Fisher & Paykel Healthcare Ltd. v ResMed Ltd
[2016] APO 48
•15 July 2016
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Fisher & Paykel Healthcare Ltd. v ResMed Ltd. [2016] APO 48
Patent Application: 2009221630
Title:Mask system
Patent Applicant: ResMed Ltd.
Opponent: Fisher & Paykel Healthcare Ltd.
Delegate: Dr W.E. Guinea
Decision Date: 15 July 2016
Hearing Date: 26 and 27 May 2016, in Sydney
Catchwords: PATENTS – section 59 – opposition to the grant of a patent – novelty – inventive step – manner of manufacture – fair basis – some claims found to lack inventive step – no other grounds successful – Regulation 5.23 invoked
Representation: Counsel for the Applicant: Angus Lang
Patent Attorney for the Applicant: Robynne Sanders and Louis Italiano of DLA Piper, Paul Green, Julian Magarey and Mark Abourizk of ResMed Ltd.
Counsel for the Opponent: Cameron Moore SC and Andrew Fox
Patent Attorney for the Opponent: Joe Seisdedos and Gilulia Fimmano of AJ Park, Ben Halberg of Fisher & Paykel Healthcare Ltd.
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2009221630
Title:Mask system
Patent Applicant: ResMed Ltd.
Date of Decision: 15 July 2016
DECISION
The Opposition is successful. Claims 1, 2, 3, 4, 6, 7, 8, 9, 10, 11, 12, 14, 15, 16, 17, 18, 19 and 20 are found to lack inventive step. All other grounds of opposition were unsuccessful.
I invoke Regulation 5.23 with regard to document D4.
I allow the proposed amendments to the statement of grounds and particulars dated 8 June 2016.
The Applicant has two months from the date of this decision to propose amendments that overcome the deficiency with respect to inventive step.
No award of costs is made.
REASONS FOR DECISION
Background
1. Patent application 2009221630 (“the opposed application”) entered national phase in Australia on 31 August 2010 from PCT application PCT/AU2009/000241.
2. ResMed Ltd. (“the Applicant”) requested examination on 14 November 2012, and the opposed application was advertised as accepted on 17 July 2014.
3. A notice of opposition was filed by Fisher & Paykel Healthcare Ltd. (“the Opponent”) on 17 October 2014. The Opponent filed a statement of grounds and particulars (“original SGP”) on 19 January 2015.
4. Evidence in support (“EIS”) was filed on 17 April 2015. This comprised:
· a first statutory declaration dated 9 April 2015 by Mr Alistair Edwin McAuley (“McAuley1”) with supporting exhibits AM-1 and AM-2;
· a second statutory declaration dated 14 April 2015 by Mr Alistair Edwin McAuley (“McAuley2”);
· a third statutory declaration dated 17 April 2015 by Mr Alistair Edwin McAuley (“McAuley3”);
· a statutory declaration dated 16 April 2015 by Mr Troy Alan Baker (“Baker”) with supporting exhibit TB-1;
· a statutory declaration dated 17 April 2015 by Mr Christopher Earl Nightingale (“Nightingale”); and
· a statutory declaration dated 2 April 2015 by Professor David Maurice Rapoport (“Rapoport”) with supporting exhibit DR-1.
5. Evidence in answer (“EIA”) was filed on 17 July 2015. This comprised:
· a statutory declaration dated 16 July 2015 by Mr Louis Claude Italiano (“Italiano”), with supporting exhibits LCI-1 to LCI-25.
6. Evidence in reply (“EIR”) was filed on 17 September 2015. This comprised:
· a fourth statutory dated 16 September 2015 declaration by Mr Alistair Edwin McAuley (“McAuley4”).
7. The Opponent filed a request to amend the SGP (“first amended SGP”) on 18 September 2015. This amendment was allowed on 9 October 2015.
8. A hearing for this matter was set for 26 and 27 May 2016. The Opponent’s written submissions (the “Opponent’s written submissions”) were filed on 12 May 2016. The Applicant’s written submissions (the “Applicant’s written submissions”) were filed on 19 May 2016.
9. A second amended SGP (the “SGP”) was filed at the second day of the hearing, being 27 May 2016. These amendments were formally filed with the Office on 8 June 2016 in response to my letter of 7 June 2016 regarding these amendments.
10. On 10 June 2016 the Applicant filed additional submissions on costs.
11. On 15 June 2016 I sent a letter to both parties indicating that certain material handed up at the hearing did not form part of the evidence, and that I would not be invoking Regulation 5.23 with respect to this material. This is discussed in more detail below.
12. On 16 June 2016 the Opponent sent a letter to the Commissioner indicating that they intended to respond to the Applicant’s submissions on costs “…within approximately 7 days.” These submissions were received by the Office on 28 June 2016.
Background to Sleep Disordered Breathing and Sleep Aponea
13. The Opposed application clearly deals with masks that are used in the treatment of sleep apnoea. Before continuing to the invention as described in the opposed application, I consider it convenient to first provide more general background on sleep disordered breathing (“SDB”) and sleep apnoea (or sleep apnea) as gleaned from Mr McAuley’s and Professor Rapoport’s evidence.
14. SDB is a general term covering a variety of sleep disorders. These include snoring and different types of sleep apnoea. Apnoea is defined as a pause in breathing of longer than 10 seconds in duration.
15. There are two types of sleep apnoea, being obstructive sleep apnoea (“OSA”) and central sleep apnoea. The vast majority of people with sleep apnoea (90%) suffer from OSA. At the risk of generalising, OSA is principally caused by the muscles, which keep a person’s airways open, collapsing whilst asleep. Central sleep apnoea, on the other hand, is largely caused by neurological issues.
16. Untreated OSA results in a person waking frequently throughout the night due to decreased levels of oxygen associated with the obstruction. This affects the quality of sleep and leads to daytime sleepiness, with consequent impacts on the probability that a person will have an accident and, unsurprisingly, on their learning ability. It is also believed that there is an increased risk of stroke and heart attack due to untreated OSA.
17. The main way to treat OSA involves keeping the airway open via the application of continuous positive air pressure (“CPAP”) while a person is asleep. This is achieved by the use of a machine that generates positive air pressure which is then supplied to a person’s airways using an air delivery tube connected to a mask system (or patient interface) worn by the person. This treatment for OSA is entirely efficacious if adhered to correctly.
18. There are several types of mask systems or patient interfaces available. These include:
· nasal pillows - these cover only the nostrils or nares of a user, via the use of prongs or pillows;
· nasal masks - these cover the entire nose of a user; and
· full face masks (or oro-nasal masks) - these cover the user’s nose and mouth and seal around the chin, cheeks and nasal bridge area.
The Invention as Described
19. The opposed application deals with a mask useful in the treatment of SDB. It is indicated that one factor affecting the efficacy of treatment for SDB is the comfort and fit of the patient interface, and at [0005] it is stated that the invention “…provides alternative arrangements of mask systems to enhance the efficacy of therapy and compliance of patients with therapy”.
20. A wide variety of “aspects” or “embodiments” of the invention are then given in the consistory clauses at [0006] to [0023]. These are also apparent in the accompanying 45 figures. However the most pertinent embodiment with respect to the claims in suit appears to be that given in figures 27 to 30. These figures relate to what I shall call the fourth embodiment of the invention. Throughout this decision, unless otherwise stated, where I refer to a mask system or component of the opposed application it will be with regard to the fourth embodiment. The features of the fourth embodiment are best understood by reference to figures 27 to 30, of which figures 27 and 28 are reproduced below.
21. As can be seen on figures 27 and 28 the fourth embodiment comprises a mask system 10 that covers the mouth and nose of the user. The principal components of the mask system comprise an elbow 70, a shroud 20, a frame 40, a cushion 44 and headgear 90. The elbow is connected via a short tube 82 to a fan or blower system (not shown) that provides positive pressure to the user’s airway via the mask system. The elbow in turn is retained to the shroud via interfacing structure 75 using a type of interference fit. A further interfacing structure 23 on the shroud connects with an interfacing structure of the frame 48 so as to attach the frame to the shroud. The cushion is co-molded with the frame during manufacture so as to form an integrated component, wherein the combination of the frame and cushion is sometimes referred to as a “cushion module”.
22. A clip receptacle 31 of the shroud is adapted to receive a headgear clip 33 so as to connect the shroud to lower headgear strap 94. A similar clip receptacle (not labelled) receives a removable arm 26, with this arm adapted to connect to an upper headgear strap 92 so as to also connect the shroud to the upper headgear. In this manner the entire mask system is retained on the face of a patient.
The Opposed Claims
23. The opposed application as accepted ends with 21 claims, of which claim 1 is reproduced below. For convenience throughout the rest of this decision I have labelled the integers of claim 1 using the numbering system as shown in brackets below.
1.(1.1) A mask system for use with a flow generator in the treatment of sleep disordered breathing to enable a supply of air at positive pressure to be delivered to a patient's airways, the mask system comprising:
(1.2) a shroud module;
(1.3) a cushion module provided to the shroud module, the cushion module defining a breathing chamber;
(1.4) a vent arrangement with more than one hole for gas washout from the breathing chamber;
(1.5) an elbow provided to the shroud module and adapted to be connected to an air delivery tube to deliver said air at positive pressure to the patient; and
(1.6) headgear removably attachable to the shroud module,
wherein:
(1.7) the shroud module is structured to retain the elbow, (1.8) the shroud module being structured to act as a bearing surface for the elbow, (1.9) the shroud module being structured to hold and secure the cushion module in an operative position with respect to the patient's face, (1.10) the shroud module including headgear connectors to connect with the headgear, (1.11) each of the headgear connectors being adapted to receive a respective headgear strap of the headgear,
(1.12) the cushion module includes a frame of relatively harder material and a cushion of relatively softer material provided to the frame such that the frame and the cushion form a one-piece integrated component,(1.13) the frame being adapted to interface with the shroud module,(1.14) the frame defines the breathing chamber,(1.15) the frame including an opening allowing said air at positive pressure to be delivered from the elbow to the breathing chamber,(1.16) the cushion being adapted to seal with the patient's face along nasal bridge, cheek, and chin regions of the patient's face, and
(1.17) the elbow includes an anti-asphyxia valve and a port that is selectively closed by a flap portion of the anti-asphyxia valve depending on the presence of pressurized gas,(1.18) the elbow including a first end portion and a second end portion,(1.19) the first end portion being attached to the shroud module,(1.20) the second end portion being provided to a swivel joint adapted to be connected to the air delivery tube,(1.21) the elbow being attached to the shroud module so that the elbow is permitted to be rotated relative to the shroud module, so as to allow the air delivery tube to assume different orientations relative to the mask system in use.
