Multigate Medical Devices Pty Ltd v B Braun Melsungen AG - [2016] FCAFC 21

FEDERAL COURT OF AUSTRALIA
Multigate Medical Devices Pty Ltd v B Braun Melsungen AG [2016] FCAFC 21

Appeal from: B Braun Melsungen AG v Multigate Medical Devices Pty Ltd [2014] FCA 1110

File numbers: VID 681 of 2014
VID 693 of 2014

Judges: BENNETT, YATES AND BEACH JJ

Date of judgment: 3 March 2016

Catchwords:
PATENTS – intravenous catheters – safety needle protecting devices – construction of integers of claims – infringement – infringement claim upheld by primary judge – leave to appeal granted – appeal allowed in part

PATENTS – cross-claim for invalidity dismissed by primary judge – chain of ancestor patents – entitlement of patents to priority dates of ancestor patents – external fair basis – whether claims of patents fairly based upon matter disclosed in ancestor patents – whether ancestor patents provided real and reasonably clear disclosure of subsequent claims – whether disclosures in ancestor patents incorporated by reference in subsequent patents – internal fair basis – novelty – appeal dismissed

Legislation: Patents Act 1990 (Cth) ss 7, 18(1), 40(3), 43(2), 79B(1)
Patents Regulations 1991 (Cth) reg 3.12

Cases cited: Australian Mud Company Pty Ltd v Coretell Pty Ltd (2011) 93 IPR 188
Bristol-Myers Squibb Co v F H Faulding & Co Ltd (2000) 97 FCR 524
CCOM Pty Ltd v Jiejing Pty Ltd (1994) 51 FCR 260
C Van Der Lely N.V. v Bamfords Ltd [1963] RPC 61
Flexible Steel Lacing Co v Beltreco Ltd (2000) 49 IPR 331
H Lundbeck A/S v Alphapharm Pty Ltd (2009) 177 FCR 151
Hill v Evans (1862) 45 ER 1195
Inverness Medical Switzerland GmbH v MDS Diagnostics Pty Ltd (2010) 85 IPR 525
Jupiters Ltd v Neurizon Pty Ltd (2005) 222 ALR 155
Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd (2001) 207 CLR 1
Kinabalu Investments Pty Ltd v Barron & Rawson Pty Ltd [2008] FCAFC 178
Leonardis v Sartas No 1 Pty Ltd (1996) 67 FCR 126
Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (2004) 217 CLR 274
Meyers Taylor Pty Ltd v Vicarr Industries Ltd (1977) 137 CLR 228
O’Kelly Holdings Pty Ltd v Dalrymple Holdings Pty Ltd (1993) 45 FCR 145
Olin Corporation v Super Cartridge Co Pty Ltd (1977) 180 CLR 236
Populin v HB NomineesPty Ltd (1982) 41 ALR 471
Rehm Pty Ltd v Websters Security Systems (International) Pty Ltd (1988) 81 ALR 79
Sachtler GmbH and Co KG (formerly Sachtler AG) v RE Miller Pty Limited (2005) 65 IPR 605
Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth [2011] FCAFC 132
Vehicle Monitoring Systems Pty Ltd v Sarb Management Group Pty Ltd (No 2) (2013) 101 IPR 496

Dates of hearing: 18, 19, 20, 21 May 2015

Date of last submissions: 28 May 2015

Registry: Victoria

Division: General Division

National Practice Area: Intellectual Property

Sub-area: Patents and Associated Statutes

Category: Catchwords

Number of paragraphs: 337

Counsel for the Appellant: Ms J Baird SC, Ms H M J Rofe QC and Ms C I Cunliffe

Solicitor for the Appellant: Chrysiliou Lawyers

Counsel for the Respondents: Mr D Shavin QC and Mr E J C Heerey SC

Solicitor for the Respondents: Davies Collison Cave Law
ORDERS

VID 681 of 2014
VID 693 of 2014

BETWEEN:
MULTIGATE MEDICAL DEVICES PTY LTD
(ACN 132 290 058)
Appellant

AND:
B BRAUN MELSUNGEN AG
First Respondent

B BRAUN AUSTRALIA PTY LTD (ACN 002 945 155)
Second Respondent

JUDGES:

BENNETT, YATES AND BEACH JJ

DATE OF ORDER:

3 March 2016

THE COURT ORDERS THAT:
1.In proceeding VID 681 of 2014, leave to appeal be granted and the appellant’s appeal be allowed in part.
2.The parties file and serve within 7 days of the date hereof minutes of orders and short submissions (limited to two pages, if necessary) as to any setting aside of or variation to the primary judge’s orders in proceeding VID 463 of 2013 numbered 1 to 5 and 9 to 12 and on the question of costs of that proceeding before his Honour and the costs of the application for leave to appeal and the appeal in proceeding VID 681 of 2014.
3.In proceeding VID 693 of 2014, the appellant’s appeal be dismissed.
4.The appellant pay the respondents’ costs of and incidental to that appeal.

Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

REASONS FOR JUDGMENT
THE COURT:

