Imarx Pharmaceutical Corp v Mallinkrodt Medical Incorporated
[1999] APO 56
•24 August 1999
OFFICIAL NOTICE
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Patent Application : No. 698209 in the name of ImaRx Pharmaceutical Corp.
Title: Low Density Microspheres
Action: Request by the applicant for dismissal of the section 59 opposition by Mallinkrodt Medical Incorporated
Decision: Issued .
Abstract
The request for dismissal of the opposition was refused and the applicant was largely unsuccessful in the proceedings, although it was found that some of the particulars were deficient. Specifically;
Directions were given that certain of the particulars, which were found to contain no material facts in support of the ground of opposition, are not to be available to be argued at the substantive hearing.
Directions were given for the opponent to provide further and better particulars relating to some aspects only of particulars relating to lack of manner of manufacture.
PATENTS ACT 1990
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Re:Patent Application No. 698209 by ImaRx Pharmaceutical Corp and a request by the patent applicant under regulation 5.5 for dismissal of an opposition by Mallinkrodt Medical Incorporated.
BACKGROUND
Patent application 698209 in the name of ImaRx Pharmaceutical Corp. (hereafter referred to as ImaRx) was filed on 6 October 1995 and was advertised as accepted on 29 October 1998. Mallinkrodt Medical Incorporated (hereafter referred to as Mallinkrodt) filed a notice of opposition under section 59 of the Patents Act on 29 January 1999 and served a statement of grounds and particulars on ImaRx on 28 April 1999.
No evidence in support of the opposition has been served but, on 28 May 1999, ImaRx made a request to the Commissioner for the opposition to be dismissed on all grounds, or dismissal on some of the grounds and/or a direction that one or more of the particulars cannot be relied upon at the main opposition hearing and/or a direction be given for further and better particulars to be provided. A hearing into these matters was held in Canberra on 2 August 1999. ImaRx was represented by Ms Katrina Howard of counsel and Dr John McCann, patent attorney of Spruson and Ferguson, Sydney. Mallinkrodt was represented by Mr David McBeth, patent attorney of Phillips Ormonde & Fitzpatrick, Melbourne.
DISMISSAL
Dismissal is provided for under regulation 5.5:
"5.5 (1) An applicant may:
(a) within 1 month of being served with a copy of a statement by an opponent under subregulation 5.4 (1) ("filing of statement"); or
(b) if the complete specification in relation to an opposed application is re-examined under subsection 97 (1) of the Act ("re-examination of complete specifications") -within 1 month from the day when the re-examination is completed under regulation 9.5 ("completion of re-examination");
request the Commissioner in the approved form to dismiss the opposition.
(2) As soon as practicable after a request is made, the Commissioner must inform the opponent of the request having been made.
(3) The Commissioner may dismiss the opposition whether or not the applicant has requested dismissal of the opposition."
ImaRx filed their request for dismissal on 28 May 1999 which is within one month from the date of being served with the statement of grounds and particulars and Mallinkrodt were duly informed of this request in a letter from this Office dated 8 June 1999. Thus the statutory requirements for request for dismissal have been complied with.
The reasons for dismissal of an opposition can be considered as similar to the reasons for summary dismissal, as described in General Steel Industries Inc v Commissioner for Railways (NSW) (1964) 112 CLR 125 at 129:
"The test to be applied has been variously expressed; 'so obviously untenable that it cannot possibly succeed'; 'manifestly groundless'; 'so manifestly faulty that it does not admit of argument'; 'discloses a case which the Court is satisfied cannot succeed'; 'under no possibility can there be a good cause of action'; 'be manifest that to allow them' (the pleadings) 'to stand would involve useless expense'."
The practice followed by Australian Patent Office has been that an opposition or a ground of opposition will only be dismissed if it is clear that the opposition could not possibly succeed and that the onus falls on the applicant to show that the opposition is clearly untenable. This practice has recently been given support by The Federal Court, see Stack v Commissioner of Patents [1999] FCA 148.
