Intellectual Property Enterprise Court

IP-2024-000024 - [2025] EWHC 492 (IPEC)

Fecha: 07-Mar-2025

Claim 3 – a flexible, deflectable tip

Claim 3 – a flexible, deflectable tip

41.

Paragraph [0025] of the Patent discusses flexibility and deflection. I will separate the relevant part of the paragraph into two parts for reasons that will become apparent:

[0025] In one embodiment of the present invention, the distal end 42 of the distal sheath 40 includes a flexible tip which will enable the user to adjust the direction of suction, irrigation, instrument placement, or removal of a stone, stone fragment or any other foreign body or tissue from a patient. The flexible tip has a length in the range of 4 to 10 cm. The flexible tip is deflectable to any angle desired by the user of the device. The flexible tip may have memory which is to say that the flexible tip may be configured into a specific angle or form and retain that configuration. It can be inserted into the body in another configuration, i.e., straight, until it is manipulated into a specific location by the user of the device. The flexible tip can then be reverted back to the original shape.

The distal portion of the distal sheath can also be deflected either actively or passively. In the active mold, the distal sheath is straight. A cable or some other mechanism along the inner (lesser) curvature of the bend can be either withdrawn or shortened gradually thus bending the distal portion 42 of the distal sheath 40 to a maximum of 360 degree. In the passive mold, the distal portion 42 of the distal sheath 40 has an inherent bend up to 360 degrees. The bendable portion can either be gradually straightened by withdrawing or shortening a cable or some other mechanism along the outer (greater) curvature of the bend or by using the rigid/semi-rigid obturator. In the preferred embodiment the bending section is about 4-6 cm. The flexible distal segment 42 is deflected by active mode.’

42.

It was agreed that the two uses of the word ‘mold’ are probably mistakes and that substituting ‘mode’ gives the right meaning.

43.

The first six sentences of paragraph [0025] are about the tip. The remainder is about the distal portion of the distal sheath. It is clear that the two are not the same. Claim 1 speaks of the sheath and that it has a proximal and distal end. There is no mention of a flexible tip. Claim 3 says ‘The device of claim 1 further comprising: a flexible, deflectable tip secured to the distal end of the distal sheath …’ (my emphasis).

44.

The second section of paragraph [25] begins: ‘The distal portion of the distal sheath can also be deflected either actively or passively’. I think that on a more natural reading, the idea being communicated is that like the tip the distal portion of the distal sheath can be deflected by active or passive means, though it could be read to distinguish the tip from the distal portion of the distal sheath in this regard. It is clear, however, that paragraph [0025] treats the deflection of the tip and the deflection of the sheath as two distinct features.

45.

I have not found CJ Medical’s case on this easy to follow. It appears, or at least appeared, to be that deflection of the tip must be active, i.e. achieved by a cable or other means pulling in one direction or another under the direction of the surgeon. In its opening written submissions CJ Medical said that there were three possible constructions of claim 3. Having rejected the first two, CJ Medical set out the third, which it adopted. I read it to mean that ‘deflection’ in claim 3 means active deflection only:

‘Construction Three: That the tip of the sheath may be deflected by the surgeon using cables or other mechanism running along respectively the inner or outer curvature of the sheath as described in the Patent at [0025]. This interpretation has much to commend itself for the following reasons:

It obviously does have considerable support in [0025];

ii.

A preferred embodiment is that the flexible distal segment (i.e. the tip) is deflected by active mode. The draftsman may thus have thought this active mode worthy of a separate claim to Claim 1;

iii.

Instinctively, one can see that a surgeon being able to use a cable or other mechanical means to actively deflect or straighten a sheath (and its tip) might have something inventive about it if in the prior art, CGK sheaths had been flexible but did not have such an active control means available to the surgeon. Indeed, Professor Somani’s view is that if the third interpretation is right, Claim 3 is inventive over traditional prior art CGK sheaths i.e. was not inherently obvious over CGK (Footnote: ¹).

iv.

The wording of Claim 3 “…which will enable the user to adjust the direction..” is consonant with the idea of a surgeon being empowered to adjust the direction of the tip of a sheath through means put at his or her disposal (e.g. cables).’

46.

In CJ Medical’s closing argument, its case on the construction of claim 3 was put this way (counsel’s italics):

‘Claim 3 is about disclosing a flexible, deflectable tip which will enable the user (surgeon) to adjust the direction of e.g. an endoscope (instrument). A merely flexible tip (however flexible) cannot do that. The endoscope can adjust the direction of the sheath but the sheath cannot adjust that do that but not the other way around. A truly passive flexible tip (hyperflexible or otherwise) cannot “adjust” the direction of an instrument such an endoscope.

