Gambro Pty Ltd v Fresenius Medical Care South East Asia Pty Ltd
[2004] FCA 323
•25 MARCH 2004
FEDERAL COURT OF AUSTRALIA
Gambro Pty Limited v Fresenius Medical Care Australia Pty Limited
[2004] FCA 323INTELLECTUAL PROPERTY – PATENTS – patent for a system for the preparation of fluid intended for medical procedures such as haemodialysis – respondent found to have infringed the patent in suit – cross claim – whether lack of novelty, lack of utility, lack of sufficiency of description, lack of fair basing and obviousness.
Patents Act 1952 (Cth)
Patents Act 1990 (Cth)Abbott Laboratories v Corbridge Group Pty Ltd [2000] FCA 1713, referred to
Abbott Laboratories v Corbridge Group Pty Ltd [2002] FCAFC 314; [2002] AIPC 91-824, referred to
Aktiebolaget Hässle v Alphapharm Pty Limited [2002] HCA 59; 194 ALR 485, referred to
Allsop Inc v Bintang Ltd (1989) 15 IPR 686, cited
Bartlem Pty Ltd v Cox Industries (Australia) Pty Ltd [2002] FCAFC 224; 55 IPR 449, cited
Bristol-Myers Squibb Company v FH Faulding & Co Ltd (2000) 46 IPR 553, cited
British United Shoe Machinery Company Ltd v A Fussell & Sons Ltd (1908) 25 RPC 631, referred to
Chiron Corporation v Organon Teknika Limited [1994] FSR 202, cited
Clark v Adie (1875) 10 Ch App 667, referred to
Codex Corporation v Racal-Milgo Ltd [1983] RPC 369, cited
Commonwealth Industrial Gases Limited v MWA Holdings Pty Limited (1970) 180 CLR 160, cited
Decor Corporation Pty Ltd v Dart Industries Inc (1988) 13 IPR 385, referred to
Eastern Counties and the London and Blackwall Railway Companies v Marriage (1860) 9 HLC 32; 11 ER 639, cited
Flexible Steel Lacing Company v Beltreco Ltd [2000] FCA 890; 49 IPR 331, referred to
General Clutch Corporation v Sbriggs Pty Ltd (1997) 38 IPR 359, discussed
General Tire & Rubber Company v Firestone Tyre & Rubber Company Limited [1972] RPC 457, cited
Graham Hart (1971) Proprietary Limited v SW Hart & Company Proprietary Limited (1976) 141 CLR 305, cited
Hill v Evans (1862) 31 LJ Ch 457; 4De G F & J 288; 45 ER 1195, cited
HPM Industries Proprietary Limited v Gerard Industries Ltd (1957) 98 CLR 424, cited
ICI Chemicals & Polymers Ltd v Lubrizol Corporation Inc (2000) 49 IPR 513, cited
Interlego AG v Toltoys Proprietary Limited (1973) 130 CLR 461, cited
Kimberly–Clark Australia Pty Limited v Arico Trading International Pty Limited [2001] HCA 8; 207 CLR 1, cited
Meyers Taylor Pty Ltd v Vicarr Industries Limited (1976) 137 CLR 228, discussed
Minnesota Mining & Manufacturing Company v Beiersdorf (Australia) Limited (1979) 144 CLR 253, discussed
Minnesota Mining and Manufacturing Co v Tyco Electronics Pty Ltd [2002] FCAFC 315; (2002) 56 IPR 248, cited
N Guthridge Limited v Wilfley Ore Concentrator Syndicate Limited (1906) 3 CLR 583, citedNational Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252, followed
Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513, cited
Olin Corporation v Super Cartridge Co Pty Ltd (1976) 180 CLR 236, referred to
Populin v HB Nominees Pty Ltd (1981) 59 FLR 37, referred to
Radiation Limited v Galliers and Klaerr Proprietary Limited (1938) 60 CLR 36, referred to
RD Werner & Co Inc v Bailey Aluminium Products Pty Ltd (1989) 25 FCR 565, referred to
Rehm Pty Ltd v Websters Security Systems (International) Pty Ltd (1988) 81 ALR 79, referred to
Rhone-Poulenc Agrochimie SA v UIM Chemical Services Pty Ltd (1986) 12 FCR 477, cited
Sabre Corporation Pty Ltd v Russ Kalvin’s Hair Care Company (1993) 46 FCR 428, discussed
Sunbeam Corporation v Morphy-Richards (Australia) Pty Ltd (1961) 180 CLR 98, referred to
C. Van der Lely NV v Bamfords Limited [1963] RPC 61, cited
Walker v Alemite Corporation (1933) 49 CLR 643, referred to
Welch Perrin & Co Pty Ltd v Worrel Company Proprietary Limited (1960) 106 CLR 588, referred to.
Wellcome Foundation v VR Laboratories (Aust) Proprietary Limited (1980) 148 CLR 262, cited
Woolworths Ltd v WB Davis and Son Ltd Inc (1942) 16 ALJ 57, citedA Selection of Broom’s Legal Maxims (10th Ed 1939) pp 461-62
Blanco White Patents for Inventions (4th Ed)
Blanco White Patents for Inventions (5th Ed)GAMBRO PTY LIMITED AND ANOR v FRESENIUS MEDICAL CARE AUSTRALIA PTY LIMITED
NG 474 of 1997ALLSOP J
25 MARCH 2004
SYDNEY
IN THE FEDERAL COURT OF AUSTRALIA
NEW SOUTH WALES DISTRICT REGISTRY
NG 474 of 1997
BETWEEN:
GAMBRO PTY LIMITED
FIRST APPLICANT
SECOND CROSS-RESPONDENTGAMBRO LUNDIA AB
SECOND APPLICANT
FIRST CROSS-RESPONDENTAND:
FRESENIUS MEDICAL CARE AUSTRALIA PTY LIMITED
RESPONDENT
CROSS-CLAIMANTJUDGE:
ALLSOP J
DATE OF ORDER:
25 MARCH 2004
WHERE MADE:
SYDNEY
THE COURT ORDERS THAT:
1.the applicants file and serve within fourteen days draft short minutes of order conformable with the reasons for judgment published today;
2.the matter stand over to a date to be fixed for the hearing of argument, if any, as to the form of those orders and for the making of orders.
Note: Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules.
IN THE FEDERAL COURT OF AUSTRALIA
NEW SOUTH WALES DISTRICT REGISTRY
NG 474 of 1997
BETWEEN:
GAMBRO PTY LIMITED
FIRST APPLICANT
SECOND CROSS-RESPONDENTGAMBRO LUNDIA AB
SECOND APPLICANT
FIRST CROSS-RESPONDENTAND:
FRESENIUS MEDICAL CARE AUSTRALIA PTY LIMITED
RESPONDENT
CROSS-CLAIMANT
JUDGE:
ALLSOP J
DATE:
25 MARCH 2004
PLACE:
SYDNEY
REASONS FOR JUDGMENT
INDEX
Introduction [2]-[7]
Background [8]-[53]
The Patent [54]-[102]
Infringement [103]-[187]
Novelty [188]-[328]
Fair Basis, Sufficiency and Utility [329]-[344]
Obviousness [345]-[429]
Residual Rulings on Evidence [430]-[446]
Conclusions [447]-[449]Introduction
The second applicant is a Swedish company which had granted to it on 5 February 1988 Australian letters patent 595423 (the Patent).
The first applicant, which is the Australian subsidiary of its Swedish parent, the second applicant, is the exclusive licensee of the Patent.
The Patent embodies a system for the preparation of fluid intended for medical procedures such as haemodialysis. A brief history of the Patent is found at [9] to [11] of the reasons for judgment of Tamberlin J in dealing with the application for amendment of the claims ([1999] FCA 1848; 48 IPR 625, 627-28). Three matters should be noted at this point. First, the above expression of the embodiment of the Patent should be taken as neutrally expressed. There is an important question as to the ascertainment of the proper field of enquiry for obviousness or inventive step. The expression of the characterisation of the invention is not irrelevant to this issue. Secondly, the relevant prefix used in the specification and claims is the American usage “hemo”. Except when quoting the specification or claims, I will use “haemo”. Thirdly, unless the context otherwise makes clear, my use of the word “invention” is conformable with Schedule 1 to the Patents Act 1990 (Cth) (the 1990 Act), and includes “alleged invention”.
The parties approached the proceedings on the basis that the relevant priority date was 6 February 1987 (“the Priority Date”).
The second applicant designs, manufactures and sells (and did so at the Priority Date) medical equipment including machines that are used for haemodialysis and related treatments, all of which are described below. The respondent is the Australian subsidiary of a German company, which (by itself and through other companies), no doubt amongst other activities, designs, manufactures and sells (and did so at the Priority Date) machines that are also used for haemodialysis and related activities. The first applicant and the respondent are (and were at the Priority Date) direct competitors in Australia.
The applicants allege that after about September 1996 the respondent, in Australia, infringed the Patent by selling, hiring or otherwise disposing of, machines and articles which infringe the claims in the Patent. The respondent denies infringement; and, further, in its cross claim, applies under s 138(1) of the 1990 Act for revocation of the Patent on the grounds of lack of novelty, lack of utility, lack of sufficiency of description, lack of fair basing and obviousness.
Background
haemodialysis
Dialysis (that is without the prefix “haemo”) involves the transport of solutes across a semi-permeable membrane. Haemodialysis is a form of dialysis where the blood of a patient suffering impaired kidney function is taken from the body and conducted along one side of a semi-permeable membrane in a dialyser or artificial kidney, at the same time as dialysis fluid passes along the other side of the membrane. By this process, toxins and other substances that would ordinarily be removed from the blood by the properly functioning kidney and thereafter excreted, are removed into the passing dialysis fluid. The process also removes various salts as well as fluid from the blood.
In haemodialysis, the toxins are removed from the patient’s blood mainly by the process of diffusion (the movement of solutes through the membrane from a concentrated solution to one that is more dilute), by osmosis (the movement of solvent through a semipermeable membrane from a dilute solution to one that is more concentrated) and by ultrafiltration (the movement of fluid through a molecular sieving membrane by application of a pressure gradient).
The principles of diffusion dialysis were first elucidated in the 1850s. Successful dialysis therapy was delayed for a century by the lack of an effective anti-coagulant and an effective membrane. By the 1940s, scientific developments had produced dialysis systems with clinical potential. By 1960, haemodialysis was undertaken in intensive care units with continuous nurse/doctor observation. By the mid-1960s, however, advances enabled the first unattended home haemodialysis to be undertaken.
The process, it should be understood, is a means of achieving the long term survival of patients with renal failure. There is an inherent danger in the technique, involving, as it does, the recirculation, excorporeally, of the patient’s blood a number of times over a period of hours. Crucial to the safe and successful operation of the technique is the accurate composition and temperature of the fluid used, within clinically set parameters. The fluid for haemodialysis contains salts and electrolytes so as to correspond as closely as possible to normal blood.
Ions in the blood are buffered by the body’s natural buffer, bicarbonate. The function of bicarbonate in the body is to act as a buffer against extreme pH changes. The bicarbonate level in the blood is regulated by the kidneys, keeping the pH of normal blood within very narrow limits, around pH 7.4. A solution is said to be buffered if it resists change in the activity of an ion on the addition of substances that are expected to change the activity of the ion. A buffer is a substance that imparts this resistance to a solution.
early techniques of haemodialysis
In early techniques, using haemodialysis baths, the buffer used in the dialysis fluid was bicarbonate – the body’s natural buffer. Ms Elizabeth Yuill, a highly experienced nurse and nurse manager gave evidence as to how dialysis was conducted in Australia from the mid-1970s, after she moved from Wellington, New Zealand, where she had begun her work in a renal unit in 1969. I accept her evidence as to the carrying out of the prior art of techniques and machines. Her evidence of the mechanisms employed with the early use of bicarbonate as a buffer illustrated the practical difficulties then encountered. A large (100 to 120 litre) tank, with a heater, was gradually filled with water. As it was filling, a nurse would tip a prescribed, pre-measured quantity of dry salts into the tank. Once the tank was full to the correct level, the nurse would stir manually with a large paddle until the solute was visibly dissolved. Through the use of a pump on the tank, the fluid could be agitated to assist in dissolution. The nurse would then test the solution. If the solution was not at the correct concentration, it would be discarded. This process of preparation had to take place shortly prior to a dialysis treatment because the solution was susceptible to bacterial growth, other contamination and deterioration of chemical composition; in particular, the bicarbonate buffer was unstable in solution.
This technique was arduous, time-consuming and provided significant room for inaccuracy and error.
There were different systems for using this large volume of bicarbonate buffered dialysate. There were recirculating systems in which the artificial kidney was immersed in the tank. There were also recirculating single pass systems in which a smaller tank was used into which the artificial kidney was placed in fluid pumped from the larger tank; there was some recirculation in the smaller tank for a time until fluid was pumped out and replaced by fresh fluid pumped from the larger tank.
important changes in the 1960s and 1970s – the move to acetate buffer
In Australia, from the early to mid-1970s, (in other countries perhaps somewhat earlier) the treatment of patients with haemodialysis changed importantly. Fluid proportioning machines were developed in the 1960s which mechanically provided for the accurate mixing of fluid concentrate with water making a diluted solution appropriate for use in the dialysis procedure. These machines allowed for the continuous (and contemporaneous) production of dialysis fluid using a proportioning device, mixing water with a fluid concentrate in given proportions. This advance allowed for quantities of available buffer in a liquid concentrate form to be mixed with water.
