(a) Alleged error by incorporation of the original ancestor into each of the patents in suit, the parent, the grandparent and the great grandparent
218 As we have set out earlier, his Honour found that the original ancestor was incorporated in its entirety by reference into each of the patents in suit, the parent, the grandparent and the great grandparent. Multigate has contended that his reasoning as to the effect of such incorporation founded his conclusions in relation to both external fair basis (in relation to the parent, grandparent and great grandparent) and internal fair basis. Multigate contended that his Honour erred both in finding that the original ancestor was incorporated in each case, and in his conclusions as to the effect of the incorporation.
219 Multigate referred to the fact that his Honour relied on the evidence of Dr Haindl and Dr Esnouf that they would have had regard to the original ancestor to see what was disclosed. Multigate contended that such evidence was irrelevant to the legal question of whether the entire disclosure of the original ancestor (or some part, and if so, which) was made part of the disclosure of the invention in the patents in suit (or any of their claimed antecedents).
220 Multigate contended that although each of the specifications of the 327 Patent and the 577 Patent referred to both the original ancestor and the parent, the form of the reference to each was "very different".
221 Multigate contended that the 327 specification and the 577 specifications each expressly incorporated the disclosure of the parent by reference. Contrastingly, each of the specifications referred to the original ancestor (327 Patent at page 1 line 9 to page 2 line 9; 577 Patent at page 1 line 9 to page 2 line 9) for the specific purpose of identifying a problem to be overcome in the following terms:
A safety intravenous catheter device is disclosed in International application WO 99/08 742 by the present applicant. Said catheter device comprises …
A catheter device of this type protecting means poses the problem that the needle protecting means must be fastened in the catheter hub, with a bend or an elbow of the needle protecting means having to be moved over the projection on 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.
(emphasis added)
222 Multigate also contended that the same problem with the original ancestor was identified in each of the alleged antecedent specifications to the patents in suit.
223 Multigate also pointed out that each specification also referred to another discrete part of the original ancestor (327 Patent at 4 lines 15 to 21, 577 Patent at page 6 lines 8 to 14):
On the needle point 18 a needle protecting means 120 is provided which is configured generally in the same way as the needle protecting means shown and described in Figs. 10A, 10B and 11 of WO 99/08 742. However, the needle protecting means may also be of different configuration and numerous configurations are suggested by the prior art. In particular the needle protecting means needs not comprise any clamping means for clamping the needle in the locked position.
(emphasis added)
224 The first reference pointed out shortcomings in the original ancestor and taught away from it, and the second directed the reader to the original ancestor for the limited purpose of referring to the configuration of the needle protecting means (i.e. needle guard) shown in Figures 10A, 10B and 11. Multigate contended that the subsequent reference that other "configurations are suggested by the prior art" did not broaden the scope of the direction beyond those three Figures to other parts of the original ancestor; it merely told the reader that the needle protecting means need not have the clamping means of those Figures.
225 Multigate said that neither of these references to the original ancestor had the consequence of incorporating the entire disclosure of the original ancestor. The first reference in each specification sought to distance itself from the invention of the original ancestor. The second reference to the original ancestor in each case provided no more assistance. At most, it incorporated Figures 10A, 10B and 11 of the original ancestor, together with as much of the specification as was necessary to understand those Figures in relation to the needle guard.
226 Generally, Multigate contended that the reader was directed to the original ancestor for a limited purpose only, and only to a limited part of the prior document. Reference for such a limited purpose did not incorporate the entirety of the disclosure of the earlier document for all purposes.
227 Generally, it was contended that his Honour erred in law in holding that the specifications of each of the 327 Patent and the 577 Patent should be construed as incorporating the entirety of the disclosure in the original ancestor by reference.
228 Braun supported the primary judge's reasoning and conclusion (at [83]) that the disclosure in the patents in suit included that which was disclosed in the "parents" and in the original ancestor. Braun also advanced the alternative contention that, even if the whole of the original ancestor was not incorporated in each succeeding generation of patent application from which the patents in suit claim priority, there was at least incorporated, and hence disclosed, the various needle guards described in the original ancestor.
229 In our respectful view, the primary judged erred in finding that the whole of the specification of the original ancestor is incorporated in the specification of each succeeding generation of the family of patent applications. In our view, the language of the text of the specifications in question does not support the incorporation of the original ancestor to this extent.
