Woo-Suk Hwang - [2004] APO 24

OFFICIAL NOTICE
DECISION OF A DEPUTY COMMISSIONER OF PATENTS
Application : No. 2003204164 in the name of Woo-Suk Hwang

Title: A method for producing chimeric embryos by employing inter-species nuclear transplantation technique

Action: Examiner’s objections

Decision: Issued: 9 September 2004
Abstract

Application claimed a method of producing a hybrid embryo using inter-species nuclear transplantation techniques. Specifically, the embryo is created by transferring the nucleus of a human cell into a bovine ovum, and activating the ovum.

The claimed invention was contrary to s.18(2), it being for a method of generating a human being. The fact that the ovum was artificially activated, and the mitochondrial DNA of the ovum was bovine, did not remove the method from the ambit of s.18(2)

Having regard to s.20(2) of the Prohibition of Human Cloning Act 2002, the claimed invention was one that was contrary to law. Furthermore it was appropriate to exercise the discretion under s.50(1)(a) of the Act to refuse the application.

Application refused.
PATENTS ACT 1990
DECISION OF A DEPUTY COMMISSIONER OF PATENTS
Re:Patent Application No. 2003204164 by Woo-Suk Hwang, and examiners objections thereto.

BACKGROUND

This application was filed on 30 April 2003 as a divisional application from application 55776/00. During examination of this parent application, the examiner raised objections under s.18(2) of the Patents Act 1990. That application lapsed through failure to gain acceptance within the 21-month period allowed under regulation 13.4. The present application was filed shortly before the parent application lapsed.
A first examination report on the present application issued on 28 January 2004. In that report, the examiner objected inter alia to the claims being in contravention of s.18(2); and also under s.50(1) asserting that the claimed invention was contrary to the Prohibition of Human Cloning Act 2002. The examiner’s report was also accompanied by a hearing notice, with advice that the Commissioner intended to refuse the application.
The hearing was initially set for March 2004. The applicant requested deferral of the hearing “as we need more time to collect evidence to support the applicant’s case”. The Commissioner agreed to defer the hearing for 6 months – resetting it for 7 September 2004. On 24 August 2004, the attorney for the applicant advised “We advise that our client does not wish to proceed with a hearing in respect of this application.” Accordingly I now need to deal with the application on the basis of the written record.
In my view, this application should be refused. Having regard to the issues that arise, it is appropriate that I give brief reasons for refusing the application.
The specification contains 12 claims, all dependent through to claim 1. Claim 1 is in the following terms:
A method for producing chimeric embryos derived by nuclear transfer using human cells as nucleus donors and enucleated bovine oocytes as recipients, which comprises the steps of:
(i)Preparing non-totipotent, non-immortalised donor somatic human cell lines;
(ii)Maturing oocytes collected from cow ovary in vitro;
(iii)Removing cumulus cells surrounding the oocytes, cutting a portion of zona pellucida of the matured oocytes to make a slit, and squeezing out a portion of cytoplasm including the first polar body through the slit to give enucleated recipient oocytes;
(iv)Transferring a nucleus into the recipient oocyte by injection of the whole donor cells into the enucleated recipient oocytes through the slit, followed by subsequent electrofusion and activation of the electrofused cells to give chimeric embryos; and
(v)Postactivating, culturing and differentiating the chimeric embryos in vitro.
In simple terms, the method creates an embryo where the nuclear DNA is human, and the mitochondrial DNA is bovine.
S.18(2) considerations
I recently considered the interpretation of s.18(2) in Fertilitescentrum AB and Luminis Pty Ltd [2004] APO 19. The present situation involves two significant differences from the factual situation in that case. Firstly, there is no step of fertilisation per se. Secondly, the embryo is a hybrid involving both human and bovine DNA.
In natural reproductive processes, the activation of an ovum arises as a direct result of the fertilisation process. However it is clear that fertilisation by a sperm is not the only way in which an ovum can be activated. In my view, an ovum that has been artificially activated is in principle no different to an ovum that has been fertilised by natural means (noting of course that the DNA content of the ovum will be different.) Accordingly the fact that the claimed method uses postactivation of the ovum does not remove the process from the ambit of s.18(2).
The embryo produced by the claimed process has both human and bovine DNA present. It is clear that the nuclear DNA is intended to be entirely human DNA. The mitochondrial DNA, which essentially is relevant to the energy use of the cell, is entirely bovine. The primary physical characteristics of mammals are governed by the nuclear DNA of the cells. In my view, the presence of the bovine mitochondrial DNA does not take away the essentially human characteristic of the embryo that is determined by the nuclear DNA. That is, the embryo that is produced by this method - while being hybrid – is properly described as human.