A consideration of the substantive issues of the opposition should not form part of the dismissal action. In L'Air Liquide, Societe Anonyme Pour L'Etude Et L'Exploitation Des Procedes Georges Claude v The Commonwealth Industrial Gases Ltd (1991) 24 IPR 77 at page 85 the delegate of the Commissioner states:
"In my view, an argument for summary dismissal that relies on interpretational analysis of the claims, pointing out that this or that feature is not present in the citation, is an argument which pre-empts the substantive opposition."
Also, in L'Air Liquide (supra), the delegate of the Commissioner found that it is possible to dismiss an opposition in respect of only some of the grounds, namely those grounds for which insufficient particulars have been stated.
"In my view, so long as at least one ground has at least one adequate particularisation, the opposition should not be dismissed in its entirety."
If there are no material facts to support a ground of opposition, the ground can be dismissed. However, in Norwood Industries v Macbird Floraprint (1992) 24 IPR 368, at 377 the delegate of the Commissioner found:
"It follows that, despite the presence of a number of ineffective particulars, dismissal of an opposition with respect to a particular ground can only occur where none of the particulars fully support that ground."
Thus, it is not possible to dismiss a ground of opposition in part.
THE STATEMENT OF GROUNDS AND PARTICULARS
Regulation 5.4 governs the requirement for a statement of grounds and particulars:
"5.4 (1) An opponent must:
(a)within 3 months of filing the notice of opposition serve on the applicant a copy of a statement that sets out:
(i) the grounds of the opposition; and
(ii) the particulars relating to each ground; and
(b)as soon as practicable after the copy of the statement has been served on the applicant, file the statement."
The function of the statement of grounds and particulars is to give the applicant fair notice of the case to be met and is very similar to the system of pleadings developed for court proceedings. On this basis, certain criteria relating to the statement were set out in Mobay Corporation v Dow Chemical Company (1992) AIPC 90-895:
"(i) the particulars must state all material facts necessary for the ground of opposition;
(ii) the particulars must only state material facts;
(iii) the evidence by which the facts are to be proved must not be included;
(iv) matters of law should not be included; and
(v) the particulars are to be in summary form."
The Hearing Officer in EI DuPont de Nemours and Company v DowElanco (1994) AIPC 91-067 set out some guidance on the type of information needed in a statement of grounds and particulars. This is useful although care should be taken not to interpret these guidelines as prescriptive requirements (see Alvern Norway A/s v Trans Global Concepts Pty Ltd 38 IPR 158).
Where an applicant considers particulars to be inadequate, there are several courses of action open to them. They may request dismissal of the opposition in whole or in part, as discussed above, or they may seek a direction that the opponent provide further and better particulars or seek a direction that certain particulars will not available to be argued at the substantive hearing. These options have been discussed for example in Mobay v Dow (supra) and Commonwealth Scientific and Industrial Research Organisation v CEM Corporation (1994) 29 IPR 72. The Commissioner is able, under regulation 5.10(1), to make a direction that the opponent provide further and better particulars where the particulars are found to be inadequate. However, it is not appropriate for the Commissioner to direct amendment of particulars in a specified way or direct that particulars be struck out. Where it is found that no material facts at all have been given in support of a particular, it is generally not appropriate to direct further and better particulars.
THE REQUEST FOR DISMISSAL
The request for dismissal states:
"We, ImaRx Pharmaceutical Corp. 1635 E. 18th Street, Tuscon, Arizona 85719, UNITED STATES OF AMERICA, apply for the dismissal of all grounds, or in the alternative, some of the grounds and/or a direction that one or more of the particulars cannot be relied upon at the main opposition hearing and/or a direction for further and better particulars in respect of the Opposition in respect of Patent Application Serial No 698209 instituted by Mallinckrodt (sic) Medical, Inc. on 29 January 1999.
Our reasons for making this request are as follows:
As a whole the Statement of Grounds and Particulars, does not specify the case the patent applicant has to answer in clear and unambiguous terms. In DuPont v DowElanco (1994) AIPC 91-067 the Delegate of the Commissioner noted that 'a Statement of Grounds and Particulars must provide sufficient details for the patent applicant to understand the case to be defended. The particulars must state all material facts necessary for the ground of opposition and they must state only material facts.'