At first instance B Braun Melsungen AG and B Braun Australia Pty Ltd claimed that Multigate Medical Devices Pty Ltd (Multigate) infringed two patents being:
(a)Australian Patent Number 2012258327 entitled “IV Catheter” (the 327 Patent) filed on 21 November 2012; and
(b)Australian Patent Number 2012260577 entitled “IV Catheter” (the 577 Patent) filed on 30 November 2012.
B Braun Melsungen AG is the patentee of both patents with Braun Australia Pty Ltd being the exclusive licensee (together, Braun). The Braun parties claimed that Multigate’s catheters infringed claim 1 of the 327 Patent and claims 1 to 6 of the 577 Patent. Multigate admitted that it had offered for sale, sold, supplied or kept for sale two catheters and that it intended to market and sell a third (referred to by the primary judge and in these reasons as catheters A, B and C respectively), but it otherwise denied infringement. It cross-claimed seeking revocation of the two patents on the grounds of invalidity.
The primary judge found that Multigate’s catheters infringed the relevant claims. He dismissed Multigate’s cross-claim. Before us Multigate has sought leave to appeal his Honour’s determination of infringement (VID 681 of 2014) and has appealed against the dismissal of the cross-claim (proceeding VID 693 of 2014).
In summary, we would grant leave to appeal to Multigate (as we have previously announced) in relation to his Honour’s determination on infringement and allow the appeal in proceeding VID 681 of 2014 in part. We would dismiss Multigate’s appeal in proceeding VID 693 of 2014.
It is convenient to address first the terms of the claims of the patents in suit and questions of construction. Our reasons and conclusions in both appeals principally turn on questions of construction.
THE PATENTS
The 327 Patent and the 577 Patent relate to a safety needle protecting device used as part of an intravenous catheter. Such a device is used in an intravenous catheter to prevent needlestick injuries. The specifications state that the invention relates to a safety needle assembly which can form part of a safety intravenous (IV) catheter device. Safety IV catheter devices comprise a needle protecting means which slides to the needle point as the needle is removed from the catheter and permanently blocks the needle point such that the needle point cannot thereafter be inserted into objects or persons.
The two patents in suit are the fifth generation of a family of patents with claims for such a device. They were applied for on 21 and 30 November 2012 respectively. The original ancestor was patent application 199895323 entitled “Spring clip as needle tip protection for a safety IV catheter”. The intermediate patents in the chain working backwards from the patents in suit included Australian Patent Application 2009233612 filed on 30 October 2009 (the parent), Australian Patent Application 2005203491 filed on 5 August 2005 (the grandparent) and Australian Patent Application 200142070 filed on 4 May 2001 (the great grandparent). The original ancestor was filed as an international application numbered PCT/EP98/05231 later published as WO99/08742. The original ancestor had an effective filing date of 18 August 1998, but claimed priority from two US patents, the first being US Patent Application No 08/915,148 filed on 20 August 1997 and the second being US Patent Application No 09/097,170 filed on 12 June 1998. Braun contended below that aspects of the original ancestor that could be relevant to the patents in suit were first disclosed in the latter mentioned application. Accordingly, the earliest possible priority date was 12 June 1998. It has not been in issue before us that this was the earliest possible priority date for the claims in suit, although the actual priority date is in issue. We will return to this question later when considering the question of external fair basis.
The 327 Patent had one claim, namely:
An IV catheter apparatus including a tubular catheter having a proximal end and a distal end, a needle having a needle shaft and a tip and wherein the needle is attached to a distal end of a needle hub, said needle being received within said tubular catheter when the needle is in a ready position, a catheter hub attached to the proximal end of said catheter, said catheter hub having a hollow interior and an inner wall, said needle being movable between said ready position in which said tip is outside of said catheter hub and a retracted position in which said tip is within the interior of said catheter hub, a needle guard positioned in the interior of said catheter hub in a spaced apart relationship from the distal end of the needle hub;
wherein the needle guard has a resilient portion engaged by said needle shaft when said needle is in its ready position, the needle guard resilient portion is movable within the interior of said catheter hub to a blocking position distal of said needle tip when said needle is in its retracted position in which said needle shaft no longer exerts a force on said resilient portion of said needle guard;
wherein an outer contact surface on the needle guard is secured to a groove formed in the catheter hub hollow interior when the resilient portion is engaged by the side of the needle shaft and biased radially outwardly; and
wherein the needle guard further includes a needle guard proximal end, wherein the needle guard is secured to the needle tip when the needle is in the fully retracted position by a portion of the needle guard proximal end making contact with a needle crimp and the resilient portion blocking the needle tip.
The 577 Patent had seven claims, but only claims 1 to 6 are presently relevant. Claims 2 to 6 depend upon claim 1. Those claims were:
1.        A safety IV catheter comprising:
a)        a needle having a needle shaft and a needle tip;
b)        said needle shaft comprising a bulge;
c)        a hollow tubular catheter having a proximal end;
d)said hollow tubular catheter is secured to the distal end of a catheter hub;
e)said catheter hub having a hub section, wherein a chamber is formed in said hub section, and having an inner wall;
f)a resilient spring clip needle guard located within said chamber being formed in said hub section of said catheter hub and having a distal end wall;
g)said needle being received within said hollow tubular catheter when in a ready position, wherein said needle extends through said chamber, a passageway and distally beyond said catheter hub and said hollow tubular catheter so that said needle tip extends beyond the tapered distal end of said hollow tubular catheter and said needle guard located within said hub chamber is adapted to automatically snap or pivot into a retracted position for blocking access to said distal needle tip and preventing further movement of said needle tip when said needle is in its retracted position;
h)said needle guard being adapted to be inserted into said catheter hub and to be urged by said needle shaft into contact with said inner wall of said catheter hub so that the needle guard is retained therein;
i)and a groove or bump being formed in said inner wall of said catheter hub for engaging a curved protrusion of said needle guard for retaining said needle guard in said catheter hub in the ready position;
j)said needle shaft of needle being adapted to engage said distal end wall of said needle guard when said needle is in its said ready position; and
k)the said catheter hub being configured such that a force exerted by said needle shaft on said needle guard in said catheter hub is released when said needle is retracted causing said needle guard to pivot or snap to the retracted position in which said distal end wall blocks said needle tip;
l)and said needle guard further comprising a proximal wall having an opening adapted to let said shaft of needle freely pass through and axially move;
m)wherein said bulge has a diameter greater than that of said opening of said proximal wall.
2.The safety IV catheter of claim 1, wherein said needle guard is adapted to automatically snap into said retracted position as said needle is being retracted for blocking access to said needle tip and preventing further distal movement of said needle tip to prevent accidental contact with said needle tip.
3.The safety IV catheter of claim 1 or 2, wherein said distal end wall terminates in a lip adapted to be engaged by said needle shaft when said needle is in its said ready position.
4.The safety IV catheter of any one of claims 1 to 3, wherein the said catheter is configured such that a lower end or curved protrusion of said needle guard is urged by said needle shaft into retaining contact with said inner wall of said catheter hub when said needle is in its said ready position.
5.The safety IV catheter of any of claims 1 to 4, wherein said spring clip needle guard is configured such that a downward or radial force exerted by said needle shaft on said spring clip needle guard in said catheter hub is released when said needle is retracted to said retracted position, and said distal tip of said needle moves past a lip of said spring clip needle guard causing said spring clip needle guard to pivot or snap to said retracted position in which said distal end wall is adapted to block said needle tip.
6.The safety IV catheter of any one of claims 1 to 5, wherein said resilient spring clip needle guard has two arms.
Both of the patents included diagrams portraying the inventions. It is useful to reproduce some of these diagrams (as the primary judge did in his reasons).
Figure 1 is a longitudinal cross-section of an embodiment of the claimed intravenous catheter device (we have added the words “Distal to User” and “Proximal to User” to assist comprehension of the issues later discussed):
Distal to User Proximal to User
Figure 2 shows a magnified part of Figure 1, particularly the distal end of the needle with the needle protecting means protecting the needle point when the needle has been removed from the catheter:
There are many common features to the claims in the 327 Patent and the 577 Patent, but there are differences. His Honour explained these differences in the following terms (at [6]) which it is convenient for us to set out. First, the claim of the 327 Patent provides that the needle has a crimp. Contrastingly the claims in the 577 Patent provide that the needle shaft comprises a bulge. Second, the claim of the 327 Patent provides that the needle guard has a resilient portion on which the needle shaft exerts a force which is engaged by the side of the needle shaft and biased radially outwardly by it, which is moveable within the interior of the catheter hub to a blocking position distal of the needle tip and which blocks the tip of the needle tip when the needle is retracted. Contrastingly, the claims in the 577 Patent:
(a)specify that the needle guard is a resilient spring clip needle guard which is adapted automatically to snap or to pivot into a retracted position for blocking access to the distal needle tip; and
(b)further specify that the needle guard has a distal end wall such that the needle shaft is adapted to engage the distal end wall when the needle is in its ready position, and the distal end wall blocks the needle tip when the needle guard is in its retracted position.
Third, the claim of the 327 Patent provides that the needle guard is secured to a groove formed in the catheter hub interior. Contrastingly the claims of the 577 Patent provide that a curved protrusion of the needle guard is engaged by a groove or bump being formed in the inner wall of the catheter hub. Fourth, the claim of the 327 Patent provides that the needle guard is secured to the needle tip when the needle is fully retracted. Contrastingly the claims of the 577 Patent provide that the needle guard blocks access to the needle tip and prevents further distal movement of the needle tip when the needle is in its retracted position. Fifth, the claim of the 327 Patent provides that a portion of the needle guard proximal end makes contact with a needle crimp when the needle is in its fully retracted position. Contrastingly the claims of the 577 Patent provide that the needle guard has a proximal wall having an opening adapted to let the shaft of the needle freely pass through and axially move where the diameter of the opening is less than the diameter of the needle bulge. Sixth, the claim of the 327 Patent does not require the feature in the claims of the 577 Patent which provide that the catheter hub is configured such that a force exerted by the needle shaft on the needle guard is released when the needle is retracted causing the needle guard to pivot or snap to the retracted position. Seventh, the claim of the 327 Patent specifies that the needle is attached to a distal end of a needle hub, and that there is a “spaced apart relationship” between the needle guard and the distal end of the needle hub. Contrastingly the claims of the 577 Patent are silent about attachment of the needle to the needle hub and any requirement for a spaced apart relationship between the needle guard and the distal end of the needle hub. Eighth, in the claim of the 327 Patent the needle has a ready position in which the needle is received within the tubular catheter, the needle tip is outside the catheter hub and the needle shaft engages a resilient portion of the needle guard, whereas in the claims of the 577 Patent the needle has a ready position in which the needle is received within the tubular catheter, the needle tip extends beyond the tapered distal end of the tubular catheter and the needle shaft is adapted to engage a distal end wall of the needle guard.
CONSTRUCTION — GENERAL
Multigate has contended that his Honour erred in his reasons at [16], [18], [24], [38], [49], [50], [56], [60] and [64] by failing to apply accepted principles of patent claim construction as expounded in cases such as Kinabalu Investments Pty Ltd v Barron & Rawson Pty Ltd [2008] FCAFC 178 at [44] to [45] per Sundberg, Emmett and Greenwood JJ and Jupiters Ltd v Neurizon Pty Ltd (2005) 222 ALR 155 at [67] per Hill, Finn and Gyles JJ and, relevantly, in Sachtler GmbH and Co KG (formerly Sachtler AG) v RE Miller Pty Limited (2005) 65 IPR 605 at [20] to [22], [41] and [42] per Bennett J. We do not need to set out these principles. They are well accepted and we incorporate by reference what has been said in Kinabalu and Jupiters. Such principles were not in contention before us. We should say at the outset that, subject to one point of construction on which our views have differed from the primary judge, we do not consider that his Honour made any error in either the exposition of the applicable principles or their application save in inconsequential respects.
Multigate elaborated on its criticisms. It contended that in construing the claims his Honour impermissibly expanded the boundaries of the monopoly as fixed by the words of the claims, by adding to those words glosses drawn from other parts of the specification. Multigate contended that in many instances his Honour had regard to what he perceived as the purpose or function of integers in order to construe the terms of the claims. In doing so, he impermissibly, so it is asserted, adopted a functional “pith and marrow” approach to construing the essential integers of the claims of the patents as well as in determining whether the claims were infringed and whether they were fairly based. Generally, in our view such a contention lacks substance. The judge acknowledged (at [9]) that the “pith and marrow” test did not permit recourse to the substantial idea disclosed by the specification rather than what was to be found in the subject of a definite claim. He also recited the limitations of the application of the “pith and marrow” principle at [10]. Multigate contended that contrary to the cautions expressed in cases such as Populin v HB NomineesPty Ltd (1982) 41 ALR 471 (to which his Honour referred at [8] and [9]) and Australian Mud Company Pty Ltd v Coretell Pty Ltd (2011) 93 IPR 188 (to which his Honour referred at [9]), the primary judge engaged in a process of reasoning extending the monopoly to ideas disclosed in the specification. We disagree.

