Rescare Ltd v Anaesthetic Supplies Pty Ltd

Re: RESCARE LTD
And: ANAESTHETIC SUPPLIES PTY LTD
No. N G156 of 1992
FED No. 811
Patents

COURT

IN THE FEDERAL COURT OF AUSTRALIA

NEW SOUTH WALES DISTRICT REGISTRY
GENERAL DIVISION
Gummow J.(1)

CATCHWORDS

Patents - infringement - validity - date at which a disclosure of best method of performing the invention must be made - whether methods or processes for treating the human body are patentable - patent granted under 1952 Act - revocation sought in proceeding under 1990 Act - changes in the law of infringement effected by the 1990 Act.

Patents Act 1952

Patents Act 1990

Patents Act 1903

Patents, Designs and Trade Marks Act 1883 (UK)

Patents and Designs Act 1907 (UK)

Patents and Designs Act 1932 (UK)

Patents Act 1949 (UK)

Patents Act 1977 (UK)

Statute of Monopolies 1623 (Eng)

Patents Act 1953 (NZ)

Interlego AG v Toltoys Pty Ltd (1973) 130 CLR 461, applied

Meyers Taylor Pty Ltd v Vicarr Industries Limited (1977) 137 CLR 228, applied

Nicaro Holdings Pty Ltd v Martin Engineering Co (190) 91 ALR 513, applied

National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252, considered

Joos v Commissioner of Patents (1972) 126 CLR 611, considered

Maeder v Busch (1938) 59 CLR 684, considered

Wellcome Foundation Limited v Commissioner of Patents (1979) 2 NZLR 591, considered

C and W's Application for a Patent (1914) 31 RPC 235, considered

Raleigh Cycle Coy. Ltd v H Miller and Coy. Ltd (1948) 65 RPC 141, applied

HEARING

SYDNEY

#DATE 9:11:1992

Counsel and solicitors Mr D K Catterns and
for the applicant: Miss J Baird

instructed by Williams Niblett

Counsel and solicitors Mr B W Rayment QC and
for the respondent: Mr Justin Gleeson

instructed by Freehill Hollingdale and Page

ORDER

The proceeding stand over to a date to be fixed for the bringing in of Short Minutes to give effect to the Reasons for Judgment delivered today.

JUDGE1

GUMMOW J. At the trial of this proceeding the applicant alleged infringement of each of claims 1, 3, 6, 7, 8, 9 and 11 of standard patent no. 560360 ("the Patent") for an invention entitled "device for treating snoring sickness". The applicant is the present registered proprietor of the Patent. It was incorporated on 29 May 1989. The inventor, who was the applicant for grant, was Professor C E Sullivan. Professor Sullivan is Professor of Medicine at the University of Sydney, and has an international reputation for research in the field of respiratory medicine and sleep disorders. He gave evidence.

Obstructive sleep apnoea ("OSA") is a syndrome associated with an extreme form of snoring in which the sufferer chokes on his or her tongue and soft palate repeatedly whilst asleep. In an article published in 1981 in "The Lancet", Professor Sullivan and 3 members of his unit in the Faculty of Medicine at the University discussed OSA. Professor Sullivan's experiments with patients, leading eventually to the conclusions expressed in this paper, had commenced in June 1980. The authors said that OSA was a common disorder particularly in middle aged overweight males. They continued: -

"The underlying problem is sleep-induced occlusion of the oropharyngeal airway, which results in multiple apnoeic episodes during sleep. There is severe fragmentation of sleep, and as the disease progresses over months or years, greater degrees of asphyxia occur; the duration of apnoea frequently exceeds two minutes and the arterial haemoglobin oxygen saturation falls below 50%. Remarkably, the patient may be unaware of his nightly struggle for breath. Rather, his major symptoms are those of excessive daytime sleepiness and snoring. The nocturnal asphyxia eventually causes a variety of clinical presentations including cardiac arrhythmias, pulmonary hypertension and right heart failure, systemic hypertension, severe morning headache, intellectual and personality changes, and polycythaemia. The true cause of these findings may not be suspected. The disease is a recognised cause of sudden "unexpected" death. In the obese subject, weight loss may reduce the number of obstructive episodes. Other measures such as neck collars and respiratory stimulants . . . are less satisfactory. The only effective treatment now available is a tracheostomy which is left open at night. This immediately results in disappearance of the excessive daytime sleepiness; and the life threatening complications of hypoxaemia, such as arrhythmias and cor pulmonale, improve dramatically within days. In patients who do not have any of the immediately life-threatening complications, a decision to do a tracheostomy is invariably difficult, despite the knowledge that the disease is progressive. We describe here a method which has prevented upper airway occlusion for an entire night of sleep in each of five patients with severe obstructive sleep apnoea."

In the summary of their paper the authors state: -

"Five patients with severe obstructive sleep apnoea were treated with continuous positive airway pressure (CPAP) applied via a comfortable nose mask through the nares. Low levels of pressure (range 4.5 - 10 cm H20) completely prevented upper airway occlusion during sleep in each patient and allowed an entire night of uninterrupted sleep. Continuous positive airway pressure applied in this manner provides a pneumatic splint for the nasopharyngeal airway and is a safe, simple treatment for the obstructive sleep apnoea syndrome."

The term "obstructive sleep apnoea" was coined by the Italian researcher Lugaresi. The evidence suggests that about 5% of the population is afflicted by OSA. But the scientists who work in the field have difficulty in defining where heavy snoring ends and OSA begins. As Professor Sullivan put it in his cross-examination, "in fact the boundary changes, it moves backwards and forwards according to conditions." Thus, those who might be described as light snorers may suffer from OSA, and heavy snoring which is not accompanied by OSA is often a precursor of OSA and is an established cause of high blood pressure. About 30% of the total population is affected by heavy habitual snoring.

The skilled addressee would approach the complete specification and the provisional specification for the Patent on this footing. This is of some importance in dealing with questions of insufficiency and related issues which arise in this case.
Further, in the majority of cases, the alleviation of severe or heavy snoring, however caused, is assisted by CPAP.
Professor Zwillich is a distinguished expert from the United States with extensive clinical experience. He is Professor of Medicine at Pennsylvania State University. He was called by the applicant. Before he read "The Lancet" article, it had never occurred to him to apply CPAP therapy to patients suffering from OSA. His evidence is that the result of Professor Sullivan's work has been to revolutionise treatment of OSA, because of the simplicity, safety, efficacy and high degree of acceptability of the CPAP therapy. There are also advantages of relatively low cost and of long term "at home" treatment of patients away from hospital. Professor Zwillich himself has effectively treated large numbers of patients who otherwise might have remained untreated.
The provisional specification was lodged on 24 April 1981, whilst the Patents Act 1952 ("the 1952 Act") was in force. On 23 April 1982, that is to say within 12 months of the date of the lodgment of the provisional specification, application was filed by Professor Sullivan under the Patent Cooperation Treaty. The result was that the provisions of Part IVA of the 1952 Act (ss. 58A-58J) applied. Sections 58B and 58C operated to modify the application of the 1952 Act in significant respects. The complete specification is to be treated as having been lodged on the international filing date of the international application, namely 23 April 1982 (sub-s. 58B(2)). The international application is to be taken as having been open to public inspection and published on the date of notification in the Official Journal, 4 November 1982. Claims 1-7 were amended after grant, on 17 December 1985. The Patent was sealed on 10 October 1987, but dated 23 April 1982. The term expires 23 April 1998.
The 1952 Act was repealed by s. 230 of the Patents Act 1990 ("the 1990 Act"). Subsection 233(1) of the 1990 Act provides that the new statute applies in relation to a standard patent granted under the 1952 Act as if the patent had been granted under the new statute. However, sub-s. 233(4) states: -

"Objection cannot be taken to a patent in subsection (1) and such a patent is not invalid, so far as the invention is claimed in any claim, on any ground that would not have been available against the patent under the 1952 Act."

Section 13 of the 1990 Act gives the patentee the exclusive rights to "exploit" and "to authorise another person to exploit the invention". Schedule 1 contains a definition of "exploit". It will be necessary to refer further to this later in these reasons. Section 117 provides that if the use of a product by a person would infringe a patent, the supply of that product by one person to another is an infringement of the patent by the supplier unless the supplier is the patentee or licensee of the patent. There is no dispute that the respondent has sold and threatens to sell various allegedly infringing equipment and apparatus. But there is a dispute as to the operation of these provisions in relation to process or method claims of the Patent. At the trial, the applicant submitted that the only process claims were claims 9 and 11 and that the others are apparatus claims. As will later appear, I accept that submission.
The respondent's products include apparatus for administering CPAP to treat OSA. The Schedules A and B to these reasons show drawings of the nasal mask (with the rotating connector) and other relevant portions of that apparatus, before assembly. It should be noted that the Sanders NRV-2 is the alternative device to the Whisper Swivel. It will be necessary to refer more closely to these drawings when dealing with issues of infringement.
In addition to denying infringement of any of the claims relied upon by the applicant, the respondent, by its cross claim, seeks revocation of the Patent. The attack on validity, as presented at the trial, was directed to those claims in respect of which the applicant pressed its case as to infringement. Thus the validity of claims 1, 3, 6, 7, 8, 9 and 11 was actively contested. These reasons will reflect this manner of conduct of the case by the parties. Various grounds of invalidity were relied upon by the respondent.
First it is said that there is lack of novelty by reason of certain prior publications and prior user. The strength of the case on novelty depends upon which of the possible priority dates are held for the claims by the applicant is made good. The applicant concedes that it must lose on the issue of novelty if the relevant date is 17 December 1985. However the applicant contends that this is not the relevant date because, within the meaning of s. 159A of the 1952 Act, the amended claims did not claim new matter "in substance" first disclosed in the specification as a result of amendment of the specification in 1985. Further, the applicant contends, and the respondent denies, that within the meaning of sub-s. 45(2) of the 1952 Act, the claims of the complete specification were "fairly based on matter disclosed in the provisional specification". The result would follow that the priority date of those claims is the date, not of lodgement of the complete specification (23 April 1982), but the date of lodgement of the provisional specification (24 April 1981).
In final address, counsel for the applicant conceded that it was vital for his client's case to establish fair basing upon matter disclosed in the provisional specification and thereby to make good the priority date of 24 April 1981. This was because of the disclosure in the article published in the issue of "The Lancet" dated April 18, 1981. The disclosure there would provide an anticipation of the claims of the Patent if the earliest priority date is that of the lodgment of the complete specification, 23 April 1982. (Whilst the issue of "the Lancet" bears the date April 18, 1981, that is to say before the date of lodgment of the provisional specification on 24 April 1981, it was submitted that I should find (and I do find), that "the Lancet" was not published in Australia until after 24 April 1981. Para. (g) of sub-s. 100(1) of the 1952 Act assesses novelty by reference to what was published in Australia).
In addition to lack of novelty, the respondent relies upon obviousness and, as to some claims, upon inutility. Further, the respondent alleges failure to comply with s. 40 in its various branches. In respect of various claims reliance is placed upon (i) the absence of fair basing of the claims upon matter disclosed in the complete specification, (ii) the claims not being clear and succinct, (iii) failure of the claims to define the invention, (iv) failure to disclose the best method of performing the invention which was known to Professor Sullivan, and (v) failure of the complete specification fully to describe the invention.
So far as relevant, s. 40 of the 1952 Act provides: -
"40(1) A complete specification -

(a) shall fully describe the invention, including the best method of performing the invention which is known to the applicant; and

(b) shall end with a claim or claims defining the invention.

