Gynelab Products, Inc. v Packard Development S.A
[1997] APO 28
•23 June 1997
official notice
decision of a delegate of the commissioner of patents
Application : No. 646630 in the name of GYNELAB PRODUCTS, INC.
Title: Intrauterine cauterizing apparatus and method
Action: Opposition under section 59 of the Patents Act 1952 by PACKARD DEVELOPMENT S.A.; hearing.
Decision: Issued .
Abstract: Opposition successful. Claim 1 not novel (p.12). Claims 1-17 do not define the invention because they lack an essential feature (p.13)
Re claims construction:
1. Presumption against redundancy and redundancy rules discussed; applied to independent claims (p.9)
2. Experts’ opinions considered to decide whether apparatus cited was suitable for the purpose claimed (p.12)
patents act 1990
decision of a delegate of the commissioner of patents
Re:Patent Application No. 646630 by Gynelab Products, Inc. and opposition under S.59 of the Patents Act 1952 by Packard Development S.A.
background
Patent application number 646630 in the name of Gynelab Products, Inc. (hereafter referred to as GYNELAB) was advertised accepted on 3 March 1994. A notice of opposition to the grant of a patent was lodged by Packard Development S.A. (hereafter referred to as PACKARD) on 2 June 1994. The statement of grounds and particulars was served on 2 September 1994 (an amendment was made on 21 November 1994 and allowed without opposition). Evidence in support was completed on 3 April 1995 (following two extensions of time), and evidence in answer was completed on 10 January 1996 (following three extensions of time). PACKARD gave notice of intention to serve evidence in reply, but did not serve any evidence within the allowed period (ie. by 10 April 1996).
On 26 April 1996 PACKARD filed a request to amend the statement of grounds and particulars, and requested leave to file further evidence. GYNELAB opposed the requests, the matter was heard in Canberra on 19 July 1996, and the Commissioner’s delegate refused to allow the amendment and refused permission to serve further evidence.
The opposition was heard in Canberra on 2 December 1996. GYNELAB was represented by Mr Adrian Ryan, barrister, assisted by Mr Brett Connor, patent attorney of Carter Smith & Beadle, Melbourne. PACKARD was represented by Mr Malcolm Bell, patent attorney of Phillips Ormonde & Fitzpatrick, Melbourne.
THE SPECIFICATION
The specification indicates that the invention particularly relates to cauterizing the tissue lining of a human body cavity, particularly the endometrium of the uterus. The claims defining the invention are as follows:
“1. An apparatus for effecting necrosis of a tissue lining in
a body cavity comprising:
a catheter comprising a length of flexible tubing having
a distal end and a proximal end;
a bladder means for insertion into a[sic] distending the body
cavity attached to said proximal end;
inflating means connected to said distal end for
introducing an inflation medium through said flexible tubing
and into said bladder;
a heating means positioned internal to said bladder for
heating said inflation medium to a temperature sufficient to
effect tissue necrosis, and
control means connected to said distal end for regulating
inflation and heating of said bladder.“2. An apparatus for effecting necrosis of an uterine
endometrium comprising:
a catheter having a proximal end and a distal end;
a distendable bladder means attached to said proximal end
for insertion into and distending the uterus;
inflating means connected to said distal end for
introducing an inflation medium into said bladder;
heating means positioned internal to said bladder for
heating said inflation medium to a temperature sufficient to
effect tissue necrosis, and
control means connected to said distal end for regulating
the inflating and heating of said bladder.“3. The apparatus of claim 1 or 2, wherein said catheter is
comprised of rigid tubing at a proximal end of said bladder,
and flexible tubing extending through said rigid tubing from
said control means to said bladder.“4. The apparatus of claim 1, 2 or 3 wherein said inflating
means comprises a pump means connected to said flexible tubing
for pumping said inflation medium through said flexible tubing
so as to inflate said bladder.“5 The apparatus of claim 4, wherein said pumping means
comprises a hypodermic barrel.“6. The apparatus of claim 5, wherein said hypodermic barrel
is connected to said flexible tubing by a three-way valve.“7. The apparatus of any preceding claim, wherein said
inflation medium is non-circulating.“8. The apparatus of claim 3, wherein said rigid tubing is
