“those likely to have a practical interest in the subject matter of [the] invention (i.e. ‘skilled in the art’)” 40. Lord Diplock went on to add to this description (at p.243): “persons with practical knowledge and experience of the kind of work in which the invention was intended to be used”
“[72] It follows that the common general knowledge is all that knowledge which is generally regarded as a good basis for further action by the bulk of those who are engaged in a particular field. It is that knowledge which those working in that field will bring to bear when they are reading or learn of a piece of prior art. It is not necessary that those persons have that knowledge in their minds, however. The common general knowledge includes material that they know exists and which they would refer to as a matter of course if they cannot remember it and which they understand is generally regarded as sufficiently reliable to use as a foundation for further work.”
“A number of technical difficulties were encountered in the early phases of percutaneous valve replacement, which to varying degrees still exists. These difficulties include optimal attachment of the valve into the stent, preservation of the function of the valve stent after compression and reexpansion, a suitable visualization method, functional anchoring mechanism, and avoidance of paravalvular regurgitation and obstruction of coronary orifices in aortic implantation.”
“We also know from clinical practice, that if you leave even a small peripheral leak, it has some very often important deleterious effect, even a rather small leak, either haemolysis or insufficiency. Knowing that you will never be able to remove all the calcium formation, then you have a high risk of having peripheral leak. How can you solve that problem?”
“More disturbingly, although it was generally believed that only moderate or severe regurgitation would impact long-term outcomes, the recently published 2-year results from the PARTNER trial showed that even mild PVL was associated with significant mortality… [footnote reference to the Kodali paper]”
“[15] We think it would unrealistic – indeed perverse – for the law to say that the notional skilled reader, probably with the benefit of skilled advice, would not know and take into account the explicit drafting conventions by which the patent and its claims were framed. Likewise when there is a reference to the patent being a divisional application, it would be perverse to work on the basis that the skilled man would not know what that means. A real skilled man reading a patent which, as in the case of the Patent, refers to ‘the parent application’ would surely say ‘what's a parent application?’ – and he would go on to ask a man who knows, probably a patent agent.”
“[48] The ‘lost space’ and the space-packing idea of using the bed to extend into it is self-evidently wholly unrelated to whether the bed flips over or not. So the skilled reader would have no reason to suppose that the patentee intended to limit his claim to flip-over bed/seats. [49] Now it is of course true that the only specific embodiment is a flip-over bed/seat. And, because that would strike the notional skilled reader as a good idea he would expect it to be patented somewhere. But because he knows (see above) that the patentee has divided out what is in this patent from a parent application he would not necessarily expect that to be done in this patent. … [54] So we think the notional skilled reader would go by the claim and not look for or expect any hidden limitations in it.”
“[0062] Figures 22-24 show another way to seal the replacement valve against leakage. A fabric seal 380 extends from the distal end of valve 20 and back proximally over anchor 30 during delivery. When deployed, as shown in figures 23 and 24, fabric seal 380 bunches up to create fabric flaps and pockets that extend into spaces formed by the native valve leaflets 382, particularly when the pockets are filled with blood in response to backflow blood pressure. This arrangement creates a seal around the replacement valve.”
“Make into a bunch or bunches; gather (material) into close folds”
“sac noun 1 BIOLOGY. A natural baglike cavity in an organism; the membrane or other structure enclosing this. 2 MEDICINE. A pouch formed by the pathological dilation or protrusion of a part; the membranous envelope of a hernia, cyst, tumour, etc.”
