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PATENTS - validity of claimed invention for measuring glucose levels in blood - novelty - sufficiency of specification - ambiguity of - meaning of the word "comprising" and the word "or" - manner of manufacture - obviousness - prior art relating to the subject - whether claims fairly based on the complete specification - whether prior claiming is available as a ground of revocation under the Patents Act 1990 (Cth)

Pojani v Minister for Immigration & Multicultural Affairs [2002] FCAFC 1283

Pojani v Minister for Immigration & Multicultural Affairs [2002] FCAFC 1283 (18 October 2002)
Last Updated: 18 October 2002


FEDERAL COURT OF AUSTRALIA
Abbott Laboratories v Corbridge Group Pty Ltd [2002] FCAFC 314


PATENTS - validity of claimed invention for measuring glucose levels in blood - novelty - sufficiency of specification - ambiguity of - meaning of the word "comprising" and the word "or" - manner of manufacture - obviousness - prior art relating to the subject - whether claims fairly based on the complete specification - whether prior claiming is available as a ground of revocation under the Patents Act 1990 (Cth)

WORDS & PHRASES - "comprising" - "or"

Patents Act 1952 (Cth) s 100(1)(f)

Patents Act 1990 (Cth) ss 18(1)(a), 18(1)(b), 18(1)(c), 40(2)(a), 40(3), 138(3), 233(4)

Statute of Monopolies 1623 (UK) s.6

Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd (2001) ALR 460, followed.

General Clutch Corporation v Sbriggs Pty Ltd (1997) 38 IPR 359, followed.

Minister for Immigration & Ethnic Affairs v Baker (1997) 73 FCR 187, cited

Advanced Building Systems Pty Ltd v Ramset Fasteners (Aust) Pty Ltd (1998) 194 CLR 171, cited

NV Philips Gloeilampenfabrieken v Mirabella International Pty Limited (1993) 44 FCR 239, followed.

British Thomson-Houston Company Ltd v Corona Lamp Works Ltd (1922) 39 RPC 49 (HL), cited.

Blanco White, Patents for Inventions 5th ed. 1983.

Terrell on the Law of Patents 15th ed. 2001.

CIPA Guide to the Patents Acts 5th ed. 2001.

ABBOTT LABORATORIES v CORBRIDGE GROUP PTY LTD

N 1166 OF 2001

LEE, EMMETT & HELY JJ

18 OCTOBER 2002

SYDNEY

IN THE FEDERAL COURT OF AUSTRALIA



NEW SOUTH WALES DISTRICT REGISTRY
N 1166 OF 2001




ON APPEAL FROM A SINGLE JUDGE OF THE FEDERAL COURT OF AUSTRALIA

BETWEEN:
ABBOTT LABORATORIES

FIRST APPELLANT



ABBOTT AUSTRALASIA PTY LTD

(ACN 000 180 389)

SECOND APPELLANT


AND:
CORBRIDGE GROUP PTY LTD (ACN 050 105 256)

FIRST RESPONDENT



INVERNESS MEDICAL ASIA PACIFIC PTY LTD (

(ACN 076 031 331)

SECOND RESPONDENT


JUDGES:
LEE, EMMETT & HELY JJ


DATE OF ORDER:
18 OCTOBER 2002


WHERE MADE:
SYDNEY




THE COURT ORDERS THAT:

1. The appeal be upheld.

2. The orders of Gyles J made on 24 November 2000 be set aside and in lieu thereof the following orders be made:-

a. the respondents be restrained from infringing Australian Patent Number 572138 by importing into Australia, or by sponsoring such importation, and supplying to wholesalers and retailers, a product known as the Excel ET Blood Glucose Test Strip; and

b. the respondents pay the applicants' costs.

3. The respondents pay the appellants' costs.

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
N 1207 OF 2001




BETWEEN:
CORBRIDGE GROUP PTY LTD (ACN 050 105 256)

FIRST APPELLANT



INVERNESS MEDICAL ASIA PACIFIC PTY LTD

(ACN 076 031 331)

SECOND APPELLANT


AND:
ABBOTT LABORATORIES

FIRST RESPONDENT



ABBOTT AUSTRALASIA PTY LTD

(ACN 000 180 389)

SECOND RESPONDENT


JUDGES:
LEE, EMMETT & HELY JJ


DATE OF ORDER:
18 OCTOBER 2002


WHERE MADE:
SYDNEY




THE COURT ORDERS THAT:

1. The appeal be upheld in part.

2. Orders 1 and 3 made by Gyles J on 18 July 2001 be varied to provide as follows:

1. DECLARE that claims 4, 5, 6, 17, 18 and 19 of Australian Letters Patent Number 572138 are, and at all material times have been, invalid.

3. ORDER that claims 4, 5, 6, 17, 18 and 19 of Australian Letters Patent Number 572138 be revoked.

3. The cross-claim in so far as it claims revocation of Australian Letters Patent Number 572138 be otherwise dismissed.

4. The matter be remitted to the primary judge for final determination of the cross-claim, pursuant to Order 13 made on 18 July 2001.

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





ON APPEAL FROM A SINGLE JUDGE OF THE FEDERAL COURT OF AUSTRALIA

N 1166 OF 2001

BETWEEN:
ABBOTT LABORATORIES

FIRST APPELLANT



ABBOTT AUSTRALASIA PTY LTD

(ACN 000 180 389)

SECOND APPELLANT


AND:
CORBRIDGE GROUP PTY LTD (ACN 050 105 256)

FIRST RESPONDENT



INVERNESS MEDICAL ASIA PACIFIC PTY LTD

(ACN 076 031 331)

SECOND RESPONDENT




N 1207 OF 2001

BETWEEN:
CORBRIDGE GROUP PTY LTD (ACN 050 105 256)

FIRST APPELLANT



INVERNESS MEDICAL ASIA PACIFIC PTY LTD

(ACN 076 031 331)

SECOND APPELLANT


AND:
ABBOTT LABORATORIES

FIRST RESPONDENT



ABBOTT AUSTRALASIA PTY LTD

(ACN 000 180 389)

SECOND RESPONDENT




JUDGES:
LEE, EMMETT & HELY JJ


DATE:
18 OCTOBER 2002


PLACE:
SYDNEY




REASONS FOR JUDGMENT
1 Abbott Laboratories ("Abbott") is the registered proprietor of Australian Patent Number 572138 ("the Sensor Patent"). Abbott Australasia Pty Ltd ("Abbott Australasia") is a licensee of the Sensor Patent. The Sensor Patent was granted on 11 October 1988 pursuant to the Patents Act 1952 (Cth) ("the 1952 Act"). Corbridge Group Pty Ltd ("Corbridge") has imported into Australia for the purposes of sale, and has supplied to wholesalers and retailers, quantities of a product known as the Excel ET Blood Glucose Test Strip ("the Excel Product"). Inverness Medical Asia Pacific Pty Ltd ("Inverness&qu;
ot;) sponsored the importation of the Excel Product into Australia.

