Kerry Chrysiliou v B. Braun Melsungen AG - [2016] APO 25

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Kerry Chrysiliou v B. Braun Melsungen AG [2016] APO 25

Patent Application: 2011287917

Title:Needle Safety Device and Assembly

Patent Applicant:                   B. Braun Melsungen AG
Opponent:  Kerry Chrysiliou
Delegate:  M. G. Kraefft
Decision Date:  5 May 2016
Hearing Date:  22 March 2016, in Canberra

Catchwords: PATENTS – section 59 – opposition to grant of a patent – whether evidence in reply was properly evidence in reply – evidence found to be properly in reply – priority date valid – whether claimed invention was novel – prior use not established – claims novel over prior art documents and over alleged prior use – whether invention described fully – whether claims fairly based and clear – opposition failed on all grounds.

Representation: Patent applicant: Mr Edward J Heerey, of counsel, assisted by Mr Michael Cooper and Mr Mathew Lucas, patent attorneys, Davies Collison Cave, and Mr Kevin Woehr of B. Braun Melsungen AG.
Opponent: Ms Kerry Chrysiliou, patent attorney, Chrysiliou IP.

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2011287917

Title:Needle Safety Device and Assembly

Patent Applicant: B. Braun Melsungen AG
Date of Decision: 5 May 2016
DECISION
The opponent’s evidence in reply is properly evidence in reply. Nonetheless the opposition fails on all grounds raised in this opposition.
Subject to appeal, I direct the application proceed to grant.
Costs in accordance with Schedule 8 awarded against the opponent, Kerry Chrysiliou.
REASONS FOR DECISION
BACKGROUND

B. Braun Melsungen AG (“the applicant”) filed patent application 2011287917 on 26 July 2011. The application claims an earliest priority date of 5 August 2010 from a US patent application (“the priority document”). Application 2011287917 was advertised accepted on 3 July 2014.
Kerry Chrysiliou (“the opponent”) filed a notice of opposition to the grant of a patent on 3 October 2014. A statement of grounds and particulars followed on 5 January 2015.
The parties completed the evidentiary stages on 14 September 2015.
SPECIFICATION
The specification describes the background to the alleged invention generally relating to needle safety assemblies and safety intravenous catheters (“IVCs”) and, in particular, to a safety IVC in which the needle tip is automatically covered after needle withdrawal to prevent unintended needle stick with the needle tip.
IVCs are primarily used to administer fluids directly into a patient’s vascular system. Typically, a catheter is inserted into a patient’s vein by a health care worker. Immediately after the withdrawal of the needle from the patient’s vein, the exposed needle tip creates a danger of an accidental needle stick occurring, which leaves the health care worker vulnerable to the transmission of various dangerous blood-borne pathogens.
The specification states this danger has led to the development of safety IVCs that cover or hide the needle tip using several different means. However, some safety IVCs that have been developed sometimes fail to prevent unintended needle sticks from occurring. For example, in some safety IVCs, the turning of the needle during removal may cause the needle tip to slide out from within the confines of the needle guard. In other IVCs, the engagement that typically occurs between the needle and the needle guard during withdrawal of the needle is unreliable.
The specification ends with 29 claims. The independent claims are claims 1, 9, 10, 18 and 25. These claims are listed below. For ease of comparison, since claims 1, 9 and 10 are very similar to each other, I have highlighted the differences of claims 9 and 10 when compared with claim 1.
Claim 1: A needle assembly comprising:
a needle guard having a non-metallic base portion comprising a wall having a bore, a bore length, a bore diameter, a proximally facing surface, and a distally facing surface; and
a first arm including a first free end and a second arm including a second free end extending generally axially in a distal direction from the base portion, the first free end extending beyond the second free end and including an angled end section comprising a first side edge, a second side edge, a length, and a width that extends toward the second arm;
an open area or open space or needle tip holding space defined at least in part by the base portion, the first arm, the second arm, and the angled end section;
a needle having a tip and a diameter;
wherein the first arm and the second arm are biased so as to move between a ready position in which the angled end section abuts the needle and a protected position in which the needle tip is confined within an open area or open space or a tip holding space; and
wherein the length and width of the angled distal end section are larger than the needle diameter and dimensioned so as to confine the needle tip within the open area or open space or needle tip holding space as the needle guard pivots and/or turns on the needle shaft.
Claim 9: A needle assembly comprising:
a needle guard having a non-metallic base portion comprising a wall having a bore, a bore length, a bore diameter, a proximally facing surface, and a distally facing surface; and
a first arm including a first free end and a second arm including a second free end extending generally axially in a distal direction from the base portion, the first free end extending beyond the second free end and including an angled end section comprising a first side edge, a second side edge, a length, and a width that extends toward the second arm;
an open area or open space or needle tip holding space defined at least in part by the base portion, the first arm, the second arm, and the angled end section;
a needle having a tip and a diameter;
wherein the first arm and the second arm are biased so as to move between a ready position in which the angled end section abuts the needle and a protected position in which the needle tip is confined within an the open area or open space or a needle tip holding space; and
wherein the length and width of the angled distal end section are larger than the needle diameter and ~~dimensioned so as~~ wherein the bore diameter has a close fit ratio versus the outside diameter of the needle shaft or the bore length is utilized in combination with the bore diameter to minimize the amount of pivoting and/or turning of the needle guard on the needle to ~~confine~~ retain the needle tip within the open area or open space or needle tip holding space ~~as the needle guard pivots and/or turns on the needle shaft~~.
Claim 10: A needle assembly comprising:
a needle guard having a non-metallic base portion comprising a wall having a bore, a bore length, a bore diameter, a proximally facing surface, and a distally facing surface; ~~and~~
a first arm including a first free end and a second arm including a second free end extending generally axially in a distal direction from the base portion, the first free end extending beyond the second free end and including an angled end section comprising a first side edge, a second side edge, a length, and a width that extends toward the second arm and the second arm comprising a distal end most surface comprising a length and a width;
a metallic plate comprising an opening attached to the non-metallic base portion;
an open area or open space or needle tip holding space defined at least in part by the base portion, the first arm, the second arm, and the angled end section;
a needle having a tip and a diameter;
wherein the first arm and the second arm are biased so as to move between a ready position in which the angled end section abuts the needle and a protected position in which the needle tip is confined within an open area or open space or a tip holding space; and
wherein the ~~length and~~ width of the angled distal end section of the first arm ~~are larger than the needle diameter and dimensioned so as~~ is greater than the width of the second free end between a fraction of to about 50% greater than the width of the second free end to confine the needle tip within the open area or open space or needle tip holding space as the needle guard pivots and/or turns on the needle ~~shaft~~.
Claim 18: A safety catheter assembly comprising:
a catheter hub with an interior cavity and having a catheter tube attached thereto;
a needle hub with a needle attached thereto projecting through the catheter hub and the catheter tube;
a needle guard disposed, at least in part, inside the interior cavity of the catheter hub,
said needle guard comprising:
a non-metallic base portion comprising a wall having bore (sic), a proximally facing surface, and a distally facing surface;
a first arm including a first free end and a second arm including a second free end extending generally axially from the base portion in a distal direction, the first free end extending beyond the second free end and including an angled end section that extends toward the second arm,
wherein the angled distal end section comprises a length and a width sized and shaped to retain a needle having a needle diameter within an open area or open space or tip holding space as the needle guard pivots and/or turns on the needle; and
wherein the width of the angled distal end section is greater than a width of the second free end and at least 125% greater than a diameter of the needle to confine the needle tip within the open area or open space or needle tip holding space.
