Respironics, Inc v ResCare Limited

[1995] APO 72

official notice

decision of a delegate of the commissioner of patents

Application        :    No. 638054 in the name of Respironics, Inc.

Title:    Method for treatment of sleep apnea and method and apparatus for providing such treatment

Action:    Opposition by ResCare Limited under section 59 of the Patents Act 1952

Decision:    Issued            .

Abstract:    Novelty and obviousness not established.  Some section 40 defects identified.  Documents particularised but not included in evidence not considered to be part of the opposition.

patents act 1990

decision of a delegate of the commissioner of patents

Re:Patent Application No. 638054 by Respironics, Inc. and Opposition thereto by ResCare Limited under section 59 of the Patents Act 1952

background

Respironics, Inc. (Respironics) filed patent application 62221/90 on 6 September 1990.  Patent application 62221/90 (now 638054) claims priority from US application 411012 which was filed on 22 September 1989.

Patent application 638054 was advertised accepted on 17 June 1993.  ResCare Limited (ResCare) filed a notice of opposition on 17 September 1993.  All evidence was served by 17 March 1995.

As the application was filed before, but accepted after, the commencement of the Patents Act 1990, section 59 of the Patents Act 1952 applies to the grounds of opposition but Chapter 5 of the Patent Regulations 1991 applies in relation to the opposition proceedings.

The matter was heard in Canberra on 12 September 1995.  Respironics was represented by Mr B. J. Hess of counsel assisted by Mr Tony Ward, patent attorney of Griffith Hack & Co., Melbourne.  ResCare was represented by Mr Lee Pippard and Mr Fraser Old, patent attorneys of Spruson & Ferguson, Sydney.  Mr Mark Abourizk of ResCare also attended.

THE SPECIFICATION

The specification is titled "Method for treatment of sleep apnea and method and apparatus for providing such treatment".  It then commences with over three pages of background information in relation to the invention.  This background information deals exclusively with the treatment of sleep apnea.  The specification then sets out a section headed "Brief summary of the invention" which commences with:

"The present invention contemplates a novel and improved method for treatment of sleep apnea as well as novel methodology and apparatus for carrying out such improved treatment method.  The invention contemplates the treatment of sleep apnea through application of pressure at variance with ambient atmospheric pressure within the upper airway of the patient in a manner to promote dilation of the airway to thereby relieve upper

airway occlusion during sleep."


Then follows a description of a method and apparatus of the invention in terms of the treatment of sleep apnea followed by a list of the objects of the invention.  Three of the four objects of the invention deal with the treating of sleep apnea but the fourth object is as follows:

"Another object of the invention is to provide an apparatus for generating alternately high and low pressure gas flow to a consumer of the gas with the higher and lower pressure flows being controlled by comparison with the average flow rate to the consumer, which average flow rate may include leakage from the system, and whereby the apparatus automatically compensates for system leakage."

The specification then provides a detailed description of the invention supported by references to the four drawings.

The specification ends with 48 claims, the 5 independent claims of which are as follows:

"1.  A method of providing gas from a source for breathing by a patient who is breathing in repeated breathing cycles each including an inspiratory phase during which a flow of such gas passes from such a source to such a patient and an expiratory phase during which a flow of such gas passes from such a patient, said method comprising the steps of:
     supplying such gas to the airway of such a patient at a positive pressure at least equal to ambient atmospheric pressure to maintain the patient's airway at such a positive pressure during said repeated breathing cycles;
     monitoring at least one of said flows of gas;
     from said monitoring, determining at least one of an instantaneous flow rate and an average flow rate of such gas;
     utilizing said at least one of said instantaneous flow rate and said average flow rate to identify the occurrence of said inspiratory and expiratory phases; and
     coordinating the patient's airway pressure with said occurrence of each said inspiratory and expiratory phase in a manner that said positive pressure is maintained in the patient's airway during a sequence of said inspiratory and expiratory phases with the magnitude of said positive pressure during selected ones of said expiratory phases in said sequence being less than the magnitude of said positive pressure during the respective immediately preceding inspiratory phases."

"9.  A method of medical treatment for a patient comprising the steps of:
     providing a flow of breathing gas from a source for delivery to the airway of such a patient during inhalation at selected higher and lower pressure magnitudes at least as great as ambient atmospheric pressure and permitting a flow of such breathing gas to pass from the patient during exhalation;
     monitoring at least one of said flows to detect an instantaneous flow rate of such breathing gas;
     processing selected parameters including said instantaneous flow rate to provide a reference indicia corresponding to an average flow rate of such breathing gas; and
     utilizing said at least one of said instantaneous flow rate and said reference indicia to select one of said higher and lower pressure magnitudes to be applied in the airway of such a patient in coordinated fashion with the occurrence of patient inhalation and exhalation in a manner that said higher pressure magnitude is applied during inhalation and said lower pressure magnitude is applied during exhalation."

"27. An apparatus for delivering pressurized gas to the airway of a patient who is breathing in repeated breathing cycles each including an inspiratory phase and an expiratory phase comprising:
     a gas flow generator means for providing such gas;
     supply means for delivery of a supply flow of such gas from said flow generator means to the airway of such a patient;
     exhaust means for allowing an exhaust flow of such gas to pass from the airway of such a patient;
     pressure controller means cooperable with said flow generator means to provide such supply flow within said supply means for delivery to the airway of such a patient at selectively variable positive pressures;
     monitoring means for monitoring the flow rate of at least one of said supply and exhaust flows;
     processor means which is cooperable with said monitoring means to provide a first indicia corresponding to an instantaneous flow rate of such gas;
     said processor means being further cooperable with said monitoring means to provide a reference indicia corresponding to an approximate average flow rate of such gas;
     decision means operable to utilize at least one of said first indicia and said reference indicia to identify the occurrence of said inspiratory and expiratory phases; and
     said decision means being cooperable with said pressure controller means to control the pressure of such gas within said supply means for varying the pressure applied within the airway of such a patient in response to identification of the occurrence of said inspiratory and expiratory phases in a manner that the positive pressure applied in the patient's airway during said inspiratory phases is greater than the positive pressure applied therein during said expiratory phases."

