ResMed Pty Ltd v Fisher & Paykel Healthcare Limited
[2024] APO 30
•5 July 2024
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
ResMed Pty Ltd v Fisher & Paykel Healthcare Limited [2024] APO 30
Patent Application: 2020223628, 2021201838, 2021201840, 2021201841, 2021201842 and 2021201843.
Title:Patient Interface and Aspects Thereof
Patent Applicant: Fisher & Paykel Healthcare Limited
Opponent: ResMed Pty Ltd
Delegate: L. F. McCaffery
Decision Date: 5 July 2024
Hearing Date: 27 and 28 March 2024 in Melbourne
Catchwords: PATENTS – opposition under section 59 to grant of patents – novelty – priority date of claims – claims entitled to earliest priority claimed – consideration of request that regard be had to information filed pursuant to regulation 5.23 – information would not change the outcome of the opposition in a significant way and not taken into account – inventive step – support – clarity – succinctness – utility – manner of manufacture – opposition unsuccessful on the grounds pressed by the opponent at the hearing – additional consideration of support pursuant to section 60(3) – claims of 2021201841 lack support – applicant given the opportunity to amend – pending an appeal, 2020223628, 2021201838, 2021201840, 2021201842 and 2021201843 directed to proceed to grant – parties given two weeks to make written submissions on costs.
Representation: Counsel for the applicant: Tom Cordiner KC and Megan Evetts
Patent attorney for the applicant: Matthew Swinn, Ann-Kathrin Goller and Vicky Zhang from King & Wood Mallesons
Counsel for the opponent: Craig Smith SC
Patent attorney for the opponent: Robynne Sanders, Ben Mawby and Nicole Harrowfield from DLA Piper
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2020223628, 2021201838, 2021201840, 2021201841, 2021201842 and 2021201843.
Title:Patient Interface and Aspects Thereof
Patent Applicant: Fisher & Paykel Healthcare Limited
Date of Decision: 5 July 2024
DECISION
The oppositions (on all applications) are unsuccessful on the grounds pressed by the opponent at the hearing.
While it was not raised by the opponent in their opposition, the claims of 2021201841 are not supported as they do not include the feature of the face-contacting side of the seal being supple to conform under internal pressure to the surfaces of the nose of the wearer, including at the side portions of the seal, to outside surfaces of the sides of the nose.
The applicant has two (2) months from the date of this decision to propose amendments to 2021201841 to overcome the issue.
Subject to appeal, I direct that 2020223628, 2021201838, 2021201840, 2021201842 and 2021201843 proceed to grant.
Parties given two (2) weeks to provide written submissions on the award of costs.
REASONS FOR DECISION
Background
1.Australian application 2020223628 (‘628) was filed on 24 August 2020 by Fisher & Paykel Healthcare Limited (the applicant).
2.Applications 2021201838 (‘838), 2021201840 (‘840), 2021201841 (‘841), 2021201842 (‘842) and 2021201843 (‘843) were all filed on 24 March 2021. These are divisional applications of ‘628.
3.The present applications are all members of a family of related patents and applications that include a number of granted patents and lapsed applications, as well as another two applications that are the subject of separate opposition proceedings.
4.The opposed applications were all advertised as accepted on 22 July 2021. Notices of opposition were filed by ResMed Pty Ltd (the opponent) on 21 October 2021. The same evidence was filed for all of the oppositions:
| Date of Declaration | Annexes | |
| Evidence in support | ||
| Melody Crinion | 21 April 2022 | MC-1 to MC-9 |
| David John Palkon (Palkon 1) | 21 April 2022 | DJP-1 to DJP-64 |
| Gregory James | 21 April 2022 | GJ-1 to GJ-6 |
| Robynne Lyndsay Sanders (Sanders 1) | 21 April 2022 | RLS-1 to RLS-124 |
| Evidence in answer | ||
| Jason Eaton | 11 August 2022 | JE-1 and JE-2 |
| Evidence in Reply | ||
| David John Palkon (Palkon 2) | 16 October 2022 | DJP-1 (65) |
| Robynne Lyndsay Sanders (Sanders 2) | 17 October 2022 | RLS-125 to RLS-164 |
Regulation 5.23 material
1.Following completion of evidence in reply, the applicant submitted that Sanders 2, with the exception of paragraph 11 and Annexes RLS-131 and RLS-132, and Palkon 2, paragraphs 264 and 265 were not properly evidence in reply. Following comments from the parties, a delegate made the direction:
“That paragraphs 5-25 and 28-34 of the Sanders #2 declaration (filed 17 October 2022) and annexures RLS-126 to RLS-155 and RLS-158 to RLS-164 (filed 17 October 2022) are not properly in reply and are not admitted into evidence.”
1.Pursuant to this direction, the applicant sought to file evidence under Regulation 5.23 (Eaton 2). The evidence was intended to deal with paragraphs 264 and 265 and Annex DJP-1 of Palkon 2. However, this led to several further rounds of evidence and submissions as the parties disputed whether certain material was limited to evidence in reply and whether even more evidence should be allowed under regulation 5.23. The parties agreed to a direction proposed by the delegate, and made on 16 January 2023, that Eaton 2 be consulted in the opposition. The opponent was given 1 month to file evidence or submissions in reply, and filed Sanders 3, Abhyankar and Palkon 3 on 28 February 2023.
2.The applicant considered that the opponent’s response was not properly in reply, and in a letter of 10 March 2023, contrary to the usual approach of seeking to have the evidence struck out and without any indication of why they considered the evidence was not properly in reply, advised that they intended to file further evidence under regulation 5.23. The applicant subsequently filed Eaton 3 together with a request to have this evidence consulted under regulation 5.23, or in the alternative, to have the opponent’s evidence (with the exception of Palkon 3, paragraphs 1 to 7 and 13 to 15) excluded on the basis that it was not in response to Eaton 2.
3.Following a detailed consideration, the delegate agreed with the applicant’s submissions and proposed a direction that, with the exception of paragraphs 1 to 7 and 13 to 15 of Palkon 3, the evidence filed by the opponent on 28 February 2023 be disregarded in the opposition. This led to further correspondence between the opponent and the delegate before, in a letter dated 10 May 2023, the delegate proposed that the issue be left for consideration at the hearing. I have dealt with this issue in my discussion of the Respironics ComfortCurve™ mask under novelty.
4.A summary of the evidence filed following the completion of EIR is given in the following table.
Date of declaration
Annexes
Evidence allowed under Reg. 5.23
Jason Eaton (Eaton 2)
9 January 2023
Evidence in reply to Eaton 2 requested under Reg. 5.23 (not yet allowed)
Robynne Lyndsay Sanders (Sanders 3)
28 February 2023
Sonali Abhyankar (Abhyankar)
27 February 2023
SA-1 to SA-3
David John Palkon (Palkon 3)
27 February 2023
Evidence requested under Reg. 5.23 (not yet allowed)
Jason Eaton (Eaton 3)
30 March 2023
1.
2.The matter was set for hearing on 27 and 28 March 2024. The opponent pressed the grounds of novelty, inventive step, clarity, support, succinctness, utility and manner of manufacture at the hearing.
3.Following the hearing, on 3 June 2021 I wrote to the parties seeking submissions on matter of concern I had concerning section 40(3) in relation to application ‘841, where these concerns had not been raised by the opponent. The parties provided their responses on the issue on 18 June 2024. This is further discussed under the ground of support below.
Onus
1.The substantive amendments to the Patents Act 1990 (Cth) (the Act) brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth) (the RTB Act) apply to the present case. The standard of proof in opposition proceedings is the balance of probabilities. If the Commissioner is satisfied, on the balance of probabilities, that a ground of opposition to the grant of the standard patent exists, the Commissioner may refuse the application. The opponent bears the onus of proof.
The expert witnesses
1.As indicated above, the opponent relied on evidence from the following witnesses:
·Melody Crinion is a Senior Paralegal employed by ResMed. Her evidence relates to documents and devices that are maintained by ResMed and entered into evidence in the opposition.
·Gregory James is Vice President of Corporate Finance and Treasury at ResMed. His evidence related to records of sales that were provided as evidence of public availability of prior art products in evidence.
·David John Palkon is the owner and Director of an engineering consultancy business, IBT Consultants. He was the main technical expert for the opponent. Between 1997 and 2006 he provided consultancy services to Tiara Medical Systems, Inc., a medical device manufacturer. This included projects on the design and commercial development of several nasal and full face masks. He is listed as an inventor on 8 patents.
·Robynne Lyndsay Sanders is a Partner of DLA Piper Australia. Her evidence included various comparisons of claims and priority documents, as well as entering a large number of documents into evidence.
·Sonali Abhyankar is a Clinical Development Specialist at ResMed, where, as a Sleep Technician, she works with patients who are undertaking sleep studies or have been diagnosed with sleep apnea, fitting them with masks. Her evidence related to the fitting of a ComfortCurve™ mask.
1.The applicant relied on evidence from Jason Eaton, who is currently a Principle Mechanical Engineer in New Product Development at MSA Safety Incorporated. Between 2000 and 2012, he was employed by Respironics, Inc., which became Philips Respironics in 2008. During that time, he was lead engineer for the design and commercial release of the ComfortGel™ nasal mask. He was also on the team involved in early concept development brainstorming sessions for the ComfortCurve™ product, as well as leading projects related to infant sleep apnea and phototherapy devices. He is named as an inventor on 25 patents.
2.The parties did not dispute that Mr Palkon and Mr Eaton have appropriate knowledge and experience to provide evidence on the present matter. However, the applicant submitted at the hearing that Mr Palkon took an over-meticulous approach to his construction of the specifications. They also noted that Mr Palkon’s own patent specifications used language that he stated was unclear in meaning in the present cases. On the other hand, the opponent submitted that Mr Eaton misunderstood the role of the body in construing patent claims, and that his approach was flawed as he read the specification and drawings as if they provide a dictionary for the meaning of certain terms in the claims.