The Opposition
24. In the SGP the Opponent pursued grounds under:
· s18(1)(a) – the invention is not a manner of manufacture;
· s18(1)(b)(i) – the invention as claimed is not novel;
· s18(1)(b)(ii) – the invention as claimed does not comprise an inventive step;
· s18(1)(c) – is not useful;
· s40(2)(a) – the specification does not describe the invention fully; and
· s40(3) – the claims are not fairly based on matter described in the specification and that the claims are not clear and succinct.
25. In contrast to the SGP, only grounds under s18(1)(a), s18(1)(b)(i), s18(1)(b)(ii) and s40(3) (fair basis only) have been specifically pursued in the Opponent’s written submissions. While the bulk of the hearing was occupied with the grounds of novelty and inventive step, Mr Moore indicated that the Opponent was not abandoning grounds of manner of manufacture and fair basis, and that I could take these as per the Opponent’s written submissions. Consequently I have confined this decision to the grounds of novelty, inventive step, manner of manufacture and fair basis.
Documents not in Evidence and Regulation 5.23
26. It is pertinent to note before I continue that several documents that the Opponent wishes to rely upon are not actually in evidence. These include WO 2007/147088 (D4) and WO 2008/007985 (D4A). In line with the principles set down in Coal Corporation of Victoria v David William Hinkley and Brian Alan Nugent [1993] APO 56, the Opponent technically is unable to rely upon these documents in presenting its case, since these are not in evidence.
27. However Regulation 5.23 was introduced as part of the so called Raising the Bar reforms, and allows the Commissioner the discretion to consider certain documents that are before her in determining an opposition. It is repeated below:
“(1) For the purposes of deciding an opposition, the Commissioner may consult a document that:
(a) is relevant to the opposition; and
(b) has not been filed under this Chapter; and
(c) is available in the Patent Office.
(2) If the Commissioner proposes to rely on the document, the Commissioner must give the parties:
(a) notice of the Commissioner’s intention to do so; and
(b) a copy of, or access to, the document; and
(c) an opportunity to give evidence or make representations about the document.”
28. The operation of regulation 5.23 with respect to whether the Commissioner should rely upon a document has been considered in Merial Limited v Bayer Intellectual Property GmbH [2015] APO 16 (“Merial”) at [25], where such documents were considered in the context of new information:
“In other words, the new information needs to be significantly better than what is already in evidence. Where the new information is a new citation, it should be considered whether it is likely that the ground of lack of novelty or lack of inventive step in the light of the citation would be made out, and whether the ground would not otherwise have been made out.”
29. At the hearing I pointed out the fact that the documents that the Opponent intended to rely upon, D4 and D4A, were not actually in evidence and that this led to the possibility of invoking Regulation 5.23 in relation to these documents. I also observed that the parties were aware of the documents in question, had given submissions and evidence with respect to these, and would be providing further submissions on the same during the course of the hearing. Consequently I indicated that I considered that both parties had been provided with an opportunity to give evidence or make representations about the documents concerned, and as such the requirements of Regulation 5.23(c) would have been met in the event that I decided to rely on any of the documents in question, since I did not propose to formally rule on the use or otherwise of Regulation 5.23 at that time.
30. I note that the use of Regulation 5.23 is at the discretion of the Commissioner and I now will consider whether such discretion is appropriate with respect to D4 and D4A.
31. Even a cursory comparison of figures 48 to 51 of D4 (reproduced further below) to figures 27 and 28 of the opposed application reveals distinct similarities in the overall structure between these masks, a fact that Mr Moore drew to my attention at the hearing. It is also apparent from the hearing that the Opponent was relying on D4 as its primary document in prosecuting its case. In view of all of this I consider that it is putatively probable that D4 would deprive at least some of the claims of novelty and/or inventive step, and in the present circumstances this would lead to it being likely in making out a ground of opposition that would not otherwise be made out. Therefore I will invoke Regulation 5.23 in relation to D4 and will be relying upon it in determining this opposition.
32. However I consider that D4A is in a different category to D4. Little similarity is apparent between any of the pictured embodiments of D4A and figures 27 and 28 of the opposed application. Notably D4A only became part of the Opponent’s case after a family member thereof was mentioned in EIA. No explanation has been provided by the Opponent as to what advantage, in terms of making out a ground of opposition, that D4A provides over D4. In addition it was apparent at the hearing that D4A was considered by the Opponent to be a secondary document in importance to D4, given that no discussion was made of D4A in connection with s7(3).
33. Consequently, it appears to me that D4A comprises little more than a speculative add-on to the Opponent’s primary case in the event that it might in some sense be better than other material, such as D4, that is putatively available to the Opponent, even though how it is better is not readily apparent on viewing D4A or via the submissions made by the Opponent. It should be clear from the Delegate’s decision in Merial that Regulation 5.23 is not intended to open the door, intentionally or otherwise, to documentary speculation by either party to an opposition in the hope that the Commissioner will either find something beneficial to their case or prejudicial to their adversary. To that end any party seeking, under whatever circumstances, the Commissioner’s discretion under Regulation 5.23 will greatly assist themselves by explaining how the new document concerned is significantly better than what is already available, to the extent that the new document would result in making out grounds that would not otherwise be made out in its absence. Failure to so will likely lead to the conclusion that the party is indulging in the documentary speculation I have just mentioned.
34. It should be apparent that in the present circumstances I consider that if I invoked Regulation 5.23 in relation to D4A, I would be opening the door to documentary speculation.Therefore I decline to invoke Regulation 5.23 in relation to D4A and will not be relying upon it in deciding this opposition.
35. Before continuing it is pertinent to note that the Applicant handed up at the hearing a copy of the relevant mask standard (ISO 17510-2) that was mentioned in Mr McAuley’s evidence. It is apparent that this document is not formally in evidence, though it could potentially be relied upon via the operation of Regulation 5.23. I have already indicated that I will not be invoking Regulation 5.23 by the letter to the parties dated 15 June 2016 where I stated that:
“(I)it is apparent from discussion of the standard at the hearing, and on further inspection afterwards, that the standard at best would seem to cast potential doubts on certain matters discussed in the expert evidence, and no direct contradiction of the expert evidence is apparent.
I consider that these circumstances fall well short of criteria set out in the Merial decision. Therefore I decline to invoke Regulation 5.23 in relation to the standard and will not be relying upon it in deciding the opposition.”
It is perhaps superfluous to note that if I invoked Regulation 5.23 I would be opening the door to the documentary speculation as I have discussed it above.
Missing Particulars from the SGP
36. I also observed at the hearing that while the first amended SGP added D4A under the particulars for novelty, it did not add D4A under the particulars for inventive step. This appeared to be contrary to the Opponent’s intentions, based on their written submissions. In the circumstances I indicated that I did not think that any principles of natural justice had been violated by this omission, however I suggested that the Opponent may wish to amend their SGP once more so as to accurately reflect their case. This apparently spurred the SGP that was delivered to me on the second day of the hearing, and formally filed with the Patent Office on 8 June 2016. I now formally allow those amendments.
The EIA, Mr McAuley’s Evidence and Ex Post Facto Analysis
37. The EIA comprises some 25 patent specifications along with lengthy extracts from the file history for each of these. These extracts typically comprise examination reports, responses to examination reports and proposed amendments from the case file history of each specification.
38. The relevance of the EIA with respect to the EIS is not immediately apparent. However a brief inspection reveals that the patent specifications list Mr McAuley as an inventor and/or have the Opponent as the Applicant. Mr McAuley anticipated in EIR that this might represent an attempt by the Applicant to discredit him as a skilled addressee by suggesting that he was inventive or was perhaps biased due to his former association with the Opponent; see McAuley4 at [2.3] and [2.4].
39. However it would seem that this material was being used as a means to discredit the veracity of Mr McAuley’s evidence in view of apparently contradictory statements, with respect to Mr McAuley’s evidence in the present matter, made during the prosecution of some of these patent specifications. This is attested at Annexure C to the Applicant’s written submissions, which comprises particular excerpts from the EIA, and in view of Mr Lang’s discussion of the same at the hearing. Mr Lang noted that Mr McAuley (see AM-1) was involved in responding to Examiner objections in conjunction with Patent Attorneys, with some discussion around the nature of the submissions made in response to Examiner objections and how these appear to support positions contradictory to Mr McAuley’s present evidence.
40. However all the EIA demonstrates is the nature of submissions made during the prosecution history of other patent specifications. Indeed these are submissions, as opposed to evidence, and there is no evidence to suggest that Mr McAuley was in fact responsible for any of these submissions. It follows that the EIA has no bearing on the present matter and I will not be considering it in deciding this opposition.
41. The Applicant also suggested, in their written submissions at [94] and [95], that Mr McAuley’s evidence was tainted by hindsight. In particular the Applicant cited Minnesota Mining & Manufacturing Company v Tyco Electronics Pty Ltd (“3M”) [2002] FCAFC 315 at [46] and [47]; (2002) 56 IPR 248:
“The manner in which the evidence of some of the experts in the present case was bought into existence suggests that relatively little weight should be given to certain of that evidence. For example, witnesses were provided with a copy of the Patent. They were either provided with a large number of other documents or found them in response to the task that was set them. That is hardly calculated to result in objective evidence as to what the hypothetical uninventive but skilled worker would have done. To give the Patent to a prospective witness is tantamount to leading the witness. Further, unless the other documents were part of the common general knowledge in Australia before the Priority Date, they are not relevant to any question of obviousness.
Evidence by "experts" on the question of obviousness it is not always likely to be helpful (see Firebelt Pty Limited v Brambles Australia Limited [2002] HCA 21 at [46]). Indeed, where evidence is obtained in circumstances such as just described, the evidence is not likely to be helpful at all.”
42. I observe that McAuley1 was made prior to Mr McAuley being shown the opposed application (see McAuley2 at [1.3]), so this evidence cannot be accused of hindsight analysis in the manner suggested by the Applicant. This leaves, however, McAuley2, McAuley3 and McAuley4 being at least open to accusations of hindsight analysis in the sense of 3M.
43. However I note that the wording used in 3M with respect to the expert evidence is “suggests that relatively little weight should be given to certain of that evidence” and that such evidence is “not always likely to be helpful” or “not likely to be helpful at all” (emphasis added). From these passages I take it that their Honours were not indicating that one must necessarily reject out of hand all evidence that could be accused of hindsight in the circumstances indicated. Rather I think that it is proper to weigh each point of evidence on its merits in view of the circumstances peculiar to the same.
44. It follows that it will be up to me, as the decision maker, to determine if any particular part of Mr McAuley’s evidence that I intend to rely upon is tainted by hindsight or ex post facto analysis, and to weigh such evidence accordingly.
