Kerry Chrysiliou v B.Braun Melsungen AG - [2018] APO 33

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Kerry Chrysiliou v B.Braun Melsungen AG [2018] APO 33

Patent Application: 2014240216

Title:Needle Assembly, Safety Catheter Assembly and Method for Assembly

Patent Applicant:                   B.Braun Melsungen AG
Opponent:  Kerry Chrysiliou
Delegate:  Xavier Gisz
Decision Date:  30 May 2018
Hearing Date:  9 March 2018, in Melbourne

Catchwords: PATENTS - opposition to the grant of the patent under s 59 – opposed on the basis of novelty, inventive step, clarity – all grounds of opposition are unsuccessful – costs awarded against the opponent

Representation: Counsel for the applicant: Ed Heerey
Patent attorney for the applicant: Fiona Galbraith of Davies Collison Cave
Thomas Griffiths (by telephone link) of Davies Collison Cave
Kevin Woehr, representative of B. Braun Melsungen AG
Barrister for the opponent: Ian Horak
Patent attorney for the opponent: Roger Green and Daniel Bolderston of Watermark
Prabhakar Mani Pratap of Indian attorney firm Vutts & Associates

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2014240216

Title:Needle Assembly, Safety Catheter Assembly and Method for Assembly

Patent Applicant: B.Braun Melsungen AG
Date of Decision: 30 May 2018
DECISION
The opposition fails on all grounds raised. Subject to appeal, I direct the application proceed to grant. Costs are awarded against the Opponent, Kerry Chrysiliou, according to Schedule 8.
REASONS FOR DECISION
Background

The Applicant (B.Braun Melsungen AG) filed the present Australian Patent Application 2014240216 (the Opposed Application) on 30 September 2014.
The Opposed Application is a divisional application of Australian Patent 2011287917 which was filed as a PCT application (international application number PCT/EP2011/003746) with an international filing date of 26 July 2011 and an earliest priority date of 5 August 2010.
The Opposed Application was published and made open for public inspection on 23 October 2014. The Applicant requested examination of the Opposed Application on 5 December 2014. The Application was accepted by the Commissioner on 29 June 2016 and that acceptance was advertised on 14 July 2016.
On 14 October 2016, Ms Chrysiliou (the Opponent), filed a notice of opposition under section 59 of the Act.
The grounds of opposition were initially set out in the Statement of Grounds and Particulars in Support of Opposition dated 13 January 2017 (SGP). On 22 June 2017, the Opponent submitted a request to file an amended SGP (the amended SGP). The Applicant objected to the amendments in a letter dated 3 July 2017. However, the amendment request was allowed on 21 July 2017
APPLICABLE LAW
The request for examination of the patent application was filed on 5 December 2014. As a consequence, substantive amendments to the Patents Act brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 that came into effect on 15 April 2013 apply to the present patent application.
Thus the standard of proof that applies in the present case is the balance of probabilities. I must accept the application if satisfied on the balance of probabilities that the application complies with the Act. If I am not so satisfied, then I can refuse the application.
Grounds of opposition
The grounds pressed by the Opponent are:
·lack of clarity
·lack of novelty
·lack of inventive step
Evidence
The Opponent filed the following Evidence in Support:
·Mr Pankaj Gupta dated 12 April 2017 (Gupta) with Exhibits PKG-1 to PKG-22;
·Mr Rishi Baid dated 12 April 2017 (Baid#1) with exhibits RB-1 to RB-25; and
·Mr John Roger Green dated 13 April 2017 (Green) with exhibits JRG-1 to JRG-6.
B Braun filed the following Evidence in Answer:
·Mr William Samuel Hunter dated 17 July 2017 (Hunter) with exhibits WSH-1 to WSH-4; and
·Ms Archana Shanker dated 17 July 2017 (Shanker) with exhibits AS-1 to AS-2.
The Opponent filed the following Evidence in Reply:
·Mr Prabhakar Mani Pratap dated 7 September 2017 (Pratap) with exhibits PMP-1 to PMP-14; and
·Mr Rishi Baid dated 15 September 2017 (Baid#2) with exhibits RB-101 to RB-107.