3.I have taken these matters into account when assessing the weight that evidence may be given in my determination.
The common general knowledge
1.A significant cause of sleep breathing disorders is the collapse of loose tissue in a patient’s airway during sleep. This can cause the airway to become obstructed and the patient to stop breathing. Continuous Positive Airway Pressure (CPAP) therapy is used to maintain positive air pressure in the patient’s airway to support the loose tissue and allow the patient to breathe more freely.
2.CPAP therapy uses a flow generator to create pressurised air which is delivered via a tube to a mask secured to the patient’s face by headgear. There were three main types of mask:
a.Full-face masks, which typically sealed around the mouth and at least some portion of the nose and cheeks;
b.Full nasal masks, which typically sealed around most of the nose exterior and above the upper lip, and often portions of the cheeks; and
c.Nasal pillows masks, which typically sealed around the nostrils.
1.Mr Eaton identified another type of CPAP mask, cannula-style masks, which typically do not have a mask frame and have prongs which insert into the user’s nostrils. The Innomed Nasal Aire II Prong Mask™ is an example of such masks. Mr Palkon appears to have included such nasal cannula masks in his reference to nasal pillows, but also stated that, while he was aware of masks like the Innomed product, he did not consider it a true alternative to the types of masks identified above because patients found it to have very poor comfort and effectiveness, and compliance was low because it caused sores inside some patient’s noses. Mr Eaton went on to state that the different types of interface existed more on a spectrum than in clearly defined and separate categories. For example, the difference between nasal pillows and cannula-style masks can be as little as the degree of extension of the seal into the nares (nostrils).
2.Certain features were generally common to all masks at the priority date:
·A rigid plastic frame;
·Soft cushions for areas that contacted the user’s face, so as to achieve a seal against the user’s face;
·Headgear that held the mask to the user’s face; and
·Some kind of swivelling attachment that connected the tube to the mask, and at the other end to the flow generator, that delivered the pressurised air.
1.The frame provides a relatively rigid attachment point for the tube and the headgear which hold the mask against the user’s face, and may be made of polycarbonate, silicone and polyethylene. Mask frames are generally designed to be low profile, but because they needed to fit faces of different shapes and sizes, as well as avoid contact with the user’s face, they cannot be too low profile. To avoid discomfort, the internal volume of the frame also has to provide sufficient volume for an inflatable seal to inflate and for the pressurised air to circulate before entering the user’s nose or mouth.
2.Tubes from the air flow generator were either connected directly to the mask or connected through an elbow. The tube/elbow was usually connected to the frame of the mask as this part of the mask was stiffer and better able to absorb the forces applied by the tube/elbow. Most elbows contained a swivel that allowed the tube to rotate independently of the mask.
3.Full-face and full nasal masks were generally in the shape of a triangle with rounded corners. Mr Palkon stated that nasal pillows were generally shaped like a U to a V, but Mr Eaton considered this an “arbitrary” description and that it was not correct to say that all nasal pillows had this shape. Nevertheless, he recalled that it was common for the geometry of nasal pillows to match the typical contours of the nose and to extend laterally outwards, and sometimes slightly backward towards the user’s face, which I understand to essentially describe a shallow V- or U-shape.
4.The cushion generally creates the seal against the user’s face, and the evidence therefore used these terms interchangeably. Cushions can be permanently attached to the frame by adhesives or by overmoulding and aftermoulding during manufacturing, or removably attached using methods such as retaining rings and clipping mechanisms. Cushions generally form the seal in one of two ways. The seal may be pressed into the user’s face until it conforms to the contours of the face. Gel and liquid silicone seals work in this way. Alternatively, the cushion is placed in partial contact with the user’s face and pressure within the mask used to inflate the seal until it conforms to the user’s face. This is how some silicone cushions function.
5.The cushion that contacts the user’s face must be soft. Silicone with a higher hardness rating than other silicone options allows a thinner layer to be used to achieve the desired properties, but hard silicone in areas that contact the user’s face can cause discomfort. While a thin layer of silicone is ideal, very thin layers of silicone do not hold their shape and are difficult to remove from moulds. Mr Palkon stated that he was unaware of any mask cushion that was more than 6.35 mm thick, as above this thickness the cushion would be too rigid, heavy and expensive.
6.If certain parts of the mask require additional rigidity, reinforcing features such as strips or ribs may be incorporated. The thickness of the silicone may also be varied, making it thicker where the mask needs to be stiffer and thinner where it needs to be more flexible, or where it contacts the face. For example, many masks use thinner silicone on the bridge of the nose because this area is quite sensitive. Thicker silicone is used in the area between the lips and cheeks which was less sensitive, but also more prone to leakage. Thicker silicone gave the cushion greater stiffness and improved the seal.
7.The purpose of the headgear is to securely hold the mask against the user’s face whilst maintaining correct orientation and equal pressure across the face, without bending or pushing too hard against the face. Keeping the mask in place is critical to achieving the best seal. Headgear is generally made of fabric that wraps around the back of the head and is adjustable to differently sized heads, for example by using Velcro at the ends of the straps.
8.Headgear is generally attached to the frame via slots or clipping mechanisms that are positioned to avoid the eyes and ears. It is possible to attach the headgear to the cushion, but this is problematic as the cushions are not designed to withstand the force of being pulled by the headgear, and it can cause the cushion to deform.
9.Masks generally incorporate stability or support features to ensure the seal remains effective despite forces from the pressurised air and movement of the user during sleep. The bridge of the nose (the upper bony part of the nose) is a particularly sensitive area as it has a very thin layer of skin, and any amount of pressure in this area is likely to cause discomfort. However, if the mask is not properly sealed around the bridge of the nose, air leakage can be directed into the user’s eyes. It is therefore common to include a forehead support which allow the mask to be pushed closer to or pulled away from the user’s face using the headgear tightness. This allows the user to customise the position of the mask and the pressure that is being applied to the bridge of their nose.
10.Mr Eaton stated that it was also an option to use cheek supports instead of, or in addition to, forehead supports. The Respironics ComfortCurve™ included cheek supports to provide stability to a relatively small mask through features other than the seal surface itself. He went on to state that it was common to want to decouple the sealing and stability functions of the mask and provide stability primarily through features other than the seal (such as the cheek or forehead supports). However, the seal itself could include support features and contribute to overall stability. For the ComfortGel™ nasal mask, the sealing and support functions provided within the seal were decoupled though use of a gel cushion, which helped stabilise the mask on the user’s face, immediately interfaced with a thin and compliant silicone flap which contacted and sealed to the user’s face. This apparently was an uncommon approach to mask design, so I do not consider that it can be taken to be common general knowledge.
The specifications and claims
1.Turning to the present applications, I note that the text of the specifications differs only in the Summary of the Invention sections. This results in some differences in the pagination of each application, but for convenience I will refer to the page numbers used in ‘628 unless otherwise indicated.
2.The field of the invention relates to patient interfaces for delivering breathing gases to a patient and aspects of patient interfaces. The invention is said to be described with reference to patient interfaces for delivering PAP therapy to a patient, for example, to a patient suffering obstructive sleep apnea (OSA) but could be used for other treatments.
3.The Summary of the Invention then sets out a number of consistory clauses and various aspects of the invention, which also appear in the claims. The first aspect of the invention is said to:
“consist in an inflatable nasal seal for a patient interface: the seal including a face contacting side, the seal being formed of a soft flexible material, and including a central portion to extend across the base of the nose, and a side portion extending from each end of the central portion, each side portion extending across a side of the nose, the face contacting side of the seal being supple to conform under internal pressure to the surfaces of the nose of a wearer, including, at the side portions of the seal, to outside surfaces of the sides of the nose, an exterior side of the seal including regions much stiffer than the supple interior side, the regions extending into the side portions of the seal.”
1.The specification goes on to say that:
“According to a further aspect, the seal includes a pair of nasal locators on the face contacting side, and the seal is stiffer in the region immediately adjacent and including the nasal locators than in a region surrounding this region, on the face contacting side of the seal.”
1.The above passages suggest that “nasal locators” are an optional feature of the invention. However, all of the embodiments in the Detailed Description comprise nasal locators. This was a point of some contention between the parties, and in particular the weight that the consistory clauses could be given. This issue is further discussed under the ground of support.
2.The seal is said to be formed from a supple material that is capable of repeated deformations without failure. Suitable materials include latex, vinyl, silicone and polyurethane. The wall thickness is below 0.5 mm and can be lower than 0.2 mm.
3.The seal is supported by a mask body or frame. The inlet opening of the seal is fitted to the frame, or directly to a conduit extending through the frame. The frame may be formed by injection moulding of an elastomeric material such as silicone or polyurethane, but rigid materials such as polycarbonate, polyester, polystyrene or nylon may alternatively be used. The preferred frame includes connection points for connecting straps to the frame. The nasal seal body may also include integral strap attachment points. These may be connection elements on the surface of the envelope, but alternatively can be integral straps or wings formed in the envelope that extend out from either side of the envelope.
4.The specification sets out numerous embodiments relating to different aspects of the patient interface, including 62 figures. For brevity I have not gone into detail about these here, but some are discussed in relation to other issues below.
5.The claims of each the applications have the following features in common:
·An (inflatable) nasal seal;
·The (nasal) seal including a face contacting side, the seal being formed of a soft flexible material; and,
·Including a central portion to extend across the base of the nose, and a side portion extending from each end of the central portion, each side portion extending across a side of the nose.
1.Most of the opposed applications also define the feature:
·The face contacting side of the seal being supple to conform under internal pressure to the surfaces of the nose of a wearer, including, at the side portions of the seal, to outside surfaces of the sides of the nose.
