Priority date - external fair basis
78 It is appropriate to proceed, as submitted by Multigate, by determining first the correct priority date before turning to the challenges to the validity of the claims in the patents. The priority dates for each of the two patents are to be determined under ss 43 and 79B of the Patents Act 1990 (Cth) and reg 3.12 of the Patents Regulations 1991 as they were in force before 15 April 2013. Section 43 relevantly provided (before it was amended with effect from 15 April 2013):
43 Priority Dates
(1) Each claim of a specification must have a priority date.
(2) The priority date of claim is:
(a) the date of filing of the specification; or
(b) where the regulations provide for the determination of a different date as the priority date - the date determined under the regulations.
(3) Where a claim defines more than one form of an invention, then, for the purposes of determining the priority date of the claim, it must be treated as if it were a separate claim for each form of the invention that is defined.
(4) The priority date of a claim of a specification may be different from the priority date of any other claim of the specification.
Section 79B relevantly provided:
79B Divisional applications prior to grant of patent
(1) If a complete patent application for a patent is made (but has not lapsed or been refused or withdrawn), the applicant may, in accordance with the regulations, make a further complete application for a patent for an invention:
(a) disclosed in the specification filed in respect of the first-mentioned application; and
(b) where the first-mentioned application is for a standard patent and at least 3 months have elapsed since the publication of a notice of acceptance of the relevant patent request and specification in the Official Journal - falling within the scope of the claims of the accepted specification.
Regulation 3.12 relevantly provided:
3.12 Priority dates generally
(1) Subject to regulations 3.13 and 3.14 and sub-regulation (2) the priority date of a claim of a specification is the earliest of the following dates:
(a) The date of filing of the specification;
(b) If the claim is fairly based on matters disclosed in one or more relevant applications - the date of making the relevant application in which the matter was first disclosed; […]
(c) If the specification is a complete specification filed in respect of a divisional application under s 79B of the Act and the claim is fairly based on matter disclosed in the specification referred to in paragraph 79B(1)(a) of the Act - the date mentioned in sub-regulation (2C).
(2) For the purposes of sub-paragraph (1)(b), "relevant application" means:
[…]
(b) the application that relates to the specification containing the claim is a Convention application, a document of any of the following kinds is a priority document:
(i) a basic application that is related to the Convention application;
(ii) a specification, or another document filed in respect of or at the same time, as, a basic application that is related to that Convention application; or
(iii) a specification in respect of a basic application that is related to that Convention application, being a specification that was filed after the basic application was made;
[…]
(2C) The date for a specification to which paragraph 3.12(1)(c) applies is the date that would have been the priority date of the claim if it had been included in the specification referred to in paragraph 79B(1)(a) of the Act.
The effect of these provisions upon the claimed priority date of the two patents in suit depends upon determining whether the claims in each of them is "fairly based on matter disclosed" in the specification of an ancestor parent. The claim will have the priority date to which it would have been entitled in each of the patents if the claim was fairly based on matter disclosed in its parent application. The priority date inherited from the parent in turn depends upon whether the claim was fairly based on the specification filed in respect of the grandparent application, because regulation 3.12(2C) requires consideration of what "would have been the priority date of the claim if it had been included in the specification referred to" in s 79B(1)(a). It is common ground between the parties that this process was to be repeated in respect of each of the preceding ancestral claims in turn to the original ancestor: see Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth [2011] FCAFC 132 ('Sigma Pharmaceuticals'), [83] and [151]. In that process the parties were also in agreement that the specifications in the alleged parent and the alleged grandparent were relevantly the same. Accordingly, each claim of the relevant patent is to be assessed as if it were a claim, first of the alleged parent and alleged grandparent, then of the alleged great grandparent, then of the alleged original ancestor.