“[0065] Referring to Figure 14, optional elements for reducing regurgitation or leakage are described. Compliant sacs may be disposed about the exterior of anchor to provide a more efficient seal along irregular interface I. Sacs may be filled with an appropriate material, for example, water, blood, foam or a hydrogel. Alternative fill materials will be apparent. [0066] With reference to Figures 15, illustrative arrangements for sacs are provided. In Figure 15A, sacs are provided as discrete sacs at different positions along the height of anchor. In Figure 15B, the sacs are provided as continuous cylinders at various heights. In Figure 15C, a single sac is provided with a cylindrical shape that spans multiple heights. The sacs of Figure 15D are discrete, smaller and provided in larger quantities. Figure 15E provides a spiral sac. Alternative sac configurations will be apparent to those of skill in the art. [0067] With reference to Figures 16, exemplary techniques for fabricating sacs are provided. In Figure 16A, sacs comprise ‘fish-scale’ slots that may be back-filled, for example, with ambient blood passing through replacement valve. In Figure 16B, the sacs comprise pores that may be used to fill the sacs. In Figure 16C, the sacs open to lumen of anchor and are filled by blood washing past the sacs as the blood moves through apparatus.”
“The new [Sapien 3] valve has an outer skirt – a cuff of fabric surrounding the valve frame – providing a seal to address paravalvular leak. The effectiveness of this solution is supported by the limited clinical experience [reference to papers published in medical journals] as detailed in two first in-human feasibility studies, which demonstrated that significant paravalvular leak was eliminated during transcatheter aortic valve implantation (TAVI)”
“In order to anticipate a patent, the prior art must disclose the claimed invention and (together with the common general knowledge) enable the ordinary skilled person to perform it: Synthon BV v Smithkline Beecham Plc [2006] R.P.C. 10.”
“[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.”
“The valvular structure of the invention, as shown in the illustrated example, includes advantageously a third part, i.e., the internal cover to be fixed on the internal wall of the frame. This internal cover prevents any passage of blood through the spaces between the bars of the frame in case the implantable valve would be positioned with the fastening line of the valvular structure on the frame not exactly on the remains of the dilated aortic valve, i.e., either above or below. It also strengthens the fastening of the valvular structure to the frame.”
“In other aspects, to prevent any regurgitation of blood from the aorta towards the left ventricle during diastole, the base of the valvular structure is preferably positioned exactly at the level of the aortic annulus against the remains of distorted stenosed valve pushed apart by the inflated balloon. Therefore, there is no possibility of blood passage through the spaces between the metallic frame bars below the attachment of the valvular structure. However, to avoid any risk of leaks, the part of the frame below the fastening of the valvular structure (about 3 to 5 mm) is preferably covered by an internal cover which is preferably made with the same tissue as the valvular structure. Thus, there would be no regurgitation of blood which is a possibility when there is any space between the valvular structure fastened on the metallic frame and the line of application of the frame on the aortic annulus. The internal cover makes a sort of ‘sleeve’ below the fastening of the valvular structure on the internal surface of the frame, covering the spaces between the frame bars of the frame at this level, thus preventing any regurgitation of blood through these spaces.”
“At Figure 6d, the internal cover 19 is extended at its lower end 19' to an external cover 19" which is rolled up to be applied on the external wall 25 of the stent 10. The internal and external cover are molded, glued or soldered to the bars of the stent 10.”
“The cuff portion of the valve means is attached to the stent member and may extend partly or wholly around the outer perimeter of the stent member. In some of the preferred embodiments of the artificial heart valve of the invention, the cuff portion of the valve means extends on only one side of the circular portion of the stent member.”
“wherein the cuff portion is configured to position the valve snugly and sealingly at a valve site;”
“The primary evidence will be that of properly qualified expert witnesses who will say whether or not in their opinions the relevant step would have been obvious to a skilled man having regard to the state of the art. All other evidence is secondary to that primary evidence.”
“Secondary evidence of this type has its place and the importance, or weight, to be attached to it will vary from case to case. However, such evidence must be kept firmly in its place. It must not be permitted, by reason of its volume and complexity, to obscure the fact that it is no more than an aid in assessing the primary evidence.”
“In the final assessment of a finely balanced argument on obviousness, it is possible that the balance will be tilted in favour of the patent if it is established that many were trying and failing: but this sort of consideration is secondary, and will draw attention away from the main question, which is what is obvious to the skilled person in the light of each cited document, taken separately and interpreted through the eyes of the skilled person. In the usual case, I think, the fact that some investigators tried and failed to solve the problem allegedly solved by the patent is irrelevant to the question with which I am confronted, unless it can be shown that those who failed were aware of the publication under consideration, and the fact of failure will therefore have the strongest effect when the common general knowledge alone is relied on, although even then it must be shown that those who tried and failed were possessed of the common general knowledge and were not the victims of idiosyncratic prejudice or ignorance.”