The disadvantages of bicarbonate were evident from the existing procedures: it was not stable in solution and its use required careful technician attendance to the production and use of the fluid. Sodium acetate was an equivalent. Sodium acetate is a source of metabolic base buffer, being converted into bicarbonate by the liver. Sodium acetate had the advantage of being stable in solution for long periods of time and was inexpensive. Thus, acetate concentrate fluid began to be used, mixed with water by the proportioning machines, to produce the dialysis fluid. The acetate concentrate was sold in five litre pre-prepared containers.
The advance of the proportioning device and the use of acetate buffer concentrate allowed for the contemporaneous, or on-line, production of dialysis fluid.
The water used in the process was heated to a temperature equivalent to that of blood in the body. Before passing to the dialysis procedure the temperature and conductivity of the fluid produced by the proportioning machine were checked for tolerance within prescribed limits. If outside those limits, the solution by-passed the dialysis machine. If within the limits, the fluid was used in a “single pass” treatment and then discarded.
The use of proportioning dialysis machines reduced by a factor of 20 to 30 the volume of solution which had to be handled on site. No longer was there a need for large tanks of 100 to 120 litres. Patients could, with a degree of training, treat themselves at home using acetate concentrate in 5 litre containers.
By the early 1970s, most, if not all, dialysis centres and renal units in Australia were phasing out the use systems requiring large 100 to 120 litre batch preparations. By the end of the 1970s, the majority of dialysis centres, hospital renal units and patients treating themselves at home in Australia were using liquid acetate concentrates and a proprietary machine called a Drake Willock single pass proportioning dialysis machine to perform haemodialysis treatments.
a move back to bicarbonate buffer
The above was the mechanism for haemodialysis until the early 1980s. From the introduction of acetate concentrate up to the early 1980s, there were advances in the biomedical aspects of haemodialysis. There was the development of more efficient and larger surface area dialyzers which shortened dialysis treatment times. With these new techniques, bicarbonates were more rapidly removed from the bloodstream and the acetate from the fluid was more rapidly taken up by the blood. Some patients had greater difficulty metabolising acetate than others; so, the more rapid the acetate take up, the more difficult some patients found the procedure. Ms Yuill described the difficulties that acetate buffer caused in patients who were intolerant to it: hypotension, nausea, vomiting and headaches. Thus, for these clinical reasons, by the early 1980s bicarbonate once again came to be used as a buffer for dialysis fluid.
In the early 1980s, proportioning machines were developed which were capable of mixing bicarbonate buffered concentrate solution with water, as well as an acid concentrate solution to form dialysis fluid. Existing acetate proportioning machines were replaced or modified. The greater complexity in the proportioning machines was brought about by the use of two separate concentrate solutions that were mixed separately with the water to create the dialysis solution. One concentrate, which became known as the “A” concentrate, contained all the electrolytes necessary for the dialysis fluid and an acid dissolved in water. The A concentrate was purchased as a commercially prepared (and stable) concentrate solution in a 5 litre container. The other concentrate, the so called “B” concentrate, contained sodium bicarbonate buffer dissolved in water, together, sometimes, with some sodium chloride. The A and B concentrates could not be premixed together (as a mixed concentrate), because the concentration and pH of the A concentrate would cause the bicarbonate in the B concentrate to react with the calcium in the A concentrate to form a calcium carbonate precipitate.
Early in the 1980s, 9 or 10 litres of B concentrate would be made up on-site by nurses, shortly prior to the dialysis treatment, by dissolving a pre-measured amount of sodium bicarbonate or sodium bicarbonate and sodium chloride, as fine powder, in a measured volume of water. The powder was purchased in bottles containing precise amounts of one or other or both of the sodium bicarbonate and sodium chloride. Pre-preparation of the B solution in water any period of time before it was needed was not done because of the well understood problems of a tendency for bacterial growth, other contamination and precipitation.
The proportioning machines thus now mixed water with A concentrate and also with B concentrate.
Early in the use of the A and B concentrates, nurses prepared B concentrate each shift before the commencement of haemodialysis treatment. Ms Yuill described the process in her affidavit as follows:
The nurse took an empty 11 litre plastic wide necked container from a storage area of the Renal Unit and placed it on the floor of the Renal Unit under a tap on the wall in the Unit. The nurse then filled the container with water from the tap up to a 9 litre line marked on the container. The nurse then tipped the dry Part B into the water. The nurse then stirred the solution with a wooden paddle for a couple of minutes and then left the solution to settle for a couple of minutes. The nurse then stirred the concentrate solution again for a number of minutes, and again left it to settle. This would be repeated 3 to 4 times or for as long as it took to visibly dissolve all of the dry Part B in order to produce a B concentrate solution of the correct concentration.
Thus produced, the full B concentrate container was taken to the dialysis machine; the nurse also took the pre-prepared 5 litre A concentrate container to the machine. A wand from the dialysis machine was placed into each container. The machine was connected to a water source. The water drawn from such source was heated. Priming took place with the proportioning device mixing the heated water with A and B concentrates. The blood lines were primed with saline. Once the temperature and conductivity of the fluid was within the prescribed parameters, the treatment would begin. The dialysis fluid was pumped through the artificial kidney. Once the patient was connected to the machine by arterial and venous needles, the patient’s blood was pumped through the artificial kidney and back to the patient.
Over the course of treatment, the dialysis machine continuously prepared the dialysis fluid by proportioning heated water with the A concentrate solution and the B concentrate solution, each in the correct ratio at the same rate as the dialysis machine passed dialysis fluid through the artificial kidney. By the end of the treatment, almost all of the A concentrate solution and the B concentrate solution were used and the containers were almost empty.
If the nurse had not dissolved the B concentrate solution fully, the conductivity meter would cause intermittent alarms that would divert fluid to by-pass the artificial kidney. Any residual powder drawn into the machine would also cause difficulties.
In Ms Yuill’s experience pharmacy departments of hospitals sometimes undertook the responsibility for preparing the B concentrate.
The correct mixture of ions, buffer and water is important. A solution too dilute with water will cause the patient’s blood cells to take up water and swell; if the blood cells burst this is a serious condition called haemolysis. If the fluid has too high a concentration of ions the patient’s blood cells lose water and shrink which is called crenation. This is why all systems used some form of conductivity and temperature measurements to control a fail safe by-pass just prior to the haemodialysis fluid entering the artificial kidney.
Whilst the preparation of the B concentrate by pharmacy departments, rather than by busy nurses, may have improved the reliability of the B concentrate used, it created logistical difficulties. Heavy 10 litre containers of B solution had to be moved around the hospital and empty containers returned to the pharmacy department.
Also in Ms Yuill’s experience, pharmacy departments sometimes provided magnetic stirrers to nurses together with instructions on their use in an effort to return the responsibility for B concentrate preparation to nurses at the site of the haemodialysis treatment.
The disadvantages of a laborious and time-consuming process of the above kind was clear; this was especially so in relation to a solution, the preparation of which was required to be thorough and precise. In a busy hospital, such as Westmead, in Sydney, where Ms Yuill worked in the 1980s, there were 5 nurses responsible for performing between 10 and 20 haemodialysis treatments a day. Notwithstanding the obvious difficulties of on-site B concentrate preparation, the great majority of hospital treatments were undertaken by the A and B concentrates being mixed and delivered by proportioning dialysis machines, because of the clear clinical advantages of using a bicarbonate buffer, over the use of only acetate.
Home dialysis patients, however, generally continued to treat themselves with acetate buffered fluid despite attendant clinical disadvantages. Though some, with instruction, could prepare the B concentrate, as the nurses did on-site.
commercial preparation and sale of B concentrate
In the mid-1980s, B concentrate began to be sold commercially pre-prepared. The first applicant sold such a product in the mid-1980s. The B concentrate was prepared in controlled preparation plants and delivered in 10 litre containers. The laborious task of on-site preparation, with its other attendant disadvantages, was done away with and a more reliable control of quality was achieved. The preparation of the concentrate under controlled industrial conditions meant that B concentrate had a longer “shelf life” than solutions manually produced on site, though it was more expensive. Further, bacterial contamination and degradation of the concentrate over time remained a problem. Solutions of sodium bicarbonate tend to release carbon dioxide over time, thereby changing the pH of the concentrate. The useful life of the concentrate was a matter of a few months, at most. Careful inventory storage was required. With deliveries of 10 litre containers sufficient for a number of weeks, further storage capacity was required; there was also the requirement of movement of containers (full and empty) to and from dialysis treatment sites. Further, there was a considerable increase in plastic (container) waste disposal.
Ms Yuill was in a position to understand how most hospitals and renal units in Australia conducted themselves in relation to dialysis. Her evidence was that “the use of liquid B concentrate was adopted very quickly and almost universally by hospitals, renal units and dialysis centres in Australia. By 1987 very few (if any) hospitals, renal units, dialysis centres and home dialysis patients in Australia were still manually preparing batches of B concentrate solution on site.”
Ms Yuill described the residual difficulties present in the use of A and B pre-prepared and supplied concentrates as:
(a)the need for storage space in hospitals or homes,
(b)the increase in plastic waste,
(c)though with a longer shelf life, the propensity of the concentrate to bacterial contamination and decomposition after a relatively short shelf life, and
(d)the need to lift and deploy heavy 10 litre containers.
aspects of available machines
Various types of proprietary machines were in use in Australia before the Priority Date. Mr Terrence West gave evidence. His affidavits were filed on behalf of the applicants. He was cross-examined. Mr West was a senior dialysis technician. He had been a dialysis technician since 1974. He trained as an electrical apprentice at BHP in Newcastle, where he became an electrician. While employed by BHP he completed further training at Newcastle College of Technical and Further Education, gaining an Advanced Electronics Certificate and a Certificate in Electrical Engineering. In due course, I will deal with the question of the place of some of Mr West’s evidence in the context of the topic of the “skilled addressee”. At this point, it only need be said that from the mid-1970s Mr West had a close working familiarity with the operational mechanics of dialysis machines in Australia directly from his employment at Royal Newcastle Hospital and at the Hunter Area Health Service, from his participation in conferences and seminars, from reading journals, from instruction from manufacturers of machines, and from consultation with the editors of a standard journal on dialysis. I accept his evidence as to how dialysis was undertaken before the Priority Date, and as to his experience in connection therewith.
Mr West was intimately familiar with the mechanics and electronics of the machines, enabling him to maintain and, where necessary, adapt them. For instance, when bicarbonate concentrate began to be used again in the early 1980s, Mr West altered and upgraded the existing Drake Willock machine at Royal Newcastle to prepare the dialysis fluid from water and the acid and bicarbonate concentrate solutions, rather than from water and acetate concentrate solution.
For present purposes, in describing the technology of, and techniques used in, haemodialysis before the Priority Date, it is important to understand some of Mr West’s evidence about the various machines in use.
There were a number of different proportioning systems in dialysis machines sold and used in Australia before the Priority Date. Some such devices used a conductivity measurement placed immediately after a mixing point to regulate the flow of concentrate into that mixing point. After a point of mixing of A or B concentrate with water the conductivity was measured which measurement controlled the inflow of the concentrate to the water or fluid line. Thus, if concentrate level was rising its injection into the mixing point could be lessened, and so forth. This was a method of regulating the correct mixture of the dialysis fluid. Some machines, such as the well-known “Drake Willock 4015”, did not employ a conductivity measurement to regulate flow of concentrate into the water, but rather used fixed volume proportioning systems with metering cylinders. It is unnecessary to describe these kinds of pumps in any detail, but they relied on fixed volumes to bring about reliable pumping of concentrate into the water or fluid line.
Dr Klaus Schindhelm, an eminent clinical and biomedical engineer, was called by the respondent. I will later deal with his evidence in relation to the question of the assessment of obviousness and other issues. For present purposes, it is necessary only to note that early in his first affidavit Dr Schindhelm appeared to state that standard dialysis machines before the Priority Date all had conductivity controlled mechanisms regulating the flow of concentrate solution into the water or fluid line. That is not the case. The textbook exhibited by Dr Schindhelm supported the evidence given by Mr West in this regard. Indeed, the cross-examination of Professor Schindhelm made that clear that there were both fixed volume proportioning means, and conductivity measuring and flow regulating means used in dialysis machines before the Priority Date, and that his evidence in chief in his affidavit should not be taken to have intended to say that all dialysis machines at the Priority Date had, or needed to have, conductivity controlled mechanisms regulating the flow of concentrate solution into the water or fluid line.
Importantly, and Mr West himself stressed this, all dialysis machines had “fail safe” temperature and conductivity measuring devices to ensure that the dialysis fluid, before passing into the artificial kidney, fell within the stated parameters of temperature and concentration. Should it not do so, the fluid by-passed the artificial organ.
