FISONS LIMITED

[1983] APO 40

IN THE MATTER of the Patents Act 1952

‑ and ‑

IN THE MATTER of Application No. 52885/77 in the Name of FISONS LIMITED

‑ and ‑

IN THE MATTER of Examiner's Objections thereto.

INTERIM DECISION OF A SUPERVISING EXAMINER OF PATENTS:
BACKGROUND
Application No. 52885/79 was lodged on 15 November, 1979 by Fisons Limited and purports to be an application for a patent of addition to Application No. 83859/75 (Patent No. 492916) and also an application for a divisional patent in respect of subject matter divided from Application No. 21589/77 (Patent No. 506878).  Since Patent No. 506878 is itself a patent of addition to Patent No. 492916, it will be convenient to refer to 52885/79 as "the daughter", to 506878 as "the parent" and to 492916 as "the grandparent".  Both the parent and the grandparent are patents in force in the name of Fisons Limited.  The relevant dates are set out below:

Parent

Lodged              11 Aug 1975         24 Jan 1977     15 Nov 1979
Accepted             8 May 1978         30 Nov 1979         ‑
Sealed               5 Oct 1978         30 Jun 1980         ‑
Published            24 Feb 1977          3 Aug 1978     15 May 1981
Prima facie Priority  10 Aug 1974         24 Jan 1977     24 Jan 1977

The date of lodgement of the daughter is such that the relevant Patents Act is the Patents Act 1952 as amended by the Patents Amendment Act 1979. The requirements for a divisional application are therefore those of section 51, in particular section 51(1), and the priority date of 24 Jan 1977 indicated above for the daughter is conditional upon those requirements having been met.

An Examiner's first report issued on 6 May 1982, so that the final date for acceptance, utilising the maximum extension available under section 54(1)B, is 6 Feb 1984.

In all, a total of four adverse Examiner's reports have been communicated to the applicant.  Of these, the first two elicited statements of proposed amendments which overcome minor objections, and for the present purpose I will consider the specification as it is proposed to be amended.  The Examiner's main objections, however, remain unresolved despite lengthy submissions in rebuttal, and in response to the Examiner's fourth report the applicant requested a hearing.  These objections in substance are that first, the application in suit is not fit subject matter for a patent of addition to the grandparent, and second, Dreyfus claiming exists between the application in suit and the parent.   At the hearing, which was held in Melbourne on 5 Aug. 1983, the applicant was represented by Mr. J. Slattery, Patent Attorney, of the firm Davies & Collison.

It will be convenient to describe the three specifications separately in the order grandparent, daughter, parent.

THE GRANDPARENT SPECIFICATION
The grandparent patent is predicated on the discovery that medicaments, when made up into pellets having certain characteristics, are suitable for administration by insufflation.  Accordingly, claim 1 is directed to:

"A medicament comprising a plurality of pellets characterised in that the pellets are soft, are from 10 to 1000 microns in diameter and comprise an agglomeration of individual medicament particles at least 90% of which have a diameter of less than 10 microns."

In an appended claim 4, the medicament is specifically disodium cromoglycate (DSCG), a well known drug; and in the single example DSCG is subjected to a particularly described process to produce pellets having the claimed characteristics.  Additionally, claim 5 (which appends to any one of the preceding claims) is directed to a medicament comprising less than 15% by weight of water.

It is explained in the specification that, within the prescribed range of 10 to 1000 microns, the pellet size is selected so as to be a compromise between a size to suit the characteristics of the insufflator to be used, on the one hand, and the requirements of internal coherence on the other.  Internal coherence is important because the pellets must remain unbroken until they leave the insufflator nozzle, but must then disintegrate into their constituent particles in the turbulence which occurs just outside the nozzle.  Although this relationship between size and internal coherence appears to be necessary to the successful functioning of the invention, it is not present as such in the claim.  However, for the reasons given below, I consider that it is effectively imported into the claim by the use of the word "soft".  It is explained that the "strength" of the pellets (which I take to be measured by their internal coherence) can be assessed by means of a machine (the Instron machine) which measures stress/strain relationships.  In this machine, continuously increasing pressure is applied by means of a piston to the material loosely packed into a die, and is transmitted by the material to be recorded on a pressure sensitive plate at the bottom of the die.  It is a feature of the pellets of the invention that the transmitted load does not increase continuously but in steps separated by periods of relaxation.  It is a natural assumption, and one made in the specification, that the periods during which there is no increase in transmitted load correspond to periods in which the applied energy is being absorbed through partial collapse of the pellets.  As well as exhibiting this periodic transmitted load reduction, the pellets of the invention are also characterised in that they are compressed by about 25 to 35% of their volume when the transmitted load is 10g., and by about 50 to 70% when the transmitted load is 1000g.

