HOECHST AKTIENGESELLSCHAFT

[1987] APO 39

In the Matter of the Patents Act 1952

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In the Matter of Application no. 15712/83 in the name of HOECHST AKTIENGESELLSCHAFT

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In the Matter of an Examiner's Objections thereto.

DECISION OF A SUPERVISING EXAMINER OF PATENTS:

Background

Patent application no. 15712/83 was lodged on 10 June, 1983 and is based on two applications made in the Federal Republic of Germany which were lodged on 11 June, 1982 and 15 April 1983.   The application is entitled "Processes for the preparation of Obligate Methylotrophic Bacteria which Express Foreign DNA, and Plasmids and Host Organisms Suitable for These."
         The examiner, in his seventh report maintained an objection that the invention had not been sufficiently described and that claim 11 was not directed to a manner of manufacture because of a lack of reproducibility of the invention.  Consequently Mr. J. Murray, patent attorney of Edwd Waters and Sons, requested that the matter be set down for a hearing, which was subsequently held in Melbourne on 14 August, 1987.

At the hearing Mr Murray made submissions and suggested amendments in response to the examiner's objection.  However, I stated that in my opinion further amendments would be necessary, and as well indicated that in my view, claims 1 and 5 were not fairly based on the description.  Mr Murray agreed to propose further amendments, and he lodged these on 31 August, 1987, together with submissions about the fair basis of claims 1 and 5.
         In a letter dated 3 September, 1987 I wrote in part to Mr Murray as follows:

"With respect to the objection to the lack of fair basis of claims 1 and 5, I do not agree that the comments on page 2 of your letter deal with this matter effectively.

...

As you were not aware that the matter of claims 1 and 5 was an issue at the time you were heard, I allow you one month from the date of this letter to lodge counter submissions, or to propose amendments under s.49.

If you do not follow either of the above alternative courses of action, I will issue a decision after the expiry of that month.

If you choose to lodge submissions rather than propose amendment, I will follow a course of action contingent upon the nature of those submissions."

Mr Murray requested extra time in which to reply and I agreed, so that his written submissions together with a proposed amendment were lodged on 9 October, 1987.  After consideration of these submissions I decided that I should issue a written decision in respect of the fair basis of claims 1 and 5.
The Specification
         The specification (after the latest proposed amendment) relates to the genetic manipulation of methylotrophic microorganisms, in particular processes for the preparation of obligate methylotrophic bacteria which express contained foreign DNA, plasmids for introducing the foreign DNA and host organisms.
         The process is described in similar terms to those found in claim 5 and step "a)" of this claim involves isolating a plasmid from an obligate methlotrophic bacterium.  The plasmid is preferably isolated from a bacterium of the genus Methylomonas, in particular from the species Methylomonas clara.  The plasmid is converted to a hybrid plasmid which contains selection markers.  The hybrid plasmid is introduced into a recipient obligate methylotrophic bacterium by the steps defined in claim 5.  Preferred recipients are bacteria of the genus Methylomonas, in particular the species Methylomonas clara.
         The description concludes with a detailed description of the isolation of plasmid pBE3 from the known Methylomonas clara strain ATCC31226.  The plasmid is characterised by the indentification of the fragments obtained when the plasmid is digested with restriction enzymes. There is also a detailed description of the preparation of a hybrid plasmid from the plasmid pBE3 and a description of the processes used to introduce the hybrid plasmid into the cells of Methylomonas clara.
         Claims 1 and 5 read as follows:

"1.A hybrid plasmid with a replicon inherent to an obligate methylotrophic bacterium.

5.Process for causing obligate methylotrophic bacteria to express foreign DNA which comprises

a)isolating a plasmid which originates from an obligate methylotrophic bacterium,

b)preparing from this and from a plasmid with selection markers a hybrid plasmid with a replicon inherent to the obligate methylotrophic bacterium,

c)introducing this hybrid plasmid by transformation into a host organism and amplifying it there,

d)after selection, treating the clones with a suitable conjugative plasmid and abolishing the mobilizability defect,

e)conjugating the clones thus obtained with, preferably plasmid‑free, obligate methylotrophic bacteria as the recipient and

f)selecting the desired clones."