Specification
The alleged invention relates to a needle assembly, safety catheter assembly and method for assembly and, in particular, to a safety intravenous catheter (IVC) in which the needle tip is automatically covered after needle withdrawal to prevent unintended injury with the needle tip (known as needlestick injury).
Various embodiments are discussed at [0007] to [0011]. Paragraph [0007] describes a needle guard in the following terms:
"[0007] In certain embodiments, a needle guard comprising a non-metallic base portion comprising a bore, a proximally facing surface, and a distally facing surface are incorporated. The guard further includes 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 section that extends towards the second arm. Wherein the angled distal end section comprises a length and a width configured to retain a needle having a needle diameter within a tip holding space and wherein the length and width of the angled distal end section are larger than the needle diameter."
The needle guard which is consistent with this description is shown in Figure 3A.
The Opposed Application includes 29 claims of which claims 1, 12, and 21 are independent claims. The independent claims are reproduced below:
1. A safety catheter assembly comprising:
a needle hub with a needle attached thereto, said needle comprising a change in profile located proximally of a needle tip, a needle shaft having a side, and a needle diameter;
a catheter hub with an interior cavity having a catheter tube attached thereto and having said needle projecting through the catheter hub and the catheter tube such that the needle tip extends beyond a distal end of 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 a bore, 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 and having a tensioning member mounted on an exterior thereof, the first free end extending beyond the second free end and including an angled end section extending towards the second arm and contacting a side of the needle shaft;
wherein the angled end section comprises a length and a width defining, at least in part, a tip holding space to retain the needle tip within the tip holding space in a protective position as the needle guard pivots or turns on the needle; and
wherein the width of the angled end section is larger than a width of the second free end and at least two times larger than a diameter of the needle to confine the needle tip within the needle tip holding space.
12. A method for assembling a needle assembly comprising:
providing a needle having a needle shaft with a diameter, 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 from the base portion in a distal direction and having a tensioning member mounted thereon on an exterior thereof and proximally of a hub engaging section, 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 contacting a side of the needle shaft and the second arm comprising a distal end most surface comprising a length and a width;
a needle tip holding space defined at least in part by the base portion, the first arm, the second arm, and the width of the angled end section being larger than but less than about 1.5 times larger than the width of the distal end most surface of the second arm to confine the needle tip of the needle within the needle tip holding space as the needle guard pivots or turns on the needle in a protective position; and
moving the needle guard along the needle shaft so that the angled end section is biased by the needle shaft and the tensioning member biases the first arm and the second arm together.
21. A needle assembly comprising:
a needle having a diameter, a needle tip, and a change in profile located proximally of the needle tip;
a needle guard having a non-metallic base portion comprising wall having a bore, a bore length, a bore diameter, 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 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 or an insert located in the bore of the non-metallic base portion;
a needle tip holding space defined at least in part by the base portion, the first arm, the second arm, and the width of the angled end section being larger than but less than about 1.5 times larger than the width of the distal end most surface of the second arm to confine the needle tip of the needle within the needle tip holding space as the needle guard pivots or turns on the needle in a protective position;
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 a tip holding space; and
wherein the change in profile on the needle stops the needle guard from displacing distally off of the needle tip when the change in profile contacts the metallic plate or the insert.
The Opponent divided claim 1 into the following integers:
Claim 1:
(1.1) A safety catheter assembly comprising:
(1.2) a needle hub with a needle attached thereto, said needle comprising a change in profile located proximally of a needle tip,
(1.3) a needle shaft having a side, and a needle diameter;
(1.4) a catheter hub with an interior cavity having a catheter tube attached thereto and having said needle projecting through the catheter hub and the catheter tube such that the needle tip extends beyond a distal end of the catheter tube;
(1.5) a needle guard disposed, at least in part, inside the interior cavity of the catheter hub,
(1.6) said needle guard comprising: a non-metallic base portion comprising a wall having a bore, a proximally facing surface, and a distally facing surface,-
(1.7) 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
(1.8) and having a tensioning member mounted on an exterior thereof
(1.9) the first free end extending beyond the second free end
(1.10) and including an angled end section extending towards the second arm and contacting a side of the needle shaft;
(1.11) wherein the angled end section comprises a length and a width defining,
(1.12) at least in part, a tip holding space to retain the needle tip within the tip holding space in a protective position as the needle guard pivots or turns on the needle; and
(1.13) wherein the width of the angled end section is larger than a width of the second free end and at least two times larger than a diameter of the needle to confine the needle tip within the needle tip holding space.