No definition of "soft" is given anywhere in the specification, and during examination it was suggested that the behaviour in the Instron machine should be used to provide such a definition.  This was strenuously resisted by the applicant.  Nevertheless I consider "soft pellets" in this context to mean pellets possessing those combinations of size and internal coherence which provide the necessary degree of friability implicit in their use in an insufflator.  I also consider that the specification teaches that such pellets may be identified by their behaviour in the Instron machine.

In addition to the specific example mentioned above, the specification also contains a more general description of how the pellets are prepared.

THE DAUGHTER SPECIFICATION
Claim 1 of the daughter reads:

1.Pellets or granules comprising disodium cromoglycate and having a loose bulk density of less than 0.3g per cc., wherein the pellets or granules are from 10 to 1,000 microns in diameter and comprise an agglomeration of individual medicament particles at least 90% of which have a diameter of less than 10 microns.

Note that this claim is directed to both pellets and granules whereas the grandparent claims refer only to pellets.  Moreover, the pellets or granules are not specified as "soft".

There is also a claim 11 (corresponding to claim 5 of the grandparent) which limits the water content:

11.Pellets or granules according to any one of the preceding claims, comprising less than 15% by weight of water.

As before, the object of the invention is to provide pellets for use in an insufflator.

The body of the specification contains two examples, Example 1 being virtually identical to the example of the grandparent.  I consider the phrase "virtually identical" to be justified, since although an amendment has been proposed which would alter the type of apparatus used in one of the steps, I do not regard this as a material alteration ‑ it is the nature of the product which is important, not the tool used to produce it, and no evidence has been presented to relate the changed apparatus to a changed product.  (I might also add that had I been persuaded that the proposed amendment did make a material difference, its allowability would have to be questioned).

There is a further difference in the two examples.  In Example 1 of the daughter it is said that the water used should be sterile and the air used should be Class 100 air.  Again I discount this as a real difference.  The use of "should" implies advisory rather than imperative status, and in any case there is no evidence to suggest that failure to use sterile water and Class 100 air would affect the gross physical properties of the product ‑ rather, such use is typical in the preparation of medicaments for internal use.

As in the grandparent there is a general description of the method of preparation, and allowing for the fact that it relates to granules as well as pellets, and to DSCG in particular rather than to medicaments generally, it is remarkably similar to the corresponding description in the grandparent.  There is no indication that the process differs in any material respect from that of the grandparent, and certainly no indication that any parameters must be controlled or modified to achieve a particular range of loose bulk density values.

What seems to me to be a further significant passage occurs at page 3 lines 10‑11 where it is said, referring to the pellets and granules of the invention:

"The pellets or granules are preferably pellets or granules described in our copending Application No. 21589/77."

Application 21589/77 is of course the parent, and as will be seen below at least some of the DSCG pellets/granules described therein are made by a process indistinguishable from that exemplified in both the grandparent and the daughter.  It therefore seems impossible to avoid the conclusion that there are at least some DSCG pellets/granules which are common to the claims of all three specifications, and a consideration of the parent specification tends to confirm this.

THE PARENT SPECIFICATION
Claim 1 of 506878 is directed to:

1.A medicament in pellet or granule form, wherein the pellet or granule is soft, is from 10 to 1000 microns in diameter and comprises an agglomeration of individual medicament particles at least 90% of which have a diameter of less than 10 microns, characterised in that the pellets or granules have

(i)a "Total Transmitted Load Reduction", as herein defined, of greater than 100g, and/or

(ii)a product of "Total Transmitted Load Reduction", as herein defined, and "Response Lag", as herein defined, of greater than 30g/cms, and/or

(iii)a "Response Lag", as herein defined, of at least 0.3cms.

Among the claims appended directly or indirectly to claim 1 are claims which limit the medicament to DSCG and the water content to less than 15%:

7.A medicament according to claim 6, wherein the inhalation medicament comprises disodium cromoglycate.