selected from the group comprising Teflon (registered trade
mark) type tubing.“9. The apparatus of claim 2, wherein said flexible tubing is
selected from the group comprising Teflon (registered trade
mark) type tubing.“10. The apparatus of any preceding claim, further comprising
means for disengaging said catheter from said control means so
that the catheter and the control means may be separated.“11. The apparatus of any preceding claim, wherein said
distendable bladder is capable of resisting an internal
pressure of at least 300 mmHg without rupturing and a
temperature of at least 250o Fahrenheit without carbonizing.“12. The apparatus of claim 11, wherein said distendable
bladder is selected from the group comprising latex rubber.“13. The apparatus of any preceding claim, wherein said control
means comprises:
volume control means;
temperature control means;
pressure control means; and
time control means.“14. The apparatus of claim 13, wherein said temperature
control means comprises:
a thermocouple internal to said distendable bladder for
measuring the temperature of said inflation medium; and
said thermocouple being connected to said control means by
an electrical lead.“15. The apparatus of claim 13 when appended to claim 3,
wherein said pressure control means comprises:
a pressure sensor connected to said flexible tubing; and
a pressure display connected to said pressure sensor for
displaying and regulating the pressure of said inflating means.“16. The apparatus of claim 13, wherein said time control means
comprises a clock.“17. The apparatus of claim 16, wherein said clock is
programmable and connected to said temperature control means.“18. A method for effecting cauterization necrosis of the
tissue lining of a mammalian body cavity comprising the steps
of:
1. inserting a distendable bladder into the body cavity;
2. inflating said distendable bladder to a predetermined
pressure with a fluid so that said distendable bladder is
in contact with substantially all of the tissue lining for
which necrosis is desired;
3. heating said fluid by means of a heating element
positioned internal to said distendable bladder;
4. controlling the temperature and pressure of said fluid
by control means connected to said distendable bladder;
and5. maintaining said bladder so inflated with said fluid at
a temperature for a period of time sufficient to effect
cauterization necrosis of substantially all of the tissue
lining of the body cavity for which necrosis is desired.
“19. A method as described in claim 18, wherein the exterior of
said distendable bladder in contact with the tissue lining is
maintained at a temperature of 190o to 215o F and preferably
about 210oF for a period of time of from 4 to 12 minutes, and
preferably around 6 minutes.“20. A method for effecting cauterization necrosis of an
uterine endometrium comprising the steps of:
1. inserting a distendable bladder into the uterus;
2. inflating said distendable bladder to a predetermined
pressure with a fluid so that said distendable bladder is
in contact with substantially all of the endometrium;
3. heating said fluid by means of a heating element
positioned internal to said distendable bladder;
4. regulating the temperature and pressure of said fluid
by control means connected to said distendable bladder;
and
5. maintaining said bladder so inflated with said fluid at
a temperature for a period of time sufficient to effect
cauterization necrosis of substantially all of the uterine
endometrium.“21. A method as described in claim 20, wherein the exterior of
said distendable bladder in contact with the endometrium is
maintained at a temperature of 190o to 215o F and preferably
about 210o F for a period of time of from 4 to 12 minutes, and
preferably around 6 minutes.“22. An apparatus substantially as hereinbefore described with
reference to the accompanying drawings.“23. The method of any one of claims 18 to 21, substantially as
hereinbefore described with reference to the accompany
drawings.”
The specification defines the following terms:
“ ‘Necrosis’ means the death of cells in tissue.
‘Endometrium’ is that portion of the inner lining of the uterus to which an embryo normally attaches and excludes the portions of the uterine inner lining forming the cervix, to which the embryo usually does not attach.”
The specification indicates that the invention is safe and efficacious when compared with the prior art, in which devices such as lasers have been used.
THE Evidence
The evidence-in-support comprises declarations by:
Mr Bell, with exhibits MNB-1 to MNB-3.