79 The parties disagreed about whether there was a difference between the concept of "external fair basis" arising from the requirement in reg 3.12(c) that the claim be "fairly based on matter disclosed" in the specification of the ancestor, and the concept of "internal fair basis" arising under s 40(3). Multigate contended that the effect of reg 3.12(2C) was to make clear that reg 3.12(1)(c) did not create a different test as between external and internal fair basis by providing that the date for a specification under reg 3.12(1)(c) is the date that would have been the priority date "if it had been included" in the specification referred to in s 79(B)(1)(a). The parties agreed, however, that whether a claim is "fairly based on matter disclosed" depends upon whether there was "a real and reasonably clear disclosure" in the ancestor. In Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (2004) 217 CLR 274 the Court said in a joint judgment, albeit in respect of the approach required by s 40(3), at 300-1 [68]-[69]:
68 Erroneous principles. The comparison which s 40(3) calls for is not analogous to that between a claim and an alleged anticipation or infringement. It is wrong to employ ''an over meticulous verbal analysis''. It is wrong to seek to isolate in the body of the specification ''essential integers'' or ''essential features'' of an alleged invention and to ask whether they correspond with the essential integers of the claim in question.
69 ''Real and reasonably clear disclosure''. Section 40(3) requires, in Fullagar J's words, ''a real and reasonably clear disclosure''. But those words, when used in connection with s 40(3), do not limit disclosures to preferred embodiments.
"The circumstance that something is a requirement for the best method of performing an invention does not make it necessarily a requirement for all claims; likewise, the circumstance that material is part of the description of the invention does not mean that it must be included as an integer of each claim. Rather, the question is whether there is a real and reasonably clear disclosure in the body of the specification of what is then claimed, so that the alleged invention as claimed is broadly, that is to say in a general sense, described in the body of the specification."
Fullagar J's phrase serves the function of compelling attention to the construction of the specification as a whole, putting aside particular parts which, although in isolation they might appear to point against the ''real'' disclosure, are in truth only loose or stray remarks.
[Footnotes omitted.]
The test of real and reasonably clear disclosure thus requires attention not to whether a subsequent claim had previously been made but whether in the body of an earlier specification there had been a real and reasonably clear disclosure of a claim which was made subsequently. The description in the earlier specification must be of the alleged invention in a broad sense. It would be senseless, as was explained by Fullagar J in SociÉtÉ des Usines Chimiques RhÔne-Poulenc v Commissioner of Patents (1958) 100 CLR 5, at 11, for the requirement of "fair dealing" to be satisfied only if the subject matter of a subsequent claim had actually been claimed in the earlier specification. A real and reasonably clear disclosure in the specifications need not be made only in the verbal description, but may be made in the accompanying drawings (CCOM Pty Ltd v Jiejing Pty Ltd (1994) 51 FCR 260, 280; Leonardis v Sartas No 1 Pty Ltd (1996) 67 FCR 126, 137) and need not be disclosed "as part of the invention" (RGC Mineral Sands Pty Ltd v Wimmera Industrial Minerals Pty Ltd (1998) 89 FCR 458, 467-8). The task of determining whether there has been real and reasonably clear disclosure is not to be undertaken with an over-meticulous verbal analysis but as an enquiry to determine whether a subsequent claim "travels beyond the matter disclosed in the specification": Olin Corporation v Super Cartridge Co Pty Ltd (1997) 180 CLR 236, 240; approved in Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd (2001) 207 CLR 1, at 12 [15] and in Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (2004) 217 CLR 274, at 296 [57].
80 Multigate submitted that each of the patents in suit, and each of the intervening antecedents claimed to descend from the original ancestor, sought to distance itself from the invention of the original ancestor and, therefore, that by "their very words, each of the specifications disclaimed the claim to priority through to the original ancestor". In that context Multigate relied upon the observation in Sigma Pharmaceuticals at [66] that:
… a patentee cannot set forth one basis for and description of the invention to obtain an early priority date and then change the basis and the characterisation and description of the invention while keeping the same early priority date.
In Multigate's submission what was described in the observation in Sigma Pharmaceuticals was "the very thing" that had occurred in the present case. Multigate's analysis of the specifications in the successive generation of patents is that they began with a statement of a problem with the prior art which, in each case, was said to be followed by each subsequent antecedent claim seeking "to distance itself from the invention of the original ancestor". This, Multigate submitted, was to be seen as each "of the specifications [disclaiming] the claim to priority through to the original ancestor".
