“Firstly, the anatomy of the colon is such that the lining is thrown into folds. As the tip of the endoscope passes along the lumen of the colon, these folds hamper the endoscope’s ability to visualise the entire surface of the mucosa and in particular, detect pre-malignant and malignant lesions tucked away on the proximal face of these folds during extubation. Secondly, the position of the tip may be difficult to maintain from the moment at which a lesion or polyp is detected to the completion of any therapeutic procedure. As the colonoscope is withdrawn the tip does not travel back at a constant speed but rather with jerks and slippages particularly when traversing a bend or length of colon where the bowel has been concertinaed over the endoscope shaft during intubation. The tip of the device may, at any moment, slip backwards thereby causing the clinician to lose position. If tip position is lost, the clinician is required to relocate the lesion or polyp for the therapeutic procedure to be continued.”
“1. A cover for a colonoscope shaft, the cover comprising an elongate tubular member and being arranged for application over a distal tip of the colonoscope shaft with the cover extending along at least a part of the length of a distal end of the shaft, the tubular member comprising an inner surface at least a part of which grips the shaft and holds the cover in place and an outer surface comprising a plurality of spaced projecting elements, characterized in that the spaced projecting elements are hinged and attached to an outer surface of the elongate tubular member, each projecting element having a tip and a base, the projecting elements being moveable about their hinged bases by an angle of between 0o, wherein the tips of the projecting elements point towards a proximal end of the colonoscope, to an angle of 170-180o wherein that the tips of the projecting elements point towards the distal end of the colonoscope or any angle between 0 to 170-180o, wherein the projecting elements are positioned in one or more rings running circumferentially around the cover, and wherein projecting elements in a distal ring are adapted to flare outwards on withdrawal from the colon to keep the instrument tip in the central part of the colon as the instrument moves backwards, and to evert colonic folds enabling their proximal surfaces to be viewed.”
“1. A cover for a colonoscope shaft, the cover comprising an elongate tubular member and being arranged for application over the colonoscope shaft with the cover extending along at least a part of the length of a distal end of the shaft, the tubular member comprising an inner surface at least a part of which grips the shaft and holds the cover in place and an outer surface comprising aplurality of8 evenly spaced projecting elements having a tip and a base that are moveable between a resting position to a position wherein the tip of the projecting element is substantially parallel to a longitudinal axis of the colonoscope and to a position that is at an angle approximately perpendicular to the longitudinal axis of the colonoscope shaft so that the projecting elements are fanned out to contact with and provide support for and to dilate a lumen wall of a colon into which the colonoscope has been inserted, wherein the projecting elements are constructed of a biocompatible material so that theyare flexible and resiliently deformable and are positioned in one or moreasingle rings running circumferentially around the cover at the distal end of theelongate tubular member, and wherein the projecting elements in a distal ring are adapted to flare outwards on withdrawal from the colon to keep the instrument tip in the central part of the colon as the instrument moves backwards, and to evert colonic folds enabling their proximal surfaces to be viewed, and wherein the projecting elements are in the form of tapered bristles.” bristles.”
“[45] … I accept that as a matter of ordinary English usage, ‘adapted’ carries a connotation of adaption or modification in design to achieve the purpose stated in the feature. However in my view, like feature (i) these are to be construed such that they contain no subjective element. To my mind it is irrelevant where the designer started and what adaptations were made in the design process. [46] Because these features must be assessed objectively, it seems to me that ‘adapted to’ and ‘adapted in use to’ mean the same thing as ‘suitable for’. I am reinforced in this view by the judgment of Birss J in Schenck [Schenck Rotec GmbH v Universal Balancing Ltd[2012] EWHC 1920 (Pat) ] in which he found ‘constructed to receive’ had the same meaning as ‘suitable for receiving’. As in the present case the relevant claim was a product claim for a mechanical device: for fastening balancing weights to rotors. [47] I do not say that in the context of other claims it will never be possible to discern a difference between ‘suitable for’ on the one hand and ‘adapted to’ or ‘adapted in use to’, or ‘constructed to’ for that matter, on the other. But I think in this claim the first three mean the same thing.”
“In use, the distal row of the projecting elements are designed to flare outwards on withdrawal.”
“turn (a structure or organ) outwards or inside out.”
“ ‘Everting’, in the context of colonic mucosal folds, describes what happens when an object makes contact with the surface of the fold, and then gently moves the fold in the distal direction (i.e. towards the anus) so that the proximal side of the fold is turned into the field of vision.”