Bertil Persson, with exhibits BRP-1 to BRP-8.
The evidence-in-answer comprises declarations by:
Robert Neuwirth, with exhibits RSN-1 to RSN-6. Prof Neuwirth is one of the inventors of the present invention.
Edwin Wood, with exhibits ECW-1 to ECW-7.
Focus at the hearing was on two exhibits, viz:
BRP-6
This is a copy of US patent No.4,160,455 to James T. Law, published before the priority date of the present application. This patent describes a heater for heating fluid within a body cavity of an animal, say for heating tumours by irrigation. The patent discloses that malignant cells, such as tumours in the stomach or bladder, may be destroyed by increasing their temperature above the normal body temperature of the animal, and that the temperature at which the malignant cells die is lower than can be tolerated by most healthy cells but higher than that tolerated by some organs in the body such as the liver and the brain, so the whole body of the animal cannot be heated to the desired elevated temperature.
The heater comprises a container having inlet and outlet ports through which fluid in the cavity is passed by an external pump, and a heating element in the container to heat at least some of the fluid that passes through the container. Pumping can be achieved by a fluid filled pipe coupled to the container and to a bellows arrangement for cyclically varying the pressure of the fluid in the pipe and container. The description of the invention indicates that, in a specific use of the invention, the container is inserted into a body cavity such as the bladder, and the discussion of the field of the invention indicates that this type of irrigation apparatus is located via a “passageway into the cavity”, thus suggesting that the invention relates to a non-surgical method of locating the heater inside a body cavity.
In the patent specification drawing, the pipe is shown as being essentially straight with a right-angled elbow bend at the heater end. The patent specification also describes other features pertinent to the present invention such as:
· the container being sealed into a fluid-tight, flexible rubber sac or membrane which deforms when filled with liquid and conforms to the interior of the body cavity,
· temperature sensing electrical circuit components- to allow the heating element to achieve a desired temperature, and
· a closed hydraulic system including a reservoir, valve and manometer.
BRP-7 and BRP-8
These documents are a copy of German patent specification No.895046 to Ulrich Doering, and a translation thereof.
The German patent specification is also published before the priority date of the present application, and it describes a device for heat treatment of internal organs such as the uterus. This device essentially comprises a flexible balloon-encased electrical heating element at the distal end of a handle, with a hand-pumped liquid reservoir connected to a flexible tube which passes through the handle into the inside of the balloon.
The opponent’s Statement of Grounds and Particulars and evidence includes many objections and matters that were not pursued at the hearing, presumably because those objections and matters carry less weight in the opposition than those referred to at the hearing. Thus I will focus my comments on the matters brought up at the hearing. Also, it is convenient to deal with the parties’ submissions matter by matter as I deal with each issue as follows.
decision
Re BRP-6:
The opponent submitted that claim 1 is not novel in the light of US patent No.4,160,455. Prof Persson discusses this citation in paragraphs 75 to 85 of his declaration. The main issues relating to this citation are: (1) use of the word “for” in the claims, (2) the pipe, (3) necrosis temperature and (4) distension of the cavity.
Use of “for” in the claims
The parties made detailed submissions, citing a number of well-known cases, on the issue of the use of the word “for” in the claims. I do not think it is necessary for me to recite those submissions; in my view the law and practice in this matter is clearly expressed in paragraph 10.8.9.2 of Volume 2 of the Patent Examiners’ Manual of Practice and Procedure, and needs no further elaboration; viz:
“10.8.9.2For claims directed to a product or apparatus, the words "for", "for use in" and the like place a limitation on what is claimed, to the extent that it must be suitable for the specified purpose. For example, if a claim refers to a "hook for a crane", this implies that the hook is of a particular structural character which makes it quite distinct from a fish hook. However .... the words "for", "for use in" and the like in claims of the form "Apparatus for ..." are merely indicative of the environment in which it is intended to use the apparatus, and do not limit the apparatus to use solely in that environment (see eg. Thurston Catton's Application, (1978) AOJP 3666). As a consequence, a claim of this form is to be construed as a per se claim to the apparatus. Similarly, a claim to a substance or composition for a particular use should be construed as relating to the substance or composition per se (see eg. Farbwerke Hoechst Aktiengesellschaft vormals Meister Lucius & Bruning, (1964) AOJP 1483).
