Terumo Corporation v B. Braun Melsungen AG
[2011] APO 71
•16 September 2011
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Terumo Corporation v B. Braun Melsungen AG [2011] APO 71
Patent Application: 2006200679
Title:Spring clip as needle tip protection for a safety IV catheter
Patent Applicant: B. Braun Melsungen AG
Opponent: Terumo Corporation
Delegate: Xavier Gisz
Decision Date: 16 September 2011
Hearing Date: 16 June 2011, in Canberra
Catchwords: PATENTS - opposition to the grant of the patent under s 59 – opposed on the basis of novelty, inventive step, manner of manufacture – consideration of novelty under s 7(1)(b) –consideration of inventive step under s 7(3)(b) – opposition is unsuccessful on all grounds – costs awarded against opponent
Representation: Patent applicant: Davies Collison Cave
Opponent:Phillips Ormonde & Fitzpatrick
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2006200679
Title:Spring clip as needle tip protection for a safety IV catheter
Patent Applicant: B. Braun Melsungen AG
Date of Decision: 16 September 2011
DECISION
The opposition is not successful on any grounds. Costs according to Schedule 8 are awarded against the opponent, Terumo Corporation.
I direct that the application be sealed after twenty-eight (28) days from the date of this decision. If the Commissioner of Patents is served with a notice of appeal from this decision before that time, then I direct that sealing not occur until the appeal has been finally decided or discontinued.
REASONS FOR DECISION
Background
Patent application 2006200679 (the Application) was filed by B. Braun Melsungen AG (the Applicant) on 17 February 2006 as a divisional of Australian patent 783650 (42070/01) which was a divisional of Australian patent 730988 (95323/98). The Application was advertised as accepted on 20 November 2008.
A notice of opposition to grant of a patent was filed on 20 February 2009 by Terumo Corporation (the Opponent).
The matter was heard in Canberra on 16 June 2011. The Applicant was represented by Edward Heerey as counsel, instructed by Leon Allen of Davies Collison Cave. Also present on behalf of the Applicant were Noel Akers, the declarant of the Evidence in Answer, and Kevin Woehr, a representative from B. Braun Melsungen AG. The Opponent was represented by David Clark and Joe Mok of Phillips Ormonde & Fitzpatrick.
Grounds of opposition
In the statement of grounds and particulars the Opponent opposed the grant of the patent on the grounds of: manner of manufacture, novelty, inventive step, usefulness, full description, fair basis, and clarity.
In the hearing the Opponent limited the grounds of opposition to novelty, inventive step and manner of manufacture.
Evidence
Evidence in Support consisted of:
- Statutory declarations by Barry Evers-Buckland with Exhibits BEB1 to BEB4 (dated 26 November 2009 and 23 September 2009).
- Statutory declaration by William Hunter with Exhibits WH1 to WH13 (dated 3 December 2009)
Evidence in Answer consisted of:
- Statutory declaration by Noel Akers (dated 27 January 2011)
Evidence in Reply consisted of:
- Statutory declaration by Barry Evers-Buckland with exhibit BEB5 (dated 4 May 2011)
- Statutory declaration by William Hunter with exhibit WH14 (dated 3 May 2011)
The experts providing evidence
The field of the invention lies in safety devices for catheters. The evidence comprises declarations from three experts.
10. The Opponent relies on the evidence provided by William Hunter and Barry Evers‑Buckland. Mr Hunter has extensive experience in the design of medical devices, and in particular in safety devices for medical devices with needles. Mr Evers-Buckland has been involved in raising awareness of safety in medical products and chaired a committee of an Australian Standards group dealing with the inclusion of safety features for syringes.
11. The Applicant relies on the evidence provided by Noel Ackers who is a patent attorney with extensive experience in all aspects of patents in the healthcare sector.
Preliminary matters
12. At the start of the hearing I noted that the Opponent had not served the prior art documents in the evidentiary stages. The Opponent acknowledged that this was an omission in the preparation of evidence. The Opponent argued that the prior art documents listed in the written submission were all patents which were particularised in the Statement of Grounds and Particulars and thus were readily obtainable.