Onus of Proof
45. As examination was requested prior to 15 April 2013, the changes brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 do not apply to the opposed application. As such the previous burden of proof applies to this opposition, namely that the opponent will only succeed if they can convince the Commissioner that it is clear or practically certain that the patent is invalid; see F Hoffman La Roche AG v New England Biolabs Inc [2000] FCA 283 at [29], [67]; [2000] FCA 283; 50 IPR 305 at 311, 319; Commissioner of Patents v Sherman [2008] FCAFC 182 at [18], [22]; [2008] FCAFC 182; 79 IPR 426; Genetics Institute Inc v Kirin-Amgen Inc [1999] FCA 742; [1999] 92 FCR 106 at [17].
The Skilled Addressee
46. The skilled addressee is taken to be a non-inventive worker in the art with respect to the invention concerned, is taken to have the CGK in the art, and could be a team of people; see Root Quality Control Pty. Ltd. v Root Control Technologies Pty. Ltd. [2000] FCA 980 at [70] to [71] (“Root Quality Control”); Catnic Components Limited and Another v Hill & Smith Limited (1982) RPC 183 at 242 to 243 and Minnesota Mining & Manufacturing Co. vBeiersdorf (Australia) Ltd. [1980] HCA 9 at [115]; (1980) 144 CLR 253 at 292. In particular in Root Quality Control at [71] Finkelstein J. stated that “... the patent is directed to a person interested in making, constructing, compounding or using the invention...”
47. I consider that the skilled addressee is a person or team of persons involved in the design, manufacture and the use of masks for treating OSA. Of the expert declarants, Mr McAuley is clearly in a position to represent the skilled addressee. It is apparent from his CV at AM-1 and [1.1] to [1.14] of his first declaration that Mr McAuley has extensive experience in the development and manufacturing of masks used in the treatment of OSA. No dispute exists between the parties as to Mr McAuley’s ability to represent the skilled addressee.
48. At the hearing Mr Moore indicated that the Opponent placed no reliance on Professor Rapoport’s evidence. The Applicant suggested that Professor Rapoport was not able to represent the skilled addressee. However, I consider that Professor Rapoport is able to represent at least part of the team that comprises the skilled addressee, given his extensive knowledge of the use of masks and mask components that were used in treating sleep apnoea before the priority date; see DR-1 and [1.1] to [1.8] of his declaration.
49. With respect to Mr Baker, I consider that his knowledge and expertise is more directed towards masks in the context of personal protective equipment; see Mr Baker’s CV at TB-1 and [1.1] to [1.10]. I therefore consider that Mr Baker is not able to represent the skilled addressee.
Novelty
50. The test for determining novelty is often expressed in the form of the reverse infringement test as given in Meyers Taylor Pty Ltd v Vicarr Industries Ltd [1977] HCA 19 at [20]; (1977) CLR 228 at page 235; 13 ALR 605 at page 611 (“Meyers Taylor”):
“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.”
51. In determining whether a disclosure comprises an infringement, it is convenient to consider the principles laid down in General Tire & Rubber Company v The FirestoneTyre and Rubber Company Limited [1972] RPC 457 at pages 485-486) (“General Tire & Rubber”) as to what a skilled addressee would do based on the disclosure in question:
“…if carrying out the directions contained in the prior inventor's publication will inevitably result in something being made or done which, if the patentee's patent were valid, would constitute an infringement of the patentee's claim, this circumstance demonstrates that the patentee's claim has in fact been anticipated ... To anticipate the patentee’s claim the prior publication must contain clear and unmistakeable directions to do what the patentee claims to have invented ... A signpost, however clear, upon the road to the patentee's invention will not suffice.”
Consideration of Novelty in view of the Prior Art
52. In their written submissions at [103] to [106] the Opponent alleges that certain claims lack novelty in view of D4, as outlined in the novelty table attached as Annexure A to their written submissions. At the hearing the Opponent supplied me with an updated version of this novelty table. The Applicant was also supplied a copy of this on the day previous to the hearing. I also note that the Applicant supplied feature tables in relation to the claims and D4 at Annexure B of their written submissions.
53. Accordingly below I will consider novelty in view of D4 based on the updated Annexure A (“Annexure A”) supplied by the Opponent in view of the evidence, and the written and oral submissions where appropriate.
54. As discussed at [03] to [08], D4 relates to a patient interface device or mask for use in the delivery of breathing gas in a non-invasive manner to a patient, for example the use of CPAP in the treatment of OSA. D4 notes that there are a number of concerns in the use of such masks including the desirability of making the mask as comfortable as possible so as to help prevent a user avoiding therapy due to problems with the comfort of the mask. D4 then discusses a number of advantages that exists for these masks in relation to the identified concerns, including:
· a mask that minimises the material on the user’s head and face, but still provides a high degree of stability so that it is not easily dislodged from the user;
· a mask that provides for even distribution of the force required to hold the mask on the user’s face at locations best suited to taking such forces;
· a mask that avoids placing structural features near the user’s eyes; and
· a mask that achieves all the above while minimising headgear forces required to hold the mask onto a user, so as to achieve an effective seal without unnecessary forces being applied to the user.
55. The stated object of D4 is to overcome the shortcomings of conventional masks, which are clearly related to the advantages identified above. The stated object is achieved, according to one embodiment, by the provision of a mask having a pair of arms and a chin support. In use the chin support is placed under the chin of the user, with each one of the pair of arms being attached to respective ends of the chin support. Headgear attachments are provided on each of the pair of arms such that the mask as a whole can be retained on the head and face of a patient. A number of different embodiments of the above are then described in D4, with each of these including nasal pillow masks, nasal masks and full face masks.
56. At the hearing Mr Moore submitted that the Opponent primarily relied upon the 12th and 13th embodiments of D4 for the purposes of novelty. The disclosure of these embodiments is best understood by reference to figures 48 and 49 (12th embodiment) and 50 to 54 (13th embodiment), all of which are reproduced below. For reasons that will become apparent later I have also included figure 55 which illustrates a 14th embodiment that is similar to the 12th and 13th embodiments. The fact that the 13th and 14th embodiments are similar to the 12th embodiment is pointed out at [107] and [112] of D4. For convenience I have only discussed the 12th embodiment in any detail.
57. As can be seen from figures 48 to 54, the 12th and 13th embodiments of D4 relate to a full face type mask. In figures 48 and 49 the mask 1230 comprises a body portion 1240 and a patient interface portion 1260. The body portion includes a chin support (not shown), arms 1244 and a circuit coupling interface 1246. Attachment structures 1245 on the arms of the body portion couple to the chin support, while headgear attachment elements 1248 allow for headgear (not shown) to be attached to the body portion. The patient interface portion attaches to the body portion via protrusion 1262 which fits tightly into opening 1250 of the body portion. A flow of gas is supplied to the patient interface portion via a circuit coupling portion 1270, this being attached to the body portion via clamps 1272 that engage with a rim 1252 on the circuit coupling interface.
58. Although not shown D4 discloses at [106] that an entrainment and/or exhaust assembly is provided on the circuit coupling portion, and that this can also be provided on the interface portion or the body member.
59. I will now consider the features of claim 1 and whether these are disclosed by the 12th embodiment of D4. Unless otherwise stated all references throughout will be to this embodiment. I will only consider the novelty of the dependent claims in view of D4 if this proves necessary.
60. With regard to feature 1.1, it is apparent from my discussion at [57] above and from figures 48 and 49 of D4 that the interface device 1230 is commensurate with the “mask system” of feature 1.1. It follows that I am satisfied that there are clear and unmistakeable directions in D4 for feature 1.1 of claim 1.
61. With regard to feature 1.2, I consider that the body portion 1240 is commensurate with the “shroud” of this integer, especially in view of the dictionary definition given at [0089] of the opposed application and repeated below:
“The term "shroud" will be taken to include components that partially or fully cover a second component within the illustrated embodiments. In an embodiment, the shroud may include the component that partially covers or is mounted on the frame components of the illustrated embodiments.”
62. It is apparent that the body portion at least partially covers patient interface portion 1260, and in this sense is a “shroud”. I observe that this is substantially the same construction as adopted by Mr Lang at the hearing, where he submitted that the plain English meaning of “shroud” (identified at [26] of the Applicant’s written submissions) was commensurate with the definition given at [0089] of the opposed application.
63. With respect to the term “module” as used in feature 1.2, the Macquarie Dictionary Online, 2016, Macquarie Dictionary Publishers, an imprint of Pan Macmillian Australia Pty Ltd, (“Macquarie Dictionary Online”) provides a number of definitions of which the following are most pertinent:
“3. a structural component, as a plexiglas cube used as a basic unit for do-it-yourself furniture. 4. a self-contained unit within a course of study…6. Electronics a small, standard unit which can be used in the construction of a piece of equipment. 7. Astronautics a detachable section of a space vehicle: command module”
64. Although none of these definitions align precisely with the present circumstances, they do nonetheless demonstrate how the term module should be construed. I take the use of “module” with respect to a “shroud module” in claim 1 to be similar in that it is denoting an individual unit, perhaps itself comprised of sub-units, which is functionally joined to other individual units so as to create a coherent whole. I also consider that this construction is also appropriate wherever a “module” is referred to in claim 1. I observe that this is substantially the same construction as asserted by Mr Lang at the hearing and in the Applicant’s written submissions at [27] and [28].
65. Given the above I consider that the body portion 1240 of D4 is therefore a “module” and consequently comprises a “shroud module” as per feature 1.2 of claim 1. It follows that I am satisfied that there are clear and unmistakeable directions in D4 for feature 1.2 of claim 1.
66. With regard to feature 1.3 it would seem that the patient interface portion 1260 is commensurate with the “cushion module” of this integer. To help determine if this is the case I observe that the most apposite definition of “cushion” from the Macquarie Dictionary Online is the second in the following: “cushion noun. 1. a soft bag of cloth, leather, or rubber, filled with feathers, air, etc., used to sit, kneel, or lie on. 2. anything similar in appearance or use.” I therefore take the use of “cushion” in the claims in suit to refer to a part of the mask system that provides a buffer of soft material in some sense. It is apparent from reading the claim as a whole that the “cushion” as used in claim 1 is required to interface with the patient’s face. I therefore take the “cushion” of claim 1 to a buffer of soft material that interfaces with a patient’s face.
67. It is clear that the patient interface of D4 comprises an interface with the patient’s face. It is not stated in D4 that this is a soft buffer. However I consider that it would be absurd to believe that the patient interface module does not provide a cushioning effect in a functional sense, given that it directly contacts a patient’s face. To that extent it must comprise a cushion in the sense that I have construed above. I note that this interpretation is consistent with McAuley1 at [11.1]:
“When I refer to the seal in this context, I mean the 'cushion' part of the mask, the part that contacts the patient's face, and provides the seal between the mask and the patient.”