Further, in Commonwealth Scientific and Industrial Research Organisation v Cem Corporation (1994) 29 IPR 72, regarding a request for dismissal of an opposition in part and for directions the delegate of the Commissioner said:
"The purpose of the statement of particulars is to give the applicant fair notice of the case to be met and to define the issues of the opposition. It must set out the material facts on which each ground of opposition is based (Mobay Corporation v The Dow Chemical Company 24 IPR 379)."
It is clear from above that the patent applicant must be able to determine from the Statement of Grounds and Particulars the case it is required to defend. It is the applicant's contention that the Statement of Grounds and Particulars of the opponent served 28 April 1999 does not make out a prima facie case in respect of any ground and thus does not provide the patent applicant with enough information to enable it to understand the case to be defended. The Statement of Grounds and Particulars sets out grounds of opposition under Sections 59(a), 59(b) (sections 18(1)(a) or 18(1)(b)) and 59(c) (sections 40(2) and (3)) of the Patents Act 1990. The particulars provided under each of these grounds do not adequately support the respective ground. Detailed reasons as to why the particulars are inadequate will be provided at the Hearing.
In essence, it will be the applicant's contention that the patent applicant does not know the case it has to answer in the opposition because none of the grounds are adequately particularised and consequently that it cannot understand the case it has to answer. Accordingly, we will be submitting that the opposition should be either dismissed in its entirety or in the alternative, a direction that one or more of the grounds be dismissed and/or the Commissioner should issue a direction that one or more of the particulars in respect of one or more of the grounds cannot be relied upon at the main opposition hearing and/or the Commissioner should issue a direction for further and better particulars in respect of one or more of the grounds."
At the start of the hearing, Ms Howard for ImaRx conceded that she would not be pursuing dismissal of all the grounds of opposition, but only some of the grounds and that she would be seeking directions for further and better particulars in regard to the remaining grounds and/or that certain particulars will not be available to be relied upon.
DECISION
Grounds of the opposition
The statement of grounds and particulars dated 28 April 1999 gives two grounds of opposition. These are:
That the invention is not a patentable invention because it does not comply with subsection 18(1)(a) or (b), and
That the specification filed in respect of the complete application does not comply with subsection 40(2) or (3).
It is also stated that the opponent contests the claim to the convention priority date of 5 April 1991 but no submissions were made concerning this issue and I will thus not give it any further consideration in my decision.
Particulars
The particulars are extensive and cover about 12 typed pages. I will not quote them in full but summarise them where necessary.
Ground 1 particular 1- manner of manufacture
That the alleged invention is not a patentable invention because it does not comply with subsection18(1)(a) of the Patents Act (1990). The invention so far as claimed in any claim is not a manner of manufacture within the meaning of section 6 of the Statute of Monopolies having regard to the following:
(i)The claimed invention lacks any necessary quality of inventiveness, and/or
(ii)The claimed invention defines nothing more than the application of known techniques/compositions to a known problem, and
(iii)When considered on the face of the specification itself and/or in the light of the publication before the priority date of the documents listed hereunder, the specification does not disclose a new invention.
(Under this particular is listed 17 documents (a-q), comprising 7 patent documents and 10 non-patent publications. For each of these is included a paragraph outlining their relevance and reference to specific passages within the documents.)
At the hearing, Ms Howard submitted that on the face of the specification the claimed invention prima facie is directed to a manner of manufacture. She briefly referred to the claims which define an aqueous suspension, a contrast medium, a kit for diagnostic imaging and methods of using the contrast medium. On this basis, the ground of opposition that the invention is not a manner of manufacture should be dismissed.
In regard to item (i) above she contended that "this is not a material fact but a legal question and therefore not a proper particular".