(1A) . . .

(2) The claim or claims shall be clear and succinct and shall be fairly based on the matter described in the specification."

The practical application by Professor Sullivan of his apparatus has been modified from time to time and the preferred form of the apparatus has changed. That which is now marketed by both sides to this litigation differs from the proffered embodiment disclosed in the drawings to the complete specification, in particular by the use of 1 not 2 tubes respectively for the supply to and expiration of air by the patient. This will be important in dealing with an issue as to "best method" and, upon the question of infringement of claim 11, with an argument as to the use in the respondent's devices of mechanical equivalents.
The method or process claims, internally identified as such, namely claims 9 and 11, are said to be invalid because they are not for a manner of manufacture. The respondent submits that they claim a monopoly for a process of treating a disease of the human body, something outside the concept of "manner of manufacture". Further, the respondent contends that the preceding claims are, not as they appear on their face, product or apparatus claims, but "disguised process claims" which are bad for the same reason as claims 9 and 11.
I turn to consider infringement. In doing so I will reach conclusions upon construction of the claims which will determine the outcome of some of the s. 40 issues.

Infringement
17. The complete specification describes the invention as relating to apparatus which may be used, among other things, for the treatment of OSA. It states that this is more commonly called snoring sickness and is characterised by occlusion of the "upper air passage" during sleep. This is said to be a common disorder, particularly in middle aged overweight males. The syndrome results from a combination of abnormally restricted upper air passages and the normal loss of muscle tone in the region of the tongue, soft pallet and posterior or oropharyngeal wall. In less severe cases the condition causes excessive daytime somnolence, heart disorder and brain damage. In its severe form the affected patient may asphyxiate some 200 to 300 times per night for periods typically of 40 to 120 seconds duration. Some lung diseases are commonly found in association with the condition.

The complete specification describes the prior art as follows: -

"Prior art methods for overcoming the problem include the use of neck collars, respiratory stimulants, loss of weight in cases of obesity and tracheostomys which are left open at night. Only the tracheostomy has been effective in overcoming the problem completely. However in cases where immediate life-threatening complications are not present, the decision as to whether this method should be used or not is obviously difficult."

An object of the invention is stated as being to provide apparatus which will ameliorate the foregoing disadvantages.

There are 11 claims. As I have indicated, the claims allegedly infringed are claims 1, 3, 6, 7, 8, 9 and 11. Claims 3, 6, 7 and 8 are dependent upon claim 1. Claim 1 is in the following terms: -

"1. Apparatus comprising: a nose piece including a cavity adapted for insertion of a patient's nose therein and to be releasably sealingly attached to a patient's face in an airtight manner; inlet tubing connecting to said nose piece with an aperture providing fluid communications with said cavity, the inlet tubing being adapted to be connected to an air source; outlet means in fluid communication with and connected to, said inlet tubing proximate the region of said aperture and providing resistance to airflow therethrough so as to maintain in the region of said aperture air pressure slightly greater than atmospheric while air is passed therethrough throughout the breathing cycle of the patient whereby the patient will have administered to the nasal passages air of slightly increased pressure sufficient to maintain the nasal passages open throughout the breathing cycle."

The primary submission of the respondent on infringement was that its devices did not possess those elements of claim 1 indicated in the passage to which I have given double emphasis. The other emphasised material is central to the submission that this is a "disguised process claim".

Claims 9 and 11 are, on their face, method or process claims. Claim 11 is addressed to a method of treating snoring and/or obstructive sleep apnoea "substantially as described with reference to the drawings". There is a dispute in general terms between the parties as to infringement of claim 11. The purchasers of the respondent's devices will use them in the manner claimed in claim 9 but there is a dispute as to whether the respondent's activities in supplying its devices render it an infringer of this method claim, and, in any event, as to the appropriateness of any injunctive relief against it based on this claim.
In construing the claims as they stand after the amendments the Court may refer to the specification without the amendments: sub-s. 157A the 1952 Act, now s. 116 of the 1990 Act.

Claim 1
22. The applicant submits that claim 1 is a claim limited by reference to result, so that the worker in the field will know he is in the territory marked out by the claim when he achieves that result. That is to say, the claim is drawn so as to provide a limitation characterising the construction of the apparatus: Interlego AG v Toltoys Pty Ltd (1973) 130 CLR 461 at 480, per Barwick C.J., Mason J. In this passage their Honours cited No-Fume Ltd v Frank Pitchford and Co Ltd (1935) 52 RPC 231 and Mullard Radio Valve Co Ltd v British Belmont Radio Ltd (1938) 56 RPC 1 at 16, per Sir Wilfrid Greene MR, where the applicable principles are discussed. See also International de Lavaud Manufacturing Corporation Ltd, The Stanton Ironworks Co Ltd v The Clay Cross Co., Ltd (1941) 58 RPC 177 at 195, Olin Corporation v Super Cartridge Co Pty Ltd (1977) 51 ALJR 525 at 537, The Wellcome Foundation Ltd v Commissioner of Patents (1980) 145 CLR 520 at 529.

In "Patents for Inventions", 5th ed, 1983, Mr Blanco White QC says (para. 4-413):

"To amount to a limitation by result, what is in the claim must at least be a limitation: something that draws a line between two classes of things that would otherwise fall within the claim: with the implication that conditions of the manufacture can be adjusted, by the reader of the specification, to secure the specified result. It is, of course, a matter of construction to determine whether words in the claim effect a limitation or merely assert that complying with the claim will secure a certain result, and this like other questions of construction affecting validity is likely in present-day conditions to be decided in favour of an otherwise meritorious patentee."

The phrasing of claim 1 is broken by a colon and 2 semi-colons. The second of these is before the words "outlet means". It was, in the end, accepted by both sides that in this second passage commencing with "outlet means", in each of the phrases "providing resistance to airflow therethrough so as to maintain . . . air pressure" and "while air is passed therethrough throughout the breathing cycle of the patient . . .", the term "therethrough" referred to characteristics of the "outlet means".
The phrase "so as" is to be read with what goes before it in this second passage. The outlet means, as claimed, must be in fluid communication with the inlet tubing. This, in turn, must be adapted to be connected to an air source which introduces air into the breathing cycle of the patient. Then the provision of resistance to the air flow through the outlet means maintains air pressure, which is slightly greater than atmospheric, in the region of the aperture to the nose piece, whilst air is passed through the outlet means throughout the breathing cycle of the patient.
It will be apparent from the above that I do not accept a submission for the respondent that claim 1 requires the outlet means to be so constructed that it, purely by itself, and without the supply of air from the air source and through the inlet tube at an appropriate pressure, will achieve the maintenance of air pressure at slightly greater than atmospheric. (The result of acceptance of this submission as to construction would have been that the respondent's products did not infringe, nor would those marketed by the applicant, no apparatus answering the description of claim 1 as construed by the respondent yet having been devised).
The result is that by means of the apparatus as claimed air of a slightly increased pressure sufficient to maintain the nasal passages open throughout the breathing cycle will be administered to the nasal passages of the patient. Apparatus not providing for this result is not claimed, and the attainment of the result limits the area of the claim. I accept the submission by the applicant that so understood claim 1 as a claim limited by result and is not a "disguised" process claim. The same is true of claims dependent upon claim 1. These claims do not employ a method of definition appropriate only to a process claim: Mullard Radio Valve supra at 10-11. They are not "disguised process claims". Nor do they fail to define the invention within the meaning of s. 40 of the 1952 Act. Nor are they insufficient for failure to claim the means which provides the air source. The provision of this may be left to the skilled reader. The body (p 3, ll. 16-20) provides information upon the subject of the preferred air supply.
Upon the foregoing reading of claim 1, the respondent's apparatus would infringe, were it not for other issues of construction of claim 1 upon which it relies.
In ascertaining the width of a particular claim it is not permissible to vary or qualify the plain and unambiguous meaning of the claim by reference to the body of the specification. Nevertheless, if the meaning of a word used in a claim is not clear it is permissible to resort to the body of the specification to define or clarify its meaning; to do so does not infringe the rule that clear and unambiguous words in the claim cannot be varied or qualified by reference to the body of the specification: Interlego AG v Toltoys Pty Ltd supra at 478-9.
The respondent submitted that the reference in claim 1 to the breathing cycle of the patient was to what it called "any normal patient". Therefore, the respondent contended, there was no infringement because, even if its apparatus exhibited the integers specified in claim 1, in any "normal" patient the apparatus would not maintain in the region of the aperture to the mask, air pressure slightly greater than atmospheric whilst air was passed therethrough throughout the breathing cycle of that patient. The necessary seal between the nasal passages and the mouth would not be created in a "normal" patient not suffering from upper airway occlusion during sleep. Thus, air would leak out of the mouth. In a normal patient the apparatus would not maintain the nasal passages open throughout the breathing cycle, because they would already be open. Accordingly, so it was submitted, there was no infringement.
These submissions are perhaps better to be understood as seeking to found an allegation of inutility, and as thus going to validity. Further, at various stages of its submissions upon infringement the respondent tended to confound the function of the claims (to define the area claimed for the monopoly) with that of the body (the teaching of the performance and putting into effect of the invention). Insofar as they are directed to infringement, these submissions should not be accepted.
On its face, the claim is concerned with patients in such a condition that there is a need to maintain open their nasal passages throughout their breathing cycles. Such patients are not "normal" in the meaning which the respondent would seek to give to that word. Further, in its ordinary sense, a patient is one under treatment or care by reason of some sickness of disability. Resort to the body of the complete specification (pages 1, 4-5) makes it clear that the apparatus is for use upon patients with conditions which are characterised by occlusion of the upper air passage and which respond to the administration of CPAP.
Then it is said that there is difficulty with the interpretation of the phrase in claim 1 "air pressure slightly greater than atmospheric." (This also appears in claim 9). The point was relied upon both in relation to infringement and to the allegation that the claims were not clear and succinct, as required by s. 40. Claims 7 and 8 which are, of course, narrower than claim 1, speak of means to adjust the relative air pressure between 1 cm H20 and 15 cm H20, and of relative air pressure ranges between 4 and 10 cms H20. In the body of the specification there is a passage which indicates the sense of the phrase "slightly above atmospheric pressure". It is said: -