In elaboration, Multigate contended that his Honour erroneously looked at whether the general idea disclosed by the specifications was substantially taken by the Multigate catheters, relying on functional similarities, rather than looking at whether the essential integers of the claim (and thus the invention as claimed) were taken. In our opinion, generally speaking, such a characterisation of his Honour’s approach has not been made good.
Multigate contended that his Honour’s erroneous approach to construction led him to misconstrue the following words and phrases:
(a)in claim 1 of the 327 Patent, “distal end” at [16], “spaced apart relationship” at [18] and [50], “ready position” at [19], “resilient portion” at [24] and “positioned in the interior” at [31]; and
(b)in claims 1 to 6 of the 577 Patent “preventing further movement” at [38], “bump” at [47] and “resilient spring clip needle guard” at [39] and [66].
As a consequence, Multigate contended that by reason of inter alia such errors, his Honour was led into error in his conclusions on validity (by applying his constructions of the terms “distal end”, “spaced apart relationship”, “resilient portion”, “positioned in the interior”, “bump” and “resilient spring clip needle guard”) and in his findings on infringement (by applying his constructions of the terms “distal end”, “spaced apart relationship”, “ready position”, “resilient spring clip needle guard” and “preventing further movement”). Apart from what we consider to be an error made by his Honour in construing “spaced apart relationship” (and its consequences for the infringement case concerning the claim of the 327 Patent), we consider that none of the other challenges made by Multigate are made out.
Multigate also asserted that his Honour should have applied but did not apply the ordinary English meaning of such words and phrases in circumstances where, so it was said,:
(a)there was no evidence that the terms were terms of art in the field of medical devices;
(b)his construction was not supported by the specifications; and
(c)his construction was other than the plain meaning of the terms.
In our opinion, none of these criticisms are made out save as we have said as to one matter dealing with his Honour’s construction of the term “spaced apart relationship”.
Before proceeding further, it is appropriate to note at this point that the field of invention of the patents in suit is the design and manufacture of safety intravenous catheters. Multigate had submitted below that the relevant notional person to whom the patents were addressed was a team of people comprising a designer or engineer skilled in medical device design and production, a clinical advisor and a toolmaker. We do not see any difficulty with the use of that composite. At trial, Multigate relied upon the expert evidence of Mark Bennett (a tool maker), Vincent Leskowich (medical devices designer) and Timothy Spencer (expert user) who, together, so Multigate contended, constituted the notional team to which the patents were directed. The Braun parties relied upon the expert evidence of Dr Hans Haindl and Dr Philip Esnouf. Dr Haindl had spent his professional life working in the design, development and manufacturing of medical devices and intravenous catheters. Dr Esnouf had been a qualified medical doctor since 1979. He had worked in various hospitals in surgical roles and in private practice. He had engaged in inserting intravenous catheters into patients on a regular daily basis. The experts gave evidence in the areas of construction and invalidity. The experts also expressed views about the presence of the integers in dispute in Multigate’s catheters A, B and C. A joint expert report was prepared and tendered. The experts were cross-examined, although perhaps not as fulsomely as one might have expected in the areas of contention. Nevertheless, the parties agreed that no Browne v Dunn type point would be taken.
It is appropriate to make several preliminary comments concerning the use of expert evidence in this context.
First, as cited by Hely J in Flexible Steel Lacing Co v Beltreco Ltd (2000) 49 IPR 331 at [147] and observed in O’Kelly Holdings Pty Ltd v Dalrymple Holdings Pty Ltd (1993) 45 FCR 145 at 156 by Sweeney and O’Connor JJ quoting the words of the trial judge in that case:
the Court’s duty is to form and act on its own original opinion, taking such assistance as it can from the opinion of experts, but it is not bound, nor should it defer, to the opinion of experts in the sense of permitting experts to hijack the fundamental fact finding obligation of the Court.
Second, and relatedly, the evidence of a skilled reader is not determinative of a construction question. It is always a matter for the Court to construe the particular claim adopting the relevant lens, but giving such weight to the expert evidence that it sees fit.
Third, it is not the province of an expert to give evidence of the meaning of words or phrases used in a claim if those words or phrases bear their ordinary English meanings and are not suggested to have a technical or special meaning.
Fourth, and relatedly, if words or phrases are used in a claim in their ordinary English meaning, their meaning cannot be distorted by an expert’s use of a functionality lens to give them an application in tension with their plain meaning.
Fifth, where an expert is opining on both construction and infringement, the expert’s opinion must be carefully assessed to ensure that the expert’s particular construction has not been given with an eye to infringement.
THE 327 PATENT
Multigate conceded before his Honour that each of its catheters A, B and C had each of the integers of the claim of the 327 Patent, except for those integers in which the following words and phrases are underlined and emboldened:
An IV catheter apparatus including a tubular catheter having a proximal end and a distal end, a needle having a needle shaft and a tip and wherein the needle is attached to a distal end of a needle hub, said needle being received within said tubular catheter when the needle is in a ready position, a catheter hub attached to the proximal end of said catheter, said catheter hub having a hollow interior and an inner wall, said needle being movable between said ready position in which said tip is outside of said catheter hub and a retracted position in which said tip is within the interior of said catheter hub, a needle guard positioned in the interior of said catheter hub in a spaced apart relationship from the distal end of the needle hub;
wherein the needle guard has a resilient portion engaged by said needle shaft when said needle is in its ready position, the needle guard resilient portion is movable within the interior of said catheter hub to a blocking position distal of said needle tip when said needle is in its retracted position in which said needle shaft no longer exerts a force on said resilient portion of said needle guard;
wherein an outer contact surface on the needle guard is secured to a groove formed in the catheter hub hollow interior when the resilient portion is engaged by the side of the needle shaft and biased radially outwardly; and
wherein the needle guard further includes a needle guard proximal end, wherein the needle guard is secured to the needle tip when the needle is in the fully retracted position by a portion of the needle guard proximal end making contact with a needle crimp and the resilient portion blocking the needle tip.
At trial, many issues of construction arose in relation to such words and phrases in such contested integers. But on appeal, only some of those questions have now been pressed. It is convenient to deal with each in turn and in the order in which they appear in the claim.
(a) Distal end
What is meant by the words “distal end” in relation to the needle hub? The differences between the parties were essentially about whether the distal end was a specific point or a region. Multigate contended that the distal end of the needle hub meant “the most distal perimeter or the outer face of the needle hub”. That was the view advanced in the joint expert report by two of Multigate’s experts, Mr Leskowich and Mr Bennett. Contrastingly, the construction advanced by Braun was that the words “distal end” referred to a region rather than to an end point.
The primary judge referred (at [16]) to the fact that the words “distal end” appeared more than once in the claim. The words appear in the second and third lines preceded by the indefinite article and in the thirteenth line preceded by the definite article in the context of the positioning of the needle guard in a spaced apart relationship. His Honour pointed out that in each case, however, the words were not used to refer to the furthest distal point of the needle hub but to a more general area which is distal to the user. As his Honour said, the patent does not use phrases such as “distal point”, “distal end point” or “furthest distal point”, which would be more specific and narrower in meaning than “a distal end” or “the distal end”. His Honour said that the words “distal end” are more general and in their ordinary and natural meaning are apt to encompass the region ending with the furthest most distal point and including the area of the needle hub up to its centre. The patent relevantly refers to the attachment of the needle to the needle hub. The place of attachment is identified as “a distal end” and informs the reader of an aspect of the construction of the catheter, namely that the attachment occurs, as can be seen by Figure 1, in a wider region than only at an end point. The needle hub is connected to the needle in the centre of the needle hub. The hub is a structure with a rotational symmetry and the needle is attached to the centre. His Honour concluded that the distal end, in that context, is that part of a wider region than just the end point at which the attachment occurs: the point of attachment is in the axial centre of the needle hub. We agree with his Honour’s reasoning and conclusion.
Multigate contended that the primary judge construed “distal end” of the needle hub as encompassing a region including the area up to the centre of the needle hub — half way along the device — and in so construing the phrase “distal end” ignored the ordinary English meaning of “end”. It is said that there was no support in the specification for him to do so. It is said that there was no evidence from a skilled addressee that the phrase had a special technical meaning or was a term of art in the field of medical devices. Further, it was said that such a definition results in uncertainty: a reader cannot know whether or not the needle in their device is attached to the distal end of the needle hub in accordance with the claim, nor whether or not it is in a spaced apart relationship from the distal end of the needle hub. Multigate contended that his Honour ought to have found that the “distal end” meant the distal boundary of the needle hub and did not extend inwards from the furthermost part of the needle hub proximally to the centre of the needle hub.
In our opinion there was no error made by his Honour on this aspect. It was supported by the expert evidence, the plain meaning of the integer and the specification as a whole.
Dr Esnouf stated in the joint expert report that the “distal end” is a regional definition, not an end point, and that this definition is consistent with Figure 1. Dr Haindl followed Dr Esnouf’s definition. Dr Haindl noted that if you look at Figure 1 of the 327 Patent, you can see that the needle hub is connected to the needle in the centre of the needle hub. The needle hub is a structure with a rotational symmetry and the needle is attached in the centre. Dr Haindl explained that “distal end point” might refer to the furthest distal point, whereas “distal end” is very general. He gave the example that “[y]ou could say in medical language the distal end of the arm is the forearm, or something on another anatomic structure, and that always means region”. The patent includes a mixture of technical language and medical language, because it deals with medical devices. He said further “I was a bit confused about this formulation ‘a distal end’ because I thought if it is a distal end, there must be multiple distal ends. But if we come to a regional understanding, I think there is no contradiction between that”.
Contrastingly, Mr Leskowich stated in the joint expert report that “the ‘distal end’ must be the extreme furthest face of the needle hub. There cannot be more than one ‘furthest point’ or region”. Mr Bennett stated that the distal end means the most distal perimeter or the outer face of the needle hub.
But in cross-examination, Mr Leskowich confirmed that he took this definition from a dictionary. He agreed that within the claim language there was no reference to a specific point of attachment, but that he obtained the description of a “point” from a dictionary. He conceded that neither claim 1 nor Figure 1 identified a specific “point” of attachment, and that Figure 1 showed an intersection of the cannula (needle) and the needle hub.
His Honour, in our view correctly, accepted the more general approach of Dr Haindl and Dr Esnouf (at [16]). In our opinion his approach reflected a reading of the specification as a whole, particularly Figure 1. This approach also avoided adding a gloss to the plain words of the claim by reading the more general “distal end” as the more specific “distal end point”.
(b) Spaced apart relationship
What is meant by the phrase “spaced apart relationship”? The words appear in the last line of the first paragraph of the claim concerning the positioning of the needle guard in the interior of the catheter hub. Multigate contended before his Honour that the term should be given its ordinary English meaning. So it contended that the needle guard and the distal end of the needle hub were required to be separate from, or be some distance apart from, each other. Thus, to be in a “spaced apart relationship” from the needle hub, the needle guard had to be physically outside the needle hub. The needle guard and the distal end of the needle hub would only be spaced apart if there was an intended gap between the needle guard and the distal end of the needle hub. Contrastingly, the construction of “spaced apart relationship” argued by Braun below was that there was no need for a gap between the needle guard and the needle hub. Of course, such a gap was seen in Figure 1. The needle guard was located within the catheter hub (numbered 26) and was to be understood to include the mechanism within the catheter hub including the features numbered 122, 126, 128, 132 and 136a. There was a space appearing in Figure 1 between the rear wall of the needle guard (numbered 126 and described in the patent as “rear wall of needle protecting means”) and the distal end of the needle hub. Braun nevertheless contended below that the words “spaced apart relationship” in the claim which described the relationship between the needle guard and the needle hub did not require there to be a gap between the two and that they could be in a “spaced apart relationship” even though they might be touching, provided that they were not constructed as connected.
His Honour held (at [18]) that the construction advanced by Braun was to be preferred. His Honour reasoned that Figure 1 did show a gap in the catheter hub in the ready position, but that the function of the requirement of a “spaced apart relationship” was to enable the needle to be withdrawn and to be secured in the needle guard. His Honour said that the invention in the patent required the needle hub to move independently of the needle guard so that the needle may be guarded when retracted. His Honour said that the relationship between the needle guard and needle hub was that they were to be placed separately within the device during the course of construction without there needing to be a gap. His Honour said that any space or gap between the two would serve no function, but that what did serve a function was that the two be separate for the operation of the device. His Honour said that the relationship of being spaced apart is not a relationship which prevents the two from having a connection or to be touching at all times. The need for a gap between the two only becomes a necessary feature in the operation of the catheter and is provided for by a construction which ensures that the gap emerges in its operation. His Honour said that the description of the words refers to a relationship of two elements of the apparatus. The description in the claim is not that the needle guard is placed in the ready position with a gap between the needle guard and the distal end of the needle hub. Rather, the claim refers to a relationship between the needle guard and the needle hub. That relationship, so his Honour said, points to a positioning of the needle guard as a separate part of the apparatus permitting movement between the two.
We disagree with his Honour’s construction. In our opinion Multigate’s position is to be preferred. It accords with the plain meaning of the language used and the specification as a whole. It also gives meaning to the separate words “spaced” and “apart”. In other words, there must be separation and in a spatial sense. They must be apart, spatially; they cannot be in the same space, including one fitting within the space of the other.
His Honour’s construction has the effect of varying or qualifying a clear and unambiguous term in the claim. There is no reason why the words “spaced apart” should be given anything other than their ordinary English meaning.
As Multigate contended, the definition of the word “spaced” in the Macquarie Dictionary is expressed in the following terms:
verb 1.past participle of space. (In turn, the verb “space” is defined as: to fix the space or spaces of; divide into spaces; to set some distance apart; Printing, etc. to separate (words, letters, or lines) by spaces.)
adjective 2. placed at specific distances apart: evenly spaced; widely spaced.
Moreover, as Multigate contended, the following definitions of the adverb “apart” in the Macquarie Dictionary connote separation, being:
1.        in pieces, or to pieces: to take a watch apart.
2.        separately or aside in motion, place, or position.
3.        to or at one side, with respect to purpose or function: to set something apart.
4.        separately or individually in consideration.
…
In our opinion “spaced apart” has an ordinary English meaning. That meaning does not encompass no gap between the relevant objects or that the objects can be in the same space or that they can be touching. Such a construction ignores the word “spaced”. Multigate contended, and we accept, that no expert suggested that “spaced apart” had a special technical meaning in the field. Indeed, his Honour did not suggest that it had a special technical meaning. Accordingly, the construction of this phrase falls to be determined from the plain meaning in the context of the integer, in the context of the claim, and in the context of the specification as a whole.
Further, the specification does not define or describe the “spaced apart” integer at any point. Nor does it suggest that the integer has a temporal aspect such that the needle guard and needle hub can be spaced apart at some times but not others, which appears to be contemplated by Braun’s construction. Indeed, the only depiction of the claimed invention in Figure 1 shows the needle guard and needle hub in a spaced apart relationship within the ordinary English meaning of that phrase.
We agree with Multigate that the primary judge’s approach was erroneously influenced by irrelevant functional considerations. His Honour’s perspective was that it was not apparent to him that a gap between the needle guard and the needle hub would serve any function. He said at [18]:
The relationship between the needle guard and needle hub is that they are to be placed separately within the device during the course of construction without there needing to be a gap: any space or gap between the two would serve no function; what does serve a function is that the two be separate for the operation of the device. … Mr Leskowich accepted that there was no need for a gap to be present for the proper functioning of the device.