A further aspect of the dialysis machines sold and used in Australia before the Priority Date to be noted is that some mixed the A concentrate with water upstream of the point of mixture of the B concentrate, and some mixed the A concentrate downstream of the point of mixture of the B concentrate. The standard texts on dialysis and dialysis machines did not prescribe one order over another.
Also, from the evidence of Ms Yuill and Mr West, I find that the method of making the B concentrate solution on site by nurses or technicians was the adding of powder to water and mixing by stirring the mixture in the container. I say this because Dr Schindhelm stated, in [33] and [34] of his first affidavit, dealing with general background principles, that:
33.There are two broad types of method known in chemistry for dissolving a soluble salt in water, that is:
(a) placing the salt in the container with the water and mixing them together (for example by stirring or shaking); and
(b) placing the salt in a container and passing the water through the bed of that salt.
34.Method (b) is used for salts (such as bicarbonate) with a lower solubility. Common applications of method (b) described in paragraph 33 above are the addition of fluoride salts to drinking water and of fertiliser to irrigation water or any other salt with low solubility eg sodium bicarbonate.
It will be necessary to return to this aspect of the evidence in dealing with obviousness. For now, it is sufficient to note that in hospitals and renal units, in Australia before the Priority Date, staff did not use the method of dissolution referred to by Dr Schindhelm in [33(b)] of his first affidavit. I should note, however, that no evidence, from either side, was led as to how commercial entities in Australia dissolved the B concentrate powder for production of the pre-mixed B concentrate sold commercially in the mid-1980s.
haemofiltration and haemodiafiltration
Two cognate techniques to treat patients with severely impaired renal function are haemofiltration and haemodiafiltration. These are other treatments whereby a patient’s blood is treated excorporeally.
In haemofiltration, the patient’s blood is passed along one side of a very permeable membrane in an artificial kidney. Toxins and waste move from the blood by convective transport together with water plasma across the very permeable membrane. Haemodiafiltration is a hybrid procedure incorporating haemodialysis and haemofiltration. One benefit of haemofiltration and haemodiafiltration is that relatively large molecules which have built up in the blood and which are too large to pass through a conventional haemodialysis membrane can be extracted. The greater ease of passage of toxins, waste and plasma through the very permeable membrane leads to the need for a large volume of sterile isotonic replacement fluid to replace the fluid removed from the blood. This replacement fluid, which is not returned, is continuously added to the blood in the venous return line (after the artificial kidney) or in the arterial take off line (before the artificial kidney). In the haemofiltration, no dialysis fluid passes through the dialyser (or “haemofilter”) on the other side of the membrane. In haemodiafiltration, dialysis fluid passes through the dialyser on the other side of the membrane, and replacement fluid is infused into the venous return blood line or the arterial take off line.
Before the Priority Date, the replacement fluid used in haemofiltration and haemodiafiltration was a sterile lactate buffered solution purchased in commercially prepared batches to minimise the risk of bacterial contamination. Lactate buffered replacement fluids were used to avoid precipitation of calcium salts which would occur with a bicarbonate buffer. Considerable quantities of replacement fluid were required: 30, and sometimes up to 50, litres for haemofiltration, and 20 litres for haemodiafiltration. The fluid was bought in 5 litre bags.
The metabolising of lactate buffered replacement fluid caused similar problems to patients as found with metabolising acetate. Not only was the use of pre-prepared fluid labour intensive, but also the fluid was relatively expensive. Ms Yuill described the administration and difficulties of these procedures before the priority date as follows:
The hospital purchased the replacement fluid in sterile 5 litre bags, so on average five or six 5 litre bags were required for one procedure. In practice, this meant that the administration of haemofiltration and haemodiafiltration procedures was very labour intensive. The nurse was required to carry and lift five or six 5 litre bags from the store room to the machine, and then lift each bag to hang it from a stand under the machine so that the machine could pump the replacement fluid into the venous return line from the dialyser to the patient’s arm. Problems such as those experienced by dialysis patients metabolising acetate … were also experienced with patients treated with lactate buffered replacement fluid in haemofiltration and haemodiafiltration. Haemofiltration and haemodiafiltration procedures required especially modified machines, were expensive to perform due to the cost of the pre-prepared replacement fluid, and were labour intensive. Patients treated with haemofiltration and haemodiafiltration also required closer monitoring during the treatment than patients treated with conventional haemodialysis. As a result, most hospitals and dialysis units, including the Dialysis Unit at Westmead Hospital, did not use haemofiltration and/or haemodiafiltration routinely until about 1989.
From time to time in these reasons, I have used and will use the expression “haemodialysis and related procedures” to mean haemodialysis, haemofiltration and haemodiafiltration.
Thus, to summarise: To the extent that there were difficulties with the efficient and convenient preparation and use of bicarbonate buffer, this had been evident in Australia since the early 1980s when the clinical need to move away from single acetate buffer became pressing. Indeed, the disadvantages of on-site contemporaneous production of bicarbonate buffer solution brought about by the instability of the solution and its proneness to contamination had been known for decades. For a time, those difficulties had been solved or avoided by the use of acetate buffer. The advances in the science of dialysis overtook, however, single acetate use. Thus, before the Priority Date, for at least some years, the optimal clinical approach to haemodialysis required the preparation in situ of B concentrate, or the more expensive purchase of pre-prepared containers of B concentrate. In either case, problems existed: bulk, the need for storage, and so forth. The chemical and physical properties of the components of the concentration in question were well known.
The Patent
the body of the specification
The Patent, and in particular the claims defining the invention, must be read and understood in the light of the amendment to the claim dealt with by Tamberlin J. As can be seen from his Honour’s reasons for judgment, and as shall be seen below, the claims are narrower and more specific than some parts of the body of the specification.
Below the heading “Title” the following appears on page 1a:
A system for preparing a fluid intended for a medical procedure by mixing at least one concentrate in powder form with water and a cartridge intended to be used in said system.
[Capitalisation in original]
The amendments to the claims can be best appreciated by understanding that 81 out of the 88 claims in the Patent commence, whether expressly or by incorporation, with the following:
A system for preparing a dialysis or replacement fluid or a component fluid thereof
This is to be compared with the title (above): “a fluid for a medical procedure”.
Under the heading “Field of the Invention” there appears a paragraph that was not amended. It states as follows:
The present invention relates to a system for preparing a fluid intended for a medical procedure and, more particularly, to a system for preparing such a fluid by mixing of at least one concentrate in powder form with water. The system of the present invention is intended, in particular, for the preparation of fluids for use in connection with medical procedures such as hemodialysis, hemodiafiltration and hemofiltration. For instance, the system of the present invention may be used in connection with the preparation of a dialysis fluid for use in connection with hemodialysis, as well as used for preparation of replacement fluids used in connection with hemofiltration or hemodiafiltration. To those skilled in the art, it will be apparent moreover that the system of the present invention can be used in connection with other medical procedures or treatment where a fluid suitable for the treatment is obtained from mixing of water with at least one concentrate in powder form, such as, for example, the production of flushing fluid for cleaning of wounds and the like.
Leaving aside, at this point, the width of the terms of the above paragraph under the heading “Field of the Invention” beyond haemodialysis, haemofiltration and haemodiafiltration (emphasised by the respondent), one can see that insofar as the invention is directed to those procedures, it is directed to the preparation of dialysis and replacement fluid by mixing at least one concentrate in powder form with water.
An important question is the identification of the relevant person “skilled in the art”. One matter should be noted at this point: the field is the preparation of a fluid, and even if it is restricted to the preparation of dialysis fluid for haemodialysis or replacement fluid for haemofiltration or haemodiafiltration, the field is not the manufacture of the whole of the relevant machine, but rather the preparation of a fluid intended for use in a dialysis machine.
The respondent submitted that the relevant field of discourse remained at the wider general level in the specification, unchanged by the amendments. One can see, the respondent submitted, that the skilled addressee was not merely the person whose only experience and exposure was as a dialysis technician, but rather, that the specification can be seen as directed to the person who could perceive and understand a broader utilisation of the invention beyond haemodialysis, hemofiltration and haemodiafiltration, using chemical engineering and biomedical engineering skills.
Returning to the body of the specification, in a little under two pages (on pages 1a to 3) the background to the invention is provided. The background is primarily directed to haemodialysis, haemofiltration and haemodiafiltration. A short description is given of each procedure. Then a description is given of the preparation of the fluid for these procedures, which is to be understood in the context of the techniques described above before the Priority Date:
Different types of control systems are normally used for hemodialysis, hemodiafiltration and hemofiltration operations, respectively. However, they all have in common that at least one concentrate fluid is mixed with pure water in order to produce either the dialysis fluid in connection with hemodialysis operations, or the replacement fluids in connection with hemodiafiltration and hemofiltration operations. Normally, the concentrate to be mixed with water is prepared in centralized preparation plants and is then transferred to the point of treatment in large kegs or other containers. Alternatively, the concentrate may be prepared directly on the spot in large tanks or the like before the treatment is to be started. Thus, in either instance, the concentrate to be used in the medical treatment is prepared in the form of a solution prior to actual use in connection with the medical treatment. At the time of treatment, the concentrate solution is then mixed with water to provide the desired prepared solution for the particular medical treatment.
This paragraph can be seen to distinguish between the preparation of the concentrate before use (whether away from the site of treatment or at the site of treatment) and the mixing of the concentrate with water at the time of treatment.
The next paragraph, amongst other references to the prior patented art, makes reference to a United States patent (No 4,158,034) which showed how concentrate solutions prepared beforehand can be mixed on-line for the preparation of suitable dialysis solution. Those familiar with the prior techniques of haemodialysis, haemofiltration and haemodiafiltration would be well familiar with the various machines described in the evidence which mixed, on-line, one or two concentrates (previously prepared in volume for a treatment) with water to produce solutions for the three procedures.
The last paragraph of this section of the body of the specification describing the background to the invention describes the prior art problems. Two problems are identified: the instability of “certain concentrates” by a proneness to precipitation; and the susceptibility of “certain concentrates” to bacterial growth. These problems are identified as arising when concentrate is prepared prior to its utilisation. Those familiar with the prior techniques of haemodialysis, haemofiltration and haemodiafiltration would understand that these were two problems which beset the production of the B concentrate in advance of use. The specification does not expressly identify the other disadvantages of the prior art described by Ms Yuill. (See [38] above.)
In the consistory clauses under the heading “Summary of the Invention”, there are descriptions of five systems and one article. Broadly, but not precisely because of the amendments to the claims, the five systems reflect claims 1 to 5 later defined, and the article deals with the cartridge claimed in claims 80 to 85 and 87 later defined.
The first system is described as follows (see pages 3 to 4 of the specification):
The present invention provides a system for preparing a fluid for a medical procedure by mixing of at least one concentrate in powder form with water, said system comprising:
a source of water;
a vessel for containing a concentrate in powder form;
first fluid conducting means having a first end communicating with said source of water for withdrawing water from said source of water, and a second end for delivering a prepared solution;
second fluid conducting means communicating with said source of water with an inlet of said vessel for introducing water from said source of water into said vessel to produce a concentrate fluid containing dissolved powder concentrate in water;
third fluid conducting means communicating with an outlet of said vessel and with a mixing point in said first fluid conducting means intermediate said first and second ends for conducting said concentrate fluid from said vessel into said first fluid conducting means to be mixed with fluid being conducted through said first fluid conducting means to thereby produce a prepared solution in said first fluid conducting means for delivery to said second end of said first fluid conducting means;
measuring means in said first fluid conducting means downstream of said mixing point for measuring the composition of the prepared solution obtained by mixing of said concentrate fluid and water in said first fluid conducting means; and
flow regulating means in said third fluid conducting means responsive to said measuring means for controlling the flow of said concentrate fluid from said vessel.
Before setting out the other summaries, it is convenient to refer to one of the drawings in order to explain the terminology used, which is also used in the body of the claims later defined. Figure 1. is included at the end of these reasons among figures 1 to 8 in the Patent.
Schematically, one sees the source of water (2), the vessel containing concentrate powder (10), the first fluid conducting means (1) from the water source (2) to the end carrying the prepared solution at the outlet (17), the second fluid conducting means (8) leading into the vessel (11) and the third fluid conducting means (also 8) leading from the vessel (11) to the mixing point (7).
The second system is similar but incorporates a second concentrate (a fluid) for mixture at a second mixing point. The summary was in the following terms on pages 4 and 5 of the specification. I have noted the differences from the first system by emphasis and notation.
