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Each department of the Federal Institute of Industrial Property (FIPS) has its own practice of considering applications for inventions. At the same time, each field of technology has its own specificity of equipment, technologies, practice of creating new solutions and their patenting. Departments associated with medicine also have their own peculiarities of patent examination.
Теги: medical technologies patenting protection of invention защита изобретений медицинские технологии патентование
In the development of medical technologies, where physics, chemistry and mechanics often need to be combined with biological techniques, the inventive step is usually achieved easily, but the quality of the filing of applications for inventions is low. This is mainly due to the fact that medical workers often do not have good technical skills and are not familiar with the basic provisions of the Unified system of design documentation, but they often have to develop equipment for themselves and patent it.
The article [1] considers patents created in 1990–2000 in the field of medicine and notes typical shortcomings of descriptions of inventions, formulas and drawings of that time. In part, these shortcomings have survived to this day. For formulas, this is an unnecessary specification of an independent item and a lack of options for its implementation, which makes it easy to circumvent such patents. For drawings, this is a too liberal interpretation of the requirements for graphic materials, for example, the lack of necessary positions in the drawings, inadequate disclosure of structural elements and their connections, the use of photographs that are loosely tied to text, and having low contrast between different elements. Such patents are difficult to perceive. Typical shortcomings of the descriptions are the absence of a dedicated section with the analysis of technical results and the low level of disclosure of claims that is a common problem of Russian patents, as foreign patent attorneys note, which hinder their international patenting. Twenty-five years ago, we were just starting to form market relations, and the significance of patents was not high, now the situation has changed, and a poor-quality patent can bring big losses. In addition, the complexity of technologies and equipment, including in medicine, is increasing, and the level of expertise is increasing and poor-quality applications at present simply will not become patents.
Let's consider some recommendations on registration of applications for inventions in the field of medicine. Patents RU2267787 "Method for detecting toxic proteins by means of scanning probe microscope investigation", RU2339036 "Method of estimation of vaccine quality", RU2472165 "Scanning probe microscope for biological applications" and RU2560567 "Method of incorporating target molecules into cells" combine medical technologies and high-tech measuring equipment. RU2267787 includes one independent and ten dependent claims. In an independent claim groups of biological and physical-technical features are presented. By themselves, these groups are known in their fields, but new technical results related to increasing the reliability of measurements that are detailed in an independent claim have determined the necessary inventive step of the proposed solution. At the same time, each of the ten dependent claims contains biological signs that are mainly known but are attached to the technologies of specific probe measurements, which did not allow the FIPS expertise to exclude them from the claims, and the patent was able to protect the maximum number of use cases of the method.
The RU2339036 includes one independent and nine dependent claims. As in RU2267787, an independent item presents a group of biological characteristics and a group of physical-technical features, and thanks to a new technical
result – an increase in the sensitivity of measurements, – the inventive step of the proposed solution is achieved. But in the dependent claims there are mainly physical and technical features, and the technical results are associated with biological characteristics, which also provided the inventive step of solution and preservation of all dependent claims in the examination process.
The RU2472165 in all seven claims includes only the physical and technical features of the controversial inventive step, but the connection of technical results that expand the possibilities for selecting measurement zones, with the features of biological research, has determined the necessary inventive step of the proposed solution.
The RU2560567 includes one independent and 19 dependent claims, with the majority of physical-technical and biological features having an independent novelty. Such claim is practically invulnerable to patent examination and is effective for patent protection of a technical solution, both at the Russian and international levels.
All considered applications contained the dedicated sections of technical results. Given the interdisciplinary nature of the applications, each of them contains a sufficient number of references to known solutions of the accompanying elements, which allows not to overload the texts, concentrate on key points and increase the evidentiary basis of industrial applicability of inventions.
The next group of inventions relates to the preparation of medicinal products and is represented by the patents RU2139935 "Method of preparing water-soluble vitamin preparation and method of preparing vitamin preparation", RU2388491 "Production method of water-soluble forms of biologically active substances", RU2344874 "Method for dispersion of liquids, their mixtures and solid substance suspensions in liquids" and RU2382682 "Two-stage rotor apparatus". The first two inventions use physical and chemical processes to produce drugs. The very necessity of simultaneous inclusion of these processes in the claims automatically increases the inventive step, but, since the parameters of the processes often have variable values, it is necessary to carefully consider the boundaries of their ranges so that competitors, beyond these boundaries, could not manufacture products without violating patent.