“On the other hand, method or process claims using words of purpose are restricted to that purpose eg. in a claim defining “A method for treating sugar cane extract fibrous material ....” which recites a number of standard steps, it should be borne in mind that those steps are restricted to treating sugar cane.
“This may not, of course, necessarily result in an inventive step for that claim, particularly if those standard steps have previously been applied to other stalk crops for the same purpose.”
The pipe issue
The opponent’s submission on the pipe issue is that the pipe must be sufficiently flexible to be inserted into a body cavity such as a stomach or bladder.
I think the first impression one gets from the drawing in the Law specification is that the pipe is rigid because it is shown as substantially straight with a right-angle bend at the distal end, and because the word “pipe” suggests rigidity more often than not. However, there is a broken outline section shown in the pipe, which suggests at least that it is longer than shown in the drawing, and that it may not necessarily be straight over its full length.
The textual description in the Law specification indicates that the heater apparatus can be inserted into a bladder or a stomach of an animal; therefore I find it difficult to imagine how the heater apparatus could be located inside a body cavity such as a bladder, via a natural orifice such as the urethra, in the position exactly as shown in the drawing, ie. at a right angle to the pipe, and given the relative size of the container cf. the small length of pipe leading into the container. The textual disclosure therefore suggests that the pipe must be flexible; this would allow the heater to be longitudinally aligned with the pipe for insertion. I note also that the Macquarie Dictionary’s definition of “pipe” includes simply “a tube”, which conveys more of an idea of flexibility.
In attempting to reconcile the confusion between the prima facie impression of the drawing and the textual disclosure in the Law specification, one could conclude that the pipe has been drawn as it is simply to fit neatly on the rectangular page, and that the word “pipe” has been used in a broad sense to mean “flexible tube”. I note that in referring to the prior art in column 1, the Law specification reads: “it is known to heat tumours by irrigating body cavities such as the stomach or bladder adjacent to the tumour with hot water ducted into and out of the cavity by pipes.” Also, in column 3 of the Law specification, specific reference is made to an embodiment of the invention which is used in the stomach. These references suggest to me that the pipes must be flexible since the stomach is a relatively inaccessible body organ.
Thus, considering the Law specification by itself, I think it is far more likely than not that the specification as a whole discloses flexible pipes. Nevertheless, I still have some doubt that this prima facie disclosure is sufficient to satisfy the requirement that an anticipation “must contain clear and unmistakable directions to do what the patentee claims to invented...” and that “a signpost... will not suffice.” See General Tire & Rubber Co v Firestone Tyre & Rubber Co, [1972] RPC 457. (It is possible, for example, although remotely so, that the Law apparatus as shown in the drawing could be adapted for some unusually configured animal).
However, a specification is to be construed by a person skilled in the art, so it is incumbent on me to consider the experts’ opinions in this matter. At paragraphs 78 and 79 of his declaration Prof Persson states:
“It is clear that for the container 10 to be able to be inserted into a body cavity such as a stomach or bladder the pipe 26 must be sufficiently flexible to be inserted. Therefore, although there is no discussion of what pipe 26 is made of, it is implicit that it is, or includes flexible tubing. If it did not, the apparatus, being remote from the liquid and power sources, would be unworkable.”
“Furthermore one of the great advantages of using apparatus such as that described in the Law specification is that treatment to body cavities can be carried out without invasive surgery by utilising the body openings. Therefore, to use the apparatus described in the Law specification for treatment of the stomach the bladder end of the apparatus is inserted through the oesophagus and into the stomach. Similarly, where treatment of the bladder is concerned the apparatus is inserted through the urethra. To enable these kinds of insertions the pipe 26 of the apparatus shown in the Law specification must necessarily be flexible and also appropriately sized. Therefore, although described in the Law specification as a pipe it is in all respects a catheter which conforms to the requirement of claim 1.”
