Benitec Australia Ltd v the Carnegie Institution of Washington and the University of Massachusetts

[2005] APO 49

ABSTRACTS OF DECISIONS

DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS

Application  :          No. 743798 in the name of The Carnegie Institution of Washington and The University of Massachusetts

Title:          Genetic Inhibition of double-stranded DNA

Action:          Opposition under Section 104 by Benitec Australia Ltd and a Request under Regulation 5.5(1) for dismissal of that Opposition

Decision:          Issued 03 November 2005.

Abstract

Opposition dismissed.  None of the opponent's arguments in the section 104 opposition were found to be tenable.  The opponent has objected to the introduction of particular terms in the amended claims under every ground of section 104.  From the nature of the objections, I was unable to identify any plausible argument supporting the opponent’s allegations and the opponent failed to provide any substantive reasoning for their objections.  As a result, the opponent has not disclosed a case with any possibility of success.  As a consequence, I dismiss the section 104 opposition in its entirety.

PATENTS ACT 1990

DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS

Re:Patent Application No. 743798 by The Carnegie Institution of Washington and The University of Massachusetts, an opposition under section 104 by Benitec Australia Ltd and a Request under Regulation 5.5(1) by the applicants for dismissal of the Opposition

BACKGROUND

1. Patent application 743798 in the name of The Carnegie Institution of Washington and The University of Massachusetts (hereafter "Carnegie") was filed on 21 December 1998 under the provisions of the PCT.  The application claims priority from two earlier US applications (68562 and 215257) filed on 23 December 1997 and 18 December 1998 respectively. 

2. The Australian application was advertised accepted on 7 February 2002 and a notice of opposition was filed on 7 May 2002 by Paul Jones who had opposed the application on behalf of the real opponent.  The notice of opposition was subsequently amended to reflect the real opponent [Benitec Australia Ltd (hereafter "Benitec")] on the agreement of the parties.  Evidence in support was completed on 7 April 2004 and on 6 July 2004, the applicant filed a request to amend the specification under section 104.  Leave was granted to amend the specification and this was advertised on 27 January 2005.

3. On 27 April 2005, Benitec filed a notice of opposition to the section 104 amendments.  The opponent served their Statement of Grounds and Particulars on 27 July 2005 and on 17 August 2005, the applicant requested dismissal of the opposition under regulation 5.5(1).  The matter was heard in Canberra on 20 September 2005.  The opponent was represented by Mr Paul Jones, patent attorney from Freehills Patent and Trade Mark Attorneys, Melbourne who appeared by phone.  The applicant did not appear but relied on written submissions from Dr Trevor Davies, patent attorney from Allens Arthur Robinson Patent and Trade Marks Attorneys, Sydney. 

   SPECIFICATION AS ACCEPTED

4. The specification relates to a method of suppressing (or "silencing") a target gene using double stranded RNA (dsRNA).  According to the specification, the process involves the introduction of RNA with partial or fully double-stranded character into the cell or into the extracellular environment.  Inhibition is sequence-specific in that a nucleotide sequence from a portion of the target gene is chosen to produce inhibitory RNA.  RNA containing a nucleotide sequence identical to a portion of the target gene is preferred for inhibition.  However, 100% sequence identity between the RNA and the target gene is not required to practice the invention as long as functionally the RNA is able to hybridise with the target gene under certain conditions (see page 11, lines 24-28).

5. The specification as accepted ends with 45 claims, of which 6 were independent.  These are outlined below:

   1.A method to inhibit expression of a target gene in a cell comprising introduction of a ribonucleic acid (RNA) into the cell in an amount sufficient to inhibit expression of the target gene, wherein the RNA comprises a double-stranded structure with an identical nucleotide sequence as compared to a portion of the target gene.

   24.      A method to inhibit the expression of a target gene comprising:

   (a)Providing an organism containing a target cell, wherein the target cell contains the target gene and the gene is expressed in the target cell;

   (b)Contacting a ribonucleic acid (RNA) with the organism, wherein the RNA is comprised of a double stranded structure with duplexed ribonucleic acid strands and one of the strands is able to duplex with a portion of the target gene; and

   (c)introducing the RNA into the target cell, thereby inhibiting expression of the target gene.

