Product with GUI of Web App
(Computer with GUI)
- Special-purpose equipment with GUI (Patient Monitor with GUI)
Q13: Should a design patent in China bear absolute novelty?
The design patent in China requires absolute novelty since October 1, 2009, in this regard, prior design disclosed worldwide can be used to challenge novelty of the design patent. This requirement is applied to Chinese design applications filed after October 1, 2009 or having priority dates later than October 1, 2009. The design for which patent right may be granted shall not be identical, or substantially identical with prior design, and shall be significantly differ from prior design or combination of prior design features.
Q14: Can pure pattern be protected by design patent in China?
A design to be protected in China shall be the design of a product. Designs in classification 32-00 (i.e. decorative patterns) are rarely accepted by the SIPO. It is the product incorporating the patterns that can be protected as a design patent in China.
Q15: Can multiple designs be filed in one Chinese application? Whether designs for the same product filed in one application can be enforced individually?
Multiple designs may be filed in one application if these designs are:
- two or more similar designs for the same product; or
- two or more designs which are incorporated in products belonging to the same class and sold or used in sets (for example, a coffee set consisting of coffee cup, coffee pot, milk pot and sugar pot).
To include more similar designs in one design application will help the applicant to obtain a broader protection scope. Each design in one application can be enforced individually. As long as the potential infringer infringes one of the embodiments, the patentee can sue this infringer. More similar designs will make it more difficult for potential infringers to design around in order to avoid infringement, but similar designs in one design application should not exceed 10.
It is the same case for multiple designs in one application of "products in set". The protection scope for "products in set" shall be understood that every design in the "products in set" should be deemed as an independent product. In this case, an accused product will be found infringing as long as it is identical or similar with either one of the designs in the patent.
It needs to be noted, there is another form of design, i.e., the "component product" which is under protection as a whole. Thus, the accused product will only be found infringing if it reproduces each and every design of the patent.
Q16: In what situation a request for reexamination may be submitted?
Upon receipt of a decision of rejection made by the examiner, within three months from the date of receipt of the decision, the applicant may request the Patent Reexamination Board (PRB) to make a reexamination. Such a case shall be examined by a panel consisting of three or five members (usually three) if interlocutory examination made by the previous examiner finds the request fails to address the rejections. After reexamination, the PRB shall make a decision of revoking or upholding the decision of rejection. During reexamination, oral hearing can be available upon request by the applicant and approval of the panel, or the panel decides to have an oral hearing. In actual practice, oral hearing seldom occurs in reexamination proceeding.
Q17: Is there any opportunity to amend claims/description and submit new evidence?
The application may be amended at the time of submitting the request for reexamination, responding to Notification of Reexamination, or oral proceedings. Submission of observations and/or new evidence can also be allowable.
For the amendments, the basic principle is no introduction of new matters. There are some limitations for the claim amendments as follows:
- where a claim amended extends the scope of protection as compared with the claim rejected in the decision of rejection,
- where a claim in the amendment is derived from the technical solution that lacks unity with the claims rejected in the decision of rejection,
- where the type of a claim is altered, or the number of claims is increased, or
- where the amendments are directed to the claims or the description that were not involved in the decision of rejection, unless they are intended merely to correct obvious clerical errors or to amend the defects of the same nature with that indicated in the decision of rejection.
Q18: How many times would the panel issue a reexamination notification? What may trigger termination of the reexamination procedure?
In most of the cases, the panel issues a reexamination notification only once if it intends to have a negative opinion toward the case. In a few rare cases, it is issued twice or more. Therefore, it is important to prepare very carefully the observations and/or evidence or make claim amendment upon receipt of such a notification to avoid final rejection by the PRB.
The reexamination procedure is terminated in the following cases:
- where the request for reexamination is deemed withdrawn for lack of response within the time limit,
- where the petitioner has withdrawn the request for reexamination before a reexamination decision is made, and
- where the accepted request for reexamination is rejected due to inconformity with the requirements of acceptance.