If this matter of the pipe was of real significance, one would expect the applicant to attempt to distinguish its invention from the prior art on this issue. The applicant made some submissions at the hearing along these lines but I think it is significant that neither of the applicant’s experts’ declarations respond to Prof Persson’s comments on this issue. This silence suggests to me that the applicant’s own experts do not dispute the idea that the pipe referred to in the Law specification would be seen as being flexible by a person skilled in the art.
The applicant’s written submissions suggest that the view that the pipe is not flexible “is reinforced by the fact that the primary embodiment does not include the sack [sic] 41, in which case one would expect the pipe to be rigid so as to prevent the heater falling onto and scalding the walls of the cavity.” I do not agree with this submission firstly because it was not a point made by either of the applicant’s experts, and secondly because there is no disclosure in the Law specification, in the embodiment without the sac, of preventing the heater touching the walls of the cavity. This notion seems to be pure speculation on the applicant’s part. One of the objects of the Law apparatus is to overcome the prior art disadvantage of the pipes “scalding their passageway into the cavity”, and this object seems to be achieved, at least in part, by the apparatus producing vigorous agitation of the fluid in the body cavity, which ensures uniform heating of the water and the interior surface of the cavity. Also, the heating element per se ie. “resistor 14” is protected by a “cylindrical container 10”. These disclosures suggest to me that the likelihood of scalding is minimised with the Law apparatus.
Thus, when the experts’ opinions are taken into account, I am satisfied that the whole disclosure in Law, ie text and drawing, can be construed as being clear and unmistakable directions that a flexible pipe is used.
Turning to the present claims, I note that the Macquarie Dictionary defines “catheter” as “a flexible or rigid hollow tube employed to drain fluids from body cavities or to distend body passages, esp. one for passing into the bladder through the urethra ...” I have decided that the Law specification discloses a flexible pipe which is used to locate a heater in the bladder through the urethra; therefore I am satisfied that the citation discloses a “catheter” as claimed.
Necrosis temperature issue
The opponent’s submissions on the necrosis temperature issue are summarized as follows:
The heater disclosed in the citation is capable of effecting necrosis
· firstly because necrosis of tissue can occur at temperatures as low as 43 degrees Celsius (110o F) and
· secondly because there is reference to “destroying” malignant cells in the citation.
The applicant’s submissions on this issue are summarized as follows:
· The heater in the Law specification is used with warm water and avoids temperatures that would scald or burn tissue, thus the operating temperature is well below necrosing temperature.
· The present invention operates at temperatures high enough to necrose healthy cells as well as malignant cells (eg. of the endometrium of the uterus) whereas the heater in the citation is merely for treating malignant tumour cells.
The evidence before me suggests that the present invention is meant to operate at higher temperatures than the heater in the Law specification, and that there may be some merit in this feature. Prof Wood for example declares: “The particular treatment of malignant cancer cells by irrigation with warm water ... has been found to be ineffective and no longer practised.”
In determining novelty however one must consider the invention as defined in the claims, and in this matter I think the following points are relevant:
Page 1 of the present specification defines “necrosis” as “the death of cells in tissue”. This definition does not specify whether the cells are malignant or healthy, so the scope of the definition could include the death of malignant cells per se. Thus, in my view, the disclosure in the Law specification to “destroying” malignant cells is, prima facie, within the scope of “necrosis” as defined in the present specification since “destroying” cells suggests death of those cells.
Independent claim 18 of the present specification claims a method for effecting “cauterization necrosis”... whereas claim 1 refers simply to effecting “necrosis”. Applying the presumption against redundancy rule of construction of patent claims, I think it is incumbent upon me to determine the affect of the difference in the wording between these claims. The Macquarie Dictionary defines “cauterize” as “to burn with a hot iron, or with fire or a caustic, esp for curative purposes ...” This suggests to me that claim 18 is clearly meant to be narrower than claim 1 by restricting the necrosis to burning or cauterizing necrosis temperatures, and that claim 1 therefore must be broad enough to include necrosis which is not at burning or cauterizing temperatures.
