*AI-generated translation, for reference only.

[Keywords] Administrative, Patent administrative case, Invalidation of invention patent, Inventive step, Positional limit and functional adaptation relationship

Case Facts

Nan [REDACTED] Medical Technology Co., Ltd. is the patentee of the invention patent with patent number 20141022****.7, titled "A Hemostatic Clip" (hereinafter referred to as "the patent”). Claim 1 of the patent is: "1. A hemostatic clip, characterized in that it comprises a clamping assembly and a clip seat, the clamping assembly comprising a clip body and a steel wire buckle connected in sequence;

the front end of the clip seat is provided with a fixed pin, the clip body is composed of two clamping arms, the tail ends of the two clamping arms are connected by a movable pin, each of the two clamping arms is provided with a sliding groove at its middle part, the fixed pin passes through the sliding grooves, the two clamping arms reciprocate along the sliding grooves to open and close the clip body; the end of the sliding groove is provided with a bent structure, when the clamping arms move so that the fixed pin is positioned in the bent structure, the two clamping arms are in a locked closed position;

the steel wire buckle is wound around the movable pin, when the tensile force applied to the steel wire buckle reaches a predetermined value, the steel wire buckle detaches from the movable pin; after the steel wire buckle detaches from the movable pin, the rear part of the clip body is fixed inside the clip seat;

the tail ends of the two clamping arms are provided with a hook structure, the clip seat is provided with a protrusion adapted to the hook structure, when the two clamping arms are in the locked closed position, the hook structures at the tail ends of the two clamping arms are engaged on the protrusion."

On August 19, 2020, Zhuji Peng [REDACTED] Medical Instrument Co., Ltd. requested the China National Intellectual Property Administration to declare the entire patent right invalid, and submitted the following main evidence: Evidence 1: US Patent Application Publication No. US4887 and its Chinese translation. Evidence 1 discloses an endoscopic biopsy forceps, which includes a cam device, wherein the cam track grooves 50 and 52 each have two continuous linear portions 50' and 50", and 52' and 52" at an angle thereto. The portions 50' and 52" of the cam track grooves 50 and 52 near the ends of the forceps jaws are angled to extend more closely in line with or more closely to the axial centerlines of the sliding member 20 and the forceps arms 24, 26. In this way, when the forceps jaws are closed, any further movement of the wire 22 tending to continue closing the jaws will provide a greater offset or clamping force to the mating jaws through the screws in the grooves, thereby enhancing the clamping action or the advantage of mechanically grasping any tissue between the jaws. Evidence 1 also states that according to an improvement of the present invention, the cam track can be a linearly angled groove structure to impart maximum clamping force to the jaws when they are closed. Due to the cam device of the present invention, the opening and closing movements of the forceps arms and forceps jaws are improved, and the advantages provided by the structure of the present invention include: preventing the sample or tissue from slipping out of the cutting area of the biopsy forceps during the closure of the forceps jaws.

Evidence 3: Chinese utility model patent document with authorized publication number CN202699, which discloses a tissue hemostatic clamping device.