Is the Evidence in Reply properly in reply?
On 17 October 2017 the Applicant wrote to the Patent Office and argued that the Opponent's evidence in reply improperly seeks to introduce new evidence, and requested the opportunity to object to the new material contained therein.
On 20 October 2017, the Commissioner agreed that the Applicant may include, in its submissions for the hearing, any submissions it wishes to make as to why parts of the Opponent's evidence in reply are not properly in reply.
The applicant alleges various parts of the Baid #2 declaration and exhibits are not properly in reply. The Applicant’s arguments in relation to Mr Baid’s evidence can be broadly grouped into two aspects: evidence on common general knowledge, and evidence on the analysis of figures of D2.
Mr Hunter makes comments about the common general knowledge in his declaration, and specifically that, in his opinion, the PolySafety device was not common general knowledge e.g. paragraphs 28-33. Mr Baid’s declaration provides further evidence that the PolySafety device was common general knowledge. I consider Mr Baid’s evidence (including reference to the Indian Court and litigation documents) relating to the common general knowledge to be replying to Mr Hunter’s evidence and thus is properly evidence in reply.
Mr Hunter analyses the relative dimensions components in D2 and specifically the dimensions of the angled end section of the first arm and the second arm at paragraphs 124-128. Mr Baid provides analysis of the relative dimensions of components in D2 at paragraphs 105 to 108. I consider Mr Baid’s evidence relating to the dimensions of D2 to be properly in reply.
In summary, all of Mr Baid’s Evidence in Reply is considered to be properly in reply.
Claim construction
The relevant principles of construction are usefully summarised by Bennett J in Sachtler GMBH & Co KG v RE Miller Pty Ltd (with Corrigendum dated 27 July 2005) [2005] FCA 788 (15 June 2005):
“Evidence can be given by experts on the meaning which those skilled in the art would give to technical or scientific terms and phrases and on unusual or special meanings given by such persons to words which might otherwise bear their ordinary meaning … Where the patent contains technical material, the Court must, by evidence, be put in a position of a person of the kind to whom the patent is addressed, a person acquainted with the surrounding circumstances of the state and the art and at the relevant time … However, if the evidence does not establish that such a technical meaning exists, words used in a patent specification should be given their ordinary meaning …
…[T]he evidence of the skilled reader is not determinative of the construction of the document. It is evidence of how a skilled reader would have read the document at the relevant time. It is then for the Court to construe the document, giving such weight to the evidence as it sees fit.
The construction of the specification is for the Court, not for the expert witness …”
Clarity
The Court in Meat & Livestock Australia Limited v Cargill, Inc [2018] FCA 51 (MLA) at [932] set out the principles in determining clarity:
"A valid claim is required to define with sufficient certainty the scope of the monopoly being claimed (s 40(3)). Given that a patent is a public instrument, the claim must be defined in such a way that it is not reasonably capable of being misunderstood so that others know the "exact boundaries of the area within which they will be trespassers": Electric & Musical Industries Ld v Lissen Ld (1939) 56 RPC 23 at 39 per Lord Russell of Killowen. A claim will lack clarity if a person skilled in the relevant art cannot ascertain whether what he proposes to do falls within the claim's ambit."
Clarity is a matter of claim construction. His Honour stated in MLA at [936] cited his Honour Justice Hely in Flexible Streel Lacing Co v Beltrco at [131]:
"Thus, I conclude that the product claim is obscure; it is fairly and equally open to diverse meanings, namely that the sipes run at right angles across the strip, on the one hand, or that the sipes run along the length of the strip on the other. Another possibility is that the claim embraces both. Sometimes, ambiguity or insufficiency in description can be resolved by a skilled addressee through the application of commonsense and common knowledge: cf Innovative Agriculture Products Pty Ltd v Cranshaw (1996) 35 IPR 643 at 666. I do not think that this is such a case."