“[77] It generally only comes into play when one is considering the question ‘if it was obvious, why was it not done before?’ That question itself can have many answers showing it was nothing to do with the invention, for instance that the prior art said to make the invention obvious was only published shortly before the date of the patent, or that the practical implementation of the patent required other technical developments. But once all other reasons have been discounted and the problem is shown to have been long-standing and solved by the invention, secondary evidence can and often does, play an important role. If a useful development was, in hindsight, seemingly obvious for years and the apparently straightforward technical step from the prior art simply was not taken, then there is likely to have been an invention.”
“[81] Another important matter to consider is the reaction of experts at the time of the invention, both before and after. Aldous J. put it this way in Chiron Corp v Organon Teknika Ltd (No. 3) [1994] F.S.R. 202 at 223: “…it will be necessary to go back to November, 1987 [the priority date] and try to understand the attitudes and thinking of those in the art at the time. That can best be achieved by looking at what was happening and the attitudes of those concerned in the field in the 1980s. Such evidence does, I believe, enable me to decide whether the opinions of the witnesses are consistent with the facts or hindsight reconstructions of the type which are not persuasive.” [82] Whitford J. put it similarly in Joseph Lucas (Batteries) Ltd v Gaedor Ltd [1978] R.P.C. 297, at p.358, lines 7–9: “…the question of obviousness is probably best tested, if this be possible, by the guidance given by contemporaneous events.” “…it will be necessary to go back to November, 1987 [the priority date] and try to understand the attitudes and thinking of those in the art at the time. That can best be achieved by looking at what was happening and the attitudes of those concerned in the field in the 1980s. Such evidence does, I believe, enable me to decide whether the opinions of the witnesses are consistent with the facts or hindsight reconstructions of the type which are not persuasive.” “…the question of obviousness is probably best tested, if this be possible, by the guidance given by contemporaneous events.”
“[85] It would be wrong to read this decision as saying that secondary evidence is always of minor importance. That would be to throw away a vast mass of jurisprudence, including many House of Lords cases, (e.g. Vickers, Sons & Co v Siddell and Technograph). It would indeed involve disregarding some of the approach actually used in Mölnlycke.”
“The question ‘if it was obvious why was it not done before?’ can play an important role in the overall assessment of obviousness. However, there may be many answers to that question showing that it was nothing to do with the invention, for example because practical implementation of the patent required other technical developments.”
“While particular variations of the seal member of the present invention are herein described such as in FIGS. 1 and 2, it is to be further appreciated by one of ordinary skill that other seal member variations may be secured to outer surfaces of implantable endovascular medical devices without departing from the scope of the invention. For example, a thrombogenic material such as collagen or Dacron fibers may be secured to an outer surface of an implantable endolumenal medical device and suitably occlude flow around that device for a particular medical application. However, clinical limitations, such as profile, lubricity, traumaticity, or toxicity may dictate the utility of a particular seal member when it is intended to be combined with a tubular member which is designed for a particular application.”
“Advantageously, the axial valve support portion includes, at its outer face, sealing means configured so as to absorb the surface irregularities that may exist at or near the remaining cardiac annulus.”
“This strip 8 defines a chamber and has a radially expandable structure, such that it has, in cross-section and in the inflated state, two widened ends protruding on either side of the strip 6. This chamber can receive an inflating fluid able to congeal within a predetermined length of time after insertion into said chamber. Once this material is congealed, the inflating catheter is sectioned.”