1.Claim 1 of each application includes additional characterising features, which I have summarised below. Before considering those features, I will construe the meaning of some of the terms that are common between most of the applications. In this regard, the opponent submitted that there is a remarkable lack of detail in Claim 1 – no overall shape for the nasal seal is defined and there is no description of the shape of any of the parts of the nasal seal. Claim 1 includes few design limitations that would assist the skilled person to go about designing a mask. This concern appears to stem from the use of relatively imprecise terminology, which the opponent refers to as “undefined” terms and the terminology used to characterise these. Some of these issues were raised under section 40 grounds and are discussed in detail later in the decision.
Construction
1.The principles underpinning construction are well-established. As noted by Middleton J in Eli Lilly and Company Limited v Apotex Pty Ltd:
“It is well settled that the Court should, from the outset, approach the task of patent construction with a generous measure of common sense. The Court must place itself in the position of a person skilled in the relevant art, being the subject matter of the patent. From this perspective, the patent is to be read as a whole, in the context of the specification and in light of the prevailing common general knowledge and state of the relevant art at the priority date.”
1.Thus, the task of construing the specification is undertaken from the viewpoint of a person skilled in the art and the prevailing common general knowledge at the priority date. The person skilled in the art is a hypothetical, non-inventive person or team likely to have a practical interest in the subject matter of the invention.
2.The Full Court in Airco Fasteners Pty Ltd v Illinois Tool Works Inc. recently reiterated the principle that experts can give evidence on the meaning which those skilled in the art would give to technical or scientific terms and phrases, and on any unusual or special meanings that would be given by skilled addressees to words which might otherwise bear their ordinary meaning. The Court is to place itself in the position of some person acquainted with the surrounding circumstances as to the state of the art and manufacture at the time. However, it is for the Court, not for any witness however expert, to construe the specification. A similar approach is taken in matters before the Commissioner.
3.As also noted by Justice Rofe in Sandoz AG v Bayer Intellectual Property GmbH, a construction that would lead to an absurd result is to be avoided. It is impermissible to approach the issues of construction with any regard to the alleged infringing articles, better understood for present purposes as the prior art.
Inflatable nasal seal
1.There was no apparent dispute between the parties that an “inflatable nasal seal” is a pressure assisted seal or cushion that forms a seal when the pressure within the mask inflates the seal until it deforms outwards and conforms to the user’s face to seal the user’s nose.
2.I note that claim 1 of only applications ‘628 and ‘841 explicitly defines an inflatable nasal seal. In contrast, claim 1 of applications ‘838, ‘840, ‘842 and ‘843 define nasal seals without any reference to them being inflatable. Both experts considered the omission of the term “inflatable” meant that the nasal seals could be a non-inflatable seal, such as masks with physical seals. But claim 1 goes on to define that the seal is supple to conform under internal pressure to the outside surfaces of the sides of the nose, so I consider this imparts a limitation on the claim that the seal is at least pressure-assisted inasmuch as the internal pressure pushes the seal (or at least some part of it) against the surfaces of the nose.
3.However, claim 2 of ‘838, ‘840, ‘842 and ‘843 define that the seal is inflatable. Construing the claims to avoid redundancy in claim 2 might suggest that claim 1 includes pressure-assisted seal types other than inflatable seals (for example Mr Eaton referred to one type of pressure-assisted seal as a flap seal). Despite this concern, there is no evidence of there being a distinction between inflatable seals and any other type of pressure-assisted seals. While this may result in Claim 2 of applications ‘838, ‘840, ‘842 and ‘843 being redundant, this in itself is not a determinative factor in the construction of the claims.
Across the base of the nose
1.There was some dispute between the experts as to what the base of the nose encompasses. Despite stating that he would generally refer to the base of the nose as the entire triangular section, Mr Palkon went on to say that the phrase “base of the nose” was not clear to him as to whether it refers to the part of the nose that meets the lip and extends from one nostril to the other (shown in red below), or whether it comprises the entire bottom triangular section of the nose (shown in green below). The specification did not assist him to understand the meaning of the term.
1.Mr Eaton stated that the base of the nose would refer to the surface of the nose visible from a viewpoint below the user’s nose, looking upwards. Mr Eaton also referred to the relevant area as the alar base, but the specification does not describe the invention in such anatomical terms. He provided diagrams from several different angles to further explain:
1.On balance, I am satisfied that the base of the nose can be taken to be the area indicated in green in the diagrams above. The experts appear to be in agreement that this would be the ordinary meaning of the term. While Mr Palkon went on to provide the alternatives above, ostensibly because the specification did not provide a definition, he provided no explanation of why he would defer from the ordinary meaning. The fact that the specification does not provide an alternative definition leads me to conclude that the ordinary meaning of the term would be taken.
2.It is probably unnecessary to consider the issue any further, but I also note that the central portion is defined to extend across the base of the nose. I understand the plain meaning of the term “across” to indicate that the central portion extends in two dimensions – length and width – as opposed to, say, the central portion being positioned along the base of the nose which indicates a single dimension (the length). The term “across”, as used in the claims, is consistent with the former interpretation and the meaning I have accepted above.
Side of the nose, face-contacting side, exterior side
1.The experts differed as to the meaning of several terms that perhaps highlight the different meanings words can take depending on the context in which they are used. In particular, the term “side” is used in different ways in the claims:
·The seal has face-contacting and exterior sides.
·Each side portion of the seal extends across a side of the nose, and the seal conforms under internal pressure to the outside surfaces of the sides of the nose.
1.On the first issue, Mr Palkon stated that it was unclear to him how the seal could have a side when it is curved. The applicant disagreed, referencing Pink Floyd’s “Dark Side of the Moon” to illustrate how a curved shape can have sides, in this case a light side and a dark side. I agree with the applicant on this point. In the present case, the two sides refer to the inward-facing surfaces of the mask and the exterior-facing surfaces of the mask. The boundary between these surfaces (or sides) is defined by the line at which the seal forms with the user’s face.
2.On the second issue, Mr Palkon stated that it was not clear to him whether the term “sides of the nose” referred to the sides of the nostrils (shown in red below) or the outside edges of the nose, shown in green below. Besides providing these two alternatives, Mr Palkon did not explicitly state what he would ordinarily understand the sides of the nose to be. In the first figure, he appears to refer only to the area on the base of the nose adjacent the nostrils (rather than the sidewall of the nose extending from the base to the bridge of the nose). In the second diagram, Mr Palkon appears to be referring only to the line between the nose and the cheek. The diagram does not appear to encompass the surface of the nose between the nasal ridge (the centre line of the nose between the tip and the bridge of the nose) and the cheeks, including the alae (the “wings” on either side of the nose, singular form being ala). As Mr Palkon provided little additional explanation of the diagrams, I have some difficulties in drawing any conclusions from this particular evidence.
1.In contrast, Mr Eaton appeared to have no difficulty with the terminology, stating that:
“I understand the sides of the nose to be the portions on either side of the nasal ridge, including the generally forward and laterally facing surfaces of the alae. I understand the nasal ridge to be the midline prominence of the nose which extends from the top of the nasal bridge to the front of the nasal tip. I understand the nasal bridge to be the upper most, bony part of the nose between the eyes and just below them, and the nasal tip to be the most projected part of the nose which points away from the user’s face. I therefore understand the sides of the nose to comprise all portions of the nose except the surfaces of the lower face of the nose (i.e., the alar base) and the central or forward-facing surfaces of the nasal ridge.”
1.On balance I prefer the evidence of Mr Eaton. Mr Palkon did not provide a clear indication of what the ordinary meaning in the art would be, and prima facie his two alternatives are formulated to read on the prior art masks. Notably neither appears to be consistent with the definition provided by Mr Eaton. But if there are any construction issues of the type suggested by Mr Palkon, I consider these can be resolved fairly easily.
2.Given the ordinary meaning of the term ‘base of the nose” as discussed above, the first interpretation given by Mr Palkon (shown in red), would not, in my opinion, be a common sense one. Firstly, the term “nose” is not synonymous with the term “nostrils” (or nares). The specification consistently uses the terms nose and nostrils differently, and there is no reason to think that the drafter has not been consistent in such an approach in their reference to the sides of the nose in the claims. Secondly, the claim defines that the seal extends across the base of the nose and across the sides of the nose. The separate identification of base and side portions indicates two different orientations rather than a continuation or extension in the same plane. Finally, having determined that the base of the nose would ordinarily be taken to include the surfaces surrounding the nostrils, the separate definition of the seal extending to the area around the nostrils in the manner suggested by the opponent would be superfluous.
3.Turning to the second alternative provided by Mr Palkon, my understanding is that the ordinary meaning of the term “side” when referring to a 2-dimensional shape is the outside boundary of the shape, such as the side of a square. Mr Palkon appears to approach the meaning of the term “sides of the nose” in this way in his second alternative. Thus, if the nose is viewed from the front as a 2-dimensional triangular shape, the sides of the nose (shown in green by Mr Palkon) are the outside boundaries of that triangular shape. In a three-dimensional shape, however, the faces (or surfaces) of the shape are generally referred to as sides, which are separated by edges. Given that the nose is a three-dimensional, essentially pyramidal, shape, the term “side” would be understood in that context to relate to a surface of the nose rather than an edge.
4.It seems to me that both interpretations are feasible if looking at the term “sides of the nose” in isolation and stripped of all surrounding context. However, in the context of the definitions given in the claim, I consider that the latter interpretation is the correct one. The central portion extends across the base of the nose and the side portions extend from the ends of the central portion across the sides of the nose. As discussed previously, the term across infers length and width, and therefore this combination of features clearly defines a surface rather than a line. If that is in any doubt, the claim goes on to define that the seal conforms under internal pressure to the surfaces of the nose.