8.A medicament according to claim 7, comprising less than 15% by weight ofwater.

The terms "Total Transmitted Load Reduction" (TTLR) and "Response Lag" (RL) are defined in terms of Instron machine readings, but the definitions are such that the specified values are not directly comparable with the readings disclosed in the grandparent.  However, there is an Example 1 describing the production of DSCG pellets, and an Example 2 which shows that the product of Example 1 has TTLR and RL values within the ranges specified.  Example 1 is very similar ‑ and in my opinion effectively identical ‑ to the example of the grandparent and hence to Example 1 of the daughter.

There is no indication, either in the example, or in the general description, that the method taught is capable of giving products which do not have the TTLR and RL characteristics claimed, or that any particular precautions must be observed to avoid arriving at a product which has the defining features of the grandparent but not those of the parent.

The parent specification also contains the following paragraph:

"The pellets and granules according to the invention have a lower loose bulk density than granules or pellets made by conventional techniques.  Thus soft pellets and granules of disodium cromoglycate have a loose bulk density of less than 0.3g per cc, preferably from 0.2 to 0.3g per cc, and most preferably from 0.22 to 0.28g per cc."

Present at lodgement, but subsequently deleted by amendment, was an approximately corresponding claim, claim 14, which read:

"Disodium cromoglycate in pellet or granule form having a loose bulk density of less than 0.3g per cc."

The above passage and claim form the basis for the divisional status of the daughter.  The claim, it will be noted, was not confined to pellets/granules having the other defining features of the inventions, viz. softness, particle size and behaviour under compression.  Had it remained in the specification it would in my opinion have been unfairly based.  Nevertheless, it formed part of the disclosure of the parent and the Examiner has not challenged the divisional status of the daughter, evidently taking the view that the claim itself, even though inadequately supported, was a sufficient disclosure on which to base a further application under section 51.  On the other hand it seems to me that this particular paragraph merely expresses an advantageous property inherently possessed by the applicant's pellets as distinct from pellets made by conventional techniques.  A similar situation occurs with respect to the properties disclosed in Example 2 of the parent.  Those are merely the results of tests applied to the product of Example 1 which, as I have stated, is substantially the same as the example of the grandparent and Example 1 of the daughter (i.e. the application in suit).

DISCUSSION OF THE EXAMINER'S OBJECTIONS
(i)  SECTION 72
The Attorney submitted that it was beyond the competence of the Examiner to assert that the property of "having a loose bulk density of less than 0.3g. per cc" is an inherent property of the DSCG pellets claimed in claim 4 of the grandparent. It is quite conceivable, said the Attorney, that the grandparent claim includes products which do not have that property as well as those which do, and the Examiner is in no position to say otherwise. That being the case, he continued, the daughter is a patent of addition since the improvement or modification lies in selecting those products which do have the property. In my view, a defence based upon selection is open only if the selection is apparent on the face of the document ‑ see Whitford J.'s comments on the Ethyl Corp. v. Westinghouse Electric case made during the course of his judgement in BASF AG. (Distler's) Application 1977 FSR 137. In the present case that requirement is clearly not met. Although the applicant was well placed to do so, it has not drafted the daughter in the form of a selection patent ‑ there is no indication whatsoever in the daughter that a selection has been made from amongst the DSCG materials claimed in either the grandparent (as the Attorney suggests) or the parent. The criteria for a selection are those propounded by Maugham J. in I.G. Farbenindustries Patent (1930) 47 RPC 289 and there is nothing in the daughter to show that those criteria are present. That is, if Mr. Slattery's submissions concerning selection are correct, then the application fails completely to satisfy the requirements of section 40, as there is no teaching therein different from the teachings of the parent and grandparent, insofar as obtaining the product is concerned.

Indeed, the wording of the  example 1 in each of the three specifications is so closely identical that it would seem they represent not three experiments but a single experiment described three times.  Be that as it may, overlap between the description and claims of the daughter and the parent is clearly indicated by the words previously quoted from page 3 of the daughter:

"The pellets or granules are preferably pellets or granules described in our copending Application No. 21589/77.";

and overlap between the grandparent and the daughter has never been denied, being in fact implicit in the Attorney's arguments in rebuttal concerning selection.  Bearing in mind my review of the three specifications set out earlier in this decision, it follows that the application in suit cannot proceed as a patent of addition to the grandparent specification since it discloses nothing further than what is disclosed in the earlier specification apart from what in my opinion is an inherent property of the pellets.  The examiner's objection is therefore well founded, and it is a corollary thereof that some, at least, of the claims of the present application are prior claimed by those of the grandparent patent.

