Added matter
Added matter
The device claimed has ‘one or more side arms’ (integer 2). So far I have discussed only what could be viewed as the principal side arm, that which is connected to the negative air pressure system via the collection container. This is integer 9:
‘… optionally, an accessory side arm (60) emanating from the outer surface (34) of said sheath (20);’
The function of the optional accessory side arm is to provide additional irrigation, or the passage of a guide wire or any other device that may be needed during the removal of stone fragments or other foreign bodies, or as an additional channel for the removal of foreign bodies.
CJ Medical’s argument on added matter at the trial (others were not pursued) was that whereas in the parent PCT Application (WO 2016/018479 A1) the accessory side arm is only disclosed as emanating from a proximal sheath, claim 1 discloses that the accessory side arm emanates from the sheath, not necessarily the proximal sheath. Put another way, the additional matter said to be disclosed in the Patent is that the additional side arm may also emanate from the distal sheath.
CJ Medical did not submit that the Patent expressly states anywhere that the additional side arm may emanate from the distal sheath. Whenever any part of the sheath is specified in the description it is the proximal sheath, e.g. in paragraphs [0023] and [0027].
The figures of the Patent which include a depiction of the accessory side arm show it only emanating from the proximal sheath.
In their written closing submissions CJ Medical acknowledged that the skilled person reading the Patent would have understood that the additional side arm must emanate from the proximal sheath because of the functions it may perform:
‘The Skilled Person would therefore understand that the accessory side arm is a functionally distinct sub-class of the more general “one or more side arms” disclosed on page 2 of the Patent, and that the requirement that it emanates from a proximal sheath is necessary for it to perform these functions.’
This assertion was not made by reference to anything the experts said. The experts seem not to have directly addressed the point at all. However, for the reasons I have given I think that CJ Medical is right about how the skilled person would have addressed the matter.
I find that the skilled person reading the Patent would have understood that the additional side arm must emanate from the proximal sheath. The objection of added matter fails.
- Heading
- Judge Hacon
- The skilled person
- The expert witnesses
- Technical Background
- The Patent
- The claims
- Construction
- Claim 3 – a flexible, deflectable tip
- The prior art
- Soble and Russo
- The law on inventive step
- Inventive step over Soble
- Differences between claim 1 and Soble
- Sleeve v sheath
- No obturator in Soble
- A clamp in Soble instead of a flexible cap
- Conclusion on Soble and inventive step
- Wan
- Piercing stylus, obturator and trocar
- Inventive step of claim 1 over Wan
- Inventive step of claim 3 over Wan
- Added matter
- Method of treatment or diagnosis
- Infringement
- Normal construction
- Sizes 10-13 as equivalents
- Conclusions
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