   40.A cell containing an expression construct and a target gene, wherein the expression construct transcribes at least one ribonucleic acid (RNA) and the RNA forms a double-stranded structure with duplexed strands of ribonucleic acid (dsRNA),

   whereby the dsRNA has a nucleotide sequence with sufficient identity to the target gene to inhibit expression of the target gene.

   43.A kit comprising reagents for inhibiting expression of a target gene in a cell, wherein said kit comprises (a) means for introduction of a ribonucleic acid (RNA) into a cell in an amount sufficient to inhibit expression of the target gene and (b) the RNA;

   wherein the RNA has a double stranded structure with an identical nucleotide sequence as compared to a portion of the target gene.

   44.      A method to inhibit expression of a target gene in a cell comprising:

   (a)selection of a transcribed sequence of the target gene, wherein the target gene is targeted for specific interference mediated by a double-stranded ribonucleic acid (dsRNA);

   (b)synthesis of the dsRNA which is comprised of first and second ribonucleotide sequences that hybridise to each other to produce a double-stranded structure, wherein the first ribonucleotide sequence is able to specifically hybridise to the transcribed sequence and the second ribonucleotide sequence is able to specifically hybridise to the transcribed sequence's complement; and

   (c)introduction of the dsRNA into the cell in an amount sufficient to inhibit expression of the target gene.

   45.A method to inhibit expression of a target gene in an organism which is a plant or animal comprising:

   (a)selection of a transcribed sequence of the target gene, wherein the target gene is expressed in the organism and targeted for specific interference mediated by a double-stranded ribonucleic acid (dsRNA);

   (b)synthesis of the dsRNA which is comprised of first and second ribonucleotide sequences that hybridise to each other to produce a double-stranded structure, wherein the first ribonucleotide sequence is able to specifically hybridise to the transcribed sequence and the second ribonucleotide sequence is able to specifically hybridise to the transcribed sequence's complement; and

   (c)introduction of the dsRNA into the organism in an amount sufficient to inhibit expression of the target gene.

   SPECIFICATION AS PROPOSED TO BE AMENDED

6. The request for leave to amend inter alia proposes amendments to four of the six independent claims which are outlined below.  Claims 44 and 45 remain unchanged by the amendment.  The proposed amendment to the other claims read as follows:

   1.A method to inhibit expression of a target gene in a cell comprising providing at least one ribonucleic acid (RNA) to the cell in an amount sufficient to inhibit expression of the target gene, wherein the RNA comprises a double-stranded structure containing a first strand having a ribonucleotide sequence which corresponds to a nucleotide sequence of the target gene and a second strand having a ribonucleotide sequence which is complementary to the nucleotide sequence of the target gene, wherein the first and the second nucleotide strand sequences are complementary sequences that hybridise to each other to form the double-stranded structure, and wherein the RNA comprising the double stranded structure inhibits expression of the target gene.

   24.      A method to inhibit the expression of a target gene comprising:

   (a)Providing an organism containing a target cell, wherein the target cell contains the target gene and the gene is expressed in the target cell;

   (b)Providing to the cell a ribonucleic acid (RNA) wherein the RNA is comprised of a double-stranded structure containing a first strand having a ribonucleotide sequence which corresponds to a nucleotide sequence of the target gene and a second strand having a ribonucleotide sequence which is complementary to the nucleotide sequence of the target gene, wherein the first and second ribonucleotide strand sequences are complementary sequences that hybridise to each other to form the double-stranded structure such that the RNA comprising the double-stranded structure inhibits expression of the target gene in the cell.