81 The specifications in each of the patents in suit, and each of the successive antecedents, began by identifying the same problem in the same terms. In each case the problem was identified as, in effect, the danger to health care workers from accidental needle sticks. The original ancestor identified the background of the invention stating:
The problem is that immediately after the withdrawal of the needle from the patient's vein, the health care worker who is, at this time, involved in at least two urgent procedures must place the exposed needle tip at a nearby location and address the tasks required to accomplish the needle withdrawal. It is at this juncture that the exposed needle tip creates a danger of an accidental needle stick occurring, which under the circumstances, leaves the health care worker vulnerable to the transmission of various, dangerous blood-borne pathogens, including AIDS and hepatitis.
This danger to the health care worker from accidental needle sticks has caused an impetus for the development of a safer IV catheter in which the occurrence of such accidental needle sticks is prevented. Safety catheters that have been developed to achieve this result are disclosed…
The prior art safety catheters all exhibit one or more drawbacks that have thus far limited their usefulness and full acceptance by health-care workers. For example, in the safety catheter disclosed in the Lemieux patent, the force required to engage the needle slot within the guard flange is relatively great and would interfere with the removal of the needle.
Each of the patents in suit, and each of the intervening descendants, referred to the intravenous catheter device disclosed in the original ancestor and each case identified some difference between the earlier claim and the new claim made in the new application. Thus, for example, the 327 Patent relevantly said:
A safety intravenous catheter device is disclosed in [the original ancestor] by the present applicant. […] In the case of the known catheter device the projection, with which the needle protecting means lockingly engages, is configured as a retaining protrusion moulded to the inner wall of the catheter hub, or a retaining groove.
A catheter device of this type protecting means poses the problem that the needle protecting means must be fastened to the catheter hub with a bend or an elbow of the needle protecting means having to be moved over the projection of the inner side of the catheter hub, such that a reliable support of the needle protecting means in the hollow space of the catheter hub is ensured.
It is an object of the present invention to provide an intravenous catheter device comprising a needle protecting means where fastening of the needle protecting means in the catheter hub is facilitated.
The identification of the original ancestor in this way and the description of how the invention in the patent application is different from a predecessor patent does not mean that the subsequent patent was not based on matter fairly disclosed by the antecedent specification. The question required to be answered by the legislation is not determined by a characterisation of the words in a patent as an attempt in a subsequent document to seek to distance itself from the invention in the preceding patent.
82 The question of what has been disclosed by prior specifications may need to be answered by considering the effect of combined specifications provided that one has unequivocally and plainly demonstrated the incorporation of the other. In Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513 Lockhart J said at 517:
The invention must appear in a single disclosure, so it is not permissible to make a pattern or mosaic of or to read together various pieces of prior art in different patents. It is, however, permissible to refer not only to the patent relied on as the source of disclosure but to another patent or other patents incorporated by reference provided that it is plain that the incorporation by reference unequivocally and plainly demonstrates that the draftsman has adopted the cross-referencing system solely as a shorthand means of incorporating a writing disclosing the invention …
In Leonardis v Sartas No 1 Pty Ltd (1996) 67 FCR 126 ('Leonardis') the Full Court at 138 described as "unquestionably correct" the view of the learned trial judge that two provisional applications had been effectively linked together by words of incorporation. The language in the second provisional specification linking the former was a reference to the previous specification followed by a general description of the invention in the first specification: see also Re Imperial Chemical Industries Ltd (Clark's) Application [1969] RPC 574, 584 ('ICI'); Danisco A/S v Novozymes A/S (No 2) (2011) 91 IPR 209, [363]-[365]; Merck & Co Inc v Arrow Pharmaceuticals Ltd (2006) 154 FCR 31, [27].
83 Each of the two patents in suit specifically referred to the disclosure both in the parent and in their common original ancestor. Each specification stated:
The disclosure of the complete specification of Australian Patent Number 2009233612 as originally filed is incorporated herein by reference.
[…]
A safety intravenous catheter device is disclosed in International Application WO 99/08 742 by the present applicant.