13. In their oral submissions the Opponent also introduced a prior art document US 4,929,241 (Kulli) that had not been particularised in the Statement of Grounds and Particulars nor mentioned in the written submissions. It is noted that the Applicant was already aware of the prior art document and made submissions in relation to the document.
14. The Applicant did not want the hearing delayed on what was essentially a technicality, and agreed to proceed as if the prior art documents had been properly introduced in the evidence. Thus the hearing was conducted, and the decision will be made, as if the prior art documents were properly introduced in the evidence.
The specification
15. The description is directed to a spring clip as a needle tip protection for safety IV catheters.
The claims
16. The specification ends with the following 9 claims.
1. An intravenous catheter comprising
a catheter hub attached to the proximal end of a tubular catheter and having a chamber,
a needle having a needle shaft and a needle tip, wherein the needle is provided with an increased diameter, and
a needle guard retained in a ready position wholly in the chamber of the catheter hub,
wherein the needle guard has two resilient arms which are urged away from each other by said needle shaft in the ready position, each arm being provided at the distal end with a distal guard wall positioned on the shaft of the needle in the ready position and wherein the distal guard walls overlap each other in front of the needle tip when the needle guard is in a blocking position, wherein the needle shaft has a segment slightly proximal to the needle tip, the segment being provided with an increased diameter in relation to the needle tip, and the needle guard having a rear wall from which the arms extend in a distal direction
wherein the rear wall includes an opening through which the needle shaft passes,
wherein the diameter of the increased diameter segment is greater than that of said opening,
and wherein an inner wall of the chamber of the catheter hub is provided with a retaining means in the form of an annular groove by which the needle guard is retained in the catheter hub in the ready position.
2. An intravenous catheter according to claim 1, wherein the distal end of an arm includes a curved protrusion extending to the distal guard wall.
3. An intravenous catheter according to claim 2, wherein the curved protrusion is engaging the annular groove formed in the inner wall of the catheter hub.
4. An intravenous catheter according to claim 1, wherein the increased diameter segment of the needle is a bulge on the needle shaft.
5. An intravenous catheter according to claim 1, wherein the arms each include a narrow portion that extends between a wide distal portion and a proximal wide portion such that the shaft of the needle can pass between intersecting arms.
6. An intravenous catheter according to anyone of claims 1 to 5, wherein the distal guard wall terminates in a curved lip engaging the shaft of the needle.
7. An intravenous catheter according to claim 1, wherein there is a hinged arrangement between the proximal ends of the arms and the rear wall.
8. An intravenous catheter according to anyone of the preceding claims wherein the increased diameter segment of the needle is positioned within the tubular catheter in the ready position.
9. An intravenous catheter substantially as described with reference to the accompanying drawings.
Claim construction
17. The Applicant and the Opponent had differing views on how the terms needle tip, the rear wall of the clip, and the annular groove should be construed. I have construed these features as follows.
Needle tip
18. The claims define:
“a needle having a needle shaft and a needle tip…”
19. The Opponent argued that the ‘tip’ can be some length less or more than the tapered portion of the needle while the Applicant argued that needle tip was the entirety of the tapered portion of the needle.
20. Mr Evers-Buckland relied on the International standards ISO 7864:1993 and corresponding Australian standard AS 1946:2002 (Exhibits BEB-2, BEB-3 and BEB-4) to show that the “needle tip” should be construed as only the very point of the needle, excluding the remainder of the tapered portion. Mr Buckland states in his declaration of 4 May 2011 at paragraph 2.4:
“…as I already explained in paragraphs 2.2 and 2.3 of my second declaration, the “needle tip” in accordance with ISO 7864:1993 (which was also adopted as Australian Standard AS1946) is the portion of the needle point that makes an angle β with the axis of the needle. The approximate extent of the needle tip is indicated by long dashed lines below:”
21. In Mr Hunter’s opinion the needle tip was more than just the tapered portion of the needle and also may include some length of the needle shaft. Mr Hunter states in his declaration of May 2011 at paragraph 2.7:
“I reiterate that the term needle tip when used in US’504 encompasses more than just the bevelled portion but also includes an undefined length of the needle shaft.”
22. The interpretations provided by both Mr Evers-Buckland and Mr Hunter are inconsistent with each other and, in my opinion, neither provide a satisfactory construal of the term “needle tip” in the context of the present claims.
