[Ruling Gist]

If the closest prior art lacks an inherent connection with, or contains reverse technical teaching against, the technical problem addressed by the invention (that is, the object of the invention), a person skilled in the art will generally find it difficult to have a motivation to make improvements taking the closest prior art as the starting point so as to complete the invention.

[Keywords]

Administrative; invalidation of a patent right for invention; inventiveness; technical teaching; hindsight; implementation scenario

[Basic Facts]

A technology joint-stock company is the patentee of the invention patent with patent number 20121022****.2, entitled "A Method for Controlling the Movement of a Capsule or Probe" (hereinafter the "patent-in-suit"). Claims 1 and 2 of the patent-in-suit read:

"1. A method for controlling the movement of a capsule or probe, characterized by comprising the following steps:

Step one: placing a capsule or probe in an enclosed region;

Step two: using an external rotating magnetic field to apply a rotating force to the capsule or probe along a variable axis, the external rotating magnetic field being generated by a movable external magnet provided by a control mechanism;

Step three: moving the external magnet to manipulate the capsule or probe and using the friction generated between the capsule or probe and the contact surface to make the capsule or probe move in any direction along the variable axis, the movement of the capsule or probe in space being a rolling movement with a constantly changing fulcrum;

the capsule or probe having, when moving, one or more supporting points with the contact surface of the enclosed region; when the capsule or probe moves and contacts the surface of the enclosed region, the external rotating magnetic field causes the capsule or probe to rotate, thereby changing the supporting points between the capsule or probe and the surface of the enclosed region, and the external rotating magnetic field controls the capsule or probe to move in any direction;

the capsule or probe containing a magnetic dipole, and the external rotating magnetic field causing the magnetic dipole to rotate so as to cause the capsule or probe to rotate.

2. The method for controlling the movement of a capsule or probe according to claim 1, characterized in that the capsule or probe is a cylinder with hemispherical ends."

On October 12, 2019, a Chongqing company filed a request for invalidation against the patent right at issue, the main ground being that claims 1-2 of the patent-in-suit lack inventiveness. The evidence submitted by the Chongqing company included Evidence 1 (U.S. patent document No. US2009/00484**** and its Chinese translation), which discloses a device, system and method for magnetically manipulating an in-vivo device; the relevant translation records as follows:

[0007] Prior-art methods typically achieve a specific but fixed viewpoint for in-vivo imaging, and do not readily allow the field of view to be broadened and/or changed during the advancement of the device within a body lumen. In addition, prior-art methods of moving a device within a living body typically cause the device to be pulled or dragged within the lumen, which may cause patient discomfort and abrasion of the internal tissue.

[0008] Embodiments of the present invention provide a device and method for controlling the movement of an imaging device within a living body, which do not have the drawbacks of the prior art.

[0023] The devices and systems as described herein may have other configurations and/or sets of components. For example, an external receiver/recorder unit, a processor and a monitor (for example, in a workstation), such as those described in the above disclosures, may be suitable for use with some embodiments of the present invention. The present invention may be practiced using an endoscope, a needle, a vascular stent, a urinary catheter, and the like. Some in-vivo devices may be capsule-shaped, or may have other shapes, for example, a peanut shape or tubular, spherical, conical or other suitable shapes.

[0024] Some embodiments of the present invention may include, for example, a typical swallowable in-vivo device. The in-vivo device need not be swallowable, and may have other shapes or configurations. Some embodiments may be used in various body lumens, for example, the GI tract, blood vessels, the urethra, the reproductive tract, and the like.

[0049] In existing solutions, the device may move along a body lumen, for example, pulled in the direction of the gradient vector of an external magnetic force. This type of movement may injure delicate tissue walls.

[0052] Referring to Figure 2, according to an embodiment of the present invention, the device is preferably caused to roll about its center of mass in a somersaulting manner, and the movement of the capsule is performed by rolling from end to end along the longitudinal axis of the device, rather than dragging or pulling it along the cavity without rotation.

[0053] According to some embodiments, the rolling or somersaulting movement of the device is more effective in cavities of large volume (such as the stomach or the colon). This movement of the device may also be used in tubular cavities (such as the esophagus).

[0054] For example, as shown in Figure 2, the capsule may initially be positioned at P1 in a certain orientation, and may then roll about its longitudinal axis to position and orientation P2, and then P3. This movement can reduce the risk of tissue injury, because the device does not scrape against or rub the wall tissue. In order to achieve this manner of movement, the position of the internal magnet, or of the magnet within the device, may preferably be away from the center of mass of the device. The center of mass is typically calculated without the addition of the magnet, and the magnet is positioned on one side of the center of mass so as to create an asymmetric center of mass in the capsule. For example, in a device having a single imaging head, the magnet may be positioned on the side of the device near the imager. In another embodiment, the device may have two imagers, for example, one imager on each side of the longitudinal axis of the device. The two imagers may have different functional capabilities. One imager may be narrowly focused for viewing near tissue, and the other may be configured to image a wider field of view. In such embodiments, the magnet may be positioned on the side of the imager having the narrow field of view, focused on the near tissue, so that the center of mass may be located closer to that side, and, as a result, the device may rest on said tissue. In another embodiment, the device may have one type of sensing on one side, namely, an imager, and another type of sensor on the other side, namely, a pressure sensor, a pH sensor, or an image sensor accompanying an optical system to perform an optical biopsy. The magnet may typically be positioned near the side of the device that may functionally need to be positioned closer to the GI-tract wall tissue.