It is a recognised tenet of Australian patent law that each claim must be read as part of the entire specification (Electrical and Musical Industries Ltd v Lissen Ltd 56 RPC 23 at 39), and thus the meaning of the words used in a claim may be affected by what is said in the body of the specification (Rosedale Associated Manufacturers Ltd v Carlton Tyre Saving Co Ltd [1960] RPC 59 at 69). While noting that it is not legitimate to narrow or expand the boundaries of monopoly as fixed by the words of a claim, by adding to those words glosses drawn from other parts of the specification (Welch Perrin & Co Pty Ltd v Worrel [1961] HCA 91; (1961) 106 CLR 588 and Decor Corporation Pty Ltd v Dart Industries Inc (supra)), it is legitimate to refer to the rest of the specification to explain the background to the claims, to ascertain the meaning of technical terms and resolve ambiguitiesin the construction of the claims (see Interlego AG v Toltoys Pty Ltd [1973] HCA 1; (1973) 130 CLR 461 at 476).
Length and width
The Opponent states:
The claims of the Opposed Application define a length and width in terms of dimensions that would define a tip holding space. No distinction is made in the claim such that the person skilled in the art would know which dimension could more appropriately be ascribed as the width and which would be ascribed the length.
The plain meaning of length and width is that the longer dimension will typically be defined as the length and the shorter dimension will be typically defined as the width. In this case, the extent of the two dimensions of the angled end section in the claims are not defined, thus on the plain meaning of the words of the claims alone there is not a clear distinction in the claims as to which direction length and width are oriented. This ambiguity can be resolved by reference to the description as endorsed in Decor (supra).
The description and figures provides the length and width as shown in Figure 3B, with length indicated as L1 and L2 and width indicated as W:
The orientation of width and length dimensions, as described and shown in the figures, are illustrated in Mr Hunter’s evidence:
I am satisfied that the ambiguity with respect of the orientation of length and width in the claim can be resolved by reference to the description. This aspect of the claim is clear.
Length and Width with reference to the words of claim 12
During the hearing the Opponent argued that the wording of claim 12 explicitly defines the width to be in the direction in which the angled end section extends. Specifically, the Opponent parsed (shown with brackets) part of the claim 12 as follows:
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 contacting a side of the needle shaft) and the second arm comprising a distal end most surface comprising a length and a width
That is, the Opponent argued that it was the width dimension that extends towards the second arm. The Opponent argued that the comma preceding this excerpt made clear that the words should be parsed together.
I consider the Opponent’s parsing of the claim somewhat strained, requiring that the width contacts a side of the needle shaft. However, it is clearly only a component and not a dimension (width) that can contact the side of a needle shaft.

The Applicant argued it is the angled end section which extends towards the second arm. The Applicant asserted that the words ‘a width’ was the last item in the list of features associated with the angled end section and thus it is the angled end section which extends towards the second arm. In other words, the comma is a serial comma (also known as an Oxford comma) which is used to separate the last two items in a list.
Thus, the Applicant parsed (shown in brackets) this part of claim 12 as follows:
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 contacting a side of the needle shaft and the second arm comprising a distal end most surface comprising a length and a width
The Applicant’s parsing is natural and leads to no further claim construction difficulties. Consequently I accept the Applicant’s parsing is correct.
I am satisfied that this aspect of claim 12 defines that the angled end section extends towards the second arm and this aspect of the claim is clear.
Law on Novelty
A claimed invention is deprived of novelty if it has been given to the public before the priority date, either by prior use of a product or process, or by publication of information that equates to the claimed invention (Justice Bennett in Danisco A/S v Novozymes A/S (No 2) [2011] FCA 282 at [248]; [2011] FCA 282; (2011) 91 IPR 209 at [248]). It is well established that the general test for anticipation 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]; [1977] HCA 19; (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.”