The present invention also provides a system for preparing a fluid for a medical procedure by mixing of at least one concentrate in powder form with water, said system comprising:
a source of water;
a vessel for containing a concentrate in powder form;
first fluid conducting means having a first end communicating with said source of water for withdrawing water from said source of water, and a second end for delivering a prepared fluid;
second fluid conducting means communicating with said source of water and with an inlet of said vessel for introducing water withdrawn from said source of water into said vessel to produce a first concentrate fluid containing dissolved powder concentrate in water;
third fluid conducting means communicating with an outlet of said vessel and with a first mixing point in said first fluid conducting means intermediate said first and second ends for conducting said first concentrate fluid from said vessel into said first fluid conducting means to be mixed with fluid being conducted through said first fluid conducting means; [Note excision]
a source of second concentrate fluid;
fourth fluid conducting means having a first end communicating with said source of second concentrate fluid and a second end communicating with said first fluid conducting means at a second mixing point intermediate said first and second ends of said first fluid conducting means for introducing into said first fluid conducting means said second concentrate fluid to be mixed with fluid being conducted through said first fluid conducting means, to thereby produce a prepared solution in said first fluid conducting means downstream of said first and second mixing points for delivery to said second end of said first fluid conducting means, said prepared solution being comprised of said first concentrate fluid and said second concentrate fluid mixed with water withdrawn from said source of water through said first fluid conducting means.
[Note excision of measuring means and flow regulating means.]
Figure 5 schematically describes such an invention summarised. It is to be noted, however, that conductivity or other measuring devices (14d and 26) are depicted to control the flow of the two concentrates (along 8d to point 7 and along 24 to point 23).
The third system summarised on pages 5 and 5a of the specification deals with the preparation of two concentrate fluids formed from mixing two concentrates in powder form in water.
The fourth system summarised on pages 5a and 5b of the specification is similar to the first system, the emphasised and excised parts showing the differences:
The present invention still further provides a system for preparing a fluid for a medical procedure by mixing of at least one concentrate in powder form with water, said system comprising:
a source of water;a vessel for containing a concentrate in powder form, said vessel including an inlet at the top thereof and an outlet at the bottom thereof;
first fluid conducting means having a first end communicating with said source of water for withdrawing water from said source of water, and a second end for delivering a prepared solution;
second fluid conducting means communicating with said source of water and with said inlet of said vessel for introducing water from said source of water into the top of said vessel to produce a concentrate fluid containing dissolved powder concentrate in water; and
third fluid conducting means communicating with said outlet of said vessel and with a mixing point in said first fluid conducting means intermediate said first and second means for conducting said concentrate fluid from the bottom of said vessel into said first fluid conducting means to be mixed with fluid being conducted through said first fluid conducting means to thereby produce a prepared solution in said first fluid conducting means, whereby water is conducted through said vessel from the top thereof to the bottom thereof to thereby maintain a relatively constant concentration level of dissolved powder concentrate in said third fluid conducting means.
[Note excision of measuring means and flow regulating means.]
The fifth system summarised on pages 5b and 5c of the specification is identical to the first except that the words “a source of water,” do not appear at the commencement of the summary.
The article summarised on page 5c of the specification provides for a cartridge described as follows:
The present invention still further provides a cartridge intended to be used in a system as described above, characterized in that it contains a quantity of powder concentrate suitable for one treatment.
With the system and cartridge of the present invention, the solution or fluid for the medical treatment can thus be prepared directly at the point of treatment and substantially at or just prior to treatment beginning. Such a system in accordance with the present invention thus avoids the necessity of preparing large quantities of concentrate solutions in liquid form, which would otherwise result in some of the concomitant problems mentioned above.
Some debate took place over the words in the second of these last cited paragraphs. The respondent, and at least one of its witnesses, said that they reveal that the invention can be used to make batches of concentrate before treatment. The respondent submitted that the language in this last paragraph only points to a capability to use the invention for the on-line production of concentrate solution. That capability or facilitative element was not mandatory and did not oust other capabilities. The language of “preparation substantially at or just prior to treatment beginning” was, it was said, redolent of the on-site batch preparation of B solution in the early 1980s before the uses of commercially obtained pre-prepared B solutions. I will come to the context of this in due course; but it is sufficient to say at this point that, armed with an understanding of the prior art of haemodialysis and related procedures, and in the context of the whole of the specification, these passages are not referring to the preparation of a batch for storage, but to preparation contemporaneously on-line: spatially (“directly at the point of treatment”) and temporally (“at or just prior to treatment beginning”) close or proximate. The phrase “just prior to” is literally correct, but in its context it means production at the same time, practically, as treatment. What is taught by the patent is contemporaneous on-line production.
The eight drawing appearing in the specification are summarised as follows:
FIGS. 1-4 illustrates four alternative embodiments of the system in accordance with the present invention for preparing a fluid for a medical procedure by mixing of a concentrate in powder form with water.
FIG. 5 illustrates a further alternative arrangement for the system of the present invention in which the fluid is prepared starting with one concentrate in powder form and a second concentrate in liquid form.
FIG. 6 illustrates a still further arrangement for the system in accordance with the present invention which again utilizes a concentrate in powder form and a concentrate in liquid form, the system of FIG. 6 being particularly adapted for use in connection with a hemodialysis-type of treatment.
FIG. 7 illustrates a cartridge intended to be used in any of the alternative system arrangements shown in FIGS 1-6, the cartridge being shown mounted in a holder therefor.
FIG. 8 illustrates a still further arrangement for the system in accordance with the present invention in which two different concentrates in powder form are utilized in connection with a further concentrate in liquid form for preparing a fluid for a medical procedure.
It is to be noted that figure 6 is said to be particularly adapted for “hemodialysis-type of treatment”. I will return to this in due course.
There then follow twenty pages of the preferred embodiments of the invention described by reference to the drawings. The particular application to haemodialysis operations is seen in the first two paragraphs of this part of the specifications on page 7:
Referring now to the drawings, wherein like reference characters represent like elements, there is shown various alternative arrangements for systems in accordance with the present invention for preparing a fluid for a medical procedure by mixing of at least one concentrate in powder form with water. As the system of the present invention is intended, in particular, for the preparation of dialysis fluids for hemodialysis operations, the system will be described mainly with reference to such an operation. However, it will be appreciated by those skilled in the art that, with minor modifications, the system of the present invention may also be used for the preparation of replacement fluids used in connection with hemofiltration and/or hemodiafiltration operations as well. Still further, to those skilled in the art, it will be apparent that the system in accordance with the present invention can also be used in connection with other medical treatments or procedures.
In connection with hemodialysis operations, the dialysis fluid in accordance with the present invention (as well as replacement fluids for hemodiafiltration and hemofiltration operations) typically may comprise a purified solution containing bicarbonate, such as sodium bicarbonate, together with salt compound such as sodium chloride or, optionally, other alkali or other alkali earth chlorides. With such dialysis solutions containing bicarbonate, there is a risk of precipitation of the bicarbonate, particularly, in such instances where the dialysis fluid with bicarbonate is prepared at central processing plants or in large quantities at a treatment facility. The system in accordance with the present invention minimizes such problems of precipitation and/or risk of bacteria growth by preparing the fluid for medical treatment by mixing of at least one concentrate in powder form with water substantially at the time of treatment.
The first of these two paragraphs last quoted contains another example of the specification that could be seen to be speaking to those skilled in an art broader than haemodialysis, haemofiltration and haemodiafiltration; in particular, the person familiar with the preparation of fluids, dissolution principles, fluid dynamics and the like, the province, it was submitted by the respondent, of the chemical engineer and the biomedical engineer.
The last sentence of the above paragraphs reinforces the proposition put by the applicants, correctly in my view, that the Patent is directing the person aware of the prior art and understanding the problems within the prior art to on-line or contemporaneous production. This is reinforced elsewhere in the specification. For instance, on page 8 of the specification, after a description of the first fluid conducting means of figure 1, there is a reference to the prior art and “the previously prepared liquid concentrate” being introduced into the main conduit.
The description of the preferred embodiments first deals with figures 1 to 4 on pages 7 to 12 of the specification.
On page 12 of the specification in the discussion of the preferred embodiments by reference to the drawings there is introduced the notions of “top” and “bottom” which are important to some of the claims. The following paragraph appears:
Further, in accordance with the preferred embodiments of the present invention, it is to be noted that water is introduced into the concentrate powder column 10 at the top of the column 10 and conducted downwardly to the bottom thereof. This is preferably in order to maintain and provide a relatively constant concentration level of dissolved powder concentrate into the primary fluid line 1. However, it should also be appreciated that water withdrawn into the concentrate fluid line 8 could be conducted through the powder column 10 from the bottom toward the top, both in connection with normal operation as well as in connection with initial priming of the system.
[emphasis added]
This paragraph can be seen (and the respondent places some reliance on this) to contain two ideas well understood to those familiar with chemical engineering: first, percolation – the dissolution of dry or solid solute by the downward flow of water over and through a bed or column or arrangement of the solute; and secondly, the use of a fluidised bed by introducing water from the bottom and moving it towards the top of the bed.
The specification also deals on page 12 of the specification with access to the source of water:
Still further, it should be appreciated that the primary fluid line 1 and concentrate fluid line 8 could both be connected directly to a source of water such as a tap water system, for example, by means of a T-coupling, instead of to a reservoir which is supplied with water. Furthermore, it should also be appreciated that the primary fluid line 1 and concentrate fluid line 8 could be connected to different sources of water, although it is preferable that they both be connected to a common source of water such as a reservoir 2 as shown in FIGS. 1-4.
This passage is relevant to an argument of the respondent concerning the meaning of the claims and the access to the water supply.
The description of the preferred embodiments then proceeds to deal with figure 5 and the use of a liquid concentrate as well as a powder. Though it is figure 6 which is said to be “particularly” intended for use in connection with a haemodialysis-type operation, a person familiar with the prior art and conduct of haemodialysis and related procedures would appreciate in the following discussion by reference to figure 5, the stable liquid as A concentrate and the powder as B concentrate:
In certain instances, the solution for a medical procedure or treatment is to be prepared from more than one concentrate, such as, for example, the dialysis solution disclosed in the aforementioned European patent specification EP-B1-0 022 922. In such situations, in accordance with the present invention, the more stable concentrate may be provided in a liquid form and the less stable concentrate or concentrates provided in powder form. In this regard, FIG. 5 illustrates a modified system in accordance with the present invention for preparing a solution for a medical procedure or treatment in which the solution is prepared from one concentrate in powder form and one concentrate in liquid form. Again, in FIG 5, the same reference characters have been used as in the remaining figures, but with the added letter “d” being used to designate modified components.
In accordance with the modified system shown in FIG. 5, a suitable reservoir 2 is provided from which fluid for preparing a solution is conducted, on the one hand, via a main or primary conduit 1 and, on the other hand, through a concentrate circuit or conduit 8d containing a powder concentrate column 10d there-in. The concentrate conduit 8d communicates with the main conduit 1 at a mixing point 7. Means for regulating the flow of fluid in the main conduit 1 and for deaeration, respectively, have been indicated by a single rectangle marked 3d, 5d, 6d. A conductivity meter or other measuring device is provided in the main conduit 1, as indicated by the reference numeral 14d. The conductivity meter or other measuring device 14d is adapted to control a flow regulating device 13d provided in the concentrate conduit 8d downstream of the powder concentrate column 10d. If the flow regulating device 13d comprises a throttle, such throttle 13 shown in FIG 1, the throttle device 3d should be located upstream of the mixing point 7. It will thus be appreciated that the foregoing description of the system according to FIG. 5 substantially corresponds with the systems described hereinabove with reference to FIGS. 1-4. In the system of FIG. 5, however, a second mixing point 23 is provided downstream of the conductivity meter 14d. At mixing point 23, a second concentrate fluid is introduced into the main duct via a second concentrate conduit or duct 24 which communicates with a source of second concentrate 25, which, in this instance, is in a Liquid form. The flow of concentrate through the second concentrate duct 24 is regulated with the aid of a conductivity meter or other measuring device 26 provided in the main conduit 1 and which controls a flow regulating device 27 provided in the second concentrate duct 24. For ultimate monitoring of the prepared solution, a pH meter 28 may be installed in the main conduit 1. If conductivity, pH, temperature, or any other parameter utilized for controlling the flow of concentrates through their respective conduits 8d, 24 do not agree or correspond with the desired value, the prepared fluid is passed via a bypass valve 29 directly to a discharge (not shown). If, on the other hand, all the parameters are correct or in accordance with their desired values, the prepared solution is passed via a valve 30 to the actual point of treatment, for example, a dialyzer.
Thus, it will be appreciated that if two concentratets [sic] are to be conducted to the main duct 1 at two separate mixing points 7, 23 in the main conduit 1 for mixing with the fluid being conducted through the main conduit 1, conductivity meters or other measuring devices 14d, 26 for accurate monitoring of the composition of the prepared solution upstream as well as down stream of the second mixing point 23 may appropriately be arranged in the main duct 1 and, in particular, arranged downstream of the respective mixing points 7 with which the concentrate conduit 8d communicates.
A number of matters should be noted about these passages. First, there is reference again to a “conductivity meter or other measuring device” adapted to control a flow regulating device for both concentrates. It is not to be forgotten, however, that in the well known prior art there were existing dialysis machines that used proportioning devices or mechanisms based on volume and not the measurement of conductivity or temperature or some other variable in the fluid line. Secondly, it should be noted that the order of the mixing of the two concentrates is specifically identified by the use of the word “downstream” on three occasions. This is relevant to the question of construction of the Patent and order of mixing to which I will come in dealing with infringement.