Each of the parent and grandparent of the patents in suit contained further reference to the original ancestor. In these circumstances, and in light of the authorities, it is sufficient to conclude that the disclosure in the patents in suit included that which was disclosed in the parents and in the original ancestor. Multigate submitted that it required an "extremely inventive person" to have "the inventive inquisitiveness to obtain" a copy of the original ancestor to determine what had been disclosed. The evidence of both Dr Haindl and Dr Esnouf is that a skilled addressee reading the patent, the parent or the grandparent would have formed the view that the original ancestor needed to be taken into account in determining what had been disclosed. Both Dr Haindl and Dr Esnouf considered it important to have reviewed all of the figures in the original ancestors to determine what had been disclosed. The patents themselves disclosed the original ancestor by specific reference to the ancestors and, therefore, disclosed the earlier specifications. I accept the evidence of Dr Haindl and Dr Esnouf that the skilled addressee would therefore have had regard to the original ancestor and to the drawings to determine what had been disclosed.
84 Multigate contended that the invention disclosed by the alleged parent had, as a necessary feature, a needle guard having two resilient arms, each joined at a proximal end to the rear wall, and crossing in a distal direction, and with a guard wall at the distal end of each resilient arm. It submitted that, read as a whole, there was "no real and reasonably clear disclosure in the alleged parent of a catheter having a needle guard that does not have two resilient arms crossing in a distal direction, with a guard wall at the distal end of each arm". These submissions relied upon the evidence of Mr Bennett who considered there to be four necessary features of the invention disclosed in the alleged grandparent namely: (a) a needle guard having a rear (proximal) wall; (b) a needle guard having two resilient arms each joined at the proximal end to the rear wall, and crossing in a distal direction; (c) a guard wall being at the distal end of each resilient arm, the guard walls abutting a needle shaft in a ready position and located in front of a needle tip in a blocking position, and (d) an enlarged needle shaft portion retaining the needle guard on the needle in the blocking position. On that basis, Mr Bennett concluded that what had been disclosed was an invention which required "a needle guard with a particular configuration", which the two patents in suit did not require. Neither of the patents in suit required the needle guard to have two resilient arms crossing in a distal direction with a guard wall at the distal end of the arm. The 327 Patent required only that the needle guard have a resilient portion which is movable to the blocking position and which blocks the needle tip. Claim 1 of the 577 Patent requires that the needle guard be a resilient spring clip needle guard having a distal end wall and claim 6, which introduced the requirement that the needle guard have two arms, did not require that the arms cross.
85 The invention disclosed in the original ancestor was said to relate generally to intravenous catheters and in particular "to a safety IV catheter in which the needle tip is automatically covered after needle withdrawal to prevent the health-care worker from making accidental contact with the needle tip". The invention was summarised as having four objects, and the specification set out a number of embodiments. At page 15 of the specification of the original ancestor there is described an embodiment depicted in figures 7A to C which are described in the embodiment as differing from the previously described embodiments "primarily with regard to the construction and operation of the spring clip needle guard 96". It is in that context that the description of the embodiments, and the diagrams showing them, disclosed the matters claimed in the subsequent patents including the great grandparent, the grandparent, the parent and each of the 327 and 577 Patents. The specification in the original ancestor relevantly provided:
As shown in Fig. 7A, spring clip needle guard 96, when in the ready position illustrated therein, is inserted within catheter hub 26 so as to allow the needle 16 to pass through opening 58 and slot 100. As in the previously described embodiments, the curved end 104 abuts against the inner upper wall of the catheter hub 26 at point b, and curved section 110 seats within the mating groove 48 at point a formed in the lower, inner wall of the catheter hub. In addition, the lower curved section 108 contacts at a point f the lower, inner wall of the catheter hub 26 at a location proximal to point b.
In operation, the needle is initially withdrawn into the catheter hub until it reaches the tab engaged position illustrated in Fig. 7B, in which is therein shown, the locking tab 118 is received within the needle groove or slot 60. At this point, the spring clip remains in contact with the inner wall of the catheter hub at points a, b and f while the needle tip 18 engages curved end 114, thereby to urge section 110 into groove 48 at point c. The relative position of point f with respect to point b prevents the needle and clip from being prematurely released from the catheter hub by preventing the distal end of the clip from tipping upwards and the proximal end from slipping downward with the clip in the tab engaged position in Fig. 7B.