His astigmatic focus was on the function of the “spaced apart” integer in the course of operation and manufacture, which he relied on as a basis for ignoring the plain meaning of the words used.
Generally, his Honour’s approach also contradicts a principle of construction that the patentee must be taken to have used words of its own choosing. Tartly expressed, what is not claimed is disclaimed.
Braun has sought to support the primary judge’s approach. It did so in part by the expert evidence adduced before his Honour.
Dr Haindl stated in the joint expert report that he understood “spaced apart” as separate in the sense that there was no direct constructive connection between parts. During the concurrent oral evidence, he explained that he did not think that there had to be a big space between the two objects to make them spaced apart. If one could just take one off from the other, i.e. there were no forces between them or connections, then to his understanding they were separate and spaced apart. In other words the two objects could touch but still be spaced apart. However, he said that if something fitted within another structure tightly, then he would not regard it as spaced apart. Dr Haindl explained further that:
[T]he 327 Patent defines multiple ready positions and in only one of these multiple ready positions it’s possible that the two structures touch one another. In all the other positions, when there is more distance between the needle hub and the needle guard, then they can’t touch one another; and if in such a multitude of positions there is one position where they might touch — I don’t say they do — then I see them in a spaced apart relationship to one another.
…
Even if they might touch in the variety of these different positions, I think they are still in a spaced apart relationship, they are not connected to one another.
Contrastingly, Mr Bennett stated in the joint expert report that the “spaced apart” relationship means separate from or some distance apart. In cross-examination during the concurrent oral evidence he added that the 327 Patent is trying to indicate that these parts are not touching or in what he would regard as a manufacturing tolerance gap and that there was a significant gap there.
Mr Leskowich stated in the joint expert report that a “spaced apart relationship” means there is an intended gap that has been designed to be in between the distal face where the needle is mounted on the needle hub and the proximal wall of the needle guard. He did not understand the need for a gap to be present for proper functioning of the device. He believed that it refers to the method by which the device is assembled; the space is created during the assembly process. In cross-examination Mr Leskowich agreed that assembling one of these devices involves urging the catheter hub onto the needle guard. He agreed “absolutely” that when you do that the needle guard will jump forward as it goes over the protrusion. Braun has contended that Mr Leskowich’s interpretation was not inconsistent with Dr Haindl’s view that the two objects may touch each other but still be spaced apart. Braun also referred to the fact that the primary judge at [18] noted Mr Leskowich’s acceptance that there was no need for a gap to be present for the proper functioning of the device. Of course, that focuses upon functionality rather than what the words of the claim or the particular integer mean.
Braun also contended that one of the Macquarie Dictionary definitions for the words “spaced” and “apart” reveals a meaning which was said to be entirely consistent with that applied by the primary judge (at [18]) and the experts. It was said that “apart” encompasses the meaning of “in pieces”, “separately”, “to or at one side”. It was said that this is entirely consistent with the acceptance by the primary judge that the phrase required that the parts were not constructed to be connected.
It was also said that there is nothing in the dictionary definitions requiring the determination of manufacturing tolerances. It was asserted that Multigate’s construction that the two parts must be “separated from, and some distance apart from, each other (significantly more than a working tolerance gap or clearance)” impermissibly adds a substantial gloss to the words of the claim.
In our opinion it is apparent from their evidence given in the joint expert report that each of Mr Bennett, Mr Leskowich and Mr Spencer read the phrase “spaced apart relationship” with its ordinary English meaning. This meaning reflects the dictionary meaning of the two words “spaced” and “apart” read together and with the word “relationship” in the phrase used in the claim. It is not, as Braun would submit, the meaning of “apart” alone. Dr Esnouf agreed that the integer required that there be a physical space or distance between the objects but also, inconsistently, agreed with Dr Haindl.
The evidence of Mr Bennett, Mr Leskowich, Mr Spencer and Dr Esnouf is consistent with Figure 1 of the 327 Patent, which shows a space between the needle hub and the needle guard, and is not contradicted by anything in the body of the specification (which is silent on this issue).
Braun has resorted to function to read down the clear words of the claim. But the words of the claim are chosen by the patentee as we have already said. It has its reasons. It is not for us to speculate as to the patentee’s motives in choosing the particular words. Speculation as to functional motives is irrelevant. It is an attempt to read down the clear words of a claim, in the absence of any evidence which would demonstrate a rationale for such a departure.
Further, Mr Leskowich’s acceptance of the method of assembly over the protrusion in the catheter hub is inconsistent with Dr Haindl’s argument that components can be touching yet spaced apart. The 327 Patent explains that the needle guard is urged over the protrusion in the inner wall of the catheter hub with a special tool (page 7 lines 15 to 21). The needle hub does not touch the needle guard in assembly of the invention described in the specification. And when the apparatus is fully constructed, there is a gap between the relevant components, as shown in Figure 1. There is no need to resort to withdrawal of the needle after use to create a gap to fit the wording of the claim.
Moreover, Braun has ignored the component “spaced” in the phrase, and has relied on the explanation of Dr Haindl, who sought to bolster his construction by reference to so called multiple ready positions. It was enough for Dr Haindl if the needle guard and needle hub components were separate pieces that moved as the needle was withdrawn from the patient. But as Multigate correctly contended, this is nothing more than what the general type of safety IV catheters, with which the specification is concerned, inherently require. The needle and needle hub have to move relative to the needle guard.
Generally, the meaning given by his Honour at [18] adds various impermissible glosses to the plain meaning, namely: in the sense of “being placed separately within the device in the course of construction, and may have a connection or be touching”; and in the sense of “in operation moving independently when withdrawn from use within a patient and in the course of being retracted”.
His Honour’s reliance on the operation of the catheter to justify his construction adds glosses that are unnecessary if the ordinary meaning is used. The claim is not to a method for the use and disposal of a safety catheter; it is an apparatus claim.
In summary, we would uphold this ground of Multigate’s appeal. Moreover, and as we will address later, the correct construction of this integer has the consequence that Multigate’s catheters A, B and C do not infringe the claim of the 327 Patent. We would note at this point, however, that the 577 Patent does not contain this integer. Accordingly, his Honour’s findings on the infringement of the 577 Patent are not affected by this construction question.
(c) The ready position
What was meant by “ready position” in relation to the position of the needle?
His Honour dealt with this at [19]. He referred to Braun’s contention that the use of the words “ready position” in the claim referred to any position where the needle tip protrudes from the distal end of the catheter hub. Mr Leskowich, in contrast, contended that the words “ready position” when used in the claim meant ready for insertion into the patient, as might be assumed to be depicted in Figure 1. His Honour said that the construction advanced by Mr Leskowich had an intuitive appeal with the words “ready position” presupposing readiness for a purpose or use. However, his Honour said that the claim is not describing the use of the intravenous catheter in connection with a patient. Relevantly what is described is the position of the needle and its moveability from a ready position to a retracted position. The former describes the situation in which the needle is outside of the catheter hub and not secured by the needle guard. The latter is that point when the needle is positioned in the interior of the catheter hub and secured by the needle guard. His Honour concluded that the ready position is where the needle tip protrudes from the distal end of the catheter hub. Multigate has taken issue with his Honour’s construction.
Multigate contended that “ready position” is not separately defined in the 327 Patent. That is correct. It contended that the term “ready” in the context of the specification means the needle tip is exposed, “ready for insertion into the patient” (e.g. as shown in Figure 1). Instead, it was said that his Honour disregarded the context and made the findings referred to above.
It was also said that his Honour ignored the evidence of a clinician with experience in using intravenous safety catheters, namely, Mr Spencer.
Multigate contended that his Honour’s preferred construction did not give the word “ready” its usual English meaning. The first Macquarie Dictionary definition is “completely prepared or in due condition for immediate action or use”. The first Oxford Dictionary definition is “In a suitable state for an action or situation; fully prepared”. It was also said that his Honour’s construction ignored the context of the specification. It is said that the description of the invention in the specification reinforces the plain and clear meaning of the word “ready”. It is accepted that the claim is to an apparatus, the product being an improved safety IV catheter. It is said to be clear from the context provided by the specification that the safety needle assembly forming part of the safety IV catheter device is designed for insertion into a patient, and that it is designed to have two modes: one in which the needle point can safely be inserted into objects or persons, and one after the removal of the needle from the catheter (that is, after use) in which it cannot. It is said that these two modes are what are described in the claim as the “ready position” and the “retracted position”. However, the claim itself makes it clear that the “said ready position [is one] in which said tip is outside of said catheter hub”; it is not necessarily limited to readiness to use in a patient.
Multigate contended that it is legitimate to refer to the rest of the specification to explain the background of the claims. It is said that the words “ready” and “retracted” in the claims take their meaning from the specification. In particular, the specification states that:
Safety IV catheter devices comprise a needle protecting means which slides to the needle point as the needle is removed from the catheter and permanently blocks the needle point such that the needle point cannot be inserted into objects or persons (p 1 lines 4 to 8).
It is said that elements of the needle assembly are also described by reference to their position in relation to the patient (see the use of “proximal” on p 3 line 25).
Multigate contended that it was anything but practical to construe, as the primary judge did, the term “ready position” in the claim as meaning any position where the needle tip protrudes from the distal end of the catheter hub, rather than a position in which the needle tip could be inserted in the patient and so be used. It was said that this want of practicality was starkly demonstrated by the judge’s acceptance (relied on by him in his construction of “spaced apart relationship”) that the partially dismantled catheter C depicted at [50] at the top of p 34 satisfied the description of “ready position” (the reference to “retracted” at p 34 line 1 of his Honour’s reasons should refer to “ready”).
In our opinion, no error has been shown in his Honour’s approach. Further, it was supported by the expert evidence, although we accept that this cannot be definitive of the question.
Dr Haindl stated in the joint expert report that lines 5 to 10 of the claim define multiple ready positions, being any position where the needle tip protrudes from the distal end of the catheter hub. In cross-examination, Dr Haindl also said that the needle is in a “ready position” until it is engaged by the needle guard. Dr Haindl also explained that once the needle tip is withdrawn inside the catheter tube a small distance, it may be pushed forward again prior to insertion into the patient, with effectively no risk of damage to the catheter tube. This evidence contradicted the evidence of Mr Spencer of a “potential” risk of the needle bevel cutting the catheter.
Dr Esnouf stated in the joint expert report that he agreed with Dr Haindl (that is, there are multiple ready positions, where the needle tip protrudes from the distal end of the catheter hub), but also agreed that a “ready position” is a position that allows insertion of the catheter into a patient.
Mr Bennett stated in the joint expert report that the “ready position” refers to the position of the needle within the hollow tubular catheter outside the catheter hub. The needle may be protruding through the distal end of the catheter. As such, Mr Bennett’s construction did not exclude Dr Haindl’s construction.
Contrastingly, Mr Leskowich stated in the joint expert report that “ready position” means ready for insertion into the patient as depicted in Figure 1. He noted however that in accordance with other integers the needle was not ready to be used on a patient, but were referred to in terms of “ready position”. Accordingly, Mr Leskowich adopted his construction notwithstanding that the effect was an inconsistency with “ready position” as used in other integers being:
(a)“said needle being received within said tubular catheter when the needle is in a ready position”;
(b)“said needle being movable between said ready position in which said tip is outside of said catheter hub and a retracted position in which said tip is within the interior of said catheter hub”; and
(c)“wherein the needle guard has a resilient portion engaged by said needle shaft when said needle is in its ready position”.
Mr Spencer stated in the joint expert report that the needle’s “ready position” means the needle is ready to be inserted into the patient and ready for use. Insofar as Mr Spencer’s construction was consistent with that of Mr Leskowich, it suffered from the same vice.
In our opinion, given the difficulties with the construction advanced by Mr Leskowich and Mr Spencer, his Honour was entitled to reject their construction and adopt a construction which gave meaning to the claim and was consistent with the evidence of Dr Haindl and Dr Esnouf and not otherwise excluded by Mr Bennett.
On appeal before us, Multigate has relied on a dictionary definition apparently not cited to the primary judge to contend that “ready position” should be construed as “ready to use position”. But Multigate’s construction adds a gloss to the plain words of the claim: the patent could have used, but did not use, the term “ready to use position”.
In summary, the term “ready position” was appropriately construed by the primary judge. It accorded with the preponderance of expert evidence. It accorded with the plain meaning. It was also consistent with other references in the claim.
(d) Resilient portion
The question of construction raised before us concerned what was meant by the “resilient portion” of the needle guard.
His Honour dealt with this at [23] and [24]. He referred to the issue of disagreement between the parties concerning the “resilient portion” of the needle guard, which was whether it included the arms identified in Figure 1 by the numbers 122 and 124. His Honour said that the word “resilient” itself indicates something which resumes its original shape or position after movement. The needle guard in the invention blocks the needle tip when the needle is in the fully retracted position because parts of the guarding mechanism block the needle from moving forward. The claim refers to “the resilient portion blocking the needle tip” and the dispute concerning the construction of those words was whether that portion was limited to those parts of the guarding mechanism physically blocking the needle when fully retracted. His Honour referred to the fact that Mr Bennett pointed to the use of the word “portion” as indicating that only part of the needle guard was referred to as resilient by the claim rather than the whole of the mechanism which effected the blockage when the needle was fully retracted. His view was that the resilient portion did not include the arms but was intended to refer more narrowly to the parts of the mechanism that blocked the needle in the fully retracted position. Mr Leskowich expressed a similar view in the joint expert report when saying that the resilient portion was the area in Figure 2 between the lip identified by the number 132 and the elbow identified by the number 128.
His Honour referred to the fact that the patent (at page 5, lines 21 to 30) refers to the arms moving “resiliently” into the position shown in Figure 2 when the needle point passes the lips and arms:
When the needle point passes the lips 132 the arms 122, 124 resiliently move into the position shown in Fig. 2 in which the front walls 129, 130 cover the needle point. … The annular projection 136a retains the needle protecting means 120 in the catheter hub 26 when the needle 16 is removed from the catheter hub 26 until the arms 122, 124 of the needle protecting means 120 are no longer supported by the needle 16 and resiliently move towards the inside.
(emphasis added)
His Honour said that what causes the movement in the needle guard is the pressure in the points on the arms, which is released when the needle tip passes (backwards) the lips of the distal end of the guard. The arms (numbered 122 and 124) in the mechanism shown in Figure 2 spring together once the needle tip moves past the distal end of the mechanism in the proximal direction. The force or pressure in the mechanism (including the arms) which had been applied to the needle is released when the needle passes the lips. It is the whole of the mechanism (including the arms by the release of the pressure but excluding the proximal (rear) end wall of the needle guard) which blocks the needle tip when it resiliently effects the blockage of the needle.
Multigate has contended that the claim requires that a “portion” of the needle assembly be resilient. It says that the word “portion” means “a part of a whole” (Oxford Dictionary; first definition) or “a part of any whole, whether actually separated from it or not” (Macquarie Dictionary; first definition).
Multigate has contended that the claim of the 327 Patent also sets out certain other defining characteristics required of the resilient portion. It provides that the resilient portion of the needle guard:
(a)is engaged by the needle shaft when the needle is in its ready position;
(b)is movable within the interior of the catheter hub to a blocking position distal of the needle tip when the needle is in its retracted position in which the needle shaft no longer exerts [an outward] force on the resilient portion;
(c)enables an outer contact surface on the needle guard to be secured to a groove formed in the catheter hub hollow interior when the resilient portion is engaged by the side of the needle shaft and biased radially outward; and
(d)blocks the needle tip when the needle is in the fully retracted position.