Taking these points into account I conclude that the scope of “necrosis” as used in the present claims is broad enough to include the destroying of malignant tissue disclosed in the Law patent specification. On the other hand “cauterizing necrosis” I think is defining the significant difference between the present invention and the apparatus in the Law specification.
At one stage in his submissions, Mr Ryan suggested that it is not correct practice in construing claims to interpret the scope of one claim in the light of another claim when the first claim in itself is clear. (In a more general sense this raises the question: is it appropriate to consider a set of claims to decide the exact meaning of words used in one of those claims?). Mr Ryan cited the “fifth rule” in Decor Corporation v Dart Industries (1988) 13 IPR 385 in his submissions. Sheppard J of the Federal Court sets out in that judgement some rules of construction of claims which are distilled from earlier authorities; the fifth rule is:
“(5) If a claim be clear, it is not to be made obscure because obscurities can be found in particular sentences in other parts of the document. But if an expression is not clear or is ambiguous, it is permissible to resort to the body of the specification to define or clarify the meaning of words used in the claim.”
In my view, this matter, in the present circumstances, is related to the redundancy and so-called presumption against redundancy rules of construction. These rules have a place in the construction of claims, but they have to be used with care, and considerable weight should be given to the circumstances of each case.
In some instances, a difference between claims in the wording of a particular feature may be of no consequence, and some words may in fact be redundant. See for example Beloit Corporation’s Application (No.2) [1974] RPC 478. In the present case I think this applies to the “bladder means” defined in claim 1 and the “distendable bladder” defined in claim 2, because the word “bladder” suggests distendability in itself.
In other instances though, a difference between claims in the wording of a particular feature may be significant and a presumption against redundancy may be the appropriate construction. In the present case I think the presumption against redundancy rule does apply in the comparison of “necrosis” in claim 1 with “cauterization necrosis” in claim 18, as previously discussed.
I comment on Mr Ryan’s abovementioned submissions in this matter as follows.
There is established precedent to show that the scope of one claim, although clear in itself, can be affected by another claim, be it independent or dependent. In Electric Construction Co Ltd v Imperial Tramways Co Ltd (1900) 17 RPC 537, a case relating to a motor for an electric railway carriage, independent claim 2 differed only from claim 1 by reference to the motor being supported by “springs”. The UK Court of Appeal decided that while claim 1 may include springs it must also include something which makes it different from claim 2; it must therefore include “without springs”, a meaning which would not necessarily have been placed on claim 1 in the absence of claim 2. See also Pierre Treand’s Application (1961) AOJP 2164 where the same principle was applied to appendant claims. .
The fifth rule in Decor v Dart, supra, does not exclude interpreting one claim in the light of another, it is referring to the different issue of the effect of obscurities.
There are other occasions when it is appropriate to give a clear claim an interpretation which may extend or alter the prima facie meaning of the claim when construed by itself. Sheppard J refers to these occasions in his abovesaid judgement on page 399, where he refers in turn to the judgement in EMI v Lissen (1938) 56 RPC 23, viz:
“In the Lissen case Lord Russell had said (56 RPC at 41): ‘I would point out that there is no question here of words in claim 1 bearing any special or unusual meaning by reason either of a dictionary found elsewhere in the specification or of technical knowledge possessed by persons skilled in the art. The prima facie meaning of words used in a claim may not be their true meaning when read in the light of such a dictionary or of such technical knowledge; and in those circumstances a claim, when so construed, may bear a meaning different from that which it would have borne had no such assisting light been available. That is construing a document in accordance with the recognised canons of construction.’ See also Terrell on the Law of Patents, 13th ed, paras 4.31-4.34, pp74-7.”
In other instances, a redundant appended claim may not be objectionable if it doesn’t affect the scope of the claim to which it is appended. See unreported decision of 2-4-96 on Application No. 620083 re: Igel International Ltd v Wesley Jessen Corp.