Claim 25: A method for assembling a needle assembly comprising:
providing a needle having a needle shaft, a needle tip, and a change in profile near the needle tip on a needle hub;
placing a needle guard slidably about the needle shaft; said needle guard comprising:
a non-metallic base portion comprising a wall having a bore, a bore length, a bore diameter, a proximally facing surface, and a distally facing surface; and
a first arm including a first free end and a second arm including a second free end extending generally axially in a distal direction from the base portion, the first free end extending beyond the second free end and including an angled end section comprising a first side edge, a second side edge, a length, and a width that extends toward the second arm and the second arm comprising a distal end most surface comprising a length and a width;
an open area or open space or a needle tip holding space defined at least in part by the base portion, the first arm, the second arm, and the angled end section;
wherein the width of the angled distal end section is greater than the width of the second free end between a fraction of to about 50% greater than the width of the second free end and cooperates with the (sic) a metallic plate located on the non-metallic base to confine the needle tip within the open area or open space or needle tip holding space as the needle guard pivots and/or turns on the needle; and
moving the needle guard to a proximal position on the needle shaft so that the angled end section is biased by the needle shaft and spaced from the needle tip.
STATEMENT OF GROUNDS AND PARTICULARS
The opponent’s grounds of opposition were that the alleged invention was not novel and did not involve an inventive step, and that the complete specification did not describe the invention fully and that the claims were not fairly based or clear. The opponent provided several particulars relating to these grounds. At the hearing the opponent no longer pressed the ground of lack of inventive step.
EVIDENCE IN SUPPORT
The opponent filed evidence in support in the form of a single declaration from Ms Michelle Di Sciascio and in the form of two declarations from Ms Kerry Chrysiliou.
At the time of her declaration, Ms Sciascio had been employed since approximately July 2008 as a customer services manager for an Australian company. She was responsible for purchase orders and the management of warehouse and customer service teams in supplying a range of imported products such as safety catheters to the Australian market on behalf of the company. Ms Sciascio principally discussed some of her company records in respect to the supply of samples of particular catheters to prospective customers and at industry conferences, and the sales of such catheters to customers.
Ms Chrysiliou is the opponent in the present case, and a solicitor and registered patent attorney. In her first declaration, Ms Chrysiliou principally exhibited documents of alleged prior art against the present application. She also discussed and exhibited some elements of prior litigation brought by the present applicant in relation to two Australian patents related to safety catheters in the same field as the present application. In her second declaration, Ms Chrysiliou provided comparisons of the claims of the application, by way of charts, against the prior art cited in the first declaration. The second declaration also included photographs of a catheter, designated Catheter B, involved in the prior litigation, and a claims chart against this alleged prior art. The particular catheter samples discussed above by Ms Sciascio appeared to be equivalent to Catheter B as presented by Ms Chrysiliou.
EVIDENCE IN ANSWER
The applicant filed evidence in answer in the form of two declarations from Mr William Samuel Hunter. Mr Hunter is a mechanical engineer and the principal of his own business. He has more than 20 years of experience in product and instrument design, including the design of medical devices including those used in high volume to prevent needle stick injury. In his first declaration, Mr Hunter principally outlined the development of safety IVCs since the early 1980s, several of the design parameters and processes involved in developing safety IVCs when seeking solutions to existing problems, and some common sources of design information to assist in those processes. In his second declaration, Mr Hunter provided charts of the claims of the application against the opponent’s alleged prior art, and interpretations as to why specific claimed features were not disclosed by the prior art. He also provided commentary of the disclosures of the claimed features in each of the present specification and the priority document.
EVIDENCE IN REPLY
The opponent filed evidence in reply in the form of a declaration from Mr Girdhari Lal Sharma and two further declarations from Ms Chrysiliou. At the time of his declaration, Mr Sharma was the assistant manager of research and development (“R&D”) for the company that supplied safety catheters to Ms Sciascio’s company. He had been employed in the R&D department since about 2007. Mr Sharma stated he was very familiar with his company’s safety IVCs and made some comment about the supply and the nature of the particular catheters mentioned by Ms Sciascio. Mr Sharma further discussed typical dimensions for the internal diameter of the needle guard bore and the outside diameter of the needle, and some allegedly common features of IVCs.
In her third declaration, Ms Chrysiliou principally provided further charts and commentary of the claims of the application to maintain the claimed invention was disclosed by the prior art in spite of Mr Hunter’s interpretations to the contrary. In her fourth declaration, Ms Chrysiliou principally presented evidence of variations of Catheter B as to size, and particularly the outcomes if there was a mismatch in size between the internal diameter of the needle guard bore and the outside diameter of the needle. This evidence appeared to be directed to the alleged lack of sufficiency of description and lack of fair basis for the close fit ratio feature of claim 9 for example, and to supplement Mr Sharma’s evidence regarding dimensions for the diameters of the needle guard bore and the needle. Ms Chrysiliou further presented evidence supposedly linking Mr Hunter as an inventor to a large number of patents and/or patent applications, and a few design registrations, and as an expert witness in several Federal Court proceedings.
There was some contention from the applicant that the evidence in reply was not properly reply evidence to the applicant’s evidence in answer. After obtaining comments from both parties, the Patent Office issued the following direction on 27 November 2015.
Point 1:That whether any or part of the evidence in reply properly forms evidence in reply is considered at the hearing and determined as part of the decision;
Point 2:that the Applicant supply written submissions three (3) weeks before the hearing outlining what material they consider is not evidence in reply and why; and
Point 3:that the Opponent supply, as part of their written submissions for the hearing, submissions responsive to the Applicant’s submissions on the evidence in reply.
APPLICABLE LAW
As a consequence of the Intellectual Property Legislation Amendment (Raising the Bar) Act 2012 (“the Amendment Act”), there are substantial changes to the Patents Act 1990. The date of effect of those changes was 15 April 2013. The application of the Amendment Act in the present case depends on the date of the request for examination. The applicant filed its request for examination on 8 April 2013. Consequently the Patents Act as in force immediately before 15 April 2013 applies in the present case.
This means the former standard for opposition proceedings applies and the opponent bears the onus of establishing that it is clear or practically certain that a valid patent could not be granted (F Hoffman-La Roche AG v New England Biolabs Inc [2000] FCA 283 at [29], [67]; 50 IPR 305 at 311, 319; Commissioner of Patents v Sherman [2008] FCAFC 182 at [18], [22]; 79 IPR 426; Genetics Institute Inc v Kirin-Amgen Inc [1999] FCA 742; [1999] 92 FCR 106 at [17]).
Section 18 of the Patents Act 1990 relates to patentable inventions. Relevant parts of subsection (1) appear below.
(1)Subject to subsection (2), an invention is a patentable invention for the purposes of a standard patent if the invention, so far as claimed in any claim:
(a) is a manner of manufacture within the meaning of section 6 of the Statute of Monopolies; and
(b) when compared with the prior art base as it existed before the priority date of that claim:
(i)is novel; and
(ii)involves an inventive step; and
(c) is useful; and ………
WHETHER THE EVIDENCE IN REPLY IS PROPERLY REPLY EVIDENCE
The decision in Sonus Pharmaceuticals, Inc v Alliance Pharmaceutical Corp and Schering Aktiengesellschaft, [2001] APO 13, described evidence in reply in the following terms:-
“Evidence in reply is clearly distinguished from evidence in support. Phipson on the Law of Evidence states that evidence in reply must be confined to rebutting the applicant’s case, and should not merely confirm the case in chief. Additionally, evidence in reply cannot raise matters that should have been raised in the evidence in support.”