5.This interpretation is consistent with the meaning given by Mr Eaton. However, I note that in response to Mr Eaton’s evidence, Mr Palkon stated that he did not consider that the sides of the nose (the nasal ridge, nasal bridge, nasal tip and alar base) could be distinguished from other parts of the nose in the manner suggested by Mr Eaton above, as the parts of the nose differ from patient to patient depending on their nasal geometry. I find this evidence unconvincing since the nasal anatomy referred to by Mr Eaton appears to be widely used and understood in the art. Indeed, Mr Palkon used similar language in describing a mask which he was involved in designing, and in a general description of nasal pillows masks. The transitions between the sides and base of the nose are certainly not sharp lines. But a degree of imprecision is permissible in patent claims providing the skilled person would be able to give the terms meaning. Moreover, I do not understand the claims to define a “one size fits all” mask. Rather, like any of the masks referred to by the experts in their evidence, the most appropriate mask size would be selected to suit the user’s facial geometry. I consider Mr Eaton’s interpretation provides a workable standard in that regard.
6.In summary, I understand anything that is visible from the underside of the nose comprises the base of the nose, while anything above the base, excluding the forward-facing ridge of the nose, constitutes the side of the nose. I will apply that meaning in my determination.
Central portion and side portion
1.One of the key construction issues raised at the hearing involved the meanings of the terms “central portion” and “side portion”. My understanding of the opponent’s submissions is that the meaning of these terms cannot be determined because they are not terms in the art and the claims provide few design details. The opponent submitted that in choosing to use such “deliberately general terms” the meaning of those terms must principally come from the context provided by the claims, read within the broader context provided by each specification as a whole. They went on to submit that because there was no dictionary in the specifications that explained the terms, the claims must be construed to determine their meaning.
2.I don’t disagree with the general principles set out in these submissions, but I do not consider it unusual that an invention is described using “general” terms, or that such terms (or indeed any term, technical or otherwise) must be construed. I would also add that the terms in a claim are generally given their plain or ordinary English meaning, unless they have a special technical meaning in the art. This is done from the point of view of the person skilled in the art and what they would understand the terms to mean. In that regard, the opponent’s written submissions on the construction of the terms “central portion” and “side portions” make no reference to the evidence given by the experts beyond a couple of criticisms of Mr Eaton’s evidence. This is perhaps not surprising given Mr Palkon’s difficulties in giving the terms any definitive meaning, and the opponent’s submissions to the extent that Mr Eaton’s opinions should be disregarded because of his reliance on the specification to interpret the terms in the claims.
3.The opponent’s written submissions referred to the terms “central portion” and “side portions” as “undefined” terms. They went on to make submissions in relation to several terms as summarised below:
·The word “central” describes the location of the relevant part, being towards the centre of the seal, but the claim does not otherwise specify to what degree that region must be centred.
·The central portion is defined to extend across the base of the nose, but no degree of extension is specified in the claims. The opponent however acknowledged that some guidance is given by the requirement that the central portion must extend across the base of the nose.
·Each side portion extends across the side of the nose, but the degree of extension is not specified. The opponent noted that the claim does not impart a requirement that the extend across the full side of the nose and argued that this similarly meant that the central portion need not extend across the full base of the nose.
·The side portion extends from each end of the central portion, but there is nothing in the claims or specification that makes clear where the central portion ends, including relative to the full width of the base of the user’s nose.
·The claim requires that the product operates as a nasal seal, and therefore the seal must contact the user’s face in such a way that a seal will form with the user’s face such that pressurised air is delivered to the nostrils. However, the claim does not otherwise provide any information as to the shape or extent of the nasal seal as a whole or the side or central portions of that seal. Such features are only introduced in dependent claims.
1.I note these generally relate to purported issues in interpreting certain terms in the claim rather than providing any resolution of those issues. The opponent’s submissions also, to a large extent, construe the meaning of terms in isolation from other features of the claims, which risks an over-meticulous verbal analysis of the claims. As cautioned by the Federal Court in Nesbit Evans Group Australia Pty Ltd v Impro Ltd, “[t]here is a danger in considering the integers of a claim individually and in isolation. This could yield a literal rather than a purposive construction”.
2.That aside, I consider the issues raised by the opponent can be resolved to give the terms in the claim meaning. The central and side portions are defined with reference to the base and sides of the nose. The central portion is positioned across the base of the nose. As suggested by the opponent, this, in isolation, does not require that the central portion extend across the entire base of the nose. However, the claim defines that the side portions extend from each end of the central portion, and those side portions extend across the sides of the nose. I understand the reference to the side portions extending across the sides of the nose implies that the side portions are at least proximate to the sides of the nose. But even if this is not the case, the claims go on to define that the seal conforms under internal pressure to the surfaces of the sides of the nose. That is, the side portions must be sufficiently close enough to the nose to enable the seal to contact and conform to the outside surfaces of the sides of the nose when the seal is inflated.
3.To the extent that the central portion may not extend the entire distance of the base of the nose, I note the principle “a construction according to which the invention will work is to be preferred to one according to which it may not do so”. The claim requires that the side portions extend from the ends of the central portion and across the sides of the nose. I do not consider that the language of the claim contemplates that the central portion does not extend the full distance of the base of the nose. This would seem to result in an absurd result, or at least one which would not work in the way required, since such an arrangement would presumably result in pinching or blocking of the nares.
4.I also do not share the concerns of the opponent in relation to the degree of extension of the side portions. I agree that the definition does not impose a requirement that the side portions extend the entire length of the nose, though this degree of extension does fall within the scope of the claim. The opponent acknowledged that the specification provides some contextual guidance for the lower end of extension, referencing the disclosure of the specification that the side portions should extend at least 10 mm, but I don’t understand the claims to be limited to this specific size. Rather, I construe the definition of the side portions as extending across the sides of the nose and expanding under internal pressure to conform with the surfaces of the nose of the wearer, including the outside surfaces of the nose, as meaning that it forms a seal with the outside surfaces of the side of the nose. This requires more than simply a de minimis degree of contact. The side portions do not merely touch the edges of the sides of the nose but extend across the surfaces of the sides of the nose and conform to them.
5.The opponent’s concerns on these matters stems from the lack of detail, or imprecision, in the definitions used in the claims. However, a degree of imprecision is permissible in claims provided the person skilled in the art would be able to determine the meaning. Indeed, it seems to me, given the differences in facial geometry, that the person skilled in the art of nasal masks would expect there to be a degree of variability in the fit of any mask. The central portion may not align precisely with the base of all noses, but to all intents and purposes that is one of the aims of the seal inflating to conform with the outer surfaces of the sides of the nose. In summary, the claim does not set out precise measurements for the central and side portions, but I am satisfied that the skilled person would give the terms in the claim a practical meaning.
Do the claims define a pre-formed seal body?
1.One of the points of dispute between the parties relates to whether the central and side portions of the mask constitute “distinct, clearly defined portions” in the mask. This arose in the context of the ground of novelty, but also impacts on the priority claimed by the applicant. Given that the construction of the specification and claims lies at the heart of the issue, I will consider this point as part of my interpretation of the specification and claims.
2.The gist of the opponent’s submissions is that the wording used in the claims imparts some kind of temporal limitation inasmuch as the shape and conformation of the seal is intrinsically linked to it being in place on the patient and in use. In particular, Mr Palkon stated that:
“In considering claim 1 of the 628 Application, I understand the requirement of ‘a central portion to extend across the base of the nose’… and ‘each side portion extending across a side of the nose’… to be referring to the location these portions will have when the mask is in position on a user’s nose, and the seal is under internal pressure. This understanding is supported by the fact that the claim requires the seal to be formed from a soft flexible material… and have a supple face contacting side to conform under internal pressure to the surfaces of the nose of a wearer... This language contemplates that the seal may not, due to its flexibility and suppleness, have a clearly defined shape relative to the user’s nose and face when it is not in place on the user’s face and/or under internal pressure, however it will engage a user’s nose in the way required by the claim once the seal is under internal pressure and brought into conformity with the user’s nose” [emphasis added].
1.This statement was made in view of prior art raised by the opponent, and in response to Mr Eaton distinguishing that prior art on the basis that the present mask comprises distinct, clearly defined portions. That is, the interpretation given was essentially a hindsight exercise of whether the terminology used in the claim could be interpreted to include a specific piece of prior art, rather than how the terminology would have been interpreted by the skilled person in view of the common general knowledge at the relevant time. I therefore consider that lesser weight can be given to this evidence in the determination of the meaning of the claim.
2.That aside, I acknowledge that the structure of the mask is certainly defined with reference to the nasal geometry of the user and the function of certain portions of the mask. But I do not consider that the wording of the claim imparts the temporal limitation suggested by Mr Palkon. Rather, the various features of the masks are distinct and clearly defined portions that are present in the mask body per se, and that, in use, are shaped to be positioned in the way indicated by the claim. The terminology used in the claim (to extend…, to conform…, etc.) simply characterises the features and shape of the mask with reference to facial geometry. Thus, for example, “a central portion to extend across the base of the nose” requires that the central portion must generally be shaped and sized to be able to sit across the base of the user’s nose. There is otherwise nothing in the language of the claim or specification to suggest that the seal is essentially shapeless.
3.I also note that the claim defines that the face contacting side of the seal is supple to conform under internal pressure to the surfaces of the nose of the wearer. The interpretation given by Mr Palkon requires the use of a frame (or other external means) to push the inflated mask against the surfaces of the face of the user and mould the seal to the required shape (which Mr Palkon refers to as being “brought into conformity”). There is no mention of such means in the specification, and contrary to Mr Palkon’s interpretation, I do not consider that this type of arrangement, involving external forces, is contemplated by the language used in the specification and claims.