"38. A method of treating sleep apnea syndrome comprising the steps of:
     providing breathing gas from a source for breathing by a patient;
     supplying an inspiratory flow of such breathing gas to the airway of such a patient;
     permitting an expiratory flow of such breathing gas to pass from such a patient;
     monitoring at least one of said flows to detect flow conditions of such breathing gas between such a source and the airway of such a patient;
     from said monitoring, determining at least one of an instantaneous flow rate and an average flow rate of such breathing gas;
     utilizing said at least one of said instantaneous flow rate and said average flow rate to identify the occurrence of each inspiratory and expiratory phase of the patient's respiration cycle; and
     coordinating the patient's airway pressure with said occurrence of each said inspiratory and expiratory phase to maintain positive pressure in the patient's airway during a sequence of said inspiratory and said expiratory phases with the magnitude of said positive pressure maintained during selected ones of said expiratory phases in said sequence being less than the magnitude of said positive pressure maintained during the respective immediately preceding inspiratory phases."

"44. A method of treating sleep apnea syndrome comprising the steps of:
     providing a supply flow of breathing gas from a source for delivery to the airway of a patient at selected higher and lower pressure magnitudes at least as great as ambient atmospheric pressure;
     permitting an exhaust flow of such breathing gas to pass from such a patient;
     monitoring at least one of said flows to detect an instantaneous flow rate of said breathing gas;
     processing selected parameters including said instantaneous flow rate to provide a reference indicia corresponding to an average flow rate of said breathing gas; and
     utilizing at least one of said instantaneous flow rate and said reference indicia to select one of said higher and said lower pressure magnitudes for said supply flow of breathing gas in a manner that said higher pressure magnitude is applied to the patient's airway during patient inhalation and said lower pressure magnitude is applied therein during patent exhalation."

STATEMENT OF GROUNDS AND PARTICULARS

The statement of grounds and particulars, which was amended on 8 March 1994, lists five grounds of opposition viz. prior publication, lack of manner of manufacture, obviousness, lack of novelty and non-compliance with section 40.  However, the ground of lack of manner of manufacture was not pursued at the hearing.

In support of the ground of prior publication, seventeen patent documents and published papers are particularised.

In support of the ground of obviousness, 38 patent and other published documents are particularised as well as reference to those documents identified in support of the ground of prior publication.  The particulars also assert that a number of the claimed features formed part of the common general knowledge in the art before the relevant priority date.

In relation to lack of novelty, the particulars refer to correspondence between a representative of the applicant company and the US Department of Health and Human Services in which the particulars allege that the representative admitted the similarity between the presently claimed invention and certain prior art.

Further in support of the ground of lack of novelty, the particulars also refer to communication within Australia of information obtained at a demonstration by the applicant in Canada.

Reference is also made of prior use of the invention at a hospital in Australia.

In relation to the ground of lack of compliance with section 40, a number of alleged defects are listed.  I will refer to the more important of these as required later in this decision.

EVIDENCE

The evidence in support consists of quite a number of statutory declarations attesting to the publication dates or accession dates of various publications.  However the four declarations providing the bulk of the evidence relied on by the opponent are as follows:

.A statutory declaration by Elizabeth Ruth Ellis who indicates that she is a physiotherapist, holds a PhD in Medicine and currently holds the position of Senior Lecturer in the School of Physiotherapy at the University of Sydney.  The declaration has 17 exhibits.

.A statutory declaration by Katharine Daffurn who states that she is a registered nurse who has been employed in the Intensive Care Unit at Liverpool Hospital in Sydney since 1972.  There are two exhibits to this declaration.

.A statutory declaration by Colin Edward Sullivan who indicates that he is a medical practitioner, Professor of Medicine at the University of Sydney and Director of Sleep Disorders Centre at Royal Prince Alfred Hospital.  The declaration includes 10 exhibits.

.A statutory declaration by Graham Cameron Grant who states that he has a Bachelor of Engineering degree in mechanical and electrical engineering, a Bachelor of Medicine and a Bachelor of Surgery.  Dr Grant indicates that he is a practising anaesthetist, a practising biomedical engineer and has been involved in the design and development of medical apparatus for 30 years.  The declaration has 12 exhibits.

The evidence in answer consists of the following declarations:

.A statutory declaration by Eugene N. Scarberry who states that he is employed by Respironics where he has been involved in development of CPAP and BiPAP devices.  Mr Scarberry also indicates that he has over 25 years experience in the area of diagnostic and therapeutic equipment for cardiopulmonary medicine and upper airway disorders.  There is one exhibit.

.A statutory declaration by Ronald J. Zdrojkowski who states that he is an actual inventor of the present invention, has a PhD in electrical engineering and is employed by Respironics as Vice President, Research and Development.

.A statutory declaration by Martha C. Douglas who indicates that during the eight years of her employment with Respironics she has been involved in the development and marketing of CPAP and BiPAP ventilator products.

.A statutory declaration by John Campbell Lawrence who states that he is a medical practitioner, is a senior staff specialist in the Adult Intensive Care Unit at the Prince of Wales Hospital and has been involved in the development of ventilators.

.A statutory declaration by Rein Simmul who has a PhD in bio-medical engineering, is employed by Royal North Shore Hospital as a senior scientist and has many years experience in the testing, evaluation and purchase of respiratory equipment.

.A statutory declaration by Mark H. Sanders who states that he is an actual inventor of the present invention, is a medical practitioner and has been engaged for a number of years in research on the control of breathing, upper airway function during wakefulness and sleep and sleep apnea.

The evidence in reply consists of two declarations, the more important of which is a second statutory declaration by Graham Cameron Grant.

SUBMISSIONS

Both parties provided me with written summaries of their oral submissions at the hearing.  During the course of the hearing Mr Hess objected to parts of Mr Pippard's written submissions which referred to various patent documents which had been cited in the particulars but which had not been introduced into evidence.  Mr Hess made the point that, because these documents were not in evidence, they could not form part of the opposition.  Mr Pippard submitted that, because they had been referred to in the particulars, the documents were available to be referred to at the hearing.