Additionally:-
“The mere fact that the evidence introduces new information does not mean it is not in reply. In fact, reply evidence must raise new information, otherwise it is merely confirming existing evidence …” (Emphasis is in the original).
It is also not necessary that the evidence in reply refer to the evidence in answer. The Sonus decision mentioned numerous paragraphs of the evidence in reply that did not refer to any parts of the evidence in answer yet were found to respond to issues raised in the evidence in answer. In Merial Limited v Bayer Intellectual Property GmbH, [2015] APO 16 at [17], the delegate found that certain evidence in that case addressed questions that appeared to be generally responsive to evidence in answer and was satisfied that this was evidence in reply.
In the present case, the applicant principally objected to paragraphs [8] and [11]-[13] and exhibits GS-2 and GS-3 of Mr Sharma’s evidence. Similarly the applicant submitted that Ms Chrysiliou’s references in her fourth declaration, for example at [11], [13] and [18], to Mr Sharma’s evidence contained new evidence. Furthermore her above-mentioned evidence of variations of Catheter B as to size, and particularly the outcomes if there was a mismatch in size between the internal diameter of the needle guard bore and the outside diameter of the needle, was clearly new evidence not responsive to the evidence in answer. The applicant particularly cited paragraphs [11]-[18] and generally exhibits KC-54 to KC-60 of Ms Chrysiliou’s fourth declaration.

I will deal with the applicant’s points by following the topical presentation in the opponent’s submissions as outlined below.
The opponent initially submitted her evidence was properly evidence in reply on the basis of three topics in Mr Hunter’s evidence. The first topic related to Mr Hunter’s interpretation of the alleged prior art not disclosing the above-mentioned close fit ratio feature. As will be discussed in more detail later, the prior art generally referred to the profile of the bore being adapted to the outer profile of the needle. Mr Sharma stated in evidence at [10] that, in his experience with safety IVCs, he understood this to mean that the inside bore diameter and the outside needle diameter were in conformity with each other. In other words, the bore diameter was neither too big nor too small vis-á-viz the needle diameter. Mr Sharma went on to explain the problems if the bore diameter were too big or too small, and presented evidence, at [11]-[13] and exhibit GS-3, of the various sized safety IVCs produced by his company together with listed dimensions of their internal bore and external needle diameters. Ms Chrysiliou’s evidence about the problems of mismatches in size appeared to expand upon Mr Sharma’s points. It would seem the experience of Mr Sharma in this field has guided his interpretation of references to adaptations to the outer profile of the needle. Mr Hunter presented a specific view of his understanding of the claimed bore and needle diameter relationship. I consider that the evidence of both of the opponent’s declarants is generally responsive to Mr Hunter’s evidence on this point.
The second topic was the interpretation of a side port on the catheter hub, as in claim 24 for example. Mr Hunter suggested, as a point of differentiation between the claim and the alleged prior art, that the prior art document did not disclose that the opening at the side included a device for regulation of fluid flow therethrough. On the other hand, Mr Sharma identified the same feature in the prior art document as simply a port, and moreover of the same type as identified as an injection port in one of the applicant’s own pieces of literature which he exhibited (GS-2). I consider this evidence to be directly responsive to Mr Hunter’s evidence on this point.
The third topic related to the supposed functional significance attached by Mr Hunter to the band or elastic tensioning element around the first and second arms in the alleged prior art. Mr Hunter asserted it was the band or tensioning element which restrained the needle tip within the open space in the event that sideways motion due to pivoting occurred. Mr Sharma and Ms Chrysiliou both presented evidence of safety IVCs with and without the band where the needle tip remained contained within the needle guard (exhibit GS-3, and paragraphs [11] and [12] together with KC-54 and KC-55, respectively). The inference from the opponent appeared to be that Mr Hunter overplayed the significance of the tensioning element in the prior art devices in respect to confinement of the needle tip within the open space. I consider the opponent’s evidence on this point to be generally responsive to Mr Hunter’s evidence.
I conclude the opponent’s evidence is properly evidence in reply.
PERSON SKILLED IN THE ART
In Root Quality Pty Ltd v Root Control Technologies Pty Ltd, [2000] FCA 980, Finkelstein J stated at [70] and [71] that the skilled addressee, or the judge adopting the mantle of the skilled addressee, is the person to whom the patent is addressed and who must construe it. Such person works in the art or science with which the invention is connected or is likely to have a practical interest in the subject matter of the invention. A variety of people may have that interest. Finkelstein J further noted various descriptions given to the skilled addressee. These included the “uninventive skilled worker in the particular field” (Leonardis v Sartas No 1 Pty Ltd, (1996) 67 FCR 126) and the “person skilled in the art” (Genentech Inc v Wellcome Foundation Ltd, (1989) 15 IPR 423).
There was contention between the parties as to the weight to be given to each party’s evidence. The opponent indicated at [8] of her second declaration that over the preceding 23 months she had read and analysed well over one hundred patent specifications relating to safety IVCs, and read evidence and several legal decisions relating to safety IVCs. At [9], the opponent considered that she had a good understanding of how safety IVCs worked and many of the issues relating to them. Whilst she acknowledged she was not a person skilled in the art, as characterised in Root Quality for example, the opponent equally suggested that the applicant’s Mr Hunter was not either. The opponent referred to Multigate Medical Devices Pty Ltd v B Braun Melsungen AG, [2016] FCAFC 21. That decision is the appeal decision arising from the prior litigation mentioned in Ms Chrysiliou’s evidence in support. At [22] of that decision, the Full Federal Court stated that the field of the invention of the patents in suit was the design and manufacture of safety IVCs. The court accepted Multigate’s position 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 tool maker. In the present case, the opponent contended that Mr Hunter was not any one of these. Rather, Mr Hunter’s evidence indicated that his experience traversed a multitude of fields such that Mr Hunter could not be regarded as a part of a team in the present field. The opponent submitted that Mr Hunter’s lack of expertise with safety IVCs was borne out by some peculiar interpretations by him of terminology in the field. Moreover the opponent cited prior cases relating to medical devices where Mr Hunter’s evidence was not accepted, for example on such basis as definitions within a patent specification being ignored (Reckitt Benckiser Healthcare (UK) Ltd v Glaxosmithkline Australia Pty Ltd (No. 5), [2015] FCA 486 at [82]) and where he made distinctions without there being any substantive difference (at [146]).
The applicant countered that the opponent, as opponent, declarant and attorney in this case, was not an independent witness contrary to Mr Hunter who was independent and had no interest in the outcome (Mr Hunter’s first declaration at [1] – [3]). I would accept there is a risk that, in the present circumstances, Ms Chrysiliou’s evidence may suffer from a lack of objectivity. Furthermore the applicant noted several patent applications in the opponent’s list that related to medical devices and listed Mr Hunter as an inventor. On this basis the applicant submitted that Mr Hunter was clearly a relevant person skilled in the art in the present case. Moreover the applicant noted that in the first instance Minnesota Mining & Manufacturing Company v Tyco Electronics Pty Ltd decision, [2001] FCA 1359 at [17], the courts accepted Mr Hunter’s evidence as useful and persuasive. In that case, Mr Hunter’s evidence was accepted on the basis of his skill and experience in the design and development of plastics regardless of the fact that his experience with electrical connectors was relatively limited.