With regard to item (ii) which seems to be concerned with the issue of analagous use, Ms Howard submitted that these were also not material facts and that the particular did not give ImaRx fair notice of the case to be answered. This particular does not specify the known problem or identify the known techniques/compositions and the precise facts about those techniques/compositions which go to analagous use. Ms Howard referred me to the decision in National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252 which discusses that a substance may be known in the sense that it has been previously identified but may be unknown for the purposes of patent law if not all features or characteristics of that substance have been discovered.
The third item under section 18(1)(a) is that the specification does not disclose a new invention when considered on the face of the specification and/or in the light of the 17 listed documents. Ms Howard submitted that:
a) when an allegation of lack of manner of manufacture on the face of the specification is made, it should be necessary to precisely identify what in the specification demonstrates that there is no invention;
b) with respect to the allegation of no manner of manufacture on the basis of prior art disclosures, the particular does not identify how the documents are relevant to manner of manufacture- this same list of documents are referred to for manner of manufacture, novelty and inventive step and it is not clear how they relate to manner of manufacture;
c) the list of prior art documents should include their publication dates- however, Ms Howard conceded that the publication dates for patent documents are a matter of public record and I note that, for the non-patent documents, in all but one of these (document q), the publication dates have been given; and
d) the words "and/or" lead to ambiguity.
In summary, Ms Howard contended that no material facts have been pleaded in support of the allegation of lack of manner of manufacture and that the ground should be dismissed.
Mr McBeth for Mallinkrodt disputed Ms Howard's assertions that points (i) and (ii) are merely statements of law and contain no material facts. He submitted that they disclose material facts in their broadest form and that, if any deficiencies were found, these could be remedied by amendment. In regard to point (iii), Mr McBeth argued that there is no reason why the same set of documents could not be relevant for manner of manufacture, novelty and inventive step and that the particular contains a lot of detail since many specific page references are made outlining relevant parts of the documents. Where the particular omits publication dates or contains ambiguous wording, such as "and/or", these deficiencies could be easily remedied by amendment to the statement of grounds and particulars. He contended that, on the face of the specification itself, there is some doubt about if there is manner of manufacture.
The decisions of the High Court in NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd (1995) 32 IPR 449 and Advanced Building Systems Pty Ltd and Anor v Ramset Fasteners (Aust) Pty Ltd (1998) 152 ALR 604 confirm that section 18(1)(a) should be interpreted as retaining a threshold requirement of an invention and excluding from a "patentable" invention any claimed process, method or use which was not, on the face of the specification, proper subject matter according to traditional principles.
In regard to particular 1 (i), that the claimed invention lacks any necessary quality of inventiveness, I believe this is directed to the threshold of invention which, in the context of manner of manufacture, is distinct from novelty and inventive step considerations. This lack of manner of manufacture must be apparent from the face of the specification itself. However, I do not consider this particular to include objection on the basis of the traditional manner of manufacture considerations such as analogous use or that certain claims define a non-patentable kit since such issues have not been identified.
It is inappropriate for me to comment on the likely success or otherwise, at the substantive hearing, of this line of argument but I must decide if the particular is adequate. It appears to be over the issue of what constitutes a material fact in the context of this alleged lack of quality of invention that the two parties disagree, Ms Howard asserting that there are no material facts at all and Mr McBeth arguing that the particular contains a very broad statement of material facts. It is difficult to know what material facts need to be given in support of this particular since construction of the specification is a matter for the hearing officer at the substantive hearing, aided by submissions and evidence. However, I do not believe that the applicant is clearly able to understand the case against it by this particular, as it presently stands, without some further information as to the nature of this lack of manner of manufacture allegation, for example, by the opponent pointing to specific places in the specification to demonstrate lack of quality of invention. I direct that Mallinkrodt provide further and better particulars in this regard.
In regard to particular 1 (ii), I agree with Ms Howard that this particular appears to go to the issue of analogous use, the material fact being that the invention defines nothing more than the application of known techniques/compositions to a known problem. In EI DuPont de Nemours (supra), the delegate of the Commissioner indicated that for manner of manufacture, the particulars should generally include:
"A brief description of the type of manner of manufacture, eg a mixture of known ingredients, together with brief details of material facts to establish a prima facie case."