THE PROCEEDING

2 Abbott and Abbott Australasia commenced a proceeding in the Court claiming orders restraining Corbridge and Inverness from infringing the Sensor Patent and other relief. By cross-claim filed in that proceeding, Corbridge and Inverness claimed, inter alia, a declaration that the Sensor Patent is invalid and an order that it be revoked. All claims concerning validity and infringement of the Sensor Patent were made under the Patents Act 1990 (Cth) ("the 1990 Act").

3 On 24 November 2000, a judge of the Court dismissed the application by Abbott and Abbott Australasia, having concluded, for reasons delivered on that day, that the Excel Product did not infringe any claim of the Sensor Patent. On 18 July 2001, for reasons delivered on 29 June 2001, the primary judge declared that certain claims of the Sensor Patent were invalid either in whole or to the extent that they were dependent on other claims. His Honour revoked Claims 4, 5 and 6 of the Sensor Patent and ordered that Claims 22, 23, 24, 25 and 26 be amended to remove all references to Claim 4.

4 However, his Honour dismissed the cross-claim in so far as it challenged the validity of Claims 1, 2, 3, 17, 18 and 19. His Honour also dismissed the cross-claim insofar as it challenged the validity of Claims 22, 23, 24, 25, and 26, except for the amendment just mentioned. His Honour reserved for further determination at first instance, if necessary, any other questions arising on the cross-claim, depending upon the outcome of appeals from the orders that his Honour made. To the extent that it was necessary, his Honour granted leave to appeal on 18 July 2001.

5 Abbott and Abbott Australasia now appeal to this Court from the orders made on 24 November 2000 dismissing the application and on 18 July 2001 concerning costs. Pursuant to the leave granted on 18 July 2001, Corbridge and Inverness appeal from the orders made on 18 July 2001, other than the revocation of Claim 4 and the amendment of Claims 22, 23, 24, 25, and 26. There has been no appeal by Abbott and Abbott Australasia from the orders revoking Claim 4 and its dependent claims.

6 The claim for infringement of the Sensor Patent depends upon the proper construction of Claim 1. No allegation is now made of infringement of any other of the Claims. The construction questions may also bear on the validity of the Sensor Patent. Logically, the validity of the Sensor Patent should be determined before considering questions of infringement. Several grounds of invalidity are relied on, which are mentioned below. However, before dealing with the questions raised by the appeals, it is desirable to say something about the Sensor Patent generally.

THE INVENTION OF THE SENSOR PATENT

7 The complete specification for the Sensor Patent ("the Specification") refers to Australian Patent Application Number 89722 of 1982, which resulted in Australian Letters Patent Number 552772 ("the Mediator Patent"). The Mediator Patent describes the construction of sensors comprising a conductive electrode coated with a mixture, or layers, of a catalytically active enzyme and a mediator compound and usually further coated with a retaining permeable membrane. Several mediator compounds are described in the Mediator Patent but the preferred mediator compounds mentioned are metallocene compounds generally, and ferrocenes in particular.

8 The Mediator Patent is treated as part of the prior art relating to the subject of the Sensor Patent. The Specification refers to the fact that, when a conductive electrode that is coated with a catalytically active enzyme and a mediator compound is contacted with a substance for which the enzyme exerts a catalytic effect, the mediator compound transfers charge to the electrode. That can be used to give a read-out signal, against a standard electrode, correlated with the concentration of that substance. That effect can be achieved even in the presence of other substances, since the enzyme chosen is one that will be highly specific in its catalytic action.

9 For example, the use of glucose oxidase or bacterial glucose dehydrogenase as an enzyme, associated with a suitable mediator compound, has been shown to give read-out signals correlating lineally with in vitro blood glucose levels over a wide range. That phenomenon gives a diagnostic or measuring tool for the measurement of blood glucose, which is of use in controlling conditions such as diabetes mellitus.

10 According to the Specification, the prior art includes equipment utilising sensor electrodes. Such equipment is, in general, suitable for research or institutional use. The claim of the Sensor Patent is to provide devices for use by laypersons, or persons without extensive technical back-up services, to detect the presence of specific substances, such as glucose in the case of diabetics. The Specification claims the establishment of "certain design criteria" in the production of devices for lay or clinical use.

11 The invention of the Sensor Patent might be described as a small scale or miniaturised sensor device for the detection, measurement or monitoring of a particular substance that forms part of a mixture of substances. It does so by means of an electric current passing through two electrodes, a sensitive electrode and a reference electrode, which are in direct contact with the mixture. As a result of this, there is an electrochemical reaction capable of being measured by a meter attached to the device or incorporated in the device. The electrochemical reaction relies upon the presence of a mediator compound and an enzyme that is specific to the substance of interest and might vary according to the substance of interest. The mediator compound and the enzyme are attached to, or form part of, the sensitive electrode.

12 The terms of the principal Claims of the Specification, being Claims 1, 3, 4, 7, 8, 12, 16, 20 and 21, are set out in the Schedule to these Reasons. Those claims might be summarised as follows:

* Claim 1 (of which Claim 2 is a variant) is concerned with two electrodes of small dimensions extending as, or supported on, an elongate member to facilitate manipulation of the elongate member during contact with live tissue or withdrawn body fluid.

* Claim 3 is concerned with an elongate member on which the two electrodes are supported and which is dipped into a liquid medium containing the substance of interest.

* Claim 4 (of which Claims 5 and 6 are variants) describes two flat electrodes on the same surface small enough to be completely coverable by a smear of blood produced from a non-expressed drop of blood generated by a needle prick. Claim 4 was revoked because there is no mention of the material of the sensitive electrode that is an essential integer of the invention of the Sensor Patent, being the enzyme and the mediator compound.

* Claim 7 is concerned with a needle probe electrode carrier for placement through tissue into a measurement location, such as a blood vessel, in the form of a generally cylindrical pointed needle.

* Claim 8 (of which Claims 9, 10 and 11 are variants) relates to a metallic needle, constituting the reference electrode, which surrounds the sensitive electrode.

* Claim 12 (of which Claims 13, 14 and 15 are variants) involves a sensor where the sensitive electrode and the reference electrode are located on opposite faces of an elongate support.

* Claim 16 describes a two-part cell assembly, each part containing an elongate recess such that, when assembled, the recesses oppose each other and define a channel through which a liquid will flow thereby contacting the electrodes accommodated in each elongate recess.

* Claim 20 is a combination of an assembly of circuitry and display means for use in producing a read-out value of blood glucose level, in the form of a pen-like hollow housing, coupled with a strip test electrode carrier that is inserted into a socket at one end of the housing.

* Claim 21 describes analytical equipment comprising a cell, the parts of which, on assembly, jointly define a low volume liquid chamber, together with a pump causing liquid mixtures to flow into the chamber, the inner surfaces of which contain the two electrodes.