A reader of many patent specifications and evidence and legal decisions in a particular field, alone, would not seem to fit the category of a skilled worker in the field in the Root Quality sense. Furthermore, in the opponent’s case, it may be noted that her readership statement relating to safety IVCs, as mentioned above, covered a period of less than 2 years prior to her declaration which was made in April 2015. This period is clearly well after the present application. In these respects it is noteworthy that Ms Chrysiliou has not claimed any relevant expertise in the field of safety IVCs at the relevant time. While Mr Hunter’s evidence may have been criticised in some cases, and the fact that he is a listed inventor in many cases may over-qualify him as the relevant “uninventive skilled worker in the particular field” (Leonardis), I am satisfied in the present case that he has had requisite experience in regard to the design of medical devices generally, including designs to prevent needle stick injury (Mr Hunter’s first declaration at [6] and [7]). Mr Hunter also indicated a good understanding of the developments relating to safety IVCs since the 1980s (at [8] – [10]). I consider that Mr Hunter was well positioned and expert in providing independent evidence regarding the design of safety IVCs at the relevant time in the present case. To the extent that there may be any contradiction between the evidence of Ms Chrysiliou and Mr Hunter, I would give the evidence of Mr Hunter more weight.
PRIORITY DATE
Subsection 43(2) of the Patents Act 1990 at the relevant time provided that the priority date of a claim is either the filing date of the specification or a date otherwise determined by the Patent Regulations. Sub-regulation 3.12(1)(b) relevantly provided that if a claim is fairly based on matter disclosed in one or more priority documents, the priority date of the claim would be the date of filing of the priority document in which the matter was first disclosed.
Subsection 40(3) of the Patents Act 1990 at the relevant time required that the claims of a specification must be fairly based on the matter described in the specification. The decision of Lockwood Security Products Pty Ltd v Doric Products Pty Ltd, [2004] HCA 58, 217 CLR 274, at [69], put this as a requirement that there be a real and reasonably clear disclosure of what is claimed.
Nichia Corporation vArrow Electronics Australia Pty Ltd, [2015] FCA 699, further provided a useful summary of the law in respect to priority dates. At [56], Yates J referred to the decision in Vehicle Monitoring Systems Pty Ltd v Sarb Management Group Pty Ltd (No. 2), [2013] FCA 395, where it was stated at [121] that the test of fair basis for determining the priority date of a claim is not the same as the test under subsection 40(3). The difference is known as external fair basis and internal fair basis. Referring back to the Nichia decision at [56], the latter test:-
“concerns claim width and is directed, in a general sense, to ensuring internal consistency between that which is described as the invention, and that which is claimed as the invention. This difference is reflected in the language of s40(3), which requires that a claim be fairly based on “the matter described in the specification”. In reg 3.12(1)(b), the inquiry is whether the claim is fairly based on “matter disclosed”. The significance of the omission of the definite article “the” in relation to “matter” in the test applied under reg 3.12(1)(b) was specifically referred to and discussed in Leonardis v Sartas No 1 Pty Ltd, (1996) 67 FCR 126 at 139, where the Full Court made clear that some part or parts of the overall disclosure made in the relevant priority document can provide “matter” on which a claim can be fairly based for the purpose of assigning a priority date to the claim.”
At [57], Yates J further stated:-
“Regard should also be had to the use of the word “disclosed” in reg 3.12(1)(b), contrasted with the word “described” in s 40(3). The word “described” as used in s 40(3) focuses attention on the invention that is required to be fully described in the specification: see s 40(2). However, in its particular context, the word “disclosed” in reg 3.12(1)(b) is a more general expression which, in conjunction with the word “matter”, reinforces that priority can be claimed by reference to some part or parts of the priority document.”
Whilst acknowledging the distinction made by Yates J, the parties also generally accepted that the Lockwood test of a real and reasonably clear disclosure usefully applied in both situations. In this context, in Multigate at [190], the Federal Court stated that, in the context of external fair basis, the test of real and reasonably clear disclosure requires attention not on whether a subsequent claim had previously been made, but whether in the earlier specification there had been a real and reasonably clear disclosure of the invention that is claimed. Further, a real and reasonably clear disclosure in the prior specification need not be made only in the verbal description, but can appear from the accompanying drawings. Further, the relevant passage(s) from the prior specification need not be disclosed as part of the invention claimed therein. In the same context, the applicant further submitted that it was “wrong to employ an ‘over meticulous verbal analysis’ ” (Lockwood at [68]).
The opponent submitted that none of the claims of the present application were fairly based on the disclosure in the priority document and therefore the earliest priority date of the claims was the date of filing of the application, 26 July 2011. Specifically the opponent noted that each of the claims included the feature of the needle guard pivoting or turning on the needle shaft. On the other hand the opponent contended that the priority document disclosed only the needle pivoting or rotating within the bore of the needle guard.
The complaint from the opponent was not explained well in the written submissions or at the hearing. In each case the opponent described the same relative motions between the needle guard and the needle shaft of the needle, albeit in one case from an external perspective as opposed to an internal perspective in the other case. The applicant submitted the opponent’s position was an example of the over meticulous verbal analysis warned against in Lockwood. I agree. In each case the needle guard pivots or turns relative to the needle.
The opponent further referred to several other particulars to challenge the entitlement of the claims to the earliest priority date. Chiefly amongst these particulars were statements that the majority of the claims were to a needle assembly not limited to safety IVCs. The opponent asserted these claims were not fairly based on matter disclosed in the priority document which disclosed safety IVCs but no other type of needle assembly.
The test to be applied under sub-regulation 3.12(1(b) at the relevant time, as stated above, was that some part or parts of the overall disclosure in the priority document can provide matter on which a claim can be fairly based for the purpose of assigning a priority date. The priority document opens with a statement that the disclosure generally relates to safety IVCs. The summary section of the priority document also generally describes embodiments of a safety IVC. On the other hand, the priority document also discusses aspects of the needle guard for confining the needle tip after withdrawal from the catheter. Paragraphs [0035] to [0040] and Figures 3 and 4 describe and illustrate pertinent features of the needle guard in relative isolation. At a minimum, the claimed needle assembly in the present case comprises the needle guard and needle, without constraint as to location such as within an IVC. Such an assembly is clearly described and illustrated in the priority document.
I find the opponent’s case against the priority date is not made out. The present claims are fairly based on matter disclosed in the priority document. Thus I conclude the claims are entitled to the earliest claimed priority date of 5 August 2010.
NOVELTY
Under subsection 7(1), an invention is taken to be novel unless it is not novel in the light of the prior art base. Information in a document forms part of the prior art base for the purposes of novelty if it was published before the priority date of a claim, or the information was contained in a specification published after the priority date of the claim under consideration and, if that information is, or were to be, the subject of a claim of the specification, that claim has, or would have, a priority date earlier than that of the claim under consideration (referred to as “whole of contents” novelty).
It is well established that the general test for lack of novelty is the reverse infringement test. The classic formulation of this test is that given by Aickin J in Meyers Taylor Pty Ltd v Vicarr Industries Ltd, [1977] HCA 19 at [20]; 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”.