The RU2139935 has two independent and five dependent claims. According to modern unspoken norms, it is desirable to have more variants of process realization, but in the description 13 examples of the method implementation are presented, which increases the umbrella of the invention in the case of international patenting.
The RU2388491 includes one independent and 18 dependent claims and this is a sufficient level of detail for an independent claim, even for foreign patenting. All ranges of parameters are expanded so as to completely exclude the possibility of competitors leaving their borders. At the same time, the feature regarding the use of nanodispersed particles was transferred from the independent to the dependent 11th claim at the stage of preparation of the application in order to avoid the circumvention of the patent by using particles whose size exceeds nanometer values. In this case, the main technical result of the invention – the expansion of the obtained nomenclature of biologically active substances, – would not change much.
General features of patenting on the example of the last two patents are described in detail in [2], here we will dwell on their medical specifics. RU2344874 describes only the physical processes of cavitation nanodispersing of liquids and extends to a wide range of products from rocket fuel to medical and cosmetic preparations. Given this range, the industrial applicability of the method can be proved in objects far from medicine, which is quite convenient, since clinical medical trials can take a long time. But, since the process in the formula is presented in a fairly general form, the obtaining of specific medications with its use does not necessarily require additional patenting.
The next stage in the protection of cavitation nanodispersing was the RU2382682 for a device for implementing this method. As noted in [3], there are tactical patents that ensure the concealment of the true objectives of patenting. Specificity of obtaining RU2382682 was that it was required not to advertise the possibility of its use in medicine. Therefore, the operation of the device has been described in the example of dispersion of abstract liquid media, which does not prevent its use in the manufacture of medical products.
The third group of inventions (RU2233490, RU2287129, RU2282257) refers to high-tech devices and technologies for 3D research of "soft" objects, including biological ones, in the nanometer range using microtomes combined with scanning probe microscopes. The general patterns of patenting of such objects are considered in [2], but here we will dwell on the peculiarities associated with their medical application. Additional electrophysical effects on the measurement zone often increase the inventive step of research equipment. When the microtome and the scanning probe microscope are combined, the measurement zone on the biological object and the measuring probe are in close proximity to each other. Thus, forming gas streams, heating, ionizing radiation, and other processes in this zone, one can simultaneously act on both the biological object and the probe. At the same time, the same distinctive feature will lead to a whole group of technical results of a different physical nature. For example, when the probe is exposed to laser or ultraviolet radiation, contamination can be removed from its tip and, accordingly, the resolution can be increased. But these same radiations make it possible to change the morphology of biological structures, for example, of the collagen protein, or the mechanical properties and structural organization of collagen fibrils as a result of cross-linking of protein molecules. Thus, there is an additional technical result, which is to increase the informativeness of the measurements. This principle of the multiplicity of technical results will hardly leave the chances of domestic and foreign expertise to refuse to grant patents, citing lack of novelty or low inventive step.
The last group of inventions belongs to the field of neurosurgery and is based on the works performed under the guidance of the professor of the Department of Neurosurgery of the Russian Academy of Medical Sciences, Doctor of Medical Sciences А.Shkarubo. The independent claim of the patent RU2615900 "Device for C1-C2 vertebrae front stabilization" describes the design of the metal plate in an extremely general way, but congruent with the form of C1 and C2 vertebrae. This allowed in nine dependent claims to present the maximum possible number of versions of the metal plate depicted in 14 drawings. Given the complexity of the operation to install and fix the stabilization device, seven 3D models and 20 images obtained using magnetic resonance imaging (MRI), spiral computed tomography (SCT) and radiography (for example, Fig.1–3) illustrate its stages. This created a complete demonstrative basis for fulfilling the criterion of patentability "industrial applicability".
Patent RU2615901 "Device for C1-C3 vertebrae front stabilization" is essentially the development of the previous solution for a more complex pathology. It was possible to formulate only two dependent claims. In this case, the invention illustrates 24 sufficiently detailed graphic representations of the design and result (for example, Fig.4–6). This detail in both cases serves as an additional obstacle to the receipt of patents by competitors using minor improvements in the described designs.