68. As the patient interface portion is a unit or module comprising a cushion, I therefore consider that the patient interface portion is a type of “cushion module”. It is clear from figures 48 and 49 that the patient interface portion is provided to the “shroud module” 1240. In addition, given that it fits over the nose and mouth of a user and receives a gas supply from the circuit coupling 1270, it must define a breathing chamber; see also [101] and [105] of D4. I am therefore satisfied that there are clear and unmistakeable directions in D4 for feature 1.3 of claim 1.
69. With regard to feature 1.4, Mr Moore suggested at the hearing that Mr McAuley’s evidence indicates that having a multi-holed exhaust valve is standard in the art. In effect Mr Moore was arguing that an exhaust valve would be inherently multi-holed as this would be understood as a requirement by the skilled addressee. I agree with Mr Moore’s contentions, due to the evidence of Mr McAuley. In particular [6.11] and [6.14] of McAuley3 reads as follows:
“6.11 Certain types of mask are also going to require certain features as standard. For example, if you were designing a full face mask at the priority date you knew you were going to need:
6.11.1 a cushion that covers the nose and mouth
6.11.2 an AAV
6.11.3 most likely an elbow (or a direct connection without an elbow, such as the Aclaim 2 nasal mask)
6.11.4 different size seals
6.11.5 typically, headgear that connects to the mask in four places
6.11.6 vent holes that are typically to be placed on the elbow or the mask frame…
6.14 The mask standard ISO 17510-2 also indicates that certain mask elements are going to be used as standard features, for example the standard includes reference to exhaust flow (from more than one opening), an anti-asphyxia valve used on a full face mask, headgear, a patient connection port etc.” (emphasis added)
Notably the 12th embodiment of D4 comprises a full face mask.
70. I observe that Mr McAuley has made other statements in his evidence that suggests the use of multiple holes was “normal” or “common” (see McAuley3 at [3.6.3] and [4.4.4]), rather than “required” or “standard”. It may be that Mr McAuley is using “normal” or “common” in these paragraphs to mean standard in the sense of [6.11] and [6.14]. This does not detract from his language at [6.11] and [6.14] as to what the skilled addressee would know they need with regard to full face masks, which is unequivocal.
71. In addition I note that Mr McAuley’s discussion of bias flow in McAuley1 at [15.1] to [15.15] is virtually exclusive with respect to bias flow being achieved using multiple holes, and thus suggests that Mr McAuley is not indulging in ex post facto analysis on this point at [6.11] of McAuley3. It is also telling that Mr McAuley did not simply place all features of claim 1 under his “required” features in [6.11] of McAuley3, suggesting that he was giving a realistic appraisal of the required features without the taint of ex post facto analysis.
72. In view of the above I consider that a skilled addressee will inevitably, in the sense of General Tire & Rubber, arrive at feature 1.4 of claim 1. It follows that I am satisfied that there are clear and unmistakeable directions in D4 for feature 1.4 of claim 1.
73. With regard to feature 1.5 the circuit coupling 1270 of the 12th embodiment clearly comprises an “elbow” as can be seen on figures 48 and 49. D4 discloses that the “elbow” allows a flow of gas to be delivered to the patient via the patient interface; see [105]. Given that D4 relates to OSA, this flow would be understood by the skilled addressee to be at positive pressure; see Rapoport at [5.1] to [5.5]. It follows that I am satisfied that here are clear and unmistakeable directions in D4 for feature 1.5 of claim 1.
74. With regard to feature 1.6, the “shroud module” 1240 clearly has attachment points for headgear at 1245 and 1248, as pointed out by the Opponent in Annexure A to their written submissions, and as attested at [102] and [103] of D4. One can then directly infer the existence of headgear in the 12th embodiment, with this headgear being attached to the “shroud module”.
75. For the avoidance of any doubt I consider the “chin support” and “headgear” of D4 to be commensurate with the “headgear” of the claims as both are used to hold the “mask system” 1230 onto the head of a patient, as can be seen from figures 48 and 49. Since these elements comprise the “headgear” as such, it will be necessary for these to be removable from the “shroud” in order to disclose feature 1.6.
76. There is no discussion or other suggestion in D4 with regard to the headgear straps of the 12th embodiment being removable. At the hearing Mr Moore contended, based on Mr McAuley’s evidence, that having removable headgear was a “standard feature”. Similar to my discussion above, I take this to be an argument that a skilled addressee would necessarily understand that removable headgear is a requirement, at least for full face masks, if not all SDB masks, thus leading to this feature being inherent in the 12th embodiment of D4.
77. However I do not consider that removable headgear is a requirement for SDB masks based on Mr McAuley’s evidence. Mr McAuley discusses how to attach headgear to the mask in McAuley1 at [10.22] to [10.28], and indicates that removable headgear is well-known in McAuley3 at [6.9] and [6.10]. It is apparent from all these passages that having removable headgear is a well-known option, and indeed it would seem that having partially removable headgear is typically necessary for full face masks. Mr McAuley’s strongest statements on this matter are in McAuley2 at [2.6.5], where he states that “…practically all SDB masks have removable headgear”.
78. However the fact that removable headgear is well-known or near ubiquitous does not mean that this is a requirement for all masks, nor does it indicate that a skilled addressee must use removable headgear in the 12th embodiment of D4. In this regard it is telling that Mr McAuley did not list removable headgear as one of the requirements for a full face mask at [6.11] of McAuley3 or in conjunction with the standard.
79. Consequently there is no evidence that leads me to believe that a skilled addressee would inevitably (in the sense of General Tire & Rubber) implement the headgear of the 12th embodiment of D4 in a fashion that is removable. It follows that I am not satisfied that there are clear and unmistakeable directions in D4 for feature 1.6 of claim 1.
80. With regard to features 1.7 and 1.8, D4 discloses that the “shroud module”1240 is structured to retain the “elbow” 1270 via the use of the rim 1252 of circuit coupling portion 1246, wherein clamps 1272 of the “elbow” engage the rim; see [105] and figures 48 and 49. It is apparent from this that the “shroud module” is also structured to act as a bearing surface for the elbow. It follows that I am satisfied that there are clear and unmistakeable directions in D4 for features 1.7 and 1.8 of claim 1.
81. With regard to features 1.9, 1.10 and 1.11, D4 discloses that the “shroud module” 1240 is structured to hold and secure the “cushion module” 1260 in an operative position with respect to the patient’s face, via the mating of protrusion 1262 in an opening 1250 of the “shroud module”; see [104]. The entire “mask system” 1230 is then held in an operative position against the patient’s face via the use of headgear attached to attachment points 1245 and 1248 of the “shroud module” ; see [102] and [103] and figures 48 and 49. It follows that I am satisfied that there are clear and unmistakeable directions in D4 for features 1.9, 1.10 and 1.11 of claim 1.
82. With regard to feature 1.12, it is not explicitly clear from D4 that the “cushion module”, as I have identified it, comprises both a “frame” and a “cushion”. From my discussion above with regard to the “cushion module” per se, it is apparent that the “cushion module” does in fact comprise a “cushion” of some sort. As for the “frame”, at the hearing Mr Moore drew my attention to the seam apparent in the “cushion module” 1260, 1360 on figures 48 and 52 as evidence that a “frame” exists in D4.
83. With respect to the “frame” it is useful to consider this as defined in the Macquarie Dictionary Online. Of these I consider the following is most apposite to the claims in suit: “frame noun …3.the sustaining parts of a structure fitted and joined together; framework; skeleton…”. Based on this definition, I consider that in the context of the claim a “frame” is a structure which sustains or holds the “cushion” in some manner. I note that Mr Lang adopted a similar construction of “frame” at the hearing, this also being based on the Macquarie Dictionary Online definitions of a “frame” as given at [40] to [42] of the Applicant’s written submissions.
84. In view of my construction of “frame” I do agree with Mr Moore’s arguments with respect the seam of the “cushion module” leads to a “frame” in the sense of claim 1. There is simply no discussion of the nature of the seam in D4, nor is there a disclosure of a “frame”. Thus there is no explicit disclosure in the 12th or 13th embodiments of D4 for feature 1.12.
85. An alternative argument was also put by Mr Moore at the hearing in relation to feature 1.12. This was that feature 1.12 was implicit to a skilled addressee on reading D4. Mr Moore’s arguments were based on McAuley1 at [9.1] in relation to “standard” features of full face masks, which was said to result in the skilled addressee understanding that this feature must exist in D4.
86. However, I see no support in any of Mr McAuley’s evidence for Mr Moore’s contention. McAuley1 at [9.1] at best suggests that a cushion and a frame are “standard” or “common” with regard to full face masks. Mr Moore appears to be suggesting that the use of standard or common here means that these features must be inherent. However I find it difficult to interpret McAuley1 at [9.1] as indicating required features, as no such language is used. It is also apparent that some of listed standard features are clearly not stated as a requirement, such as the elbow which is clearly very common (90-95% of full face masks have this), rather than mandatory. In addition a frame is not listed as one of the required features for full face masks in McAuley3 at [6.11]. I therefore take [9.1] of McAuley1 to be a list of features that are well-known, but not necessarily required. Thus there is no implicit disclosure, to a skilled addressee, in the 12th or 13th embodiments of feature 1.12.
87. Another alternative argument for feature 1.12 was put by the Opponent in their Annexure A. Here the Opponent points to D4 at [68] as providing disclosure of feature 1.12, with particular regard to the relatively hard/soft frame/cushion:
“Patient interface portion 460 is also defined by a support member 464 that couples to an end of circuit portion 450 and a cushion assembly 466, which includes nasal cushions 462, that couples to the support member. Support member 464 is more rigid than cushion assembly 466.”
88. This passage clearly discloses a relatively hard frame and a relatively softer cushion. The difficulty here is that [68] relates to a completely different embodiment than has been discussed hitherto. Notably the 12th embodiment of D4 comprises a full face mask, while [68] relates to the 5th embodiment which comprises a nasal pillows type mask, as pointed out by Mr Lang at the hearing.
89. The question of course is, are there “clear and unmistakeable directions” in the sense of General Tire & Rubber for a skilled addressee to utilise the “relatively hard frame and a relatively softer cushion” of the 5th embodiment in implementing the “cushion module” of the 12th embodiment, i.e. would the skilled addressee undertake an “internal mosaic” of these different embodiments in D4 and so arrive at feature 1.12?.
90. The issue of mosaicing separate documents for the purposes of novelty, where documents have been incorporated by reference, has been considered in Nicaro Holdings Pty. Ltd. and Others v Martin Engineering Co. and Another [1990] FCA 40; (1990) 16 IPR 545 at 570 (“Nicaro Holdings”):
“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 Sharp & Dohme case. 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 Sharp & 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".”