Claims 22, 23, 24, 25 and 26 are variants of the earlier Claims in which the material of the active electrode, the reference electrode, the enzyme or the mediator compound are specified.

13 The Specification describes the invention of the Sensor Patent as one that relates to sensor electrodes, and their combination with reference electrodes, as well as to the manufacture of such electrodes; to apparatus utilising the electrodes; and to electrical circuitry into which the electrodes can be incorporated. The invention is said to be concerned with providing sensor electrodes and equipment for use by lay persons or those without extensive technical back-up services.

14 After referring to the establishment of "design criteria" for the production of electrodes for lay, or clinical use, the Specification says that such electrodes can be used:

(a) in an invasive probe (i.e. one which enters body tissue to contact a body fluid such as whole blood or subcutaneous tissue fluid); or

(b) as part of an external test upon a withdrawn sample (using a syringe); or

(c) upon an expressed sample (e.g. using a needle-prick device).

15 The "design criteria" as disclosed in the Specification are:

* "in each instance" (i.e. presumably in the case of each of the uses referred to in (a), (b) and (c) of paragraph [14] above) the electrode must be "as small as practical to avoid trauma either on invasion of the tissue or withdrawing of the sample";

* if invasive, "it" must be throwaway, to avoid cross-contamination and to prevent encapsulation by fibroblast cells which occurs with long-term implants;

* "it" must be elongate, either to fit within a pointed needle, or for ready handling as an electrode for ready assembly to equipment on the one hand and contact with the sample on the other;

* "it" must be "sensitively manipulable"; and

* "it" must carry, prior to assembly or in the assembled structure, the reference electrode as well as the "sensitive" electrode, in a spaced non-contiguous relationship.

16 The Specification then provides that "the present invention, in a major aspect, consists [of] sensor means" (emphasis added). The Specification then describes the sensor means, in terms identical to the terms of Claim 1, as follows:

"...sensor means for selective detection, measurement or monitoring of a given dissolved substrate in a mixture of dissolved substrates, comprising:-
(a) an area of first electrode material comprising an enzyme catalytic of the said substrate and a mediator compound to transfer charge to the electrode when the enzyme is catalytically active, adjacent to but non-contiguous with;

(b) an area of reference electrode material; both electrodes being of small dimension, and extending as or supported on an elongate member to facilitate manipulation before or during contact with live tissue or a small withdrawn sample of body fluid."

(emphasis added)

There is a semi-colon immediately before the part emphasised. There also appears to be a semi-colon in Claim 1 itself, although that is not entirely clear in the copy of the Specification in the appeal books. In any event, it is clear enough that the part of (b) that is emphasised, which is in identical terms in Claim 1, should be read as qualifying both (a) and (b). Neither party submitted to the contrary.

17 Ordinarily, a patent specification includes a consistory clause, although there is no requirement that it should do so. The consistory clause is conventionally the widest description of the invention. It is often in the same terms as the first claim. One would ordinarily expect that a consistory clause would describe the invention in a way that would include subsequent claims.

18 "The present invention consists of" are conventional words of introduction in a consistory clause. However, in this case that part of the Specification that might qualify as a consistory clause describes what the invention consists of in a major aspect. The words that we have emphasised signify that Claim 1 is not all encompassing. That this is so, is reinforced by an examination of subsequent claims. Claim 1 does not cover dipping sensors such as those described in Claim 3 (which do not include the Claim 1 limitations flowing from the use of the term "small"). Nor does Claim 1 cover assemblies such as those described in Claim 16 or the pen-like device described in Claim 20.

19 The Specification then describes four categories into which the sensor devices can be divided being:

* external sensors;

* invasive sensors;

* sensors with dual capacity; and

* sensors assembled in situ.

20 External sensors are described as those used by dipping into, or similarly contacting, a liquid substance, such as blood, with both electrodes. The section on external sensors describes sensors in terms of Claims 3 and 4.

21 Invasive sensors are described as being generally needle-like in nature or able to fit within a hollow needle. One form described in the Specification provides a needle probe electrode carrier for placement through tissue into a measurement location such as a blood vessel. In that case, the device takes the form of a generally cylindrical pointed needle having formed in it, near the pointed end, two flat depressions spaced apart longitudinally. The active and reference electrodes are contained in the two flat depressions. The section on invasive sensors describes sensors in terms equivalent to Claims 7, 8, 10 and 11.

22 Dual capacity sensors are described as sensors that are structured such that they may be dipped into an extraneous substance or mixture, or used within a needle. One example of such a device is where the sensitive electrode and the reference electrode are located on opposite faces of an elongate non-conductive support of rectangular cross-section. The section on dual capacity sensors describes sensors in terms equivalent to Claim 12.

23 Assembled sensors are described as sensors made up as permanent support strips. It is said to be within the ambit of the invention to provide a two-part cell assembly, an assembly of circuitry and display means and analytical equipment comprising a cell. The section on assembled sensors describes sensors in terms equivalent to Claims 16, 20 and 21.

24 After describing a two-part cell assembly in terms of Claim 16, the Specification describes defects in the colourimetric method of testing for glucose levels which, if undertaken by means of a blood test, needs a large enough sample to cover the test surface. Blood samples, if taken on a self-treatment basis by a needle-prick of a finger, are normally not large enough and must be expressed, that is squeezed or massaged out, to form a larger drop. Over time the tissue of the extremities becomes scarred and coarsened by such treatment, such that finding fresh testing sites may present a problem:

"In order to embody the invention on a home-diagnostic basis a main object of the present invention in one aspect is as described above the provision of small scale non-traumatic test pieces, either as a small diameter invasive probe electrode or as an external test electrode strip capable of using the naturally-arising small blood droplet from a needle-prick tester, without tissue massage. Examples are described in more detail below."
25 The Specification then states:

"These small-scale electrodes are intended as single-use throwaway articles and are utilised in conjunction with electrical circuitry and a readout means, to which they must be easily attachable and detachable. Such circuitry and readout means is itself preferably embodied on a very small scale."
26 The Specification then describes a pen-like device the subject of Claim 20 for use in connection with a "detachable test member":

"Such equipment is of course particularly adapted for use with the non-invasive strip sensor defined above, but may also be used with the needle-type invasive sensors."
27 Figures 13a and 13b are diagrammatic views of a pen-like portable holder, "of particular utility for the electrodes shown in figures 4, 5 and 6". Figures 4, 5 and 6 show various forms of strip-supported electrode configuration. Figures 13a and 13b show a holder that is particularly adapted to utilise electrodes as shown in figures 4, 5 and 6 but which could, if necessary, utilise electrodes as shown in figures 1, 2, 3, 7 and 8, at least, of the various embodiments shown. Figures 1 and 2 are strip-supported electrodes, figure 3 is an invasive probe electrode, figure 7 is an alternative supported electrode and figure 8 shows a combination of two electrode supports.