Construction Three is taught (enabled) in [0025]. Using the cable or other means along the curvature of the bend (inner curve when sheath is straight (active) and outer curvature when sheath is pre bent (passive) is clearly taught. It is these means that enable the use to adjust the direction of the sheath. The wording of the claim and the teaching are entirely consonant with each.’

47.

The emphasis here is on flexibility enabling the user to adjust direction. I agree, but not that it enables the surgeon to adjust the direction of the endoscope itself, rather the direction of suction etc. Direction of suction etc. may be assisted by the separate adjustment of the endoscope but this is not what claim 3 is concerned with. This aside, the submission seems again to be that claim 3 requires active deflection.

48.

In oral closing submissions CJ Medical’s counsel gave some attention to the part of paragraph [0025] which refers to the mode in which the tip has a memory. It is pre-bent upon insertion and then straightened using a cable or some other mechanism.

49.

The embodiment with the memory discussed in paragraph [0025] is inserted straight and if required manipulated into another shape which, unless further manipulated, it will retain. This seems to me to have nothing to do with whether the manipulation, the deflection, is active or passive.

50.

Well Lead submitted that deflection may be active or passive. According to Well Lead, passive deflection involves pressing the tip against a structure within the kidney or other part of the body so as to deflect the tip in one direction or another. In my view this construction better fits the words of the claim and the specification as a whole.

51.

Well Lead had a point on the construction of ‘flexible’. It submitted that the word should be purposively construed. The tip has to be flexible enough to be suitable for the treatment of any kidney stone a surgeon is liable to come across. This assumes that claim 3 would be understood as being directed solely to ureteroscopy and both sides appeared to take that view. Flexibility according to Well Lead means that the tip must be flexible enough so that it could potentially access any of the calyces in the kidney. This must include the calyx which is the most difficult to reach. The point can be illustrated by this diagram:

52.

The eight bulb-shaped structures in the diagram are calyces within a kidney. The tip must be flexible enough to bend into the most awkwardly placed calyx. The diagram illustrates the tip reaching the lowest calyx, which as shown is the most difficult to reach but one.

53.

There is support for this construction of ‘flexible’ in paragraph [0025] which says that the tip is deflectable to any angle desired by the user. However, claim 3 is not so specific. In my view, the tip must be flexible enough to enable the user adjust the direction of suction etc. to some significant extent, but nothing more than that.

54.

I found the evidence on deflection largely unhelpful. Mr Saeb-Parsy said in his written evidence that the tip in claim 3 can be actively or passively deflected, not on the basis of his technical knowledge, just from reading paragraph [0025] of the specification. Professor Somani in his written evidence blurred the distinction between the tip and the distal portion of the distal sheath and seemed also to blur the difference between active and passive deflection on the one hand and alternative shapes that a tip with memory may have on the other.

55.

I was referred to several passages of Professor Somani’s cross-examination which were said to support Well Lead’s construction of claim 3. I will not set them out, partly because they are long and partly because I do not find them of help on points of construction.

56.

This is from Mr Saeb-Parsy’s oral evidence to which my attention was drawn:

‘Q. If the tip was merely passive, in other words it just could flex, but there was no control means to bend it, the surgeon could not adjust the direction of the endoscope, could he, using the sheath? It would be the endoscope adjusting the direction of the sheath, not the other way round; correct?

A. Sorry, could you repeat that again?

Q. You have a passively flexible sheath; all right? Something like this, but there is no means for bending it, there is no wire or anything like that to bend it. I cannot use that by inserting, to change the direction, can I, of the endoscope. It is passive. It does nothing. It can follow the way the endoscope changes, but it cannot adjust the direction of the endoscope, can it?

Correct.’

57.

The first question may have been directed towards whether a tip that is deflected only passively would be of practical use. But the question which Mr Saeb-Parsy understood and answered was about the passive deflection of the sheath, not the tip.

58.

I am thrown back on to the words of claim 3. The user must be able to adjust the direction of suction, irrigation, etc. If it were technically possible to do this only by using active deflection, the skilled person would know that active deflection must be implied. But I was not shown any such evidence.

59.

The words of claim 3 do not specify active or passive deflection of the tip, one way or the other. I conclude that it could be either. This is consistent with the more natural reading of paragraph [0025]. The tip must be flexible enough to enable the user to adjust the direction of suction etc.