This test is satisfied if the alleged anticipation discloses all of the essential features of the invention as claimed (Nicaro Holdings Pty Ltd v Martin Engineering Co [1990] FCA 40 at [19]; [1990] FCA 40; (1990) 16 IPR 545 at 549). To meet this requirement, the prior art must contain “clear and unmistakable directions” to the claimed invention (Pfizer Overseas Pharmaceuticals v Eli Lilly and Co [2005] FCAFC 224 at [314]; [2005] FCAFC 224; (2006) 68 IPR 1 at 67 [314]). However, if the prior publication contains a direction which is capable of being carried out in a manner which would infringe the patentee’s claim, but would be at least as likely to be carried out in such a way that would not do so, the patentee’s claim will not be anticipated (General Tire & Rubber Co v Firestone Tyre & Rubber Co Ltd (1971) 1A IPR 121 at 138). Where a prior publication does not explicitly disclose all of the integers of the claimed invention, it would still deprive the claimed invention of novelty if (i) the skilled reader understands the disclosures of the prior publication to include a missing integer, and (ii) if the document contains a direction to use a process that inevitably or inexorably results in something within the claim (Justice Bennett in Danisco (No 2) [2011] FCA 282 at [248]; [2011] FCA 282; (2011) 91 IPR 209 at [248]).
Law on Inventive Step
The test for obviousness is whether it would have been a matter of routine to proceed to the claimed invention. In Wellcome Foundation Ltd v V.R. Laboratories (Aust.) Pty Ltd [1981] HCA 12 Justice Aickin stated:
“The test is whether the hypothetical addressee faced with the same problem would have taken as a matter of routine whatever steps might have led from the prior art to the invention, whether they be the steps of the inventor or not.”
Novelty
EP2016963 (D1)
The Opponent’s arguments in relation to D1 are predicated on the length and width dimensions are the reverse of the orientations as described in the specification. I have found that the Opponent’s construction of the claim is incorrect, and have instead adopted the construction consistent with the orientations described in the specification.
D1 provides essentially no information about the relative width of components of the invention disclosed. Thus D1 does not disclose the feature of “the width of the angled end section is larger than a width of the second free end”. Consequently the claims are novel in light of D1.
IN1965/DEL/2009 (D2)
Publication date
The Applicant argues that evidence suggests that IN1965/DEL/2009 (D2) was not published on 18 June 2010.
The Applicant states at paragraph 206:
“...Ms Shanker gives evidence as the senior partner and head of patents and designs of an Indian intellectual property firm. At [3] she attests that the Indian Patent Office’s Official Journal published on 18 June 2010 does not refer to Indian Patent Application 1965/DEL/2009.”
Paragraph 3 of Ms Shanker’s declaration states:
On 18 June 2010, the Indian Patent Office published Issue Number 25/2010 of the Official Journal, across three parts. In total, this document (the 18 June 2010 Official Journal) contains 1257 pages. An electronic copy is accessible at (The 18 June 2010 Official Journal has not been annexed to this declaration due to its length.) The 19 June 2010 Official Journal does not refer to Indian patent application IN 1965/DEL/2010. Further, page 15739 of the Journal of 18 June 2010 has the publication of Indian patent application number 75/CHENP/2010 and not 1965/Del/2010.
The Applicant states at paragraphs 207 and 208:
“At [5] and Annexure AS-1, Ms Shanker gives evidence that this Indian Patent Application was included in the Indian Patent Office’s Official Journal published on 6 June 2014.”
“That 6 June 2014 Official Journal also included a public notice, which reported that “[d]ue to a technical snag" certain patent applications had not been published in the Official Journal and were now being made available through this special issue of the Official Journal, although they had been made available through the Indian Patent Office website at some other prior unspecified date.”
The Official Journal is a periodic publication that lists all the actions and bibliographic details of patent applications and granted patents as required by the legislation. It is notable that the Official Journal does not publish the entire specifications of patent applications that have become open to public inspection. The specifications that have become open to public inspection can be obtained from the patent office (either via the patent office website or directly from the patent office).
The Applicant argues that the Opponent has not provided sufficient evidence that IN1965/DEL/2009 (D2) was actually open to public inspection on 18 June 2010.