Multigate asserted that rather than construing the term on the basis of the claim language having regard to the above defining characteristics, his Honour relied on a description in the specification of the arms as moving “resiliently” into position. It is said that on that basis his Honour concluded that the operation described involved the whole of the guard (but excluding the proximal end wall) (at [24]). Multigate has contended that in so doing, his Honour ascribed a meaning to the integer at odds with the words of the claim.
But again, in our view no error was made by his Honour. His construction was supported by the expert evidence and the claim language.
Dr Esnouf stated in the joint expert report that he understood the “resilient portion” of the needle guard to be that section which was capable of reciprocal movement during the operation of the needle guard. He believed this portion to be most of the needle guard excluding the proximal end wall. He did not believe that it was necessary for the resilient portion to be inherently resilient. In other words, in regard to the portion that was deemed resilient, it was not necessary that every part of it must be resilient. He believed this to be the case in regard to the needle guard shown in Figures 1 and 2.
In cross-examination, Dr Esnouf explained that it was not necessary that every part of the needle guard be resilient. Referring to Figure 1, Dr Esnouf did not see the area marked 132, which is the lip, as resilient in its own right. His reading of the nature of the formation of that metal curve suggested to him that it was quite rigid, not particularly resilient, and his interpretation of it was that the resilient portion included the lip, the wall, the elbow and the arms. His view was that the only portion that he would not regard as the resilient portion was the proximal end wall. In Figure 2, the parts he pointed to were all one physical part and it was consistent with his understanding of resilient portion in that Figure that it be one piece, but that not every part of that one piece be resilient. The resilient portion needed to move. There was a requirement for reciprocal motion, which gave it a characteristic that it would return to its original position after movement.
Dr Haindl stated in the joint expert report that he agreed with Dr Esnouf. If he compared Figure 1 with Figure 2, Dr Haindl saw that the crossing point of the arms would also move, which proved that they were also resilient.
Mr Leskowich stated in the joint expert report that, as defined in the patent, the “resilient portion” of the needle guard was defined as the area between the lip 132 and the elbow 128 on Figure 2. However, in cross-examination Mr Leskowich agreed that the arms were resilient because they moved resiliently. He also agreed that from page 5 line 27 of the patent the arms were identified as the resilient part of the needle protecting means.
Multigate’s other witness Mr Bennett took a position which adopted a narrow and uncertain construction of “portion”. Mr Bennett stated in the joint expert report that the “resilient portion” needed to satisfy a number of criteria, including having the ability to move without assistance from other elements to a blocking position when the needle shaft no longer exerted a force. He also stated that the use of the word “portion” indicated that only part of the needle guard was referred to as resilient and engaged the needle shaft in the ready position. In cross-examination Mr Bennett stated that the walls (items 129 and 130 in Figure 2) were part of what he would call the resilient portion. He maintained that these were the only parts of the needle guard referred to as the “resilient portion”, and said that “the arms may be resilient, but they’re not part of what I regard as the resilient portion, as described in the patent”. Mr Bennett’s opinion thus proceeded on a narrow construction of “portion”. He stated that the arms could not be part of the resilient portion because “that would no longer be a portion, it would be the entire needle guard”, notwithstanding that it would not include the proximal wall. He stated further that “[t]he resilient portion to me is a small part of the whole. If we were talking about the arms as being part of the resilient portion, it would be 99 per cent of the device, because the end wall is only 1 per cent of the entire length”.
The preponderance of expert evidence supported his Honour’s position. His Honour also noted (at [24]) that the patent refers to the arms moving “resiliently”. This was consistent not only with the views of Braun’s experts, but also with the view of Multigate’s expert Mr Leskowich. Even Mr Bennett agreed that the arms may be resilient, but took an isolated position based on his narrow construction of “portion”.
In our view, no error has been demonstrated in the construction of the primary judge that the term “resilient portion” of the needle guard includes its arms.
(e) “Positioned in the interior”
The final topic for construction of the claim of the 327 Patent concerned the catheter hub. There was only one issue of construction raised before us on appeal, namely, the meaning of “positioned in the interior of said catheter hub” in relation to the needle guard.
His Honour dealt with this issue at [30] and [31]. As he identified the issue, the dispute focused upon the extent, if any, to which the needle guard was to be positioned in the interior of the catheter hub. Dr Haindl’s view was that the needle guard would be positioned in the interior of the catheter hub if the majority of its length or volume was positioned in the interior. The view expressed by Mr Bennett overlapped with that of Dr Haindl, but Mr Bennett expressed himself as construing the words to be satisfied if the needle guard was positioned partially (even less than the majority) or wholly within the catheter hub. Contrastingly, Mr Leskowich expressed the view that his review of the Figures showed that the words required that the whole of the needle guard be entirely positioned in the interior of the catheter hub.
His Honour referred to the fact that the needle guard shown in Figure 1 was wholly positioned in the interior of the catheter hub, but the claim was not limited in that way and should not be interpreted as if it were limited. His Honour also said that there was no reason to reject Mr Bennett’s view that the words might be satisfied by less than the majority of the needle guard being positioned within the interior of the catheter hub. His Honour said that the extent of the positioning within the interior of the catheter hub may be so slight that it could not be regarded as being positioned in the interior of the catheter hub in any meaningful sense, but the words need not be restricted to a 50% or more interior placement of the needle guard within the catheter hub.
In our opinion, no error has been shown in his Honour’s approach to construction on this aspect.
THE 577 PATENT
Multigate has conceded that its catheters A, B and C had each of the integers to claims 1 to 6 of the 577 Patent, except for those integers in which the following words and phrases are underlined and emboldened:
In claim 1 of the 577 patent:
A safety IV catheter comprising:
(a)       a needle having a needle shaft and a needle tip;
(b)       said needle shaft comprising a bulge;
(c)       a hollow tubular catheter having a proximal end;
(d)said hollow tubular catheter is secured to the distal end of a catheter hub;
(e)said catheter hub having a hub section, wherein a chamber is formed in said hub section, and having an inner wall;
(f)a resilient spring clip needle guard located within said chamber being formed in said hub section of said catheter hub and having a distal end wall;
(g)said needle being received within said hollow tubular catheter when in a ready position, wherein said needle extends through said chamber, a passageway and distally beyond said catheter hub and said hollow tubular catheter so that said needle tip extends beyond the tapered distal end of said hollow tubular catheter and said needle guard located within said hub chamber is adapted to automatically snap or pivot into a retracted position for blocking access to said distal needle tip and preventing further movement of said needle tip when said needle is in its retracted position;
(h)said needle guard being adapted to be inserted into said catheter hub and to be urged by said needle shaft into contact with said inner wall of said catheter hub so that the needle guard is retained therein;
(i)and a groove or bump being formed in said inner wall of said catheter hub for engaging a curved protrusion of said needle guard for retaining said needle guard in said catheter hub in the ready position;
(j)said needle shaft of needle being adapted to engage said distal end wall of said needle guard when said needle is in its said ready position; and
(k)the said catheter hub being configured such that a force exerted by said needle shaft on said needle guard in said catheter hub is released when said needle is retracted causing said needle guard to pivot or snap to the retracted position in which said distal end wall blocks said needle tip;
(l)and said needle guard further comprising a proximal wall having an opening adapted to let said shaft of needle freely pass through and axially move; [denied for Catheters A and C, admitted for Catheter B]
(m)wherein said bulge has a diameter greater than that of said opening of said proximal wall. [denied for Catheters A and C, admitted for Catheter B]
In claim 2 of the 577 Patent:
“wherein said needle guard is adapted to automatically snap into said retracted position as said needle is being retracted for blocking access to said needle tip and preventing further distal movement of said needle tip to prevent accidental contact with said needle tip.”
In claim 3 of the 577 Patent:
“wherein said distal end wall terminates in a lip [denied for Catheter B, admitted for Catheters A and C] adapted to be engaged by said needle shaft when said needle is in its said ready position.”
In claim 4 of the 577 Patent:
“wherein the said catheter is configured such that a lower end or curved protrusion of said needle guard is urged by said needle shaft into retaining contact with said inner wall of said catheter hub when said needle is in its said ready position.”
In claim 5 of the 577 Patent:
“wherein said spring clip needle guard is configured such that a downward or radial force exerted by said needle shaft on said spring clip needle guard in said catheter hub is released when said needle is retracted to said retracted position, and said distal tip of said needle moves past a lip of said spring clip needle guard causing said spring clip needle guard to pivot or snap to said retracted position in which said distal end wall is adapted to block said needle tip.”
In claim 6 of the 577 Patent:
“wherein said resilient spring clip needle guard has two arms.”
Only a limited number of construction issues regarding these integers now remain in contention before us.
(a) “Preventing further movement”
The relevant part of claim 1 in which this integer appears is:
“…said needle guard located within said hub chamber is adapted to automatically snap or pivot into a retracted position for blocking access to said distal needle tip and preventing further movement of said needle tip when said needle is in its retracted position.”
The primary judge found (at [38]) that the experts were largely in agreement as to the meaning of “preventing further movement” in this context. His Honour accepted their view that the phrase conveyed the meaning of preventing the movement of the needle in the distal direction (beyond, perhaps, manufacturing tolerances) but not necessarily preventing rotational or other movement.
Multigate contended that his Honour’s construction of “preventing further movement” did not reflect the ordinary meaning of the phrase, nor was there any technical definition which was used in the specification or in the field.
Multigate said that his Honour impermissibly construed the phrase “preventing further movement” in the claims of the 577 Patent by reference to a “similar” word in the claim of the 327 Patent, stating at [38] that “[t]his phrase is similar to the word ‘secured’ previously considered in the context of patent 327”. It was said that his Honour’s association of these terms was central to his conclusion on infringement (at [64]). Multigate contended that it was not permissible to construe the terms of an independent patent claim by reference to another claim, particularly one from another patent.
It was said by Multigate that his Honour’s reliance on the function of “securing” to construe “preventing further movement” revealed the judge’s misconceived approach to claim construction. It was said that this flawed approach was apparent from the judge’s observations on the meaning of the phrase at [64] in the context of infringement:
However, the words “preventing further movement” mean that the needle could not escape the needle guard, not that there was no further movement within the needle guard. The purpose of the invention is to ensure that the needle, once fully retracted, is safely within the needle guard and cannot escape from the needle guard so as to cause needle prick.
We accept that it would be wrong to use the term “secured” in the 327 Patent as an aid to construction of the phrase “preventing further movement” as used in claim 1 of the 577 Patent. However, if that is what his Honour did, such error was, ultimately, without significance.
Multigate pointed to this part of claim 1, namely (emphasis added):
… for blocking access to said distal needle tip and preventing further movement of said needle tip when said needle is in its retracted position …
and said that the addition of “further” introduces an additional limitation to the prevention of movement inherent in the integer “blocking access to said distal tip” which, Multigate submitted, stops movement of the needle tip outside the needle guard. Multigate argued that the claim specifies that the needle guard is adapted to snap or pivot into a retracted position both for blocking access to the needle tip and for preventing further movement of the needle tip. Multigate submitted that the primary judge’s construction robs each integer of a separate meaning.
Multigate also pointed to dependent claim 2, which includes the additional limitation of “preventing further distal movement of the needle tip to prevent accidental contact with said needle tip” (emphasis added). In doing so, Multigate seems to submit that it was appropriate to use this claim to construe claim 1 – which is, of course, what the experts did, albeit in a way contrary to Multigate’s proffered construction.
Braun submitted that the primary judge construed the claim having regard to the purpose of the invention and that his Honour’s “purposive construction” was within established principles. It also relied on the understanding of its experts on this aspect.
We do not accept either approach. The primary judge accepted the evidence of the experts, in particular Dr Haindl and Mr Leskowich. In the joint expert report, Dr Haindl (with whom Mr Leskowich agreed) said that further movement in claim 1 meant “preventing further distal movement of said needle tip to prevent accidental contact with the said needle tip”. However, those additional words do not appear in claim 1. Dr Haindl (and, it would seem, Mr Leskowich) impermissibly relied on the further limitations of claim 2 and imported them into claim 1. The result was to add a gloss to the words of claim 1.
The phrase “preventing further movement” is to be construed according to its ordinary English meaning. It is not necessary to resort to notions of “purposive construction”. The experts did not give the phrase a technical meaning. Rather, they engaged in an impermissible mode of claim construction. The primary judge’s finding at [38] was affected by that error.
When claim 1 is read in its totality and in the context of the specification, it is apparent that when the needle guard is in a retracted position, it is adapted to block access to the needle tip and to prevent further movement of the needle tip beyond the confines of the retracted needle guard. This is, in fact, the construction adopted by the primary judge when considering (at [64]) the question of infringement. We agree with that construction. It is consistent with the object of the invention, as stated in the specification, of a needle protecting means which is fastened or retained in the catheter hub of the safety IV catheter device.
It is difficult to understand what limitations are added by claim 2 although, at the end of the day, it is not necessary for us to come to a view on that question. It may be, as Braun suggested in oral submissions, that claim 2 imports the limitation that the needle guard snaps into the retracted position “as the needle is being retracted”. But it does not seem to us that the words “preventing further distal movement of said needle tip to prevent accidental contact with said needle tip”, as used in claim 2, provide any practical limitation that is not already encompassed within, and effectively addressed by, the words “preventing further movement” as used in claim 1.
(b) “Resilient spring clip needle guard”
What was meant by the words “resilient spring clip needle guard”?
His Honour dealt with this issue at [39] and made the following observations. Integer (f) of claim 1 described the catheter as comprising a resilient spring clip needle guard located within the chamber being formed in the hub section of the catheter and having a distal end wall. The experts differed on the meaning of the words “resilient spring clip needle guard” and their disagreement included whether such a clip could be produced by any material other than metal. Dr Esnouf, with whom Dr Haindl agreed, said that the words “resilient spring clip needle guard” were to be understood as referring to a needle guard which had the characteristics of a spring (that is, which had the capacity to store energy), and was resilient such that following deformation the clip could return to its pre-deformation state. Dr Esnouf believed that it was possible to fabricate a resilient spring clip needle guard of a similar pattern to the design in Figures 1 and 2 from non-metallic material. He was cross-examined but confirmed his opinion that it would be possible to fabricate a resilient spring clip needle guard of the appropriate size to fit inside an intravenous catheter other than from metallic material although he did not necessarily say that the wall thickness of the guard would be identical. His evidence was of personal experience with folding material of sheet plastics, some of which had been reinforced with non-metallic materials in the context of a very small resilient ring used in a laryngeal mask. Mr Bennett and Mr Leskowich, in contrast, maintained that the words meant a spring metal material such as stainless steel or spring steel. Mr Leskowich in the joint expert report also stated that the resilient spring clip needle guard was to be made of “sheet metal”. His Honour concluded that the terms in the patent do not require the words in question to be construed as limited to a spring clip made from a metallic substance. His Honour said that the words were to be understood as referring to a clip having a resilient feature in the sense of moving back into a position after its static state was altered.
Before us, Multigate persisted with its contention that a “resilient spring clip needle guard” is one that is made of a metallic material with spring and resilient characteristics.
Multigate said that in construing the phrase his Honour relied on Dr Esnouf’s “belief” that a resilient spring clip needle guard possibly could be made of a non-metallic material (at [39]). It said that although evidence of Dr Esnouf’s belief in relation to this issue was given on the basis of his experience as an inventor, it was apparent from his Honour’s reasons at [12] that he accepted Dr Esnouf’s evidence on the basis that he was a qualified medical practitioner; contrastingly, contrary evidence was given by the toolmaker Mr Bennett and the medical device maker Mr Leskowich.