23. The claims define two distinct portions of the needle: the needle shaft and the needle tip. From this wording in the claims it is clear that the term ‘needle tip’ defines the entirety of needle that is not the needle shaft, i.e. the tapered portion of the needle. Consequently I am in substantial agreement with the Applicant on the construction of the term needle tip – the needle tip is the entirety of the tapered portion of the needle.
Rear wall
24. The claims define:
“…the needle guard having a rear wall…”
25. The rear wall provides the following functions:
“…a rear wall from which the arms extend in a distal direction wherein the rear wall includes an opening through which the needle shaft passes, wherein the diameter of the increased diameter segment is greater than that of the said opening…”
26. The Applicant and Opponent agreed that the term “rear wall” in the context of the claims defined an element which functioned to: a) connect the two resilient arms, and b) have an opening through which the needle shaft slides. However, the Applicant argued that the term “rear wall” provided an additional limitation on the geometry and shape of this feature (although they did not articulate what this limitation was), whereas the Opponent argued that no such limitation existed.
27. In the absence of any evidence or submissions about what type of geometry or shape the term “rear wall” should be restricted to, I conclude that the term “rear wall” defines an element that achieves the aforementioned function but without limitations on its geometry or shape.
Annular groove
28. The claims define:
“…an inner wall of the chamber of the catheter hub is provided with a retaining means in the form of an annular groove…”
29. The Applicant and Opponent provided alternative interpretations of the term ‘groove’.
30. The Applicant argued that the term should be given its plain meaning. Specifically, ‘groove’ means a rut, furrow or channel formed in a surface.
31. The Opponent argued that the term ‘groove’ should be construed as something that is designed to direct motion. The Opponent bases this interpretation on the evidence given by Mr Evers-Buckland at paragraph 3.12:
“…it is according to the Dictionary meaning of “groove” designed to direct motion and therefore could be considered as a groove.”
32. It is my understanding that Mr Evers-Buckland is referring to one of the functions that a groove can be used for; for example, the groove on a vinyl record directs the motion of the pickup needle. However, I do not accept this interpretation of the term groove for two reasons. Firstly, the groove in the claimed invention is not used to direct motion of the clip, but rather to retain the location of the clip. Secondly, even if it were conceded that grooves may be used to direct motion it does not follow that anything that directs motion is a groove.
33. The term ‘annular’ is construed by its plain meaning as a ring or circle shape.
34. I am in substantial agreement with the Applicant in that the term ‘groove’ should be given its ordinary meaning of a rut, furrow or channel in a surface. In the present context, an ‘annular groove’ is a rut, furrow or channel that extends (in a ring or circular shape) around the inner wall of the chamber of the catheter hub.
Law of novelty and inventive step
35. The relevant portions of section 7 of the Act states:
(1) For the purposes of this Act, an invention is to be taken to be novel when compared with the prior art base unless it is not novel in the light of any one of the following kinds of information, each of which must be considered separately:
(a) prior art information … made publicly available in a single document or through doing a single act;
(b) prior art information … made publicly available in 2 or more related documents, or through doing 2 or more related acts, if the relationship between the documents or acts is such that a person skilled in the relevant art would treat them as a single source of that information;
(2) For the purposes of this Act, an invention is to be taken to involve an inventive step when compared with the prior art base unless the invention would have been obvious to a person skilled in the relevant art in the light of the common general knowledge as it existed in the patent area before the priority date of the relevant claim, whether that knowledge is considered separately or together with the information mentioned in subsection (3).
(3) The information for the purposes of subsection (2) is:
(a) any single piece of prior art information; or
(b) a combination of any 2 or more pieces of prior art information;
being information that the skilled person mentioned in subsection (2) could, before the priority date of the relevant claim, be reasonably expected to have ascertained, understood, regarded as relevant and, in the case of information mentioned in paragraph (b), combined as mentioned in that paragraph.