   40.A cell containing an expression construct and a target gene, wherein the expression construct transcribes at least one ribonucleic acid (RNA) and the RNA forms a double-stranded structure, wherein the double stranded structure contains a first strand having a ribonucleotide sequence which corresponds to a nucleotide sequence of the target gene and a second strand having a ribonucleotide sequence which is complementary to the nucleotide sequence of the target gene, and wherein the first and second ribonucleotide strand sequences are complementary sequences that hybridise to each other to form the double stranded structure, such that the RNA comprising the double-stranded structure inhibits the expression of the target gene in the cell.

   43.A kit comprising reagents for inhibiting expression of a target gene in a cell, wherein said kit comprises

   (a) means for introduction of a ribonucleic acid (RNA) into a cell in an amount sufficient to inhibit expression of the target gene; and

   (b) at least one ribonucleic acid (RNA);

   wherein the RNA comprises a double-stranded structure containing a first strand having a ribonucleotide sequence which corresponds to a nucleotide sequence of the target gene and a second strand having a ribonucleotide sequence which is complementary to the nucleotide sequence of the target gene, and wherein the first and second ribonucleotide sequences are complementary sequences that hybridise to each other to form the double-stranded structure, and wherein the RNA comprising the double stranded structure inhibits expression of the target gene in a cell.

   LEGISLATION

7. This opposition relates to the operation of section 102 of the Act, the relevant parts of which read:

   (1)  An amendment of a complete specification is not allowable if, as a result of the amendment, the specification would claim matter not in substance disclosed in the specification as filed.

   (2)  An amendment of a complete specification is not allowable after the relevant time if, as a result of the amendment:
   (a)       a claim of the specification would not in substance fall within the scope of the claims of the specification before amendment;  or
   (b)       the specification would not comply with subsection 40(2) or (3).

   (2A)  For the purpose of subsection (2),

   relevant time means:
   (a)       in relation to an amendment proposed to a complete specification relating to a standard patent -  after the specification has been accepted;  …

   (2B)  …

   (3)  This section does not apply to an amendment for the purpose of correcting a clerical error or an obvious mistake made in, or in relation to, a complete specification.

8. I note that the only grounds for opposing an amendment under section 104 are in relation to section 102 and that the Commissioner has no discretion about whether to allow an amendment under section 104 which meets all the requirements of section 102 [see regulation 10.5 (1)(a) and note F. Hoffman La Roche AG v New England Biolabs Inc [2001] FCA 787 (27 June 2001)].

   TEST FOR DISMISSAL

9. The provisions of regulation 5.5(1) enable an applicant to request the Commissioner to use her power under regulation 5.5(3) to dismiss an opposition.  The principles to be applied in considering whether to dismiss an opposition are well established and are similar to the reasons for summary dismissal which are described in General Steel Industries Inc v Commissioner for Railways (NSW) and others (1964), 112 CLR 125:

   "It is sufficient for me to say that these cases uniformly adhere to the view that the plaintiff ought not to be denied access to the customary tribunal which deals with actions of the kind he brings, unless his cause of action - if that be the ground on which the court is invited  .. to exercise its powers of summary dismissal - is clearly demonstrated. 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".

10. At times the test has been put as high as saying that the case must be so plain and obvious that the court can say at once that the statement of claim, even if proved, cannot succeed; or "so manifest on the view of the pleadings, merely reading through them, that this is a case that does not admit of reasonable argument"; "so to speak apparent at a glance".

11. On this basis, an opposition or a ground of opposition will be dismissed only if it is clear that the opposition could not possibly succeed.  In bringing this action the onus falls on the applicant to show that the opposition is clearly untenable as the dismissal action is not intended to be de facto hearing of the substantive opposition.  Barwick J in General Steel Industries Inc v Commissioner for Railways (NSW) and others (supra) states that "great care must be exercised to ensure that under the guise of achieving expeditious finality a plaintiff is not improperly deprived of his opportunity for the trial of his case by the appointed tribunal".  However, Barwick J. also noted that dismissal is not reserved for cases where argument is unnecessary to evoke the futility of the plaintiff's claim and that it can be invoked in clear cases where the court is satisfied "that it has the requisite material and the necessary assistance from the parties to reach a definite and certain conclusion".  This suggests that the purpose of a dismissal action is to ensure that there are real issues of dispute between the parties which are properly resolved at a substantive hearing. 