Multigate argued that claim 1 of the 327 Patent and claims 1 to 6 of the 577 Patent were not fairly based on the matter described in their respective specifications because a “groove” was not described. In support of this argument, Multigate said that the original ancestor was not incorporated in the specifications of the patents in suit and the consistory statements in the specifications of the patents in suit do not provide a sufficient basis. Thus, according to Multigate, the relevant claims travel beyond the descriptions of the inventions that have been given.
We reject these contentions. They are answered by our findings and conclusions at [264] to [272] above.
In particular, we do not accept that the consistory statements for claim 1 of the 327 Patent and claim 1 of the 577 Patent (on which claims 2 to 6 are dependent, directly or indirectly), considered in the context of the descriptions made, particularly with respect to Figure 1, do not provide a fair basis for the invention claimed.
(b) 577 Patent — catheter hub feature
Claim 1 of the 577 Patent requires that “the catheter hub be configured such that a force exerted by said needle shaft on said needle guard in said catheter hub is released when said needle is retracted”. His Honour found that this feature was concerned with the means by which the distal end walls of the needle guard block the needle tip when the needle is retracted (at [120]).
Multigate has contended that the passages relied on by his Honour to support his construction do not disclose the feature. The first passage described the removal of the needle but not that the design of the catheter hub plays a role in ensuring that the force exerted by the needle will be released when the needle is retracted. The second passage described the means by which the catheter hub is constructed, and does not refer to the needle at all. The third passage explained that the dimensions of the annular projection need to be such that the needle guard cannot slide out of the catheter hub and is retained in the catheter hub when the needle is withdrawn. It does not describe the needle as exerting any force.
It is said that the specification of the 577 Patent does not provide any description of how the integer might function. The only references to the integer are in the first consistory statement and claim 1. It is said that it is not possible to give the feature a meaning by regard to the specification. In summary, it is said that the feature is not fairly based on the description in the specification of the 577 Patent.
Generally, it is said that his Honour ought to have found that the catheter hub feature of the claims of the 577 Patent was not fairly based on the disclosure in the body of the specification.
We do not accept any of these contentions. We agree with Braun that Multigate has ignored the role played by Figure 1 and the basis that its role played in his Honour’s reasons.
NOVELTY — 327 PATENT
Multigate has contended that the invention claimed in the 327 Patent was anticipated by the Kuracina patent being patent WO199731666, published on 4 September 1997 in Switzerland. This is the only relevant prior art left in the frame if his Honour’s and our views are correct concerning the priority date.
Multigate submits that the Kuracina patent disclosed every integer of claim 1 of the 327 Patent. The Kuracina patent was published in Australia on 16 September 1997, earlier than the earliest possible priority date of the claim of the 327 Patent. It is said that the Kuracina patent therefore qualified as prior art information under s 7(1)(a) and was capable of anticipating the claim of the 327 Patent.
Section 18(1)(b) relevantly provides that:
… an invention is a patentable invention … if the invention, so far as claimed in any claim:
…
(b)when compared with the prior art base as it existed before the priority date of that claim:
(i) is novel; …
In relation to “novelty” s 7(1) relevantly provides:
Novelty
(1)For the purposes of this Act, an invention is to be taken to be novel when compared with the prior art base unless it is not novel in the light of any one of the following kinds of information, each of which must be considered separately:
(a)prior art information (other than that mentioned in paragraph (c)) made publicly available in a single document or through doing a single act;
(b)prior art information (other than that mentioned in paragraph (c)) made publicly available in 2 or more related documents, or through doing 2 or more related acts, if the relationship between the documents or acts is such that a person skilled in the relevant art would treat them as a single source of that information;
(c)prior art information contained in a single specification of the kind mentioned in subparagraph (b)(ii) of the definition of prior art base in Schedule 1.
The term “prior art information” used in s 7(1) is defined in the dictionary in schedule 1 of the Act by reference to the “prior art base” as follows:
prior art base means:
(a)in relation to deciding whether an invention does or does not involve an inventive step or an innovative step:
(i)information in a document that is publicly available, whether in or out of the patent area; and
(ii)information made publicly available through doing an act, whether in or out of the patent area.
(b)      in relation to deciding whether an invention is or is not novel:
(i)        information of a kind mentioned in paragraph (a); …
(a)       His Honour’s reasons
Multigate contended, and Braun did not dispute, that although the terms of s 7 and the definition of “prior art base” have subsequently altered, nothing relevantly turned on the changed wording.
His Honour referred to the test for anticipation explained by Aickin J in Meyers Taylor Pty Ltd v Vicarr Industries Ltd (1977) 137 CLR 228 at 235:
The basic test for anticipation or want of novelty is the same as that for infringement and generally one can properly ask oneself whether the alleged anticipation would, if the patent were valid, constitute an infringement …
His Honour also referred to Bristol-Myers Squibb Co v F H Faulding & Co Ltd (2000) 97 FCR 524 where Black CJ and Lehane J said at [67]:
What all those authorities contemplate, in our view, is that a prior publication, if it is to destroy novelty, must give a direction or make a recommendation or suggestion which will result, if the skilled reader follows it, in the claimed invention. A direction, recommendation or suggestion may often, of course, be implicit in what is described and commonly the only question may be whether the publication describes with sufficient clarity the claimed invention or, in the case of a combination, each integer of it.
His Honour also referred to Hill v Evans (1862) 45 ER 1195 at 1199; 1A IPR 1 where Lord Westbury LC expressed the test in terms of whether a person with ordinary knowledge of the relevant subject would be able practically to apply the prior published discovery without the necessity of carrying out further experiments: see also H Lundbeck A/S v Alphapharm Pty Ltd (2009) 177 FCR 151 at [173] and [174] per Bennett J (with whom Middleton J agreed).
Before the primary judge, Multigate relied upon the Kuracina patent as disclosing each integer of claim 1 of the 327 Patent. Braun admitted that the Kuracina patent disclosed various integers of claim 1 of the 327 Patent but said that there was absent in the Kuracina patent the features italicised below from the integers in claim 1 of the 327 Patent, namely:
(a)“said needle being moveable between said ready position in which said tip is outside of said catheter hub and a retracted position in which said tip is within the interior of said catheter hub”;
(b)“a needle guard positioned in the interior of said catheter hub in a spaced apart relationship from the distal end of the needle hub”;
(c)“the needle guard resilient portion is moveable within the interior of said catheter hub to a blocking position distal of said needle tip when said needle is in its retracted position in which said needle shaft no longer exerts a force on said resilient portion of said needle guard”.
In essence, the dispute before his Honour concerning the disclosure of the Kuracina patent came down to whether the blocking mechanism disclosed by the Kuracina patent was located within the catheter hub. The experts were asked whether there was a needle guard located within the chamber in the Kuracina patent. Conflicting opinions were expressed. Dr Haindl expressed the view that the needle guard was not located within the chamber of the catheter hub, but that it was connected with it by a modified cone and a moveable arm to hook into a recess in the catheter chamber. Mr Bennett took the contrary view, namely, that the needle guard was located in the catheter hub. Mr Leskowich referred to some additional drawings to which the other two had not made reference in which he maintained that the needle guard was shown to be located within the catheter hub of the chamber.
As we have said, the Kuracina specification was published on 4 September 1997 in Switzerland. It is entitled “needle tip guard for hypodermic needles” and disclosed a range of hypodermic needle devices including IV catheters. The invention was summarised in various embodiments. It referred to a needle guard assembly containing a moveable needle trap that was biased against or towards the hypodermic needle, which had a tether or other limiting means to limit the forward movement of the needle guard along the needle. On page 6, one embodiment was described:
In one embodiment the needle guard assembly of the present invention includes a needle guard that is slidably mounted on a hypodermic needle having a needle tip located at the distal end of the needle. The needle guard contains a moveable needle trap that is biased against or towards the hypodermic needle. The needle trap advances over the tip of the needle, entrapping the needle tip as the needle guard is urged forward near the sharpened distal end of the hyper‑dermic needle. A tether, or other limiting means, limits the forward movement of the needle guard along the needle. In one embodiment, the needle guard is manually urged forward along the shaft of the needle by the user. In yet another embodiment, a spring, or other biasing means, is used to move the needle guard along the shaft of the needle.
Later, the specification provided:
In one embodiment, the coupling mechanism includes an arm having a proximal end and a distal end. The proximal end of the arm is attached to the moveable needle trap. The distal end of the arm includes a projection that is releasably retained within a recess of a catheter hub. Hence, as the needle trap moves inward to entrap the needle tip, the arm also moves inward. The inward movement of the arm causes the arm’s distal projection to be released from the catheter hub recess, thereby permitting a separation between the needle guard assembly and the catheter hub.
Figures 61 to 63 were described as illustrating a catheter in accordance with one embodiment of the Kuracina invention. The Figures principally relevant to the present issue were those numbered 61 to 63, although before his Honour, Mr Leskowich referred to 114, 118 and 123.
Figures 61, 62 and 63 showed a catheter in accordance with the Kuracina invention:
The Kuracina patent described Figures 61 to 63 in the following terms:
Figure 61 is a cross sectional top view of the invention shown on an indwelling catheter 29 embodiment, having a movable needle guard 22a and a separable indwelling I.V. catheter 29, said catheter 29 being fixedly attached to a catheter hub 13, an I.V. catheter mounting section 9 having a fixedly attached hollow bore hypodermic needle 10 having a sharpened distal end 11; a hub portion 15 having a section 16 for removably attaching a protective storage cover 54, a slidable needle guard 22a being fixedly attached to said hub portion 15 by means of a limiting tether, said needle guard 22a having a projection or finger post 80 for advancing said separable catheter 29 and said needle guard 22a along said hypodermic needle 10 so said catheter may be inserted into a blood vessel, said hypodermic needle 10 being slidable through a guide aperture 47 in said movable needle guard 22a, said needle guard 22a having a movable needle trap 41 with a corresponding slot 31 for receiving the needle trap 41 when said trap 41 moves beyond the needle tip 11, said needle guard 22a having an open collar or washer 30 for retaining the resilient member 19 on the proximal end of said needle guard 22a, said resilient member 19 being slidably held on said needle guard 22a by the notch or indentation 60, said movable needle trap 41 having a lead-in area 33 for locating said resilient member 19 on said needle guard 22a into notches 60 and/or 61, said needle trap 41 also having a notch or indentation 61 for retaining said end coils of said resilient member 19, with the distal end of said needle guard 22a having a male section 78 for removably attaching an indwelling I.V. catheter hub 13, with a section of said male section 78 having a movable arm 42 for releasably retaining a catheter hub 13 from said male section 78 during initial insertion of the catheter 29 into a patient. Said catheter hub 13 having an inner channel, recess, slot or undercut 32 for being releasably held by said movable arm 42. Said movable arm 42 could also comprise a metal component which is inserted during or after said male section 78 is manufactured.
Said hub portion 15 could also comprise the latching arm 26 shown in other drawings in this application, otherwise said needle guard 22a would be releasably held adjacent to said hub portion 15 prior to use by a frictional or wedged means.
Figure 62 is a cross sectional top view of the movable needle guard 22a shown in Figure 61 on an indwelling catheter embodiment, containing the elements shown and described in the movable needle guard 22a, whereby the catheter 29 has been inserted in a blood vessel and the needle 10 is being retracted into said needle guard 22a as the needle 10 is being pulled away from said catheter insertion site, whereby the movable arm 42 on the male section 78 is free to move where the needle has been residing within the distal male section 78 of the needle guard 22a, allowing the catheter hub 13 to remain in the blood vessel and freely separate from the needle guard 22a, with the needle trap 41 sliding on said needle 10. The needle guard 22a is attached to the hub portion 15 shown in Figure 61 whereby a fixedly attached tether (not shown) limits the forward movement of the needle guard 22a, safely trapping the needle tip 11.
Said catheter hub 13 having an inner channel, recess, slot or undercut 32 for being releasably held by said movable arm 42.
Figure 63 is a cross sectional top view of the movable needle guard 22a shown in Figures 61 and 62 on an indwelling catheter 29 embodiment, containing the elements shown and described in Figures 61 and 62, including the movable needle guard 22a, a tether (not shown) and catheter 29, whereby the catheter 29 has been inserted in a blood vessel and the needle 10 is safely retracted within said needle guard 22a whereby the movable arm 42 has moved inwardly releasing the hold on the catheter hub 13, with the needle trap 41 now safely trapping the needle tip 11. Movable arm 42 includes a corresponding receiving slot 166 for receiving said movable arm 42. Said needle guard 22a having said movable needle trap 41 located within the corresponding slot 31 after said trap 41 has moved beyond the needle tip 11. Said needle guard 22a is attached to the hub portion 15 as shown in Figures 61 and 62 whereby a tether limits the forward movement of the needle guard 22a, safely trapping the needle tip 11. Said catheter hub 13 having an inner channel, recess, slot or undercut 32 for being releasably held by said movable arm 42.
The movable arm protrusion 42 can comprise a “v” shaped configuration which allows the catheter hub 13 to separate even in the event the movable arm 42 has taken a set during storage. A set during storage could inhibit the separation of said catheter hub 13 from said mounting section 78.
Before his Honour much of the dispute between the parties concerned the role played by items 41 and 42 in the diagrams and the description in the patent. Mr Bennett concluded that Kuracina disclosed a needle guard positioned in the interior of the catheter hub because item 42 was located within the catheter hub. That assumed that moveable arm 42 of Figures 61 to 63 blocked the needle tip. Mr Bennett said:
The problem for the designer is that now unless item 42 blocks the needle tip, the device is actually dangerous because the catheter hub can fall away and the needle will be exposed and that’s why he’s created this groove here, exactly the same situation as in the other blocking device. So my interpretation of the drawing is that this is definitely designed to act as a needle guard in what I’m calling the retracted position …
Contrastingly, Dr Haindl saw the needle trap as the item numbered 41 and that the item labelled 42 was only a moveable arm to couple the needle guard to the catheter hub. Dr Haindl’s opinion was said to be consistent with Figure 63 and what was said in the body of the specification, namely, that 42 releases the hold on the catheter hub while 41 traps the needle tip.
His Honour considered that the better view was that of Dr Haindl. In our view his Honour was quite entitled to prefer Dr Haindl’s opinion. His Honour elaborated. Figures 61, 62 and 63 showed the point of attachment of the needle protecting means and the catheter hub. The hub is separate from the needle protecting means and the latter is not within the interior of the catheter hub. The moveable arm 42 does not, as can be seen in Figure 63, block the needle tip, but has as its only function the attachment of the needle guard to the catheter hub. His Honour said that the evidence of Dr Haindl was also to be preferred on this question because of his extensive expertise in the design, development and manufacture of medical devices in comparison to Mr Bennett’s relative lack of experience in the field. His Honour said that Mr Bennett’s view about the role of moveable arm 42 should also not be accepted because his view of the blocking role of moveable arm 42 was not the subject of a direction, recommendation or suggestion by the patent itself.
His Honour also said that the Kuracina patent did not disclose the integer referred to in [311(a)] above in claim 1 of the 327 Patent because the claim required the tip of the needle to be blocked within the catheter hub in its retracted position and the moveable arm in Figure 63 of the Kuracina patent was not within the catheter hub in its retracted position.
His Honour referred to the fact that Mr Leskowich offered an additional comment in support of Multigate’s contention that the relevant feature of the 577 Patent could be seen to be located within the catheter hub from Figures 114, 118 and 123. His Honour said that the relevant features were best seen from Figure 118 of the Kuracina patent:
Multigate submitted to his Honour, based upon Mr Leskowich’s observation, that it was apparent from Figure 118 that lip 42 was located within the catheter hub. Mr Bennett was asked about Figure 118 in light of the description of the needle guard in the Kuracina patent as being adjacent to the catheter hub rather than being located within the interior. His evidence was that, despite the patentee’s wording, the needle trap 41 was actually inside the catheter hub as shown in Figure 118. That was because, according to Mr Bennett, the lip part numbered 42 in Figure 118 is part of the needle trap numbered 41 and the lip part numbered 42 is located within the chamber of the catheter hub. His Honour said that it was true that Figure 118 shows that part of the feature including both items numbered 41 and 42 was within the catheter hub but he said that to regard that part numbered 41 as being within the catheter hub because a small portion of it (namely that numbered 42) is within the catheter hub would not be an accurate statement as a matter of language or function of the invention. His Honour said that an element of the needle trap shown in Figure 118 was within the interior of the catheter hub but it was not wholly “located within” or “within the interior” of the catheter hub nor was it substantially or significantly located within the interior of the catheter hub such as to be an anticipation of the 327 Patent.