CONSTRUCTION OF CLAIM 1

28 The integers of Claim 1 are:

* sensor means,

* for measuring a given substrate in a mixture of dissolved substrates,

* comprising:

- an area of first electrode material comprising an enzyme and a mediator compound;

- an adjacent, but not contiguous, area of electrode material;

- both electrodes being of small dimension; and

- both electrodes extending as, or supported on, an elongate member.

The Claim discloses the purpose of the last integer as being:

"to facilitate manipulation before or during contact with live tissue or a small withdrawn sample of bodily fluid."
29 It is common ground that a device involving "contact with live tissue" is an invasive device. The Specification describes that type of device as "an invasive probe - ie, one which enters body tissue to contact a body fluid such as whole blood or subcutaneous tissue fluid". On the other hand the Specification describes a test on a small withdrawn sample as being an external test, albeit the withdrawn sample may have been obtained by use of a syringe. A distinction is also drawn, in relation to samples of blood generated from a needle prick, between blood that is expressed as a result of tissue massage and blood that arises naturally from a needle prick. It is not clear what, if any, significance that distinction has.

The meaning of "comprising"

30 The primary judge held that "comprising" is used in the sense of including or containing the integers described, rather than in the sense of being composed only of them. It is obvious that sensor means cannot operate without something like the fourth integer of Claim 3, namely a separate electrical connection to each electrode for attachment to a readout means. It is also obvious that the first electrode must include conductive material. The primary judge held that as Claim 1 does not expressly refer to either of these matters, "comprising" should be read as "including", as the other construction would result in a claim of no practical use.

31 If Claim 1 is for a sensor means, the only requirement of which is that it includes certain features, then the scope of the claim might be enormous, and could include devices far beyond those described in the body of the Specification. In the context, it is difficult to construe "comprising" as meaning anything other than "consisting of" - see General Clutch Corporation v Sbriggs Pty Ltd (1997) 38 IPR 359 at 372-376.

32 Construing "comprising" in the sense of "consisting of" does not lead to the conclusion that Claim 1 is of no practical use. Claim 1 describes an electrochemical cell. The relevant addressee of the patent would fully understand that there must be a connection of each electrode to a readout means that will reflect the extent of the electrical reaction when the gap of the electrodes is bridged. The specification expressly discloses that the small-scale electrodes are used in conjunction with electrical circuitry and readout means to which they must be easily attachable and detachable.

33 The need for connections to a metering device are no part of the description of the invention, hence the omission of any reference to them in Claim 1 leads nowhere. The fact that they are expressly referred to in Claim 3 does not require a contrary conclusion. Alternatively, Claim 1 should be construed as impliedly incorporating the fourth integer of Claim 3.

34 That construction is not so much a matter of construing the word "comprising" as meaning "including". Rather it is a question of construing Claim 1 by reference to the Specification as a whole. The purpose of the sensor described in Claim 1 is to provide a means for detection, measurement or monitoring of a substance of interest by use of an electrical reaction. The reaction must be measured in some way, as is apparent from the body of the Specification. The integers of the invention are fairly stated. It is clear from the context of Claim 1, in the light of the description of the invention in the body of the Specification and in the other Claims, that there must be a connection of each electrode to a readout means which will reflect the extent of the electrical reaction when the gap between the electrodes is bridged.

35 Although there is no reference to the material of the electrodes in Claim 1, as there is in Claim 3, to the effect that the electrodes are to be of "electrically conductive material", there is no need for such a reference. It is clear enough that the enzyme and mediator compound must be on the outer surface of, or be part of, the sensitive electrode. An electrode is, by definition, a conductor by which electricity enters or leaves an object or substance - see Shorter Oxford English Dictionary. There is no need to construe "comprising" as meaning "including" in order to understand that the device of Claim 1 involves two electrodes that consist of electrically conductive material. It follows from the use of the word "electrode" that the electrodes must include conductive material. Otherwise they would not be electrodes.

Whether Claim 1 requires an invasive device

36 The primary judge found that in order to infringe Claim 1, the device in question must be capable of relevant contact with live tissue, although it may also be capable of manipulation before or during contact with a small withdrawn sample of bodily fluid. His Honour described as "compelling", the argument that the words "during contact with live tissue" describe invasive contact which, in the context, must involve a needle or needle-like structure. However that argument does not deal with the point that the relevant phrase includes the alternative of manipulation before or during contact with a small withdrawn sample of body fluid.

37 The primary judge also found that the Specification draws a distinction between a drop of blood generated from a needle-prick on the one hand, and a small sample of body fluid withdrawn by syringe on the other:

"The kind of device which would be capable of invasion would be easily adapted to dipping into a withdrawn sample of blood, but hardly adapted to dipping into an unexpressed drop of blood for the purposes of forming a circuit.
These pointers lead me to accept the submission that the claim relates to an invasive sensor."

However, Claim 1 (unlike Claim 3) does not refer to "dipping into" a withdrawn sample of blood. The specification in at least one place appears to treat a "withdrawn sample of blood" as including both an expressed sample obtained by use of a needle-prick device as well as a sample obtained by use of a syringe. Claim 1 describes the electrodes, rather than the particular device in which electrodes of that description are embodied.

38 At least inferentially the primary judge has construed "or" as part of the phrase "with live tissue or a small withdrawn sample of bodily fluid" in a conjunctive sense, leading his Honour to conclude that every device described by Claim 1 must be capable of invasive use. By parity of reasoning, every device covered by Claim 1 must also be capable of use in connection with a small withdrawn sample of bodily fluid, although the primary judge concluded that it was optional ("may also be") whether the device was also capable of use in this respect.

39 "Or" quite commonly and grammatically can have a conjunctive sense: Minister for Immigration & Ethnic Affairs v Baker (1997) 73 FCR 187 at 195. Thus the phrase, "I need a computer for use at home or in the office", conveys that the computer should be suitable for both uses.

40 Certain aspects of the Specification and its structure may have a bearing on the question whether Claim 1 should be confined or limited to a device capable of use as an invasive sensor:

* Claim 1 does not refer, in terms, to an invasive probe, nor does it, in terms, require a needle, or needle-like integer as an element of the sensor described in the claim;

* the "design criteria" (see par [15] above) provide that the electrodes must be elongate either to fit within a pointed needle or for ready assembly to equipment on the one hand and contact with the sample on the other;

* the "consistory clause", which incorporates Claim 1, appears in the Specification before the division of the invention into subsets. Whereas other claims are given as examples of an external sensor, an invasive sensor or a dual capacity sensor, Claim 1 is not described in the Specification as an illustration of any of those subsets;

* the discussion in the Specification of the pen-like portable holder as shown in Figures 13a and 13b proceeds on the basis that:

"such equipment is of course particularly adapted for use with the non-invasive strip sensor defined above, but may also be used with the needle-type invasive sensors."
41 Claim 1 is for a device, rather than for a method of using the device. The phrase "to facilitate manipulation before or during contact with live tissue or a small withdrawn sample of body fluid" is a characteristic of the electrodes extending as, or supported on, an elongate member. The phrase suggests that electrodes extending as, or supported on, an elongate member should be of a type suitable for the achievement of the stated purpose, but without further explication (see generally: Blanco White, Patents for Inventions, 5th ed. 1983 at 2-117 and Terrell on the Law of Patents, 15th ed. 2000 at 6.53.)