4.In short, I consider that the language of the claim requires that the various portions are pre-formed in the seal body.
Supple
1.My understanding is that the opponent has no formal objections to the terms “supple”, though they refer to the term as being vague in scope. Despite this submission, it seems to me that the experts do not differ significantly as to the meaning of the term supple in the context of the invention disclosed. For example, Mr Eaton understood supple to mean the ability to move freely with minimal resistance to force and/or pressure. In the context of CPAP masks, he understood it to mean a surface, material or component likely to deform substantially under forces generated through the provision of positive airway pressure or patient contact. He went on to state that, as used in the specification, “supple” would be understood as being sufficiently soft, compliant, and flexible to conform to the users face in response to positive air pressure, while avoiding wrinkling, folding or deformation which could impair the effectiveness of the seal.
2.Mr Palkon similarly understood the specification to require something which is sufficiently flexible that it will deform under the usual pressure of the CPAP mask, but not so flexible that it collapses either under atmospheric conditions or when subjected to the pressures usually experienced by a CPAP mask. The specification lists a range of materials and thicknesses of materials that can be used to form the supple portions of the mask. Mr Palkon noted that these materials differ in hardness and some, such as silicone, are available in different hardnesses. The range of thickness will also impact on the ability of the material to deform. Mr Palkon stated that he therefore could not determine what is required for the portion of the seal to be considered supple.
3.Mr Palkon’s concerns appear to be directed at being able to determine the materials and properties that would be capable of achieving the desired outcomes, rather than the meaning of the term “supple” per se. Notwithstanding this concern, the claim does not use the term in isolation but rather defines that the material is “supple to conform under internal pressure to the surfaces of the nose”. That is, the term is linked to a particular function and the conditions under which that function is achieved. The meaning of terms is also determined with reference to the skilled person and the common general knowledge in the art. Both experts were aware of inflatable (and pressure-assisted) seals, and it would therefore seem reasonable to me that they would also be aware of suitable materials for such seals. Moreover, the opponent did not raise this issue (or indeed any issue) under the ground of sufficiency, so it may be assumed that they consider the specification provides a clear enough and complete enough disclosure in that regard.
4.Turning now to the specific terms used in each of the different applications:
Claim 1 of ‘628
1.Claim 1 of ‘628 is directed to an inflatable nasal seal for a patient interface. In addition to the features set out above, the claim defines that:
“an exterior side of the seal including regions much stiffer than the supple interior side, the regions extending into the side portions of the seal.”
1.I understand the reference to interior and exterior sides to mean that the inflatable seals defined by the claims consist of a hollow body assembly. The patient-facing side corresponds to the section of the wall of the hollow seal body bounded by the parts of the seal contacting the patient’s face. The external portion of the mask corresponds to the walls of the seal that are outside of that boundary. The invention is further characterised by the configuration of the exterior side (or wall) of the seal body to incorporate regions that are defined to be much stiffer than the supple interior side of the mask. The evidence suggests that the incorporation of reinforcing features such as ribs was routine if regions of the mask required greater rigidity, but the opponent made submissions on the clarity of the term “much stiffer” and “extending into the side portions”. I have discussed these in detail below.
Claim 1 of ‘838
1.Claim 1 of ‘838 is directed to a nasal seal for a patient interface. In addition to the features set out above, the claim defines:
“wherein the side portions each include an outward face portion and an inward face portion and a peripheral edge portion that joins the inward face portion and the outward face portion.”
1.Mr Palkon considered that the wording of this feature was an attempt to identify sub-portions of the side portion, but he could not determine where each of the portions began or ended. On the other hand, Mr Eaton understood the peripheral edge portion to be the point at which the two face portions meet. He referred to the peripheral section of the mask shown in Figure 15 to illustrate this interpretation, and highlighted the exterior portion in red, the face contacting portion in green, and the peripheral portion in blue.
1.I agree with the meaning provided by Mr Eaton. The peripheral portion is a distinct region on the outer edges of the surface which demarcates the inward and outward faces. That is, the arrangement results in three distinct areas or surfaces – one which faces in the direction of the patient (the inward facing portion), one that faces away from the patient (the outwards facing portion), and an intermediate edge portion joining the opposing surfaces. I consider that the skilled person would be able to give this practical meaning.
Claim 1 of ‘840
1.Claim 1 is directed to a patient interface that is characterised by the nasal seal that includes the features set out above, it further defines that:
“an exterior side of the seal including regions much stiffer than the supple interior side, the regions extending into the side portions of the seal,
a mask body assembled to the seal, the mask body formed of a material more rigid than the seal,
and together with the seal forming an enclosure having an inlet opening and a patient outlet opening.”
1.There was no real dispute between the parties that Claim 1 of ‘840 is directed to the patient interface as a whole, which would include the seal and the mask body, but also other components such as the headgear, which would be required by the patient in use. Like ‘838, ‘840 does not define the seal to be inflatable but includes the feature that the seal conforms under internal pressure to the surfaces of the nose. Like ‘628, the seal is defined to include regions made of a much stiffer material than the supple material in the inner face.
2.Claim 1 of ‘840 further includes the definition of the mask body, which includes that the mask is made of a material that is more rigid than the seal. Mr Palkon stated that all masks he was aware of as at 2006 had a mask body that was made of a harder material than the seal, and therefore more rigid. They also had an inlet opening to provide gas to the mask, and an outlet opening for gas to be provided to the patient. I note that Mr Eaton stated, and I understand it to have been conceded by Mr Palkon, that not all patient interfaces contain a mask body and, further, not all mask bodies are formed of a material more rigid than the seal. For example, cannula style interfaces do not necessarily have a mask body/frame arrangement. This does not impact significantly on the interpretation of the claims since they are limited to where a mask body is present.
Claim 1 of ‘842
1.Claim 1 is directed to a nasal seal for a patient interface. In addition to the features set out above, it defines:
“wherein a peripheral portion of the seal joining the face contacting side to the exterior side, is supple and allows the interior side of the seal to displace relative to the exterior side.”
1.Like ‘838, the claim defines a peripheral portion of the seal that joins the face-contacting and exterior sides of the seal. In ’842 the peripheral portion is further characterised by the seal being configured to enable the inner surface to displace relative to the outer face. Mr Eaton stated that the function of the peripheral portion is to decouple the outward and inward face portions and create a rolling bellows configuration within the pressurised part of the seal. This enhances displacement of the supple, interior side of the seal relative to the stiffer, exterior side while ensuring that the interior side does not displace relative to the user’s face. This ensures the mask conforms to the user’s face while maintaining an effective, leak-free seal.
Claim 1 of ‘843
1.Claim 1 is directed to an assembly for a patient interface which comprises a nasal seal having the features set out above. The claim further defines:
“an exterior side of the seal including regions much stiffer than the supple interior side, the regions extending into the side portions of the seal,
the seal includes an extension to go over the user's mouth, and a mask body assembled to the seal, the mask body formed of a material more rigid than the seal, and together with the seal forming an enclosure having an inlet opening and a patient outlet opening.”
1.Similar terms are used to define the invention in ‘843 as discussed above, and a similar construction applies here. The additional feature of ‘843 relates to the further inclusion in the patient interface of an extension to go over the user’s mouth. There was no dispute as to the meaning of the claim in this regard.
Claim 1 of ‘841
1.The claim is directed to a patient interface that comprises an inflatable nasal seal, and is further characterised by:
“a mask body connected to the seal, including a seal engaging portion that engages an exterior side of the seal, a mask body inlet opening and at least two strap engaging portions,
each strap engaging portion extending laterally away from the mask body inlet opening, from opposite sides of the mask body inlet opening”.
1.Notably, Claim 1 is characterised by the inclusion of an inflatable nasal seal, and by side portions that at least extend across a side of the nose. However, ‘841 differs from the other applications in that the claim does not include the feature of the “face contacting side of the seal being supple to conform under internal pressure to the surfaces of the nose of a wearer, including, at the side portions of the seal, to outside surfaces of the sides of the nose”.
2.Besides the terms already discussed above, there was no apparent dispute between the experts as to the meaning of the terms used in Claim 1 of ‘841.
Priority considerations
1.As noted above, the present applications are members of a family of related patents and applications. Present applications ‘838, ‘840, ‘841, ‘842 and ‘843 are divisional applications of ‘628.
2.Another application, 2021240146, is also a divisional of ‘628. Application 2021273595 is a divisional of 2021240146. These two applications are the subject of opposition proceedings but have yet to progress to hearing.
3.Application ‘628 is itself one in a series of divisional applications originating with 2010246985:
Application
Filing date
2019200263
16 January 2019
2017200991
14 February 2017
2016204384
27 June 2016
2015202814
25 May 2015
2010246985
10 May 2010
1.
2.The original application (2010246985) was filed under the Patent Cooperation Treaty (PCT) as application number PCT/IB2010/052061. It claimed priority from two earlier applications: PCT/NZ2009/000072 (‘072) filed on 12 May 2009, and US 61/260590 (‘590) filed on 12 November 2009. Notably ‘072 claims priority from an earlier application, US 60/052362, which was filed on 12 May 2008.
3.The opponent submitted that each of the present applications claims priority by reference to their parent application(s), and therefore rely on regulation 3.13D. The priority of the applications ultimately leads back to 2010246985. As this application was filed on 10 May 2010, the pre-RTB regulations apply. The gist of the opponent’s submissions is that the present applications cannot rely on the basic applications ‘072 and ‘590 for earlier priority since these were not the first applications for the present invention in a convention country. The basic application ‘072 claims priority from an earlier application which was filed more than 12 months before 2010246985. The opponent argued that the consequence is that the present applications cannot claim a priority date earlier than 10 May 2010 (the filing date in Australia of 2010246985).