However, ImaRx have been given very little notice of the case against them by this particular. I believe that, at the very least, Mallinkrodt should specify the known problem and identify the known techniques and compositions. Consequently, I direct that Mallinkrodt provide further and better particulars to include this detail.
Particular 1(iii) is under the heading that the invention is not for a manner of manufacture and thus should be construed as going to issues other than novelty and inventive step where possible, although the words "the specification does not disclose a new invention" do not clearly relate to manner of manufacture. This is an indication that the particular has some deficiencies.
In particular 1(iii), the words "and/or" cause some ambiguity although this is a minor problem and a meaning can be given; that the specification is considered a) on the face of the specification itself, b) in the light of the documents and c) both on the face of the specification and in the light of the documents. It is difficult to determine how this differs from particular 1(i) above when the particular relates to lack of invention on the face of the specification and my comments in regard to particular 1(i) equally apply here. Consequently, I direct that further and better particulars are provided to give the applicant some indication of the nature of the alleged lack of invention or identify some specific parts of the specification to demonstrate this.
With regard to documents a) to q), recent Patent Office practice has been that, when considering a large number of cited documents, the overriding consideration is whether the applicant can reasonably be expected to understand the case against them rather than setting down any rigid numerical limits or requirements (see Dominion Mining v Technological Resources 31 IPR 609 ).
In my view, the present list of 17 documents are adequately particularised and their study will not place an undue burden on the applicant. For each of the documents, the particular contains a short paragraph outlining the relevance of the document with, in most cases, page references given. Some of these paragraphs are more than half a page in length. While their relevance to manner of manufacture has not been separated out from their relevance for novelty or inventive step, nor has there been any indication of which claims are allegedly anticipated by each document, there seems to me to be adequate information given regarding the type of information contained in each document. The documents appear to relate to the general fields of contrast media or perfluorocarbon gases and thus, without going too far into an analysis of the specification of the presently opposed application which is a matter for evidence or submissions, would seem to be relevant. Although the specification contains 59 claims, the only independent claim is claim 1, all other claims containing additional features and being appended back to claim 1. I do not believe that relating the documents to particular claims will be unduly onerous in this case.
The issue of the publication dates of the documents has been discussed above. This is a very minor issue. I do not believe that there is any strict requirement that the publication date should be included in a statement and in fact, it could be argued that publication dates are part of the evidence to establish that the documents were published before the priority date of the presently opposed application. Thus, I am thus satisfied that the particular is adequate in regard to these documents
In conclusion on particulars relating to manner of manufacture, I direct that further and better particulars be provided in order to:
In 1 (i) and (iii), give some indication of the nature of the alleged lack of quality of invention
In 1 (ii), specify the known problem and identify the known techniques and compositions
Ground 1 particular 2- novelty and inventive step
The alleged invention is not a patentable invention because it does not comply with subsections 18(1)(b) of The Patents Act (1990). The alleged invention so far as claimed in any claim, when compared with the prior art base as it existed before the priority date of that claim:
(i)Lacks the necessary quality of inventiveness:
(ii)Does not comply with subsection 18(1)(b)(i) in that it is not novel having regard to the following:
(a)The documents a to q listed under paragraph 1(iii) above.
(b)The known properties of perfluorocarbons, and in particular their use in gas-filled microspheres for diagnostic imaging.
(iii)Does not comply with subsection 18(1)(b)(ii) in that it does not involve an inventive step having regard to the following:
(a)The documents a-q listed under paragraph 1(iii) above and the known properties of perfluorocarbons, and in particular their use in gas-filled microspheres for diagnostic imaging.
The information contained in each of these documents is information which the skilled person could, before the priority of the relevant claim, be reasonably expected to have ascertained, understood and regarded as relevant art in the patent area. In addition, these publications form part of the common general knowledge of the skilled person.
The skilled person in the art is the professional worker and/or academic in the field of diagnostic medicine and in particular diagnostic imaging including the use of gas filled microspheres.