91. One may observe that the issue in Nicaro Holdings is somewhat different from the present circumstances, in that it involves an external mosaic, rather than an internal mosaic. However both NCI Packaging Pty Ltd v Huhtamaki Australia Limited [2002] APO 28 at [55] and Innovia Security Pty. Ltd. v Giesecke & Devrient GmbH [2014] APO 78 at [44] deal with the issue of “mosaicing” different embodiments contained within a single document. It is apparent that the approach to this issue in both these decisions is consistent with Nicaro Holdings, even though neither decision explicitly references Nicaro Holdings for the purposes of “internal mosaicing”. Consequently I consider that the principles laid down in Nicaro Holdings for “external mosaicing” are apposite to the question of “internal mosaicing”. I will therefore adopt the approach in Nicaro Holdings in resolving the issue of internal mosaicing.
92. At the hearing Mr Moore pointed to [114] of D4 in support of the Opponent’s contention of “internal mosaicing”. This paragraph is repeated below
“Although the invention has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments, it is to be understood that such detail is solely for that purpose and that the invention is not limited to the disclosed embodiments, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present invention contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.” (emphasis added)
In particular Mr Moore directed me to the passage in emphasis from [114].
93. These arguments amount to an assertion that there is a sufficient “degree of connection”, in the sense of Nicaro Holdings, between the different embodiments in D4 to allow for the “internal mosaicing” suggested by the Opponent.
94. However I do not consider that [114] provides such a “degree of connection” so as to provide clear and unmistakable directions to mosaic the 12th and 5th embodiments in the manner asserted by the Opponent. In this regard it is worth noting that D4 comprises no less than 14 embodiments of various types of masks. Each of these embodiments comprises a series of particular features that are peculiar to each, notwithstanding the general commonality of these being masks as such. In these circumstances the mere suggestion of [114] that “…to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment” amounts to no more than a large series of vague possibilities for the skilled addressee to assess for plausibility before perhaps ascertaining feature 1.12 by combining the requisite features of the 12th and 5th embodiments, assuming of course that such a combination is possible. This is the antithesis of “clear and unmistakeable directions” and as such I reject this line of reasoning.
95. In view of the above I do not agree that the skilled addressee will inevitably, in the sense of General Tire & Rubber, arrive at feature 1.12 from the disclosure of D4. It follows that I am not satisfied that there are clear and unmistakeable directions in D4 for feature 1.12 of claim 1.
96. With regard to features 1.13, 1.14 and 1.15 it should be apparent that the lack of a “frame” also means that these features are absent in D4. It follows that I am not satisfied that there are clear and unmistakeable directions in D4 for features 1.13, 1.14 and 1.15 of claim 1.
97. With regard to feature 1.16, it is apparent from figures 48 and 49 and [101] of D4 that the “mask system” 1230 is a full face mask and hence the “cushion” will necessarily seal around the nasal bridge, cheek and chin regions of a patient’s face, as attested by Mr McAuley’s evidence on this point; see McAuley1 at [4.6] and AM-2. It follows that I am satisfied that there are clear and unmistakeable directions in D4 for feature 1.16 of claim 1.
98. With regard to feature 1.17, paragraph [106] of D4 discloses the “elbow” 1270 having an “entrainment valve and/or exhaust assembly”. It is apparent from Mr McAuley’s evidence at AM-2 that an entrainment valve is simply another name for an anti-asphyxia valve (“AAV”). It is also apparent from McAuley1 at [16.2] and AM-2 that an AAV comprises “a port that is selectively closed by a flap portion of the AAV depending on the presence of pressurised gas”. It follows that I am satisfied that there are clear and unmistakeable directions in D4 for feature 1.17 of claim 1.
99. With regard to features 1.18 and 1.19, these features are apparent from figures 48 and 49 of D4. It follows that I am satisfied that there are clear and unmistakeable directions in D4 for features 1.18 and 1.19 of claim 1.
100. With regard to feature 1.20, D4 discloses that the second end portion is adapted to be connected to the air delivery tube (this is inherent based on the disclosure of [105] and figures 48 and 49). However there is no explicit disclosure in D4 of the second end portion being provided to a swivel joint adapted to be connected to the air delivery tube. Therefore D4 does not explicitly disclose feature 1.20.
101. The Opponent argues that this feature is provided by the 5th embodiment. I take this to be a form of “internal mosaicing”. I therefore reject this argument for similar reasons as outlined in [96] above. It follows that I am not satisfied that there are clear and unmistakeable directions in D4 for feature 1.20 of claim 1.
102. With regard to feature 1.21, D4 discloses that the elbow is attached to the shroud module so that the elbow is permitted to be rotated relative to the shroud module, so as to allow the air delivery tube to assume different orientations relative to the mask system in use; see [105]. It follows that I am satisfied that there are clear and unmistakeable directions in D4 for feature 1.21 of claim 1.
Novelty – Conclusion
103. D4 does not disclose features 1.6, 1.12, 1.13, 1.14, 1.15 or 1.20 of claim 1. Consequently none of the claims were established to lack novelty. This ground of opposition is unsuccessful.
Inventive Step
104. The statutory basis for inventive step is set out at s7(2) and s7(3) of the Act, and is reproduced below:
“(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.”
105. Although not expressly referred to in the 1990 Act, it has been accepted by the authorities that lack of inventive step in the 1990 Act is commensurate with the previous concept of obviousness under the 1952 Act (albeit relying on a different prior art base); see Re James EarlWinner and Donna C Winner v Ammar Holdings Pty. Limited [1992] FCA 377 at [12]; (1992) 24 IPR 137 at 140. The question of obviousness has been extensively considered by the courts. In particular Aickin J. stated in Wellcome Foundation Ltd. v VR Laboratories (Aust) Pty. Ltd. [1981] HCA 12 at [45]; (1981) 148 CLR 262 at 286 (“Wellcome Foundation”):
“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.”
106. In situations where the invention may lie in a combination of features, it is appropriate to consider whether the combination is obvious, not whether each of the separate integers of the combination is obvious: Minnesota Mining & Manufacturing Co. v Beiersdorf (Australia) Ltd. [1980] HCA 9 at [116]; (1980) 144 CLR 253 at 293 and Aktiebolaget Hassle v Alphapharm Pty. Ltd [2002] HCA 59 at [119]; (2002) 212 CLR 411 at 455 (“Aktiebolaget Hassle”):
“In reaching these conclusions, the primary judge made it clear that he was not considering the irrelevant question of whether the individual integers of the combination were obvious. Instead, he was addressing the relevant question, namely whether the combination was obvious [157]. In this Court, the primary judge was criticised for applying the test of obviousness to the separate integers of the formulation. Had he done this it would indeed have been a mistake [158]. With inventions it will often be the case that particular steps in the right general direction, viewed in isolation and separately (and especially with the benefit of hindsight [159]), will be obvious although the combination of such steps (from all the others that would theoretically be possible) will constitute the "inventive step" and negate the claim of obviousness.”
107. The test outlined in Wellcome Foundation is demonstrative of the approach frequently taken to assess lack of inventive step or obviousness, being the so called problem-solution approach, which I will use in determining the inventiveness of the claims below.
The Problem
108. I observe that there has been comparatively little discussion on the problem to be solved, either in the written submissions or at the hearing. The Opponent does not seem to identify a problem as such or believe that identification of a problem is necessary, beyond the general motivation to improve the masks that were already in use, as asserted at the hearing and in the Opponent’s written submissions at [140]. The Applicant identified the problem in written submissions at [139] as “efficacy of therapy and compliance of patients”.
109. The opposed application briefly states some issues with respect to masks used in SDB at [0004] and [0005]. These paragraphs are repeated below:
“[0004] One factor in the efficacy of therapy and compliance of patients with therapy is the comfort and fit of the patient interface.
[0005] The present invention provides alternative arrangements of mask systems to enhance the efficacy of therapy and compliance of patients with therapy.”
110. Consequently I consider that the problem to be solved is how to improve the comfort and fit of the patient interface so as to enhance the efficacy of therapy for sleep disordered breathing.
111. It should be apparent that I consider that the Opponent’s problem is not that of the opposed application upon a fair reading of the same, as identified by the passages I have cited above. I also consider that the Applicant’s problem comprises a generalised truncation of the problem that I have identified.
112. I note that the issue of mask comfort and the impact that this has on the efficacy of sleep apnoea therapy has been identified as a known issue by both Mr McAuley and Professor Rapoport in their evidence; see McAuley1 at [6.1] to [6.3] and Rapoport at [11.1] to [11.12]. As such I am satisfied that the above formulation of the problem does not breach the principles laid down in AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99, to the extent that the problem does not comprise information that is not available to the skilled addressee from common general knowledge (“CGK”) or under s7(3).
Lack of Inventive Step in View of the Opponent’s Submissions
113. The Opponent’s lack of inventive step arguments are presented at [107] to [162] of their written submissions. The Opponent has argued that the claims lack inventive step in view of common general knowledge alone (s7(2)) or in view of the common general knowledge when read in combination with D4 (s7(3)). I will consider these arguments below, initially with regard to claim 1. I will only consider the dependent claims if this proves necessary.
Lack of Inventive Step in View of Common General Knowledge (s 7(2))
114. This argument is put at [138] to [141] of the Opponent’s written submissions. Annexure B of the Opponent’s written submissions provides a schedule of alleged CGK as at the priority date, as determined from Mr McAuley’s evidence. In particular the Opponent alleged at the hearing and in their written submissions that the invention of the opposed application was nothing more than “…a combination of known features with known functions” (Opponent’s written submissions at [138]).
115. There appears to be two related, but slightly different aspects of Mr McAuley’s evidence that are pertinent to the s7(2) question. Firstly Mr McAuley indicates in a number of places that each individual feature of claim 1 was CGK; see McAuley2 at [2.4] to [2.9] and McAuley3 at [6.9].
116. Secondly Mr McAuley refers to a number of masks, including two variants of the Opus nasal pillows mask (McAuley2 at [2.6] to [2.6.13]) and the ComfortFull2 full face mask (McAuley2 at [2.7] to [2.9]) as comprising CGK. In the passages cited Mr McAuley outlines various features of these masks which overlap with claim 1 of the opposed application.
117. After this it is stated in McAuley2 at [2.9] that it is “…normal practice for mask designers to review masks that are on the market, to transfer features from one style of mask, for example from nasal mask to full face mask, and to combine features from different masks”.