As the needle is withdrawn further away from the patient, as shown in Fig. 7C, the needle tip passes beyond curved end 114, thereby releasing the downward force that had been previously exerted on curved end 114 by the needle.
This sudden release of the downward force on the spring clip end causes the distal end of the spring clip 96 to pivot upward so that distal end 112 of spring clip 96 moves rapidly to a position in which it prevents or blocks motion of the needle in the distal direction. The spring clip 96 is retained on the needle 16 and will be removed from the catheter hub 26 when the needle is completely removed. Movement of the spring clip 96 from its protecting or retracted position shown in fig 7C is further prevented by the insertion of the locking in tab 118 into the needle groove 60 which prevents the spring clip from rotating around the periphery of the needle. This, in turn, secures the spring clip on the needle even if the clip were subjected to a twisting and pulling force.
The specification continued by describing the use of a locking tab inserted into a needle groove. This integer is described in the specification by specific reference to the catheter illustrated in figures 7D and 7E:
The safety IV catheter illustrated in fig 7D and 7E is the same as that illustrated in fig 7A and 7B except that the slot 60 in the needle shaft in the latter is replaced in the former by a bulge 61 whose diameter is greater than that of opening 58 in vertical arm 54. If an attempt is made to move the protected needle illustrated in fig 7D in the rearward or proximal direction, bulge 61 would engage with wall 54 and will not be able to pass through opening 58, so as to prevent any further proximal movement of the needle and removal of the needle from the needle guard, as desired.
The parent and grandparent to the patents in suit referred to the original ancestor and at page 5 specifically referred to the configuration of the needle protecting means being different. The parent and grandparent relevantly stated:
On the needle point 18 a needle protecting means 120 is provided which is configured generally in the same way as a needle protecting means shown and described in figs 10A, 10B and 11 of WO99/08 742. However, a needle protecting means may also be of different configuration and numerous configurations are suggested by the prior art. In particular the needle protecting means need not comprise any clamping means for clamping the needle in the locked position.
These words, consistent with the evidence of Dr Haindl to the same effect, making reference to the original ancestor and to the parent and grandparent of the patents in suit, meant that the needle guard disclosed in the parent and grandparent was not limited to one having precisely the same configuration as shown in the figures of the parent and grandparent. The configuration disclosed by these references, consistently with the view expressed by Dr Haindl, was that the needle guard could be as shown in the original ancestor. A skilled addressee referring to the original ancestor, including the figures in the original ancestor, would have seen configurations which do not have two arms or two arms crossing each other. However, neither claim of the 577 Patent nor claim of the 327 Patent requires the resilient needle guards to have two arms. The figures in the parent and grandparent showed a needle guard having two arms but the disclosure by incorporation was broader and the terms of the claims in the patents in suit was not limited to a configuration with two arms or two arms crossing. Claim 6 of the 577 Patent added such a limitation to claim 1 but the claim was not so limited.
86 On a fair reading of the parent, features of claim 1 in each of the 327 and 577 Patents were disclosed in the parent, including, by incorporation, the disclosure in the original ancestor. The invention in each of the two claims involved a safety IV catheter with a resilient needle guard where the resilience affects how the needle guard is securely held in the catheter hub, how the needle guard moves to block the needle tip, and how the needle guard remains in a position which blocks the needle tip once the needle is fully retracted from the catheter hub. The disclosure in the parent, grandparent and original ancestor was not limited to a needle guard having crossing arms but, as shown in a number of the figures in the original ancestor, included configurations with only one arm moving to block the tip of the needle when retracted. It follows that the 327 and 577 Patents are entitled to the priority date from at least the parent and grandparent.
87 Multigate next contended that the claims in suit could not have the priority date of the alleged great grandparent because an essential parameter of the invention disclosed in the great grandparent had been omitted from the claims in suit. Mr Bennett's evidence had been that the invention claimed in each of the claims in suit were substantially different from the matter disclosed in the alleged great grandparent because it required "the catheter hub to have a projection with a generally annular configuration", but, as was contended, the claims of the patents in suit did not.