Patent RU2620888 "Method for treatment of invaginated C2 vertebra odontoid process associated with type I Chiari malformation" protects a particular solution regarding the use of a stabilization device according to RU2615900. In this case, it was important to unambiguously visualize the treatment process, therefore, in addition to 3D models and X-ray images (for example, Fig.7), drawings of process steps with clear boundaries between the human skull areas (for example, Fig.8) were used. The utmost clarity of the description of a rather complex process enabled the patent to be obtained without critical comments of the expertise. In this case, both images have a unique relationship through the numbering of the elements.
The formula of the patent RU2621421 "Electrode for cranial nerves identification" has only design features, but they are used in neurosurgery to determine the exact location of the cranial nerves during the operation. Distinctive features of the claims concern the exact fixation of the electrode position and minimization of the probability of causing injuries. If this electrode was used in the electrical industry, then most likely the patent could not be obtained. But the detailed technical results, first of all, reduction of traumatism and expansion of functional capabilities, presented in an independent section and closely related to the features of biological objects, determined the inventive step.
Patent RU2621419 "Method for visualization of arterial and venous vessels of human skull base and brain for their topographic and anatomical examination" protects the solution in which it was possible to visualize the arterial and venous vessels of the base of the skull as much as possible, first of all, for their study. The essence of this invention lies in the filling of vessels with various liquids and their mixtures at different temperatures and pressures. As a result of the research, the optimal values of the parameters and their limits were determined, on the basis of which the ranges of values were indicated in the claims. Thanks to this, the invention has been maximally protected. If competitors go beyond these ranges, they will not get the required characteristics. As an illustrative material photos of brain sections with isolated veins and arteries are presented. In this case, it was necessary to ensure high quality of photos, especially of the boundaries of color fields of different saturation, with the visibility of extension lines (for example, Fig.9). The invention is presented in 16 photographs with the designations of all elements mentioned in the description. To use color images as illustrations of inventions is acceptable, however, when preparing applications, it is necessary to check how much the contrast between the elements is preserved in the black and white version.
In conclusion, we will give general recommendations on the patenting of medical technologies. In the claims, where wide ranges of values are used, these ranges are allowed to break into fragments and for each of them to allocate their technical results. This is necessary to prevent competitors from identifying narrow fragments in wide ranges, discovering new technical results and patenting these solutions. Technical results should be singled out as an independent section, and the multiplicity of technical results of different physical nature increases the novelty and inventive level of technical solutions. When preparing graphic materials, different types of illustrations (photographs, drawings) should be agreed upon taking into account the requirements of paragraphs 10.9 and 10.11 (11) of the Administrative Regulations approved by the order of the Ministry of Education and Science of the Russian Federation No. 327 of 29.10.2008. ■
The article [1] considers patents created in 1990–2000 in the field of medicine and notes typical shortcomings of descriptions of inventions, formulas and drawings of that time. In part, these shortcomings have survived to this day. For formulas, this is an unnecessary specification of an independent item and a lack of options for its implementation, which makes it easy to circumvent such patents. For drawings, this is a too liberal interpretation of the requirements for graphic materials, for example, the lack of necessary positions in the drawings, inadequate disclosure of structural elements and their connections, the use of photographs that are loosely tied to text, and having low contrast between different elements. Such patents are difficult to perceive. Typical shortcomings of the descriptions are the absence of a dedicated section with the analysis of technical results and the low level of disclosure of claims that is a common problem of Russian patents, as foreign patent attorneys note, which hinder their international patenting. Twenty-five years ago, we were just starting to form market relations, and the significance of patents was not high, now the situation has changed, and a poor-quality patent can bring big losses. In addition, the complexity of technologies and equipment, including in medicine, is increasing, and the level of expertise is increasing and poor-quality applications at present simply will not become patents.
Let's consider some recommendations on registration of applications for inventions in the field of medicine. Patents RU2267787 "Method for detecting toxic proteins by means of scanning probe microscope investigation", RU2339036 "Method of estimation of vaccine quality", RU2472165 "Scanning probe microscope for biological applications" and RU2560567 "Method of incorporating target molecules into cells" combine medical technologies and high-tech measuring equipment. RU2267787 includes one independent and ten dependent claims. In an independent claim groups of biological and physical-technical features are presented. By themselves, these groups are known in their fields, but new technical results related to increasing the reliability of measurements that are detailed in an independent claim have determined the necessary inventive step of the proposed solution. At the same time, each of the ten dependent claims contains biological signs that are mainly known but are attached to the technologies of specific probe measurements, which did not allow the FIPS expertise to exclude them from the claims, and the patent was able to protect the maximum number of use cases of the method.