12. In the context of a section 104 opposition, a mere allegation that an amendment contravenes section 102 on its own is insufficient to identify a real issue of dispute.  Any amendment to a specification inevitably involves a textual change but not all such amendments fall foul of section 102.  To demonstrate a real issue of dispute (as is required by the statement of particulars), there has to be a substantive reason for how the particular change in text might cause a problem under section 102.  That problem might be self-evident or ascertainable by a detailed analysis of the allegation or the specification.  However, if a potential problem cannot be found by any of these means, then the onus resides on the opponent to explain the basis of their argument.  If they fail to provide a substantive explanation, then their "argument" is merely an unsupported allegation and has no possibility of success.  In such an event, their opposition is subject to dismissal.

    DECISION

13. The applicant’s proposed amendments to the specification appear in part to address certain section 40 deficiencies which the opponent raised in their section 59 opposition.  In particular, the opponent’s section 59 Statement of Grounds and Particulars (SGP) alleged that the words “introduce” and “introduction” in claim 1 (as accepted), were unclear in meaning or scope [see page 7, points (b)(1), (b)(5) and (b)(6) and page 8 point (b)(7)].  The SGP did not raise a problem with the word “identical” in their section 59 SGP but the opponent’s declarant (Dr Forster) raised some concerns about the term in his evidence in support (see his paragraph 4.11, for example).

1. The applicant inter alia proposes to replace the words “introduction” and “identical” with different terms under section 104 and these are the only amendments being opposed.  The opponent’s opposition can be summarised as follows: 

   a)Replacing the word "introduction" or "contacting" with the term "providing" was contrary to section 102(1) because the term "providing" had not been used in the specification as filed and there was therefore "no real and reasonably clear disclosure" of the terms in the specification as filed.  Further, the opponent argued that the term "providing" was unclear [in contravention of section 102(2)(a)] and was broader than either of the unamended terms [in contravention of section 102(2)(b)].  Hence, the proposed amendments to claims 1 and 24 are not allowable

   b)Replacing the word "identical" with the words "corresponds" or "complementary to" was contrary to section 102(1) because there was no real and reasonably clear disclosure of these terms in the specification as filed.  Further, the opponent argued that the words "corresponds" or "complementary to" are unclear [in contravention of section 102(2)(a)] and are broader in scope than the unamended term "identical" [in contravention to section 102(2)(b)].  Hence, the proposed amendments to claims 1, 10, 15, 16, 24-26, 32, 40 are not allowable.

2. I will deal with these two issues separately.

Replacing the words "introduction" or "contacting" with the term "providing"

1. The opponent argued that as the word “providing” did not appear in the specification as filed, its inclusion by amendment introduced new subject matter contrary to sections 102(1).  It is unclear that there is a real basis for the opponent’s allegation.  The term "providing" has a well-known meaning which the Australian Concise Oxford Dictionary (3rd edition) defines as "furnish or supply".  That same dictionary defines the term "contact" as "touching, meeting or communicating" and as "introduction" as "insert or place in".  In the context of the claims, all three terms (ie: “introduction", "contacting" and "providing") convey the same concept of allowing the RNA into the cell to inhibit expression of the target gene.  I am unable to see that there is any difference in the disclosure by the substitution of one term for another.  In my view, the applicant appears merely to have substituted one term for another in an attempt to overcome the alleged clarity objections (raised in the section 59 opposition).

2. The opponent argued that section 104 oppositions inevitably involve construction of the claims for which the Commissioner would necessarily require input from a skilled expert.  According to the opponent, the Commissioner cannot dismiss a section 104 opposition without having regard to input from a skilled expert.  Of course if this argument is correct, a section 104 opposition could never be dismissed − which I do not accept.  The key question in a dismissal is whether there are any real issues in dispute.  Without a real issue, there is nothing to resolve and no consequential need for evidence.  I also observe (as an aside) that the construction of a specification is a legal question and is ultimately a matter for the arbitrator of the dispute (ie: the Commissioner or the Court).  Therefore as a matter of general principle, I do not agree that expert evidence will always be necessary to resolve a section 104 dispute. 