On May 13, 2021, the China National Intellectual Property Administration made the Invalidation Request Review Decision No. 49785 (hereinafter referred to as the Contested Decision), holding that: Compared with Evidence 1, Claim 1 of the patent comprises the following distinguishing features: (1) The patent protects a hemostatic clip, the end of the sliding groove is provided with a bent structure, and when the clamping arms move so that the fixed pin is positioned in the bent structure, the two clamping arms are in a locked closed position; whereas Evidence 1 discloses an endoscopic biopsy forceps, and does not disclose the bent structure capable of placing the clamping arms in a locked closed position. (2) The clamping assembly of the patent further includes a steel wire buckle connected to the clip body, the steel wire buckle is wound around the movable pin, and when the tensile force applied to the steel wire buckle reaches a predetermined value, the steel wire buckle detaches from the movable pin; after the steel wire buckle detaches from the movable pin, the rear part of the clip body is fixed inside the clip seat; whereas the pivots 28, 30 in Evidence 1 are integrally formed with or fastened to the sliding member 20 which has one end fixed to the wire 22, i.e., the wire in Evidence 1 is fixedly connected to the movable pin. (3) The tail ends of the two clamping arms of the patent are provided with a hook structure, and the clip seat is provided with a protrusion adapted to the hook structure; when the two clamping arms are in the locked closed position, the hook structures at the tail ends of the two clamping arms engage on the protrusion; whereas Evidence 1 does not have a hook mechanism and protrusion structurally adapted to each other on the clamping arms and the clip seat. Based on the above distinguishing features, the actual technical problem solved by Claim 1 is: how to facilitate the convenient detachment operation of the hemostatic clip while ensuring the stability of the hemostatic clip in a locked state. The arrangement angle of the cam track groove in Evidence 1 only increases clamping force, and is not for locking. Therefore, Evidence 1 does not disclose the bent structure of the patent that can place the clamping arms in a locked closed position, nor does it provide a teaching for arranging a bent structure to lock the two clamping arms in a closed position; Evidence 2-4 do not disclose the double-insurance locking structure in Claim 1 of the patent, nor do they provide a corresponding teaching. Furthermore, by arranging the steel wire buckle wound around the movable pin, the patent makes the detachment operation of the hemostatic clip convenient, achieving beneficial technical effects. Therefore, Claim 1 of the patent possesses an inventive step. Since Claim 1 possesses an inventive step, dependent claims 2-8 also possess an inventive step.The China National Intellectual Property Administration accordingly decided: to maintain the patent right effective based on the amended claims 1-8 submitted by Nan [REDACTED] Medical Technology Co., Ltd. on November 10, 2020.

Dissatisfied, Zhuji Peng [REDACTED] Medical Instrument Co., Ltd. filed a lawsuit with the Beijing Intellectual Property Court, requesting the revocation of the Contested Decision and an order for the China National Intellectual Property Administration to make a new decision.

The Beijing Intellectual Property Court held that: The function of the bent structure in the patent is to increase the clamping force of the clamping arms, causing the two clamping arms to be in a locked closed position. After the two clamping arms are in the locked closed position, the hook structures at the tail ends of the two clamping arms engage on the protrusion, thereby locking the clamping arms in the closed state. Distinguishing Feature (1) is already disclosed by Evidence 1. Distinguishing Features (2) and (3) are disclosed by Evidence 3. Therefore, on October 24, 2022, it rendered the administrative judgment (2021) Jing 73 Xing Chu No. 13666: revoking the Contested Decision, and ordering the China National Intellectual Property Administration to make a new review decision. Both the China National Intellectual Property Administration and Nan [REDACTED] Medical Technology Co., Ltd. were dissatisfied and filed appeals respectively. The Supreme People's Court rendered the administrative judgment (2023) SPC IP Admin. Final 801 on December 24, 2024: revoking the first-instance judgment, and dismissing the claims of Zhuji Peng [REDACTED] Medical Instrument Co., Ltd.

Judge's Opinion

The focus of the dispute in this case is whether Claim 1 of the patent possesses an inventive step.