118. Based on Mr McAuley’s evidence, though not put directly in that way in written submissions or at the hearing, it would seem to me that there are two slightly different arguments being put by the Opponent in relation to s7(2). The first is that all of the individual features of claim 1 are simply CGK. The second is that certain combinations of some of these features are known to be CGK, as embodied in the Opus and ComfortFull 2 masks, with the remaining differences being either uninventively added from CGK known beyond these masks or by appropriately combining features from each of these masks together. The upshot of both these arguments is that the Opponent has characterised claim 1 as no more than “…a combination of known features with known functions”.
119. However I see difficulties with either of these arguments. In relation to the (first) argument of individual features being CGK, even if I accepted the Opponent’s framing of the problem (which I do not) as no more than a general motivation to combine or mix features from different masks so as to improve on previous masks, this would still not render the invention of claim 1 obvious. It is apparent from the number of features comprising claim 1 (as exemplified in McAuley2 at [2.3.1] to [2.3.18]) that the skilled addressee would need to make a series of more than a dozen different choices before arriving at the invention of claim 1.
120. These choices begin with, for example, to make one of a nasal pillows mask, a nasal mask or a full face mask, with further features in some circumstances being defined by this choice (for example the inclusion of an AAV in a full face mask). Nowhere does Mr McAuley state that the actual combination of features from individual elements of CGK, as allegedly defined in claim 1, is obvious nor does he provide any precise motivation as to why a skilled addressee would select these features from the large number of potential options available to the skilled addressee on starting out with individual elements of CGK. Thus the evidence does not establish that the asserted combination of CGK is obvious, and consequently this argument does not accord with the principles outlined in Aktiebolaget Hassle, as submitted by Mr Lang at the hearing. It follows that the first argument must be rejected.
121. The second argument suffers from similar defects as the first. While we are already presented with combinations of features that are said to together comprise CGK (in the form of different masks), Mr McAuley’s evidence and the Opponent’s arguments go no further than to state that the skilled addressee could select these masks (being items of CGK) from other items of CGK and mix and match features from each of the masks mentioned together and/or with known individual items of CGK and so arrive at the invention of claim 1. This again represents a failure to establish obviousness in accordance with the principles of Aktiebolaget Hassle. It follows that the second argument must also be rejected.
122. For completeness I note that similar reasoning as above applies when starting with the problem as I have identified it. There is simply no evidence to establish that the skilled addressee would arrive at the invention of claim 1 as a matter of routine starting from elements of CGK as identified by Mr McAuley.
123. In conclusion I am not satisfied that the evidence establishes that claim 1 lacks inventive step in view of CGK alone. It follows that the same conclusion applies to the dependent claims.
Lack of Inventive Step in View of Common General Knowledge and Prior Art (s 7(3))
124. This argument is put at [142] to [161] of the Opponent’s written submissions. The Opponent has relied upon D4 both for the purposes of s7(3) in their written submissions and at the hearing. I will consider D4 for the purposes of s7(3) below.
Ascertained, Understood and Regarded as Relevant
125. Under s7(3) it is necessary for a prior art document to have been ascertained, understood and regarded as relevant by the skilled addressee before it becomes available for the purposes of assessing inventive step. I will now consider this in relation to D4.
126. I note that I have identified the problem to be solved as how to improve the comfort and fit of the patient interface so as to improve the efficacy of therapy for sleep disordered breathing. D4 deals with masks used in treating OSA and aims to ameliorate issues with patient compliance due to the comfort of masks; see D4 at [05] to [07].
127. In addition Mr McAuley indicates that he would regularly review patents covering SDB mask technology; see McAuley1 at [3.16] and [3.20]. Based on his evidence I conclude that a skilled addressee would readily consult patent databases.
128. I therefore consider that a skilled addressee would readily ascertain D4, since it is directed towards solving a similar technical problem in the same art, and given the propensity of the skilled addressee to search patent databases.
129. I also consider that the skilled addressee would both understand and regard D4 as relevant, given that it is in the same technical field as the opposed application and is directed towards solving a similar technical problem.
130. I am therefore satisfied that a skilled addressee would ascertain, understand and regard D4 as relevant in view of the problem to be solved.
Consideration of s7(3) in view of D4
Claim 1
131. I have noted above that D4 does not disclose features 1.6, 1.12, 1.13, 1.14, 1.15 or 1.20 of claim 1. I will now consider whether the missing elements from D4 in comparison to claim 1 are elements that the skilled addressee would come to as a matter of routine in view of the CGK and the problem to be solved.
132. With regard to feature 1.6, Mr McAuley indicates at multiple times in his evidence that it was common or well-known to have headgear that was removable or using materials for the headgear, such as Velcro, that are inherently removable: see McAuley1 at [10.11] and [10.22] to [10.27] and McAuley2 at [2.6.5]. Professor Rapoport’s statements at [17.10] of his declaration corroborate this. Consequently I am satisfied that removable headgear was CGK before the priority date.
133. As noted in the discussion on novelty above, the skilled addressee understands that headgear is required in the 12th embodiment of D4, but there is no teaching as to how this is to be achieved. In view of this I consider it to be a matter of routine for the skilled addressee to implement the headgear in D4 as being removable from the “shroud module”, the use of such removable headgear being CGK. I am therefore satisfied that the skilled addressee would, as a matter of routine in view of the CGK and the problem to be solved, arrange for the headgear in D4 to be removable.
134. With regard to feature 1.12, D4 as noted, does not disclose the “cushion module” having a “frame”. There is however a “cushion” as discussed earlier. In implementing the “cushion” of D4 the skilled addressee clearly needs to make appropriate choices for the material that comprises the same. McAuley1 at [11.2] establishes that it is well known, if not ubiquitous to use liquid silicone rubber (“LSR”) for the cushion. From McAuley1 at [11.3] to [11.21] it is apparent that in general the materials used to form the cushion are soft and flexible in nature, such as polyurethane foam, gels or LSR, so as to provide a comfortable fit to a patient’s face. Consequently I consider it to be a matter of routine for the skilled addressee to decide upon the use of LSR (or other soft and flexible materials known to be used in the art) in constructing the “cushion” of the “cushion module” 1260 of D4.
135. .In carrying out the directions of D4, the skilled addressee would appreciate that the protrusion 1262 of the “cushion module”, which is used to interface with the “shroud” 1240 needs to comprise an appropriate material such that it fits as stated at [104] of D4 “…snugly into opening 1250, and both are configured such that the patient interface portion is assembled with the body portion, there is little or no movement, such as rotation of the these components relative to one another.” It is apparent that the soft and flexible material that the skilled addressee would use for the “cushion” of the “cushion module” is unsuitable for this purpose.
136. However McAuley1 at [12.1] to [12.3] and [13.1] to [13.2] indicates that it is well-known to provide a “frame” of relatively hard material, comprising polycarbonate, nylon or polypropylene, to a soft “cushion”. These passages also indicate that it is well-known to provide the “cushion” to the “frame” such that these are formed in an integral fashion, i.e. comprising a single unit. In view of the necessity to attach the “cushion module” in D4 in the manner described, and my earlier discussion on the material of the “cushion”, I consider that it would be a matter of routine for the skilled addressee to provide a comparatively hard “frame”, comprising the protrusion 1262, to a comparatively soft “cushion” so that these are integrally formed in implementing the mask system of D4.
136.It is perhaps convenient here to discuss how a skilled addressee would implement the “frame” as I have identified it. In this regard it is clear that the “cushion” of D4 will define a perimeter on a patient’s face that comprises the nasal bridge, cheek and chin regions of a patient’s face; see the discussion with regard to feature 1.16 in the novelty section of this decision. It is also clear that the “cushion”, due to its flexibility and intended use as a seal between the patient and the mask system, will collapse in use between the face of the patient and the “frame”; see McAuley1 at [11.1] to [11.22] which supports such a conclusion. These properties of the “cushion” mean that the skilled addressee would necessarily implement the “frame” such that it comprises the face of the “cushion module”1260 of D4 that includes the protrusion 1262 and the opening 1264, so as to provide the required support to the “cushion”. This face can be seen as the face of the “cushion module” in figure 49 that is closest to the “shroud” 1240. Similarly the nature and purpose of the cushion means that the skilled addressee would necessarily implement the “frame” in D4 comprising a volume that accommodates the nose and mouth of a patient upon the collapse of the cushion.
137. For the avoidance of any doubt I note that McAuley1 at §11 to §13 demonstrates that there is nothing in the development of the “cushion” and “frame”, as I have discussed above with regard to D4, that is beyond the routine skill of the skilled addressee.
138. I observe that Mr Lang pointed out at the hearing that the precise nature of the “frame” as discussed by Mr McAuley does not actually exist in D4. The most pertinent passages are from McAuley1 at [13.1]:
“The frame ties everything together. It is the anchor point for all the components of the mask. The frame typically connects to the seal and connects to the headgear.”;
and AM-2:
“Mask base/Mask frame -This is a component of the mask that connects the headgear and seal together.”
139. It is apparent that Mr Lang is correct in that the headgear of D4 connects to the body portion 1240 (or “shroud”) rather than to a “frame” as identified by Mr McAuley. However the question is not whether the skilled addressee would arrive at the precise form of a frame as known in the art and as identified by Mr McAuley. Rather it is whether it would be a matter of routine to arrive at the “frame” as defined in claim 1 in implementing the mask system of D4. It is apparent that I have answered this question in the affirmative.
140. In view of the discussion above it follows that I am satisfied that a skilled addressee would arrive at feature 1.12 in implementing the mask system of D4 as a matter of routine in view of the CGK and the problem to be solved.
141. With regard to features 1.13, 1.14 and 1.15 it is apparent that these features are rendered obvious via my discussion above with regard to feature 1.12. Notably I consider that the volume I have identified in [136] is defined by the “frame” and is thus commensurate with the “breathing chamber” of feature 1.14. It follows that I am satisfied that a skilled addressee would arrive at features 1.13, 1.14 and 1.15 in implementing the mask system of D4 as a matter of routine in view of the CGK and the problem to be solved.
142.With regard to feature 1.20, D4 fails to disclose the second end portion of the elbow being provided to a swivel joint adapted to be connected to the air delivery tube, as noted previously. However, McAuley1 at [14.1] indicates that the air supply tube from CPAP machines ends in a taper. It is well known for this taper to have a swivelling mechanism to prevent hose tangles (McAuley1 at [14.2]). McAuley1 at [14.3] indicates that it is well known for the swivel to clip into the elbow by a push fit. The inevitable conclusion from these paragraphs is that it is CGK for the end of the elbow closest to the CPAP machine (commensurate with the “second end portion” of claim 1) to be provided to a swivel joint that is adapted to be connected to the air delivery tube.
143.In view of the above I am therefore satisfied that feature 1.20 would be arrived at by the skilled addressee, in implementing the mask of D4, as a matter of routine in view of the CGK and the problem to be solved.