Ultimately, his Honour held that there had been no anticipation.
(b) Multigate’s arguments
Multigate has contended that his Honour gave the phrase “positioned in the interior” of the catheter hub an uncertain and indeterminate meaning, which was not supported by anything in the specification. As we have said earlier, we reject that contention.
As his Honour noted at [106], the dispute between the parties concerning the disclosure of the Kuracina patent came down essentially to whether the blocking mechanism disclosed by the Kuracina patent was located within the catheter hub.
This issue was dealt with as topic 15 of the joint expert report, which posed the question: does the Kuracina patent disclose a needle guard “positioned in the interior” of a catheter hub?
Mr Bennett’s answer was “Yes, shown in Figure 61/62(42), item 42 is positioned in the interior of the catheter hub and acts as a needle guard during needle retraction”.
Figures 61, 62 and 63 have been reproduced earlier at [316]. It is apparent that item 42 (movable arm) is located wholly within the catheter hub both prior to the retraction of the needle (Figure 61) and when it moves during retraction of the needle (Figure 62).
But there was no dispute that item 41 (needle trap) is a “needle guard”. And item 41 is located outside the catheter hub at all times.
Contrary to Multigate’s submissions, the acceptance or rejection of Mr Bennett’s evidence did not turn upon a construction of “positioned in the interior”, but rather turned on whether movable arm 42 constituted a “needle guard” which blocked the needle in addition to needle trap 41.
The issue of alleged lack of clarity asserted by Multigate is without substance.
At [109] the primary judge accepted Dr Haindl’s evidence that the movable arm 42 of the Kuracina patent does not block the needle tip, but has as its only function the attachment of the needle guard to the catheter hub. The primary judge correctly held that this can be seen in Figure 63.
Generally, the primary judge at [109] preferred the evidence of Dr Haindl over that of Mr Bennett because of Dr Haindl’s extensive directly relevant experience by contrast with that of Mr Bennett.
Dr Haindl’s evidence confirms that the Kuracina specification, as the primary judge correctly identified, does not direct, recommend or suggest that the “movable arm 42” has a blocking role, whereas it does do so with respect to “the needle trap” 41. As the “needle trap 41” is not within the needle hub, Figures 61 to 63 of the Kuracina patent did not anticipate claim 1 of the 327 Patent.
CONCLUSION
We have rejected all of Multigate’s grounds of appeal on invalidity. Accordingly its appeal in VID 693 of 2014 must be dismissed. We also do not see any good reason why costs ought not follow the event.
As to Multigate’s appeal on the question of construction and infringement, Multigate has had partial success in that we have concluded that its catheters A, B and C do not infringe the claim of the 327 Patent. Accordingly, the appeal in VID 681 of 2014 should be allowed in part.
We will give the parties an opportunity to file short submissions in terms of the appropriate consequential orders that should be made in VID 681 of 2014 and on the question of costs.