The description of the preferred embodiments then proceeds on pages 14 and 15 of the specification to deal with figure 6, directed particularly, as I have said, to haemodialysis. In this configuration, the entry points of the concentrates have been reversed (the liquid A, first, and the concentrate solution from dissolved powder, B, second). Once again, pumps controlled by conductivity meters are referred to. The description includes the following:
FIG. 6 shows a still further modified system in accordance with the principles of the present invention which is particularly intended for use in connection with preparation of a dialysis fluid for use in connection with a hemodialysis operation. Once again, the same reference characters have been used to designate like components, with the added character “e” being included with respect to modified components. The system shown in FIG. 6 is similar to that in accordance with FIG. 5 in that it is used to prepare a solution from two different concentrates, one in liquid form and one in powder form. The system of FIG. 6 differs from FIG 5, however, with respect to the Location the concentrate fluids obtained from the Liquid and powder sources are introduced into the main duct or conduit 1.
In accordance with the system of FIG. 6, water for use in preparing the dialysis fluid is introduced to a heating vessel or reservoir 2 for heating the water to the desired temperature. From the heating vessel or reservoir 2, the main part of the water used in preparing the dialysis fluid is conducted from the reservoir 2 through a main or primary conduit 1. In the main conduit 1, the flow is degassed by means of a throttle 3e and, a pump 5e and a deaerator 6e, shown together in FIG. 6 as a single rectangle. A liquid concentrate line or duct 24e communicates with the main conduit 1 at a mixing point 23e downstream of the throttle 3e and the rectangle 5e, 6e. The concentrate duct 24e includes a concentrate pump 27e therein which pumps a liquid concentrate from a liquid concentrate container 25e. The conductivity of the mixture after introduction of the liquid concentrate is measured in the main conduit 1 by means of a conductivity meter 26e which controls the pump 27e.
A smaller portion of the water in the reservoir 2 is fed through a concentrate fluid circuit comprised of a concentrate conduit 8e. A column or vessel 10 containing a concentrate in powder form is provided in the concentrate conduit 8e so that, as with the other embodiments discussed hereinabove, the smaller portion of water withdrawn from the reservoir 2 is fed through the column 10 from the top toward the bottom thereof, and from there through a continuation of the concentrate conduit 8e to a concentrate pump 13e. From the pump 13e, the concentrate fluid obtained from the vessel 10 is then conducted to the main conduit 1 at a mixing point 7e where it is mixed with the main flow of water from the reservoir 2, which includes the liquid concentrate therein. The conductivity is thereafter measured once again, utlizing the conductivity meter 14e which controls the pump 13e in the concentrate conduit 8e.
The description also goes on to describe (on page 15 of the specification) the ultimate fail safe monitoring and diversion of the fluid if it departs from the relevant parameters.
Also, there is a description on pages 15 to 17 of the specification of the somewhat more complex body of schematic piping and equipment on the left hand side of figure 6 between the vessel (10) and the pump for the liquid (27e). This piping and equipment is for priming and sterilisation. It would be understood by the reader familiar with the prior art and its application that haemofiltration and haemodiafiltration involve the delivery (and not return) of fluid (referred to in the patent as “replacement fluid”) to the body, venously or arterially and thus the need for such fluid to be sterile.
The respondent sought to take some comfort from the fact that figure 6, particularly directed to haemodialysis operations, mixes the A, (liquid) concentrate first, upstream of the B concentrate created from the dissolution of powder by the invention. No particular advantage for dialysis is described in the specification from this order of mixing. The prior art machines had both arrangements. I will return to this in discussing infringement. It suffices at this point to note that the priming and disinfecting attributes would also make figure 6 “particularly adapted for use in connection with haemodialysis – type of treatment”.
The description of the preferred embodiments then deals on pages 17 and 18 of the specification with the use of the cartridge, by reference in particular to figure 7. Whilst it is of course necessary to remember that this is not the body of claims, the following should be noted about the cartridge there appearing: the cartridge is “totally closed”, it has membranes at the upper inlet and lower outlet adapted to be penetrated by connection devices at the ends of the fluid circuit (in and out) and information about desirable particle size is given to obtain a uniform solution. The following appears at pages 17 and 18 of the specification.
Further in accordance with the present invention, the powder concentrate columns or vessels 10 utilized in the various embodiments described hereinabove may conveniently be in the form of a self-contained cartridge containing a quantity of powder concentrate therein suitable for one treatment procedure, the cartridge being totally closed and provided with penetrable membranes at its upper inlet and its lower outlet which are adapted to be penetrated by suitable connection devices for the ends of the conduit in the fluid concentrate circuit 8 or 8d or 8e. Also, preferably, [sic] the cartridge is internally sterile, such as by having been exposed to radiation such as gamma radiation. Fig. 7 shows such a cartridge 10f, as well as a holder 43 therefor, which is specifically constructed to accommodate a cartridge of a particular configuration.
As shown in FIG. 7, the cartridge column 10f comprises a closed vessel provided with penetrable membranes 62, 64 at its upper inlet end and its lower outlet end, respectively. Within the cartridge vessel, there is provided a supply of powder concentrate of sufficient quantity so as to be suitable for a single treatment. For instance, in connection with preparation of a dialysis fluid or solution, the concentrate in powder form may consist of sodium bicarbonate material, and the quantity thereof contained in the cartridge would be on the order of magnitude of 400-900 grams and, more preferably, approximately 600 grams. Also, the contents of the cartridge 10f are preferably sterilized, such as by means of gamma radiation.
Further, in order to obtain an even flow of fluid through the powder concentrate vessel or column 10f and, thus, a uniform solution of the powder in the fluid, it has been found that there is a preferable minimum particle size for the powder concentrate. For many materials, and especially bicarbonate materials, it has been found that the particles of powder should be of a size of at least 100 microns ( µ ), and preferably larger than 150 microns ( µ ). A minor blending in of smaller particles may, however, be acceptable. In this regards, a suitable mixture, for example, may be comprised of powder particles having a size of between 130 and 500 microns ( µ ).
The cartridge 10f is adapted to be mounted in a holder 43 provided with a pair of upper and lower swinging arms 44 and 45 mounted on a suitable support structure 60. The arms 44, 45 are provided with spike connectors 46 and 47, respectively, which are intended to penetrate the membranes 62, 64 at the upper inlet and the lower outlet of the cartridge vessel 10f. In this regards, the upper inlet and lower outlet of the cartridge 10f are each provided with an outwardly protruding nipple having the penetrable membranes 62, 64 therein, which nipples are adapted to be received in suitable recesses in the arms 44, 45 so that the end of the spike connectors 46, 47 may penetrate same when the arms 44, 45 are swung into essentially horizontal positions to hold the cartridge 10f. In this regards, the spacing between the arms 44, 45 is such as to correspond to the height of the cartridge 10f. The upper or inlet spike 46 is intended to be connected to the conduit in the concentrate fluid circuit 8e which is upstream of the cartridge 10 as shown in FIG. 6, whereas the outlet spike 47 is intended to be attached to the concentrate conduit which is downstream of the cartridge 10 in the fluid concentrate circuit 8e. It will thus be appreciated that connection of the cartridge 10f in the circuit 8e is accomplished relatively easily by moving the arms 44, 45 apart, positioning the cartridge 10f therebetween and then moving the arms 44, 45 into horizontal, parallel, positions so that the spikes 46, 47 penetrate the membranes 62, 64.
The respondent emphasised, in connection with understanding the meaning of the word “cartridge” as used in the claims, the importance of the adaption or fitting of the vessel into a space with the surrounding configuration – to produce a satisfactory and integral “fit”.
The description of the preferred embodiments then at pages 19 to 21 of the specification deals with the mixture of two powders, by reference to figure 8. (The two powders are identified in figure 8 as sodium bicarbonate and sodium chloride.) Those familiar with the prior art and operation of haemodialysis and related procedures before the Priority Date would understand that sodium chloride is sometimes within the A concentrate and sometimes not. It is unnecessary to set out much of the detailed description of the operation of figure 8. It is sufficient to note, however, that figure 8 reveals, and the description of the preferred embodiment provides for, the acid, or A concentrate, being mixed (at 53) upstream of the concentrates derived from the powders (at 23g and 7g). Once again, at least this time for the concentrates derived from powder, conductivity meters are used to control the flow to the mixing points. This part of the description of the preferred embodiment contains material relied upon (at least initially) by the respondent to the effect that the Patent is not only directed to on-line production for delivery, but also is directed to batch production. The following appears on pages 21 and 22 of the specification:
By way of example, for preparation of a dialysis fluid, the cartridge 10g1 may contain a bicarbonate material in powder form, such as sodium bicarbonate, whereas the cartridge 10g2 may contain a different concentrate powder form, such as sodium chloride powder. In this instance, the quantity of sodium bicarbonate in cartridge 10g1 may be on the order of 400-900 grams and, more preferably, approximately 600 grams, whereas the quantity of sodium chloride in the cartridge 10g2 would preferably be on the order of 1,000-3,000 grams and, more preferably, 1,300-2,700 grams and, still more preferably, approximately 1,400 grams. Such cartridges 10g1 and 10g2 for use in connection with preparation of a dialysis fluid, i.e., a cartridge 10g1 containing bicarbonate material and a cartridge 10g2 containing sodium chloride material, both in powder form, may also be used in practice, together with a liquid concentrate 50 which contains other substances necessary for the treatment, such as, for example, acid, calcium, potassium, magnesium, glucose, or the like. A suitable composition for the liquid concentrate 50, for example, may be as follows:
CH3C00H 44.17 g
KC1 36.54 g
CaCl2 + 6H20 93.94 g
HgCl2 + 6H20 24.92 g
H20 210 g
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Total approx. 410 gThe quantities provided in the example hereinabove correspond to that necessary for one treatment operation or procedure, with the quantity of water being determined so that no precipitation should be able to occur during storage at refrigerating cabinet temperature. With a smaller quantity of water, there is a risk of precipitation. In the example above, it will be appreciated that instead of acidic acid, other acids could be used, such as, for example, hydrochloric acid or citric acid.
[emphasis added]Reliance was initially placed by the respondent on the word “storage”. Though not made clear by the balance of the evidence, from reading this part of the specification, the “storage” there referred to is of the A solution. This part of the specification is not of any real assistance to the respondent in the manner initially asserted. In final submissions the respondent withdrew this submission, recognising that the “storage” being referred to was of the A solution.
Finally in this section of the specification, the various embodiments are summarised by reference to the base numbers in the drawings; and the description concludes with a paragraph of the kind dealt with by the High Court in Welch Perrin & Co Pty Ltd v Worrel (1961) 106 CLR 588, 614. The following appears at pages 24 to 26 of the specification:
It will thus be apparent from the foregoing description that the present invention provides a system for preparing a fluid intended for a medical procedure by mixing of at least one concentrate in a powder form. The system in accordance with the present invention comprises a reservoir 2 for a source of water, and at least one vessel 10 for containing a concentrate in powder form, and a fluid conducting circuit 8 for withdrawing a small quantity of water from the reservoir 2 and passing same through the vessel 10 containing the concentrate in powder form in order to dissolve the concentrate before it is mixed with the rest of the water withdrawn from the reservoir 2 through a main or primary fluid conducting means 1 downstream of the liquid containing reservoir 2. In accordance with one aspect of the present invention, measuring means 14 are provided in the primary fluid conduit means 1 downstream of the mixing point 7 for measuring the composition of the prepared solution obtained by mixing of the produced concentrate fluid in the concentrate fluid circuit 8 with water being conducted through the primary conduit 1, and flow regulating means 13 provided in the concentrate fluid circuit 8 downstream of the concentrate vessel 10 which is responsive to the measuring means 13 for controlling the flow of concentrate fluid from the vessel 10.
In accordance with a further aspect of the present invention, a source of second concentrate fluid 25, 10g2 is provided as well, and fluid conducting means 24 are provided for introducing the second concentrate fluid into the primary fluid conducting means 1 at a second mixing point 23 therein to be mixed with the fluid being conducted therethrough to thereby produce a prepared solution downstream of the two mixing points, 7, 23, the prepared solution being comprised of a mixture of water with a first concentrate fluid produced by conducting water from the reservoir 2 in the vessel 10, 10g1 containing the concentrate in powder form and a second concentrate fluid from the source 25, 10g2 thereof. In one embodiment of the present invention, the source of second concentrate fluid comprises a concentrate in liquid form 25, wheras [sic], in a further embodiment of the present invention, the second concentrate fluid is produced by conducing water from the reservoir 2 through a second vessel 10g2 containing powdered concentrate therein to dissolve the second powdered concentrate in the water to produce the second concentrate fluid.