4.The relevant law that applied at the time the original application was filed (10 May 2010) was set out in subsection 94(1) as follows:
A Convention applicant in relation to a basic application may make a Convention application or 2 or more such applicants may make a joint Convention application, within the prescribed period.
1.The prescribed period was set out in Regulation 8.5(2) as 12 months from the day on which a basic application is first made in a Convention country in respect of the invention. Where an earlier application was made for the invention more than 12 months before the filing date of the Convention application, Section 96(1) provided for that earlier application to be disregarded under certain circumstances:
(1) Where, at the time when a Convention application is made in respect of an invention:
(a) an application has been made for protection in respect of the invention in a Convention country; and
(b) the application has been withdrawn, abandoned or refused without becoming open to public inspection; and
(c) the application has not been used as the basis of claiming a right of priority in a Convention country under a law of that country corresponding to this Part; and
(d) a later application has been made by the same applicant for protection in respect of the invention in the Convention country in which the earlier application was made;
the applicant may ask the Commissioner to disregard the earlier application for the purposes of this Part.
1.Notably, Section 96(1) required that all the conditions set out in (a) to (d) must be met for the applicant to make a request that the earlier application be disregarded. The opponent noted that no request had been made for the earlier application to be disregarded in the present case. The opponent also noted that the earlier application (US 60/052362) had been used as the basis of claiming right of priority for PCT/NZ2009/000072 and therefore would not have met the requirements of section 96(1) in any case.
2.Section 96(1) refers to a Convention application made in respect of an invention, and an (earlier) application made for protection in respect of the invention in a Convention country. Similarly, regulation 8.5(2) refers to the first application in a convention country in respect of the invention. This essentially requires that the invention that is the subject matter of the Convention application is the same invention as that disclosed in the earlier application.
3.The present situation also involves multiple priority documents and, potentially, multiple priority dates. For simplicity I have attempted to condense the relevant considerations into the following general example where multiple applications are filed:
Application 1 Invention A
Application 2 Invention A and Invention B
Application 3 Invention B
1.In this case, application 2 could validly claim priority from Application 1 for invention A, provided that application was made within 12 months of the earlier application.
2.If application 2 disclosed additional subject matter (invention B) to that disclosed in the first earlier application (which only described invention A), then this would be the first application in a convention country for invention B.
3.A subsequent convention application (application 3) could make a valid priority claim for invention B based on the first disclosure of that invention in application 2, provided application 3 was made within 12 months of the date on which application 2 was filed. The key consideration is whether invention B is the same invention as invention A.
4.At the hearing the opponent submitted that the definition of the term “invention” as used in the legislation should be taken to be that set out by the High Court in Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd. Section 40(2), as it existed at the time, required that the complete specification describe the invention fully, as well as end with a claim or claims defining the invention. The Court referred the various meanings given to the term “invention” before stating that the correct meaning for the purposes of section 40(2) was:
“The embodiment which is described, and around which the claims are drawn. This is the sense used in the Act: cf. the phrase of s 32, ‘the invention so far as claimed in any claim.’”
1.Where a claim of a Convention application was fairly based on matter disclosed in a basic document that was lodged more than 12 months before the filing date of the Convention application, the practice under the Pre-RTB Act was that the priority date was taken to be the date of filing of the Convention application. This fair basis consideration required a “real and reasonably clear” disclosure of the invention in the priority document. Under the RTB Act a valid priority claim requires the earlier priority document to disclose the invention in a manner that is clear enough and complete enough for the invention to be performed by the person skilled in the art.
2.The differences in the legislation do not impact on the present consideration since, as detailed below, I do not consider the invention(s) claimed in the present applications were disclosed in the earlier application (whether under RTB or pre-RTB). In making that assessment, the consideration is whether the invention in the later application is the same as the invention disclosed in the earlier application. A key consideration is whether all of the features of the invention claimed in the later application were disclosed in the earlier application.
3.In the broadest sense, the earlier application (US 60/052362) disclosed:
“a patient interface comprising a supple envelope, bag or balloon, with an air supply aperture and a pair of protruding nostril locators protruding from the envelope, each nasal locator including an outlet aperture, the envelope, bag or balloon inflating under internal pressure from a pressurised gases supply and when pressed against the face of a user, creating a seal with the nose or face of the user in addition to any seal provided by the nasal locators.”
1.The earlier application goes on to state that the body of the envelope, in use, forms a substantially continuous seal against the user’s nose and face that surrounds the nostril locators, more specifically, the nose, upper lip and the cheeks. When inflated the envelope is said to have a general blob shape, and is so supple that it does not hold its shape.
2.The figures below illustrate the manner in which the seal body inflates to form the seal with the user’s nose and face. The seal body is said to broadly be shaped to have a sidewall (108) and a seal surface (110). In use, either or both of these press against the user’s face to form a seal that conforms around the nose and surrounds of the nostril locators.
1.The seal is used together with a frame that presses the inflated seal body against the face of the user right out to the periphery of the frame. A nasal ridge of the frame may press the uppermost periphery of the compressed seal against the ridge of the user’s nose, and side peripheral portions of the frame may press the side peripheral portions of the seal body against the lower cheeks of the user.
2.The ‘072 priority document discloses two embodiments. The first embodiment corresponds to the invention described in the earlier application. The second embodiment relates to an alternative seal that the applicant submitted is the crux of the present inventions. In particular, Figures 10 to 12 (which correspond to Figures 10 to 12 of the present applications) depict a seal body which is shaped to wrap around the user’s nose. The seal body is said to have side portions or wings that extend completely over the sides of the user’s nose and may also extend partially over the user’s cheeks. In use the gases inflate the seal body and cause it to press against and about the user’s nose. The nostril locators are caused to seal in or about the user’s nose and the pressurised gases pass through the locators into the user’s nostrils. The application goes on to state that:
“The seal body is made from a flexible material. Examples of possible materials include latex, vinyl, silicone and polyurethane. In a preferred form the seal body’s outer surface is made from a thicker material than the inner surface. In this way the seal body has a better ability to hold a predetermined shape.”
1.It would seem to me that this is the disclosure around which the claims of 201024698 and, in turn, the claims of the present applications are drawn. None of the embodiments described in the earlier application (US 60/052362) comprise a distinct and preformed shape as required by the present claims (as discussed under construction), including the central and side portions of the seal, or of other features such as the stiffer regions in the external side of the mask. While the seal of the earlier application may extend to the ridge of the user’s nose and cheeks, this is the result of the frame pressing on the relatively amorphous balloon seal to force it outwards to the periphery of the frame rather than any preformed shape in the mask.
2.AU 201024698 was filed within 12 months of ‘072, which was the first disclosure of the invention comprising the distinct and preformed shape defined by the present claims (in addition to other characterising features defined in claim 1 of each application). I therefore consider that the present applications are entitled the earliest priority date of 12 May 2009.
Novelty
1.An invention is taken to be novel when compared with the prior art base unless it is not novel in light of certain types of prior art information, each of which must be considered separately. For the purposes of the present consideration, the following kinds of information are relevant:
·Prior art information made publicly available in a single document or through doing a single act;
·Prior art information made publicly available in 2 or more related documents, or through doing 2 or more related acts, if the relationship between the documents or acts is such that a person skilled in the relevant art would treat them as a single source of that information.
1.It is well-established that the general test for anticipation is the reverse infringement test:
“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.”
1.Thus, the test is satisfied if the alleged anticipation discloses all of the essential features of the invention as claimed. Furthermore, as stated by the Full Court in AstraZeneca v Apotex:
“… for a prior art document to be anticipatory, there must be … a clear description of, or clear instructions to do or make, something that would infringe the patentee’s claim if carried out after the grant of the patentee’s patent.”
1.A classic formulation of this principle was given in General Tire v Firestone, which stated that the prior art “must contain clear and unmistakable 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. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee.”
2.The opponent raised a number of citations under the ground of novelty:
D1 US 5,243,971 (Sullivan) published 14 September 1993;
D2 US 2005/0199242 (Matula) published 15 September 2005;
D3 US 5,724,965 (Handke) published 10 March 1998;
D4 US 5,540,233 (Starr) published 30 July 1996.
1.The opponent also relied on certain information made publicly available through the following acts:
U1 Since at least 1996, each public display, sale, offer for sale or use of the Sullivan Bubble Mask;
U2 Since at least 2005, each public display, sale, offer for sale or use of the Respironics ComfortCurve™;
U3 Since at least 2000, each public display, sale, offer for sale or use of the Respironics Monarch Mini.
1.The opponent also relied on the following documents pursuant to the present application having a deferred priority date of 12 November 2009.
D9 US 2009/0120442 (Ho) published 14 May 2009.
1.I have determined that the priority claim of 12 May 2009 is valid. This pre-dates the publication date of D9. I therefore do not consider that D9 is relevant to the ground of novelty (or inventive step) and have not considered this document any further below.
Document D1 (Sullivan)
1.D1, which is also referred to in the evidence as “Sullivan”, discloses nasal masks that are suitable for use with CPAP machines. The nasal masks comprise a membrane which defines a chamber, the membrane being formed from an elastomeric material and the chamber having a thin walled externally convex end region which is arranged in use to be depressed by, and to accommodate, the nose of the wearer.
2.Two different configurations of mask are disclosed. The opponent’s submissions did not specifically refer to the first embodiment, but the opponent confirmed at the hearing that both embodiments were pressed. The first type of mask (Figures 6 and 7 below) uses an inflatable membrane (13) with nipples (41) that are inserted into the nostrils.
1.In use, the mask is connected to the pressurised air supply so that the membrane distends outwardly from the shell. The face contacting portion of the mask is placed in contact with the user’s face and positioned so that the nipples align with the user’s nasal passages. The inflated mask is pushed onto the face which moulds the membrane to the facial contours of the user.