“[139] … It is not essential that an item of prior art should expressly disclose all the features of an invention for that prior art to deprive the invention of novelty. It may be that one or more integers are disclosed by inference. But this must be an inevitable inference drawn by the skilled person reading the prior art. In Smithkline Beecham Plc’s (Paroxetine Methanesulfonate) Patent[2005] UKHL 59 ;[2006] RPC 10 , Lord Hoffmann, with whom the rest of the House of Lords agreed, considered the observations of Lord Westbury L.C. in Hill v Evans (1862) 31 L.J. Ch (NS) 457 at 463 and those of the Court of Appeal in General Tire and Rubber Co v Firestone Tyre and Rubber Co Ltd [1972] R.P.C. 457, at 485-486. On the facts of Smithkline Beecham Lord Hoffmann was concerned with the knowledge of the author of the prior art, but also emphasised that if the prior art allows even for the possibility that its performance would not result in the claimed invention, it will not deprive that invention of novelty: “[22] If I may summarise the effect of these two well-known statements, the matter relied upon as prior art must disclose subjectmatter which, if performed, would necessarily result in an infringement of the patent. That may be because the prior art discloses the same invention. In that case there will be no question that performance of the earlier invention would infringe and usually it will be apparent to someone who is aware of both the prior art and the patent that it will do so. But patent infringement does not require that one should be aware that one is infringing: “whether or not a person is working [an] … invention is an objective fact independent of what he knows or thinks about what he is doing”: Merrell Dow Pharmaceuticals Inc v H N Norton & Co Ltd [1996] R.P.C. 76, 90. It follows that, whether or not it would be apparent to anyone at the time, whenever subject-matter described in the prior disclosure is capable of being performed and is such that, if performed, it must result in the patent being infringed, the disclosure condition is satisfied. The flag has been planted, even though the author or maker of the prior art was not aware that he was doing so. [23] Thus, in Merrell Dow, the ingestion of terfenadine by hay-fever sufferers, which was the subject of prior disclosure, necessarily entailed the making of the patented acid metabolite in their livers. It was therefore an anticipation of the acid metabolite, even though no one was aware that it was being made or even that it existed. But the infringement must be not merely a possible or even likely consequence of performing the invention disclosed by the prior disclosure. It must be necessarily entailed. If there is more than one possible consequence, one cannot say that performing the disclosed invention will infringe. The flag has not been planted on the patented invention, although a person performing the invention disclosed by the prior art may carry it there by accident or (if he is aware of the patented invention) by design.” “[22] If I may summarise the effect of these two well-known statements, the matter relied upon as prior art must disclose subjectmatter which, if performed, would necessarily result in an infringement of the patent. That may be because the prior art discloses the same invention. In that case there will be no question that performance of the earlier invention would infringe and usually it will be apparent to someone who is aware of both the prior art and the patent that it will do so. But patent infringement does not require that one should be aware that one is infringing: “whether or not a person is working [an] … invention is an objective fact independent of what he knows or thinks about what he is doing”: Merrell Dow Pharmaceuticals Inc v H N Norton & Co Ltd [1996] R.P.C. 76, 90. It follows that, whether or not it would be apparent to anyone at the time, whenever subject-matter described in the prior disclosure is capable of being performed and is such that, if performed, it must result in the patent being infringed, the disclosure condition is satisfied. The flag has been planted, even though the author or maker of the prior art was not aware that he was doing so. [23] Thus, in Merrell Dow, the ingestion of terfenadine by hay-fever sufferers, which was the subject of prior disclosure, necessarily entailed the making of the patented acid metabolite in their livers. It was therefore an anticipation of the acid metabolite, even though no one was aware that it was being made or even that it existed. But the infringement must be not merely a possible or even likely consequence of performing the invention disclosed by the prior disclosure. It must be necessarily entailed. If there is more than one possible consequence, one cannot say that performing the disclosed invention will infringe. The flag has not been planted on the patented invention, although a person performing the invention disclosed by the prior art may carry it there by accident or (if he is aware of the patented invention) by design.”
“[97] … Figure 6 shows the endoscope being inserted into the colon. Figure 7 shows the physician withdrawing the endoscope (in the direction of the arrow B), causing the projecting fins of the cover to engage with the colon wall, causing the walls behind the tip of the scope to concertina, and the colon itself to straighten. Figure 8 shows the result of the physician continuing to pull the endoscope back from the position in Figure 7, further concertinaing the wall behind the scope tip and straightening both the colon and the colon wall ahead. [98] The purpose of the projecting fins is to provide traction against the colon wall. The force exerted by the projecting fins on the colon wall through the physician pulling the scope backwards, causes both the walls of the colon to be drawn back (see Figure 7) and straightens the colon ahead of the scope (see Figure 8). This enables the physician to recommence intubation.”
“… and wherein projecting elements in a distal ring are adapted to flare outwards on withdrawal from the colon to keep the instrument tip in the central part of the colon as the instrument moves backwards, and to evert colonic folds enabling their proximal surfaces to be viewed.”
“The clear difference is between intubation and extubation. In intubation, you advance, deflate, advance, deflate. You suck, suck, suck because the more air you put in, the more you stretch the colon and the harder it is to get round and the more it loops. In extubation, it is very important that you inflate to stretch the lining of the colon.”