88 The great grandparent, like the parent and grandparent to the claims in suit, referred to the original ancestor. The skilled addressee was, therefore, alerted to the original ancestor to understand what the patentee was disclosing. The specification to the great grandparent stated that the invention related to an intravenous catheter device and went on to state:
An intravenous catheter device, on which the characterising part of claim 1 is based, is known from WO99/08 742 [namely, the original ancestor].
A further reference to the original ancestor contained the same words concerning different configurations being possible and being suggested by the prior art apart from those configurations shown in figures 10A, 10B and 11 of the original ancestor.
89 Whether the claims in the patents in suit were fairly based upon matter disclosed in the great grandparent is not to be determined by an identification and comparison of what are said to be the "essential features" of the prior disclosures with the present claim. The question is, rather, whether the present claim was fairly based on prior disclosures. The great grandparent describes safety IV catheters having a resilient guard that works in the same way as the IV catheter of claim 1 of the 577 Patent and claim 1 of the 327 Patent. Each of the features of those claims of the patents in suit are described in the great grandparent from the information in the figures of the great grandparent. In particular, as Dr Haindl observed in his evidence: (a) the groove (being a feature of integer (k) of claim 1 of the 327 Patent and of feature (i) of the 577 Patent) is disclosed on page 1 of the specification of the great grandparent and in figure 1 of the figures in the specification of the great grandparent; and (b) a bulge formed by a crimp on the needle shaft is described on page 7 of the great grandparent. The great grandparent also refers to a "bend 128" in the needle guard with the function disclosed in the passage "when the bends 128 abut the annular projection 136a the advance movement of the needle protecting means is stopped".
90 Dr Esnouf also drew attention to the fact that the specification of the great grandparent was almost identical to the specifications of the two patents in suit and that the figures in all three were identical. Figure 1 in each of the three specifications included a groove. Dr Esnouf tendered a copy of figure 1 from the three patents on which he marked the location of what he said was a groove:
What is depicted as the groove, but bearing in mind that the annotation itself was not evidence, is formed by the annular projection disclosed in the great grandparent. The annotation of the annular projection as forming a groove is not evidence of a groove but the projection itself is evidence as is the figure. The relevant feature of the claim in each of the two patents in suit is, therefore, formed by the annular projection disclosed in the great grandparent and performs the same function of securing the needle guard in the ready position. This aspect of the claim of the patents in suit is described in a general sense in the great grandparent and is not a claim of a characteristic of the invention about which the great grandparent had been wholly silent: cf F Hoffman-La Roche & Co Aktiengesellschaft v Commissioner of Patents (1971) 123 CLR 529, 539. It follows that the two patents in suit are fairly based on matter disclosed in the great grandparent and, therefore, are entitled at least to the priority dates of the great grandparent.
91 Next, Multigate submitted that the patents in suit were not entitled to the priority date of the original ancestor because there were at least two significant differences between the claims of each of the 327 and 577 Patents and the disclosure of the original ancestor. The critical differences were said to be that: (a) the patents in suit do not require that the needle guard be a unitary spring clip needle guard and (b) that the two patents in suit do not require that the needle guard operates by clamping onto the needle shaft.
92 Multigate's focus in its submission upon essential features in prior disclosures should not distract attention from the task of determining whether the claims in the patents in suit are fairly based upon matter disclosed in the original ancestor. That task may conceivably be helped by describing the subject matter of what may need to be found as having been disclosed but description or characterisation of what is to be found is apt to distract attention from the proper task to be undertaken as was explained in Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (2004) 217 CLR 274. A fair reading of the original ancestor, however, shows that the two features relied upon by Multigate were not limitations in what was disclosed in the original ancestor.
93 The embodiments of the needle guard disclosed in the original ancestor were not limited to a "unitary" needle guard. The body of the specification referred to a unitary spring clip by reference to figures as described:
As shown in Figs. 1A and 1B, the needle tip guard 40 is in the form of a unitary spring clip that is preferably made of a resilient metal such as stainless steel. The spring clip includes a distal arm 42 terminating at its upper end in a curved lip 44, and at its lower end in a pointed end 46, which, in the embodiment of figure 1, is received within a mating groove 48 formed in the lower interior wall of catheter hub 40.
