Cutter (Canada) Ltd. v.
The Baxter patent claims called for a cannula (tube) to puncture a membrane and allow fluid passage between the two sections of the blood bag.
1. In parenteral fluid administration equipment a donor tube having needle means at one end and communicating with a flexible, collapsible, hemo-repellant blood container at the other end, a length of resilient tubing connecting said container to a second flexible, collapsible container to form a unitary system, a removable, transverse membrane positively closing said connecting tubing to the flow of fluid between said containers and a free moving membrane-removing, hollow cannula located wholly within said tubing, the cannula being completely unattached to said tubing and any part of said system, said cannula being proportioned to readily fit in and move within said tubing so that the cannula can be externally manipulated to remove said membrane without opening said tubing, said cannula being further manipulatable substantially out of said tubing into one of said containers.
2. In a multi-container closed system for handling blood comprising at least two flexible, collapsible, hemo-repellant sterile blood containers joined together by lengths of resilient connecting tubing, an improved removable closing means for controlling flow between said containers which means provides initially for a complete and positive obstruction to flow through said tubing and between said containers, and upon removal for a substantially and unobstructed flow through said tubing, said means comprising a removable transverse membrane barrier positively closing said connecting tubing to flow and a free moving membrane piercing cannula proportioned to fit in and freely move within said tubing, said cannula being completely unattached to said tubing and any part of said system so that it can be manipulated from outside said tubing to substantially remove said membrane and then may be further manipulated substantially out of said tubing into one of said containers so that flow through said tubing is substantially unobstructed and non-turbulent.
3. In a multi-container system for the conditioning and handling of blood comprised of at least two flexible, collapsible, hemo-repellant sterile blood containers, each having a blood inlet and an outlet, a length of resilient tubing connecting said flexible containers, a transverse membrane positively closing said tubing to flow and preventing flow between the containers joined by said tubing and a free moving membrane removing member located wholly within said tubing, said membrane removing member being completely unattached to said tubing and being so proportioned as to fit in and move freely within said tubing so that it can be externally manipulated without opening said tubing to remove said membrane and may further be manipulated substantially out of said tubing into one of said containers so that flow through said tubing and between said containers is substantially unobstructed and non-turbulent.
4. In a multi-container closed system for the storage and handling of blood, which system comprises at least two flexible, collapsible hemo-repellant containers joined together by a length of resilient connecting tubing, at least one of said containers containing a substance which it is desired to isolate in said container, an improved means for preventing flow through said tubing and among said containers, and isolating said substance in said container, the improved means of preventing flow providing for positive closing of said tubing to flow, and comprising a removable transverse membrane completely closing said connecting tubing to fluid flow and a free moving, membrane piercing hollow cannula located wholly within said tubing, the cannula being completely unattached to said tubing and any part of said system, said cannula being proportioned to readily fit in and freely move within said tubing so that the cannula can be externally manipulated from without said system to substantially remove said membrane as an obstacle to fluid flow without opening said closed system and thus allow for the introduction into another container of the system of the previously isolated substance.
The Cutter device had a spike that punctured the membrane.
"The law with respect to the inventive ingenuity required to sustain a patent is discussed at some length in the judgment of Pigeon J., in Farbwerke Hoechst Aktiengesellschaft vormals Meister Lucius & Bruning v. Halocarbon (Ontario) Ltd. et al (1979) 42 C.P.R. (2d) 145, 104 D.L.R. (3d) 5,  2 S.C.R. 929 at p. 943. In the course of the discussion the learned judge said at pp. 156-7 C.P.R., pp. 944-46 S.C.R.:
In my view, the true doctrine was clearly stated by the Privy Council in Pope Appliance Corp. v. Spanish River Pulp & Paper Mills, Ltd.  1 D.L.R. 209,  A.C. 269, where Viscount Dunedin said (at pp. 280-1):
"After all, what is invention? It is finding out something which has not been found out by other people. This Pope in the present patent did. He found out that the paper would so stick, and the practical problem was solved. The learned judges below say that all this might have been done by any one who experimented with "doctors" and air blasts already known. That is that some one else might have hit upon the invention. There are many instances in various branches of science of independent investigators making the same discovery. That does not prevent the one who first applies and gets a patent from having a good patent."
The same result will be obtained by putting, as the trial Judge did (at p. 113 C.P.R., p. 274 F.C.), the "Cripps question" as to which Viscount Simon said in Martin and Biro Swan Ltd. v. H. Millwood Ltd.,  R.P.C. 125 at pp. 133-4):
"Your Lordships at least have the opportunity of affirming that the law on this matter is as stated by Jenkins, L.J., in Allmanna Svenska Elektriska A/B v. Burnstisland Ship Building Coy. Ltd. (1952) 69 R.P.C. 63, and that the proper question to ask is that which was formulated by Sir Stafford Cripps as counsel in Sharpe & Dohme Inc. v. Boots Pure Drug Coy. Ld. (1928) 45 R.P.C. 153 at p. 163:
"Was it obvious to any skilled chemist in the state of chemical knowledge existing at the date of the patent that he could manufacture valuable therapeutic agents by making the higher resorcinols by the use of the condensation and reduction processes described. If the answer is "No" the patent is valid, if "Yes" the patent is invalid."
"In applying these principles it is necessary to bear in mind that the issue of obviousness is one of fact and that as the patent is prima facie valid it was for the appellant to satisfy the court both at the trial and on the appeal that the alleged invention was obvious, that having regard to the prior art inventive ingenuity had not been necessary to conceive it. It should also be remembered that it is established by the evidence that the patented device represents a significant advance in the art and that it has had very substantial acceptance in the market and has been commercially successful. That indicates, if nothing more, that it is a practical device, something which could not be said for some of the patented items in the prior art. Was there then a need for inventive ingenuity to conceive it or was a mere workshop effort required. I find myself in agreement with the conclusion of the learned trial judge.
"It seems to me to be plain that the Cutter spike is, as found by the learned trial judge, the functional equivalent of the cannula referred to in claims 1, 2 and 4. Both are operated by the technician in the same way. Both rupture the membrane and establish a channel or channels through which blood or its components or anticoagulants can flow. Both do it in the same way. The evidence shows that the cannula ruptures the membrane by causing a transverse slit which permits the blood to flow around the outside wall of the cannula as well as through its lumen.
Moreover, both devices are in the tube and are unattached.
Further, in my view, the precise structure or configuration of the device to be used to rupture the membrane and establish a flow channel is not an essential element of the invention. As I see it, it would not matter whether a cannula or a vaned spike or a device of some other sort, such as, for example, a device of the like proportions with a semicircular cross section, were used or whether it would cut out in whole or in part or merely rupture the membrane. The substance of the invention, its "pith and marrow", would be taken so long as the rupturing device had the essential elements of being in the tube and being unattached. I think therefore that the substance of the invention has been taken and that all the claims of the patent were infringed by the Cutter device."