42 Claim 1 refers to "before or during contact with live tissue or a small withdrawn sample of bodily fluid" [emphasis added]. It is reasonably clear that or, when first used in that phrase, is used in the sense of "as well as". That is because manipulation may need to be facilitated both before and during the relevant contact if the device is to serve its intended function. The electrodes must be elongate to facilitate manipulation of the device in all four of the circumstances described. That is to say, the fact that the electrodes are elongate facilitates manipulation in each of those circumstances.

43 It does not follow that Claim 1 is confined to a device that is capable of use as an invasive sensor. As the design characteristics make clear, elongation is required so that the electrodes will either fit within a pointed needle or be capable of ready handling as an electrode for:

* ready assembly to equipment on the one hand, and

* contact with the sample on the other.

44 Thus Claim 1 is broad enough in its scope to describe electrodes for use in external testing as well as invasive probe electrodes. The device into which the electrodes are incorporated may either be an invasive probe, or a device adapted for use in connection with external testing. The drafting of the Claims of the Sensor Patent leaves a great deal to be desired in terms of consistency and symmetry. Nonetheless, if Claim 1 describes a device that must be capable of being used both as an invasive probe and as part of an external test, there would be a curious limiting of the invention. On our construction, Claim 1 fits more happily (although nonetheless imperfectly) into the conventional scheme of cascading claims.

VALIDITY OF THE SENSOR PATENT

45 Several grounds are relied on by Corbridge and Inverness in their attack on the validity of the Claims of the Sensor Patent. It is convenient to deal first with the grounds relied on in relation to Claim 1, since, with one exception, no other grounds are relied on in relation to subsequent Claims and certain of the grounds of invalidity advanced in relation to Claim 1 do not apply to other Claims.

CLAIM 1 AND DEPENDENT CLAIMS 2, 22, 23, 24 & 25 (TO THE EXTENT OF THEIR DEPENDENCY)

46 The validity of Claim 1, and its dependent Claims, is challenged on the following grounds:

* Ambiguity;

* Lack of Fair Basing;

* Inutility;

* Insufficiency;

* Lack of Novelty;

* Obviousness;

* Absence of Manner of Manufacture;

* Prior Claiming.

It will be convenient to deal with each of those grounds separately.

Ambiguity

47 Corbridge and Inverness contend that Claim 1 fails to comply with the requirement of s 40(3) of the 1990 Act that each of the claims of a complete specification must be clear.

48 First, it is contended that the expression "both electrodes...extending as...an elongate member" is devoid of meaning. The problem is said to be in understanding how two electrodes can extend as a single elongate member. It is said that non-contiguous electrodes cannot both extend as a single elongate member.

49 However, two electrodes might together constitute an elongate member, notwithstanding that they are not contiguous, if contact between them is prevented by a separating layer or strip. The presence of such a separating strip or layer between the two electrodes would not of itself render inapt a description of both electrodes as extending as an elongate member. Meaning can be given to the expression. Accordingly, this ground of invalidity fails.

50 Secondly, it is contended that, if Claim 1 is not limited to invasive type devices, the words "of small dimension" are devoid of meaning. That phrase is not defined and the phrase has no accepted scientific meaning in the context of the Sensor Patent. The contention is that the phrase is therefore meaningless.

51 It is permissible to use a relative term, or words of degree, in a claim if the meaning of the term or words in question would be clear to a skilled addressee: Blanco White at 4-904; Terrell at 6.56; CIPA Guide to the Patents Acts, 5th ed, 2001, 14.28 at 216. Thus, for example, a claim referring to a "filament of large diameter" has been upheld: British Thomson-Houston Company Ltd v Corona Lamp Works Ltd (1922) 39 RPC 49 (HL).

52 Claim 1 requires that both electrodes be of small dimension in order to facilitate manipulation of the elongate member, inter alia, before or during contact with live tissue. Whether or not Claim 1 is limited to an invasive device, one of the manifestations contemplated by Claim 1 is an invasive device. The expression "of small dimension" must be understood in that context. Whether the device might also be capable of being used otherwise than in an invasive fashion, does not detract from the meaning thereby given to the phrase "of small dimension".

53 Finally, it is contented that, in the absence of any mention in Claim 1 of an electrical connection, the integers identified are incapable of constituting a "sensor means". For the reasons indicated earlier in dealing with the construction of Claim 1, this ground is not established.

Fair Basing

54 Section 40(3) of the 1990 Act requires that the claims of a complete specification must be fairly based on the matter described in the complete specification. Corbridge and Inverness contend that Claim 1 is, in a number of respects, not fairly based on the matter described in the Specification.

55 First, they contend that Claim 1 is not fairly based on the matter described in the Specification because there is nothing in the Specification that supports a device in which the electrodes "extend as an elongate member". However, the Specification provides that the device must be elongate "either to fit within a pointed needle or for ready handling as an electrode for ready assembly to equipment on the one hand and contact with the sample on the other". A requirement that the two electrodes themselves extend as an elongate member is fairly contemplated by the statement that the device be "elongate". As explained above (para [49]), the two electrodes, even if separated, may together constitute an elongate member. The requirement of Claim 1 that the electrodes extend as an elongate member is fairly based on the material described in the Specification.

56 Secondly, Corbridge and Inverness contend that the requirement that the electrodes be roughly equal or the same size is not fairly based on anything in the body of the Specification. The primary judge referred to the invention of the Sensor Patent as a device having "two electrodes of roughly equal or the same size in direct contact with the solution or mixture to be analysed". However, notwithstanding his Honour's observation, there is nothing in Claim 1 that requires the electrodes to be roughly the same or equal size. Nor does the specification describe it as a feature of the invention, or the inventive step, that the electrodes should be of roughly the same size. For example, in figure 5, the electrodes are not of equal size, nor are they roughly the same size. This ground, therefore, does not arise.

57 Thirdly, it is contended that the only embodiments of the invention described in the Specification use ferrocene as the mediator compound and that there is no disclosure of an embodiment using any other mediator compound. On the other hand, the Claims cover devices using mediator compounds that are not limited to ferrocene. To that extent, it is said, the Claims are not fairly based on the Specification.

58 However, while examples are given in the Specification of mediator compounds, it is clear that the invention of the Sensor Patent is a device. It is not limited, either in the Specification generally or in any of the Claims, to a particular process involving any particular enzyme or mediator compound. While the Specification says that metallocene compounds generally, and ferrocenes in particular, are the preferred mediator compounds, the Specification is not limited to those mediator compounds. That is clear from the presence of Claims 24 and 25, in which the invention is limited to specific mediator compounds. This is not a basis for concluding that the Claims are not fairly based on the Specification.