2.I consider I can deal with this particular embodiment fairly briefly, as the consideration goes to the same issues that I have already dealt with separately under construction and priority. In particular, I have construed the claims to define masks in which the central and side portions are pre-formed in the mask body. This is not disclosed by the first embodiment described in D1.
3.The second embodiment disclosed by D1 also comprises a membrane formed from a soft, flexible plastic. Figures 2 and 3 provide front and side views of the mask, while Figure 5 gives a cross section view along the section plane 5-5 indicated in Figure 3. An aperture (39) is formed in the membrane (13). The aperture is shaped to provide an air passage to the user’s nasal passages. The shell body portion (24), to which the air supply, harness and upper head engaging portion (30) are connected, engages with the connector moulding (27) via the shell lip (26) and recess (35). The moulding (27) can be configured to provide support for the membrane (13), or alternatively the moulding may be formed integrally with the membrane. The moulding shown in Figure 5 above is formed separately of the membrane and includes an integral wall (36) which is profiled at (37) to locate around the nasal bridge of the wearer, and at region (38) to fit against the upper lip of the wearer. Mr Palkon took the moulding (27) and flange (34) to be the exterior side of the seal which includes stiffer regions.
1.The mask operates much the same as the first embodiment in that the user’s nose is aligned with the aperture and the mask is moved to contact the user’s face. The aperture is adjacent the air orifices (20). The mask is held in its final position by the headgear as shown in Figure 8C below.
1.Mr Palkon provided a comparison of the features of the claim and what he considered was the corresponding disclosure in the specification. Despite his difficulties in determining the meaning of the terms, he identified a portion of the seal that could be described as central and that extends across the base of the nose, indicated by the orange lines below.
1.Having identified the central portion as shown, Mr Palkon considered that the regions on each side of the central portion could be described as a side portion. He stated that these extend across a side of the nose when positioned on the face of the user and moulded around their nose. The applicant considered this an artificial exercise that ignores the teaching in D1 that the seal does not have a specific shape, unlike the present invention. At the hearing they further submitted that D1 does not provide clear and unmistakable directions to the present invention in that the specific positioning of the mask against the nose cannot be gleaned from the specification or from the figures.
2.To a large extent the consideration here is much the same as for the first embodiment. Mr Palkon has identified a region of the mask that could be considered a central portion, but the side portions are only made to conform to the sides of the nose by the action of pressing the inflated mask against the face, rather than by internal pressure inflation of the seal. Absent such actions, the side portions concave away from the user’s face. I also share the concerns of the applicant regarding whether D1 provides clear and unmistakable directions in relation to the placement of the mask. My understanding is that, in use, the wearer’s nose sits within the aperture and the membrane lies across the area between the upper lip and the base of the nose. This is indicated in Figure 5 above, where the wearer’s upper lip region is pressed against the inner wall at (38). This would result in the user’s nose being positioned further into the body of the mask. In such a configuration, the seal does not consist of a central portion that extends across the base of the nose. Rather the base of the nose lies within the mask body and (presumably) adjacent to the lower wall of the mask shell rather than the face contacting side of the seal.
3.Furthermore, in this position the sides portions of the seal do not appear to extend from the sides of the base of the nose, but rather from the upper lip area and around the nose. But because D1 does not provide specific details as to how the mask is positioned on the user’s face, I am unable to determine with any certainty how the different portions of the Sullivan mask are positioned on the user’s nose.
Application 2021201841 Claims
1. A patient interface comprising:
an inflatable nasal seal including a face contacting side, the seal being formed of a soft flexible material, and including a central portion to extend across the base of the nose, and a side portion extending from each end of the central portion, each side portion extending across a side of the nose,
a mask body connected to the seal, including a seal engaging portion that engages an exterior side of the seal, a mask body inlet opening and at least two strap engaging portions, each strap engaging portion extending laterally away from the mask body inlet opening, from opposite sides of the mask body inlet opening.
2. The patient interface according to claim 1, wherein the central portion of the mask body defines a convex shape generally matching a convex shape of an outwardly facing wall of the seal.
3. The patient interface according to claim 2, wherein the strap engaging portions extend away from the central portion at an angle outwardly aligned relative to the general convex shape.
4. The patient interface according to any one of claims 1 to 3, wherein the strap engaging portions diverge from an outwardly facing wall of the seal.
5. The patient interface according to claim 4, wherein the strap engaging portions diverge at an angle of between 300 and 80°
6. The patient interface according to any one of claims 1 to 5, wherein the strap engaging portions extend beyond the extreme width of the seal.
7. The patient interface according to claim 6, wherein the strap engaging portions have a distance from the extreme width of the seal to a tip of the strap engaging portion between 10mm and 35mm.
8. The patient interface according to any one of claims 1 to 7, wherein a loop strap extends from the strap engaging portion to secure the interface to the patient.
9. The patient interface according to claim 8, wherein the strap is a hollow elongated tube or a solid elongated tube.
10. The patient interface according to any one of claims 1 to 9, wherein an overall plan form of the seal is parabolic, half elliptical, half oval or U-shaped.
11. The patient interface according to any one of claims 1 to 10, wherein the seal curves about and does not extend over a region of the user's nasal bridge.
12. The patient interface according to any one of claims 1 to 11, wherein the side portions extend completely over the sides of the user's nose.
13. The patient interface according to any one of claims 1 to 12, wherein the side portions extend at least partially over the user's cheeks.
14. The patient interface according to any one of claims 1 to 13, wherein the seal includes an extension to go over the user's mouth.
15. The patient interface according to claim 14, wherein the extension includes an outlet directed to the user's mouth.
16. The patient interface according to any one of claims 1 to 15, wherein the central portion of the seal defines a width of the seal, with the side portions of the seal extending away from lateral ends of the central portion.
17. The patient interface according to any one of claims 1 to 16, wherein the side portions of the seal are substantially parallel to each other and substantially normal to the central portion of the seal.
18. The patient interface according to any one of claims 1 to 17, wherein the mask body is formed of a material more rigid than the seal.
19. The patient interface according to any one of claims 1 to 18, wherein the seal is permanently attached to the mask body.
20. The patient interface according to any one of claims 1 to 19, wherein the seal is permanently attached to the mask body by overmoulding or bonding.
Application 2021201842 Claims
1. A nasal seal for a patient interface:
the seal including a face contacting side and an exterior side, the seal being formed of a soft flexible material, and including a central portion to extend across the base of the nose, and a side portion extending from each end of the central portion, each side portion extending across a side of the nose,
the face contacting side of the seal being supple to conform under internal pressure to the surfaces of the nose of a wearer, including at the side portions of the seal, to outside surfaces of the sides of the nose,
wherein a peripheral portion of the seal, joining the face contacting side to the exterior side, is supple and allows the interior side of the seal to displace relative to the exterior side.
2. The nasal seal according to claim 1, wherein the seal is inflatable.
3. The nasal seal according to claim 1 or 2, wherein the supple portions of the seal comprise a silicone material with a thickness between 0.05mm and 0.5mm.
4. The nasal seal according to claim 1 or 2, wherein the supple portions of the seal comprise an elastomer with a thickness between 0.1mm and 0.2mm.
5. The nasal seal according to any one of claims 1 to 4, wherein the exterior side of the seal includes regions much stiffer than the supple interior side, the regions extending into the side portions of the seal.
6. The nasal seal according to claim 5, wherein the regions much stiffer than the supple interior side are formed of thicker material than the face contacting side.
7. The nasal seal according to claim 5 or 6, wherein the regions much stiffer than the supple interior side of the seal comprise a silicone material with a thickness between 2mm and 5mm.
8. The nasal seal according to claim 5 or 6, wherein the regions much stiffer than the supple interior side of the seal comprise an elastomer with a thickness between 2mm and 3mm.
9. The nasal seal according to any one of claims 5 to 8, wherein the regions much stiffer than the supple interior side resist outward flexing of the side portions of the seal when the seal is inflated under pressure.
10. The nasal seal according to any one of claims 5 to 9, wherein the regions much stiffer than the supple interior side include a composite material or combination of parts.
11. The nasal seal according to any one of claims 5 to 10, wherein the regions much stiffer than the supple interior side include a reinforcement or a flexible insert of stiff material.
12. The nasal seal according to claim 11, wherein the insert of stiff material is integrated to a mask body.
13. The nasal seal according to any one of claims 1 to 12, wherein the side portions provide resistance to flexing with an effective stiffness of at least 1N force at the end of the regions much stiffer than the supple interior side to flex the side portion through an angle of about 60°.
14. The nasal seal according to any one of claims 1 to 13, wherein the exterior side includes regions having a stiffness corresponding to a silicone material with a thickness between 2mm and 5mm and a Shore A hardness of 40, the regions extending into the side portions of the seal.
15. The nasal seal according to any one of claims 1 to 14, wherein the exterior side of the central portion of the seal includes an opening for passing gases to and from the interior of the seal.
16. The nasal seal according to claim 15, wherein the opening is configured to be fitted to a mask body, or directly to a conduit extending through a mask body.
17. The nasal seal according to claim 15 or 16, wherein the opening includes lips and/or channels to engage with channels and/or lips on the mask body.
18. The nasal seal according to claim 15 or 16, wherein the opening is formed with clip portions, or clip portions are attached to or over-moulded to a perimeter of the opening to facilitate engagement with the mask body.
19. The nasal seal according to any one of claims 15 to 18, wherein the central portion extends above and below the opening, the central portion including regions above and below the opening that are thin and supple.
20. The nasal seal according to any one of claims 15 to 19, wherein above the opening, the central portion includes an outer-facing wall, an inward-facing wall and a perimeter portion, wherein at least the inward-facing wall and the perimeter portion are thin and supple.