“[56] Turning to intermediate generalisation, this occurs when a feature is taken from a specific embodiment, stripped of its context and then introduced into the claim in circumstances where it would not be apparent to the skilled person that it has any general applicability to the invention. [57] Particular care must be taken when a claim is restricted to some but not all of the features of a preferred embodiment, as the TBA explained in decision T 0025/03 at point 3.3: “According to the established case law of the boards of appeal, if a claim is restricted to a preferred embodiment, it is normally not admissible under Art.123(2) EPC to extract isolated features from a set of features which have originally been disclosed in combination for that embodiment. Such kind of amendment would only be justified in the absence of any clearly recognisable functional or structural relationship among said features (see e.g. T 1067/97, point 2.1.3).” [58] So also, in decision T 0284/94, Neopost/Thermal Printing Mechanism [2000] E.P.O.R. 24, the TBA explained at points 2.1.3-2.1.5 that a careful examination is necessary to establish whether the incorporation into a claim of isolated technical features, having a literal basis of disclosure but in a specific technical context, results in a combination of technical features which is clearly derivable from the application as filed, and the technical function of which contributes to the solution of a recognisable problem. Moreover, it must be clear beyond doubt that the subject matter of the amended claim provides a complete solution to a technical problem unambiguously recognisable from the application. [59] It follows that it is not permissible to introduce into a claim a feature taken from a specific embodiment unless the skilled person would understand that the other features of the embodiment are not necessary to carry out the claimed invention. Put another way, it must be apparent to the skilled person that the selected feature is generally applicable to the claimed invention absent the other features of that embodiment. [60] Ultimately the key question is once again whether the amendment presents the skilled person with new information about the invention which is not directly and unambiguously apparent from the original disclosure. If it does then the amendment is not permissible.” “According to the established case law of the boards of appeal, if a claim is restricted to a preferred embodiment, it is normally not admissible under Art.123(2) EPC to extract isolated features from a set of features which have originally been disclosed in combination for that embodiment. Such kind of amendment would only be justified in the absence of any clearly recognisable functional or structural relationship among said features (see e.g. T 1067/97, point 2.1.3).”
“[28] The passage on p.4 of the application is, to my mind, a clear disclosure of a class of configurations of PSB which are in fact asymmetric about a lateral axis. The teaching of the document is that the PSB follows the outer lateral edge of the limb and turns around the corner to follow the leading or trailing edge as appropriate. The application thus contains a clear and unambiguous disclosure of a class of PSBs which would fall within claim 1 of the granted patent because they would necessarily possess all the features of that claim, including feature (6). [29] Is the patent nevertheless bad for added matter because it claims a wider class of asymmetric PSBs than are disclosed in the application? The judge thought it did because it claimed all asymmetric PSBs and not just hockey stick shaped ones. Whether he was right depends on an analysis of the extent to which it is legitimate to add features to a claim which describe the invention in more general terms than a specific embodiment. [30] There is no doubt that the claims of the patent form part of the disclosure for the purposes of assessing whether there is added matter. However the claims perform a different function from the disclosure in the body of the specification. The primary function of the claims is to delimit the area of the patentee's monopoly. Thus in Texas Iron Works Inc's Patent [2000] R.P.C. 207 the patentee had disclosed ‘slips and cones’ which acted as hanger units in an oil well hanger. In the granted patent the patentee coined the phrase ‘liner hanger unit’ to define his monopoly, although the phrase was apt to cover units other than slips and cones. Aldous LJ. (with whom Simon Brown and Mantell LJJ. agreed) said this at p.245: “ … the purpose of the claims in a patent is the identification of the ambit of the protection and disclosures are normally a matter for the specification. The application before the amendment clearly and ambiguously disclosed slips and cones which acted as hanger units. The amendment did not alter that disclosure. By using the phrase “liner hanger unit” in the claim the patentee did not disclose any other construction of liner hanger: the term was used to widen the ambit of the monopoly.” [31] In AC. Edwards Ltd v Acme Signs & Displays Ltd [1992] R.P.C. 131 it was argued that three features of a claim of the granted patent were stated in more general terms than the disclosure of the specific embodiment. Thus, for example, the application disclosed the use of a coil spring and cotter arrangement as a retaining means, but the relevant added feature simply specified a ‘spring means’ Fox LJ. (with whom Staughton LJ. and Sir Michael Kerr agreed) concluded