I will refer to other submissions where relevant in the course of my decision.

DECISION

At the hearing, I indicated that, based on Coal Corporation of Victoria v David William Hinkley et al (an unreported decision of the Commissioner of Patents on patent application 621944 dated 17 September 1993), the documents that had been particularised but which had not been put into evidence could not now be relied on to support the opponent's case in relation to prior publication, lack of novelty and obviousness.

As a result of this ruling, Mr Old questioned whether or not these excluded documents could form the basis of a bar to sealing action by the Commissioner.  I do not think that Coal Corporation v Hinkley (supra) provides support for such an action.  In that case, the opponents failed to serve any evidence at all and as a consequence the delegate of the Commissioner decided that the public interest would best be served by considering a bar to sealing action.  In the present circumstances, the opponent has served a considerable amount of evidence.  For whatever reasons, the opponent has chosen to include only certain of the particularised documents in this evidence.  At the hearing Mr Pippard indicated that the further documents provided only further supporting examples of the disclosures in those documents already in evidence.  In this respect I tend to agree with Mr Hess that if these documents not in evidence only provide support for the disclosures of the documents already in evidence then the opponent is not greatly disadvantaged by their non-inclusion.  The public interest has not been disadvantaged.  On this basis I do not see the need for the documents not in evidence to be considered in a bar to sealing action.

Section 40

The particulars itemise a number of matters in relation to section 40.  Mr Pippard provided submissions at the hearing on most of these.  I understand the major issues raised by the opponent to be as follows and I have included in italics the corresponding submissions made on behalf of Respironics:

.The invention is not fully described because there is no disclosure of what pressures should be selected by the person skilled in the art to carry out the invention.  For example there is no disclosure of what pressures should be used to treat obstructive sleep apnea.  (The opponent's declarants do not appear to have had difficulty in reading the specification which is directed at a person skilled in the art.  Sanders indicates that the application is directed to a method and apparatus for applying pressure of a magnitude selected by a physician.  The specification does not disclose how pressures are determined because physicians know how pressures are determined.)

I note that, in the Ellis declaration, at paragraphs 53, 54 and 56, Dr Ellis assigns various pressure levels without any apparent difficulty including those needed to treat obstructive sleep apnea.  Consequently, I do not believe that the invention is not fully described in this respect because the person skilled in the art would be readily able to determine the required pressure levels for the particular patient being treated.

.The specification and claims are not clear in relation to the meaning of "continual" and "continually" given the ordinary meaning of "uninterrupted" when compared to the definition of "continual" on page 16, lines 9 to 11 which is: "Where this or other operations are described herein as continual, the scope of meaning to be ascribed includes both continuous (i.e. uninterrupted) or periodic (i.e. at discrete intervals)".  (In paragraph 13 of the Sanders declaration, reference is made to Miriam Webster's Collegiate Dictionary, 10th Edition as follows: "continually often implies a prolonged succession or recurrence whereas continuous usually implies uninterrupted flow or extension".)

It is well established law that the applicant is entitled to draft the specification so that words can be defined to have a particular meaning which meaning should be given to those words wherever they appear in the specification even though the words might normally have a different meaning.  I believe that the applicant has done no more than this.  I note that the claims which include the word "continual" or "continually" do not lack  clarity given this definition of "continual".

.While most of the description is directed to the treatment of sleep apnea, the bottom portion of page 11 of the specification refers to the use of endotracheal tubes.  As the use of endotracheal tubes automatically prevents obstructive sleep apnea, the specification is confusing as to what the invention actually is.

I must admit that I do find this disclosure in the description somewhat confusing.  It seems to me that the specification in general is dealing with two particular aspects of patient ventilation, one being the treatment of sleep apnea and the other being the compensation in ventilation systems for leakage from the system such as is experienced with nasal or face masks.  (I note that the objectives of the invention listed on pages 9 and 10 of the specification refer to these two aspects.)  In either case, the problem does not appear to exist if an endotracheal tube is used.  Such a tube acts as a mechanical splint so that obstruction from sleep apnea does not occur. Such a tube also avoids the leakages which may occur with nasal or face masks.  Consequently, I agree with Mr Pippard that the specification is confusing in this aspect.  Therefore I find that the invention is not fully described.

.Most of the claims are not restricted to the treatment of sleep apnea and are therefore not fairly based on the specification.  The description, especially in the object of the invention and the brief summary of the invention, is directed to the treatment of sleep apnea.  (The objects of the described invention are not exhaustive.  The applicant is entitled to use the invention in ways other than for the treatment of sleep apnea.)

When considering the issue of fair basis, "the question is whether there is a real and reasonably clear disclosure in the body of the specification of what is then claimed, so that the alleged invention as claimed is broadly, that is to say in a general sense, described in the body of the specification"  (Rehm Pty Ltd v Websters Security Systems (International) Pty Ltd (1988) 11 IPR 289 at 304).

I agree with the opponent's submissions that the thrust of the specification is towards the treatment of sleep apnea.  Certainly, a casual reader could be forgiven for thinking that the invention deals exclusively with the treatment of sleep apnea.  The background of the invention including the summary of the prior art, the brief summary of the invention, most of the objects of the invention and the preferred embodiments are all directed to such treatment.  However, one of the objects of the invention is directed at providing an "apparatus for generating alternately high and low pressure gas flow to a consumer of the gas...whereby the apparatus automatically compensates for system leakage".  Thus, while all the other objects of the invention mention the treatment of sleep apnea, this one does not.  It seems to me that this provides a real and reasonably clear disclosure of a method and apparatus which is not restricted to the specific treatment of sleep apnea.

.Claim 1 is not clear in relation to the wording "a positive pressure at least equal to ambient atmospheric pressure" in that in this particular art ambient pressure is generally considered to be zero level pressure.  Any pressure equal to ambient atmospheric pressure would not be considered to be positive.  (The applicant has chosen to define positive pressure as ambient or higher.)

