The Supreme People’s Court pointed out in an administrative appeal that, for product claims containing a subject name with usage limitation, the usage limitation must be considered when determining the scope of protection. However, its actual limiting effect depends on the impact on the product itself claimed for protection. If the usage limitation imposes no impact on the claimed product or equipment, but only describes their use or way of use, the usage limitation generally does not substantively affect the assessment of novelty or other relevant determinations.
This case involves an invalidation decision. The case circumstance is introduced as follows:
Company A is the patentee of the invention patent involved in this case (hereinafter referred to as “this Patent”), which is titled “Removable Integrated Thrombus Device Clot”. Claim 1 of this Patent is:
1. A self-expanding device for removing thrombus in blood vessels (hereinafter referred to as Feature A), the self-expanding device comprising:
a mesh structure containing a first set of multiple grids, the mesh structure has a proximal end and a distal end, wherein the distal end of the mesh structure is configured to be implanted in at least a portion of the thrombus, thereby forming an integrated thrombus device mass that can be removed from the occlusion site of the patient (hereinafter referred to as Feature B);
a conical portion comprising a second set of multiple grids, the conical portion is arranged towards the proximal end of the mesh structure; and a connection point, where the conical portions converge, and the connection point is located at the proximal end of the conical portion; wherein
the self-expanding device is preformed to adopt a volume-expanding form, wherein, in said volume-expanding form, the self-expanding device is configured in the form of a longitudinally open tube that tapers toward the connection point.
Company B and Company C filed invalidation requests against this Patent separately. Their major evidence was Evidence 1.1: A US patent document involving a medical implant with a rollable matrix structure.
The CNIPA issued the Decision on the Examination of Request for Invalidation (hereinafter referred to as the challenged decision), deeming claims of this Patent as not being practical, novel, or inventive and thus declared this Patent entirely invalid.
Company A, dissatisfied, filed a lawsuit with the first-instance court, requesting to revoke the challenged decision and order the CNIPA to make a decision anew.
The first-instance court issued an administrative ruling to revoke Company A’s litigation claims. The first-instance court held that: Feature A is a usage feature and does not imply structural changes between the patented product and Evidence 1.1, i.e. Feature A does not have a substantive impact on the self-expanding device itself. Such usage feature does not function as a limitation, and is only a description of the use or way of use of the self-expanding device. Thus, Feature A shall not be considered when examining the novelty and inventiveness. Feature B is a limitation on the functionality or effect of the distal end of the mesh. Where a claim contains a technical feature defined by a function limitation, such feature shall be understood as covering all embodiments for achieving the recited function. The scope of protection of the technical solution contained in claim 1 of the Patent fully covers the self-expanding device of Evidence 1.1. Thus, claim 1 of this Patent lacks novelty over Evidence 1.1.
Company A, dissatisfied, filed an appeal. The Supreme People’s Court made an administrative judgement to reject the appeal and upheld the original judgement.
The effective judgement made by the Supreme People’s Court holds that:
(I) Impact of Feature A in Claim 1 on the determination of the novelty
For product claims containing a subject name with usage limitation, the usage limitation must be considered when determining the scope of protection. However, its actual limiting effect depends on the impact on the product itself claimed for protection. If the usage limitation imposes no impact on the claimed product or equipment, but only describes their use or way of use, the usage limitation generally does not substantively affect the assessment of novelty or other relevant determinations..
In this case, Feature A in Claim 1 is the subject name “A self-expanding device for removing thrombus in blood vessels,” which includes a usage limitation, so its effect on the claimed product shall be considered in the novelty and inventiveness assessment. Company A claimed in the first instance that this usage limitation implies structural differences between the product and Evidence 1.1, including those in their net structure, connection joints structure, tensile strength, connection mechanism, working form, physical characteristics requirements, and so on. In the second instance, Company A further argued that Evidence 1.1, as a medical implant, must be detachable at the connection point where tapered sections met, whereas the patented device for thrombus removal is not detachable at the connection point. However, neither argument establishes a necessary structural difference between the thrombus removal device and the medical implant. For example, whether the connection point in this Patent is detachable has no inseparable corresponding relationship with the thrombus removal function. Description of this Patent also clearly discloses that Evidence 1.1 may “be combined herewith as a whole through reference”, which indicates that the overall structure of Evidence 1.1 may be incorporated into this Patent. Therefore, Company A’s claim that Feature A implies a structural limitation distinguishing the claimed device from Evidence 1.1 is not sufficiently supported.