Distension of the cavity
The applicant’s submission on the distension issue is that “there is no suggestion that the [Law] device should make contact with the lining of the cavity, let alone distend it. The purpose of the sack 41 is merely to prevent absorption by the cavity of the fluid in the sack..”
In this matter I note the following:
In column 1, the Law specification discloses that “The sac may be of a flexible membrane which will deform when filled with fluid and conform to the interior of the body cavity.” Different words are used but I think it is clearly disclosed that the device “makes contact with the lining of the cavity”.
Prof Persson discusses the matter in paragraph 80 of his declaration, viz:
“... the construction of the apparatus described in the Law specification and the preferred embodiment described in the opposed specification is so similar that any distending of the body cavity actually achieved by the apparatus of the opposed specification would in my view also be achieved by the apparatus of the Law specification. The opposed specification makes no reference to the pressure at which the apparatus is to be used. Necrosis of the tissue lining of the body cavity is effected simply by applying heat through the bladder wall contacting the tissue lining. There is no teaching that an increase in pressure above what is necessary for the bladder wall to be brought into contact with the tissue lining is necessary or advantageous.”
The applicant’s experts make no mention of the Law device not distending the body cavity into which it is inserted, and do not dispute Prof Persson’s comments.
Taking all these matters into account, I am satisfied that the rubber sac disclosed in the Law specification would be suitable for and capable of distending the body cavity in which it was used.
The claims
I will now consider particular claims in the light of the Law specification.
Re claim 1: I have already indicated that the citation discloses “necrosis” of tissue, as defined, that the pipe disclosed can be construed as a “catheter”, that the rubber sac could distend the body cavity into which the apparatus was inserted, and that the other claimed features of an inflating means, heating means and control means are also disclosed in the citation.
The applicant’s written submissions referred to “the use of the article “a” in the phrase “a tissue lining in a body cavity” in lines 1 and 2 of claim 1, and suggested that this meant that the Law device “must be able to destroy the whole or substantially all of the endometrium of the uterus or other tissue which lines a body cavity and not just a few cells which have become cancerous....”
In my view, notwithstanding the effect of the article in the abovesaid phrase, claim 1 is not restricted to an apparatus for effecting necrosis of the whole tissue lining of the body cavity because the phrase “for effecting necrosis” allows for complete or partial necrosis of a tissue lining.
The citation indicates that the apparatus can be inserted into a body cavity such as a stomach, and that “the sac may be of a flexible membrane which will deform when filled with fluid and conform to the interior of the body cavity” and under these circumstances I think it follows that there would be some necrosis of the tissue lining of the said stomach being treated.
Taking all these matters into account, I conclude that claim 1 is anticipated by and therefore not novel in the light of US patent 4,160,455 to James T Law.
Claim 2 is particularly directed to apparatus for effecting necrosis of a uterine endometrium. Thus for the claim to be anticipated by the Law specification I must conclude that the apparatus in the Law specification would be suitable for effecting necrosis of a uterine endometrium.
The Law apparatus is stated to be generally suitable for destroying malignant cells in “body cavities of animals” and particular reference is made to its use in a bladder or a stomach; there is no reference to use in the uterus. Prima facie, it could be argued that the apparatus would be suitable for effecting necrosis of a uterine endometrium, since the uterus is no less accessible than an animal’s bladder or stomach. However, drawing a conclusion on this basis alone may be too simplistic because there may be other factors which should also be considered; I think to determine how a person skilled in the art would construe the specification in this matter I must again refer to the experts’ opinions.
In paragraph 76 of his declaration, Prof Persson states that “the Law specification discloses each and every feature of a number of the claims of the opposed specification in particular claims 1,2,18 and 20”, but other than this statement he makes no specific reference to the invention as defined in claim 2.