The applicant envisages in the description at page 8, lines 21 to 23, that the lower pressure, in some cases, could equal  atmospheric pressure.  While the argument that atmospheric pressure is zero pressure and therefore not positive pressure may be technically correct, I do not think that a person skilled in the art would be in any doubt at all that the claim is referring to pressure which is atmospheric or above.  As a consequence, I do not think that the wording of the claim puts anyone in doubt as to what is included within its scope.  Therefore, I do not find that claim 1 lacks clarity in this respect.

.Claims 1,3 to 9 and 11 to 48 are not fairly based on the specification because they include within their scope monitoring of the exhaust gas flow but there is no disclosure in the description of anything but the monitoring of the flow of gas from the source to the patient.  (On pages 12 and 13 of the description, the pressure controller is preferably downstream of the flow generator and the flow transducer is preferably downstream of the pressure controller.  This allows the flow transducer to be located in the exhaust part of the circuit although there are other ways in which the exhaust flow may be monitored.  There is also a disclosure of the flow sensor detecting exhaust flow as the exhaust flow pushes a column of supply air backward in the supply tubing through the flow transducer.)

While I note that the applicant has identified a particular portion of the description which indicates that exhaust gas flow can also be monitored by the flow monitor when located in the supply line, I can find no real and reasonably clear disclosure of an arrangement whereby only the exhaust gas flow is monitored.  Therefore I agree with Mr Pippard that the above claims lack fair basis in this respect.

.Claim 1 is not fairly based on the specification as the claim includes within its scope that either one or both of the instantaneous flow rate and average flow rate can be used to identify inspiration and expiration.  However the description discloses that the average flow rate is determined from the instantaneous flow rate and then both are used to identify inspiration and expiration.  Similarly claim 9 is not fairly based because the claim refers to the processing of selected parameters including instantaneous flow rate but the specification discloses only instantaneous flow rate and no other parameters.  (Sanders states in paragraph 11 of his declaration that claims 1 and 9 do not say that only one of the flow rate parameters is used.  The claims say that at least one of the parameters must be used.  Other necessary parameters may have been developed at an earlier time.  Otherwise the claims would be so limited that infringement could be avoided by an inconsequential delay between the development of one parameter and another.  Also there is a disclosure on pages 23 and 24 of the use of only one of the parameters viz. the instantaneous flow rate when average flow rate and leak flow rate cancel out and the average flow rate only when instantaneous flow rate crosses over zero.)

I do not agree with the argument provided in the Sanders declaration on behalf of the applicant in relation to claim 1.  Whether or not a possible infringer could avoid the claim by developing one of the parameters at an earlier stage (and I doubt that this could be done), the question is whether or not there is a real and reasonably clear disclosure in the matter described in the specification of utilising only one of the two identified parameters.  The term "at least one" not only includes "more than one" but also includes "only one" within its scope.

The embodiment in relation to Figure 1 of the drawings clearly requires the use of both instantaneous and average flow rates.  The embodiment in Figures 2 and 3 is not so clear cut.  Certainly instantaneous flow rate is one parameter that is used.  However, the other main parameter used is called the estimated leak flow rate.  I note on page 22, lines 17 to 24, that the low pass filter operates to provide a long term average system flow rate.  However, the specification indicates that this long term average flow rate adjusts the estimated leak flow rate reference signal only when system flow conditions are changing very slowly i.e this average flow rate is not used all the time to determine the occurrence of the inspiratory and expiratory phases.  Consequently, I think that this embodiment discloses a method where the instantaneous flow rate is used but not the average flow rate.  As a result, I find that there is a real and reasonably clear disclosure of the use of an instantaneous flow rate parameter without the use of an average flow rate parameter.

The applicant's argument that average flow rate is used sometimes by itself is less clear cut.  The applicant has argued that this can be inferred from pages 23 and 24 of the specification.  However, although Mr Hess provided some detailed submissions at the hearing on what could be inferred from pages 23 and 24, he was unable to identify the particular passages which allowed one to infer what the applicant argues is disclosed.  The applicant's own declarants do not provide any assistance about what pages 23 and 24 disclose to a person skilled in the art in relation to this particular matter. Therefore, I feel I am bound to say that there is no real and reasonably clear disclosure of the use of an average flow rate parameter without the use also of the instantaneous flow rate parameter.  Therefore I find that claim 1 is not fairly based on the matter described in the specification in this respect.

While there is certainly disclosure of the use of other parameters to produce the estimated leak flow rate reference signal, I agree with the opponent's argument in relation to claim 9 that there are no other disclosed parameters in conjunction with the instantaneous flow rate to provide the average flow rate reference indicia.  Therefore I find that claim 9 is not fairly based on the matter described in the specification.

.Claim 9 is not fairly based on the specification as there is no disclosure of how the selected higher or lower pressure magnitude is selected.  Claim 1 has a similar problem with the term "selected".  (Sanders offers a similar argument to the one mentioned in the previous point.)

I noted previously that Dr Ellis was able to select particular pressure levels without any apparent difficulty, including those needed to treat obstructive sleep apnea.  Thus, I have found that on reading the specification as a whole, the person skilled in the art would be able to select particular pressures for particular purposes such as treating obstructive sleep apnea.  I particularly note the passages on pages 8 and 9 of the description where guidance is given as to the levels of pressure that might be selected for particular patients who do not tolerate certain pressure levels during certain breathing phases. Therefore I do not believe that claim 9 includes any feature that a person skilled in the art would not readily determine from the description.

With respect to claim 1, the term "selected" is used in the phrase "during selected ones of said expiratory phases".  I am unable to find a real and reasonably clear disclosure for any selection of expiratory phases in the specification as a whole.  It seems to me that the specification in general discloses a method in which the pressure level during all expiratory phases is lower than the pressure level during the inspiratory phases.  The submissions provided by the applicant are not helpful in this respect.

I find that claim 1 is not fairly based on the matter described in the specification because there is no real and reasonably clear disclosure for the selection of particular expiratory phases during which the pressure magnitude is reduced.