In accordance with a still further aspect of the present invention, the vessel 10 containing the concentrate in powder form therein includes an inlet at the top thereof and an outlet of the bottom thereof, with the vessel 10 being arranged in the concentrate fluid circuit & so that water withdrawn from the reservoir 2 is introduced into the top of the vessel 10 to produce a concentrate fluid containing dissolved powder concentrate therein, and so that the concentrate fluid is withdrawn from the bottom of the vessel 10 and conducted to the primary fluid conducting means 1 to be mixed with water being conducted therethrough. In this manner, water is conducted through the powder concentrate vessel 10 from the top thereof to the bottom thereof to thereby maintain and provide a relatively constant concentration level of dissolved powder concentrate. Conveniently, the powder concentrate vessel 10 may comprise a normally completely closed cartridge 10f, having penetrable membranes 62, 64 at its inlet and outlet outlets which are adapted to be penetrated upon being connected to the concentrate fluid circuit 8. The cartridge 10f contains a quantity of powder concentrate therein suitable for one treatment procedure. In this manner, for different treatment operations, it is only necessary to connect new cartridges 10 and/or other sources 25, 50 of liquid concentrate to the system, with the remaining components of the system being reusable for different medical procedures or treatments.
As will be readily apparent to those skilled in the art, the present invention may be used in other specific forms without departing from its spirit or essential characteristics. For example, the components included in the system may be varied within wide limits, both with regard to their form and their function. Furthermore, it will be apparent to those versed in the art that the system of the present invention can readily be modified by combinations of one or more powder concentrates, either alone or in further combination with one or more liquid concentrates, for producing a desired prepared solution for a medical procedure or treatment. The preferred embodiments described hereinabove are therefore to be considered as illustrative and not restrictive, the scope of the invention being indicated by the claims rather than the foregoing description, and all changes which come within the meaning or range of equivalents of the claims are therefor intended to be embraced therein.
The respondent emphasised the width of the invention and its field – a system for preparing a fluid directed to a medical procedure. The last paragraph quoted above was relied upon by the respondent in emphasising this width of field and, concomitantly, the width and depth of skill of the skilled addressee.
The applicants emphasised the elucidation of “top” and “bottom” in the second last paragraph quoted above – the top is at or above the powder column and the bottom is the place at the bottom of the powder column where the fluid is withdrawn.
the claims
The complaints in the variously amended application and statement of claim concern claims 2, 4, 5, 11, 24, 25, 28, 35, 80, 81 and 88 of the Patent. In the light of arguments on infringement and on the cross-claim, it is appropriate to set out those claims together with claims 1, 3, 6, 7, 8, 9, 10 and 50 to 55.
THE CLAIMS DEFINING THE INVENTION ARE AS FOLLOWS:
1.A system for preparing a dialysis or replacement fluid or a component fluid thereof by mixing of at least one concentrate in powder form with water, said system comprising:
a source of water;
a vessel containing a powder concentrate;
first fluid conducting means having a first end communicating with said source of water for withdrawing water from said source of water, and a second end for delivering a prepared dialysis or replacement fluid or component fluid thereof;
second fluid conducting means communicating with said source of water and with an inlet of said vessel for introducing water from said source of water into said vessel to thereby produce a concentrate solution containing dissolved powder concentrate in water;
third fluid conducting means communicating with an outlet of said vessel and with a mixing point located in said first fluid conducting means intermediate said first and second ends for conducting said concentrate solution from said vessel into said first fluid conducting means where it is mixed with fluid being conducted through said first fluid conducting means to thereby produce the prepared fluid in said first fluid conducting means;
measuring means located in said first fluid conducting means downstream of said mixing point for measuring the composition of the prepared fluid; and
flow regulating means located in said third fluid conducting means and being responsive to said measuring means for controlling the flow of said concentrate solution from said vessel.
2.A system for preparing a dialysis or replacement fluid or a component fluid thereof by mixing of at least one concentrate in powder form with water, said system comprising:
a source of water;
a vessel containing a powder concentrate;
first fluid conducting means having a first end communicating with said source of water from said source of water, and a second end for delivering a prepared fluid for use in a hemodialysis, hemofiltration or hemodiafiltration procedure;
second fluid conducting means communicating with said source of water and with an inlet of said vessel for introducing water withdrawn from said source of water into said vessel to thereby produce a first concentrate solution containing dissolved powder concentrate in water;
third fluid conducting means communicating with an outlet of said vessel and with a first mixing point located in said first fluid conducting means intermediate said first and second ends for conducting said first concentrate solution from said vessel into said first fluid conducting means where it is mixed with fluid being conducted through said first fluid conducting means;
a source of second concentrate solution; and
fourth fluid conducting means having a first end communicating with said source of second concentrate solution for withdrawing second concentrate solution from said source of second concentrate solution, and a second end communicating with a second mixing point located intermediate said first and second ends of said first fluid conducting means for introducing said second concentrate solution into said first fluid conducting where it is mixed with fluid being conducted through said first fluid conducting means to thereby produce the prepared fluid in said first fluid conducting means downstream of said first and second mixing points, said prepared fluid being comprised of said first concentrate solution, said second concentrate solution and water withdrawn from said source of water through said first fluid conducting means.
3.A system for preparing a dialysis or replacement fluid or a component fluid thereof by mixing of at least two concentrates in powder form with water, said system comprising:
a source of water;
a first vessel containing a powder concentrate;
a second vessel containing a second powder concentrate different from said first powder concentrate;
first fluid conducting means having a first end communicating with said source of water for withdrawing water from said source of water, and a second end for delivering a prepared dialysis or replacement fluid or component fluid thereof;
a concentrate solution circuit communicating with said source of water and with said first fluid conducting means, said concentrate solution circuit including first connection means at a first location in said concentrate solution circuit for connecting said first vessel to said concentrate solution circuit so as to introduce water from said source of water into said first vessel to dissolve said first powder concentrate and to withdraw a first concentrate solution containing said dissolved first powder concentrate from said first vessel, and second connection means at a second, different location in said concentrate solution circuit for connecting said second vessel to said concentrate solution circuit so as to introduce water from said source of water into said second vessel to dissolve said second powder concentrate and to withdraw a second concentrate solution containing said dissolved second powder concentrate from said second vessel, said first and second connection means being different from one another so that said first vessel is only connectable at said first location in said concentrate solution circuit and said second vessel is only connectable at said second, different location in said concentrate solution circuit, said concentrate solution circuit being arranged for conducting and delivering said first and second concentrate solutions into said first fluid conducting means at a location intermediate of said first and said second ends of said first fluid conducting means where they are mixed with fluid being conducted through said first fluid conducting means to thereby produce the prepared fluid being comprised of solutions from said concentrate solution circuit and water withdrawn from said source of water.
4.A system for preparing a dialysis or replacement fluid or a component fluid thereof by mixing of at least on concentrate in powder form with water, said system comprising:
a source of water;
a vessel containing a powder concentrate, said vessel including an inlet at the top thereof and an outlet at the bottom thereof;
first fluid conducting means having a first end communicating with said source of water for withdrawing water from said source of water, and a second end for delivering a prepared fluid;
second fluid conducting means communicating with said source of water and with said inlet of said vessel for introducing water from said source of water into the top of said vessel, whereby a concentrate solution containing dissolved powder concentrate in water is produced in the vessel; and
third fluid conducting means communicating said outlet of said vessel with a mixing point located in said first fluid conducting means intermediate said first and second ends for conducting said concentrate solution from the bottom of said vessel into said first fluid conducting means to thereby produce the prepared fluid, wherein the system is arranged such that a relatively constant concentration level of dissolved powder concentrate is maintained in said third fluid conducting means by fluid being conducted through said vessel from its top to its bottom.
5.The system of claim 1, 2, 3 or 4 wherein said source of water comprises a reservoir for containing water.
6.The system of claim 5, when appended to claim 1, wherein said measuring means comprises a conductivity measuring device.
7.The system of claim 5, when appended to claim 1, wherein said flow regulating means comprises a throttling device.
8.The system of claim 7 further including a suction pump arranged in said first fluid conducting means downstream of said mixing point for conducting water from said reservoir through said first fluid conducting means and for conducting water from said reservoir through said second and third fluid conducting means.
9.The system of claim 8 further including a throttling device arranged in said first fluid conducting means intermediate said reservoir and said mixing point, and further including a deaerating device arranged in said first fluid conducting means downstream of said suction pump.
10.The system of claim 1 wherein said flow regulating means comprises a suction pump.
11.The system of claim 1 or 2 wherein said inlet of said vessel is at the top thereof and said outlet of said vessel is at the bottom thereof so that water is conducted through said vessel from the top thereof to the bottom thereof whereby a relatively constant concentration level of dissolved powder concentrate is maintained in said third fluid conducting means.
…
24.The system of claim 1, 2 or 4 wherein the powder concentrate has a particle size which is greater than 100 microns.
25.The system of claim 24 wherein said powder concentrate comprises a bicarbonate material having a particle size between 130 and 500 microns.
…
28.The system of claim 1, 2 or 4 wherein said vessel comprises a self-contained cartridge containing a quantity of said powder concentrate suitable for one treatment procedure.
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35.The system of claim 28 wherein said powder concentrate in said cartridge comprises bicarbonate material, the quantity of said bicarbonate material in said cartridge being of the order of 400 to 900 grams.
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50.The system of claim 2 further including first and second measuring means in said first fluid conducting means, said first measuring means being downstream of said first mixing point and operative to measure the composition of fluid in said first fluid conducting means downstream of said first mixing point and said second measuring means being downstream of said second mixing point and operative to measure the composition of fluid in said first fluid conducting means downstream of said second mixing point.
51.The system of claim 50 further included first flow regulating means responsive to said first measuring means for controlling the flow of said first concentrate solution through said third fluid conducting means, and second flow regulating means responsive to said second measuring means for controlling the flow of said second concentrate solution through said fourth fluid conducting means.
52.The system of claim 51 wherein said first and second flow regulating means each comprise a suction pump.
53.The system of claim 51 further including a throttling device, a suction pump and deaerating device arranged in said first fluid conducting means.
54.The system of claim 53 wherein said throttling device, said suction pump and said deaerating device are all arranged in said first fluid conducting means downstream of said source of water and upstream of both of said first and second mixing points.
55.The system of claim 50 wherein said first and second measuring means each comprise a conductivity measuring device.
…
80.A cartridge arranged for use in a system in accordance with any one of the preceding claims, characterised in that the cartridge contains a quantity of said powder concentrate suitable for one treatment.
81.A cartridge as claimed in claim 80 arranged for a dialysis procedure involving the use of at least one concentrate in powder form, wherein the cartridge contains a quantity of the order of magnitude of 400 to 900 grams sodium bicarbonate, preferably approximately 600 grams.
…
88.A system according to any one of claims 28 to 30, wherein the powder concentrate is arranged as a column between the inlet and outlet of the cartridge so that, in operation, the powder concentrate becomes dissolved in water flowing through the vessel, and said second fluid conducting means and said cartridge are so dimensioned, as to produce a substantially saturated solution of the powder concentrate in water.
Professor Schindhelm was provided with the Patent at the outset. There was some confusion in the evidence as to what Professor Schindhelm looked at in coming to his views on obviousness . In his affidavit ([17] and exhibit KS 4) Professor Schindhelm stated that he was provided with Stasz and Mund for the purpose of giving his opinion on the validity of the invention claimed in the Patent. In cross-examination, (at Tpp 301-302), however, he said he saw Stasz and Mund after formulating his opinion on obviousness. Stasz and Mund were not shown to be part of the common general knowledge. Whilst I accept, without hesitation, the truthfulness of this evidence in cross-examination by Professor Schindhelm, his opinion was formed with the Patent in mind (that is, knowing of the claimed development) and the knowledge of material not part of the common general knowledge, though gained after first formulating his view, could only go to reinforce a view reached with the compromising effect of the knowledge of the Patent. This problem of disentangling consideration of material not shown to be in the common general knowledge is best exhibited by [98] of his first affidavit where Stasz and Mund are used as reinforcement for a conclusion of obviousness which begins from an appreciation of the patentee’s claimed improvement to solve a pre-existing problem:
In view of the well known principles of percolation which I have just described, if confronted with the perceived problems which the Patent purports to solve (see paragraph 38 above), I believe that as at the Priority Dates, the Hypothetical Addressee would have found to be self evident and have adopted the solution reached by Gambro in the patent (that is, passing water through a container holding the sodium bicarbonate in powdered form in order to produce an effluent stream from the container which has a relatively constant concentration).
I am supported in this view by the fact that a number of other people working in the dialysis field prior to the Priority Date, including the inventors of the Stasz and Mund Patents, reached the same conclusion well before the Priority Date to produce a dialysis solution by adding water to powdered concentrate in a vessel.
Professor Schindhelm was also given a copy of Remington’s Pharmaceutical Sciences. This too was not shown to be common general knowledge of the relevant chemical engineer. Remington’s itself stated that it was a textbook and reference work for pharmacists, physicians and other medical scientists. Professor Coster said that the book was directed to chemical engineers. He is not a chemical engineer, though he is an eminent scientist. I accept that it is a work which a chemical engineer would find of utility. Nevertheless, Professor Coster’s answer in cross-examination does not establish that Remington’s was part of the common general knowledge of the chemical engineer, or the person involved in designing or improving these machines who had a chemical engineering background. It was one of the documents given to him to help him assess the validity of the invention.
Professor Coster likewise was provided with the Patent and Remington’s and the Alza Patent (which also was not shown to be part of any relevant person’s common general knowledge). Professor Coster said that he also looked at several patents related to Alza. These were not shown to be part of any relevant person’s common general knowledge.