“3. Deflate the colon (without losing the view) to shorten it and make it as pliable as possible.”
“The projections which were suitable for gripping the colon wall for the purposes of concertinaing the deflated colon during the intubation phase would not be suitable for improving visualisation of the colon walls during the withdrawal phase.”
“[9] In the end the question is the simple one posed by Jacob J. (as he then was) in Richardson-Vick Inc's Patent [1995] R.P.C. 568 at p.576 (approved by him as Jacob L.J. in Vector Corp v Glatt Air Techniques Ltd[2007] EWCA Civ 805 , [2008] R.P.C. 10 at [4]): ‘I think the test of added matter is whether a skilled man would, upon looking at the amended specification, learn anything about the invention which he could not learn from the unamended specification.’” specification.’”
“… wherein the projecting elements in a distal ring are adapted to flare outwards on withdrawal from the colon to keep the instrument tip in the central part of the colon as the instrument moves backwards, and to evert colonic folds enabling their proximal surfaces to be viewed.”
“…the projecting elements being moveable about their hinged bases by (a) an angle of between 0o, wherein the tips of the projecting elements point towards a proximal end of the colonoscope, to an angle of 170-180o wherein that the tips of the projecting elements point towards the distal end of the colonoscope or (b) any angle between 0 to 170-180o, …”
“In use, the distal row of the projecting elements are designed to flare outwards on withdrawal. They keep the instrument tip in the central part of the bowel lumen as the instrument moves backwards, gently holding the mucosa to prevent the tip from flipping backwards, they maintain position during therapy and improve all-round visualisation. During extubating they evert the folds enabling their proximal surface to be viewed.”
“… in so far as similarities between the designs at issue relate to common features…, those similarities will have only minor importance in the overall impression produced by those designs on the informed user.”
“[28] As regards the degree of freedom of the designer of a design, it is apparent from the case law that that is determined, inter alia, by the constraints of the features imposed by the technical function of the product or an element thereof, or by statutory requirements applicable to the product. Those constraints result in a standardisation of certain features, which will thus be common to the designs applied to the product concerned (judgment of9 September 2011 in Kwang Yang Motor Co Ltd v Office for Harmonisation in the Internal Market (Trade Marks and Designs) (OHIM) - Honda Giken Kogyo (Internal combustion engine) (T-10/08), judgment of9 September 2011 , not yet reported, at [32], and judgment in Wristwatch case EU:T:2013:214 at [112]). [29] Therefore, the greater the designer’s freedom in developing a design, the less likely it is that minor differences between the designs at issue will be sufficient to produce different overall impressions on an informed user. Conversely, the more the designer’s freedom in developing a design is restricted, the more likely it is that minor differences between the designs at issue will be sufficient to produce different overall impressions on an informed user. Consequently, if the designer enjoys a high degree of freedom in developing a design, that reinforces the conclusion that designs that do not have significant differences produce the same overall impression on an informed user (judgments in Internal combustion engine at [33], and Wristwatch case EU:T:2013:214 at [113]). [30] In the present case, the Board of Appeal correctly found that, in the context of fashion items like handbags, the designer’s degree of freedom was high. Moreover, the applicant does not contest that assessment. However, it submits, in essence, that the Board of Appeal erred inasmuch as the ‘freedom of the designer’ test should have been an integral part of the analysis of the individual character of the contested design and that the Board of Appeal inverted the steps involved in that analysis. Accordingly, the applicant maintains that the Board of Appeal’s approach of, first, comparing the two designs at issue in order to conclude that they did not produce the same overall impression on the informed user and, secondly, examining the argument relating to the freedom of the designer, is incorrect. Furthermore, it takes the view that the differences between the designs at issue are not significant enough to produce a different overall impression on the informed user. [31] First, it must be stated that a ‘two-step test’, such as advocated by the applicant, is not required by either the applicable legislation or the case law. [32] The text of art.6 of Regulation 6/2002, concerning the assessment of individual character, lays down, in para.1 thereof, the criterion of the overall impression produced by the designs at issue and states, in para.2, that the degree of freedom of the designer must be taken into consideration for those purposes (see para.20 above). It is apparent from those provisions, and in particular from art.6(1)(b) of Regulation 6/2002, that the assessment of the individual character of a Community design is the result, in essence, of a fourstage examination. That examination consists in deciding upon, first, the sector to which the products in which the design is intended to be incorporated or to which it is intended to be applied belong; secondly, the informed user of those products in accordance with their purpose and, with reference to that informed user, the degree of awareness of the prior art and the level of attention in the comparison, direct if possible, of the designs; thirdly, the designer’s degree of freedom in developing his design; and, fourthly, the outcome of the comparison of the designs at issue, taking into account the sector in question, the designer’s degree of freedom and the overall impressions produced on the informed user by the contested design and by any earlier design which has been made available to the public (see, to that effect, judgment of7 November 2013 in Budziewska v Office for Harmonisation in the Internal Market (Trade Marks and Designs)(OHIM) - Puma (Bounding feline) (T-666/11) EU:T:2013:584 at [21] and the case law cited). [33] As is apparent from the case law and from the case law cited in [29] above and referred to by the applicant itself, the factor relating to the designer’s degree of freedom may ‘reinforce’ (or, a contrario, moderate) the conclusion as regards the overall impression produced by each design at issue. It is not apparent either from the alleged pattern which the applicant identifies in the case law or even from the extract from the judgment of the Bundesgerichtshof (Federal Court of Justice, Germany) reproduced in para.29 of the application that the assessment of the designer’s degree of freedom constitutes a preliminary and abstract step in the comparison of the overall impression produced by each design at issue.”