"While in operation the apparatus provides a normal air mixture to the nostrils of the patient at an adjustable pressure that is slightly above atmospheric pressure. The pressure is initially set at a low level and while the patient is asleep it is gradually increased until occlusions no longer occur. This set pressure should then be adequate for the patient in the future. Although, approx. 4 litres of air per second is delivered by the pump much of this leaves the apparatus, via the end restriction, never having been breathed by the patient. The patient inhales normally, the excess pressure merely overcoming the abnormal resistance of the upper air passages and preventing their inward collapse."

The body of the specification also states: -

"A typical relative pressure for a patient may be 6 cm H20 although a range from 4 to 10 cms H20 would cover most if not all individuals."

The respondent's apparatus delivers a range of pressures between 2.5 cms and 20 cms H20 and between 4 cms and 20 cms H20. Within the teaching of the specification, to which, in my view regard may be had to resolve any indeterminacy that might otherwise be presented by the phrase "air pressure slightly greater than atmospheric", and given the characteristics I have described of the respondent's apparatus, there is infringement. Also, the allegation under s. 40 fails. There is provision by claim 1 of what has been called "a workable standard" suitable to the intended use of the apparatus: Decor Corporation Pty Ltd v Dart Industries Inc (1989) AIPC 90-549 at 38,830.

The next points taken by the respondent in the comparison between its apparatus and the terms of claim 1, concern the phrase: -

"A nose piece including a cavity adapted for insertion of a patient's nose therein and to be releasably sealingly attached to a patient's face in an airtight manner."

Before amendment the corresponding passage of claim 1 read: -

"A nose piece including a cavity shaped for the insertion of a patients (sic) nose and adapted to be releasably sealed to the patient's face in an airtight manner."

I accept the submission for the applicant that, contrary to what was put for the respondent, the phrase "adapted for" in claim 1 as it now stands qualifies "nose piece" rather than "cavity". Further, in my view, in its amended form claim 1 is so drawn as to treat the adaptation of the nose piece as concerned not only with the insertion of the patient's nose but also with the attachment of the nose piece to the patient's face in an airtight manner, "releasably" and "sealingly". The nose piece must be adapted for insertion of the nose of the patient and adapted to be attached, as described, to the face of the patient.
In his oral rather than his written submissions, counsel for the respondent submitted that upon its proper construction claim 1 requires that seal be effected not by means of the mask itself but by external means. The submission was that a self-adhering device is not claimed; what is claimed is a non-self-adhering device which is sealed by glue or some other additional means. The respondent's nose masks are "self-adhering" in this sense. Therefore, it followed, on this submission, that there was no infringement.
However, in my view, there is nothing in the phrase "releasably sealingly attached" which requires any particular means by which the seal is to be effected. A self-adhering device may still answer the description of one that is "sealingly" attached to the patient's face in the meaning of claim 1.
The same phrase "to be releasably sealingly attached" appears in the consistory clause in the body of the specification. There the invention "in one broad form" is said to consist in apparatus which is then described in terms corresponding to claim 1. A lengthy description is later given of the best mode of carrying out the invention, which is described (p 5 ll. 11-14) as merely one example of an embodiment of the invention, various modifications being possible without departing from the scope of the invention. Reference is made (p 3 ll. 30-35) to a particular means of effecting the seal, namely by use of surgical grade silicon. But phrases used in a particular sense in some parts of the body, outside the consistory clause, should not be used to narrow the boundaries of the monopoly defined by the plain words of the claim: Blanco White supra, para. 2-103. Nor does it follow from the reference to the use of surgical grade silicon to effect the seal when the apparatus is placed in its working position on the patient, mean that the claim is not "fairly based" within the meaning of s. 40.
The issue of construction of claim 1 to which most attention was devoted in argument arises from the use there of the phrase "connected to".
The sense in which the participle "connected" meaning conjoined or linked together is used in any given context is to be understood in association with the meaning of the verb "connect". Thus, in the sense of joining or linking together 2 objects A and B, "connect" may be used of the medium or instrumentality by which that relationship is effected between A and B. It may be said that C connects A to B or that A and B are connected by C. "Connect" and "connected" may also be used merely of A and B themselves to describe the join, linkage or other association which is brought about between A and B. So it may be said that A is connected to B.
Accordingly, whilst A and B may be described as "connected" each to the other, if they are brought into immediate physical relationship, each being fastened to the other so that they are the only parts of the one combination, they may, in a given context, also be described as connected if that relationship is effected by the medium of C. Further, in a given context the phrase "connected to" may be used in both senses. Claim 1, in my view, provides such an example.
An instance of this second usage appears in claim 2. Claim 2 is narrower than claim 1. Claim 2 states: -

"2 Apparatus as defined in claim 1 wherein said tubing is connected to said nose piece by a rigid intermediate portion of tubing and said outlet means is connected to said inlet tubing by said intermediate portion."

Here, to adapt what is said above, the inlet tubing A is connected to the nose piece B by the rigid intermediate portion of tubing C. Likewise, the outlet means D is connected to the inlet tubing A, also by the intermediate portion C. Thus, the inlet tubing is connected both with the nose piece and the outlet means, not by their being immediately conjoined, but by means of a separate integer, the "rigid intermediate portion of tubing."

In contrast with this usage in claim 2 in the second sense I have described, the respondent contends that in the relevant integers of claim 1, "connected to" is used only in the first sense. The result of this construction is said to be that there is no infringement. I do not accept that submission. In my view the use of the phrase "connected to" in claim 1 is not limited to use in the first sense I have described.
In claim 1, the term "connected to" appears 3 times, on each occasion in relation to the inlet tubing. As to the apparatus of the respondent, it is accepted that of what in the drawings annexed to these reasons for judgment is shown as "Tubing" answers the description of "inlet tubing" within the meaning of claim 1.
Claim 1 requires that the inlet tubing be adapted to be connected to an air source. There is no dispute that the respondent's apparatus possesses this integer. The difficulty arises from the other 2 operations of the phrase "connected to". These appear from the following passage in claim 1: -

". . . inlet tubing connected to said nose piece with an aperture providing fluid communications with said cavity, . . . ; outlet means in fluid communication with and connected to, said inlet tubing proximate the region of said aperture and providing resistance to airflow therethrough. . .".

From the drawings in Schedules to these reasons it will be apparent that the inlet tubing is not connected to the Rotating Connector component of the nose piece, in the sense of being brought itself into immediate combination with the nose piece so that the inlet tubing and the nose piece are the only 2 elements of the one combination. There is interposed either the Whisper Swivel or the Sanders NRV-2. But, in my view, and contrary to the submission for the respondent, that does not mean, on a proper construction of claim 1, that the inlet tubing of the respondent's apparatus is not connected to the nose piece with an aperture providing fluid communications with the cavity in the nose piece.
I accept the submission for the applicant that when the allegedly infringing apparatus is read against claim 1, the "inlet tubing" ends where the corrugated tubing shown in the drawings ends, but such that the position of the Whisper Swivel and the NRV-2 do not produce the result that inlet tubing, so understood, is other than "connected to" the nose piece.
I have already referred to the usage of the term "connected to" in claim 2. As I indicated, claim 2 is made narrower than claim 1 by the introduction of the rigid intermediate portion of tubing. Nevertheless, the sense in which the phrase is used in claim 2 is consonant with the interpretation of the same term in claim 1 so as to yield the result that the inlet tubing, adapted to the connected air source, will be connected to the nose piece with an aperture providing fluid communication with the cavity in the nose piece. This will be so not only if the connection is the result of an immediate linkage of the 2 integers (as the respondent would have it) but also if the connection is achieved by the interposition of an intermediate element between the nose piece and the inlet tubing. What is required is that the inlet tubing be adapted to be connected to the air source and fluid communication is then provided to the aperture in the nose piece by reason of the existence of a connection between the inlet tubing and the nose piece.
The Whisper Swivel contains 3 slots which serve as an outlet means. That outlet means is in full communication with the inlet tubing. It is also connected to it because the Whisper Swivel is directly joined with the inlet tubing.
Claim 1 also requires that the outlet means be "proximate the region of" the aperture providing fluid communications between the inlet tubing and the cavity included in the nose piece. Counsel for the respondent relied upon the term "proximate" as taking the outlet means provided by the 3 slots in the Whisper Swivel out of the area claimed by claim 1.
He also contended that the term rendered the claim not clear and succinct so that it falls foul of s. 40 of the 1952 Act.
In ordinary usage, one object would be proximate to another if it is next, very near to it, or separated from it by a relatively small spatial distance. The requirement here is not that the outlet means not be proximate the aperture which provides fluid communication with the cavity in the nose piece. The claim requires that the outlet means be proximate the region of that aperture. In my view, plainly this is so in the apparatus of the respondent. The use of the term "proximate" is sufficiently specific for the skilled addressee, the experts had no difficulty with it. The submission based on s. 40 fails.
A particular argument was addressed only to the Sanders NRV-2. This had as the outlet means, a "one-way valve". When the patient exhales, the valve will be depressed and will open to provide what the respondent describes in his literature as the expiratory port of the circuit. As the patient breathes in, the valve will revert to its previous position. The point upon which the respondent relies is that whilst the expiratory port is open, the fluid communication between the inlet tubing and the aperture to the nose piece will be shut off. The respondent submits that this inlet means is not permanently in fluid communication with the nose piece. It submits that this is required by claim 1.
I accept the submission for the applicant that claim 1 is concerned with the operation of the apparatus throughout the breathing cycle of the patient. There must be the claimed inlet means from an air source, for the inhalation by the patient and the outlet means for exhalation by the patient. It is sufficient that the inlet tubing be in fluid communication with the nose piece during the first part of the breathing cycle. Claim 1 should be construed and the alleged infringement assessed by reference to the respondent's apparatus as it operates. If this is done, then there is infringement.
It follows that claim 1 is infringed.