Novelty
36. The Opponent argued that the claims of the application lack novelty in light of:
- US 5,135,504 (McLees) (hereinafter referred to as US’504) and
- the combined teachings of US’504 and US 5,215,528 (Purdy et al) (hereinafter referred to as US’528)
37. The test for novelty has been discussed in the Full Federal Court decisions of Pfizer Overseas Pharmaceuticals v Eli Lilly and Company [2005] FCAFC 224 and Bristol-Myers Squibb Company v FH Faulding & Co Limited [2000] FCA 316; (2000) 97 FCR 524. As noted in both decisions, the basic test for novelty is the "reverse infringement test" as set out in Meyers Taylor Pty Ltd v Vicarr Industries [1977] HCA 19; (1977) 137 CLR 228 at page 235 where Aickin J stated:
“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.”
38. Infringement is said to occur where "each and every one of the essential features of that claim have been taken" (Rodi and Wienenberger AG v Henry Showell Ltd (1969) RPC 367).
US 5,135,504 (McLees)
39. US’504 discloses a guard for the tip of an intravenous needle. The Opponent asserts that each of the features of claim 1 are disclosed in US’504.
40. The Applicant asserted that following five of the features of claim 1 are not disclosed in US’504:
a. the needle shaft having a segment slightly proximal to the needle tip, the segment being provided with an increased diameter in relation to the needle tip,
b. the needle guard having a rear wall from which the arms extend in a distal direction,
c. the rear wall including an opening through which the needle shaft passes,
d. the diameter of the increased diameter segment being greater than that of said opening,
e. the inner wall of the chamber of the catheter hub being provided with a retaining means in the form of an annular groove by which the needle guard is retained in the catheter hub in the ready position.
41. I will now assess whether these features are present in US’504.
Segment with increased diameter
42. The claims define the position of the segment in relation to the needle tip as follows: “a segment slightly proximal to the needle tip”. The term ‘slightly proximal’ is construed to mean ‘slightly distant from’. Thus there must be some distance between the needle tip and the segment; they are not immediately adjacent or touching.
43. The diameter of the segment in relation to the needle tip is defined as follows: “the segment being provided with an increased diameter in relation to the needle tip”. I have determined that the needle tip refers to the entirety of the tapered portion of the needle. Since a needle tip is tapered and thus its cross-section does not have a uniform diameter, when construing the phrase “increased diameter in relation to the needle tip” the only reasonable diameter being referred to must be the maximum diameter of the cross-section of the needle tip.
44. US’504 discloses a portion of the needle shaft that has an increased diameter. However, the needle tip extends directly from the increased diameter portion. Thus the increased diameter portion is not slightly proximal to the needle tip, nor does the increased diameter portion have an increased diameter with respect to the needle tip.
45. In summary, US’504 does not disclose a segment with increased diameter as claimed.
Rear wall
46. I have found that the term ‘rear wall’ does not provide a shape and geometry limitation. The opponent stated during the hearing that US’504 discloses a cylindrical wall from which two resilient arms extend. To be clear about this point, I used a drinking glass as an analogy and asked if the wall disclosed in US’504 was analogous to the lip of the glass or the sides (but not the base) of the glass. The Opponent stated that, using this analogy, it was the sides of the glass (excluding the base) which formed the rear wall and not the lip. The cylindrical wall of US’504 is considered to be at the rear of the device with the resilient arms forming the front of the device. Therefore I am satisfied that US’504 discloses a cylindrical rear wall.
Opening in rear wall
47. The inside surface of the cylindrical rear wall defines an opening through which the needle shaft passes. However the cylindrical wall defining an opening does not constitute a rear wall which includes an opening. In my opinion, a rear wall that includes an opening means the opening must be formed in the wall. Thus US’504 does not disclose an opening in the rear wall.
Diameter of segment greater than opening
48. Since I have found there is no opening in the rear wall, it logically follows that the feature of the diameter of the segment greater than an opening is also not disclosed.
Annular groove
49. I have determined that the term ‘groove’ is construed as a furrow, rut or channel formed in a surface. US’504 does not disclose a groove.
Summary of features disclosed in US’504
50. Of the five features of the claims which the applicant argues are not present in US’504, I have found that one of the features – that of the rear wall – is disclosed in US’504 while the other four of the features are not disclosed in the US’504. Consequently none of the claims lack novelty in light of US’504.
Combined disclosure of US 5,135,504 (McLees) and US 5,215,528 (Purdy et al)
51. The Opponent argued that the disclosures of US’504 and US’528 could be read together as a single source of information as pursuant to s 7(1)(b).
