‘My name is Professor Bhaskar Somani and I’m going to share with you the advantage of using the suction ureteral access sheath and I’ve used the Seplou Access Sheath which I think is brilliant. And I think suction sheaths are quite revolutionary and will change the game of endourology.’
‘… all the inventions focus on the access and fragmentation of the stones. Extracorporeal shock wave lithotripsy uses pressure waves to crush the stone, but then requires the patient to pass the stone fragments on their own. Amplatz percutaneous nephrostomy sheaths and various ureteral sheaths allow access to the stones for lithotripsy. However, they require either the patient to pass the stone fragments on their own or to have the stone removed at the time of lithotripsy using pressure irrigation, stone basket, and/or stone forceps.’
‘While the stone retrieval devices known in the prior art performed adequately, there is significant room for improvement. The stone retrieval device disclosed below is an improvement over those known in the art.’
‘In one embodiment, the diameter of the lumen 53 of the side arm 50 is up to 20% smaller than the diameter of the lumen 33, 43 of the proximal 30 and the distal sheath 40. In another embodiment, the diameter of the lumen 53 of the side arm 50 has a diameter which is the same or up to 20% larger than the diameter of the lumen 33, 43 of the proximal 30 and the distal sheath 40. According to the present invention, the diameter of the lumen 53 of the side arm 50 is the same as the diameter of the lumen of the sheath 23, 33, 43 to facilitate the efficient evacuation of stones, stone fragments or other foreign bodies.’
‘One important feature of the current invention is a sheath 20 that has a side arm 50 that has an identical or nearly identical luminal circumference.’
‘When the stone fragments are larger, but still small enough to enter the sheath lumen 23, the endoscope can be withdrawn to a location that is just proximal to the distal end 52 of the side arm 50. … With the scope in this position, the sheath 20 and the side arm lumens now have a similar caliber channel with the side port channel equal or slightly larger than the sheath channel. The stone fragments or foreign body have an unimpeded evacuation route. This allows a continuous evacuation channel for the stone fragments to reach the collection container 80.’
‘An inconsistency between the description and the claims cannot be removed by introducing at the beginning of the description a generic statement such as "embodiments not falling under the scope of the appended claims are to be considered merely as examples suitable for understanding the invention" without indicating which parts of the description are no longer covered. To remove the inconsistency, such a statement has to refer to specific embodiments (e.g. "Embodiments X and Y are not encompassed by the wording of the claims but are considered as useful for understanding the invention"). The terms "disclosure", "example", "aspect" or similar, on their own, do not necessarily imply that what follows is not encompassed by an independent claim. Unambiguous expressions have to be adopted to mark an inconsistent embodiment (e.g. by adding "not encompassed by the wording of the claims", "not according to the claimed invention" or "outside the subject-matter of the claims") instead of merely replacing the terms "embodiment" or "invention" by one of the aforementioned terms. As long as the resulting text of the description does not present conflicting information to the reader, an inconsistent embodiment may also be remedied by ensuring that it is not referred to as being "according to the invention" throughout the description and by complementing the reference to it with an explicit statement to the effect that it is retained due to being useful for understanding the invention (e.g. "embodiment useful for understanding the invention", "comparative example from background art".’
‘The distal portion of the distal sheath can also be deflected either actively or passively’
‘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: i. 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 Somani 1 §§312-313 . 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).’
‘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.’
‘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? A. Correct.’
‘When any piece of prior art is considered for the purposes of an obviousness attack, the question asked is “what would the skilled addressee think and do on the basis of this disclosure?”’
‘Whether the suction port is linked to a source of positive pressure, negative pressure or both, the suction port may be further connected to a switch or valve that turns the pressure on and off (e.g. a trumpet valve), and/or a pressure-regulator. Examples of such control devices are described in publications such as U.S. Pat. No. 5,882,348 to Winterton et al., U.S. Pat. No. 5,938,589 to Wako et al., and U.S. Pat. No. 5,730,727 to Russo, all incorporated herein by reference.’