The RU2339036 includes one independent and nine dependent claims. As in RU2267787, an independent item presents a group of biological characteristics and a group of physical-technical features, and thanks to a new technical
result – an increase in the sensitivity of measurements, – the inventive step of the proposed solution is achieved. But in the dependent claims there are mainly physical and technical features, and the technical results are associated with biological characteristics, which also provided the inventive step of solution and preservation of all dependent claims in the examination process.
The RU2472165 in all seven claims includes only the physical and technical features of the controversial inventive step, but the connection of technical results that expand the possibilities for selecting measurement zones, with the features of biological research, has determined the necessary inventive step of the proposed solution.
The RU2560567 includes one independent and 19 dependent claims, with the majority of physical-technical and biological features having an independent novelty. Such claim is practically invulnerable to patent examination and is effective for patent protection of a technical solution, both at the Russian and international levels.
All considered applications contained the dedicated sections of technical results. Given the interdisciplinary nature of the applications, each of them contains a sufficient number of references to known solutions of the accompanying elements, which allows not to overload the texts, concentrate on key points and increase the evidentiary basis of industrial applicability of inventions.
The next group of inventions relates to the preparation of medicinal products and is represented by the patents RU2139935 "Method of preparing water-soluble vitamin preparation and method of preparing vitamin preparation", RU2388491 "Production method of water-soluble forms of biologically active substances", RU2344874 "Method for dispersion of liquids, their mixtures and solid substance suspensions in liquids" and RU2382682 "Two-stage rotor apparatus". The first two inventions use physical and chemical processes to produce drugs. The very necessity of simultaneous inclusion of these processes in the claims automatically increases the inventive step, but, since the parameters of the processes often have variable values, it is necessary to carefully consider the boundaries of their ranges so that competitors, beyond these boundaries, could not manufacture products without violating patent.
The RU2139935 has two independent and five dependent claims. According to modern unspoken norms, it is desirable to have more variants of process realization, but in the description 13 examples of the method implementation are presented, which increases the umbrella of the invention in the case of international patenting.
The RU2388491 includes one independent and 18 dependent claims and this is a sufficient level of detail for an independent claim, even for foreign patenting. All ranges of parameters are expanded so as to completely exclude the possibility of competitors leaving their borders. At the same time, the feature regarding the use of nanodispersed particles was transferred from the independent to the dependent 11th claim at the stage of preparation of the application in order to avoid the circumvention of the patent by using particles whose size exceeds nanometer values. In this case, the main technical result of the invention – the expansion of the obtained nomenclature of biologically active substances, – would not change much.
General features of patenting on the example of the last two patents are described in detail in [2], here we will dwell on their medical specifics. RU2344874 describes only the physical processes of cavitation nanodispersing of liquids and extends to a wide range of products from rocket fuel to medical and cosmetic preparations. Given this range, the industrial applicability of the method can be proved in objects far from medicine, which is quite convenient, since clinical medical trials can take a long time. But, since the process in the formula is presented in a fairly general form, the obtaining of specific medications with its use does not necessarily require additional patenting.
The next stage in the protection of cavitation nanodispersing was the RU2382682 for a device for implementing this method. As noted in [3], there are tactical patents that ensure the concealment of the true objectives of patenting. Specificity of obtaining RU2382682 was that it was required not to advertise the possibility of its use in medicine. Therefore, the operation of the device has been described in the example of dispersion of abstract liquid media, which does not prevent its use in the manufacture of medical products.
The third group of inventions (RU2233490, RU2287129, RU2282257) refers to high-tech devices and technologies for 3D research of "soft" objects, including biological ones, in the nanometer range using microtomes combined with scanning probe microscopes. The general patterns of patenting of such objects are considered in [2], but here we will dwell on the peculiarities associated with their medical application. Additional electrophysical effects on the measurement zone often increase the inventive step of research equipment. When the microtome and the scanning probe microscope are combined, the measurement zone on the biological object and the measuring probe are in close proximity to each other. Thus, forming gas streams, heating, ionizing radiation, and other processes in this zone, one can simultaneously act on both the biological object and the probe. At the same time, the same distinctive feature will lead to a whole group of technical results of a different physical nature. For example, when the probe is exposed to laser or ultraviolet radiation, contamination can be removed from its tip and, accordingly, the resolution can be increased. But these same radiations make it possible to change the morphology of biological structures, for example, of the collagen protein, or the mechanical properties and structural organization of collagen fibrils as a result of cross-linking of protein molecules. Thus, there is an additional technical result, which is to increase the informativeness of the measurements. This principle of the multiplicity of technical results will hardly leave the chances of domestic and foreign expertise to refuse to grant patents, citing lack of novelty or low inventive step.