A public notice in the Official Journal dated 6 June 2014 at page 15256 stated (with my emphasis in bold):
“Some patent applications were opened to the public at the expiry of the prescribed period and were sent for publication in the Official Journal that is published every Friday. Due to a technical snag these applications were not published in the PDF format of the Journal, however, these applications were made available to the public through /PAIRS at Specific Journal numbers in which the applications were supposed to have been, published and corresponding publication dates were duly ascribed to the respective applications. Such patent applications, which have already been published under /PAIRS, are now being made available in PDF format through this special issue of the Official Journal.”
I am satisfied that the statement in the Official Journal for the Indian patent office establishes that the application was available for download from the Indian patent office website on 18 June 2010. I am further satisfied that the provisional patent application on which IN1965/DEL/2009 (D2) is based was also available on 18 June 2010.
Novelty analysis of D2
Width of components in D2
On the basis of the specification as a whole, the components in the claimed invention are taken to be of essentially uniform width. This is in contrast to the components in D2 which have non-uniform width. This leads to the difficulty that the term width is indefinite for an object of non-uniform dimensions. The width of an object with non-uniform width can be measured in various ways. For example: at its narrowest point, at its widest point, or at an average (e.g. median).
This is further complicated because the width is non-uniform in two directions. In one direction, the width changes at different lengths. This is illustrated below:
In this direction the width of the angled end section tapers from a maximum width (designated width 1 in the illustration above) to a smaller width (designated with 2 in the illustration above) and then to zero. I consider that the maximum width is the only sensible interpretation of width in this direction. I note that both the Opponent’s and Applicant’s submissions are based on the assumption that the width is measured at a maximum. For the purposes of this decision, I will assume the width (in this direction) to be measured at its maximum.
The width of the device changes with height as illustrated below:
The width of the device has wider portion (designated width 4) tapering to a minimum width (designated width 3) at the angled end section.
Is the width of the angled end section larger than the width of the second free end?
The Applicant’s submissions appear to be based on the assumption that the width (as it varies at different heights) is measured at a maximum, whereas the Opponent’s submissions appear to be based on the assumption that this width is measured at a minimum. Since there is no clear reason to adopt one interpretation over the other, I will consider both cases: width taken at a maximum and width taken at a minimum.
D2 discloses in the embodiment of Figures 3A, 3B, 3C, 3D:
The claims define an angled end section. This appears to correspond to the distal wall in the description which is item 50. The end view of the device in figure 3C shows the outline of the first and second arm, however does not distinctly show the outline of the angled end section of the first arm. The outline of the angled end section can be seen in orthogonal view in Figure 3D. Combining the information about the angled end section from Figure 3D and Figure 3C I have added the curved end of the angled end section in an approximation with a green line as follows:
Width taken at a maximum
Mr Hunter states at paragraphs 125 and 126:
“I consider that it is also possible to identify, from Figure 3C in 1965/DEU2009, the approximate width of the shorter arm of the needle guard. This is also shown in the annotated version of figure 3C, below.
It is evident to me from the annotated Figure 3C above that the width of the angled end section is less than the width of the second arm. It is not possible, from the information provided in 1965/DEU2009, to determine the width of the angled end section relative to the diameter of the needle.”
Mr Hunter’s analysis is based on the interpretation that the width is measured at the widest point of the second free arm. On this interpretation, Mr Hunter is correct that the width of the second arm (the shorter arm) is greater than the width of the angled end section.
This can also be seen in the corresponding side view shown in Figure 4C:
Width taken at a minimum
Mr Baid in his evidence in reply states:
Now referring to the annotated Figure 3C of Mr Hunter at 124 and 125, the dimension marked by Mr Hunter of the second arm is not the dimension of the distal most surface of the second arm. Referring to Figures 30, 48 and 6, the dimension of distal most surface of the second arm is clearly shown above in red. Thus, the correct view of Figure 3C is as annotated as below:
Mr Baid’s analysis is based on an interpretation that the width is measured at the narrowest point of the second free arm.
I consider that Mr Baid’s drawing of the end surface of the second free end is misleadingly small. The relative widths of the components is clear in the corresponding side view in figure 4C:
It is clear that the width of the second free end (of the second shorter arm) is greater than the width of the angled end section.