230 In finding that the whole of the original ancestor had been incorporated, his Honour placed significant reliance on what some of the expert witnesses had said about what they considered to be necessary for them to read in order to understand the invention described in the specifications of the patents in suit. Whilst we would not rule out the possibility that evidence from those who are representative of the person skilled in the art might, in an appropriate case, be an aid to construction on the question of whether, and if so what, externally made statements have been incorporated into a particular patent specification, we do not think that such evidence is of assistance in the present case, where the question can, and should, be answered by a consideration of the text alone of each specification. However, for the reasons given below, it does not seem to us that the incorporation of the whole of the original ancestor in the succeeding patent specifications is necessary in order for the claims of the patents in suit to have the priority dates which the original ancestor would provide.
231 Unquestionably, the specification of the parent (Australian Patent Application No 2009233612), as originally filed, is incorporated, by express reference, in the specification of each patent in suit. Further, Multigate accepts that the specifications of the parent and the grandparent are in materially the same terms and make like disclosures. Thus, at this point in the analysis, the inventions as claimed in each patent in suit would have the priority dates accorded by, at least, the grandparent, provided they are fairly based on their own incorporated disclosures.
232 Further and significantly, the specification of each patent in suit, and the specifications of each earlier generation deriving from the original ancestor (parent, grandparent, and great grandparent), makes explicit reference to the original ancestor in two ways.
233 First, there is a reference to, and description of, a particular embodiment of a safety intravenous catheter device said to be disclosed in the original ancestor. It is said, however, that this particular embodiment has "a problem" with the fastening of the needle protection means in the catheter hub, which the invention seeks to address by providing a retaining element. The retaining element comprises a projection within the catheter hub. The projection is of a generally annular configuration extending, at least, at two diametrical locations in the hub.
234 Second, when describing an embodiment of the invention that is claimed, each specification refers to an exemplification of a needle protecting means disclosed in the original ancestor. The relevant passage referring to the original ancestor is quoted at [223] above. This passage is significant. In our view, it incorporates into each specification not only Figures 10A, 10B and 11 of the original ancestor, but also the written description of those Figures. Multigate accepted this to be the case. We point out that Figures 10A and 10B are the same as Figures 1 and 2 in the specifications of the patents in suit as well as the specifications of the parent, grandparent and great grandparent: see [11] and [12] above. Figure 11 is depicted at [210] above.
235 The description of Figures 10A, 10B and 11 in the original ancestor is as follows:
The embodiment of the spring clip needle guard 120 disclosed in Figs. 10A, 10B, and 11 comprises first and second arms 122 and 124 respectively joined at their proximal ends in a hinged arrangement at 125 to the ends of a rear wall 126. The distal ends of arms 122, 124 each include a curved protrusion 128 extending to a distal end wall 130, which in turn terminates in a lip 132. As seen best in Fig. 11, rear wall 126 includes a central opening 134, and arms 122 and 124 each include a narrow portion 142 that extends between a distal wide portion 140 and a proximal wide portion 144. A lateral clamping edge 146 is defined at the distal wide portion 144.
As shown in Fig. 10A, when the needle guard 120 is in its ready position, the curved protrusions 128 in each of arms 122, 124 are received in an annular groove or ring 136 formed in the inner wall of catheter hub 26, which, as in the prior embodiments, is removably fit into the distal end of a needle hub 12. Also as in the prior embodiment, a needle 16 having a sharpened tip 18 at its distal end is received within a tubular catheter 24, which is secured to the distal end of catheter hub 26. The proximal end of needle 16 passes through opening 134 in rear wall 126. Needle 16 includes an increased diameter bulge 138, which is sufficiently small to allow needle 16 to move axially along catheter 24, but greater in diameter than opening 134 for reasons to be described below.
In the ready position illustrated in Fig. 10A, the needle shaft passes through the needle guard and applies an outward radial force on resilient arms 122, 124 by means of its engagement with lips 132, so as to urge the curved protrusions 128 of each of the arms into the annular groove 136, so as to retain needle guard 120 in a fixed position within the inner wall of catheter hub 26. The shaft of needle 16 that passes through the needle guard 120 frictionally engages the inner edges of the narrow portions 142 of arms 122, 124 so as to further retain the needle in its ready position.