(II)  DREYFUS
I turn now to the Dreyfus objection. This objection is one based upon the decision of the Solicitor‑General In the Matter of Two Applications by Henry Dreyfus 44 RPC 291. The basis of the Solicitor‑General's decision was that an applicant ought not receive separate grants of Letters Patent for matter which should properly be the subject of a single grant. The objection arises where an applicant has proposed claims of substantially identical scope in separate applications, and having the same priority date. One of the applications may have proceeded to grant, but in any case, there would be nothing to prevent it doing so, as the problem only arises where there would be multiple grants. In the present case, Dreyfus objection has been raised on the daughter specification in relation to the parent, of which the daughter purports to be a divisional. I have already stated that in my view the daughter specification discloses nothing new over the parent specification. The parent specification in its granted form still contains the paragraph (set out in full earlier in this decision) ‑

"The pellets and granules according to the invention  ... have a loose bulk density of less than 0.3g per cc, preferably from 0.2 to 0.3g per cc, and most preferably from 0.22 to 0.28g per cc".

However the claims of the parent make no reference to the loose bulk density, whereas those of the daughter specify ranges thereof eg.

Claim 1 specifies "a loose bulk density of less than 0.3g per cc"
Claim 2 specifies "a loose bulk density of from 0.2 to 0.3g per cc", and
Claim 3 specifies "a loose bulk density of from 0.22 to 0.28g per cc".

It can be seen that the ranges specified in these claims correspond respectively to the general, preferred and most preferred ranges as described in the parent specification.  A comparison of claim 1 of the daughter and claim 7 of the parent (appended via claims 6, 5 to claim 1) reveals that the only differences reside in the specification, respectively, of certain properties therein.  Thus claim 1 of the parent specifies properties of "Total Transmitted Load Reduction", the product of "Total Transmitted Load Reducation " and "Response Lag" and "Response Lag" ‑ see paragraphs (i), (ii), (iii) of claim 1 set out earlier in this decision.  These properties are imported into claim 7 of the parent as features of the pellets defined therein by virtue of its appendancy to claim 1.  Claim 1 of the daughter specification is characterised by reference to a loose bulk density of 0.3g per cc for the pellets.  In my view, from the nature of the respective descriptions in the two specifications, all of the pellets have all the aforesaid properties, in the general form in which they appear in the said claim 1 (daughter) and 7 (parent).  These claims are therefore of substantially identical scope.  Similarly, claim 11 of the daughter specification and claim 8 of the parent specification are of substantially identical scope.  Not all claims of these specifications however are so wide as to include the properties referred to in a general form.  For example, claims 2 and 3 of the daughter specification are more restrictive of their requirements in relation to bulk density ‑ in contrast this property as attributed to the pellets as claimed in the parent specification must be taken to be in the general form ie. "less than 0.3g per cc".  Conversely, the properties set out (in the general form) in paragraphs (i), (ii) and (iii) of claim 1 of the parent specification occur in appended claims thereof in more restricted form, which does not characterise any of the claims of the daughter specification.  I conclude, therefore, that the Dreyfus objection obtains only to claims 1 and 11 of the application in suit.

SECTION 40
The application describes and claims specific ranges of loose bulk density (see in particular claims 2 and 3) which are said to be preferred.  It is a requirement of Section 40 that a complete specification shall describe the best method of performance known to the applicant.  In this case, there is no manner of performance described at all for the preparation (or separation) of pellets having the preferred ranges of loose bulk density.

DECISION
This application may not proceed as an application for a patent of addition to Patent No. 492916; also a Dreyfus objection applies to claims 1 and 11, respectively on comparison to claims 7 and 8 of Patent No.  506878, and further, the complete specification fails to define the best method of performance.

Pursuant to these defects, I direct that the applicant lodge a statement of amendments to my satisfaction within the time remaining for acceptance.  However, it seems to me that it may not be possible to propose satisfactory amendments to the specification of application No. 52885/79.  I would consider, as an alternative approach, that the claims of parent patent 506878 could be amended to incorporate reference to the loose bulk density of the pellets.

J.L. ROVETA
  Supervising Examiner