(b)The common general knowledge in Australia as it existed before the earliest filing date of the opposed application, regarding use of perfluorocarbons for use in gas-filled microspheres for diagnostic imaging.
Gas-filled microspheres for diagnostic imaging have been widely known and used in Australia for many years prior to the filing date of the opposed application.
Techniques for using perfluorocarbons in gas-filled microspheres have also been known for years.
Optimisation of certain properties of perfluorocarbons to make them suitable for use in gas-filled microspheres for diagnostic imaging is well known to the skilled practitioner in Australia.
Ms Howard submitted that particular 2(i), which refers to "quality of inventiveness", is not a particular of either novelty or lack of inventive step but goes to manner of manufacture. I note the similarity in wording between this particular and particular (i) under manner of manufacture discussed previously. For an invention to be held invalid for reasons of section 18(1)(b) it must be shown that it is not novel or involves no inventive step when compared with the prior art base as it existed before the priority date. The prior art base is defined in schedule 1 and includes publicly available documents and information made publicly available through doing an act. I find that particular 2(i) of ground 1 does not contain any material facts at all relating to prior art documents or details of prior use and, as such, does not constitute a proper particular for the purposes of section 18(1)(b).
Particular 2 (ii) relates to lack of novelty and has two parts- part (a) which refers back to the 17 documents previously detailed under manner of manufacture and part (b) which goes to "the known properties of perfluorocarbons, and in particular their use in gas-filled microspheres". Ms Howard's submissions on part (a) were that it is not clear how each of the documents is an anticipation of the invention or which claims are allegedly anticipated. She referred me to ICI Chemicals Industries v Irenco (1993) 26 IPR 154 in which the delegate of the Commissioner found that "where a statement of particulars by reference to a long list of documents makes the substance of the opponents case difficult to determine, then further and better particulars should be sought even if more detail is obtained than would otherwise be the case."
Mr McBeth argued that the particulars give a detailed summary for most of the citations and that it would place an undue burden on the opponent to provide more detail which would, in any case, form part of the evidence in support of the opposition. It should not be necessary in the particulars to identify each and every claim for which the citations are relevant since this also would comprise expert evidence.
In my view, as I have already discussed in relation to manner of manufacture above, the present list of 17 documents are adequately particularised and their study will not place an undue burden on the applicant. While their relevance to novelty has not been separated out from their relevance for manner of manufacture or inventive step, nor has there been any indication of which claims are allegedly anticipated by each document, there seems to me to be adequate information given regarding the type of information contained in each document and, in most cases, page references are given. I am thus not satisfied that these particulars are inadequate.
Ms Howard's submissions on part (b) of particular 2(ii) of ground 1 were that the applicant could not understand the particular. In the context of novelty, these matters can only be relevant if they are prior published in writing, in which case the document or documents should be identified, or by prior use, in which case particulars of the alleged prior use should be given. Mr McBeth's submissions in relation to particular 2(ii)(b) were that the properties of perfluorocarbons were those of their use in gas-filled microspheres for diagnostic imaging and that to particularise any further would require expert evidence.
I note the similarity in wording between part (b) of particular 2(ii) (novelty) and part (a) of particular 2(iii) (inventive step), which is strongly suggestive to me that the interpretation of the words go to the issue of common general knowledge, which is not a relevant consideration by itself for novelty. As a particular for lack of novelty, this particular gives no material facts to support lack of novelty in light of a publicly available document or in light of prior use, ie date and place of use, details of the disclosure etc. I find this particular inadequate.
Particular 2 (iii) deals with lack of inventive step and contains two parts. Part a) again cites documents a) to q) discussed previously and refers to the known properties of perfluorocarbons in gas-filled microspheres for diagnostic imaging. Comments on these two issues by both Ms Howard and Mr McBeth have been given previously in regard to novelty. Part b) describes three aspects of the common general knowledge regarding gas-filled microspheres.
