Nose Dive – ResMed’s Opposition Gets a Rude Awakening

ResMed Pty Ltd v Fisher & Paykel Healthcare Limited [2024] APO 30

Background

In a recent decision of the Australian Patent Office, Delegate McCaffery has ruled on opposition proceedings between ResMed Pty Ltd (ResMed) and Fisher & Paykel Healthcare Limited (Fisher & Paykel).  The proceedings concerned six patent applications relating to patient interfaces for delivering breathing gases, with specific focus on nasal seals for continuous positive airway pressure (CPAP) therapy:

• AU2020223628 (‘628)
• AU2021201838 (‘838)
• AU2021201840 (‘840)
• AU2021201841 (‘841)
• AU2021201842 (‘842)
• AU2021201843 (‘843)

Each application claimed an inflatable nasal seal with a soft, flexible central portion and stiffer side portions conforming to the nose under pressure, including nasal locators with varying stiffness to ensure proper fit and seal. 

ResMed challenged the validity of these applications on multiple grounds, such as novelty, inventive step, clarity, support, succinctness, utility and manner of manufacture.  ResMed failed on all grounds of invalidity it raised.  However, in exercising his discretion under section 60(3) of the Patents Act 1990 to consider additional grounds of invalidity, the Delegate found the ‘841 patent’s claims invalid for lack of support.

Key Issues:

The key issues included:

Novelty

ResMed raised several prior art citations on novelty: four US patents, as well as public use information regarding the Sullivan Bubble Mask, the Respironics ComfortCurve™, and the Respironics Monarch Mini. In all cases, the Delegate found that the prior art did not anticipate the claims, noting:

• the lack of “clear and unmistakable directions” in respect of the US patents; and
• the lack of clear evidence that users, at the relevant time, fitted the prior use masks in a manner that took all the essential features of the claims in issue.

Inventive Step

ResMed presented two main arguments on inventive step based on common general knowledge (CGK) alone:

1. The applications failed to disclose useful advances over prior art, solutions to particular problems, or overcoming any difficulty.

2. Absent a specific problem, the invention merely related to an alternative nasal mask for CPAP therapy, with the claims’ features being “well known” or routine variations.

Ultimately, the Delegate was satisfied that the combination of features in the claims was not obvious in light of the CGK alone.  The Delegate highlighted that the invention’s configuration, where side portions seal against the outer surfaces of the sides of the nose to support and stabilize the seal, was not CGK.  The evidence suggested such designs were typically avoided due to potential discomfort, and demonstrated a focus on low-profile masks that sit below the user’s nose.

ResMed also argued obviousness on the basis of CGK taken together with individual prior art masks. ResMed argued that each prior art mask was an example of a useful inflatable mask, and any differences between each prior art mask and the claimed mask were routine variations.  ResMed did not support its position with any evidence. The Delegate rejected ResMed’s arguments, describing ResMed’s submissions as “boilerplate submissions” which were “so vague as to preclude any identification of the case to be answered.”

Clarity

The Delegate dismissed ResMed’s submissions that several terms in the claims lacked clarity.  The Delegate was satisfied that:

• a skilled person could give terms, such as “side portions” and “central portions”, practical meaning, including where users have varying facial geometry;
• terms like “outer-wall”, “inward-facing wall” and “perimeter portion/peripheral portion” were clear when read in context as referring to the structure forming the inflatable seal; and
• terms like “top edge”, “end edge” and “lower edge” were clear in the context of the mask’s structure.

ResMed argued that terms like “substantially parallel” and “substantially normal” lacked a practical benchmark. The Delegate disagreed, finding that the specification provided sufficient context for proper interpretation.  The term “much stiffer” was challenged as being unclear, but the Delegate agreed with expert evidence that a skilled person would understand this to mean the material is sufficiently stiff to achieve the desired structural purposes.

Support

ResMed argued that the specification did not disclose an invention at all or identify the relevant technical contribution; and that, to the extent that the embodiments disclosed some technical contribution, then the claims were broader than those embodiments.  The Delegate dismissed these arguments, noting that ResMed’s submissions did not engage with key considerations relevant to the ground of support and that there was no requirement for the specification to explicitly state the technical contribution.  A key deficiency of ResMed’s case was that its expert was unable to determine what the invention actually was; so the Delegate considered that it followed that this expert would not be in a position to provide a definitive opinion on where the technical contribution lay.

The Delegate identified the technical contribution as a nasal seal with specific features, including a face-contacting side made of soft flexible material, a central portion extending across the nose base, and side portions extending from each end to cover the sides of the nose.  The seal’s face-contacting side was described as supple, conforming to the nose’s surfaces under internal pressure. Exercising his discretion under s 60(3) of the Patents Act 1990 to consider additional grounds of invalidity, the Delegate noted that the ‘841 patent’s claims did not include all these features and thus exceeded the technical contribution.  Fisher & Paykel conceded this point, indicating its intention to amend the ‘841 patent after the opposition decision was delivered.

Remaining grounds of opposition and finding

The Delegate quickly addressed the remaining grounds of opposition: succinctness, utility, and manner of manufacture.  On succinctness, ResMed’s argument regarding the “extraordinary” number of claims across the patent family was rejected, as each application had only a single independent claim and was not “unduly prolix” according to the Delegate.  On utility, the Delegate agreed with Fisher & Paykel that the patents provided a useful choice by offering an alternative CPAP interface with an inflatable nasal seal design.  On manner of manufacture, the Delegate found the mask’s features had a working interrelationship and were not a mere collocation of parts.

Outcome

ResMed’s opposition was entirely unsuccessful, with ResMed failing on all the grounds of invalidity it raised. The only successful ground (support) was one raised by the Delegate exercising his s 60(3) discretion. Accordingly, the Delegate directed all applications (except ‘841) to proceed to grant.  The ‘841 claims were found to be unsupported as they lacked the feature of a supple material conforming to the surface of the user’s nose.  Fisher & Paykel was given two months to propose amendments to ‘841’s claims to address this issue.

Implications

This decision emphasises the critical importance of expert evidence in opposition proceedings, as well as the power of the discretion given to the Commissioner and his delegates under s 60(3) of the Patents Act 1990 to consider additional grounds of invalidity.  In this case, ResMed’s evidence and arguments fell short in key respects, leading to ResMed failing on all the grounds of invalidity it raised.  The only successful ground (support) was one raised by the Delegate exercising his s 60(3) discretion.

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