59 Finally, Corbridge and Inverness contend that, if Claim 1 includes the Excel Product, it is not fairly based on the matter described in the Specification because the essential features of the alleged invention would then include certain requirements to which Claim 1 is not limited. Those requirements are that:

* the electrodes are on the same surface of a single elongate member;

* the first electrode is of an area small enough to be completely coverable by the smear of blood produced from a non expressed drop of blood generated from a needle prick;

* the reference electrode is sufficiently close to the sensitive electrode area that the smear of blood also reads the sensitive electrode so as to complete an electrical current; and

* there are conductive elements communicating with the electrodes for connection to a readout means.

60 It is not to the point to refer to the features of a device that may or may not infringe Claim 1 and say that those features are not fairly based on the matter described in the Specification. The question is whether Claim 1 is fairly based on the matter described in the Specification. The conclusion relied upon above that "comprising" means "consisting of" does not mean that Claim 1 is for other devices having further integers.

61 Further, for the reasons given above in dealing with the construction of Claim 1, Claim 1 is to be taken to have the last feature mentioned above. That feature is clearly based on matter described in the Specification. The Specification describes a device that is intended to be connected to, or to encompass, a read-out means. The essential object of the invention is to detect, measure or monitor a substance of interest by a read-out means.

62 Further, the Specification, in dealing with external sensors, describes a device where both electrodes are on the same surface and are close enough together and small enough so that a drop of non expressed blood generated from a needle prick will cover the sensitive electrode and bridge the gap between them (see paragraph [20] above).

Inutility

63 Section 18(1)(c) of the 1990 Act requires that, to be patentable, an invention must be useful. It is contended that Claim 1 covers devices that are without features that are essential to its successful working, namely, a connection to each electrode for attachment to a readout means. Accordingly, so it is said, the invention of the Sensor Patent is useless. For the reason indicated above in dealing with the construction of Claim 1, this ground is not made out, since a connection is to be implied.

64 Next, it is contended that Claim 1 covers combinations of mediator compound, enzyme and substances of interest, that do not work. There was evidence that some mediator compounds referred to in the body of the Specification were entirely unsuitable. However, the invention of the Sensor Patent is a device, not a chemical reaction or process. Claim 1 is not limited to particular substances of interest, enzymes or mediator compounds. The invention of the Sensor Patent is effective in relation to some substances of interest. That is sufficient to satisfy the requirement of utility.

Sufficiency

65 Under s 40(2)(a) of the 1990 Act, a complete specification must describe the invention fully, including the best method known to the applicant of performing the invention. Corbridge and Inverness contend that the Specification does not describe the invention of the Sensor Patent fully. Reference is made in this context to the fact that the Claims cover all substances of interest, enzymes and mediator compounds. The matters referred to in paragraph [64] above are relied upon under this heading. However, this contention is also disposed of by the conclusion that the invention of the Sensor Patent is a device, not a chemical reaction or process.

66 Corbridge and Inverness also contend that the utility of a two electrode system depends on variables not sufficiently addressed in the Specification. The Specification states that the second electrode can be any "convenient reference electrode" and then goes on to say that a silver/silver chloride reference electrode has been found useful. The effectiveness of a two electrode device employing a silver/silver chloride reference electrode depends on the presence of a sufficient level of chloride in the solution. However, no levels are disclosed in the Specification.

67 It is not a ground of invalidity that a specification does not describe every manifestation of the devices covered by the claims. So long as there is a description of an example of a device within the claims, that is sufficient - Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd (2001) 177 ALR 460 at 469. In the present case, the reference electrode does not need to be of silver/silver chloride. The Specification gives examples that would enable the appropriate addressee of the Sensor Patent to produce something within each Claim and gives sufficient instruction to enable each discrete device of the claims to be manufactured. This ground of invalidity is not made out.

Novelty

68 Corbridge and Inverness contend that the invention of Claim 1 was not novel as required by s 18(1)(b)(i) of the 1990 Act, since it was anticipated by United States Patent No. 4225410 ("the Pace Patent"). However, it was accepted that the ground falls away if Claim 1 is construed as being limited to a device that has electrodes of conductive material that are connected to a readout means. Further, in the Pace Patent, layers or membranes, whose net effect was to prevent contact between a blood sample and electrodes, are present. One of the features of the invention of the Sensor Patent is that the mixture or solution to be analysed is in direct contact with the electrodes. The primary judge correctly concluded that the device of Claim 1 was not anticipated by the Pace Patent.

Obviousness

69 Corbridge and Inverness contend that the device of Claim 1 does not involve an inventive step as required by s 18(1)(b)(ii) of the 1990 Act. This claim was rejected by the primary judge.

70 The primary judge made the following findings on the issue of obviousness:

* the party seeking revocation carries the onus of proving obviousness;

* the question is whether, at the relevant date, the claimed invention would have been obvious to the unimaginative and non-skilled technician in the trade in Australia equipped with the common general knowledge of those in that trade;

* Corbridge and Inverness had failed to establish that there was an identity between the common general knowledge as it existed in Australia at the relevant time and as it existed in other places in the world;

* the only evide nce which addressed the state of knowledge in Australia at the priority date was some literature searches and the evidence of Professor Alexander;

* prior art does not equate to common general knowledge. A publication is not part of common general knowledge unless evidence establishes that it is. It is not appropriate to make a mosaic of prior publications to compare with the invention in order to test obviousness;

* Professor Alexander was a research scientist, rather than the required skilled but unimaginative non-inventive technician and was not representative of such a party. His knowledge at the time does not represent the common general knowledge;

* Corbridge and Inverness failed to establish the relevant common general knowledge that is the baseline from which to judge the obviousness of the invention. That is not surprising, as there was no commercial entity involved in the field in Australia at the priority date. The field was entirely theoretical in Australia at the relevant time;

* in any event: "there would have been serious contra-indications at the time in relation to choice of a two-electrode system and in relation to the electrodes being in direct contact with the solution to be analysed, particularly blood and particularly if the electrodes were on the one support member of roughly the same size." (emphasis added) A two-electrode system, with both electrodes of roughly equal size in direct contact with the solution on the one support, was not obvious.

71 There is nothing in the Specification, or in the Claims, which indicates that both electrodes should be "of roughly the same size". In the case of certain of the embodiments of the invention as shown in the drawings, the electrodes are not of roughly the same size.

72 Senior counsel for Corbridge and Inverness submitted that the challenge to the validity of the Sensor Patent on the ground of obviousness only failed because his Honour found that it was not obvious to make a two-electrode device with exposed electrodes, where the electrodes were roughly the same size. Implicit in that conclusion is the finding that it was obvious to make a two exposed electrode device where the reference electrode was significantly bigger than the active electrode. As Claim 1 is not limited to electrodes that are roughly the same size, it comprehends something that is obvious although it may also comprehend something that is not obvious and is thus invalid.