3. The opponent also argued that the test for dismissal was very high and that it should not succeed unless it was manifestly clear that the opponent had no possible argument.  However, as noted above, the purpose of a dismissal action is to ensure that there are real issues of dispute to resolve at a substantive hearing.  In the context of a section 104 opposition, it is not sufficient to simply allege that the change of words contravenes section 102.  There has to be some basis for a problem potentially caused by the change in text.  I am unable to identify any change to the disclosure caused by the amendments even after a detailed analysis.  The onus therefore lies with the opponent to explain the basis for their objection.  However they failed to provide any substantive reasons for their objection.  In particular, they failed to identify the nature of the alleged new subject matter that would be included by the change in wording.  As a result, my view is that the opponent has not presented a serious argument and I do not believe there is a real dispute to resolve under section 102(1).  I therefore find this particular untenable.

1. I am also unable to find any clarity problem with the proposed introduction of the word “providing” in the claims [in contravention of section 102(2)(b)] as alleged by the opponent. The word “providing” has a plain meaning as outlined above and it appears to be used in its correct context in the claims.  The opponent’s allegation that the word is unclear is unsupported by any substantive reasoning in either their section 104 SGP or their submissions at the hearing.  It is therefore not apparent to me that there is a potential problem with lack of clarity and in my view, there is no real dispute in relation to section 102(2)(b).  This particular is therefore untenable.

2. The opponent's argument in relation to section 102(2)(a) infers that the word "providing" is broader than both the words "introduction" and "contacting" and that therefore the amended claims must necessarily be broader in scope that the claims prior to amendment.  However as noted above, the term "providing" describes the same concept of getting the RNA into the cell to inhibit expression of the target gene as the unamended terms had done.  It is not clear how the word “providing” broadens the scope of the claims and the opponent did not provide any potential examples where there could be infringement of the amended claim which did not exist prior to amendment (as per Distillers Co Ltd's Application (1953) 70 RPC 221 at page 223 and W.J .Voit Rubber Corp's Application (1965) AOJP 1752).  I am unable to see any real basis for a problem under section 102(2)(a) and in my view, the opponent’s argument in relation to section 102(2)(a) is untenable.  

Replacing the word "identical" with the terms "complementary" or "corresponding"

1. The opponent alleged that the inclusion of the words "complementary" and "corresponding" were not allowable amendments because they introduced new subject matter [contrary to section 102(1)].  Both words replace the word "identical" in the original claims.  The opponent's expert Dr Forster had alleged that there were clarity problems with the term "identical" in claim 1.  According to Dr Forster, RNA contained different sugars to DNA as well as one different base nucleotide (uracil instead of thymidine) and hence could never be “identical” to DNA as required by the claims (see paragraph 4.11, for example).

1. Despite this allegation, Dr Forster did not have any difficulties construing the claims for the purposes of novelty and inventive step.  In particular, he read the word “identical” as meaning identical in sequence rather than exact identity (see paragraph 7.9 for example).  In fact, this is the only plausible interpretation of the term "identical" in the context of the claim because RNA is clearly not an identical molecule to DNA.  However even given this definition, I accept that the term "complementary" does not mean “identical”.  As defined in Henderson's Dictionary of Biological Terms, the term “complementary” is "two strands of DNA or RNA that can base pair with each other".  While this requires an identity of sequence to allow hybridisation of the dsRNA and target gene, the “complement” is actually identical to the anti-sense strand of the target gene rather than being identical to the gene itself.