The embodiments described to include "a unitary spring clip" are depicted in a number of the figures. Alternative embodiments, however, are also disclosed in the specification which do not include a "unitary spring clip". A lengthy passage in the specification from pages 15 to 18, and the figures to which they refer, disclosed embodiments which were not limited to a unitary spring clip. It is also doubtful that the word "unitary" was used in the original ancestor in the sense taken by Multigate in its submissions. The word "unitary" appearing before the words "spring clip" may have been used to suggest that the spring clip was part of the unit making up the assembly rather than as a description of a feature of the spring clip itself. That, if it mattered, is the better construction of the word and is consistent with the whole of the drawings and other terms of the specification which do not insist upon the spring clip itself to be something satisfying the description as a "unitary" feature. In any event, it is clear from the figures in the original ancestor that what was disclosed included matter beyond a "unitary spring clip" in the sense used in Multigate's submissions. Furthermore, it cannot be said that the configuration of the needle guard claimed in each of the patents in suit was not based on matter disclosed in the original ancestor. Figure 11 of the original ancestor disclosed features of the spring clip needle guard of the kind claimed in each of the 327 and 577 Patents:
94 The second limitation said to have been part of the disclosure in the original ancestor but said not to be found in the patents in suit was that the needle protecting means was to operate by clamping onto the needle shaft. The original ancestor, however, disclosed some embodiments of the invention which did not include a clamping means. Figures 7D and 7E in the original ancestor were two embodiments which do not include any clamping means:
Figures 7D and 7E are described in the body of the specification as follows:
The safety IV catheter illustrated in Figs. 7D and 7E is the same as that illustrated in Figs. 7A and 7B, except that the slot 60 in the needle shaft in the latter is replaced in the former by a bulge 61 whose diameter is greater than that of opening 58 in vertical arm 54. If an attempt is made to move the protected needle illustrated in Fig. 7D in the rearward or proximal direction, bulge 61 will engage wall 54 and will not be able to pass through opening 58, so as to prevent any further proximal movement of the needle and removal of the needle from the needle guard, as desired.
The original ancestor did not disclose devices limited to the needle guard operating by clamping onto the needle shaft. The patents in suit made clear that "the needle protecting means need not comprise any clamping means for clamping the needle in the locked position", but the claim, without that limitation, was fairly based on what had been disclosed in the original ancestor. The purpose of the needle guard clamping onto the needle shaft in some embodiments is to stop the needle guard sliding off the end of the needle when the needle has been removed from the catheter. However, stopping the needle guard from sliding off the end of the needle may be achieved, as shown in the figures disclosed in the original ancestor, by use of a tether (figure 6B) or by use of a bulge on the needle shaft which engages the needle guard (as in figures 7E and 10B). The bulge referred to in the description of Figure 7E and said to be numbered 61 does not appear in the diagrams but is clearly enough shown and marked by the line extending to the right of the figure and which may be assumed to have been intended to have had the number 61 placed next to it (as Dr Esnouf believed to have been intended). The omission of the number appears to have been an oversight.
95 The disclosure of the specification of the original ancestor is, as Dr Esnouf demonstrated in his evidence, broader than the inventions disclosed in the 327 and 577 Patents. Dr Esnouf drew attention to the features of each of the devices claimed in the patents in suit which were disclosed in the body of the specification of the original ancestor. These included the description in the original ancestor of different types of needle guard, including those claimed in the 327 and 577 Patents. The needle guards disclosed in the original ancestor included needle guards with one or two arms and needle guards that use different types of means for contacting the needle shaft in order to secure the needle tip within the guard. These means included the use of a tether and the use of a tab on the needle guard to engage with a groove in the needle shaft. Figure 11 in the original ancestor (depicted above) disclosed features of the spring clip needle guard in claim 1 of the 577 Patent. The original ancestor describes features of a groove in the inner wall of the catheter hub used to retain the needle guard. An example of such a groove was shown in figure 10A as item 136 of the original ancestor:
That groove is depicted in a different way from the groove shown in figure 1 of the 327 and 577 Patents but, as shown in the figure annotated by Dr Esnouf, what is disclosed is relevantly a "groove" as claimed in each of the 327 and 577 Patents.