This test is satisfied if the alleged anticipation discloses all the essential features of the invention as claimed (see Nicaro Holdings Pty Ltd v Martin Engineering Co, [1990] FCA 40; (1990) 91 ALR 513 at 517). In order to meet this requirement, the prior art must "contain clear and unmistakeable directions to do what the patentee claims to have invented" (The General Tire & Rubber Company v The Firestone Tyre and Rubber Company Limited, [1972] RPC 457 at 486). In a similar vein, what a prior art document teaches is to be distinguished from what might be “included” or “encompassed”. “A prior broad disclosure thus may not be sufficient ‘in the absence of the skilled addressee understanding or perceiving’ the later claimed invention therein” (Sanofi-Aventis Australia Pty Ltd v Apotex Pty Ltd (No. 3), [2011] FCA 846 at [180]).
The opponent principally relied on the following documents, all naming Rishi Baid as the inventor, and having similar disclosures. The applicant for each of these documents was the company Mr Sharma worked for and which also supplied the Catheter B items to Ms Sciascio’s company.
WO 2009/116080 (“Baid 1”) – Published 24/9/2009
This document relates to a needle safety device for a medical device such as an IVC. Figures 1(a) to 1(c) of Baid 1, as depicted below, are suitable illustrations.
The needle safety device comprises a base portion 18 having a bore 24 extending in an axial direction therethrough for receiving a needle. An elongate portion 20 extends from the base portion in the axial direction and forms a first jaw. A second opposing jaw similarly extends from the base portion generally in the axial direction. The elongate portion is of semi-cylindrical shape and forms an extension of the bore in the base portion. The elongate portion has a free end 30 at its distal end. The second jaw is in the form of a clip 14 and is adapted to engage with the base portion. At the distal end, the straight section of the clip passes into a head section 62 which extends beyond the free end 30 of the elongate portion 20. The head section has a generally V-like shape with the peak of the V pointing in the axial direction and the free leg 63 of the V extending back towards the elongate portion. The second jaw or clip is formed from a strip of sheet metal having spring-like properties. Due to these properties the jaw may be deflected against a restoring force by a needle extending all the way through the needle safety device such that it snaps in front of the needle tip as soon as the needle tip is moved in between the two jaws, thereby safely guarding the needle tip. The base portion and elongate portion are made of a plastic material.
Baid 1 contains the core constructional features of a needle guard as claimed in at least claims 1, 9, 10, 18 and 25 of the present application. The claimed dimensional relationships though between the various items of the needle assembly or the safety IVC assembly require further scrutiny. Moreover the relationships have a further claimed functional feature of confining or retaining the needle tip within an open or a holding space as the needle guard pivots and/or turns on the needle shaft. For instance, claim 1 defines the length and width of the angled distal end section being larger than the needle diameter and dimensioned so as to confine the needle tip within a space as the needle guard pivots and/or turns on the needle shaft. The question then is whether there is sufficient disclosure in Baid 1 of the angled distal end section therein being larger by length and width than the needle diameter and that the length and width are dimensioned to inherently confine the needle tip within an open or a holding space as the needle guard pivots and/or turns on the needle shaft.

Such aspects are not discussed in Baid 1. At best, one may need to infer them from the drawings alone. The opponent submitted both the length and width of angled end section 62 were greater than the needle bore 24 and therefore must be larger than the needle diameter. The opponent referred to Figure 1(b) and page 4 lines 18-21 to state that this disclosed that when the needle tip is located in the open or holding space, the angled end section extends across part of free end 30 to confine the needle tip in the space regardless of pivoting or turning of the needle guard on the needle shaft. However these sections of Baid 1 are insufficient to allow a conclusion that the length and width of the angled end section are greater than the needle diameter.
In respect to confinement of the needle tip, the applicant contended, through Mr Hunter’s evidence (for example, exhibit WSH-3 at page 2), that the elastic element or tension ring 16 was responsible for limiting the sideways or pivotal movement of the needle guard relative to the needle to confine the needle tip within the open or a holding space. The applicant further contended that the semi-cylindrical shape of the elongate portion 20 was similarly responsible for confining the needle tip within the open or a holding space. On the other hand, it would appear that the applicant has overplayed the significance of the elastic element and the elongate portion’s semi-cylindrical shape in this respect. Page 1, lines 9-17 of Baid 1, describes the function of needle safety devices to prevent accidental pricking by the needle after removal of the needle from a medical device. At this passage, Baid 1 further describes the object of the invention therein being to provide an improved needle safety device, which object is satisfied by a needle safety device having the features of claim 1 of Baid 1. Notably, claim 1 of Baid 1 is silent in respect to an elastic element and the shape of the elongate portion. In fact the elastic element is not defined until claim 12. Moreover page 3 line 23 of Baid 1 states that an elastic element surrounding the first and second jaws may be provided. Page 4, lines 7-9, states that the elastic element helps prevent the needle tip from protruding sideways out of the needle safety device. The above references suggest the elastic element is optional. Similarly Baid 1 does not appear to place any outstanding importance on the semi-cylindrical shape of the elongate portion.
On the one hand, Figure 1(b) clearly shows the elastic element or tension ring 16 at least partially performing the function of extending the angled end section 62 across part of the free end 30 of the elongate portion when viewed from the axial direction to confine the needle tip within the open or holding space. On the other hand, Baid 1 at the top of page 7 states that Figure 1(c) shows a view of the needle safety device in a relaxed state without a tension ring. This figure shows the angled end section extending substantially up to the free end 30 of the elongate portion when viewed from the axial direction. It would thus appear that the extension of the angled end section up to and across the free end 30 has more to do with the spring-like properties, with or without the tension ring, of clip 14, with angled end section 62 at its end, than the length and width of the angled end section. Either way, at least sideways protrusion of the needle in Baid 1 appears to be inhibited by means other than necessarily the length and width of the angled end section relative to the needle diameter, or any other dimensioning of the angled end section.
The opponent’s assertion that the length and width of the angled end section was greater than the needle diameter, and that the angled end section was dimensioned to confine the needle tip as claimed cannot be clearly established from the drawings of Baid 1. On the contrary, a cursory inspection of Figure 1 appears to show the needle bore diameter being larger than the relevant length 63 of the angled end section 62. Moreover, if the needle guard turned relative to the needle shaft, after withdrawal of the needle into the needle guard and when the needle safety device was in the relaxed state (Figure 1(c)), such that the needle was pointed to the left side of the bore adjacent the elongate portion 20, then it would seem that the needle tip would not necessarily be confined by the angled end section within the open or holding space. I find that Baid 1 has no clear and unmistakable directions (General Tire) of a needle assembly as in claim 1 of the present application. I conclude that claim 1 is novel over Baid 1.
Claim 9 similarly defines the above dimensional relationship between the length and width of the angled distal end section and the needle diameter. On this point, as for claim 1, I conclude that claim 9 is novel over Baid 1. For the sake of completeness however, I will discuss some other elements of claim 9.