that this did not add matter. Fox LJ. said: “ … claims, as a source of disclosure, have no greater force than the other admissible documents … Mr Whittle is, I think, correct when he says that the claim covers those matters because the patentee chose to limit its claim by reference to features other than the three in question. In practical terms I do not think there is anything very surprising about that result since the purpose of the claims is the identification of the ambit of protection. Disclosures are normally a matter for the specification. One looks, no doubt, at the whole of the issued patent specification in determining what it discloses, but even so, I find no disclosure in claim 1.” [32] In Decision T 0653/03, Toyota Jidosha KK,8 April 2005 (unreported), the Technical Board of Appeal of the European Patent Office concluded that the replacement of the term ‘diesel engine’ by the term ‘combustion engine’ in a claim to a method of purifying exhaust gas constituted added matter. The Board concluded that the disclosure of the granted patent would be understood to mean that the method of the invention was suitable for any type of engine, not merely diesel engines, and that such a teaching could not be derived from the application as filed. [33] It is clear from these decisions that the law does not prohibit the addition of claim features which state in more general terms that which is described in the specification. What the law prohibits is the disclosure of new information about the invention. In the Toyota case there was such a disclosure of new information, namely the new information that the invention was suitable for engines other than diesel engines. However in Texas Iron Works and A. C. Edwards the specification and claims when read together did not disclose any new technical information, despite the generalisation involved in the added claim feature.” “ … the purpose of the claims in a patent is the identification of the ambit of the protection and disclosures are normally a matter for the specification. The application before the amendment clearly and ambiguously disclosed slips and cones which acted as hanger units. The amendment did not alter that disclosure. By using the phrase “liner hanger unit” in the claim the patentee did not disclose any other construction of liner hanger: the term was used to widen the ambit of the monopoly.” “ … claims, as a source of disclosure, have no greater force than the other admissible documents … Mr Whittle is, I think, correct when he says that the claim covers those matters because the patentee chose to limit its claim by reference to features other than the three in question. In practical terms I do not think there is anything very surprising about that result since the purpose of the claims is the identification of the ambit of protection. Disclosures are normally a matter for the specification. One looks, no doubt, at the whole of the issued patent specification in determining what it discloses, but even so, I find no disclosure in claim 1.”
“In T 653/03, the original term ‘diesel engine’ in claim 1 was replaced by the term ‘combustion engine’. Thus the suitability of the claimed method was generalised to any type of combustion engine. The board decided that the treatment of exhaust gas in the original application was always related to a diesel engine, and it could not be inferred by the skilled person that the subject-matter of the granted patent extended to a method which was suitable for any type of combustion engine. The technical contribution was that the amended method was suitable for any type of combustion engine, whereas in the original form it was suitable only for a diesel engine. The generalisation was not admissible.”
“[40] In my judgment, the judge's conclusion on this issue was wrong. Having correctly concluded that the description in the application of the hockey stick shaped PSBs was of something ‘necessarily asymmetrical’ he should have gone on to ask himself whether there was any added disclosure in the granted specification. The description of the PSBs in claim 1 as ‘asymmetric’ has to be read as part of the disclosure of the specification of the granted patent as a whole, taking account of the different function of the claims and the specification. When this is done the skilled person would understand that the patentee has drafted his claim so that it covers asymmetric PSBs generally. However I am not persuaded that the specification read as a whole discloses any configuration of PSB which is not disclosed in the application. The skilled person would understand from the granted patent, just as in the case of the application, that the PSBs disclosed include those which follow a lateral and leading edge (and therefore are asymmetrical about the lateral axis). The skilled person would also understand that the PSBs are exemplified by the hockey stick shapes described in the specific embodiments. He or she would not, therefore, learn any new information about the invention.”
“Figures 32-34 show another way to seal the replacement valve against leakage. A fabric seal extends from the distal end of the valve and back proximally over anchor during delivery. When deployed, as shown in Figures 33 and 34, fabric seal bunches up to create fabric flaps and pockets that extend into spaces formed by the native valve leaflets, particularly when the pockets are filled with blood in response to backflow blood pressure. This arrangement creates a seal around the replacement valve.”