144.It is apparent from my discussion above that I am satisfied that the skilled addressee, in implementing the mask of D4, would arrive at the invention of claim 1 as a matter of routine in view of the CGK and the problem to be solved. It follows that claim 1 lacks inventive step in view of D4 and CGK as per s7(3) of the Act.
Claim 2
145.This claim adds the following features to claim 1: wherein the shroud module includes a portion to provide forehead support.
146.Mr McAuley’s evidence establishes that it was well-known for full face masks to include a forehead support, with this being between the upper contact points of the headgear straps; see McAuley1 at [10.15] and McAuley2 at [3.4.1]. McAuley1 at [17.1] indicates that forehead supports were “…added to improve side to side stability and reduce pressure on the bridge of the nose”, and at [17.5] he states that “(T)the forehead support clips into the frame, or in some cases is integrally formed with the frame”.
194.The first pair of interfacing structures (or structure for the 12th embodiment), defined by the edges in the shroud that delineate the openings are not, to my mind, provided to the inner side as I have identified it, in the sense that they are not furnished or supplied to that side. Indeed these interfacing structures are at right angles to and terminate at the beginning of either of the principal sides. I therefore do not consider that the interfacing structures (or edges) are provided to the inner side of the shroud for either of the 12th or 13th embodiments of D4.
195.It could be argued that the edges defining the interfacing structures themselves comprise inner sides. However the claim language suggests that the interfacing structures are something that is provided or supplied to an inner side, and one would not, in any sense, speak of the edges as something that is provided to themselves. In addition, even if I accepted this rather absurd construction, the claim refers to the interfacing structures being provided to an inner side, not two sides. To fall within the scope of claim 12 (and thus claim 13) I have referred to the interfacing structures of the 13th embodiment. Under the absurd construction I have identified, the 13th embodiment would have two inner sides, being each of the edges delineating the openings 1349a, 1349b.
196.It follows from the above that I am not satisfied that D4 does disclose the features added by claim 13.
197.Of course one may ask whether this claim is obvious over D4 in view of the CGK. Mr McAuley’s evidence may suggest that the features of claim 13 are CGK, especially in view of his comments in McAuley4 at [4.1(c)] and [4.2]. Notwithstanding this it is apparent that both the 12th and 13th embodiments of D4 comprise an attachment mechanism between the “shroud module” and the “cushion module” that involves a fit between protrusion(s) of the “frame” and edge(s) in the “shroud” that define opening(s). Even if the additional features of claim 13 are CGK, there is no evidence given by Mr McAuley that suggests a skilled addressee would either add or substitute the features of this claim to/for the existing attachment means, as a matter of routine and in view of the problem to be solved. Nor is any such motivation apparent in D4 or otherwise from the evidence.
198.In view of the above it follows that I cannot be satisfied, based on the evidence provided, that claim 13 lacks inventive step in view of D4 and the CGK as per s7(3) of the Act.
Claim 14
199.This claim adds the following features to any one of claims 1 to 13: wherein the shroud module is structured to act as a bearing surface for the elbow.
200.As noted by the Opponent at the hearing, this claim merely repeats a feature that is already present in claim 1. I have indicated earlier in this decision at [80] that D4 discloses this feature. I am therefore satisfied that the skilled addressee would, as a matter of routine in view of the CGK and the problem to be solved, arrive at the invention defined in claim 14 in implementing the mask system of D4. It follows that claim 14 lacks inventive step in view of D4 and CGK as per s7(3) of the Act.
Claim 15
201.This claim adds the following features to any one of claims 1 to 14: wherein the frame and the cushion are co-molded with one another to form an integrated component, the relatively harder material of the frame comprising a first molded material adapted to interface with the shroud module, and the relatively softer material of the cushion comprises a second molded material adapted to interface with patient’s face.
202. The Opponent in their Annexure A suggested that this feature is inherent to a skilled addressee based on figure 49. I do not agree, since the “frame” is absent in D4 as discussed previously. However I have already noted that the skilled addressee would arrive at the “frame” as a matter of routine. The question now is whether the skilled addressee would adopt the features of this claim in attaching the “cushion” to the “frame”?
203.The Opponent argued that “co-molding is a known and traditional process (McAuley1 at [12.1] and [12.5])”. That is the Opponent argues that co-molding comprises CGK. Paragraph [12.1] is reproduced below:
“Traditionally the cushion would be permanently attached to the frame, which was the case with some masks in the 1990's. This could be done by over moulding. That is, moulding the cushion onto the frame or by permanently hard clipping them together.” (emphasis added)
204.I note that Mr McAuley refers to “over moulding” rather than “co-molding”. At first glance it is not entirely apparent that these are the same thing. However it is clear from the references to co-molding” in the Opposed Application that the terms are synonymous, as attested at [00215] of the Opposed Application:
[00215] In an embodiment, as shown in Figs. 27-30, the frame 40 and cushion 44 may be co-molded with one another to form a one-piece, integrated component. For example, the frame 40 may be molded of a first material adapted to interface with the shroud 20 and the cushion 44 may be co-molded onto the frame 40 of a second material adapted to interface with (sic) patient's face. (emphasis added)
205.Other passages of the opposed application, such as [0010], suggest co-molding of the frame to the cushion, rather than the other way around. However this does not detract from the general conclusion that “co-molding” as used in the claims and “over molding” as identified by Mr McAuley are effectively the same thing, being the additional molding onto or over another component also formed by molding.
206.I note that Mr McAuley also refers to “co-molding”, rather than “over molding in his second to fourth declarations. However this does not suggest any genuine difference between the two terms. Indeed it suggests that Mr McAuley understands the two terms to be synonymous.
207.Consequently I agree with the Opponent’s assertion that co-molding of a cushion to a frame was CGK before the priority date. Therefore in seeking to attach the relatively soft “cushion” to the relatively harder “frame” (this hard/soft frame cushion combination already been found to be obvious over D4) as an operative unit in D4, I consider that it would be a matter of routine for the skilled addressee, in view of the CGK and the problem to be solved, to adopt co-molding as outlined in claim 15. It is apparent from McAuley1 at [12.1] that co-molding will necessarily result in integrated components.
208.In view of the above I am satisfied that the skilled addressee would arrive at the invention defined in claim 15 as a matter of routine in view of the CGK and the problem to be solved in implementing the mask system of D4. It follows that claim 15 lacks inventive step in view of D4 and CGK as per s7(3) of the Act.
Claim 16
209.This claim adds the following features to claim 15: wherein the integrated co-molded component comprises a chemical bond between the first and second molded materials.
210.The Opponent points to their arguments with respect to claim 15, and indicates that co-molding inherently results in a chemical bond as defined in this claim.
211.In McAuley2 at [3.4.5] it is stated that “(I)it is a well-known molding process to chemically bond materials together when co-molding.” It is not entirely clear from this whether co-molding inherently involves chemically bonding components together. Nevertheless it at least indicates that chemically bonding via co-molding was CGK before the priority date.
212.Consequently I am satisfied that it would be routine, in view of the CGK and the problem to be solved, for the skilled addressee to co-mold the cushion and frame of claim 15 together using a chemical bond in implementing the mask system of D4. It follows that claim 16 lacks inventive step in view of D4 and CGK as per s7(3) of the Act.
Claim 17
213.This adds the following features to any one of claims 1 to 16: further comprising a mechanical interlock to mechanically interlock the elbow and the shroud module to form a combined elbow and shroud module, and a snap-fit attachment mechanism that releasably snap-fits the combined elbow and shroud module with the frame of the cushion module.
214.The Opponent suggests that these features are disclosed at [104] and [105] of D4. To that end I agree that clamps 1272 of the “elbow” 1270 that engage with the rim 1252 of the “shroud module” 1240 comprises a mechanical interlock as per claim 17. It is apparent that once the clamps engage the rim that there is a combined elbow and shroud module as per claim 17.
215.It is, however, less clear if the disclosure of a snug fitting in [104] (recited below) inherently leads to a snap fit as per this claim:
“Protrusion 1262 is sized and configured to fit snugly into opening 1250, and both are configured such that the patient interface portion is assembled with the body portion, there is little or no movement, such as rotation of the these components relative to one another.”
216.Unsurprisingly the Opponent submitted that a snap-fit was inherent, while the Applicant disagreed with this. The passage in [104] is suggestive, but the difficulty for the Opponent here is that there is no evidence that suggests a skilled addressee would understand the “snug fit” of [104] to inherently mean a “snap fit”. Therefore I cannot be satisfied that D4 discloses a snap-fit as per claim 17.
217.Notwithstanding this, Mr McAuley’s evidence indicates that it was CGK to use snap-fits for connecting various components of masks, as attested by McAuley2 at [3.4.5]:
“Push fits and snap fits are used in most masks to connect components…It is common to connect components together using snap fits, in particular seals to frames…”
I am therefore satisfied that it would be routine for the skilled addressee, in view of the CGK and the problem to be solved, to implement the “snug fit” of the 12th embodiment as a snap fit.
218.A final question is whether use of a releasable snap fit is CGK, or if snap fits are known to be inherently releasable to the skilled addressee. Mr McAuley appears to indicate that releasable snap fits are CGK at [3.4.5] of McAuley2:
“Most elbows connect to mask components using snap fits. This is true of the Opus, in particular Opus v2. It is also removable from the cushion, leaving the elbow and the shroud connected. Push fits and snap fits are used in most masks to connect components.”
219.To the extent that there is any ambiguity at [3.4.5] of McAuley2, Professor Rapoport discusses the use of snap fits in conjunction with the attachment of the elbow to the frame at [19.9] of his declaration, which is repeated below:
“Early masks were not able to be detached from the site at which the CPAP tube connected. Then Respironics made shells in different sizes and introduced an O-ring that would attach the tubing elbow and leak element to the mask. The technology then moved to a snap fit connection between the tube and the mask.” (emphasis added)
220.I take this passage to mean that while initially one could not remove the air delivery tube from its connection point on the mask, the technology rectified this by including means that would allow removal of the air delivery tube from the mask, with these means being an O-ring element and later a snap fit connection. It is thus apparent that the snap fit connection referred to by Professor Rapoport is releasable.
221.In view of the above I am satisfied that releasable snap fits were CGK in the art before the priority date.
222.I have already noted above the fact that different sized cushion modules were CGK before the priority date. In particular in McAuley1 at [12.8] it is stated that “(I)t was common for one sized frame to be provided with various sized cushions or for various sized masks and cushions to be produced in the same range”. Consequently there is motivation in the CGK for the skilled addressee to have the frame being releasable from the shroud (with or without the elbow attached) to facilitate different sized cushion modules. There is also additional motivation to do this in view of the problem to be solved, given the clear benefits with respect to patient comfort from the availability of different sized “cushion modules”.