Where a person skilled in the art can determine that technical solutions that are substantively identical can be applied to the same technical field to solve the same technical problems and achieve the same expected effect, such technical solutions should not be deemed as constituting different invention or utility model simply because their uses are different.
In this case, first, the usage limitation in Feature A is a limitation on treatment use. Under Article 25.1(iii) of the Patent Law, diagnoses and treatment methods of diseases shall not be granted a patent. Where the only difference between a medical device product claim and the prior art lies in the treatment method, granting a patent on this basis would raise ethical and moral concerns, such as restriction the freedom of medical practitioners. Therefore, a limitation on the treatment method shall not be considered as a feature that has a substantive impact on the examination of novelty and inventiveness of a product claim. Company A argued that the use of a medical device shall be protected with reference to medical use claims. However, medical devices and pharmaceutical products are different and cannot be directly compared. The use of medical devices usually cannot be protected with reference to medical use claims. Finding a new use of a pharmaceutical product based on a different mechanism when it is applied to different diseases in human bodies is not analogous to applying a medical device to a human body in a different physical way for different diseases. Therefore, the use of a medical device usually cannot be granted protection with reference to medical use claims.
Second, Evidence 1.1 has disclosed all structural features of claim 1 in this Patent, and a person skilled in the art, based on their general cognition, may confirm that the technical solutions of Evidence 1.1 and this Patent may be applied to the same technical field to solve the same technical problems, and achieve the same expected effect. This is further supported by other reference documents cited in the comments on inventiveness in the challenged decision. Therefore, Company A’s relevant appealing grounds are neither tenable nor supported.
(II) Impact of Feature B in Claim 1 on the judgement of novelty
For product claims containing usage features, it should be considered whether such usage feature implies that the claimed product has a particular structure and/or component. If the usage is dictated by the product’s intrinsic feature and the usage feature does not imply any change in the product’s structure and/or component, the product claims limited by such usage feature generally lacks novelty over the product disclosed in a reference documents. The same principle also applies to the assessment of inventiveness regarding whether such technical features are identical.
In this case, feature B in Claim 1 (i.e. the distal end of the mesh structure is configured to be implanted in at least a portion of the thrombus, thereby forming an integrated thrombus device mass that can be removed from the occlusion site of the patient) does not imply any change in the product structure. Based on similar reasons as those mentioned in the analysis on Feature A, Feature B cannot affect the assessment of novelty of this Patent either.
In view of above, where neither Feature A and Feature B can affect the novelty assessment of this Patent, and Evidence 1.1 has disclosed all structural features specifically limited by Claim 1, technical solution in Claim 1 and that of Evidence 1.1 have constituted substantively identical technical solutions, and a person skilled in the art can confirm that the two substantively identical technical solutions may apply to the same technical field to solve identical technical problems, and achieves the same expected effect. Therefore, Claim 1 has no novelty over Evidence 1.1.
This case clarifies the examination standard of usage features contained in claims of medical device products, which is: Usage limitation has a imitating effect only when it imposes an impact on the product itself. If the limitation merely describes a treatment use and does not imply any structural change, it does not affect the novelty assessment. Specifically, treatment usage limitation shall not serve as a basis for grant, so as to avoid ethical problems such as restriction the freedom of medical practitioners. When the prior art has disclosed all structural features and the person skilled in the art can confirm that the two technical solutions apply to the same technical field to solve the same problems and achieve the same effect, they constitute substantively identical technical solutions even if their usages are different. Consequently, the product claim lacks novelty. This judgment provides clear guidance to drafting and invalidation examination of medical device patents, and also represents the value orientation that the Patent Law, which encourages genuine technological innovation and prevents abuse of rights.
(2023) Zui Gao Fa Zhi Xing Zhong No. 475
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