96 Another figure in the original ancestor, figure 2A, shows a retaining bump on the inner wall of the catheter for the purpose of retaining the needle guard. Some of the other figures in the original ancestor show a "bulge" on the shaft of the needle identified as item 61 on figures 1C and 1D in the original ancestor and described in the text of the specification. It is also described by reference to figure 7E (shown above), said to be numbered as 61 in that figure (being the feature near item 58). It is probable, as Dr Esnouf believed, and as said above, that the number 61 was intended to have been inserted on the line to the right of the drawing indicating the position of the bulge.
97 The original ancestor also discloses the use of a crimp on the shaft of the needle as claimed in the 327 Patent. The original ancestor describes the feature of a bulge on the shaft of the needle. One way of forming a bulge on the shaft of a needle is to deform the needle by crimping it. The references to "bulge" in the specification of the original ancestor are apt to encompass a bulge that has been created using a crimping process. The item described as numbered 61 in figure 7E of the original ancestor, but marked by the line without a number, depicts a crimp. Figure 10A in the original ancestor contains item numbered 138 (described in the specification as an "increased diameter bulge") which is the same as item 138 of figures 1 and 6 of the 327 Patent. The original ancestor also uses the terms "retracted" and "fully retracted" in relation to the needle and refers to the needle guard pivoting or snapping into the retracted position. It also refers to the resilient arms and the distal end wall of the needle guard performing the blocking function.
98 Multigate appeared also to contend that there were "at least two significant differences between the disclosure of each of the 327 and 577 Patents and the disclosure of the original ancestor". It is not clear from their submissions whether these two "significant differences" were intended as a separate challenge or as a conclusion from those previously contended. The second was plainly that considered immediately above, namely, that the needle protecting means of the catheter devices in the two patents in suit "need not comprise any clamping means" and, for the reasons given above, that need not be considered separately. The other difference, however, was said to be that the two patents in suit each provided additional disclosure which facilitated the fastening of the needle protecting means in the catheter hub. The submission was not independently developed in Multigate's submissions but appears to be a repetition either of its argument concerning the unitary spring clip needle guard or of the contention concerning the feature of a groove in the inner wall creating the annular groove or ring which was also considered above. The original ancestor described the feature of a groove in the inner wall of the catheter hub used to retain the needle guard. The specification in the original ancestor described this item as "an angular groove or ring" and depicted it differently from the "groove" in figure 1 of the 327 and 577 Patents, but appears to disclose the same feature: SociÉtÉ des Usines Chimiques RhÔne-Poulenc v Commissioner of Patents (1958) 100 CLR 5. Figure 2A of the original ancestor also disclosed a "retaining bump" on the inner wall of the catheter hub for the purpose of retaining the needle guard. There are several disclosures of features "which facilitates the fastening of the needle protecting means in the catheter hub". Figure 4A identifies item 68 which is described in the specification as a "bump". Figures 7A-E contain an item numbered 48 which is described in the specification as a "mating groove". A fair reading of the original ancestor reveals that the claims in the two patents in suit do not travel beyond or broaden the disclosures in the original ancestor.
99 The original ancestor does provide a real and reasonably clear disclosure of the inventions in each claim of the 327 and 577 Patents including (a) a needle guard which is not limited to being "unitary"; (b) a needle protecting means which is not limited to having a clamping means; and (c) an additional feature facilitating the fastening of the needle guard to the wall of the catheter hub including an annular groove or projection. It contains "a description of the general nature of the invention [in the patents in suit], its field of application and the anticipated results" in the sense considered in ICI and endorsed in Leonardis. What is claimed by the patents in suit was described in the original ancestor in a general sense and is not inconsistent with the original ancestor or includes a feature as to which the original ancestor was wholly silent: Re Mond Nickel Co Ltd's Application [1956] RPC 189; approved by Gibbs J in F Hoffman-La Roche & Co Aktiengesellschaft v Commissioner of Patents (1971) 123 CLR 529. Accordingly the patents in suit are entitled to the priority date of the original ancestor, as derived from PD2 (being the earliest ancestor which discloses the bulge or crimp feature), namely 12 June 1998.