73 That submission should be rejected for two reasons. First, Corbridge and Inverness lost on the issue of obviousness because they failed to establish what the relevant common general knowledge was at the relevant time (see the seventh dot point in paragraph [70] above). It has not been shown that the primary judge erred in coming to that conclusion. Second, the primary judge did not make an explicit finding that it was obvious to make a two exposed electrode device where the reference electrode was significantly bigger than the active electrode. Nor did his Honour anywhere find that the fact that the electrodes were of roughly the same size was an element of the invention. Rather, his Honour found that a two-electrode system with the electrodes being in direct contact with the solution to be analysed was not obvious, as it was counter-intuitive at the time, particularly if the electrodes were on the one support member and of roughly equal size.

74 There is nothing in the Specification, or in the Claims, that supports the proposition that the Sensor Patent was about two electrodes of roughly the same size. We do not construe his Honour's findings on this topic as an implicit finding that equality in size of the two electrodes was an unclaimed, but essential integer of the invention. That was not the matter with which his Honour was dealing. Rather, his Honour was giving reasons why he was not satisfied that it would have been a routine, non-inventive exercise for Professor Alexander to produce any of the devices claimed.

75 This ground of invalidity fails.

Manner of Manufacture

76 Corbridge and Inverness contend that the Sensor Patent does not satisfy s 18(1)(a) of the 1990 Act, which requires that, to be patentable, an invention must be a manner of manufacture within the meaning of s 6 of the Statute of Monopolies 1623 (UK) (21 Jac I c 3). They contend that, since electrochemistry was not part of the invention in Claim 1 and electrochemistry must logically include the feasibility of two electrodes and contact between the substance of interest and the electrodes, the only question relates to the design of the devices. In so far as the design considerations amount to no more than ensuring that the substance of interest is in contact with both electrodes, they say that is not a manner of manufacture.

77 The Specification discloses a device created by the joining together of various materials to form something that is both new and useful, as the primary judge held. The mere fact that electrochemistry is necessary for the design disclosed is not a basis for concluding that there is no manner of manufacture involved.

78 Although there will be no manner of new manufacture where lack of invention is admitted on the face of a specification (Advanced Building Systems Pty Ltd v Ramset Fasteners (Aust) Pty Ltd (1998) 194 CLR 171 at 192), there is no basis for concluding that lack of invention was admitted on the face of the Specification in this case.

Prior Claiming

79 Section 100(1)(f) of the 1952 Act provided that a ground of revocation was that the invention, so far as claimed in any claim, was the subject of a valid claim of earlier priority date contained in the complete specification of another patent. Corbridge and Inverness contend that the invention of Claim 1 is the subject of valid claims of the Mediator Patent that cover any device that contains a sensitive electrode of the type there described. Claim 1 of the Sensor Patent describes devices each of which comprehends, in at least one variant, a sensitive electrode within the meaning of the Mediator Patent. It is said, therefore, that Claim 1 is simply one application of the Mediator Patent invention.

80 However, none of the claims of the Mediator Patent has a reference electrode as an integer. No claim of the Mediator Patent refers to the structural or spatial relationship between the sensitive electrode and the reference electrode. On the other hand, a reference electrode and the relationship between it and the sensitive electrode, are essential integers of Claim 1. There is therefore no substance in this ground.

81 Further, there is a real question as to whether prior claiming is available as a ground of revocation under the 1990 Act, even in relation to a patent granted under the 1952 Act. Section 138(3) of the 1990 Act provides that the Court may revoke a patent, either wholly or insofar as it relates to a claim in one or more of the grounds specified in s 138(3) but on no other ground. There is no equivalent of s 100(1)(f) of the 1952 Act as a ground of revocation in s 138(3). While s 233(4) provides that objection cannot be taken to a patent granted under the 1952 Act, and that such a patent is not invalid on any ground that would not have been available against the patent under the 1952 Act, there is no provision of the 1990 Act that preserves a ground of invalidity under the 1952 Act after its repeal. Accordingly, s 100(1)(f) of the 1952 Act would not be available in this proceeding - see NV Philips Gloeilampenfabrieken v Mirabella International Pty Limited (1993) 44 FCR 239 per Lockhart J at 253-4.

CLAIMS 3, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 & 21 AND CLAIMS 22, 23, 24, 25 & 26 (TO THE EXTENT OF THEIR DEPENDENCE ON ONE OR OTHER OF THE EARLIER CLAIMS)

82 Corbridge and Inverness advance in relation to these Claims, some of the grounds advanced in relation to Claim 1. However, no ground is advanced in relation to these Claims that is not advanced in relation to Claim 1. The disposition of the grounds advanced in relation to Claim 1 governs the disposition of the grounds advanced in relation to these further Claims. It follows that none of the grounds advanced is established in relation to these further Claims.

CLAIMS 17, 18 & 19

83 It is apparent from the history of the application that resulted in the grant of the Sensor Patent that there was a claim in the Specification in its provisional form that described a "pen like assembly", which is depicted in figures that form part of the Specification. That claim was originally numbered 17. However, it is clear that that claim was deleted from the Specification at some stage and that the subsequent claims were renumbered. Specifically, the present Claims 17, 18 and 19 were originally numbered 18, 19 and 20.

84 Claims 17, 18 and 19 are related. Each describes "an assembly as claimed in Claim 1", coupled with further integers. However, no "assembly" is claimed in Claim 1. It is clear that the reference in Claims 17, 18 and 19 to "claim 1" was intended to be a reference to the claim originally numbered 17. Accordingly, Claims 17, 18 and 19 would have been dependent on that claim. Since that claim no longer forms part of the Specification, the present Claims 17, 18 and 19 are nonsensical in referring to Claim 1 and should be revoked for lack of clarity. It should be recorded that the particular reasoning that leads to the revocation of Claims 17, 18 and 19 was not advanced before the primary judge.

CLAIM 20

85 The only ground of invalidity advanced in relation to Claim 20 is that it is not fairly based on the body of the Specification, in that it is not confined to electrodes having roughly the same or equal dimensions. This ground has been dealt with in relation to the construction of Claim 1. It is not made out in relation to Claim 20.

INFRINGEMENT

86 The Excel Product consists of a small flat strip containing two electrodes side by side, being a sensitive electrode and a reference electrode. It is designed so that it can be inserted into a meter that will measure electric current that flows when a drop of blood is placed on it in such a way as to bridge the gap between the sensitive electrode and the reference electrode. It has the features that were referred to above when dealing with fair basis (see paragraph [59]). That is to say, the two electrodes are on the same surface and are small enough and sufficiently close together that a non-expressed drop of blood generated from a needle prick will both cover the sensitive electrode and bridge the gap between the two electrodes. It is an external non-invasive test member for a blood droplet, which was designed to work in conjunction with Abbott's "Exactech" Meter.

87 Since the only basis for contending that the Excel Product does not infringe Claim 1 of the Sensor Patent is that Claim 1 is limited to an invasive sensor and does not extend to an external sensor, it follows that the Excel Product infringes Claim 1.