Ms Howard contended that an opponent is required to particularise the actual common general knowledge being relied upon including a brief description of the alleged common general knowledge and identification of the person skilled in the art. However, Mr McBeth submitted that it was not the role of the statement of particulars to provide specifics of common general knowledge as that is a matter for evidence and that the particular does in fact identify the person skilled in the art and what the art is. He referred to Borden Inc v Elkem A/S (1992) AIPC 90-893 in which the delegate of the Commissioner found:
"I believe, applying a purposive construction, that the term "prior art base" in the present Statement of Grounds and Particulars should be taken as a reference only to "common general knowledge". I note that the gathering of evidence to establish common general knowledge may be a time consuming endeavour. Hence to have the expectation that a Statements of Particulars should contain anything more than rudimentary details of the common general knowledge to be produced in the opposition would seem both unrealistic and unreasonable."
Mr McBeth did agree with Ms Howard in that in the third statement under particular 2 (iii)(b), "optimisation of certain properties ", the words "diagnostic imaging is well known" contain an error and should actually read "diagnostic imaging was well known" since, for inventive step considerations, it is the common general knowledge at the priority date of the opposed claim which is important. This error is a minor clerical error which does not render the particular deficient since the applicant is clearly aware of the true meaning of the particular.
I am not convinced that the particulars relating to inventive step are inadequate. Particular (iii)(a) clearly refers to the documents a) to q) and relates this to the known properties of perfluorocarbons and in particular their use in gas-filled microspheres for diagnostic imaging. In the context of inventive step, this is a clear statement of the field of the common general knowledge. The particular even states who is considered as the person skilled in the art and where the art lies, in paragraph 3. I believe that any further description of the common general knowledge lies in the province of evidence. As I discussed above in regard to documents a) to q), for each document a summary of the information contained therein is given, along with page references in most instances and the documents appear to be relevant.
Part b) specifically refers to the common general knowledge "regarding use of perfluorocarbons for use in gas-filled microspheres for diagnostic imaging" and thus has identified the area of technology relied upon. Paragraphs 2, 3 and 4 contain further details concerning the common general knowledge. In this case the person skilled in the art is not identified but I do not consider this to be a strict requirement, rather this is a matter for submissions or evidence in support of the case relating to inventive step.
In conclusion on particular 2 of ground 1, relating to issues of novelty and inventive step, I have found that:
Items (i) and (ii)(b) give no material facts and I direct that these particulars are not to be available to be argued at the main hearing.
Ground 2 particular 1- section 40(2) (full description)
That the specification filed in respect of the complete application does not comply with subsection 40(2) because:
(a)The specification does not describe or sufficiently describe the invention including the best method known to the applicant of performing the invention as claimed in the claims.
Ms Howard contended that this particular is merely restating the wording of section 40(2) and that
this ground of opposition should be dismissed since it contains no material facts at all. She submitted that the opponent should specify the skilled reader, the respects in which that person would consider the description insufficient and identify all relevant passages of the specification. Mr McBeth disagreed that the particular contained no material facts at all but submitted that, should I find the particular deficient, the opponent should be given an opportunity to amend the statement.
In my view, this particular gives no material facts at all to support the ground of opposition and amounts to nothing more than a statement of law. No facts relating to which features of the invention are inadequately described are given nor brief description of specific subject matter to which the section 40 (2) ground applies-such facts as would enable the applicant to understand the case it has to answer as recommended in EI DuPont de Nemours v DowElanco (supra). Ms Howard requested dismissal of this ground but, since ground 2 includes both section 40(2) and 40(3) matters and no request for dismissal has been made in regard to section 40(3) (see also discussion following), I am unable to dismiss the ground in full and cannot dismiss a ground in part [see Norwood Industries v Macbird Floraprint (supra) ]. Consequently, I direct that this particular is not available to be argued at the substantive hearing.
Ground 2 particular 2- section 40(3) (claims clear and succinct and fairly based)
That the specification filed in respect of the complete application does not comply with subsection 40(3) because:
(a) The claims are not clear and succinct, for instance:
(i)The claims are not clear as to what constitutes "a substantially homogeneous suspension".