I certify that the preceding three hundred and thirty-seven (337) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justices Bennett, Yates and Beach.
Associate:
Dated: 3 March 2016

Appeal from:	B Braun Melsungen AG v Multigate Medical Devices Pty Ltd [2014] FCA 1110
File numbers:	VID 681 of 2014 VID 693 of 2014
Judges:	BENNETT, YATES AND BEACH JJ
Date of judgment:	3 March 2016
Catchwords:	PATENTS – intravenous catheters – safety needle protecting devices – construction of integers of claims – infringement – infringement claim upheld by primary judge – leave to appeal granted – appeal allowed in part PATENTS – cross-claim for invalidity dismissed by primary judge – chain of ancestor patents – entitlement of patents to priority dates of ancestor patents – external fair basis – whether claims of patents fairly based upon matter disclosed in ancestor patents – whether ancestor patents provided real and reasonably clear disclosure of subsequent claims – whether disclosures in ancestor patents incorporated by reference in subsequent patents – internal fair basis – novelty – appeal dismissed
Legislation:	Patents Act 1990 (Cth) ss 7, 18(1), 40(3), 43(2), 79B(1) Patents Regulations 1991 (Cth) reg 3.12
Cases cited:	Australian Mud Company Pty Ltd v Coretell Pty Ltd (2011) 93 IPR 188 Bristol-Myers Squibb Co v F H Faulding & Co Ltd (2000) 97 FCR 524 CCOM Pty Ltd v Jiejing Pty Ltd (1994) 51 FCR 260 C Van Der Lely N.V. v Bamfords Ltd [1963] RPC 61 Flexible Steel Lacing Co v Beltreco Ltd (2000) 49 IPR 331 H Lundbeck A/S v Alphapharm Pty Ltd (2009) 177 FCR 151 Hill v Evans (1862) 45 ER 1195 Inverness Medical Switzerland GmbH v MDS Diagnostics Pty Ltd (2010) 85 IPR 525 Jupiters Ltd v Neurizon Pty Ltd (2005) 222 ALR 155 Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd (2001) 207 CLR 1 Kinabalu Investments Pty Ltd v Barron & Rawson Pty Ltd [2008] FCAFC 178 Leonardis v Sartas No 1 Pty Ltd (1996) 67 FCR 126 Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (2004) 217 CLR 274 Meyers Taylor Pty Ltd v Vicarr Industries Ltd (1977) 137 CLR 228 O’Kelly Holdings Pty Ltd v Dalrymple Holdings Pty Ltd (1993) 45 FCR 145 Olin Corporation v Super Cartridge Co Pty Ltd (1977) 180 CLR 236 Populin v HB NomineesPty Ltd (1982) 41 ALR 471 Rehm Pty Ltd v Websters Security Systems (International) Pty Ltd (1988) 81 ALR 79 Sachtler GmbH and Co KG (formerly Sachtler AG) v RE Miller Pty Limited (2005) 65 IPR 605 Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth [2011] FCAFC 132 Vehicle Monitoring Systems Pty Ltd v Sarb Management Group Pty Ltd (No 2) (2013) 101 IPR 496
Dates of hearing:	18, 19, 20, 21 May 2015
Date of last submissions:	28 May 2015
Registry:	Victoria
Division:	General Division
National Practice Area:	Intellectual Property
Sub-area:	Patents and Associated Statutes
Category:	Catchwords
Number of paragraphs:	337
Counsel for the Appellant:	Ms J Baird SC, Ms H M J Rofe QC and Ms C I Cunliffe
Solicitor for the Appellant:	Chrysiliou Lawyers
Counsel for the Respondents:	Mr D Shavin QC and Mr E J C Heerey SC
Solicitor for the Respondents:	Davies Collison Cave Law

JUDGES:	BENNETT, YATES AND BEACH JJ
DATE OF ORDER:	3 March 2016