CONCLUSION

88 It follows from the above that the appeal by Corbridge and Inverness against the orders dismissing the cross-claim as to validity should be upheld insofar as it relates to the validity of Claims 17, 18 and 19 of the Sensor Patent. In lieu thereof, there should be an order that Claims 17, 18 and 19 of the Sensor Patent be revoked and that the cross-claim as to validity be otherwise dismissed. The appeal by Corbridge and Inverness should be otherwise dismissed with costs.

89 It also follows that the appeal by Abbott and Abbott Australasia from the orders made by the primary judge dismissing the application for orders restraining infringement of the Sensor Patent should be upheld. In lieu of the order dismissing the application and the orders for costs, there should be an order restraining Corbridge and Inverness from infringing the Sensor Patent. They are entitled to their costs before the primary judge and on the appeal.

I certify that the preceding eighty-nine (89) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Court.




Associate:

Dated: 18 October 2002

Counsel for the Appellants:
Mr J. Ireland QC & Mr R. Webb






Solicitor for the Appellants:
Sprusons Solicitors






Counsel for the Respondents:
Mr A. Bannon SC & Mr R. Cobden






Solicitor for the Respondents:
Mallesons Stephen Jaques






Date of Hearing:
4, 5, 6 March 2002






Date of Judgment:
18 October 2002





the schedule

RELEVANT CLAIMS DEFINING THE INVENTION OF THE SENSOR PATENT

1. Sensor means for selective detection, measurement or monitoring of a given dissolved substrate in a mixture of dissolved substrates, comprising:-

(a) an area of first electrode material (of electrically conductive material) comprising an enzyme catalytic of the said substrate and a mediator compound to transfer charge to the electrode when the enzyme is catalytically active, adjacent to but non-contiguous with;

(b) an area of reference electrode material:

both electrodes being of small dimension, and extending as or supported on an elongate member to facilitate manipulation of the elongate member before or during contact with live tissue or a small withdrawn sample of body fluid.

...........................

3. A sensor for contact with a liquid mixture of components for detecting the presence of, measuring the amount of an/or monitoring the level of one or more selected components capable of undergoing an enzyme catalysed reaction, the sensor comprising:-

(a) an elongate support member,

(b) on a surface thereof towards one end an expanse of a first electrode of electrically conductive material comprising at least at/an outer surface thereof the combination of an enzyme and a mediator compound which transfers electrons to the first electrode when the enzyme is catalytically active,

(c) on a surface of the elongate support member and also towards the said end thereof an expanse of a second, reference, electrode, and

(d) separate electrical connection to each electrode for attachment to a read-out means denoting presence, amount, or monitored level of the said one or more selected components in a liquid medium into which the support member is dipped to contact both electrodes.

4. A sensor means comprising (a) a flat first electrode area of known areas small enough to be completely coverable by the smear of blood produced from a non-expressed drop of blood generated from a needle-prick at a bodily extremity, (b) a reference electrode area on the same surface separate from but sufficiently close to the sensitive electrode area that the said blood smear also reaches the reference electrode to establish electrical communication and (c) separate conductive elements extending along the same surface of the elongate support member, communicating one with each electrode for connection to signal read-out means attachable to one end of the member.

...........................

7. A needle probe electrode carrier for placement through tissue into a measurement location such as a blood vessel, in the form of a generally cylindrical pointed needle having formed therein near the pointed end two flat depressions spaced apart longitudinally, each depression with a floor at right angles to the needle radius and each with a protective shoulder at each end of that floor: wherein the floor of one such depression is coated with an adherent layer comprising an enzyme and a mediator compound to transfer charge from the enzyme when it is contacted with its specific substrate and hence catalytically active; the floor of the other such depression is coated with an adherent reference electrode layer; and separate conductive elements are provided along the surface of the needle, communicating one with each electrode layer, for connection to signal readout means attachable at the outer end of the needle.

8. A sensor for selective detection, determination or monitoring of a given dissolved substrate in a mixture of dissolved substrates, of the type in which an electrode is provided with an enzyme catalytic of said substrate and with a mediator compound to transfer charge to the electrode to provide a read-out signal against a reference electrode: wherein the reference electrode is a metallic needle surrounding, insulated from, and made of or coated with suitable reference electrode material to, the sensitive electrode.

...........................

12. A sensor for selective detection, determination or monitoring of a given dissolved substrate in a mixture of dissolved substrates, of the type in which an electrode is provided with an enzyme catalytic of said substrate and with a mediator compound to transfer charge to the electrode to provide a read-out signal against a reference electrode: wherein the sensitive electrode and the reference electrode are located on opposite faces of an elongate non-conductive support of rectangular cross-section.

...........................

16. A two-part cell assembly, each part containing an elongate recess accommodating one elongate electrode, the first electrode comprising an enzyme and charge-transferring mediator on a conductive support and the second electrode being a reference electrode: the said parts, when assembled with the recesses opposed, defining a through flow liquid channel between the thereby located and spaced electrodes, whereby the combination is sensitive to the substrate of the enzyme passing through the channel.

...........................

20. The operative combination of:

(I) an assembly of circuitry and display means for use in producing a readout value of blood glucose level as a diagnostic aid in treatment or control of diabetes, comprising:

(a) a pen-like hollow elongate housing;

(b) an electrically conductive socket one end of said housing suitable to receive a detachable strip electrode carrier, and

(c) a digital readout window towards the other end of said housing connected to said socket for exhibiting a numerical value corresponding to the said glucose level; and

(II) a strip test electrode carrier held at one end in said socket, carrying:

(a) a flat electrode of area not greater than 25 sq. mm and comprising a glucose catalytic enzyme and a metallocene mediator whereby it is sensitive to blood glucose levels,

(b) a reference electrode area non-contiguous with but closely adjacent to the said sensitive electrode area and

(III) separate conductive elements extending along the strip communicating one with each electrode for connection to the socket.

21. Analytical equipment for detecting the presence of, measuring the amount of and/or monitoring the level of one or more selected components of a liquid mixture, comprising:

* a cell the parts of which on assembly jointly define a low-volume liquid chamber, at least one of the said cell parts being provided with liquid inlet and outlet ports communicating with the said defined chamber when the parts are assembled;

* a selectively operable pump for causing the liquid mixture to flow into the inlet means and out of the outlet means either continuously or intermittently;

* a first electrode in the form of a thin expanse of conductive material and comprising at least at an external surface thereof the combination of an enzyme and a mediator compound which transfers electrons to the electrode when the enzyme is catalytically active;

* a second, reference, electrode also in the form of a thin expanse of conductive material;

* each said electrode presenting an operative surface within said defined low-volume liquid chamber;

* a potentiostat for poising a predetermined voltage difference between the electrodes;

* means for detecting or measuring current flow between the electrodes when a liquid sample is introduced in to the chamber; and

* signal storage and/or readout means operatively connected to the means for measuring current flow.
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