52. Before considering the argument itself, I first note that the statement of grounds and particulars does not have particulars to support this ground of opposition. The Applicant has made submissions in response to this ground and does not wish for further delay so I will consider this ground of opposition in the present decision.
53. Some guidance concerning when two or more documents constitute a single source of information is provided in Nicaro Holdings Pty Ltd v Martin Engineering Co, 16 IPR 545 at page 570 where Gummow J stated:
“What degree of lack of connection between two or more documents will make them 'independent' and so forbid the making of a mosaic to destroy novelty, will be very much a question in the particular case. Much will depend upon the nature of the art in which the skilled addressee is to be treated as versed at the priority date; this appears to have been important in the Sharpe & Dohme (1927) 44 RPC 367, (1928) 45 RPC 153. Plainly, the degree of connection which is stated to exist in the documents themselves will be important. It is difficult to see how mere identification of prior patents as related or prior art would bring them sufficiently closely together for the purpose under consideration here. Again, even where there is a further description of the prior publication, it may nevertheless be that the purpose of the reference is to direct the reader away from it, as disclosing something outmoded or defective. On the other end of the scale, the terms of the specification of the patent in suit in the Sharpe & Dohme case indicated that the patentees themselves had been relying upon the prior publications in question; and the publications themselves formed what Astbury J called 'one consistent whole'.”
54. Section 7(1)(b) requires consideration of whether the relationship between these two documents is such that a person skilled in the relevant art would treat them as a single source of information.
55. The Opponent argued that the relationship between the two documents was established because of the similarity of the documents. The Opponent notes that in US patent litigation proceedings, B. Braun themselves had asserted that US’504 bore a striking similarity to US’528. However, even if I were to accept that there is a striking similarity between US’504 and US528, this does not necessarily imply a relationship.
56. The relationship required by s 7(1)(b) must be stated to exist in the documents themselves. There is no cross-reference between the documents, either implicit or explicit, so the documents cannot be used as a single source of information. Therefore, no further analysis of the novelty of the invention in light of the combination of these documents is necessary.
Inventive step
57. 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.”
58. Before determining whether the invention is obvious, it must be determined whether those prior art documents would have been ascertained, understood and regarded as relevant by the person skilled in the art.
59. The Opponent relied upon the following prior art documents either alone or in various combinations (as ‘mosaics’).
US 5,135,504 (McLees)
US 5,215,528 (Purdy et al)
US 5,599,310 (Bogert) (hereinafter referred to as US’310)
US 4,929,241 (Kulli) (hereinafter referred to as US’241)
Person skilled in the art
60. The person skilled in the art is someone who would be expected to solve the problem addressed by the patent. In this case, such a person would be an engineer with experience in the design and manufacture of medical devices.
The problem the invention overcomes
61. The patent specification notes several known safety catheters and the associated deficiencies such as effectiveness and cost. I consider the problem addressed by the claimed invention is that known safety catheters are not sufficiently effective and thus a more effective safety catheter was sought.
Ascertained, understood, regarded as relevant
62. There was no evidence that persons skilled in the art consulted patent literature as a source of technical information at the priority date. However, I consider it reasonable to expect that an engineer would review patent literature in seeking existing solutions to a particular problem since patents are widely known to be a comprehensive source of technical information.
63. Thus I find that the prior art documents would be ascertained by the person skilled in the art. The prior art is written in English and would be readily understood by the person skilled in the art. The prior art is directed to the same problem that the person skilled in the art would have been searching for existing solutions, thus would clearly be regarded as relevant.
Common general knowledge
64. The opponent argued that there were three ‘pools’ of common general knowledge as follows:
· Pool 1 – patents and in particular, US’504 and US’310.
· Pool 2 – safety IV catheters as exemplified in the exhibits WH 7 to WH 12
·Pool 3 – generic snap fittings as exemplified in the “Handbook or Plastics Joining” which was exhibit number WH14.
65. Information in relevant textbooks can be considered common general knowledge, as can magazine and other publications specific to the field. I consider that the information found in WH7 to WH12 and WH14 is the type of widely available information that constitutes common general knowledge. Thus pool 2 and 3 would have been considered common general knowledge to a person skilled in the art at the priority date.