Claims 3, 6, 7 and 8

56. The respondent's devices possess each of the additional integers required by these claims. Claim 3 is in respect of an apparatus as defined in claim 1 or claim 2 "further comprising a headband adapted to be worn about the patient's head so as to comfortably secure the nose piece thereto."

Claim 6 requires an apparatus as defined in any of the preceding claims "further including an air source connected to said inlet tube and providing air at substantially constant air pressure." Claims 7 and 8 include respectively, means to adjust the relative air pressure in the region of the aperture referred to in claim 1 between 1 cm H20 and 15 cms H20. An apparatus wherein the relative air pressure between 4 and 10 cms H20. Claims 3, 6, 7 and 8 are also infringed.
I will defer consideration of infringement of the method claims 9 and 11 until I have dealt with the issues of validity touching the apparatus claims.

Section 40
59. I set out earlier in these reasons the relevant portions of the text of s. 40. I have already dealt with a number of the issues arising under s. 40 when discussing infringement of claims 1, 3, 6, 7 and 8. Some of these may be deferred for consideration with the utility issues.

As I have indicated, the respondent submits that the complete specification does not include the best method of performing the invention known to the applicant, that is to say to Professor Sullivan. I deal now with this issue. It arises in the following way.

Best Method
61. The evidence indicates that the use of the "one tube" apparatus rather than the "two tube" apparatus has distinct advantages, for example, by assisting the plaintiff to sleep with his or her head in various positions whilst the apparatus is in operation. The evidence also indicates that the "one tube" apparatus was not known to Professor Sullivan as the best method of performing the invention on the international filing date, 23 April 1982. That date is the priority date by reference to which, for example, issues of anticipation and obviousness of the claims are assessed under s. 100 of the 1952 Act. On its face, s. 40 would suggest that the complete specification should include the best method of performing the invention known to the applicant when lodging the complete specification.

On the other hand, the respondent contends that the relevant date for the disclosure of the best method is the date of publication. In the present case, as I indicated earlier in these reasons, that is 4 November 1982. The respondent contends, and the applicant denies, that at that date the best method known to Professor Sullivan involved use of the "one tube" apparatus, whereas only the "two tube" apparatus is described in the complete specification.
Thus issues are presented both of fact and law. I turn to consider the evidence.
In re-examination Professor Sullivan said that he could not remember the details sufficiently to say whether in April 1982 he was using with patients the "one tube" method. He had agreed in cross-examination that "at the end of 1982" his preferred method was the "one tube" system. But, taken as a whole, Professor Sullivan's oral evidence, including the manner in which it was given by him, gave me the firm impression that he had no specific recollection of dates when they were not supported by contemporary records or by memorable events such as the presentation of papers at learned conferences.
In May 1982, after the priority date, Professor Sullivan presented a paper at the annual meeting of the American Thoracic Society. The learned journal which published the paper received it in its original form on 13 September 1982 and in a revised form on 4 January 1983. That was well after 4 November 1982, the publication date and that contended for by the respondent as the relevant date for disclosure of the best method. In figure 2 in the paper as published there appears a drawing of the apparatus using the "two tube" system for the provision of nasal CPAP. In the body of the paper it is said that it was this apparatus which was used to supply nasal CPAP to the patients whose treatment is discussed in the paper.
On 20 July 1983 Professor Sullivan attended and presented material at the 4th International Congress of Sleep Research at Bologna. He was embarrassed at not having a Paper ready for presentation on that occasion. He later wrote his paper, with other co-authors from his team, and the paper was submitted almost 9 months after the conference. It was published in 1984. It gives what is described as a preliminary account of the results of home CPAP treatment to 35 patients, with detailed information being given of the treatment of 5 patients over periods of up to 5 or 6 months. It is said that a number of methods of nasal CPAP were used. A description is given both of the "two tube" and the "one tube" method, the latter being described as "the latest method of applying nasal CPAP in the home." This is consistent with Professor Sullivan's oral evidence that over an indeterminate period he and his team "were transitioning between two and one tube" and that whilst eventually they did change over "I couldn't describe it as quickly."
Upon consideration of the evidence as a whole, I find that the respondent has not discharged to the necessary degree its burden of showing that by 4 November 1982, more than 6 months before the Bologna conference, the best method known to Professor Sullivan was the "one tube" method.
In the light of that finding it is unnecessary to determine the issue of law which, if decided favourably to the applicant would have the effect of moving the relevant date back to the international filing date, namely 24 April 1982. If the matter is assessed from that date, of course, the position of the applicant on the evidence as to this issue becomes even stronger. In the circumstances, I should express my views on the point.
Section 36 of the Patents Act 1903 ("the 1903 Act") stated: -

"36. A complete specification must fully describe and ascertain the invention and the manner in which it is to be performed, and must end with a distinct statement of the invention claimed."

This provision followed sub-ss. 5(4), (5) of the British Patents, Designs and Trade Marks Act 1883 (UK). Express provision as to disclosure of best method was not introduced into British legislation until the insertion in 1932 (by the Patents and Designs Act 1932 (UK), of para. (j) in sub-s. 25(2) of the Patents and Designs Act 1907 (UK). This expressly provided that the patent might be revoked if the complete specification did not disclose the best method known to the applicant "at the time when the specification was left at the Patent Office" must be disclosed.

The view has been expressed (a) that the law as expressly so provided has not been altered by subsequent legislation in the United Kingdom which omits these particular words, and (b) that even before any specific legislative provision was made in the modern legislation, such a ground of repeal was available in respect of letters patent, under the general law. This appeared to have been on the footing both that the requirement of making known the best method ensured good faith on the part of the applicant so that grants would not be obtained on false suggestions or representations, and that the patentee should not get the benefit of a monopoly without giving to the public the corresponding consideration of the best method of performing the invention. See American Cyanamid Company v Ethicon Limited (1979) RPC 215 at 269; Fox, "The Canadian Law and Practice Relating to Letters Patent for Inventions", 4th ed, 1969, pp 180-183.
That a failure to disclose the best method was a ground of repeal under the old law is indicated by such decisions as Crossley v Beverley (1830) 1 WPC 112, Heath v Unwin (1852) 2 WPC 236 at 243, and British Dynamite Company v Krebs (1896) 13 RPC 190 at 195. The temporal element was expressed by reference to knowledge prior to the date of the filing of the complete specification: Frost "Letters Patent for Inventions", 4th ed, 1912, vol 1, pp 226-235.
The enactment of s. 40 of the 1952 Act brought with it, in Australia, an express reference to the disclosure of the best method. The section is differently expressed from para. 32(1)(h) of the Patents Act 1949 (UK). This stated: -

"(h) that the complete specification does not sufficiently and fairly describe the invention and the method by which it is to be performed, or does not disclose the best method of performing it which was known to the applicant for the patent and for which he was entitled to claim protection;"

On the other hand, s. 40 uses the words "fully describe the invention" and the requirement of "best method of performing the invention which is known to the applicant" is stated as being included within the obligation to fully describe the invention, rather than being expressed disjunctively, as in para. (h) set out above.

In Welch Perrin and Co Pty Ltd v Worrel 106 CLR 588 at 609-610, Dixon C.J., Kitto and Windeyer JJ. said that the requirements of s. 40 of the 1952 Act differed, in Australia, from the corresponding provisions of the 1903 Act, namely s. 36. Their Honours continued: -

"What differences there may be between s. 40 of the present Act and s. 36 of the repealed Act are probably of no importance . . . The main requirements are that the specification shall fully describe the invention and the manner in which it is to be performed and shall end with a claim or claims."

In the United Kingdom the position appears to be that a specification must be sufficient at the date of publication, that it cannot subsequently be rendered as insufficient, and that sufficiency at the date of publication is enough, whatever may have been the position at the date of filing. It has been said that there is good reason for saying that sufficiency at the date of publication is enough, for until then, no addressee of the specification can be puzzled or mislead by the insufficiency of the directions for putting the alleged invention into practice: Blanco White supra para. 4-108. See also Illinois Tool Works Inc v Autobars Co (Services) Limited (1974) RPC 337 at 369, where Graham J differed from his own earlier view (in American Cyanamid Company (Dann's) Patent (1970) RPC 306 at 329) that the complete specification must be sufficient at the date of filing, whether this be the original date or some later date resulting from post-dating after amendments.
In the United Kingdom the temporal element in the requirement of disclosure by the inventor of the best method known to him has been differently formulated. I have referred above to what, in 1912, was said in Frost. The matter later was dealt with expressly in s. 3 of the Patents and Designs Act 1932 (UK), which restated the grounds for revocation in s. 25 of the 1907 Act. In Blanco White supra, para. 4-518, the following appears, with reference to para. (h) of sub-s. 32(1) of the Patents Act 1949 (UK):

Under the older law (ie in the 1932 Act) it was expressly provided that the best method known to the applicant "at the time when the specification was left at the Patent Office" must be disclosed. It would not seem that the law has been altered on this point: the applicant would not be entitled either to insert a description of or to claim protection for an improvement of which he was not aware at the date of filing.

I accept the applicant's submission that what is there said should be treated as applicable to the requirement in s. 40 of the 1952 Act of the disclosure by the inventor of the best method known to the inventor, notwithstanding the differences in the text between s. 40 and s. 32 of the 1949 United Kingdom Act.