Professor Coster also conducted unspecified searches in the library “on related subjects”. He was also provided with some documents, otherwise unidentified.
The evidence of both Professors Schindhelm and Coster suffered from defects referred to in 3M v Tyco at [45], in particular in relation to both, the provision of the Patent.
To the extent that the evidence of Professor Schindhelm was in terms or in substance to the effect that the changes made by the Patent to existing systems was not inventive, I think that evidence must be set against his agreement that the use of percolation to obtain a solution of a given concentration was not usual, and also be set in the light of the compromising effect of knowing the patentee’s claims and of absorbing similar conceptions of other patents not shown to be part of the general knowledge. These factors explain his fundamental reliance upon the well known dissolution principles of percolation to answer the antecedent and different (though related) question of the inventiveness of the idea of bringing those principles into play. He was given that answer. Thus, he, naturally, tended to emphasise the well known principles to explain it.
Professor Coster, as I have said, did tend to advocate the respondent’s position. I approach his evidence with a modicum of caution. Professor Coster sought in his affidavits to describe known methods of preparation of dialysis fluids as including the use of methods which could be said to reflect the percolation process feeding concentrate solution into a stream of water (see [28] of his first affidavit) and [18] of his second affidavit).
In [28(d) and (e)] of his first affidavit he said:
[28]In preparing the dialysis fluid for use in haemodialysis, the aim is to produce a stable, contaminant-free dialysis fluid with the concentration of the desired solutes in a tightly defined range. This can be achieved either by:
…
(d) by a process of percolation, where water is passed through a packed column to produce a stream of a solution containing the dissolved solute, the concentration of which can be adjusted by further mixing with a stream of water in a controlled manner (Method D); or
(e) by withdrawing solution from a vessel containing a saturated solution of the solute and mixing this solution with a stream of water. The source of the saturated solution being maintained by the continuous or intermittent addition of water to the aforementioned vessel which contains an excess of the powder solute (Method E).
At best, this evidence can be seen as to how, with the benefit of the knowledge of the Patent, this could be done. The evidence of Mr West and Ms Yuill (and the lack of evidence to the contrary by Professor Schindhelm) was clear that the fourth and fifth methods identified by Professor Coster (methods D and E in [28] of his first affidavit and [18] of his second affidavit) were not used in the operation of the prior art.
Further, Professor Coster’s accession (though not immediate) to the proposition that it was not usual to use percolation to obtain a solution of a specific concentration and the lack of any examples (other than the creation of sugar syrup) of use of percolation to dissolve a solute to create a solution sit uneasily with his statements that percolation and the withdrawal of a saturated solution from a vessel and the mixing of it with a stream of water would have been well known to someone in the field of improving dialysis systems. He was not in that field, and he was not a chemical engineer. His views may be seen to go beyond even those of Professor Schindhelm. To the extent that he was saying that a skilled but non-inventive person in that field would have been led directly by common general knowledge to use percolation and withdrawal of produced solution to place into a water stream, he perhaps can be seen as saying no more than Professor Schindhelm. Professor Coster’s views are compromised by the matters which affect Professor Schindhelm’s evidence, as well as the further unexplained material to which he had recourse, and what I perceived to be somewhat of a combative advocacy which he displayed. From the evidence of those with direct knowledge of how the art worked, and from the evidence of Professor Schindhelm with his deep experience in chemical engineering and his familiarity with dialysis techniques, I do not think it open to conclude that those engaged in the art (or those concerned with improving dialysis machines) used techniques, or would have thought it usual to use techniques, for the preparation of dialysis fluid with the concentration of the desired solutes in a highly defined range by the means described in [28(d) and (e)] and [18(d) and (e)] of Professor Coster’s first and second affidavits respectively. To the extent that Professor Coster was seeking to say in these paragraphs or in evidence such as [33] to [38] of his first affidavit the same as Professor Schindhelm in the first paragraph of [98] of his first affidavit, I am not persuaded that that is reliable evidence to contradict the illuminating evidence of Dr Davies and the balance of the evidence.
In his third affidavit (dated 18 July 2003) Professor Coster said in [7] the following:
In paragraph 28 of my First Affidavit I refer to five different ways by which concentrated fluids for use in dialysis may be prepared. Before the priority date I regularly used each of these methods for making up solutions and instructed students from time to time to use these methods, as appropriate.
Professor Coster accepted that method E ([28(e)] and [18(e)] of his first and second affidavits, respectively) was not used in relation to haemodialysis before the Priority Date. The example proffered by Professor Coster was described by him at Tp 344:
Ms Howard:And you've given no examples of this being done?
Prof Coster:In haemodialysis?
Ms Howard:Yes?
Prof Coster:No. It's a nice exercise for students which I used to set. If you haven't got a balance and you want a two molar solution of sodium chloride but you've got data, how can you do it? Well, one way of doing it is to get some water, chuck in an excess of sodium chloride, until it's saturated, then you can look up what that concentration is and then you know much to dilute it to get two molar, so you can do it without weighing. And it's a nice little exercise.
This, with respect, was neither method E nor the invention described and claimed. No other example was given.
Overall, the balance of Professor Coster’s evidence was to the same effect as Professor Schindhelm’s – that the basic principles were such that the step taken in the Patent to improve the dialysis system was self evident to the skilled but uninventive designer or improver of such systems. For the reasons I have given I do not find that evidence persuasive to outweigh Dr Davies’ evidence.
The problems involved in the use of B concentrate had been evident for decades. They resurfaced in the early 1980s when the use of acetate alone became a problem for clinical reasons. The priority date is February 1987. There is no evidence before me upon which I can conclude that the design of the system, once the conception of the use of powder in a vessel on-line was made, would take very long. Indeed the evidence of Professor Schindhelm and Professor Coster would indicate that the fundamental principles were basic. If the conception was obvious and the principles to put it into effect basic, no explanation was given of why no person had redesigned dialysis machines before to employ such a system. The difficulties of B concentrate were well known. As Professor Schindhelm said the solution of the Patent was “very nice”. He accepted that it was a simple, effective and efficient solution to the problem. The evidence permits the inference of the presence of commercial organisations interested in improvements to such machines. Years passed from the re-emergence of the use of B solution and its attendant problems, to the Priority Date.
The approach of the respondent must be set in this context. That approach was to analyse the intellectual elements of the approach to the improvement. The following formed part of the respondent’s approach which, taken element by element, as a process of analysis, can be accepted: it was tolerably clear that the problem would be solved by removing water from the solution, see Dr Davies evidence referred to above; that left solid bicarbonate (whether powder or other dry state); the low solubility of bicarbonate was well known; thus, the answer to the problem was bringing water to the dry bicarbonate on-site; there were two known broad types of method known in chemistry for dissolving a soluble salt in water – placing the salt in a container with water and mixing, by stirring or shaking, and placing the salt in a container and passing water through the bed of that salt; the second such method was known to be more suitable for salts of low solubility; and the principles of percolation or leaching were well known to chemical engineers as part of their fundamental knowledge.
At this point the respondent refers to the evidence of Professor Schindhelm at [92] of his first affidavit that at the Priority Date the principles governing the dissolution of soluble salts in water referred to above were well known to a person with a chemical engineering qualification as well as some understanding of the elements of mechanical or fluid engineering. Further, and importantly however, he concluded [92] by saying:
[I]t was well known to such persons that a liquid-solid system based on percolation could produce a flow of solution at a known concentration.
With this link the respondent submitted that the inventive step was obvious. The intellectual process from the recognition of the need for withdrawal of water to its in situ replacement by percolation, at each step, was said to be obvious. Put another way, Professor Schindhelm said the following at [41] of his first affidavit:
In my opinion the change made by Gambro to the existing dialysis systems is neither new nor inventive. The Patent involves the replacement, as a source of the bicarbonate concentrate solution, of a vessel containing liquid bicarbonate with a vessel containing bicarbonate in powder form to which water is added. No other change is made to the existing dialysis systems.
There are a number of important difficulties with, or at least qualifications to, accepting this reasoning process as determinative of the question of obviousness. First, the evidence of Professor Schindhelm of the kind in [92] referred to above must be understood against the recognition that he accepted that it was not usual to use percolation to prepare a solution of a specific concentration. Secondly, percolation or leaching was not shown to produce solutions from pure solute (as opposed to extracting solute by leaching) other than sugar syrup. Thirdly, none of the references provided by Professors Schindhelm and Coster refers to production of dialysis fluids by passing water through a vessel. Fourthly, someone (namely, Dr Davies) of eminent qualifications, who fitted the description of a person with chemical engineering training, with an understanding of concepts of mechanical or fluid engineering and with an understanding of the prior art (though given to him for the exercise) did not come to the invention or improvement in the Patent.
Overall, weighing all the evidence of Professors Schindhelm and Coster and Dr Davies, I am not prepared to conclude that the invention was obvious. Indeed I do not think that it was.
Particular submissions were put in relation to the individual claims in relation to obviousness.
It was submitted that if “containing” means “includes” then a “vessel containing a powder concentrate” does not have a limitation requiring that the vessel have no water in it. It was submitted that the claim in claims 1 and 2 was sufficiently wide to incorporate the mixing method used in the 1980s. I cannot agree. The vessel contains powder, not powder and water and water is introduced by the second fluid conducting means. Read in the light of the prior art and the body of the specification, for the reasons I have earlier set out, on-line continuous operation is contemplated by the claims.
Submissions were made that there was nothing inventive about passing of water from top to bottom (being no more than leaching), the requirement for a constant concentration (which could be effected by a batch method or use of percolation), the requirement of a particular particle size and the use of a cartridge. These submissions reflected the emphasis of the respondent’s case that the explanation of the successful operation of the Patent could be explained by well known principles. That however does not make obvious the conception and implementation of the idea in the manner claimed.
I am fortified in my conclusion that the invention is not obvious by a number of facts and circumstances. First, at the conclusion of the cross-examination of Professor Schindhelm the following exchange took place:
Mr Catterns: When you were at the centre at the university, what was its correct title?
Prof Schindhelm: The Centre for Biomedical Engineering, at that time.
Mr Catterns: Your colleagues were working at biomedical engineering solutions to a number of problems in your various fields, weren't you?
Prof Schindhelm: Yes.
Mr Catterns: And as well as operating at a high level of academic excellence, it was a fairly entrepreneurial centre wasn't it?
Prof Schindhelm: Yes.
Mr Catterns: It was, amongst other things, aware of the value of patents from the point of view of the centre, and if you could find something patentable?
Prof Schindhelm: It would have been, yes.
Mr Catterns: I think, was it at the time he was head of the centre that Professor Farrell was Businessman of the Year?
Prof Schindhelm: I don't know, my memory is not good.
Mr Catterns: But if you or your colleagues came up with something that you thought was patentable, did you patent them or seek advice as to whether something was patentable?
Prof Schindhelm: We did.
Mr Catterns: And are you yourself named as an inventor on any patents?
Prof Schindhelm: Yes.
Mr Catterns: Have you got a rough idea how many?
Prof Schindhelm: Eight to ten.
Mr Catterns: Are there any, broadly speaking, in the field of dialysis?
Prof Schindhelm: No.
Mr Catterns: Were you aware in 1987 of any problems caused or inconvenience caused by the making of the B solution in nine or ten litre drums by nurses at the point of haemodialysis?
Prof Schindhelm: I was aware of the inconvenience and the problems posed by it, yes.
Mr Catterns: But it didn't occur to you or your colleagues to come up with a solution of the type that the Gambro patent does?
Prof Schindhelm: No.
Mr Catterns: Would you agree that it is an elegant solution to that problem?
Prof Schindhelm: It is a very nice solution to that problem.
Mr Catterns: And it's simple, effective and efficient?
Prof Schindhelm: It works, yes.
Mr Catterns: But it's simple, effective and efficient, isn't it?
Prof Schindhelm: Yes.
Mr Archibald submitted that this exchange was limited to the cartridge, which enters the claims at claim 28. I did not understand this evidence at the time, nor do I read it, as so limited. I think this exchange with Professor Schindhelm, together with his ready acceptance of the proposition that it was not usual to prepare a solution of solute of a given concentration by using a percolation process and the evidence of Dr Davies, illuminated the question of whether it could be said that the respondent had proved that there was not even a scintilla of invention in the conception and implementation of the ideas set out at [352] by the claims in the Patent.
Secondly, the apparent commercial success and acceptance of the applicants’ system conforms with a conclusion that an appreciable practical advance was made. In June 1996, the respondent reported to its parent company that the biBag system was vital to the respondent, since most hospitals would not consider the purchase of machines if an on-line bicarbonate system was not offered. One document, a marketing plan of the respondent in 1996 for Australia, identified as a threat to the respondent’s business new technology and innovation such as Bicart (the name of the applicants’ on-line cartridge system) which was identified as one of the applicants’ strengths in Australia. Whilst one needs to exercise caution in taking too much from the indicia of some commercial success without a complete understanding of the business and the market it trades in, in particular one needs to recognise that such indicia are not to be used as a surrogate for analysis of the evidence of the art and the relevant principles, they are considerations which are not foreign to drawing an overall conclusion as to whether the respondent has proved that there was no inventive step: the 3M case at 298, and Firebelt Pty Ltd v Brambles Australia Ltd at 292-93 [47]-[51].