At the hearing, Mr Pippard addressed the issue of the absence of any disclosure of pressure levels in the specification.  He submitted if the expiratory pressure is at ambient pressure the patient must reduce the pressure level below ambient pressure in the airway to switch to the inspiratory phase and therefore suffer from an airway obstruction due to sleep apnea.  I note that paragraph 14 of the Sanders declaration addresses this issue.  I understand this paragraph to be saying that it is negative pressure during the expiratory phase which causes sleep apnea not negative pressure during the start of the inspiratory phase.  Thus I see no problem with the issue raised by Mr Pippard.

In summary, I have found that the invention is not fully described and claims 1,3 to 9 and 11 to 48 are not fairly based.

Novelty

The basic test for anticipation is set out in Meyers Taylor Pty Ltd v Vicarr Industries Ltd (1977) 137 CLR 228 at page 235, that is:

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

As to what constitutes infringement, I am guided by the view expressed by Lord Upjohn in Rodi & Wienenberger A.G. v. Henry Showell Ltd (1969) RPC 367 at 391 which view was adopted by Gibbs J. of the High Court of Australia in Olin Corporation v. Super Cartridge Co Pty Ltd and Another 14 ALR 149 at 157. The relevant words of Lord Upjohn are:

"To constitute infringement the article must take each and every one of the essential integers of the claim.  Non-essential integers may be omitted or replaced by mechanical equivalents; there will still be infringement."

It follows that if a citation discloses all the integers of the claim, the claim will lack novelty.  If the citation does not disclose all the integers of the claim, the claim will still lack novelty provided the citation discloses all the essential integers of the claim, but if the essential integers are not disclosed in the citation, the claim is novel - Nicaro Holdings v Martin Engineering 16 IPR 545 and Catnic Components Ltd v Hill and Smith (1982) RPC 183.

In the present case, the opponent relies mainly on US Patent No. 4550726 and exhibit ERE 15, an extract from volume 39 of the American Review of Respiratory Disease, as paper publications in support of the grounds of prior publication and lack of novelty.

However, neither of these publications disclose the use of flow rate parameters to trigger the change between higher and lower pressure magnitudes or to determine the inspiratory and expiratory phases.  In paragraph 20 of the first Grant declaration, this point is conceded.  Dr Grant considers that an engineer would routinely manipulate either pressure or flow but it seems to me that this is more an issue for obviousness considerations rather than novelty.  I am of the view that the use of flow rate parameters is an essential feature of all of the claims as it is this parameter which indicates the change between the patient's inspiratory and expiratory breathing phases or which triggers the change between higher and lower pressures.  As the publications do not contain this essential feature, I find that they do not prior publish or otherwise render the claims not novel.

The opponent also relied on alleged disclosures made by Dr Sullivan in Australia after attending a conference in Banff, Canada. Dr Sullivan discusses the matter in his declaration in relation to the present applicant's display stand at this conference.  He indicates that access to the display stand was by invitation only and he was not invited.  Dr Sullivan then states in paragraph 5 of his declaration:

"However, during the conference I met with Professor Elliot Phillipson and Dr T.D. Bradley, both of the University of Toronto, who had attended a demonstration at the Respironics, Inc. exhibition.  They advised me that Respironics Inc. demonstrated a new ventilator appliance that was called a BiPAP device.  Prof. Phillipson and Dr Bradley explained that the device was developed for assisting ventilation of patients and particularly for the treatment of obstructive sleep apnea.  I was further informed by them the BiPAP device operated to provide a first continuous positive airway pressure (CPAP) during inspiration and a second, lower CPAP pressure during expiration.  I was advised by Prof. Phillipson and Dr Bradley that the reason for the difference was to allow the patient to expire more easily as well as providing an (sic) boost to the patient during inspiration.  Neither Prof. Phillipson or Dr Bradley felt that the information conveyed to them was in any way a secret or confidential, otherwise they would not have told me about the BiPAP device."

Dr Sullivan then indicates that he passed this information on to some of his Australian colleagues who subsequently returned to Australia before September 1989.

The applicant contends that:

.    this does not constitute a disclosure in Australia;

.    the disclosure was in confidence; and

.in any case there has been no disclosure of the claimed invention.

I agree with the third dot point above.  Dr Sullivan makes no reference to a number of features which are part of the presently claimed invention.  He fails to mention for example the use of flow rate parameters to either trigger the change between higher and lower pressure magnitudes or to determine the inspiratory and expiratory phases.  As I believe that this is an essential integer of all the claims, I do not think that the opponent has established a prior disclosure of the claimed invention.  As to whether or not there has been a disclosure in Australia or, if there has been, whether or not that disclosure was in confidence, I do not have to decide.  I find that the Banff disclosure does not deprive the claims in suit of novelty.

I do note that, in paragraph 21 of his declaration, Dr Sullivan indicates that the device described in the presently opposed specification is the same as that described to him at Banff.  I assume Dr Sullivan is implying that the Banff disclosure included a reference to the use of flow rate parameters.  However this is at odds with what he has indicated at paragraph 5 of his declaration to which I have referred above where no mention is made of the use of flow rate parameters.

Dr Sullivan also suggests, in paragraph 7 of his declaration, that the concept disclosed to him at Banff "was equivalent to providing intermittent positive pressure ventilation (IPPV) with positive end expiration pressure (PEEP), or pressure support (PS) with PEEP, to a patient, those being arrangements I had used in Australia on many occasions before September 1989".  For a similar reason of absence of the use of flow rate parameters to that I have indicated above in relation to the Banff disclosure, I do not consider that such an arrangement renders the claimed invention not novel.

Dr Sullivan also provides a number of exhibits purporting to be copies of correspondence between the applicant and the United States Food and Drug Administration in relation to the seeking of pre-marketing notification approval of a product called the BiPAPEasy device.  Dr Sullivan concludes from this material that the applicant is admitting that this device is the same in function and structure to known ventilatory devices in Australia before September 1989.

The applicant argues that there is no evidence that this material has been published in Australia.  In any case the admissions made in these documents do not constitute a disclosure of the presently claimed invention.