Sections 67 and 68 of the 1952 Act provided for a term of a standard patent of 16 years, reckoned from the date of the patent, this being the date on which the complete specification was lodged. The adequacy of the disclosure should be judged by reference to the time from which dated the monopoly granted the applicant in exchange for the disclosure. In the present case that is the international filing date, 23 April 1982. This is the date from which the term of the patent runs.

Fair Basing Upon Provisional Specification
77. As I have indicated, it is essential for the case put by the applicant that it maintain 24 April 1981 as the priority date. The article in "The Lancet" published shortly thereafter in Australia would provide an anticipation if the applicant is left with the date of lodgment of the complete specification, 23 April 1982, as the priority date.

In the 5th edition of his "Patents for Inventions" Mr Blanco White QC says (para. 2-209): -

"It should be noted that the question of "fair basing" upon a provisional specification is not altogether analogous to that of "fair basing" upon a complete specification . . . It has always been considered legitimate to develop an invention to some extent after filing a provisional specification, and the expression "fairly based" in the present context allows for such development."

See also Cooper's Animal Health Australia Limited v Western Stock Distributors Pty Ltd (1987) 76 ALR 429 at 436 (where reference is made by Fox J to permissible "greater definition" in the complete specification) and Rehm Pty Ltd v Webster's Security System (International) Pty Ltd (1988) 81 ALR 79 at 92-94.

The respondent pointed to 4 respects in which claim 1 travelled impermissibly beyond the provisional specification.
First, the respondent contends that in the provisional specification, whilst there is a seal covering the inlet tubing and the nose of the patient, the tubing enters the nose directly, and, unlike claim 1, there is no inlet tubing connected to a nose piece with an aperture for fluid communications.
However, a passage in the provisional specification (p 3 ll. 20-29) indicates that the inlet tubing does not enter the nose directly and that rather it is connected to nasal tubes. The passage is as follows:-

"Two nasal tubes . . . are adapted from soft tubular material to be inserted into the patient's nostrils. They are attached, at an appropriate angle for a comfortable fit, to the air supply tube . . . approximately 30 cm from one end, although this distance is in no way critical. The tube . . . can be a composite of tubes with appropriate bends . . . or produced in flexible concertina type tubing. One end . . . of the air supply tube is connected to an air supply (not shown) via a flexible tube which is preferably of the previously mentioned concertina type."

Accordingly, I reject this submission.

Secondly, it is said that the attachment of the mask to the nose of the patient so as to form a seal is described in the provisional specification only by reference to the use of an adhesive material to glue the mask to the nose; on the other hand, the respondent says, claim 1 claims a mask by whatever means it might be sealingly attached.
In my view, there is no suggestion in the provisional specification that any particular method of achieving the seal, as distinct from the presence of the seal, is part of the invention claimed or described. What the provisional specification does is disclose the integer of a nose piece which is adapted to be releasably sealingly attached and it goes on to teach one method of achieving this. I reject the second submission.
Thirdly, the respondent submits that in the provisional specification there is no description of an outlet means connected to the inlet tubing, the only outlet means being the outlet end of the inlet tube. Further, it is said that the inlet tube does not "feed directly into the nose piece" as required by claim 1.
However, there is no requirement in claim 1 that the inlet tubing should feed directly into the nose piece; the requirement is that it be "connected" to the nose piece. I refer to what I have said earlier in these reasons as to the meaning of the term "connected to" when dealing with infringement. Further, the provisional specification does not describe any particular outlet means as a separate physical device. What is required (p 4, ll. 5-10) is the incorporation in the air supply tube of a variable restriction which allows the air pressure at the nasal tubes to be adjusted to suit the particular patient using the apparatus. The outlet means claimed in claim 1 provides such a restriction.
I reject the third submission.
Finally, the respondent submits that in the provisional specification "there is no reference to the effect to the achieved on the "nasal passages" of the patient". The phrase "nasal passages" appears in claim 1, whereas the provisional specification teaches the application of CPAP via the nostrils to "the upper air passages". In his evidence Professor Sullivan treated the two expressions as coextensive but the respondent would urge that the "nasal passages" as commonly understood are part of but not all of the "upper air passages". Even if that be true, the result would be that claim 1 would be narrower than, and thus fairly based on, the disclosure in the provisional specification. It will be necessary to return to this question of the meaning of the phrase "nasal passages" when dealing with the objections based on alleged lack of utility.
I conclude that the respondent has not shown that claim 1 is not fairly based on matter disclosed in the provisional specification. The result is that the priority date is the date of lodgment of that provisional specification. Accordingly, and subject to what follows, issues of alleged anticipation and obviousness are to be assessed by reference to the state of affairs in Australia on 24 April 1981. I should now deal with the significance of the 1985 amendments.

The Effect of the 1985 Amendments
89. The question here is whether, as the respondent contends, claim 1, and the dependent claims, claim matter in substance disclosed as a result of the amendments effected to the complete specification in 1985. If so, the priority date of the claims will be 17 December 1985 and, of course, they will be invalid as anticipated by reason of the displacement of the earlier priority date of April 1981. Whilst the amendments made in 1985 were made to the complete specification, the relevant comparison for the issues as they arise in this litigation is to be conducted by reference to the priority date of 24 April 1981, that is to say between the specification as amended and the disclosure in the provisional specification. That is how the respondent's case is to be put if it is to succeed on this issue. Does the amended claim 1 claim matter in substance disclosed (for the first time) in the complete specification as a result of amendment of that specification?

The consistory clause in the body of the specification was amended, as was claim 1. The allegedly new matter claimed is : -

". . . inlet tubing connected to said nose piece with an aperture providing fluid communications with said cavity, the inlet tubing being adapted to be connected to an air source; outlet means in fluid communication with and connected to, said inlet tubing proximate the region of said aperture and providing resistance to airflow therethrough. . ."

That matter is disclosed, in terms, in the amended consistory clause. But I accept the submission for the applicant that all the integers comprising this matter in claim 1 were in substance disclosed in the provisional specification. I refer in particular to the accompanying drawings and the passage commencing on p 3, l. 20 and concluding on p 4, l. 10. This includes the sentence "A variable restriction in the air supply tube in incorporated in the end 4."

The evidence of the experts indicates that it does not matter precisely where the outlet means is situated so long as it provides the appropriate resistance. Hence the adequacy on p 4, l. 5 of the provisional specification of the expression, "a variable restriction in the air supply tube". Professor Sullivan (in cross-examination, transcript pp 121-122) and Dr Lawrence (p 143) gave evidence supporting the proposition that to the skilled addressee it would not matter precisely where the outlet means was situated so long as it provided the appropriate resistance.
I turn to consider the objections of lack of novelty and obviousness in relation to claim 1 and the dependent apparatus claims.

Lack of Novelty
93. Sub-s. 100(1)(g) of the 1952 Act provides that a standard patent may be revoked, either wholly or insofar as it relates to any claim in the complete specification on the ground: -

"(g) that the invention, so far as claimed in any claim of the complete specification . . . was not novel in Australia on the priority date of that claim;"

There was no dispute as to the applicable principles. In Meyers Taylor Pty Ltd v Vicarr Industries Limited (1977) 137 CLR 228 at 235, Aickin J said: -

"The basic test for anticipation or want of novelty is the same as that for infringement and generally one can properly ask oneself whether the alleged anticipation would, if the patent were valid, constitute an infringement."

Further, each of the integers of the claim in question must be present in the alleged anticipation, save for the substitution of a mechanical equivalent for an inessential integer: Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513.

The respondent relied for anticipation both upon instances of public user and upon certain printed publications.
As will be apparent, claim 1 and the dependent apparatus claims claim a combination. The primary submission for the applicant is that none of the alleged anticipations relied upon by the respondent disclose either or both of two essential integers of that combination. First, it is submitted that there is no disclosure of an outlet means in fluid communication with inlet tubing connected to the air source and providing resistance to air flow through the outlet means so as to maintain air pressure slightly greater than atmospheric whilst air is passed through the outlet means throughout the breathing cycle of the patient. Secondly, it is submitted that there is no disclosure of a nose piece "adapted . . . to be releasably sealingly attached to a patient's face in an airtight manner."
The respondent points to use of nose masks to administer anaesthetic and what it said was the state of "nose mask technology" at the priority date. It submits that the recognition that an old article can be used in a different way cannot justify an apparatus claim for that article: The Wellcome Foundation v Commissioner of Patents supra at 529-30. However, the claim here is for a new combination of which the nose mask is but an integer. And the nose piece must be sealed to the face of the patient "in an airtight manner".
Professor Sullivan was seeking to devise a mask which might be sealed comfortably on the patient's face so that the patient might sleep at home throughout the night with the device attached. The importance of the seal and the need for the domestic use of the apparatus did not direct Professor Sullivan's inquiries towards nasal masks in use by anaesthetists.
Doctor Lawrence was called by the respondent. (So were Dr Magnus and Dr Simmul). He has been a senior staff specialist in anaesthetics and intensive care at Prince of Wales Hospital, Randwick, New South Wales since January 1975; he has had an interest in respiratory support equipment and its techniques since 1966. In the intensive care unit at his hospital Dr Lawrence is responsible for overseeing the maintenance and use of respiratory support equipment. In the late 1970s he began to work with the administration of nasal CPAP to a number of his patients. His first attempt was to use a commercially available dental nose mask, sold under the name Dupaco. Such masks had been used to administer a mixture of oxygen and nitrous oxide by the nose to patients undergoing dental surgery. Doctor Lawrence made various adaptations to the Dupaco mask but found that there were leaks around the side of the mask which would have required further improvements to make it suitable for his purposes of administering CPAP. The leaks occurred because the seals supplied in the Dupaco mask were insufficient to withstand the air pressure generated in the CPAP circuit. This differed significantly from that used in dental anaesthesia. Doctor Lawrence did not have the technical means or knowledge available to him to make any further developments which might have supplied what is an essential integer of claim 1 of the Patent.
Further, Dr Lawrence said that whilst he had used the modified Dupaco mask on a number of patients to administer CPAP before October 1983, as to the time of commencement he could not "put any definite time to it". It was possible that all the patients had been treated in a period before October 1983 which had not commenced in April 1981. I conclude that, in any event, the respondent has not discharged the onus of showing that the alleged anticipation by Dr Lawrence was published in the necessary sense before the priority date, 24 April 1981.
currently President of the State branch of the Australian Dental Association. He used nasal masks before the priority date for the administration of anaesthesia to dental patients. The masks included an inflatable cuff forming what he described in his affidavit as "an airtight seal around the nose". But, in the light of the evidence of Dr Lawrence, this reference has to be understood with an appreciation of the lower pressures supplied by the anaesthesia.
Dr Simmul is a Senior Hospital Scientist in the Respiratory Investigation Unit at the Royal North Shore Hospital at St Leonards in Sydney. He gave evidence that prior to 1981 CPAP was used primarily in intensive care for treatment of adult respiratory distress syndrome ("RDS"). CPAP was applied to the patient by use of a face mask covering both nose and mouth. He first became aware of the treatment of OSA by administration of CPAP to the upper airways, via the nose, after reading "The Lancet" article, that is to say after the priority date. He then experimented with different forms of nose masks and, over a period of some months, developed a nose mask suitable for use by his patients. Those activities cannot be relied upon to establish any case of anticipation.
I turn to consider the alleged paper anticipations. In address, counsel for the respondent limited his case to 3 articles published in foreign learned journals, which were received in Australia before the priority date. Further articles had been relied upon in the Particulars of Objections. The 3 articles were identified as those by Arp (published 1969), Kattwinkel (published 1973) and Wung (published 1975). These articles related to research conducted in the United States.
All three articles are concerned with the use of CPAP devices in paediatric medicine, in particular for the treatment of RDS and apnoea of prematurity in premature and full term infants. Before the priority date Professor Sullivan had been aware of this use of CPAP devices but he did not consider it could have relevance in treating the adult sleep disorder OSA. This was because of differences in aetiology of RDS in neonates and apnoea of prematurity, compared with the aetiology of OSA.
RDS was thought to be caused by a lack of a surface active agent (or surfactant) in immature lungs, something which caused them to collapse. Physical inability of the lungs was not seen to be the cause. The aetiology of apnoea of prematurity was thought to be caused by failure in the central nervous system to maintain the neurological responses required for breathing.
In this field of paediatric medicine, CPAP was not used for the purpose of maintaining the opening of the upper airways. This was not thought, and still is not thought, to be a cause of RDS or of apnoea of prematurity or to be relevant to the treatment thereof. CPAP here was used not to create any form of "air splint" of the upper airways, but to maintain lung volume so as to prevent lung collapse until the lungs of the infant could function unassisted. OSA was not a syndrome which, in 1981, was observed in neonates.
The Arp article had been read by Professor Sullivan before April 1981. It is entitled "A New Approach to Ventilatory Support of Infants with Respiratory Distress Syndrome." It contains the following passage:

"The mask consists of a plastic shell slightly larger than the infant's nose. It is filled with a soft, quick-setting, denture-lining material which molds itself exactly to the nasal contours with 10 to 15 seconds of intermittent pressure to the infant's moistened nose. The shells are fabricated from dental acrylic and are made in various sizes.

An exhaust port in the end of the mask is closed, during delivery to the infant of a preselected volume of air-oxygen mixture, by inflating a rubber diaphragm. The diaphragm is deflated at the end of a delivery phase of the respirator to allow the infant to exhale freely . . . ."

A critical factor is the lack of any means providing resistance to air flow so as to maintain pressure during the breathing cycle. Nevertheless, the respondent submits that there is no reason to believe that such a mask could not have been used successfully to apply nasal CPAP to keep open the upper airways of a patient suffering with OSA rather than an infant with RDS who required resuscitation. The evidence does not show that the apparatus described in the Arp article could have been so used. In any event, it would have to be shown that the article contained "clear and unmistakable directions" so to use the apparatus: Flour Oxidizing Company Ltd v Carr and Co Ltd (1908) 25 RPC 428 at 457-9; Nicaro supra at 517, 529-30. Plainly that is not the case with the Arp article.
The Kattwinkle article is entitled "A Device for Administration of Continuous Positive Airway Pressure by the Nasal Route." This article also deals with the treatment of RDS in very young infants. Again, the paediatric CPAP treatment with which this article is concerned was not directed to keeping open the upper airways by maintenance of air pressure slightly greater than atmospheric during inspiration, as claimed in the Patent. Professor Sullivan's evidence was that the pressure upon the upper airways to infants to whom paediatric CPAP was administered in accordance with the discussion in this article (and the Wung article) is not required to be greater than atmospheric pressure at all times throughout the breathing cycle of the patient. This is not the result of any neglect or failing on the part of the authors of these articles. Rather, it is because the paediatric CPAP with which they are concerned involves the use of intermittent positive pressure ventilation (IPPV) administered to infants by means of a nasal mask. The purpose of IPPV is to provide a mechanical aid to inspiration by the infant. The objective is to increase lung volume by synchronisation of the mechanical aid to the spontaneous inspiratory efforts of the infant, rather than to maintain the opening of the upper airways.
In addition, the Wung article entitled "A New Device for CPAP by Nasal Route" does not disclose the use of a nose mask. It teaches the use of nasal cannulae (or small tubes) which are inserted into the nostrils of the infant suffering with RDS. Thus an essential integer of claim 1 is omitted. In the end, the respondent appeared not to rely upon this disclosure as an anticipation.
I should refer also, for the sake of completeness, to an article "Upper Airway Patency in the Human Infant: Influence of Airway Pressure and Posture". This was published in 1980 in the United States and was described in evidence as the Wilson and Thach article. Professor Sullivan had read this article before April 1981. It describes a number of experiments conducted on the corpses of dead infants to establish whether there is a connection between airway pressure and posture on airway patency. No airflow was involved in the normal sense of breathing, the pressures being applied in a static manner involving no air flow. Pressurised air was supplied from a syringe into a short tube inserted into one nostril of the dead infant. The other nostril and the mouth were taped closed and the oesophagus was tied off. Thus there was no nose mask, and no apparatus for administering nasal CPAP as claimed in claim 1 of Patent.
None of these articles is a disclosure amounting to an anticipation, in the sense of the authorities, of claim 1 of the Patent, Obviousness

or of the dependent apparatus claims.
113. It is a ground of revocation under para. (e) of sub-s. 100(1) of the 1952 Act that the invention, so far as claimed in any claim of the complete specification "was obvious and did not involve an inventive step having regard to what was known or used in Australia on or before the priority date of that claim." The requirement of "an inventive step" is rather differently formulated in s. 7 of the 1990 Act, but nothing turns upon that in this case by reason of the transitional provisions in sub-s. 233(4) of the 1990 Act.

The submissions of the respondent on this business tended rather to isolate particular integers of the combination claimed in claim 1 and to ask whether the addition of that integer was obvious. However, the issue of obviousness essentially concerns the problem solved by the whole apparatus. The question is whether the combination claimed in claim 1 was obvious in the necessary sense.
The matter was put as follows, with particular reference to combination patterns, by Aickin J in Minnesota Mining and Manufacturing Co v Beiersdorf (Australia) Limited (1980) 144 CLR 253 at 293: -

"The proper question is not whether it would have been obvious to the hypothetical addressee who was presented with an ex post facto selection of prior specifications that elements from them could be combined to produce a new product or process. It is rather whether it would have been obvious to a non-inventive skilled worker in the field to select from a possibly very large range of publications the particular combination subsequently chosen by the opponent in the glare of hindsight and also whether it would have been obvious to that worker to select the particular combination of integers from those selected publications. In the case of a combination patent the invention will lie in the selection of integers, a process which will necessarily involve rejection of other possible integers. The prior existence of publications revealing those integers, as separate items, and other possible integers does not of itself make an alleged invention obvious. It is the selection of the integers out of, perhaps many possibilities, which must be shown to be obvious. . . The opening of a safe is easy when the combination has been already provided."

See also The Wellcome Foundation Limited v V R Laboratories (Aust) Pty Ltd (1981) 148 CLR 262 at 270-271. As Aickin J also pointed out in the first cited case (at 298) where, under the 1952 Act, reliance is placed upon a particular publica-tion it must be shown that the information contained in it was common general knowledge in Australia at the relevant time.

None of the articles to which I have referred had entered the body of common general knowledge in Australia at the priority date. No expert asserted that they had entered the body of common general knowledge. Professor Sullivan's evidence was expressly to the contrary. As I have indicated, Professor Sullivan had read some of the articles. His evidence was that he did not derive a benefit from them in wrestling with the problems with which he was concerned before April 1981.
Dr Margaret-Anne Harris, an Australian consultant paediatrician who was called by the applicant was an impressive witness. So was Professor Zwillich. He had read various articles, including the Wilson and Thach article, but before he read "The Lancet" article by Professor Sullivan it had never occurred to him to apply CPAP therapy as there described. Dr Harris was shown the Arp article. She was not familiar with it in 1981. She read it and the Wilson and Thach article for the purposes of giving evidence in this case. She gave reasons for her conclusion that neither article would have taught her anything of use in treating obstructive apnoea by the administration of CPAP.
The evidence of Professor Sullivan, as well as that of Dr Lawrence and Dr Simmul to which I have referred in dealing with alleged anticipation of claim 1, supports the existence in the field of treatment of OSA, prior to April 1981, of a recognised need which had not been met. Taken as a whole, the evidence indicates that it was the publication of the article in "The Lancet" which first made it clear, not only in Australia but in other countries, that need had been answered; cf Allsop Inc v Bintang Ltd (1989) 15 IPR 686 at 701-703. The allegation of obviousness fails.

Utility
119. I have referred already to the concept embodied in s. 40 of insufficiency. The distinction between insufficiency and ambiguity on the one hand, and inutility on the other, is said to be that insufficiency occurs when the apparatus cannot be made, and inutility occurs when the apparatus can be made but, when made, does not work. However, as has been pointed out, the distinction is often less clear in practice: Blanco White, supra para. 4-404. The result in this case is that there has been some overlapping in the submissions on these topics.