Thirdly, the respondent has the onus of proof in respect of obviousness. It is the Australian subsidiary of the German parent which designed and designs and manufactured and manufactures, amongst other things, dialysis machines and systems. I was not assisted by any evidence whatsoever of the development of the biBag system. Further, only a handful of documents were discovered by the respondent concerning research and development by the German parent and related bodies corporate in relation to the biBag system. Shortly after 10 May 2002, Tamberlin J made an order (in [2002] FCA 581) of the kind suggested by Lockhart J in Sabre Corp Pty Ltd v Russ Kalvin’s Hair Care Co (1993) 46 FCR 428, 432. The order was that the respondent take all reasonable steps to obtain such documents from other companies in the Fresenius Group. No such documents were discovered. A stay was sought. Tamberlin J refused to stay the cross-claim: [2002] FCA 1359; 56 IPR 446. His Honour did, however, conclude that the cursory efforts disclosed by the evidence did not amount to all reasonable attempts to obtain the documents. Whilst I accept that there may well have been significant logistical difficulty in those in Germany identifying and collecting documents concerned with the research and development of the biBag system, the evidence allows me to conclude that there was no disconformity in interest between the respondent and its German parent. If there was evidence that the biBag system was developed in circumstances, which demonstrated facts to assist the assertion of obviousness, I would have expected that it be called. The applicants, similarly, did not lead evidence of the “process of invention” undertaken. But the respondent bore the onus on the question of obviousness. Overall, I do not ascribe significant weight to this factor, except to say that it is a factor to weigh in the balance in giving me comfort in the conclusion that I have otherwise drawn that the Patent was not obvious.
Residual Rulings on Evidence
During the hearing, after discussion with both senior counsel for the parties, I took the course of admitting some material in affidavits subject to objection. I indicated to the parties that I would rule on these matters on a final basis in my judgment. Both sides indicated that not only did this not cause them any difficulty, but that in the circumstances it was the preferable course.
The rulings on evidence made during the course of the trial are contained in exhibit C and exhibit C1, being the rulings on applicants’ objections to respondent’s affidavits and summary of rulings on respondent’s objections to the applicants’ evidence, respectively.
Exhibit C – Rulings on Applicants’ Objections to Respondent’s Affidavits
First Affidavit of Professor Schindhelm 27 December 2001
Whole I will not reject the whole of the affidavit , rather I will deal with relevant particular objections.
Para 17 and remainder of affidavit so far as it relates to obviousness The applicants objected by reason of the material before Professor Schindhelm not being part of the common general knowledge. I do not propose to reject the evidence of Professor Schindhelm for this reason. As can be seen by what I have earlier said, I think he is in the correct field of expertise and any particular difficulties with the foundation for his evidence goes to weight. Paras 20-21 I allow the paragraphs. Paras 33-37 I allow the paragraphs. Para 34 I allow the paragraph. Para 40 I reject the paragraph, but allow it, as I did with other paragraphs at the trial, to remain as a submission. The issue is one of the construction of the claims. I do not see the necessity for any particular expertise of the witness in reading the claims in the respects set out in this paragraph. Para 90 I allow the paragraph. Para 91 I allow the paragraph. Para 93 I allow the paragraph. Para 94 I allow the paragraph. Para 95 I have earlier referred to the fact that it was not proved that Remington’s was part of the common general knowledge of the relevant worker in the field. To that extent the evidence should perhaps be rejected. However, I have dealt with it on the basis that it is not material of that kind and I will allow it subject to weight and also to form the foundation for understanding my reasons otherwise. Para 96 I allow the paragraph. This evidence is sufficient in my view to support the proposition that someone with the chemical engineering background had as part of his or her common general knowledge the applications of the leaching process referred to in the work. Para 98 I have already commented upon the difficulties of the two paragraphs of [98] of the affidavit. I think the better course is to allow the paragraphs to remain. They have the difficulties to which I have earlier referred. I have taken the view that those matters go to weight. Others may have a different view. Another course would be to reject this evidence. If there were any doubt about the legitimacy of discounting Professor Schindhelm’s views because of the effect of the operation of knowledge of Stasz and Mund in this thinking (although obtained after he initially formulated his view) I would reject the two paragraphs. Para 99 I make the same observations. Para 100 I reject this paragraph. Para 101 I allow the paragraph.
Professor Schindhelm’s second affidavit 16 June 2003
Whole I do not propose to reject the whole of the affidavit.
Para 9 from the words “and any team” in the third sentence to the end. I allow these parts of the paragraph. Para 12 second last sentence I allow the sentence. Para 14 I reject the paragraph. The question of the skilled addressee or the relevant worker is not assisted by the evidence of Professor Schindhelm in this regard. Para 15, third, fifth, sixth and seventh sentences I reject the third sentence. Professor Schindhelm lacks personal knowledge for this evidence. I allow the fifth sentence and I reject the sixth and seventh sentences on the basis that Professor Schindhelm lacks the personal knowledge to give that evidence. Para 16 second sentence and last sentence I allow both sentences. Para 38 third, fourth and fifth sentences I reject these sentences. They are not based on Professor Schindhelm’s personal knowledge. Para 39 I reject this paragraph on the same basis. Paras 41-77 The parties were to identify portions to be rejected and portions to remain as submission only. In the document which was sent to my chambers the relevant schedule for paragraphs 41-47 was not attached. The parties should identify that schedule so that exhibit C can be completed. Para 78 Other than dealing with the sentences already dealt with in exhibit C, I do not propose to reject the balance of paragraph 78. Para 80 I have dealt with part of paragraph 80. I otherwise admit it. Paras 82 and 83 Although Professor Schindhelm had some experience of working with nurses and dialysis technicians as revealed exhibited in his third affidavit, I do not think, in form, that these paragraphs should be allowed. He does not purport to be recalling his experiences. I reject paragraphs 82 and 83. Para 85 second and third sentences For the same reasons I reject these sentences. Para 85 last sentence I reject this sentence. It is an argumentative submission. Para 86 I think this is argumentative submission and should be rejected. Para 87 I allow the paragraph. It sets Remington’s in its place. However, I do not think that it amounts to proof that it is in the common general knowledge of someone with chemical engineering expertise who is attempting to improve a dialysis machine. Para 88 This concerns the dissolution of sugar into a syrup which I have already described and dealt with. I will allow it. Para 89 Again I have dealt with this earlier in a manner going to weight. I will allow the paragraph. Para 91 I allow the paragraph. Para 92 I allow the paragraph. The paragraph shows, it seem to me, the difficulty of disclosing the Patent to the witness. The thought processes involved at paragraph 92 flow from the existence of the general principles and are necessarily divorced from a conception of looking forward from the Priority Date without the benefit of the improvement identified in the Patent. Para 94 second sentence I allow the sentence. Para 95 second sentence I reject the sentence. Para 97 last sentence of second paragraph I allow the sentence
Professor Coster’s First Affidavit 27 December 2001
Whole I do not propose to reject the whole of Professor Coster’s affidavit.
Para 18 I allow the paragraph.
Professor Coster’s Second affidavit 28 May 2003
Whole I refuse to reject the whole of Professor Coster’s second affidavit.
Para 5 I admit the first, second and third sentences. I reject the balance of paragraph 5 as not shown to be within Professor Coster’s personal knowledge or expertise. Para 10 second sentence I reject the sentence as being beyond his expertise and personal knowledge.
Affidavit of Lindsay Malcolm Berry 12 November 2001
Mr Berry’s affidavit was relied upon as material going to the skilled worker in the field as to obviousness. Mr Berry was a dialysis technician, as was Mr West. After a career in the Navy Mr Berry took up being a dialysis technician. His evidence revealed his skill in that field. However, he was not a chemical engineer or scientifically trained. Some of his evidence was the subject of agreement, such as the schematic representation of the type two and type three systems. Mr Berry did not begin to be employed as a dialysis technician until after the Priority Date. Much of his evidence is a description of how the machines work and a description of the alleged infringing systems.
I do not understand his evidence as to the operation of the various systems to be in dispute. Mr Berry was not cross-examined. However, to a degree, woven into Mr Berry’s evidence could be said to be statements as to the common general knowledge or the state of the art at the time of the Priority Date. I will deal with Mr Berry’s evidence in this way that I will allow it to the extent that it is a description of the respondent’s system, but reject it to the extent that it can be said either expressly or impliedly that it seeks to give or has the effect of giving evidence as to the common general knowledge or state of the art at the Priority Date or the meaning of the terms in the Patent.
Affidavit of Terrence James West 13 November 2001
It follows that I would reject the whole of Mr West’s evidence in this and later affidavits to the extent that he seeks to interpret the Patent or give evidence as to the relevant worker in the field.
I would make the same conclusion as to Ms Yuill’s evidence.
It should be noted however, that the evidence of Mr West and Ms Yuill was of invaluable assistance in understanding the nature of the procedures undertaken leading up to the Priority Date and the practical day to day aspects of dialysis and related procedures.
I will turn to the particular affidavits of both Mr West and Ms Yuill.
Affidavit of Terrence James West sworn 13 November 2001
All matters in this affidavit were dealt with by the rulings on transcript pages 103 and 104.
Affidavit of Terrence James West sworn 17 February 2003
Paragraph 2.1 save for the I reject paragraph 2.1.
second last sentence which was admitted subject to the limitation referred to at page 125 of the transcript Para 5
Para 2.7 third sentence to end I reject this part of the paragraph. Para 2.8 I reject this part of the paragraph. Para 3.2 first two sentences I reject the sentence. Para 16.5-16.31 and
16.33-16.3I reject these paragraphs. Mr West does not have the relevant expertise. Para 19.4 second sentence. I reject the sentence. Para 21.1 I allow the paragraph. This is not expert evidence from the skilled worker for the purposes of obviousness, it is direct evidence as to practice that Mr West had experienced as to the use of the percolation process. I limit the effect of the evidence to Mr West’s personal knowledge. Para 22.7 to 22.10 I reject these paragraphs as not based on his expertise.
Affidavit of Terrence James West sworn 8 July 2003
Objection is taken to the affidavit because it was served late. Whilst it was served late the respondent had ample time to develop any aspect of cross-examination to it. More particularly is the difficulty of the kind of evidence Mr West was attempting to give in the affidavit. It is a continuation of the discourse he attempted to have with Professor Schindhelm and Professor Coster. I do not think any of the affidavit is useful. Mr West is not the relevant worker in the field for the improvement of dialysis of machines. His views on Professor Schindhelm’s and Professor Coster’s affidavit are not helpful and are not relevant, save to the extent that what he says is a statement of fact as to practice at the time before the Priority Date. To this extent I allow paragraphs 2.3, 2.4, 2.7, 2.8, 3.2, 3.5 and 3.6.
Affidavit of Elizabeth Jane Yuill 18 February 2003
Para 14 I allow the paragraph. This is not inadmissible evidence of someone who is not the relevant worker in the field. It is real evidence of the introduction of the various systems into the market. Ms Yuill was entitled and qualified to deal with all matters otherwise than those previously rejected in paragraph 14.5.
Para 15 With the exception of paragraph 15.4 otherwise dealt with at transcript pages 75, 76 and 78, I allow paragraph 15. Para 16 Save for the matters otherwise dealt with at transcript pages 76, 78, 80, 85 and 86, I allow the paragraph. Once again, it is not inadmissible evidence of a worker who is not the skilled worker rather, it is real evidence of events of which Ms Yuill is qualified to give evidence.
Conclusions
It follows from the above that I would make orders conformable with my conclusions that there has been infringement of the claims as pleaded by the applicants and that I would dismiss the cross-claim. The parties requested that I not make orders so that they may have an opportunity to consider my reasons and formulate what they think are the appropriate orders to reflect what I have said. I am content with that approach.
Should the parties take the view that any aspect of the case has not been dealt with I would expect the parties to raise that matter in the context of the formulation of the orders. This is not an invitation for reargument.
May I once again, having done so at the trial, thank counsel and solicitors for their skilled and efficient presentation of the case. The presentation at the hearing took place, if I may be permitted to say so, with economy, comprehensiveness and despatch.
I would expect the solicitors for the parties to remedy the deficiency in exhibit C concerning [41]-[77] of Professor Schindhelm’s second affidavit after contacting my associate.
I certify that the preceding four hundred and forty-nine (449) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Allsop .
Associate:
Dated: 25 March 2004
Counsel for the Applicant:
Mr D K Catterns QC
Ms K Howard
Solicitor for the Applicant:
Blake Dawson Waldron
Counsel for the Respondent:
Mr A Archibald QC
Mr S Burley
Solicitor for the Respondent:
Allens Arthur Robinson
Dates of Hearing:
21, 22, 23, 24, 25, 30 and 31 July and 1 August 2003
Last Submissions filed:
7 August 2003
Date of Judgment:
25 March 2004
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