‘113. There are, however, a number of errors and points in the specification that the Skilled Urologist would find difficult to understand why they have been written in the way they have: (a) The most significant issue is the description of item 6 as a “stylus”. From the way that it is drawn in Figures 3 and 5, it appears to be a very large needle. I also understand from Clyde & Co that Well Lead considers that the correct translation of the Chinese words used for item 6 is “piercing needle”. However, the Skilled Urologist would be puzzled as to why a needle would be necessary. Paragraph [0004] says that an opening has already been made at the surgical site when the “stylus” is inserted. I take this to mean that the patient’s skin has been punctured. This suggests that Wan is contemplating the “stylus” being used as a needle to puncture a passageway into the organ being operated on (the kidney, gall bladder or bladder). (b) However, if item 6 is a needle, it is a very sizeable one that would only be suitable for puncturing in a straight line directly into a hollow organ making sure that there are no other structures or organs in its path that could be pierced or damaged by it. This would make even an experienced urologist very hesitant about using the device, especially in the kidney. In contrast to this, the PCNL procedure that is used in practice to get access to the kidney, involves making a small incision in the skin and passing a very small, fine needle into the kidney. A guidewire for a serial dilator or balloon dilator is then passed into the kidney. Once the urologist is happy the guidewire is in the kidney and the collecting system, the dilator is inserted following the guidewire and is used to serially dilate the hole in the kidney until it is large enough to be able to insert the access sheath (or sleeve tube as it is called in Wan). This is not, though, a procedure that the Skilled Urologist would carry out as it is a sub-specialist area of surgery (though the Skilled Urologist would be aware of it from their training). (c) For the reasons in (a) and (b), I had taken item 6 to be a form of “introducer” similar to an obturator for a UAS. (d) The procedures that Wan says its device can be used for are also somewhat puzzling. These are “percutaneous nephroscopic surgery, gall bladder-preserving surgery, and cystolithotrity in women” (paragraph [0001]). My understanding is that Wan’s device is essentially for percutaneous surgery only. As indicated above, by percutaneous nephroscopic surgery, I take Wan to mean PCNL. “Cystolithotrity” is incorrect terminology and should be “cystolithalopaxy” (the treatment of bladder stones normally via the urethra). I can see no reason why Wan says that this procedure is for women and not for men as well. The procedure is routinely used in the treatment of both men and women. But more importantly, the Skilled Urologist would not want to use a rigid (see below) access sheath with a large, sharp “stylus” in the urethra due to the risk of repeatedly puncturing the urethra’s walls. (e) In addition to the above points, “lithotrity” in paragraph [0003] should be “lithotripsy”. (f) Overall, these points and the way in which Wan is written generally suggest that it may have been drafted by a product engineer, who is not fully familiar with how urological procedures are carried out or the correct terminology to use for them rather than being written by a clinician or by a product engineer working in conjunction with a clinician.’
‘Wan does not say what materials its tubes are made of but the assumption from its specification is that they would be hard, rigid ones. This is partly from the need for Embodiment 1 to push the sleeve tube into the piercing tube during an operation (which would require rigidity of materials) and partly from the comment in paragraph [0011] on sterilisation. This is another passage that the Skilled Urologist would be puzzled by – there is no reason why having a control slit in the branch tube would assist in sterilisation – but the fact that Wan envisages its device undergoing sterilisation would suggest to the Skilled Urologist that is intended to be reusable and made of a robust material. Generally urological devices that are reusable are made of stainless steel.’
‘A trocar was a device used to create a channel into a cavity such as the abdomen to allow passage of instruments such as a laparoscope into that cavity. A trocar typically consisted of three main components: a sharp-tipped obturator, a cannula, and a valve mechanism. The obturator was a rigid, pointed instrument used for the initial puncture of the abdominal wall or hollow organ.’
‘As discussed in our opening, the answer to Pozzoli 4 depends on the correct construction of Claim 3. If either Construction One or Two is correct, the Defendant contends that both were CGK, and thus obvious over Wan. But neither party contends that these constructions are correct. If, as the Defendant asserts, Construction Three is correct (i.e. Claim 3 requires the active or passive means taught at [0025]), then the Defendant’s position is that this would not have been obvious to the Skilled Person over Wan as at the Priority Date.’
‘… optionally, an accessory side arm (60) emanating from the outer surface (34) of said sheath (20);’
‘The Skilled Person would therefore understand that the accessory side arm is a functionally distinct sub-class of the more general “one or more side arms” disclosed on page 2 of the Patent, and that the requirement that it emanates from a proximal sheath is necessary for it to perform these functions.’
‘4A. (1) A patent shall not be granted for the invention of – (a) a method of treatment of the human or animal body by way of surgery or therapy, or (b) a method of diagnosis practised on the human or animal body.’
‘European patents shall not be granted in respect of: … (c) methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods.’
‘Would such a reader of the patent have concluded that the patentee nonetheless intended that strict compliance with the literal meaning of the relevant claim(s) of the patent was an essential requirement of the invention?’
‘[456] Again, this is an instance of a principle recognised by the BGH that, where the specification discloses several ways in which a particular technical effect can be achieved but only one way is claimed, the conclusion that use of the other (disclosed but not claimed) ways to achieve the technical effect cannot amount to infringement as an equivalent extends to further undisclosed ways in which the technical effect can be achieved where the further ways operate in a manner more similar to the disclaimed than the claimed methods: see Case X ZR 69/10 – Diglyzidverbindung (Diglycid compound) at [45]-[46].’
‘In yet another embodiment, the diameter of the lumen 53 of the side arm 50 is the same or larger than the diameter of the lumen of the sheath 23, 33, 43 to facilitate the efficient evacuation of stones, stone fragments or other foreign bodies.’
‘According to the present invention, In yet another embodiment, the diameter of the lumen 53 of the side arm 50 is the same asor larger than the diameter of the lumen of the sheath 23, 33, 43 to facilitate the efficient evacuation of stones, stone fragments or other foreign bodies.’