It is also important to bear in mind two related propositions. The first is that a claim may have utility even though the promised advantage is not achieved in all cases and the second is that there may be infringement of an apparatus claim if the machine can be used in a manner which infringes even though it can also be used in a manner which does not infringe: Martin Engineering Co v Nicaro Holdings Pty Ltd (1991) AIPC 90-799 at 37,582-3, per Burchett J.
Section 100(1) provides that a standard patent may be revoked either wholly or insofar as it relates to any claim of the complete specification on the ground that: -

"(h) that the invention, so far as claimed in any claim of the complete specification . . . is not useful;"

The ground of inutility is not concerned with the question of whether, in the present case, the apparatus to be used by following the directions in the Patent would not be commercially viable; rather, the question is whether the invention as claimed does not attain the result promised for it by the patentee: Decor Corporation Pty Ltd v Dart Industries Inc supra at 38,829 per Lockhart J. A distinction is to be drawn between cases where the invention claimed is not useful unless an additional integer or integers be added (such claims being invalid) and those cases where qualifications and expedients necessary to make work the article which has been claimed can be, and on a proper construction of the claim are, left to the skilled reader to supply for himself; Welch Perrin and Co Pty Ltd v Worrel supra at 601, 2, Blanco White, supra para. 4-409. See also Washex Machinery Corporation v Roy Burton and Co Pty Ltd (1975) 49 ALJR 12 at 18-19.

Thus, in the present case, whilst claim 1 and some of the dependent claims do not claim an apparatus including a blower (an absence relied upon by the respondent) this does not mean that there is a lack of utility. The need for a particular air source would be apparent to the skilled addressee. If it be necessary, resort to the body of the specification shows that the air supply in a preferred form consists of a high volume air pump and one particular proprietary product is described as having been found to be ideal (p 3, ll. 16-20).

In the Patents Act 1953 (NZ) the Statute of Monopolies was drawn into the definition of "invention" in the same way as, in Australia, it appeared in the 1952 Act. In Wellcome Foundation Limited v Commissioner of Patents (1979) 2 NZLR 591, Davison C.J. directed that there proceed to grant an application for a process for treating or preventing meningeal leukemia or neoplasms in the human brain. The Chief Justice referred to the Australian decisions and to various English decisions given before the commencement of the 1977 Act and concluded (at 621): -

"My consideration of the development of patent law, and my consideration of the scientific and commercial developments which have occurred over the last two decades, satisfy me that the appellant's application is a proper subject of letters patent in accordance with those principles which have been developed for the application of section 6 of the Statute of Monopolies."

In the course of his judgment Davison C.J. made various points, which are relied upon by the applicant in the present case, and which I accept.
Davison C.J. referred to what counsel had said was a long established practice in the United Kingdom, before the introduction of the 1977 Act, to refuse grants for methods of medical treatment. The decision to which particular reference is usually made is that of the Solicitor-General in the matter of C and W's Application for a Patent (1914) 31 RPC 235. Sir Stanley Buckmaster, as the second Law Officer, was entrusted by the Patents and Designs Act 1907 (UK), ss. 7, 93, with the determination of appeals against refusals of grants. He upheld the refusal of a grant in respect of a process for extracting metals from living bodies, particularly for extracting lead from persons suffering from lead poisoning.
It was later suggested in England that the reasons for the exclusion from grant were to be seen as based in ethics rather than logic: Eli Lilly and Company's Application (1975) RPC 438 at 445. Of this Davison C.J. ((1979) 2 NZLR at 617-9) referred to 1894 text by Cunynghame, "English Patent Practice", and said: -

"An examination of the development of the law on this topic indicates that the exclusion was based squarely on a practice which existed prior to the C and W case in 1914, which practice was reaffirmed in that case and the basis for the practice clearly set out. Ethical considerations did not apply. The basis was that it was not "an art of manufacture" (Cunynghame) or was not a form of manufacture or of trade (C and W case). Now that the foundation for the decision in the C and W case has been removed by subsequent decisions (particularly the NRDC Case), the Courts have been grasping for some other ground on which to base a refusal to exclude processes for medical treatment from patent protection. I find no warrant in law for grounding such refusal on ethical considerations."

The Chief Justice also referred to the lack of logic in any distinction which produced the result that a product for treating the human body would be patentable but not a method of treating the human body.

Counsel for the applicant also pointed out that in Australia under the 1952 Act, unlike the position in some of the other jurisdictions to which reference was made, the compulsory licensing and Crown use provisions applied, in general terms, both to patented articles and patented processes; see ss. 108-112, 125-132.
However, the decision of Davison C.J. in Wellcome Foundation Ltd v Commissioner of Patents was reversed by the Court of Appeal, (1983) NZLR 385. The result was that patents might not be granted under the 1953 New Zealand statute for a method of treating disease or illness in human beings. Cooke J (at 389) described the resolution of the issue as "a balancing exercise". His Honour also said (at 388) that there was a deep-seated sense that the art of physician or the surgeon in alleviating human suffering "does not belong to the area of economic endeavour or trade and commerce." Cooke J also (at 391-2) referred to evidence showing that there was a contest as to whether or not there would be increased costs in New Zealand in importing or manufacturing drugs as perhaps supportive of the case against grant. He concluded (at 392-3) by indicating that his judgment largely turned upon the history of the matter as disclosed by the case law, the principal case law to which reference was made having been that of the United Kingdom. McMullin J (at 398) said: -

"Patent law is a rather artificial, highly complex and somewhat refined subject. It involves scientific and commercial features outside everyday experience and the knowledge of the Courts. Therefore, any major thrust should be left to Parliament."

As I have indicated, the Australian experience, exemplified by the decision in the NRDC Case and in the retention in the 1990 Act of the previous definition of "invention", has been to the contrary.

The third member of the Court of Appeal, Somers J, (at 404) referred to the absence of any case of grant in the United Kingdom, Australia or New Zealand in respect of a method of treatment of humans. It is apparent that the Court of Appeal was not referred to the position taken in Australia by the Commissioner following the Joos case.
Counsel for the respondent relied upon the considerations which moved the New Zealand Court of Appeal. However, as I have indicated, not all of them are applicable to Australian circumstances, and in any event, in my respectful opinion the reasoning in the judgment of Davison C.J. has the advantage of greater cogency and is closer to that of Barwick C.J. in Joos.
Counsel for the respondent also submitted that a claim in terms of claims 9 and 11 of the Patent was "generally inconvenient" within the Statute of Monopolies because (i) modern medicine depends on technological innovation and it is in the public interest that this should be published and freely available, (ii) to grant a monopoly in respect of methods of treatment of disease would be "inconsistent" with the teaching of medical students and practitioners of such methods, (iii) if such grants were permitted the medical practitioner who applied the treatment without a licence and the patient who authorized the treatment would be infringers, and (iv) the dissemination of the description of the method by a teacher or medical writer might amount to exploitation of the invention within the meaning of the definition of "exploit" in Schedule 1 of the 1990 Act and thus to infringement; and (v) the patentee would be able to refuse to license the invention or to charge substantial licensing fees, subject only to the operation of the compulsory licence and Crown use provisions in Chapters 12 and 17 of 1990 Act.
Counsel for the applicant responded to point (v) that the position was no different with patents for pharmaceutical products. As to the other points, it was most unlikely that the patient who authorized the use of the process upon his or her person would be held to infringe or that a medical teacher or writer would either exploit the invention or authorize such exploitation within the meaning of the 1990 Act. It will be necessary to refer later in these reasons to the law in this respect as it now stands. It is sufficient at this stage to say that the conclusions urged by counsel for the applicant should be accepted.
Counsel for the applicant also relied upon what in Australia is now the long established practice of the Commissioner of accepting applications in respect of inventions of the character of the present patent. He pointed to the lack of evidence of deleterious consequences having flowed from the implementation of the Commissioner's practice. Counsel submitted, and I accept, that this is a circumstance which marks off the Australian experience from the position in countries such as the United Kingdom and New Zealand. There the courts and tribunals were concerned not with the revocation of grants but with unsuccessful applications for grant where the existing practice was against allowing such applications to proceed.
In all the circumstances, I accept the submissions of counsel for the applicant that (a) the respondent has not shown that claims 9 and 11 should be revoked on the footing that the claims are not an invention within the meaning of the definition in the 1952 Act, and (b) under that statute there was no normative distinction to be drawn between those processes for treatment of the human body for disease, malfunction or incapacity, and for cosmetic purposes.
I thus hold that the attack upon claims 9 and 11, based upon para. 100(1)(d) of the 1952 Act, fails.

Other grounds for revocation of Claims 9 and 11
164. It is submitted that claims 9 and 11 were not fairly based upon matter disclosed in the complete specification. They refer to treatment of snoring (in "a patient" in claim 9), whereas the complete specification qualifies the reference to treatment of snoring by the adjective "severe". In my view, although the epithet "severe" is not used in the claims, the references therein to treatment of a patient are not to be construed as claiming a monopoly for the administration of CPAP to those who snore only to a degree not calling for medical treatment. Thus construed, the claims do not travel beyond what is fairly based upon matter in the complete specification.

Then it is submitted by the respondent that there is no fair basing between claims 9 and 11 and the provisional specification. As explained earlier, this aspect of fair basing is vital to the applicant so as to fix a favourable time for assessment of the case against it on novelty. First, it is said that the drawings referred to in claim 11 and the term "a nose piece" in claim 9, "are different to" the "nostril attachments" and "nasal tubes" referred to in the provisional specification. In my view there is no substance in this branch of the case as to lack of fair basing.
A more difficult question arises from the submission that whilst the methods claimed in claims 9 and 11 are for the treatment of "snoring and/or obstructive sleep apnoea", and whilst, as it happens, in the body of the complete specification a specific reference is made to the treatment of severe snoring as well as to the treatment of OSA, in the provisional specification the term "snoring sickness" is used synonymously with OSA, and there is no disclosure of application of the method to the treatment of heavy or severe snoring which has not developed into OSA.
I have referred earlier in these reasons to the effect of the evidence as regards the relationship between heavy habitual snoring and OSA and to the significance this would have for the relevant skilled addressee.
I accept the respondent's submission that the claims for treatment of snoring, as distinguished from OSA, which are made in claims 9 and 11 in question are not fairly based as regards the provisional specification. However, as indicated in argument, if the applicant wishes to press the matter I will hear the parties at a later convenient time as to whether any amendment should be allowed, limiting the ambit of these claims so as to preserve a valid core.
In the meantime, in these reasons I will proceed on the footing that the claims are to be read as if the words "snoring and/or" were deleted.