I. Regarding the distinguishing features and the actual technical problem solved

The Contested Decision determined that there are three distinguishing features between Claim 1 of the patent and Evidence 1. The first-instance judgment determined that Distinguishing Feature (1) was disclosed by Evidence 1. In this regard, first, based on the content of the specification and the general working principle of hemostatic clips, it is understood that the bent structure in Claim 1 not only defines the position of the clamping arms, but further defines that the clamping arms should be in a locked closed state; otherwise, the "double-insurance" effect of the patent would be impossible. Second, the angle formed by the linear portions of the cam track groove in Evidence 1 differs from the bent structure of the patent in terms of arrangement position, function achieved, and effect attained. (1) The angle in Evidence 1 is arranged at the middle section of the cam track groove, whereas the bent structure of the patent is arranged at the end of the sliding groove. (2) The purpose of the angle arrangement in Evidence 1 is to provide greater clamping force when the two clamping arms are closed, thereby preventing the sample or tissue from slipping out of the cutting area of the biopsy forceps; in contrast, the purpose of the bent structure of the patent is to ensure that the clamping arms are in a locked closed state. It is known from the general working principle of biopsy forceps that it does not require locking the clamping arms; on the contrary, when removing the sample or tissue, the clamping arms need to be opened flexibly. Therefore, the greater clamping force provided by the cam track groove in Evidence 1 is already sufficient to achieve its intended purpose. A conclusion that the cam track groove can limit the clamping arms to a locked closed position cannot be drawn from the content disclosed in Evidence 1. Furthermore, although the specification of the patent includes content relating to "being able to clamp and retrieve cut diseased tissue," this record no longer corresponds to the technical solution defined by Claim 1 after multiple amendments. The mere reliance on this record in the specification is insufficient to negate the above interpretation of Claim 1. In summary, Evidence 1 did not disclose Distinguishing Feature (1). The recognition in the Contested Decision on this point was correct. The recognition in the first-instance judgment regarding whether Distinguishing Feature (1) was disclosed by Evidence 1 was erroneous, and this is hereby corrected.

Regarding the actual technical problem solved by Claim 1, in addition to the problem identified by the Contested Decision ("how to facilitate convenient detachment operation of the hemostatic clip while ensuring its stability in the locked state"), since Distinguishing Feature (1) also includes the distinction between a "hemostatic clip" and an "endoscopic biopsy forceps," the actual technical problem solved also includes "how to modify the biopsy forceps into a hemostatic clip."

II. Regarding the technical teaching

The first-instance judgment determined that there is a technical teaching for combining Evidence 1 and Evidence 3, and that Evidence 3 has disclosed Distinguishing Features (2) and (3). In this regard, first, as discussed above, Evidence 1 did not disclose Distinguishing Feature (1), and Evidence 3 also did not disclose Distinguishing Feature (1). There is no other evidence on record proving that the prior art contains a technical teaching for Distinguishing Feature (1). Under these circumstances, regardless of whether Distinguishing Features (2) and (3) are disclosed by Evidence 3, Claim 1 of the patent possesses an inventive step. Second, the biopsy forceps disclosed by Evidence 1 has no requirement for locking the clamping arms. Even considering the combination of Evidence 1 and Evidence 3, the resulting technical solution only achieves a "single-insurance" locking of the clamping arms in the closed position through an anti-loosening structure of interlocking barbs and inclined blocks. The prior art does not provide a technical teaching for simultaneously arranging a bent structure and a hook structure to achieve a "double-insurance" locking of the clamping arms in the closed position. Finally, in the technical solution of the patent, the fixed pin and the bent structure, and the hook structure at the tail ends of the clamping arms and the protrusion on the clip seat, cooperate together to achieve the technical effect of a double-insurance locking of the clamping arms in the closed position. Furthermore, there are certain positional limitation relationships among the above structures. Therefore, in evaluating the inventive step, the above technical features and the cooperative relationship among them should be considered holistically, rather than simply comparing each technical feature in isolation with the prior art. Otherwise, it may improperly underestimate the inventiveness of the overall technical solution, committing the error of "hindsight."

Judgment Digest

In the evaluation of inventive step, if the distinguishing technical features of the patent in question over the closest prior art have a certain mutual positional limitation and functional adaptation relationship, the above distinguishing technical features, their mutual cooperative relationship, and the actual technical problem solved should be considered holistically. The technical features cannot simply be compared individually with the prior art in isolation, thereby improperly underestimating the inventiveness of the overall technical solution.

Related Index

Article 22, Paragraph 3 of the Patent Law of the People's Republic of China (The provision applicable in this case is Article 22, Paragraph 3 of the Patent Law of the People's Republic of China as amended in 2008)

First Instance: Beijing Intellectual Property Court, (2021) Jing 73 Xing Chu No. 13666 Administrative Judgment (October 24, 2022)

Second Instance: Supreme People's Court, (2023) SPC IP Admin. Final 801 Administrative Judgment (December 24, 2024)