66. Common general knowledge does not extend to information that the skilled worker might find in conducting searches. There is no evidence that the prior art patent documents were considered common general knowledge at the priority date. Consequently I am not satisfied that any of the patent prior art documents are themselves common general knowledge and thus pool 1 is not considered common general knowledge.
Obviousness in light of Pool 1 of the common general knowledge alone
67. The opponent argued that the claimed invention is obvious in light of Pool 1 of the common general knowledge, i.e. US’504 and US’310. However, since I have found that none of the prior art patent documents themselves form common general knowledge, the claims cannot lack an inventive step on this basis.
Obviousness in light of prior art documents and the common general knowledge
68. The following inventive step analysis is performed with respect to various prior art documents in light of the common general knowledge as exemplified in the previously mentioned common general knowledge designated pool 2 and pool 3.
US 5,135,504 (McLees)
69. The Applicant notes that US’504 was not raised in the particulars of the Statement of grounds and particulars. I consider that the statement of grounds contains a typographic error, and it is clear in its context that the reference to AU’679 at designation “(a)” on page 5 is supposed to read US’504.
70. The submissions in relation to the ground of lack of inventive step are predicated on the assumption that only one feature is missing from the US’504 (the annular groove). However, I have found in the novelty analysis above that four of the features of the claimed invention are not disclosed in US’504. Without evidence to support the contention that all four of the features claimed which are missing from US’504 would be added as a matter of routine by a person skilled in the art, further consideration of this point is considered moot. Consequently the claimed invention does not lack an inventive step in light of US’504.
Combining documents
71. The question of whether a person skilled in the art would have considered it routine to combine the teachings of two or more prior art documents for the purposes of showing a lack of inventive step, commonly known as mosaicing, is considered in the Minnesota Mining & Manufacturing Co v Beiersdorf (Australia) Ltd [1980] HCA 9; (1980) 144 CLR 253 (16 April 1980). Although this decision was made under the Patents Act 1952, it is still instructive when considering ‘mosaicing’ of documents under s 7(3)(b) of the current Act. In that decision Aickin J stated at paragraph 116:
“In the case of alleged lack of an inventive step the question of making a mosaic must operate (if at all) in a very different matter [to that of novelty]. An allegation of want of inventive step is not made out by saying you may take one or two, or twenty-one or twenty-two, prior publications and then select from them appropriate extracts or pieces of information, which will add up to the invention claimed and so demonstrate that it was obvious. So to proceed is to mistake the nature of an invention and the nature of the objection of obviousness. The question is, is the invention itself obvious, not whether a diligent searcher might find pieces from which there might have been selected the elements which make up the patent. If this were not so, there could never be a valid patent for a new combination of old integers. The proper question is not whether it would have been obvious to the hypothetical addressee who was presented with an ex post facto selection of prior specifications that elements from them could be combined to produce a new product or process. It is rather whether it would have been obvious to a non‑inventive skilled worker in the field to select from a possibly very large range of publications the particular combination subsequently chosen by the opponent in the glare of hindsight and also whether it would have been obvious to that worker to select the particular combination of integers from those selected publications. In the case of a combination patent the invention will lie in the selection of integers, a process which will necessarily involve rejection of other possible integers. The prior existence of publications revealing those integers, as separate items, and other possible integers does not of itself make an alleged invention obvious. It is the selection of the integers out of, perhaps many possibilities, which must be shown to be obvious.”
Combined teachings of US 5,135,504 (McLees) and US 5,599,310 (Bogert)
72. In support of their submission that US’504 and US’310 could be combined for the purposes of inventive step, the Opponent referred to Mr Hunter’s declaration of 3 May 2011 at paragraph 4.7:
“Furthermore I would consider it sensible or reasonable to combine US’504 with US’310 since both documents are directed to solving the same problem (i.e. prevention of needle stick injury upon withdrawal of a catheter needle from the patient) and the IV catheter designs of the two documents have similarities, especially considering that both designs include a cylindrical needle guard or tip that is retained by a retaining means within the catheter hub while the needle is being withdrawn from the patient.”