When the needle is retracted axially, to the right as viewed in Fig. 10A, within the catheter hub, and moves past the end lip 132 of the needle guard, the radial force previously exerted on arms 122, 124 of needle guard 120 is suddenly released. This causes the distal end walls 130 of the needle guard to be released from their seat in the annular groove 136 and to pivot inwards into the catheter hub until, as seen in Fig. 10B, the end walls 130 overlap one another at a location distally in front of the needle tip, thereby to form a barrier that prevents inadvertent contact with, and distal movement of, the needle tip. At the same time, the clamping edges 146 of the needle guard are urged against the needle tip to restrict further axial movement of the needle.
As also shown in Fig. 10B, the needle guard 120 and the needle clamped to the needle guard after needle retraction can be removed from the catheter hub as a unitary assembly, and safely discarded. If an attempt is made, intentionally or inadvertently, to pull the needle further to the right, as viewed in Fig. 10B, out of the needle guard, the bulge 138 on the needle shaft will come into contact with the end wall 126, and since its diameter is greater than that of opening 134, the end wall 126 will at this point prevent any further axial movement of the needle out of the needle guard.
236 However, the passage quoted at [223] above is also significant in that it makes clear that the needle protection means does not have to be configured in this way. It can be configured in numerous different ways - it being disclosed that there are numerous configurations suggested by the prior art. In particular, the needle protection means need not be configured so as to clamp the needle (i.e. it may or may not be configured so as to the clamp the needle).
237 Contrary to Braun's submission, we do not think that the passage quoted at [223] above incorporates the specific descriptions of the various needle protecting means otherwise exemplified in the original ancestor or, indeed, that might be exemplified in other prior art disclosures. Nevertheless, the person skilled in the art is taught that the configuration of the needle protecting means shown in Figures 10A, 10B and 11 of the original ancestor is but an example. It is not itself limiting of the broader "matter" concerning the needle protecting means that is disclosed. Thus, we do not accept the thrust of Multigate's submission that the disclosure of the passage quoted at [223] above is limited to the configuration of the needle protecting means shown in Figures 10A, 10B and 11.
238 It is convenient at this point to also record that we do not accept Multigate's submission that simply because the specifications of the patents in suit, and the specifications of the parent, grandparent and great grandparent, each express the object of overcoming a perceived "problem" in a particular embodiment of an IV catheter disclosed in the original ancestor, each patent application proceeding from the original ancestor cannot be a divisional application for the purposes of s 79B(1) of the Act or that the inventions as claimed in those applications cannot be fairly based on matter disclosed in the original ancestor.
239 In this connection, Multigate relied on certain observations in Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth (2011) AIPC 92-428; [2011] FCAFC 132 at [242]-[243] per Yates J (Bennett J concurring at [92]) to support its submission. Multigate argued that the statement in the specifications of the patents in suit as to the identified deficiency in the described embodiment cannot be ignored by "cherry picking useful elements from the earlier documents to provide fair basis". At a high level of generality, this might be true. But the statements made in the specifications under consideration in Sigma are far removed from the statement (on which Multigate relies) made in the specifications under consideration in the present case.
240 In any event, the fact remains that the applications for the patents in suit, the parent, the grandparent and the great grandparent were filed as divisional applications under s 79B of the Act, ultimately deriving from the original ancestor. The relevant question is what, in that state of affairs, is the priority date accorded to the relevant claims of the patents in suit having regard to the serial or iterative application of regs 3.12(1)(c) and 3.12(2C) to each alleged priority document?
241 Thus, at this point in the analysis, it is convenient to ask whether the relevant claims in suit are fairly based on "matter" disclosed in the specifications of the parent, grandparent and great grandparent, considered separately (but noting the commonality of the disclosures in each), and, if so, whether, in turn, they are fairly based on matter disclosed in the original ancestor? In answering this question, it is not to the point that the parent, grandparent and great grandparent might themselves have claimed, as inventions, different or, arguably, more limited embodiments of the IV catheter apparatus claimed in the 327 patent or the safety IV catheter claimed in the 577 patent. The question in each case is, what "matter" is disclosed in the earlier specifications?
242 We note at this point that Multigate accepts that, if the relevant claims of the patents in suit are fairly based on the original ancestor, then those claims are entitled to a priority date of 12 June 1998.
243 We now turn to consider specific contentions made by Multigate in relation to the applications of regs 3.12(1)(c) and 3.12(2C).