Claim 9 further defines a close fit ratio between the bore diameter and the outside diameter of the needle shaft. The parties gave significant attention to the expression “close fit ratio” in their evidence and at the hearing. Mr Hunter attempted to distinguish this feature from the prior art by stating this meant the ratio was as close to 1:1 as possible. However he also acknowledged there needed to be allowance for the needle shaft to slide through the bore. It is difficult to see what the distinction thus is with Baid 1’s disclosure of the bore being adapted to the outer profile of the needle, especially as Mr Sharma interpreted this feature to mean that the bore diameter was neither too big nor too small vis-á-viz the needle diameter. In respect to Mr Sharma’s comment, the applicant thus submitted that Baid 1 merely disclosed a relationship of looseness and closeness generally, but nothing specific about how loose or close the bore diameter and needle diameter needed to be. The applicant went further to suggest the definition of “close fit ratio” was not biased to looseness but only to closeness. In this respect, and perhaps most telling, Figure 3C of the present application clearly shows some space between the needle and the bore and highlights the pivoting that is possible. Figure 4(a) of Baid 1 shows at least as close a fit. I conclude the close fit ratio feature of claim 9 is disclosed in Baid 1.
The alternative claimed combination in claim 9 of the bore length and bore diameter being used to minimise the amount of pivoting and/or turning of the needle guard on the needle does not appear to be particularly limiting. I would note that minimisation, not elimination, of pivoting or turning is defined. Thus the bore length and diameter do not have any particularly restrictive dimensions other than to aid retention of the needle tip within the open or holding space. I conclude that Baid 1 discloses a bore length and bore diameter combination to minimise at least the pivoting of the needle guard to retain the needle tip within the open or holding space.
Overall, in view of the claimed dimensional relationship between the length and width of the angled distal end section and the needle diameter, I conclude that claim 9 is novel over Baid 1.
Claim 10 defines the width of the angled distal end section being greater than that of the second free end by a mere fraction to about 50% greater to confine the needle tip as the needle guard pivots and/or turns on the needle. The opponent’s submissions contended this was disclosed in Baid 1 on the basis of measurements, taken from the drawings, of various features of the angled end section and the free end of the semi-cylindrical elongate portion in Baid 1. There are some flaws with this approach. Firstly, there is no discussion in Baid 1 of any such dimensional relationship between these items of the needle safety device. Secondly, the approach assumes the drawings of Baid 1 are technical drawings with exactness of scale and measure not usually the case or expected of drawings in patent specifications. In fact the opponent relied on measurements of features taken from each of Figures 1-3 of Baid 1. There is no description in Baid 1, nor should it be assumed, that each of these figures exactly illustrates all aspects of the needle safety device to exactly the same scale. Visually from the figures, I think little can be conclusively established about the comparative widths of the angled end section and the free end of the elongate portion. I find there are no clear and unmistakable directions in Baid 1 of the claimed relationship between the widths of the angled distal end section and the second free end. I conclude that claim 10 is novel over Baid 1.
Claim 18 essentially defines a safety IVC with a needle guard, similar to that in the preceding claims, disposed at least in part in the catheter hub. Baid 1, from page 10 and in Figure 4, describes and illustrates a safety IVC with a needle guard mounted therein. I am satisfied this aspect of claim 18 is adequately disclosed in Baid 1. Claim 18 further defines the width of the angled distal end section being greater than that of the second free end and at least 125% greater than a diameter of the needle to confine the needle tip within an open or a holding space. This definition combines elements from claims 10 and 1, respectively. For similar reasons as discussed in respect to claims 1 and 10 above, I conclude that claim 18 is novel over Baid 1.
Claim 25 defines a method of assembly. The device disclosed in Baid 1 inherently requires assembly broadly as claimed. Claim 25 also defines the needle having a change in profile near the needle tip on a needle hub. Baid 1 does not disclose this feature. Claim 25 further defines the dimensional relationship of the width of the angled distal end section being greater than that of the second free end by a mere fraction to about 50% greater, as in claim 10 which I have concluded to be novel. Similarly, I conclude that claim 25 is novel over Baid 1.
I conclude the claims of the present application are novel over Baid 1.
WO 2011/036574 (“Baid 2”) – Published 31/3/2011 – Priority date 22/9/2009
This document is in the “whole of contents” category mentioned above, having been published later but having an earlier priority date than the priority date of the present application. Baid 2 similarly relates to a needle safety device for use in a medical device such as an IVC. The device includes a base portion having a needle passage or bore extending therethrough. First and second arms extend substantially in an axial direction from the distal side of the base portion. A distal wall at the distal end of the first arm is arranged transversely across the alignment of the bore toward the second arm. A tension element surrounds the first and second arms.
The focus of Baid 2 is on a stopping element generally in the base portion of the needle guard. The stopping element can be a circular disc, a ring or a washer, and prevents an enlargement section of the needle from being pulled through the base portion of the needle guard. Nonetheless Baid 2 contains the core constructional features of a needle guard as claimed in at least claims 1, 9, 10, 18 and 25 of the present application. As with Baid 1 though, Baid 2 has no substantive discussion of the dimensional relationships between features of the needle guard.
The following drawings, from Figures 3A to 3D of Baid 2, are suitable illustrations of the needle guard.
The opponent submitted that Figures 3C and 3D at reference numeral 50 pointed to dimensional features between the distal wall and the second arm consistent with the claimed invention. The angled end section in Baid 2, effectively being the distal wall 50 of the first arm 46, clearly overlaps the second arm when viewed from the axial direction, and would appear to achieve confinement of the needle tip within the open or holding space in use. A recess 68 also is provided in the proximal region 64 of the first arm to facilitate deflection of the first arm in use. Baid 2 at [32] and [33] describes the distal wall 50 as extending in a direction transverse to an axial direction, and blocking the needle tip to limit axial movement once the needle tip is received in the needle guard.
In respect to claim 1 of the application, it may be that the length of the transverse distal wall 50 of the first arm is larger than the needle diameter. Figures 3A and 3B for example appear to show the length of the distal wall 50 being larger than the substantive diameters of the holding space 54 and the needle passage 56, and thus the length of the distal wall would be larger than the needle diameter. On the other hand, I think it cannot be conclusively established that the width of the distal wall 50 (perhaps best seen with the axial view in Figure 3C) is larger than the needle diameter. In Figures 3A and 3C, a groove 70 in the distal wall 50 for guiding the needle shaft is clearly smaller than the length or width of the distal wall itself. However the extent to which the groove would wrap around the needle shaft, and thereby provide an indication of the needle diameter, cannot be determined from the figures. The more appropriate determinants of the needle diameter in the figures are the holding space 54 and the needle passage 56 which are larger than groove 70. I find there are no clear and unmistakable directions in Baid 2 of the width of the angled distal end section being larger than the needle diameter. I conclude claim 1 of the application is thus novel over Baid 2. Claim 9 has a similar limitation and thus is also novel over Baid 2.
As mentioned earlier, claim 10 of the application defines the width of the angled distal end section being greater than that of the second free end by a mere fraction to about 50% greater to confine the needle tip as the needle guard pivots and/or turns on the needle. The opponent referred to Figures 3C and 3D of Baid 2 to submit that the width of the distal wall 50 was greater than the width of the free end of the second arm 48. On the other hand I think that cannot be conclusively established from the drawings. I find there are no clear and unmistakable directions in Baid 2 of this feature of claim 10. Claims 18 and 25 also define the above limitation, amongst other things.
I conclude the claims of the present application are novel over Baid 2.