The China National Intellectual Property Administration issued, on January 25, 2021, Invalidation Request Examination Decision No. 47958 (hereinafter the "challenged decision"), declaring the patent right at issue wholly invalid. The technology joint-stock company was dissatisfied and filed a lawsuit with the first-instance court, requesting revocation of the challenged decision and an order that the China National Intellectual Property Administration make a new decision.

The first-instance court rendered an administrative judgment on January 20, 2022: revoking the challenged decision, and ordering the China National Intellectual Property Administration to make a new examination decision. The technology joint-stock company was dissatisfied and appealed. On March 12, 2024, the Supreme People's Court rendered administrative judgment (2022) Zui Gao Fa Zhi Xing Zhong No. 256: dismissing the appeal and upholding the original judgment.

[Judgment Opinion]

The effective judgment of the court held:

First, according to the descriptions in paragraphs [0007]-[0008] and paragraph [0049] of the specification of Evidence 1, it provides a device and method for controlling the movement of an imaging device within a living body, which do not have the prior-art drawbacks of not readily allowing the field of view to be broadened or changed and of possibly causing patient discomfort and abrasion of internal tissue due to pulling or dragging. Its technical solution is intended to avoid "the contact and friction produced by pulling or dragging". Reading together the description of its flipping principle in paragraphs [0052]-[0054] of the specification of Evidence 1 and Figure 2, it can be seen that Evidence 1 changes the position and/or orientation of the device by applying, around an asymmetric center of mass, an external torque that causes a rotational movement, rather than applying an external gradient force that produces the pulling contact with the inner wall which injures tissue. Because Evidence 1 does not disclose contact with the inner tissue wall, it does not adopt the manner in the patent-in-suit of continuing to move by using contact fulcrums to "constantly change the supporting points". The patent-in-suit, by contrast, forms supporting points through contact between the capsule or probe and the enclosed region, and performs a rolling movement using the friction generated by those supporting points, with the supporting points constantly changing. It can be seen that, compared with Evidence 1, the patent-in-suit embodies a different inventive concept: in the patent-in-suit the capsule or probe maintains contact with the contact surface of the enclosed region, and performs a rolling movement around the supporting points formed by the contact and using friction, whereas Evidence 1 does not require the capsule or probe to maintain contact with the contact surface of the enclosed region, nor does it deliberately use the friction formed by contact to achieve a rolling movement around supporting points; the two differ in force conditions, differ in the supporting points of the rolling movement, and differ in their forms of movement.

Second, paragraphs [0023]-[0024] of the specification of Evidence 1 also record that, in narrow situations, the technical solution of Evidence 1 may be practiced using a vascular stent, a urinary catheter, and the like; and paragraph [0053] records that the rolling or somersaulting movement of the inventive device is more effective in cavities of large volume (such as the stomach or the colon). It can thus be seen that the so-called "unavoidable contact of the capsule within the gastrointestinal tract" inferred by the challenged decision is not the intended application scenario of the technical solution of Evidence 1.

Third, and more importantly, in assessing the inventiveness of a patent, where there is an obvious difference in inventive concept between the patent-in-suit and the closest prior art, finding that a person skilled in the art, starting from an implementation scenario not contemplated by the closest prior art, would readily think of using the distinguishing technical features between the patent-in-suit and the closest prior art to solve the technical problem to be solved by the patent-in-suit, is suspected of hindsight and should ordinarily be avoided. In this case, even if the so-called situation of "unavoidable contact of the capsule within the gastrointestinal tract" inferred by the challenged decision occurs, Evidence 1 merely discloses achieving a rolling movement by relying on torque to detach from the inner wall, and does not provide any teaching of using friction to achieve the rolling movement with constantly changing supporting points as defined in the patent-in-suit. Therefore, the challenged decision's inference - based on the premise that "a capsule cannot always travel through the human gastrointestinal tract in a suspended manner without contacting the inner wall of the gastrointestinal tract" - that Evidence 1 would necessarily produce supporting points and use the friction thereby generated to achieve a "somersaulting" movement, lacks basis. Moreover, given that Evidence 1, in order to solve the problem of avoiding injury to the inner wall caused by pulling or dragging the capsule, has already chosen a manner in which the capsule detaches from contact with the inner tissue wall to perform its flipping movement, it would not be obvious for a person skilled in the art to further change its force state so as to return the capsule to the inner tissue wall while still achieving the technical problem of avoiding dragging; this requires creative effort. Furthermore, the beneficial technical effects achieved by the technical solution of the patent-in-suit - stable movement of the capsule or probe within the enclosed region, advantage in overcoming obstacles, and accurate positioning - are also not addressed by Evidence 1.

Therefore, claim 1 of the patent-in-suit is inventive over the combination of Evidence 1 and common general knowledge in the art. On the basis that claim 1 is inventive, claim 2 is also inventive.

[Related Index]

Article 22, paragraph 3 of the Patent Law of the People's Republic of China (the version applied in this case is Article 22, paragraph 3 of the Patent Law of the People's Republic of China that took effect on October 1, 2009).

Source: Intellectual Property Court of the Supreme People's Court, 2026-09-04. Original: https://ipc.court.gov.cn/zh-cn/news/view-6025.html