The last group of inventions belongs to the field of neurosurgery and is based on the works performed under the guidance of the professor of the Department of Neurosurgery of the Russian Academy of Medical Sciences, Doctor of Medical Sciences А.Shkarubo. The independent claim of the patent RU2615900 "Device for C1-C2 vertebrae front stabilization" describes the design of the metal plate in an extremely general way, but congruent with the form of C1 and C2 vertebrae. This allowed in nine dependent claims to present the maximum possible number of versions of the metal plate depicted in 14 drawings. Given the complexity of the operation to install and fix the stabilization device, seven 3D models and 20 images obtained using magnetic resonance imaging (MRI), spiral computed tomography (SCT) and radiography (for example, Fig.1–3) illustrate its stages. This created a complete demonstrative basis for fulfilling the criterion of patentability "industrial applicability".
Patent RU2615901 "Device for C1-C3 vertebrae front stabilization" is essentially the development of the previous solution for a more complex pathology. It was possible to formulate only two dependent claims. In this case, the invention illustrates 24 sufficiently detailed graphic representations of the design and result (for example, Fig.4–6). This detail in both cases serves as an additional obstacle to the receipt of patents by competitors using minor improvements in the described designs.
Patent RU2620888 "Method for treatment of invaginated C2 vertebra odontoid process associated with type I Chiari malformation" protects a particular solution regarding the use of a stabilization device according to RU2615900. In this case, it was important to unambiguously visualize the treatment process, therefore, in addition to 3D models and X-ray images (for example, Fig.7), drawings of process steps with clear boundaries between the human skull areas (for example, Fig.8) were used. The utmost clarity of the description of a rather complex process enabled the patent to be obtained without critical comments of the expertise. In this case, both images have a unique relationship through the numbering of the elements.
The formula of the patent RU2621421 "Electrode for cranial nerves identification" has only design features, but they are used in neurosurgery to determine the exact location of the cranial nerves during the operation. Distinctive features of the claims concern the exact fixation of the electrode position and minimization of the probability of causing injuries. If this electrode was used in the electrical industry, then most likely the patent could not be obtained. But the detailed technical results, first of all, reduction of traumatism and expansion of functional capabilities, presented in an independent section and closely related to the features of biological objects, determined the inventive step.
Patent RU2621419 "Method for visualization of arterial and venous vessels of human skull base and brain for their topographic and anatomical examination" protects the solution in which it was possible to visualize the arterial and venous vessels of the base of the skull as much as possible, first of all, for their study. The essence of this invention lies in the filling of vessels with various liquids and their mixtures at different temperatures and pressures. As a result of the research, the optimal values of the parameters and their limits were determined, on the basis of which the ranges of values were indicated in the claims. Thanks to this, the invention has been maximally protected. If competitors go beyond these ranges, they will not get the required characteristics. As an illustrative material photos of brain sections with isolated veins and arteries are presented. In this case, it was necessary to ensure high quality of photos, especially of the boundaries of color fields of different saturation, with the visibility of extension lines (for example, Fig.9). The invention is presented in 16 photographs with the designations of all elements mentioned in the description. To use color images as illustrations of inventions is acceptable, however, when preparing applications, it is necessary to check how much the contrast between the elements is preserved in the black and white version.
In conclusion, we will give general recommendations on the patenting of medical technologies. In the claims, where wide ranges of values are used, these ranges are allowed to break into fragments and for each of them to allocate their technical results. This is necessary to prevent competitors from identifying narrow fragments in wide ranges, discovering new technical results and patenting these solutions. Technical results should be singled out as an independent section, and the multiplicity of technical results of different physical nature increases the novelty and inventive level of technical solutions. When preparing graphic materials, different types of illustrations (photographs, drawings) should be agreed upon taking into account the requirements of paragraphs 10.9 and 10.11 (11) of the Administrative Regulations approved by the order of the Ministry of Education and Science of the Russian Federation No. 327 of 29.10.2008. ■
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