However, in paragraph 28 of his declaration, Prof Wood states:
“As a general comment in relation to the prior patents referred to by Professor Persson, I can say that I have never actually seen the devices described in those patents, but if I had seen them prior to September 1988, I do not believe that I would have tried to use any of them to effect necrosis of an uterine endometrium unless this was a suggested use of the device. It does not appear to me from the descriptions of the devices in the prior patents that they would have been suggested for such use. Furthermore, I regard the invention of Neuwirth and Bolduc which is the subject of 646630 to be a significant and helpful improvement over the prior methods which were actually applied in Australia in the necrosis of the uterine endometrium ...”
In this matter I think the weight of evidence is in the applicant’s favour and I conclude that the Law specification does not disclose apparatus which would be suitable for necrosis of a uterine endometrium. I am therefore satisfied that claim 2 is novel in the light of the Law specification.
Re claims 3-17. There were no submissions made at the hearing in relation to these claims and there is only a minimal amount of evidence relating thereto, so my prima facie observation is that either they contain inessential features or that there is little or no inventive merit in adding these features to the apparatus as defined in claims 1 or 2. Thus I conclude that these claims are not novel when appended to claim 1 or are novel when appended to claim 2.
Claims 18-21 are particularly directed to a method of cauterization necrosis; I have previously indicated that cauterization temperatures are not disclosed in the citation, so I conclude that these claims are not anticipated. I have also indicated that the evidence suggests that there is some merit in the cauterizing process of the present invention so I believe that there is no lack of inventive step in the invention defined by these claims.
Omnibus claims 22 and 23 specifically relate to the drawings of the present specification; the apparatus and method described in the drawings is specifically related to cauterization necrosis, so my conclusions on claims 18-21 also apply to the omnibus claims.
Re BRP-7 and BRP-8
The apparatus in the Doering specification is considerably less sophisticated than the same in the Law specification, and in my view it does not disclose a catheter, it is arguable whether “control means” as presently claimed are disclosed, and there is no disclosure of any effect which could be described as “necrosis”. The device is merely to affect a therapeutic hyperaemia in the body cavity to which it is applied. Consequently I am of the view that the present invention is novel and inventive in the light of this citation.
OTHER GROUNDS OF OPPOSITION
The opponent submitted that the invention was not a manner of new manufacture and lacked subject matter because it could be construed as merely using known apparatus at higher necrosing temperatures. I reject this argument because the apparatus of the present invention is not the same as the prior art. I think some practical difficulties have been overcome in developing the invention for the high-temperature application intended, particularly in the inflation and heating control means.
The opponent submitted that “if the present invention is in the operational parameters then the invention fails under Section 40.” Mr Bell cited the judgements in Mullard v Philco 52 RPC 323 and Sami Svendsen v Independent Products (1969) AOJP 647, and in particular suggested that the necrosing temperature is an essential feature not claimed. He suggested that 65o C is the temperature at which death of cell tissue is instantaneous. In my view it is not necessary for the independent claims to be restricted to methods or apparatus operating at a particular temperature; this is too narrow a concept of the invention. I think the inventive concept is inherent in the cauterization feature defined in claims 18-23; this is the main thrust of the applicant’s evidence, thus claims 18-23 adequately define the invention. Conversely, claims 1-17 do not define the invention because they do not contain this essential feature, and therefore do not comply with Section 40.
On a minor issue, both parties agreed that there was a problem with the description and with claims 19 and 21 because the temperatures and times claimed have not been referred to in the description. Mr Ryan agreed that it was appropriate to suitably amend the specification.
Conclusion
The opposition to grant of a patent for application No. 646630 is successful because I have found that claim 1 is not novel, claims 3-17 are not novel when appended to claim 1, and that claims 1-17 do not define the invention.
However, in my view there is patentable subject matter in the specification, so I allow Gynelab Products Inc 60 days from the date of this decision to propose amendments to overcome the objections to the specification.
costs
The usual practice in oppositions is to award costs against the losing party; I see no reason to change that practice in this case so I award costs in accordance with Schedule 8 against Gynelab Products Inc.
John Welsh
Delegate of the Commissioner of Patents
Patent attorneys for the applicant : Carter Smith & Beadle, Melbourne
Patent attorneys for the opponent : Phillips Ormonde & Fitzpatrick, Melbourne
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