WO 2011/154767 (“Baid 3”) – Published 15/12/2011 – Priority date 16/4/2010
This document also is in the “whole of contents” category. Baid 3 relates to a catheter apparatus comprising a catheter and a catheter hub. A needle guard is also disclosed which is retained in the catheter hub when the needle extends through the catheter hub, and which is removable from the catheter hub once the needle tip is received in the needle guard upon withdrawal of the needle from the catheter. At [15] of Baid 3, one embodiment of the needle guard is described as comprising a generally cylindrical base portion in the region of its proximal end as well as first and second arms extending in a generally axial direction from a distal side of the base portion. Like Baid 2, a transverse wall is arranged in a distal region of the first arm in Baid 3. Baid 3 thus similarly contains the core constructional features of a needle guard as claimed in at least claims 1, 9, 10, 18 and 25 of the present application. At [42], the dimension of the transverse wall, as seen in the radial direction, is selected to overlap the second arm, when the needle tip is received in the needle guard such that the needle tip is blocked by the distal transverse wall from distally protruding from the needle guard. On the other hand, there is no further substantive discussion in Baid 3 of the dimensional relationships between needle diameter, or lengths or widths of the angled end section, or width of the second free end, as claimed in the present case. The overlap of the transverse wall over the second arm and the consequential blocking of distal protrusion may suggest a length and width of the distal transverse wall larger than the needle diameter as in claim 1, for example, of the present application. However, from the drawings of Baid 3, the overlap appears to have at least as much to do with the ability to deflect the first arm ([19] and [44] of Baid 3) that carries the transverse wall, rather than the length or width of the wall necessarily being greater than the needle diameter. In any case, I think there is insufficient disclosure in Baid 3 to conclusively establish that the width of the transverse wall is greater than the needle diameter.
Figures 3A to 3C and Figure 4 of Baid 3 illustrate relevant features of the needle guard in substantially the same way as Figures 3A to 3D of Baid 2 above, that is, with a distal wall of the first arm extending in a direction transverse to the axial direction. Figures 5A, 5B and 6A to 6C of Baid 3 illustrate relevant features of the needle guard in substantially the same way as Figures 1(a) to 1(c) of Baid 1 above, that is, with the distal end of the first arm being generally of V-like shape.
I conclude the claims of the present application are novel over Baid 3.
WO 2012/038899 (“Baid 4”) – Published 29/3/2012 – Priority date 21/9/2010
Baid 4 has a later priority date than that of the present application. Consequently Baid 4 would only have been valid prior art if the priority date of the present application was deferred. Since I have found the present claims are entitled to their earliest priority date, nothing turns on considering Baid 4. In any case, on my inspection of Baid 4, I would conclude that Baid 4 is no better a document for the opponent against the claimed invention than any of Baid 1, Baid 2 or Baid 3.
Prior Use
Subsection 7(1) refers to prior art information made publicly available in a document or through doing an act for novelty considerations. In respect to doing an act, two types of actions often come to mind in this area. They are prior use, as the opponent has indicated, or prior oral disclosure.
Prior use requires a relatively high standard of proof. The UK Appeal Tribunal discussed the standard of proof required to establish prior use in Seiller's Application [1970] RPC 103. At page 106 Graham J. stated:
"In my judgement it is necessary that proof of prior user in opposition cases should be very clear. Normally in the absence of cross-examination, this will involve corroboration of a mere statement as to recollection in a declaration, particularly where the time interval involved is considerable. Such corroboration is often best found in documents contemporary with the fact to be proved. Each case, however, must be considered on its own facts, and I say expressly that I am not attempting to lay down any rule as to what is or is not sufficient in any given case."
The UK Court of Appeal approved these comments in Dunlop Holdings Limited's Application [1979] RPC 523 at 548. A similar approach is evident in Windsurfing International Inc v Borsimex Pty Ltd, (1984) AIPC 90-135. Towards the end of section 8.38 Waddell J. stated:
"It is essential that an allegation of prior public use should be strictly proved. Evidence which is uncorroborated is undoubtedly suspect and should be scrutinised with particular care. The Court must be satisfied that the proof is sufficient in the circumstances, having regard to the gravity of the allegation.”
Similarly in Aspirating IP Limited v Vision Systems Limited, [2010] FCA 1061, (2010) 88 IPR 52, at [200], Besanko J stated:-
“The correct principle is that a prior public use must be strictly proved and evidence which is not corroborated must be scrutinised with care, particularly where it is evidence of events which occurred many years ago.”
In Damorgold Pty Ltd v JAI Products Pty Ltd, [2015] FCAFC 31, Yates J at [94]-[96] commented on the essential features of the invention (a spring-assisted roller blind mechanism in that case) only being discernible by disassembling the product. Where the evidence pointed to no potential customer having disassembled the product and no complete examination having taken place, then the features of the product were not disclosed to customers. At [96], Yates J stated that the relevant question is not whether the product was made publicly available. In applying the notion of “enabling disclosure”, as explained in Merrell Dow Pharmaceuticals Inc v H N Norton & Co Ltd, (1995) 33 IPR 1, neither the mere public availability of a product, nor its use in public, necessarily means that the features of the product have been made publically available.
Catheter B

The opponent relied on Ms Sciascio’s evidence. She indicated the processes employed in her company supplying safety IVCs in Australia. Ms Sciascio particularly discussed a batch process related to Catheter B which was supplied to her company by Mr Sharma’s company from overseas. From a batch delivered in late 2009, Ms Sciascio stated that her company first provided samples for inspection and trial to potential customers in Australia in February 2010 (Ms Sciascio’s declaration at [5]-[9]). In the same month, samples of Catheter B were also provided for an exhibition at an industry conference ([12]).
Ms Sciascio did not present evidence of sales to customers before the priority date. The earliest indication of any sales to any customer is 11 October 2010 (at [13]), approximately two months after the priority date. At [14], Ms Sciascio stated that she received confirmation, from a representative of that customer, of receipt of the Catheter B stock on 12 October 2010. It may be noted that the representative herself did not present evidence in this opposition. Ms Sciascio’s evidence on this sales transaction, and other subsequent sales transactions to other parties absent any other evidence, is thus uncorroborated. In any case, little turns on this since I have determined that the claimed priority date is valid.
The opponent is left with only the provision of samples to potential customers and at an exhibition as possible examples of prior use. Ms Sciascio’s evidence at [9] and [12] listed only a handful of occurrences that pre-dated the priority date, in February and in July 2010. Again there is no corroborating evidence to support Ms Sciascio’s statements. I accept this does not mean Ms Sciascio’s evidence can be dismissed. The Aspirating decision only required that uncorroborated evidence be scrutinised with care. In Glenwood Systems Pty Ltd v Andrew Laurence Gooden, [1993] APO 23, and in Robyn Ann Roelofs v Endurequip Pty Ltd, [1993] APO 64, uncorroborated evidence was found to be sufficient proof. In each of those cases, evidence from a single recipient was found sufficient on the basis that the evidence was prima facie credible, there was no contradictory evidence and the declarant was an independent witness. In the present case, there is no evidence from any supposed recipient of the Catheter B samples. Moreover Ms Sciascio claimed in evidence that she maintained and inspected company records of deliveries to prospective customers and at industry conferences. However those records were not presented in evidence either. As mentioned earlier, prior use requires a relatively high standard of proof, and the opponent bears the onus of establishing that proof. In accordance with the Aspirating decision, I find the opponent has not adequately proven public prior use in this case. Nonetheless, for the sake of completeness I will go on.