Written Submission
         The written submission made by Mr Murray on behalf of the applicant commences by referring to several documents which describe experiments to determine if both facultative and obligate methylotrophic bacteria contain plasmids.  Having briefly summarised each of the references Mr Murray then asserts that the present invention marks a distinct advance in the development of the art.
         The submission continues as follows:

"For the first time, a suitable plasmid was isolated from a methylotrophic bacterium.  The plasmid as isolated could be further processed into a hybrid with a known plasmid such as pBR322 and amplified in a known host organism such as E. coli.  Such a hybrid plasmid is specific for E. coli and maintains the safety aspect.

All the knowledge existed at the earlier priority date to apply this clear advance in the art to other methylotrophic bacteria.  Thus a person skilled in the art could apply Portnoy's "routine" technique to screen different obligate methylotrophic bacteria so that other plasmids could be found which could then be combined with further plasmids."

Decision
The relevant principles which are applicable in deciding whether a claim is not fairly based on the description are stated in the authorities set out in Montecatini Edison SpA v Eastman Kodak Co. (45 ALJR 593 at page 597). In this case Gibbs J. found as follows:

"The present claims are not fairly based on the matter described in the specification, because they are wide enough to cover polypropylene which may be produced in a way completely unrelated to the method disclosed by the respondent, and are thus wider than "the consideration".

The same principles were applied in Olin Corporation v Super Cartridge Co. Pty Ltd (14 ALR at pages 161 and 172) wherein Stephen and Mason JJ. said as follows:

"The invention supplied a process for the production of the article and at the relevant time it was the only process by which the article could be produced.

Is this enough to justify the appellant obtaining a monopoly for the production of the article whether it be produced by its process or not?  We do not think it is.  It would enable the appellant to assert his monopoly against others who develop other, more efficient and more economic means of manufacturing the product, thereby giving him a reward greater than the consideration which he has provided in the form of the disclosure which he has made.  It would tend to discourage research and development in the same field, much to the disadvantage of the public, and to that of manufacturers who are minded to develop improved versions of the product.

This is not a case in which the inventor has conceived of and brought into existence an entirely new or revolutionary product which stands so far in advance of, and apart from, previous developments that it works a radical transformation in the field in which it is introduced, as, for example, the invention of the electric light globe.  In such a case the inventive step or the merits of the invention may be so great that it may be proper to reward the patentee with a monopoly in the product or article, unlimited by reference to the actual process according to which it is produced.   Then it may be said the monopoly confered is proportionate to the great benefit which has been given to the public by the patentee's disclosure."

Turning to the present specification, Claim 5, and the description which corresponds to this claim, state in parts "a)" and "b)" that the process comprises isolating a plasmid which originates from an obligate methylotrophic bacterium and preparing from this a hybrid plasmid with selection markers.     According to the detailed description in the specification, fermentation of strain ATCC 31226 of Methylomonas clara on a large scale and over a long period produces several new strains of micro‑organism, which contain one plasmid in each cell.  However only plasmid pBE 3 from strain DSM 2397 was processed into a hybrid plasmid with known selection markers.  There is no exemplification in the specification of similar fermentations of other species of Methylomonas nor are the other plasmids obtained from Methylomonas clara characterised by digestion with restriction enzymes processed into hybrid plasmids with selection markers.
         Mr Murray submits that all the knowledge existed at the priority date of the earlier basic document to apply the advance broadly described in the specification to other methylotrophic bacteria.  However it seems to me that I should seek guidance in respect of this knowledge by referring to the references which accompanied Mr Murray's written submission.
         Reference 4 is a paper which appears to have been published after the date of lodgement of the present specification (Mary E. Lidstrom and Ann E. Wopat, Arch. Microbiol. (1984) 140, 27).  The authors concluded that plasmids were a common feature of methylotrophic bacteria after investigating species from the genera Methylobacter, Methylomonas, Methylosinus and Methylocystis.  The paper discloses a map of the fragments produced when the smallest plasmid which the authors found was digested with restriction enzymes.  However the paper contains a statement which reads as follows:

"Future investigations should be directed towards determining the nature of plasmid‑encoded genes, as well as the possible use of the replicons of these plasmids in the construction of cloning vectors."

I conclude that the isolation and characterisation of a plasmid from a species of obligate methylotrophic bacteria was not knowledge which existed in the art at the priority date established by the earlier basic application.   Moreover I  conclude that the preparation of a suitable hybrid plasmid with known selection markers requires inventive experimentation.  Thus I think that the granting of a patent with the term "an obligate methylotrophic bacterium" in part 2 "a)" of claim 5 would tend to discourage research and development in this field to the disadvantage of the public.  After consideration of the historical developments of the isolation of plasmids from methylotrophic bacteria set out in the references in Mr Murray's written submission I am of the opinion that the applicant has not conceived and brought into existence an entirely new or revolutionary process and product which stands so far in advance of, and apart from, previous developments that it will work a radical transformation in the field.  Consequently I am satisfied that claim 5 is not fairly based on the description in so far as it defines a process applicable to an "obligate methylotrophic bacterium".
         Claim 1 and part "b)" of claim 5, as well as the corresponding part of the description, state that the hybrid plasmid has "a replicon inherent to an obligate methylotrophic bacterium" whereas lines 12 to 20 of page 7 read as follows:

"Furthermore, the invention relates to the plasmids from the Methylomonas clara strain DSM 2397 and the hybrid plasmids with a replicon inherent to an obligate methylotrophic bacterium, in other words plasmids which are replicated in the bacteria of the genus Methylomonas, preferably of the species Methylomonas clara, in particular the strain ATCC 31226, in which prokaryotic or eukaryotic DNA is integrated, in particular that for the expression of insulin."

I note the authors of reference 4 (supra) state that in general the plasmids carried by different species of obligate methylotrophic bacteria appear to be distinct and showed little or no homology in hybridisation experiments.   The paper then reads as follows:

"The exception was hybridization between the two Methylosinus species (M. sporium and M. trichosporium) which contained different plasmids that showed a small region of homology.  The identity of this region is unknown, but it could reflect common plasmid replication or transfer functions, or common plasmid‑encoded genes of some other function."

According to Mr Murray's written submission the first reported evidence for a plasmid in an obligate methylotrophic bacterium (also a Methylomonas species) appears to have been published between the priority dates of the basic documents (reference 3B, M.J. Monteiro, M.A. Typas, B.F. Moffett and B.W. Bainbridge, FEMS Microbiology Letters 15 (1982) 235).
         Thus I conclude that a hybrid plasmid which is derived from plasmid pBE3 may have a replicon which is inherent to the genus Methylomonas.   However I think that inventive experimentation would be required to show that the hybrid plasmid prepared from plasmid pBe3 has a replicon inherent to an obligate methylotrophic bacterium.   Thus the hybrid plasmid defined in claims 1 and 5 may be produced in a way completely unrelated to the method disclosed in the present specification.   Therefore I consider the definition of the replicon as being "inherent to an obligate methylotrophic bacterium" goes beyond the consideration which the applicant has given to the public by the disclosure in the specification.  Consequently I am satisifed that claims 1 and 5 are not fairly based on the description.
         Therefore I am satisifed that there are still lawful grounds of objection to application No. 23146/84 and I afford the applicant an opportunity to lodge a statement of proposed amendments to my satisfaction within the time remaining for acceptance.

(J. ROVETA)
   Supervising Examiner of Patents