“[23] … according to the case-law cited in paragraph 19 above, the designer’s degree of freedom may be limited by the constraints of the features imposed by the technical function of the product or by statutory requirements applicable to the product. However, a general design trend cannot be regarded as a factor that restricts the designer’s freedom (Joined Cases T-83/11 and T-84/11 Antrax It v OHIM – THC (Radiators for heating) [2012] ECR, paragraph 95).”
“[37] In the contested decision, the Board of Appeal took account of the fact that the cushions were not a fixed element, but elements that were easily separated from the main product, and that they were often sold and purchased separately, at a relatively low cost compared to that of the structure of an armchair. It inferred therefrom that those factors decreased the importance that could be attributed to the cushions in assessing the overall impression and that the informed user would attribute far more importance to the overall impression produced by the structures of the armchairs. The Board of Appeal added that the informed user might perceive the cushions as a mere optional accessory and that they could hardly be considered to be ‘a significant part of the design’. [38] The Board of Appeal was right in taking the view that, because they are not fixed, the informed user will perceive the cushions as less important and be more sensitive to the overall structure of armchairs. It found that the overall impression produced by the designs at issue was dominated by the structure of the armchairs itself and not by the cushions, which could be regarded as secondary elements. Contrary to what the applicant claims, it is not irrelevant to assessing the individual character of the contested design that the cushions are removable elements.”
“[67] Thus a feature of the design of an article which promotes stable interaction with another article may be excluded from design protection under s.213(3)(b)(i). That need not be the only function of that article, see the passage from Ocular Sciences quoted above and Dyson Ltd v Qualtex (UK) Ltd[2006] EWCA Civ 166 ; [2006] R.P.C. 31, at [40]-[44]. [68] There will be a limit to the exclusion of design right protection under this provision. I take the view that the shapes of the relevant parts of the connecting articles must be such that there is a degree of precision in the interrelationship between one article and the other, i.e. the designs afford some precision in the fit. For example, it would be surprising if the handle of a coffee mug were refused design protection solely because it is shaped to enable a human hand to connect to it to pick up the mug. (I use the convenient term ‘fit’ but this does not imply that the articles must touch. Section 213(3)(b)(i) can apply to features of shape or configuration of an article which enable it to be placed around another article and so there may be a gap between them, see Dyson at [31]-[38]).”
“[58] In Virgin Atlantic Airways Ltd v Premium Aircraft Interiors Group Ltd[2009] EWHC 26 (Pat) ; [2009] ECDR 11, Lewison J said this: … … 33. Although, at least in theory, two separate criteria must be satisfied viz. copying and making articles exactly or substantially to the copied design, it is not easy to conceive of real facts (absent an incompetent copyist) in which a design is copied without the copy being made exactly or substantially to the copied design. In practice, if copying is established, it is highly likely that the infringing article will have been made exactly or substantially to the protected design. If copying is not established, then whether the article is the same or substantially the same as the protected design does not matter. However, similarity in design may allow an inference of copying to be drawn. [59] In this last paragraph Lewison J drew on what the House of Lords had said in Designers Guild Ltd v Russell Williams (Textiles) Ltd[2001] 1 All ER 700 ;[2001] FSR 11 . Both judgments come close to endorsing “the rough practical test that what is worth copying is prima facie worth protection” without quite going that far. This comes from the judgment of Peterson J in University of London Press Ltd v University Tutorial Press Ltd[1916] 2 Ch 601 , at 610, in the context of whether examination papers were original copyright works, though the majority in Ladbroke (Football) Ltd v William Hill (Football) Ltd[1964] 1 WLR 273 (HL) found force in Peterson J’s maxim in the context of copyright infringement (Lord Reid at 279, Lord Hodson at 288 and Lord Pearce at 294.)”
“We really cannot come out with a Endocuff clone, nor do we want to. I think that it is reasonable for us to incur the cost of three molds and the parts …”