In applying Damorgold, the next issue is whether the ability to disassemble and examine the catheters would have provided sufficient enabling disclosure to anticipate the claimed invention. The present case is somewhat different from the Damorgold case where the features of the claimed invention could only be seen if the product was disassembled. In the present case, Ms Sciascio’s evidence firstly indicated that the Catheter B hub was translucent enabling the needle guard and needle to be viewed. Secondly, in use the needle guard could clearly be examined, such as after withdrawal of the needle from the catheter hub. I would thus expect that potential customers had the ability to thoroughly check the device and test its mode of operation. Similarly I would expect the same was possible by attendees at the above-mentioned exhibition.
Ms Sciascio’s evidence included a photograph of a Catheter B in its original packaging, and another of a Catheter B removed from its original packaging and partially disassembled by removing the safety shield for the needle and the end plug (exhibit MDS-2). On the other hand this exhibit does not show sufficiently clear detail within the catheter hub, such as the nature of the needle guard. Ms Chrysiliou’s second declaration though contained several further exhibits (KC-34 to KC-41) of photographs relating to Catheter B. Some of these exhibits were enlargements more clearly illustrating the needle guard within the translucent catheter hub. The exhibits also illustrated various stages of operation of the device such as the relationship between the needle guard and needle before, during and after withdrawal of the needle from the catheter hub. Evident from the photos is a needle guard having the same core constructional features as the needle guard as claimed in the present application. Together with the relationship and mode of operation of the needle guard with the needle as shown in these exhibits, I regard Catheter B to disclose a needle assembly, and its method of assembly, with a core construction that is equivalent to that claimed in the present claims.
Catheter B is visually similar in many respects to the devices shown in at least Baid 2, Baid 3 and Baid 4. Given that Catheter B originated from the same company named as applicant of the Baid applications, this would perhaps be unsurprising. As with the Baid documents though, the claimed dimensional relationships between the various items of the needle assembly in the present application require closer scrutiny with respect to catheter B. In this respect the evidence for Catheter B similarly does not provide clear and unmistakable directions of a needle assembly, its method of assembly, or a safety IVC assembly as claimed in the present application.
I conclude the claimed invention is novel over Catheter B.
S 40(2) FULL DESCRIPTION
The High Court in Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd, [2001] HCA 8, 207 CLR 1, provided a test for full description at [25] as follows:
“The question is, will the disclosure enable the addressee of the specification to produce something within each claim without new inventions or additions or prolonged study of matters presenting initial difficulty?”
The opponent contended that the specification did not describe the invention fully in respect to the feature of claim 9 of the bore diameter having a close fit ratio versus the outside diameter of the needle shaft. The opponent’s assertion was that there was no description of how to perform that feature (Ms Chrysiliou’s second declaration at [23]) or of what material the needle guard was made to determine the close fit ratio (fourth declaration at [20]-[23]). On the latter point the opponent referred to [0043] of the specification to note the possibility of compression or distortion of part of the bore by the needle when pivoting, and that, for any chosen material, the skilled addressee would have to make prolonged studies to determine the close fit ratio.
The applicant referred to Mr Hunter’s second declaration at [26]-[28]. Specifically at [28], Mr Hunter stated the close fit ratio was where the bore diameter was as close in tolerance to the needle diameter as possible while still allowing respective slidability between the needle and the guard. Mr Hunter indicated this gave him sufficient information to understand how to perform this feature. Referring also to the discussion earlier of the relevant person skilled in the field of safety IVCs, I would note the finding of the Full Federal Court in Multigate that the relevant notional person was a team of people comprising a designer or engineer skilled in medical device design and production, a clinical advisor and a tool maker. As also alluded to earlier, Mr Hunter fitted the category of a designer of medical devices. The clinical advisor may be regarded as a person in the user category in a clinical environment. In an annexure to a declaration filed in the above-mentioned prior litigation (declaration filed in this opposition by the opponent under exhibit KC-17), Mr Vincent Edmund Leskowich at [73] referred to clinical advisors as nurses and/or doctors. I would think the above personnel, together as part of a team, would have been able, at the relevant time, to bring sufficient knowledge to bear, without new inventions or additions or prolonged study of matters, to understand what was meant by close fit ratio in the present case and design a workable needle assembly device incorporating this feature.
The opponent made a similar contention against the feature of claim 9 of the bore length being utilised in combination with the bore diameter to minimise the amount of pivoting and/or turning of the needle guard on the needle. Mr Hunter addressed this in a similar way at [29]-[31] of his second declaration and similarly concluded at [32] that the specification gave him sufficient information to understand how to perform this claimed function. I concur.
I conclude the specification describes the invention fully, including a best method of performing it.
S 40(3) FAIR BASIS
The opponent repeated the above particulars against claim 9 under the ground of lack of fair basis. The assertion was that the lack of description comprised lack of support for each of the features of claim 9 mentioned above. Since I have found that the specification describes the invention fully, the opponent’s ground of lack of fair basis would fall away. In any case, Mr Hunter’s second declaration at [27] and [30] referenced the relevant passages of the present specification. At [0043] of the specification, there is a real and reasonably clear disclosure (Lockwood) of the features of claim 9. I find the claimed features have adequate fair basis.
I conclude that claim 9 is fairly based on the matter described in the specification.
S 40(3) CLARITY
The opponent asserted that each of claims 1, 9, 10 and 25 was unclear as to whether, at first instance, the angled end section as a whole or just the width thereof extended toward the second arm. There was some discussion at the hearing of Figure 3B of the application providing a basis of the width of the angled end section extending toward the second arm. Figure 3B is an end view of the needle guard accentuating the width of the angled end section. While it seems correct that the width does so extend, it would be a strained construction in the context of the specification as a whole to hold that only the width of the angled end section extended toward the second arm.
Sheppard J summarised the rules of construction for a patent specification in Décor Corporation Pty Ltd v Dart Industries Inc, [1988] FCA 399 at [14], (1988) 13 IPR 385 at 400. The Full Federal Court endorsed this summary in Pfizer Overseas Pharmaceuticals v Eli Lilly and Company, [2005] FCAFC 224 at [249]. The pertinent ones relevant to the present matter are that the specification should be read as a whole, a purposive construction should be employed rather than a purely literal one, and if an expression in a claim is not clear or is ambiguous, it is permissible to resort to the body of the specification to define or clarify the meaning of words used in the claim. Applying such rules in the present case, the sentence bridging pages 6 and 7 of the specification for example states the angled end section to extend toward the second arm. Figure 3A of the specification similarly illustrates the whole of the angled end section extending toward the second arm. Moreover, a specification should be construed so as not to lead to a foolish result or one which the patentee could not have contemplated (Electric and Musical Industries Limited v Lissen Limited, 56 RPC 23). I conclude the claims are clear in defining the angled end section as a whole extending toward the second arm.
CONCLUSION
I have concluded that the opponent’s evidence in reply is properly evidence in reply. I also conclude the opponent though has been unsuccessful on all grounds of opposition raised against the patent application.
Subject to appeal, I direct the application proceed to grant.
COSTS
Both parties generally accepted the principle that costs should follow the event. In the present case I see insufficient reason to depart from that practice.
The opponent has been successful on the evidence in reply matter. However the applicant’s objection to the evidence in reply did not appear to add any significantly increased complexity or excessive delay to this case.
The opponent has been unsuccessful on all the substantive grounds of opposition raised in this case. Accordingly I award costs in accordance with Schedule 8 against the opponent, Kerry Chrysiliou.
M. G. Kraefft
Delegate of the Commissioner of Patents