21. The nasal seal according to any one of claims 15 to 20, wherein below the opening, the central portion includes an outer wall portion, an inner wall portion and a peripheral portion, wherein at least the inner wall portion and the peripheral portion are thin and supple.
22. The nasal seal according to any one of claims 1 to 21, wherein the side portions of the seal are substantially parallel to each other and substantially normal to the central portion of the seal.
23. The nasal seal according to any one of claims 1 to 22, wherein an overall plan form of the seal is parabolic, half elliptical, half oval or U-shaped.
24. The nasal seal according to any one of claims 1 to 23, wherein the seal curves about and does not extend over the region of the user's nasal bridge.
25. The nasal seal according to any one of claims 1 to 24, wherein the seal has an overall width from outside surface of one side portion to outside surface of the other side portion of between 30mm and 60mm.
26. The nasal seal according to any one of claims 1 to 25, wherein the seal has an overall depth, from the outer surface of the central portion to a line joining the extreme ends of each side portion, between 40mm and 65mm.
27. The nasal seal according to any one of claims 1 to 26 including an extension to go over the user's mouth.
28. The nasal seal according to claim 27, wherein the extension includes an outlet directed to the user's mouth.
29. A patient interface comprising the nasal seal according to any one of claims 1 to 28.
30. The patient interface according to claim 29 including a mask body assembled to the seal, the body being formed of a material more rigid than the seal, and together with the seal forming an enclosure having an inlet opening and a patient outlet opening.
31. The patient interface according to claim 30 further including a swivelling elbow connected to the inlet opening.
32. An assembly comprising the nasal seal according to any one of claims 1 to 28 supported by a mask body, the mask body being formed of a material more rigid than the nasal seal.
33. The assembly according to claim 32, wherein the mask body together with the seal forms an enclosure having an inlet opening and a patient outlet opening.
34. The assembly according to claim 32 or 33, wherein the seal is permanently attached to the mask body.
35. The assembly according to claim 34, wherein the seal is attached by overmoulding or bonding.
Application 2021201843 Claims
1. An assembly for a patient interface, the assembly comprising:
a nasal seal including a face contacting side, the seal being formed of a soft flexible material, and including a central portion to extend across the base of the nose, and a side portion extending from each end of the central portion, each side portion extending across a side of the nose,
the face contacting side of the seal being supple to conform under internal pressure to the surfaces of the nose of a wearer, including, at the side portions of the seal, to outside surfaces of the sides of the nose,
an exterior side of the seal including regions much stiffer than the supple interior side, the regions extending into the side portions of the seal,
the seal includes an extension to go over the user's mouth, and
a mask body assembled to the seal, the mask body formed of a material more rigid than the seal,
and together with the seal forming an enclosure having an inlet opening and a patient outlet opening.
2. The assembly according to claim 1, wherein the seal is inflatable.
3. The assembly according to claim 1 or 2, wherein the extension includes an outlet directed to the user's mouth.
4. The assembly according to any one of claims 1 to 3, wherein the seal is permanently attached to the mask body.
5. The assembly according to claim 4, wherein the seal is attached by overmoulding or bonding.
6. The assembly according to any one of claims 1 to 5, wherein the seal includes overmoulded or bonded rigid plastic barbs configured to clip into correspondingly shaped recesses formed in the mask body and hold the nasal seal in sealing engagement with the mask body.
7. The assembly according to any one of claims 1 to 5, wherein the seal has a periphery that is formed with an overmoulded or bonded rigid plastic looped clip configured to clip to the mask body.
8. The assembly according to any one of claims 1 to 5, wherein the mask body includes a nasal seal engaging portion that engages the exterior side of the seal.
9. The assembly according to any one of claims 1 to 8, wherein the seal comprises an opening and the mask body comprises a seal opening for engaging with the opening of the seal.
10. The assembly according to claim 9, wherein the opening of the seal is in an outwardly facing wall of the central portion of the seal.
11. The assembly according to claim 10, wherein the opening of the seal includes features to engage with complementary features on the mask body.
12. The assembly according to claim 11, wherein the feature on the opening of the seal are lips and/or channels and the complementary features on the mask body are channels and/or lips.
13. The assembly according to any one of claims 1 to 12, wherein the regions much stiffer than the supple interior side include a reinforcement or a flexible insert of stiff material.
14. The assembly according to claim 13, wherein the insert of stiff material is integrated to the mask body.
15. The assembly according to any one of claims 1 to 14, wherein an opening of the seal is commensurate with the extent of the mask body, this extent being commensurate with the general width of the assembly and approximately with the width of the nose of the intended wearer.
16. The assembly according to any one of claims 1 to 15, wherein a region adjacent and including an opening of the seal is much stiffer than the rest of the seal.
17. The assembly according to any one of claims 1 to 16, wherein a region adjacent and including an opening of the seal is formed thicker in the same material than the rest of the seal.
18. The assembly according to any one of claims 1 to 17, wherein a region adjacent and including an opening of the seal is formed of a stiffer material than the rest of the seal.
19. The assembly according to any one of claims 1 to 18, wherein the central portion extends above and below an opening, the central portion including regions above and below the opening that are thin and supple.
20. The assembly according to any one of claims 1 to 19, wherein above an opening, the central portion includes an outer-facing wall, an inward-facing wall and a perimeter portion, wherein at least the inward-facing wall and the perimeter portion are thin and supple.
21. The assembly according to any one of claims 1 to 20, wherein below an opening, the central portion includes an outer wall portion, an inner wall portion and a peripheral portion, wherein at least the inner wall portion and the peripheral portion are thin and supple.
22. The assembly according to any one of claims 1 to 21, wherein the side portions each include an outward face portion and an inward face portion and a peripheral edge portion that joins the inward face portion and the outward face portion.
23. The assembly according to claim 22, wherein the peripheral edge portions of the seal allow the mask body to displace both laterally and vertically relative to axes of the patient's face.
24. The assembly according to any one of claims 1 to 23, wherein the mask body includes at least one strap engaging portion for engaging a loop strap to secure the interface to the patient.
25. The assembly according to claim 24, wherein the central portion of the mask body defines a convex shape generally matching a convex shape of an outwardly facing wall of the seal, with the strap engaging portion extending from a lateral extreme of the central portion, the strap engaging portion extending away from the central portion at an angle outwardly aligned relative to the general convex shape.
26. The assembly according to claim 24 or 25, including at least two strap engaging portions, wherein each strap engaging portion extends laterally away from the inlet opening, from opposite sides of the inlet opening.
27. The assembly according to any one of claims 24 to 26, wherein the strap engaging portion extends away from the exterior side of the seal with an included angle between the strap engaging portion and the exterior side greater than 30°.
28. The assembly according to any one of claims 24 to 27, wherein the strap engaging portion extends beyond the extreme width of the seal.
29. The assembly according to claim 28, wherein the distance from an extreme width of the seal to a tip of the strap engaging portion is between 10mm and 35mm.
30. The assembly according to any one of claims 1 to 29, wherein the mask body includes a socket for connecting with a supply conduit.
31. The assembly according to any one of claims 1 to 30, wherein the mask body is made from a plastics material.
32. The assembly according to claim 31, wherein the mask body is made from polycarbonate or silicone
33. The assembly according to any one of claims 1 to 32, wherein the mask body includes small apertures as part of a gas washout vent.
34. The assembly according to any one of claims 1 to 33, wherein the regions much stiffer than the supple interior side as well as the supple interior side comprise a silicone material, and/or comprise a neoprene material.
35. The assembly according to any one of claims 1 to 34, wherein the regions much stiffer than the supple interior side and the supple interior side are formed in the same material.
36. The assembly according to any one of claims 1 to 35, wherein the regions much stiffer than the supple interior side are formed thicker in the same material as the rest of the seal.
37. The assembly according to claim 36, wherein the regions much stiffer than the supple interior side taper in thickness to reach the thickness of the interior side.
38. The assembly according to any one of claims 1 to 5, wherein the seal comprises an opening in an outwardly facing wall of the central portion of the seal including features to engage with complementary features on the mask body, and the mask body comprises a seal opening for engaging with the opening of the seal, wherein the feature on the opening of the seal are lips and/or channels and the complementary features on the mask body are channels and/or lips, and wherein below the opening, the central portion includes an outer wall portion, an inner wall portion and a peripheral portion, at least the inner wall portion and the peripheral portion being thin and supple.
39. The assembly according to any one of claims 1 to 5, wherein the seal comprises an opening in an outwardly facing wall of the central portion of the seal including features to engage with complementary features on the mask body, and the mask body comprises a seal opening for engaging with the opening of the seal, wherein the feature on the opening of the seal are lips and/or channels and the complementary features on the mask body are channels and/or lips, and wherein the regions much stiffer than the supple interior side are formed thicker in the same material as the rest of the seal and taper in thickness to reach the thickness of the interior side.
40. The assembly according to any one of claims 1 to 5, wherein the seal comprises an opening in an outwardly facing wall of the central portion of the seal including features to engage with complementary features on the mask body, and the mask body comprises a seal opening for engaging with the opening of the seal, wherein the feature on the opening of the seal are lips and/or channels and the complementary features on the mask body are channels and/or lips, wherein below the opening, the central portion includes an outer wall portion, an inner wall portion and a peripheral portion, at least the inner wall portion and the peripheral portion being thin and supple, and wherein the regions much stiffer than the supple interior side are formed thicker in the same material as the rest of the seal and taper in thickness to reach the thickness of the interior side.
41. A patient interface comprising the assembly according to any one of claims 1 to 40, and a strap extending from the assembly in a loop, the strap departing a first portion of the assembly at one end and a second portion of the assembly at its other end.
42. The patient interface according to claim 41, wherein the strap has a stiffness less than 2N per 100mm extension from a relaxed condition.
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