(ii)Claim 15 and 32 are not clear as to what constitutes an amount of gas-filled microspheres "effective to provide a contrast medium for computed tomography imaging".
(iii)The method claims 55 to 58 are not clear as to how the contrast medium is administered to the patient.
(b)That the claims are not fairly based on the matter described in the specification, for instance:
(8 Paragraphs relating to specific instances of alleged lack of fair basis are then given.)
Ms Howard's submissions in regard to part a) are that the particulars given under points (i) to (iii) relate to clarity only and that no particulars have been given with regard to succinctness which is a separate requirement under the Act. In addition, the words "for instance" suggest that the points (i) to (iii) are examples only but ImaRx denies that Mallinkrodt has the right to add to these examples without a specific direction from the Patent Office.
I am in agreement with Ms Howard on these two matters. I believe that the particular only provides basis for arguing that the claims are not clear and succinct with regard to the specific points (i) to (iii) as listed, which points are all directed to clarity issues not succinctness. There is no basis for the opponent to argue lack of succinctness of the claims or any other clarity issues. The words "for instance" are thus of no effect. I do not propose to make any directions in regard to part a) since I believe this has a clear meaning and does not mislead the applicant of the case to be mounted against it.
Part b) of particular 2 relates to fair basis and lists 8 specific examples where fair basis is allegedly lacking. I note that the numbering of these examples is inconsistent [there are two items (ii) and (iii)], but consider this is only a minor clerical error and does not lead to uncertainty as to the case to be answered. I also note that only example (v) actually identifies specific claim numbers while the other examples refer to "a number of claims" or "the claims". Again, I do not believe that this is unclear or places an undue burden on the applicant since the examples clearly disclose the features which are allegedly absent and, while there are 59 claims, the only independent claim is claim 1 with all other claims adding additional features and being appended back to claim 1. The words "for instance " are used again in this particular and I make a similar point as in part a) above, that I consider that the particular only provides basis for argument on the 8 specific points listed.
Conclusion
The applicant has not been able to establish that the opposition is clearly untenable as would be required for me to order dismissal. I find that the case for dismissal of the whole opposition or of either of the grounds of opposition has not succeeded although have found above that certain of the particulars are deficient. Specifically, I direct that :
A. The following particulars are not available to be argued at the substantive hearing:
Ground 1 particular 2 [section 18(1)(b)] parts (i) and (ii)(b)
Ground 2 particular 1(a) [section 40(2)]
B. Further and better particulars be provided in relation to the following:
Ground 1 particular 1[section 18(1)(a)], parts (i), (ii) and (iii)
I allow Mallinkrodt 21 days from the date of this decision, subject to any appeal, to provide further and better particulars in relation to ground 1 particular 1 parts (i), (ii) and (iii) as outlined above. These further and better particulars can be provided by amending the statement under regulation 5.9 by filing a new statement incorporating the amendments, a copy of which is to be served on the applicant. If a satisfactory response is not provided within this time, I will direct that the relevant particulars are not to be available to be relied upon at the substantive opposition.
Since I have not dismissed the opposition, in accordance with regulation 5.8 (1)(a)(iii), evidence in support is due to be served within 3 months from the date of this decision.
Costs
The applicant has not succeeded in their application for dismissal of the opposition either in whole or in part, although I note that their application and submissions made alternative requests that certain particulars may not be relied upon or that a direction be given for further and better particulars. I have decided that some directions are appropriate as outlined above but have found that most of the particulars have been allowed to stand as they are. I also note the opponent's apparent willingness to make amendments to the statement if required, suggesting to me that, although there are some acknowledged deficiencies in the particulars, these matters may have been able to have been resolved between the parties without the need for a hearing. Since ImaRx has largely been unsuccessful in these proceedings, I award costs in accordance with schedule 8 against ImaRx.
Gillian Jenkins
Delegate of the Commissioner of Patents
Patent attorneys for the applicant : Spruson & Ferguson, Sydney
Patent attorneys for the opponent : Phillips Ormonde & Fitzpatrick, Melbourne
0
9
0