Conclusion on width of second free end and angled end section
I have analysed two possible interpretations of the width of the features of the prior art document D2 – the width is measured at a) a maximum or b) a minimum. Both interpretations lead to the same conclusion – the second free end of the second arm is wider than the angled end section.
Is the width of the angled end section two times larger than the width of the needle?
The relative widths of the needle and angled end section can be approximated from figures 4A and 4C:
The needle width is roughly the same width as the side edge (38) of the needle guard. The width of the angled end section (taken at its maximum) appears to be approximately twice the width of the needle width. However, I do not consider this to be a clear and unmistakable disclosure of the angled end section being at least twice the width of the needle.
Novelty conclusion for D2
D2 does not provide a clear and unmistakable disclosure of either: a) the width of the angled end section being twice the width of the needle, or b) angled end section being wider than the second free end of the second arm.
Claims 1, 12 and 21 are novel in light of D2. It follows that all dependent claims are also novel in light of D2.
Related provisional (D7)
The invention disclosed in D7, the provisional related to D2, discloses essentially the same information as D2. It fails to disclose the claimed invention for the same reasons as discussed for D2.
PolySafety versions 1 and 2 (prior use)
There are two versions of the PolySafety Safety IV Cannula. I will call these version 1 and version 2.
Mr Baid states in declaration 1:
An example of safety IVCs that existed at and before the Priority Date included Poly Medicure’s Polysafety™ Safety IV Cannula, as described in European patent publication 2016963 A1 (Exhibit RB-4) [D1], which was published on 21 January 2009. A version of this device has been in use and in the market since 2007.
Mr Baid’s declaration supports the contention, and both parties agree, that PolySafety version 1 was OPI before the priority date. Polysafe version 1 does not add anything of substance over the document D1 (EP 2016963 A1) which has been considered above. Thus for the reasons in relation to D1, I also find that the claims are novel in light of the PolySafety version 1.
PolySafety version 2 is shown in Exhibit 7 (RB-7) of Baid#1 declaration:
Was the PolySafety version 2 OPI before the priority date?
Mr Baid states at paragraph 21:
A subsequent version of the Poly Medicure’s Polysafety™ Safety IV Cannula was released in 2009. This version is described in Indian patent publication 1965/DEL/2009 (Exhibit RB-6) [referred to as D2 throughout this decision], which was published on 18 June 2010. This new version has been in use and in the market since 2009. In contrast to the Polysafety™ Safety IV Cannula of European patent publication 2016963 A1 (described above), this version of the Polysafety™ Safety IV Cannula (18G to 26G) is provided with a retaining means such as a stopping element in the base portion of the needle guard for further inhibiting removal of the needle from the needle guard. Polysafety™ Safety IV Cannula was the first safety IVC in the market before the Priority Date with a retaining means.
As noted in the Applicant’s submissions, the evidence supporting Mr Baid’s declaration regarding the prior use of the PolySafety Safety IV Cannula is unclear about which version is being referred to.
Mr Baid states at paragraph 22 (with my emphasis in underline):
Photographs showing the Polysafety™ Safety IV Cannula that existed before the Priority Date are attached as Exhibit RB-7, some of which are shown below.
Whether a device existed before the priority date does not help when determining whether a device was used publicly before the priority date.
Overall, the evidence is insufficient to establish there was prior use of PolySafety Safety IV Cannula version 2 before the priority date.
Inventive Step
The characterising feature of the invention is that the width of the angled end section is greater than the width of the second arm. It is commonly accepted by the parties that an angled end section with an adequate width is useful to prevent the needle from slipping past the end section. However, there is no information provided in the specification, the evidence, or in the submissions to the hearing to explain the significance of the second arm being narrower than the angled end section.
The problem
The Applicant states in their submissions:
“Mr Hunter considers that the Applicant has, for the first time, recognised serious problems that may occur when the needle turns or pivots within the needle guard, and, as described in Part 5 above, the Applicant's invention stems from the recognition of that problem.”