170 I turn to the objections alleging a lack of novelty and obviousness as regards claims 9 and 11. The reasoning which led to the rejection of the respondent's case presented under these heads against the apparatus claims, also leads to the conclusion that the case that claims 9 and 11 are obvious and lack novelty has not been made out.

It was submitted that because some snoring might not successfully be treated by CPAP, for example where the obstructive event was due to a temporary illness such as hay fever or a cold, claim 9 lacked utility. But, as I have earlier pointed out, a claim may have utility even though the promised advantage is not always achieved.
A point under s. 40 was taken in relation to the phrase "air pressure slightly greater than atmospheric". As indicated earlier in these reasons this appears not only in claim 9 but also in claim 1. The reasoning by which the point was resolved favourably to the applicant, as regards claim 1, applies also to claim 9.
Next, the respondent contended that claim 11 does not, within the meaning of s. 40 of the 1952 Act, "define" the invention. This was said to be because the drawings do not "describe a method of treatment."
Claims drawn in the manner of claim 11, using a phrase such as "substantially as described with reference to the drawings" are frequently encountered in relation to apparatus claims. For example, in the patent considered by the House of Lords in Raleigh Cycle Coy. Ltd v H Miller and Coy. Ltd (1948) 65 RPC 141, claim 5 was for: -

"An electric generator for a cycle, constructed, and arranged substantially as herein described, with reference to and as illustrated in the accompanying drawings."

Of such claims Lord Morton said (at 157): -

"I think that the reason why such a claim has been inserted, in the present case and in countless other cases, is as follows. The patentee fears that his earlier claims may be held invalid, because they cover too wide an area or fail sufficiently and clearly to ascertain the scope of the monopoly claimed. He reasons as follows: "If I have made a patentable invention and have described the preferred embodiment of my invention clearly and accurately, and without any insufficiency in the directions given, I must surely be entitled to protection for that preferred embodiment, and that protection may fairly extend to cover anything which is substantially the same as the preferred embodiment.""

The phrase "substantially as described" includes the description to be found in the body of the complete specification: Blanco White supra para. 2-113. Further, a method claim may be limited by reference to an apparatus or product; an example is provided by claims 1, 2 and 3 of the complete specification considered in the NRDC Case supra at 260-261.

Remaining Infringement Issues
175. I accept the respondent's submission that there is no infringement of claim 11, even if it be read in a notionally amended form. The drawings are incorporated into the claim and questions of infringement must be assessed accordingly. The drawings involve the use of a device that has as essential features the use of a single pipe and the placement of the outlet means at the end of the pipe. It was somewhat faintly argued by the applicant in reply that in these respects the allegedly infringing apparatus did no more than substitute mechanical equivalents. But it is apparent from the evidence that development work took place over a number of years, the results of which are exemplified in the various and rival devices now marketed or sought to be marketed by the parties. The extent of the development work by Professor Sullivan and his team is apparent from the evolving range of apparatus displayed in Exhibit 6. Much work lies behind the distinctions to be drawn between the device exemplified in the drawings and the alleged infringements by the respondent's devices. The changes involve more than the substitution of mechanical equivalents; cf Raleigh Cycle supra at 160-161.

There remains the alleged infringement of claim 9, read, so as to be valid, in a notionally amended form. In the particulars of infringement complaint is made that the respondent promoted, displayed and offered for sale certain devices at Concord Hospital in the State of New South Wales and, in Queensland, at the Princess Alexandra Hospital in Brisbane. The respondent contends that these activities do not amount to infringement of this method claim. In particular it is submitted that s. 117 of the 1990 Act "does not convert a sale of a product into an infringement of a method claim."
The 1990 Act discards the traditional description of the patent monopoly (used in s. 69 of the 1952 Act) as one "to make, use, exercise and vend the invention."
Sub-section 13(1) of the 1990 Act provides: -

"13 (1). Subject to this Act, a patent gives the patentee the exclusive rights, during the term of the patent, to exploit the invention and to authorise another person to exploit the invention."

Exploitation and authorization thus are distinct concepts. The term "exploit", which is new to Australian patent law, is defined in Schedule 1 as follows: -

""exploit", in relation to an invention, includes:

(a) where the invention is a product - make, hire, sell or otherwise dispose of the product, offer to make, sell, hire or otherwise dispose of it, use or import it, or keep it for the purpose of doing any of those things; or

(b) where the invention is a method or process - use the method or process or do any act mentioned in paragraph (a) in respect of a product resulting from such use."

The phrase "a product resulting from such use" in para. (b) of this definition causes some difficulty for the patentee in relation to claim 9. Where a product does result from user of a method or process then there will be an infringement by the doing in respect of that product of any act mentioned in para. (a), such as the disposition or use of the product. However, here the use of the method claimed in the Patent does not result in any "product", vendible or otherwise. That, of course, after the NRDC Case, is no objection of itself to validity but in considering whether infringement has occurred or is threatened other than by use of the method or process, para. (b) has a limited reach.

Where the use of a product by one person would infringe, the supply of it to another is an infringement by the supplier, unless the supplier is the patentee or a licensee. This follows from sub-s. 117(1). Sub-s. 117(2) gives content to the expression "use" in sub-s. (1). It states: -

"117(2) A reference in sub-section (1) to the use of a product by a person is a reference to:

(a) if the product is capable of only one reasonable use, having regard to its nature or design - that use; or

(b) if the product is not a staple commercial product - any use of the product, if the supplier had reason to believe that the person would put it to that use; or

(c) in any case - the use of the product in accordance with any instructions for the use of the product, or any inducement to use the product, given to the person by the supplier or contained in an advertisement published by or with the authority of the supplier."

In the present case, the applicant urges that it follows that there is a relevant use if the respondent's devices are used in accordance with any instructions for use or in accordance with any inducement to use them, in either case given by the supplier or contained in an advertisement published by or with the authority of the supplier. Therefore, it is submitted, the supply of the allegedly infringing devices by the respondent, with instructions for use, is itself an infringement of claim 9, a method claim, by the respondent as supplier.

The difficulty with that proposition is that a pre-condition to the operation of s. 117 in relation to a method claim such as claim 9, is that there is a product the use of which by the respondent would infringe claim 9. In other words, that user would have to amount an "exploitation" within the monopoly conferred by s. 13, which is to be read with para. (b) of the definition of "exploit".

As I have indicated, where the invention relevantly claims a method or process, exploitation occurs, other than by use of the method or process, only by the doing of an act mentioned in para. (a) of the definition of "exploit". There must be an act done "in respect of a product resulting from such use." Here, the respondent urges, and I agree, there is no such product with the result that, in a case such as the present, s. 117 has no operation.
The position as thus disclosed may be compared with that established in the United Kingdom by s. 60 of the 1977 Act. In particular, para. 60(1)(b) deals with the situation where the invention is a process and renders a person an infringer if: -

". . . he uses the process or he offers it for use in the United Kingdom when he knows, or it is obvious to a reasonable person in the circumstances, that its use there without the consent of the proprietor would be an infringement of the patent."

In the alternative to reliance upon s. 117 of the 1990 Act in relation to the alleged infringement of claim 9 by the respondent, the applicant takes two further points. First, it relies upon what counsel submits is the body of law which forbids the procuring of infringement and which supplements particular statutory provisions dealing with infringement; see Kalman v PCL Packaging (UK) Limited (1982) FSR 406 at 421-4 and Windsurfing International Inc v Petit (1984) 2 NSWLR 196 at 204-206. In Walker v Alemite Corporation (1933) 49 CLR 643 at 658, one of the authorities discussed in the latter decision, Dixon J emphasised the narrow view taken on the authorities as to what constituted a participation in infringement or threatened infringement.
Secondly, the applicant relies upon the introduction into Australian patent law of the concept of authorisation by s. 13 of the 1990 Act. It is an infringement not only to exploit the invention but also to authorize another person to exploit it. Counsel submitted that the effect of this was to make it appropriate to have recourse, by way of analogy, to the body of case law interpreting the concept of authorisation in copyright law; see Copyright Act 1968, ss. 36, 101.
In the copyright law there are 2 strands of thought in the authorities as to the meaning of "authorisation". One derives from what was said by Bankes L.J. in Falcon v Famous Players Film Company (1926) 2 KB 474 at 491, that to authorize means to "sanction approve and countenance". The second derives from the statement of Atkin L.J. in the same case (at 499) that to authorize means to "grant or purport to grant to a third person the right to do the act complained of"; see, generally, WEA International Inc v Hanimex Corporation Limited (1987) 77 ALR 456, Australasian Performing Right Association Limited v Jain (1990) AIPC 90 - 718.
Counsel for the respondent did not dispute the width of the expression "authorise another person to exploit the invention", and accepted the continued subsistence of the law in Walker v Alemite after the commencement of the 1990 Act. But he submitted that in the circumstances of the present case the supply of the devices with instructions for use should not be met by a general injunction against sale founded upon the apprehended use of the devices, whether by the immediate purchaser or by third parties. He submitted that at worst, the injunction should restrain sales or supply by the respondent of the devices without the drawing of the attention of the buyer to the need for a licence. There is, in my view, much to be said for that submission.
In the event, claim 9 will be invalid, unless amended. On the other hand, because the applicant has been successful in its case based upon infringement of claim 1 and a number of the dependent apparatus claims it is entitled to injunctive relief to restrain "exploitation" within the terms of para. (a) of the definition in Schedule 1. That injunctive relief will strike directly at a range of activities by the respondent. Such relief will confer adequate protection on the applicant. Even if it were otherwise appropriate now to do so, I would not grant further injunctive relief founded upon claim 9.

Result
187. The applicant should bring in short minutes for declaratory and injunctive relief in respect of the infringement by the respondent of claims 1, 3, 6, 7 and 8 of the Patent, claims whose validity has been unsuccessfully called into question. I will hear the parties upon any application for an inquiry as to damages or an account of profits, as to any proposed amendment of claims 9 and 11, and as to costs of the proceeding as to date. The cross-claim, save as to any issue arising as to amendment of claims 9 and 11 should be dismissed.

[1992] FCA 811

09 NOVEMBER 1992