It seems to me that, whatever submissions the applicant has made in order to get pre-marketing approval in the United States, I am bound to consider the present claims in the light of disclosures made in Australia before the priority date of the present claims.  It is not entirely clear to me that the BiPAPEasy device has all the features of the presently claimed device.  More importantly, there is little evidence to establish that the other devices referred to in this material were available in Australia before the priority date of the present claims.  The Daffurn declaration refers to the Bird Mark 7 ventilator but there is little disclosure of how this ventilator, that Nurse Daffurn used, operated.  Certainly there is no disclosure that this device used flow rate parameters to either trigger the change between higher and lower pressure magnitudes or to determine the inspiratory and expiratory phases.  Consequently, I find that this material provides me with no basis to conclude that the claims in suit lack novelty.

Although the opponent has particularised and included in evidence an article by Kaemarck referred to in the Ellis declaration and exhibited as exhibit ERE-5 in relation to obviousness, it has not relied on this article nor particularised it in relation to novelty.  I have discussed this article in much more detail in the following part of my decision on obviousness.  I note that this article refers to the use of flow parameters for the triggering of inspiratory and expiratory phases similar to many of the claims in suit.  However, the article concerns ventilators which appear to use artificial airways or endotracheal tubes, such devices supplying air directly to the patient's lungs.  As such, these ventilators differ from the claimed method and apparatus which define the maintaining of pressure in the patient's own airway which seems to me to be essential to the claimed invention.  Therefore this document does not deprive the claims of novelty.

In conclusion, I find that the opponent has not established that any of the claims lack novelty.

Obviousness

I note that the 1952 Act applies to this opposition and therefore the law on obviousness is the law in relation to obviousness under the 1952 Act.  Therefore, I note the remarks of Aickin J. in Wellcome Foundation Limited v VR Laboratories (Aust.) Pty. Ltd. (1982) RPC 343 at 346:

"It is as well to bear in mind that the question of obviousness involves asking the question whether the invention would have been obvious to a non-inventive worker in the field, equipped with the common general knowledge in that particular field as at the priority date, without regard to documents in existence but not part of such common general knowledge." 

Thus I must consider the extent of the common general knowledge in the field at the priority date.

I believe that it has been generally agreed by both parties that the person skilled in the art would have both a medical and engineering background.

ResCare argues that it was well known to provide intermittent positive pressure ventilation (IPPV) with positive end expiration pressure (PEEP), or pressure support (PS) with PEEP, to a patient before the priority date of the present claims.  This argument is supported by Dr Ellis, Nurse Daffurn, Dr Sullivan and Dr Grant.  The applicant's declarants do not dispute that IPPV and PEEP or PS and PEEP were known and used before the priority date of the claims in question.  Therefore I am prepared to accept that the use of IPPV or PS and PEEP was part of the common general knowledge in the relevant art at the priority date in question.

I should here set out what I understand the evidence is saying is a PEEP plus IPPV or a PEEP plus PS system.  I will refer to the Ellis declaration, paragraphs 20 and 21 of which are as follows:

"20.Some patients however were not affected by OSA, but rather failure of the chest to adequately pump air from the lungs.  Those patients were generally treated with nasal intermittent positive pressure ventilation (IPPV). IPPV involved applying a positive pressure to the patient during the inspiratory phase until the pressure reaches a preset level, generally between 10 cm H2O and 30 cm H2O, at which time the positive pressure was removed allowing the patient to naturally breath out to ambient atmospheric pressure.  IPPV was applied using both pressure cycled ventilators, and volume-cycled ventilators.  In the latter case, the positive pressure was applied until a preset inspiratory volume was reached.

21.In some cases, patients were afflicted with both OSA and pump failure type symptoms.  Such patients were treated with IPPV plus PEEP which effectively provided a high inspiratory pressure to overcome pump failure symptoms of the chest, and a PEEP to ensure maintenance of a positive pressure at the end of expiration thereby preventing the occurrence of apnea in the upper airway......."

I now refer to the Scarberry declaration, paragraphs 21, 22 in part and 23 as follows:

"21.I note that in the Statutory declarations of Ellis, Daffurn and Grant, numerous allegations appear that the invention is the same as such known ventilator operating modes as IPPV plus PEEP, pressure support (PS) plus PEEP, and the like, and further that PEEP is equivalent to CPAP.  I note that the claims of the opposed application all specify supplying gas to the airway of a patient at positive pressure during both the inspiratory and expiratory phases of the patient's respiration.  I note therefore that PEEP is not commensurate with supplying of gas at positive pressure and a PEEP valve has no capability whatever to supply gas at positive pressure.

22.Further, PEEP and CPAP are not equivalent.  PEEP, or positive end expiratory pressure, utilizes a threshold resistor in a manner to place a lower limit, greater than ambient pressure, on exhalation pressure so that as the patient on PEEP exhales airway pressure drops to the predetermined PEEP pressure, but no lower. CPAP, by contrast, is commonly understood and prescribed as application of a specified uniform breathing gas supply pressure, not an application of varying pressure, to maintain positive pressure in the patient's airway....

23.In an unsealed system particularly, PEEP is not in any sense equivalent to CPAP.  Specifically, in such a system, the patient's exhaled gas flows through the PEEP valve as pressure falls to a predetermined PEEP pressure.  Typically the PEEP valve allows exhalation pressure to drop quickly to the PEEP threshold.  Therefore, any other uncontrolled leak in the system will allow additional gas to escape under pressure thereby permitting the patient's airway pressure to drop below the PEEP value.  The threshold resistor or PEEP valve has no capability whatever to maintain PEEP pressure in the presence of such additional uncontrolled leakage.  By contrast, CPAP supplies gas flow to the system at a predetermined pressure and therefore is capable of maintaining the predetermined pressure by adding gas volume sufficient to offset the uncontrolled leak.  As a PEEP valve has no ability whatever to achieve this result, it may be seen that PEEP and CPAP are in no sense equivalent."