73. Mr Hunter’s declaration of 3 May 2011 at paragraph 4.5 supports the Opponent’s submission that the claims lack an inventive step in light of the combination of documents:
“Further, I consider that the feature of US’504 and US 5,599,310 (US’310) discloses all recited features of claim 1. Specifically US’310 discloses a guard 32 with flexing fingers where a detent 46 on the distal ends of the fingers lock into corresponding recess 50 in the inner wall of the catheter hub 14 (see column 2, lines 46-52 and Fig. 3 reproduced below). The shape of the recess 50 in the catheter hub 14 as shown in Fig. 3 of US’310 appears to be radially symmetrical. I therefore consider that recess 50 teaches an annular groove as claimed in claim 1 of AU’679.”
74. The Applicant’s submissions provide several reasons why the documents cannot be properly combined for the purposes of inventive step. The Applicant’s submissions further provide several reasons why a combination of features from the two documents fails to establish that the claims lack an inventive step.
75. In this instance it is not necessary to decide whether the documents can be properly combined for the purposes of inventive step since the outcome remains the same. Even if it were assumed that the annular groove of US’310 could be combined with the invention disclosed in US’504, this is only provides one additional feature of the four features claimed in the opposed patent and missing from US’504. Without evidence or submissions of why the other three features would also be considered obvious in light of the combination of US’504 and US’310, the consideration of the inventiveness of the claims in light of the combination of documents is moot.
Combined teachings of US 5,135,504 and US 5,215,528
76. In support of their submission that US’504 and US’528 could be combined for the purposes of inventive step, the Opponent referred to Mr Hunter’s declaration of 3 May 2011 at paragraph 2.13:
“In providing my opinion at paragraphs 2.11 to 2.13, I regard both US’504 and US’528, which I have no trouble understanding, as relevant because they each relate to needle guards for an IV catheter (to prevent accidental needle stick injury), where the guard is deployed automatically when the needle is withdrawn. Furthermore I would consider it sensible or reasonable to combine US’504 and US’528 since both documents are directed to solving the same technical problem (i.e. prevention of needle stick injury after a catheter needle is withdrawn from the patient). The description of the circumferential widening of a portion of the needle (near the distal end) to engage the needle guard is similar in the 2 documents.”
77. Mr Hunter’s declaration of 3 May 2011 at paragraph 2.11 supports the Opponent’s submission that the claims lack an inventive step in light of the combination of documents:
“Regardless of whether US’504 alone discloses a “segment being provided with an increased diameter in relation the needle tip”, I consider that this feature is disclosed by a combination of US’504 and US 5,215,528 (US’528).”
78. The Applicant’s submissions refute both that the documents can be properly combined and that the features drawn from the documents establish a lack of inventive step.
79. In this instance it is not necessary to decide whether the documents can be properly combined for the purposes of inventive step since the outcome remains the same. Even if it were assumed that features of US’528 and US’504 could be ‘cherry-picked’ to match the features of the claimed invention, there is still at least one feature that is not present in either of these documents – an annular groove. Without an explanation of why the annular groove would also be considered obvious in light of the combination of US’504 and US’528, the consideration of this point is moot.
80. It is further noted that combining the teachings of US’241 with US’504 and US’528, as proposed by the Opponent, even if allowable would still not establish a lack of inventive step since feature of the annular groove would still be missing.
Inventive step summary
81. The claims do not lack an inventive step in light of common general knowledge or the prior art either individually or the potential combinations submitted by the opponent.
Manner of manufacture
82. The opponent argued that the invention does not satisfy the threshold test for inventiveness as set out in the authorities of Bristol Myers Squibb v FH Faulding & Co Ltd [2000] FCA 316 and NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd [1995] HCA 15.
83. As is clear from the considerations of novelty and inventive step there is a prima facie difference between the present invention and the prior art. Thus, on its face, the claimed invention is new. Therefore I am not satisfied that the claimed invention lacks a manner of manufacture.
Conclusion
84. I have found the opposition fails on all grounds argued by the opponent. Claims 1-9 of the application have not been found to lack novelty, inventive step or manner of manufacture.
Costs
85. The award of costs is a discretionary matter. It is a general principle in matters such as these that costs follow the event, and I see no reason to depart from this practice. Terumo Corporation has been unsuccessful in this opposition. I award costs in accordance with Schedule 8 against Terumo Corporation.
Xavier Gisz
Delegate of the Commissioner of Patents
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