223.In view of the above I am satisfied that it would be routine, in view of the CGK and the problem to be solved, for the skilled addressee to arrive at claim 17 in implementing the mask system of D4. It follows that claim 17 lacks inventive step in view of D4 and CGK as per s7(3) of the Act.
Claim 18
224.This claim adds the following features to any one of claims 1 to 16: wherein the cushion module and the shroud module are attached via a snap fit attachment mechanism.
225.In view of my discussion with regard to claim 18, and in particular the cited passage from [3.4.5] of McAuley2, I am satisfied that it would be routine, in view of the CGK and the problem to be solved, for the skilled addressee to arrive at claim 18 in implementing the mask system of D4. It follows that claim 18 lacks inventive step in view of D4 and CGK as per s7(3) of the Act.
Claim 19
226.This claim adds the following features to any one of claims 1 to 18: wherein the shroud module includes an annular or part annular retaining portion structured to hold and secure the cushion module.
227.The Macquarie Dictionary Online defines annular as “adjective 1. having the form of a ring”. It is apparent from figures 48 to 51 that the 12th and 13th embodiments comprise part annular retaining portions in the guise of the edges defining the openings 1250, 1349a, 1349b in respective shroud modules 1240, 1340. D4 therefore discloses the additional features of this claim. I am therefore satisfied that it would be routine, in view of the CGK and the problem to be solved, for the skilled addressee to arrive at claim 19 in implementing the mask system of D4. It follows that claim 19 lacks inventive step in view of D4 and CGK as per s7(3) of the Act.
Claim 20
228.This claim adds the following features to claim 19: wherein the retaining portion is part annular.
229.It is apparent from my discussion with regard to claim 19 that D4 discloses the additional features of claim 20. I am therefore satisfied that it would be routine, in view of the CGK and the problem to be solved, for the skilled addressee to arrive at claim 20 in implementing the mask system of D4. It follows that claim 20 lacks inventive step in view of D4 and CGK as per s7(3) of the Act.
Claim 21
230.This claim adds the following features to any one of claims 19 or 20: wherein the retaining portion includes opposed flanges adapted to interlock with respective locking structures.
231.I note that the Opponent conceded that this feature is not disclosed in D4. I agree with that assessment.
232.At the hearing Mr Moore submitted that the features of this claim merely comprised “a standard way of interlocking”, that is it comprises CGK. Even if this is the case, the difficulty for the Opponent is that there is no evidence or suggestion as to why the skilled addressee would add such flanges to the already existing retaining portion of the shroud in the manner defined in this claim. Therefore I cannot be satisfied that the skilled addressee would, as a matter of routine in view of the CGK and the problem to be solved, arrive at claim 21 in implementing the mask system of D4.
Inventive Step – Conclusion
233.I am satisfied that claims 1, 2, 3, 4, 6, 7, 8, 9, 10, 11, 12, 14, 15, 16, 17, 18, 19 and 20 lack inventive step in view of D4 and the CGK according to s7(3) of the Act.
Fair Basis
234.The statutory grounding for fair basis is given at s40(3) of the Act, which states that the claims must be fairly based on the matter described in the description. The requirement for the claims to be fairly based has been treated by the authorities as a requirement for consistency between the invention outlined in the specification and the invention as claimed in the claims, as noted in Kimberly Clark at [15]:
“... where the issue is one under s 40(3) of ''fair-basing" of a claim, what the 1990 Act requires is a comparison between the matter described in the specification and the claim which defines the scope of the monopoly.”
235.This requirement for consistency between the invention claimed and the invention as described has been expressed in the following terms in Rehm Pty Ltd v Websters Security Systems and Others [1988] FCA 162 at [54]; 81 ALR 79 at 95 (“Rehm”):
“…the question is whether there is a real and reasonably clear disclosure in the body of the specification of what is then claimed, so that the alleged invention as claimed is broadly, that is to say in a general sense, described in the body of the specification.”
The Opponent’s Fair Basis Arguments
236.The Opponent’s arguments with respect to fair basis are given at [56] to [60] of their written submissions. In particular at [59] and [60] the Opponent states:
“As described previously with regard to the purported invention (in section E), the specification as a whole teaches that the invention is directed to a mask system “without a forehead support”. The main independent claim, however, is not limited in a way that includes this feature. Indeed, claim 2 is directed to “the shroud module include[ing] a portion to provide forehead support”, which suggests that claim 1 encompasses a mask system with a forehead support.
Therefore, when a comparison is made between the matter described in the specification and claim 1, which defines the scope of the monopoly sought by ResMed in the broadest possible manner, it is clear that claim 1 travels beyond what is fairly taught as the inventive concept in the specification. As such, at least claim 1 is not fairly based on the specification.”
237.At the hearing Mr Lang submitted that these arguments by the Opponent were based on an unduly narrow interpretation of the opposed application. I agree. There is no indication in the opposed application that the absence of a forehead support is somehow fundamental to the invention as described. The absence of a forehead support is merely included at [0006], [0018] and [0020] as one aspect amongst a significant number of other aspects of the invention. In addition [0091] states that “(A)although the system is designed such that a forehead support is not required, such a forehead support can be added if desired.”
238.In view of the above I am not satisfied that any of the claims lack fair basis.
Fair Basis – Conclusion
239.None of the claims were demonstrated to lack fair basis. This ground of opposition is unsuccessful.
Manner of Manufacture
240.The statutory basis for manner of manufacture is found at s18(1)(a) of the Act which states:
“an invention is a patentable invention for the purposes of a standard patent if the invention, so far as claimed in any claim is a manner of manufacture within the meaning of section 6 of the Statute of Monopolies.”
241.Notably Schedule 1 to the Act comprises a Dictionary which defines invention as follows:
“‘invention’ means any manner of new manufacture the subject of letters patent and grant of privilege within section 6 of the Statute of Monopolies, and includes an alleged invention”.
242.In particular it has long been held that the mere collocation of known integers that have no working interrelationship, or potential working interrelationship, is not a manner of manufacture; see British Celanese Ltd. V Courtaulds Ltd. 52 RPC 171 (“British Celanese”) at 193-194:
“It is accepted as sound law that a mere placing side by side of old integers so that each performs its own proper function independently of any of the others is not a patentable combination, but that where the old integers when placed together have some working inter-relation producing a new or improved result then there is patentable subject-matter in the idea of the working inter-relation brought about by the collocation of the integers.”
243.The Opponent’s arguments with respect to manner of manufacture were supplied at [61] to [102] of their written submissions. The primary thrust of the Opponent’s arguments is given at [62] and [101] of these submissions:
“62. Implicit in this definition of manner of manufacture is the notion that a claimed invention cannot merely be a collocation of known integers with no working interrelationship between the integers which produces no new result. That is, where each part (or feature) of a claimed invention performs its normal function independently of the others, there can be no invention in bringing those parts together…
…101. Therefore, there is no invention claimed in claim 1 of the Patent Application. The mask system comprises a number of known integers where there is no working interrelationship which results in a new or improved result. Each part performs its normal function, and is not functionally dependent on any other part.”
It is apparent that the Opponent is alleging that the claimed invention comprises a collocation of known integers.
244.The difficulty for the Opponent’s arguments here is that even if the individual integers of the claims are known, it is beyond question that there is a working interrelationship between those integers. As claimed the integers function together to provide a mask system for use in the therapy of SDB. To that extent the claims cannot be characterised as a mere collocation in the sense defined in British Celanese.
245.However I do note the Opponent’s use of “no new result” at [62] and similar wording in British Celanese (emphasis added). At a superficial level one could take the wording of British Celanese to result in the incorporation of the requirements of novelty and inventive step from s18(1)(b) into an amorphous test along with manner of manufacture from s18(1)(a). That, in a general sense, is not the case.
246.The degree to which “newness” is imported into s18(1)(a), due to the wording of that subsection and the definition of invention as given in the Act has been considered by Brennan, Deane and Toohey JJ in NV Philips Gloeilampenfabrieken v Mirabella International Pty. Ltd. (“NV Philips”) 183 CLR 655; [1995] HCA 15 at [9]:
“The effect of those opening words of s 18(1) is that the primary or threshold requirement of a "patentable invention" is that it be an "invention". Read in the context of s 18(1) as a whole and the definition of "invention" in the Dictionary in Schedule 1, that clearly means "an alleged invention"(18), that is to say, an "alleged" "manner of new manufacture the subject of letters patent and grant of privilege within section 6 of the Statute of Monopolies"(19). In the light of what has been said above about what is involved in an alleged manner of new manufacture, that threshold requirement of "an alleged invention" will, notwithstanding an assertion of "newness", remain unsatisfied if it is apparent on the face of the relevant specification that the subject matter of the claim is, by reason of absence of the necessary quality of inventiveness, not a manner of new manufacture for the purposes of the Statute of Monopolies. That does not mean that the threshold requirement of "an alleged invention" corresponds with or renders otiose the more specific requirements of novelty and inventive step (when compared with the prior art base) contained in s 18(1)(b). It simply means that, if it is apparent on the face of the specification that the quality of inventiveness necessary for there to be a proper subject of letters patent under the Statute of Monopolies is absent, one need go no further.”
247. In the present case this means that, for the purposes of manner of manufacture, one need not go any further if it is apparent that the claims in suit lack inventiveness on the face of the specification. I see no reason to make such a conclusion based on the opposed application. I am therefore satisfied that the claims meet the threshold requirement for manner of manufacture as outlined in NV Philips.
248.Having considered the threshold requirement from, it is a further question as to whether the claimed invention is a mere collocation. As noted above I do not consider this to be case. Any further questions of “newness” properly belong to the realm of s18(1)(b), as outlined in NV Philips.
249.In view of the above it follows that I am not satisfied that that the claimed invention lacks a manner of manufacture.
Manner of Manufacture – Conclusion
250.None of the claims were established to lack a manner of manufacture. This ground of opposition is unsuccessful.
Conclusion
251.The Opposition is successful. Claims 1, 2, 3, 4, 6, 7, 8, 9, 10, 11, 12, 14, 15, 16, 17, 18, 19 and 20 lack inventive step. No other grounds of Opposition were successful.
252.The deficiency with respect to inventive step can be overcome by amendment. I therefore allow the Applicant two months from the date of this decision to propose amendments that overcome this ground of opposition.
Costs
253.Costs usually follow the event. However evidence that was determinative in reaching this decision was filed out of time, and only became part of the opposition via the operation of Regulation 5.23. Therefore I make no award of costs.
Dr W.E. Guinea
Delegate of the Commissioner of Patents
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