Mr Hunter states at paragraph 69 of his declaration:
“In my view, the Applicant has recognised a serious problem that may occur when the needle turns or pivots. Seeking to identify problems which may occur during use of a medical device is an important part of medical device design, and I have seen numerous instances of medical devices being used by healthcare workers "in the field" in a way that was not anticipated by me as a medical device designer. Accordingly, a "Failure, Modes, Effects and Criticality Analysis" is a technique I typically use to assess the risks to users of medical devices (including both healthcare workers and patients) and rank the probability and severity of those risks occurring.”
I am satisfied that the problem to be overcome is to prevent the needle from slipping out of the safety device when the needle turns or pivots within the safety device.
The person skilled in the art
The person skilled in the art would have knowledge of mechanical engineering and medical devices particularly related to the design and operation of needle assemblies, safety catheter assemblies and, more particularly, safety IVCs (see paragraph [0002] of the description). The evidence of Mr Gupta, Mr Baid and Mr Hunter are all useful in providing insight into the person skilled in the art.
The common general knowledge
The Opponent state in their submissions:
Safety catheter devices are generally classified into two categories. Those that require active activation where the safety feature needed to be manually activated and those that require passive activation. The former were phased out and it was at the priority date common to have a safety feature which is activated upon withdrawal of the needle from the safety catheter. The advantage of a passive activation is that no additional effort has to be expended for the activation.
The Applicant states:
“Mr Hunter considers that his CGK at the priority date included:
a. safety IV catheters and the need for safety IV catheters to reduce needle stick injuries;
b. "active" and "passive" safety IV catheters;
c. B Braun's (passive) Introcan Safety IV catheter;
d. "active" safety IV catheters such as Becton Dickinson's Insyte Autoguard product and ProtectIV; and
e. a small number of other safety IV catheters.”
I am satisfied that safety catheter devices were common general knowledge at the priority date.
Would the person skilled in the art modify D1 or D2 such that the second free end of the second arm was narrower than the angled end section?
The description states at paragraph 39:
“The width (height) of the angled end section 214 may be designated by the variable W, which is more clearly shown in end-view 3B-3R. In one embodiment, the length Ln and width W are selected so that the angled end section 214 is configured to adequately block the needle tip when the needle guard is in the protected position. In one particular embodiment, the length Ln and the width W of the guard are selected so that the tip is blocked or covered by the end section 214, even when the needle is rotated so the point of the bevel still faces the end section 214 or when the needle pivots side-to-side when in the protected position. In addition, the width W and the length Ln are to be wide enough to prevent the needle bevel from contacting an edge of the angled end section 214 since some plastics such as polycarbonate or ABS can be chipped when struck by the needle bevel.”

It was acknowledged by both parties that having an angled end section with a sufficiently large length and width was important to prevent the needle from escaping past the angled end section.
During the hearing I asked the Applicant the significance of the second free end of the second arm being narrower than the width of the angled end section. The Applicant was unable to explain the significance of this feature.
The Opponent argued that difference in dimension is a minor difference and cannot constitute an inventive step.
There are practical constraints on the variations to dimensions of the free end of the second arm and of the angled end section. For example, the device needs to be able to fit inside the hub and readily removed from the hub when the needle is withdrawn. Thus the components should not be significantly larger than necessary.
If a side wall (i.e. either the first arm or the second arm) were too narrow, the needle could poke through the side of the tip holding space, thus requiring a larger angled end section to compensate. The second free end of the second arm could also break if it was too narrow.
The Opponent asserted that a person skilled in the art would be expected to make variations on the dimensions of D1 or D2, however the Opponent was unable to explain why a person skilled in the art would be motivated to make the second free end of the second arm narrower than the angled end section.
Given the potential problems in making the second free arm narrower than the angled end section, and given the absence of reasons why a person skilled in the art would make such a modification, I am not satisfied that a person skilled in the art would modify D1 or D2 such that the second free end of the second arm would be narrower than the angled end section of the first arm.
Conclusion
The opposition fails on all grounds raised in this opposition. Subject to appeal, I direct the application proceed to grant.
Costs
Costs typically follow the event. I can see no reason to depart from this practice. Costs are awarded against the opponent, Kerry Chrysiliou, according to Schedule 8.
Xavier Gisz
Delegate of the Commissioner of Patents