2. In the context of the amended claim, this distinction is not relevant because the amendments do not simply replace the word “identical” with “complement”.  Where originally the dsRNA was described as a total entity, the amendments now define the two strands that make up the entity.  Both strands of the dsRNA are defined as being “complementary” to each other.  One strand is the “complement” of the target gene and the second “corresponds” to the target gene.  Because the target gene itself is also double stranded, it follows that each of the two strands of the RNA will have a corresponding sequence to one of the strands of DNA and be complementary to the other.  This means that the dsRNA is necessarily identical in sequence to the target DNA.  The concept of using a dsRNA which was complementary to (and corresponded to) the target gene was therefore always understood from the word “identical”.  The amendment is simply articulating a concept that was clearly understood by the opponent's expert in the section 59 opposition (Dr Forster) in his discussion on novelty and inventive step.  As a consequence, I am unable to identify any change to the disclosure caused by the amendments even after a detailed analysis of the allegation.

3. The onus therefore lies with the opponent to explain the basis for their objection.  However they failed to provide any substantive reasons for their objection.  In particular, they failed to identify the nature of the alleged new subject matter that would be included by the change in wording.  As a result, my view is that the opponent has not presented a serious argument.  They have simply made a broad allegation that the words “complementary” or “corresponding” claim matter not in substance disclosed without providing any reasons in support of their allegation.  I do not believe there is a real dispute to resolve under section 102(1) and I find this particular untenable. 

1. The opponent's argument in relation to section 102(2)(a) is that the words "complementary" and "corresponding" were broader in scope than the term "identical" and that therefore the amended claims must necessarily be broader in scope that the claims prior to amendment.  However as I noted above, Dr Forster's use of the term "identical" is actually synonymous with the words "complementary" and "corresponding" when read together in the context of the claims.  Both require an identity of sequence to allow hybridisation of the dsRNA and target gene and the substitution of "identical" with "complementary" and “corresponding” does not alter the scope of the claim.  The opponent failed to provide any substantive basis for their allegation by providing specific examples of potential infringement of the amended claim where one did not exist prior to amendment (as per Distillers Co Ltd's Application (1953) 70 RPC 221 at page 223 and W.J .Voit Rubber Corp's Application (1965) AOJP 1752).  As a consequence, I am unable to see any real argument under section 102(2)(a) and my view is that the opponent's argument in relation to section 102(2)(a) is untenable.

1. The opponent argued that the words "complementary" and "corresponding" were unclear [contrary to section 102(2)(b)].  The opponent argued that both terms must mean that the dsRNA was an identical molecule to the target DNA because they replaced the term “identical” in the claims.  They suggested that as complementary doesn't mean "identical", the terms must mean something else and are therefore not clear.  However, the terms "complementary" and "corresponding" have plain meanings.  As noted above, those meanings when read together are synonymous with the term "identical" used in the original claims.  The two terms can therefore substitute the term “identical” without changing either of their meanings in the context of the claims.  I fail to see any possible problem with the clarity of these terms and the opponent did not provide any reasoned explanation for their argument.  As a consequence, there is no real basis for an objection under section 102(2)(b) and I find the opponent's argument untenable.

   CONCLUSION

2. The opponent has objected to the introduction of particular terms in the amended claims under every ground of section 104.  From the nature of the objections, I was unable to identify any plausible argument supporting the opponent’s allegations and the opponent failed to provide any substantive reasoning for their objections.  As a result, the opponent has not disclosed a case with any possibility of success.  As a consequence, I dismiss the section 104 opposition in its entirety.

3. I will proceed to allow the request to amend the specification filed on 6 July 2004 unless the Commissioner is served with a notice of appeal of this decision within 30 days of the date of this decision.  Once the parties have been advised of the allowance of the amendments, the applicant will have 1 month to serve evidence in answer in the section 59 opposition.  This period can be extended under regulation 5.10(2) provided the applicant can establish that the extension is appropriate in all the circumstances.

COSTS

1. In matters before the Commissioner, costs generally follow the event.  I see no reason to depart from this in the current case.  As the applicant was successful in their request for dismissal, I award costs against the opponent.

   Karen Ayers
   Delegate of the Commissioner of Patents
   03 November 2005

   Patent attorneys for the applicant  :  Allens Arthur Robinson, Sydney

   Patent attorneys for the opponent   :  Freehills Carter Beadle, Melbourne