Finally, paragraph 8 of the second Grant declaration states:

"8.Referring now to the declaration of Scarberry, in paragraph 21, he notes that a "PEEP valve has no capability whatever to supply gas at positive pressure".  Mr Scarberry is correct, however in this connection I note that many of the claims of the opposed patent specification (eg. claim 1) state that "said positive pressure is maintained in the patient's airway" (my emphasis).  As indicated in my earlier declaration, a PEEP valve is a device specifically developed to maintain a positive pressure in the patient's airway at the end of expiration and therefore its operation falls clearly within the scope of the claims.  The claims in general are not limited to applying gas at positive pressure.  Referring to paragraph 23 of Scarberry, I have not suggested that CPAP and PEEP are equivalent, but rather that PEEP can be used in combination with other supply arrangements to achieve a result consistent with the method claimed in claim 1, for example, of the opposed application.  Scarberry is correct that a PEEP valve will not be able to maintain the PEEP pressure in the presence of an uncontrolled leakage.  However, it should also be noted that this may be the case with traditional CPAP arrangements or the BiPAP arrangement of the opposed application.  In this connection, there is no qualification in the opposed specification as to what a "uncontrolled leakage" comprises, and I understand this will be related to the maximum rate at which gas can be supplied to the patient in the particular system.  This will also depend upon the flow rate permitted through the exhaust port of a CPAP/BiPAP system and the pressure drop between the patient's airway and the air supply source.  As the opposed specification provides no qualifications or even suggest typical examples as to these values in its detailed description, there are no quantifiable details in the opposed patent specification that permit a determination as to whether or not the disclosed BiPAP arrangement can compensate for the so-called "uncontrolled leakage".  This, in my opinion, is a substantial deficiency of the opposed patent specification.  For example, if the EPAP level is set at 5cm H2O which is determined at the pressure controller 26 (see Fig.1 of the opposed specification), there is no disclosure in the opposed specification that supports any contention that the pressure at the patient's upper airways will be close to the preset level of 5cm H2O.  In the presence of an "uncontrolled" leakage at the mask, it is conceivable that a reasonable, if not substantial (eg. 4-5cm H2O), pressure drop can occur through the flow transducer 28 and the conduit 20 irrespective of the ability of the pressure controller 26 to maintain a constant preselected pressure at its own output during the expiratory phase."

From all of this, I conclude that this particular facet of common general knowledge at the priority date of the claims in question consisted of the use of intermittent positive pressure ventilation (IPPV) applied nasally to the patient during the inspiratory phase.  This pressure was removed after it reached a preset level of pressure.  However, instead of allowing the pressure to fall to ambient pressure, a positive end expiration pressure (PEEP) was maintained.  PEEP was maintained by the use of a PEEP valve which maintained a pressure which was higher than ambient pressure but lower than the pressure supplied during IPPV.

I believe that there is no major disagreement in the evidence filed by both parties in this although there is some debate as to how IPPV plus PEEP would function in a system where leakage occurs.  I also believe that pressure support (PS) plus PEEP was used at about the same time and that it functions in a similar fashion to IPPV plus PEEP.

With regard to the use of flow rate parameters to trigger the change between higher and lower pressure magnitudes or to detect the inspiratory and expiratory phases, the opponent makes the point that the choice of whether pressure or flow rate parameters are used in this art is something that a person skilled in the art would routinely make.  In support of this, the opponent relies on the evidence of Dr Grant to demonstrate that pressure and flow are inter-related and that an engineer would be "routinely able to manipulate either one or both of pressure and flow to obtain a desired control function".

The Grant declaration refers to three patent specifications which measure the flow of gas in ventilation systems to support the premise that the use of flow parameters in ventilators is well known.  However, generally the courts have warned against the use of patent specifications to establish the common general knowledge in the art.  I note for example the words at page 294 of General Tire & Rubber Company v Firestone Tyre and Rubber Company Ltd, (1972) RPC 457:

"... it is clear that individual patent specifications and their contents do not normally form part of the relevant common general knowledge .."

However, as was stated in Minnesota Mining & Manufacturing Co v Beiersdorf (Australia) Ltd, (1980) 144 CLR 253 at page 294:

"There may be some fields of endeavour in which those who work therein study and make themselves familiar with all patent specifications as they become available for inspection in one or in many countries so that what was contained therein becomes common general knowledge in that particular trade or field of manufacture in the country in question."

However, I have no evidence before me to suggest that the particular field in which the present invention resides is such a field.  Certainly a number of the witnesses have authored numerous publications.  Dr Sullivan lists over 100 of them.  It therefore could be said that persons skilled in the art would probably make themselves familiar with scientific publications in the art.  However, that argument was not pursued.  Even if this were the case, that is not to say that they would also do so with patent specifications.  Therefore I do not believe that these patent documents provide any basis, by themselves, for the establishing of the extent of common general knowledge in the art.

Therefore the only support in his declaration for Dr Grant's contention that pressure and flow are inter-related and that an engineer would be "routinely able to manipulate either one or both of pressure and flow to obtain a desired control function" is that Dr Grant, himself, has said so.  Dr Grant does not say that an engineer would have done this before the priority date of the claims in suit.  I note that Dr Grant does not say specifically that he, himself, would have routinely chosen either pressure or flow parameters before the priority date of the claims in suit.  However, Dr Grant does say in his second declaration that, in his experience, he has become aware of the limitations of each of pressure, flow and volume parameters and that any teaching away from the use of pressure would immediately imply to him the use of flow sensing.  He does not say whether this implication would have occurred to him before the relevant priority date.

Mr Hess made the point at the hearing that Dr Grant is not entitled to express an opinion about what all engineers would do but only indicate what he himself would do.  I'm not sure that I agree.  Dr Grant is entitled to express his view on what he believes the common general knowledge in the art to be i.e. the knowledge that all skilled people in the art would have.  I think the more important aspect of Dr Grant's evidence is that he does not indicate whether the particular common general knowledge existed before the priority date.  The fact that he does not state that he, himself, would be "routinely able to manipulate either one or both of pressure and flow to obtain a desired control function" also reduces the weight which should be given to his assessment of the state of common general knowledge in the art.

In this particular matter, I note that the Daffurn declaration exhibits an extract from a manual which Nurse Daffurn asserts is the standard text in intensive care units.  I note also that the applicant concedes in written submissions provided at the hearing that there is some evidence that this particular manual forms part of the common general knowledge.  On page 94 of this manual, particular modes which can be used to terminate the inspiratory phase in ventilators are referred to and flow cycling is explained as follows:

"Inspiration is terminated when gas flow to the patient falls to a critical preset value.  It is an uncommonly used mechanism." (my underlining)

I do not think that this assists the opponent's argument that an engineer would routinely choose either pressure or flow parameters.  It seems to me that, if the manual is indicative of the common general knowledge in the art, a person skilled in the art would be most unlikely to use flow parameters to detect the inspiratory and expiratory phases.

There is another relevant document which Mr Pippard encouraged me to read.  It is exhibited as ERE-5 as part of the Ellis declaration and is an article by R.M.Kaemarck in Respiratory Care, Vol. 33, No. 2, dated 2 February 1988.  There is a statutory declaration by a Ms Egan which suggests that this edition of this journal has an accession date of 15 April 1988 in the Sydney University Nursing Library in NSW.

The article provides a review of a number of ventilators providing pressure support.  Two of these ventilators, the Engstrom Erica and the Ohmeda CPU-1, are indicated as having an inspiratory as well as an expiratory flow sensing trigger.  Most of the other ventilators are classed as having an expiratory flow sensing trigger with an inspiratory pressure sensing trigger.  I note that the ventilators appear to be associated with the use of artificial airways or endotracheal tubes.

However, I do not know if the journal originates from Australia.  Given that the author is employed at Harvard Medical School I suspect that the journal is published in the USA and is therefore more indicative of the art in that country.  Certainly Dr Ellis does not claim that it forms part of the common general knowledge in the art in Australia.  It is certainly at odds with what the Daffurn declaration indicates is the state of common general knowledge in Australia.  Also there is no evidence that most of these machines were available in Australia at the relevant date.

The Daffurn declaration refers to a number of ventilators, only one of which, the Engstrom Erica, is referred to in the Kaemarck article.  Nurse Daffurn does not claim that the Engstrom ventilator was so well known that it formed part of the common general knowledge.  In any event, the Daffurn declaration does not indicate that the Engstrom Erica ventilator makes use of flow parameters at all.

The Pippard declaration exhibits a letter and brochure from a medical equipment company stating that the Siemens Servo 900C, also referred to in the Kaemarck article, was released into the market in 1981. (I assume that the market referred to is the Australian market.  This is supported by the Manners declaration in the evidence in reply.)  However, there is no evidence at all that this ventilator was well known in the art in Australia at the relevant date.  As indicated above, the Daffurn declaration refers to a number of ventilators which Nurse Daffurn has used but the Siemens ventilator is not one of them.  Therefore, without any evidence to the contrary, I must conclude that the Siemens Servo 900C did not form part of the common general knowledge.

In summary, I find that, although Dr Grant asserts that any engineer would routinely choose either pressure or flow parameters, it is not clear that any engineer or he, himself, would have done so before the priority date of the opposed claims.  On the other hand, I find that the manual referred to in the Daffurn declaration indicates that flow parameters would be uncommonly used to determine the end of the inspiratory phase.  As indicated above, there is no other evidence of any probative value in relation to this matter.  It seems to me therefore that there is not sufficient evidence before me to find that a person skilled in the art would have as part of his or her common knowledge the concept that pressure and flow parameters can be readily interchanged.  To the contrary, the evidence seems to suggest that the use of flow parameters at least to determine the end of the inspiratory phase is not something normally done.

Even if I were to decide that the person skilled in the art would routinely choose either pressure or flow parameters, I believe that the opponent has still failed to clear the final hurdle in establishing obviousness.  There is no evidence before me which clearly establishes that a non-inventive person skilled in the art would have as a matter of routine used the flow parameters specified in the claims instead of pressure parameters in an IPPV and PEEP system to detect the inspiratory and expiratory phases.  Dr Grant's evidence falls short in this regard.  For example, Dr Grant does not say that he, himself, would have done this as a matter of routine.  Dr Grant does say in his second declaration that, in his experience, he has become aware of the limitations of each of pressure, flow and volume parameters and that any teaching away from the use of pressure would immediately imply to him the use of flow sensing.  However, there is no evidence of any teaching away from the use of pressure parameters in IPPV plus PEEP.  Certainly the opponent's other declarants do not provide any support for this at all.  Indeed as I have indicated above the common general knowledge in the art seems to point away from using flow parameters at least in detecting the end of the inspiratory phase in a ventilator system.

In this respect, I note the following question posed in Allsop & Another v. Bintag Ltd., (1989) AIPC 90-615 at page 39331:

"Would the hypothetical non-inventive person skilled in the art faced with the problem have taken as a matter of routine whatever steps might have led from the prior art to the invention claimed?"

There has been little discussion by the parties about the problem solved by the presently opposed invention but I understand from the applicant's declarants that at least part of the problem solved is to compensate for leakages in a ventilation system.

Given the fact that the common general knowledge in the art seems to point away from using flow parameters at least in detecting the end of the inspiratory phase in a ventilator system and that there is no other convincing evidence that a person skilled in the art would use flow parameters when faced with this problem, I find I must answer the above question in the negative.

Therefore, I do not believe that the opponent has made out its case in regard to obviousness.

CONCLUSION

I have found that the opponent has succeeded on the ground of non-compliance with section 40 but has failed to establish the grounds of prior publication, lack of novelty and obviousness.  As I believe that the section 40 defects can be overcome, I allow the applicant 60 days from the date of this decision to file amendments to overcome these defects.

COSTS

The opponent has been successful in some of the section 40 matters but has failed to establish prior publication, lack of novelty and obviousness.  I note that the particulars list 17 documents in relation to prior publication (8 of which were included in evidence) and 43 documents in relation to obviousness (17 of which were included in evidence) so that the applicant has been faced with a large number of documents to consider in relation to the anticipation grounds.  On the other hand, I also note that the opponent has successfully identified section 40 defects which are of some significance.

In the circumstances, I award costs and against the applicant, Respironics, Inc., except those costs associated with the serving of evidence in support and evidence in reply.

R.W. HALLETT

Delegate of the Commissioner of Patents

Patent attorneys for the applicant  :  Griffith Hack & Co, Melbourne

Patent attorneys for the opponent   :  Spruson & Ferguson, Sydney