Accordingly I am satisfied that the claimed method falls within the exclusion of s.18(2) – by reason of it being a method for the generation of a human being.
S.50(1)(a) considerations
S.50(1)(a) of the Patents Act 1990 provides
The Commissioner may refuse to accept a request and specification relating to a standard patent, or to grant a standard patent;
(a) for an invention the use of which would be contrary to law:
I note that this provision is rarely invoked, and there is little precedent for its operation. The entire guidance provided by the Patent Office Manual of Practice and Procedure is as follows:
8.6.1 Under sec 50(1)(a) the Commissioner may refuse to accept a patent request and specification, or to grant a patent, for an invention the use of which would be contrary to law. It should be noted that this is a discretionary power, and should only be applied in the clearest of circumstances
Section 50(1)(a) is to be understood as covering broadly statute law, including regulations and ordinances, and case law.
8.6.2 Some guidance as to the meaning of "contrary to law" can be obtained from Official Rulings 1923 C, (1923) 40 RPC Appendix iv, where it was said that:
"An invention 'contrary to law' may be either (1), one the primary use of which would be a criminal act, punishable as a crime or misdemeanour, or, (2), one the use of which would be an offence by reason of its being prohibited under by-laws or regulations made for police and administrative purposes.
Inventions belonging to the former class would always be refused protection. As regards the latter class, the nature and possible uses of the invention and the exact terms of the prohibition would have to be considered in each case."
8.6.3 Where the invention could be used both for lawful and for unlawful purposes, there is authority in Pessers and Moody v. Haydon & Co., (1909) 26 RPC 58, for saying that a patent in respect of it would not necessarily be bad.
In any particular case, regard must clearly be had to the main purpose of the invention, that is to the consideration whether the invention is primarily devised or intended for a lawful, or for an unlawful, use. For example, an invention which in the United Kingdom has been refused on this basis is an explosive safe designed to kill or injure a burglar
8.6.4 Objections under sec 50(1)(a) should be taken only against claims where an unlawful use and no lawful use has been described.
Where a claim is objectionable under sec 50(1)(a), an objection to this effect is to be included in the report under sec 45(1)(c) or sec 48(1)(b). If the objection is disputed by the applicant and the examiner considers it should be maintained, the file should be referred to the supervising examiner before the next report is made
The relevant legislation that is said to render the claims contrary to law is the Prohibition of Human Cloning Act 2002. Section 20 of that Act provides:
20 Offence—creating a chimeric or hybrid embryo
(1) A person commits an offence if the person intentionally creates a chimeric embryo.
Maximum penalty: Imprisonment for 10 years.
(2) A person commits an offence if the person intentionally creates a hybrid embryo.
Maximum penalty: Imprisonment for 10 years.
The Act includes the following definition of a hybrid embryo:
(d)an animal egg into which the nucleus of a human cell has been introduced; or
Prima face, the product of the present method is a hybrid embryo within the meaning of this Act. Furthermore, a person performing the claimed method in Australia is prima facie liable to the penalty provided by that Act – of imprisonment for up to 10 years. Clearly this fits within the first category of laws contemplated by the aforementioned Official Rulings 1923 C.
I note that while this legislation came into existence after the date of filing the parent application – it was in force when the present divisional application was filed. Accordingly the doctrine of accrued rights (assuming any such arguments might have been available in respect of the parent application) is not available to argue that the legislation does not apply to this application.
The Manual suggests that a relevant consideration is whether there are any uses of the invention that would not be contrary to law. While it might be thought that the method might have application in mammals other than humans, both the description and claims are specific in the application of the invention to humans only.
Finally, the provision is a discretionary provision. It is noteworthy that the grounds for refusal to accept such an application are not available as a ground of opposition or of revocation. In my view, this suggests that refusal should only occur in the clearest of circumstances. Furthermore, it seems to me that a relevant consideration is whether the relevant law is of an ephemeral nature – that is, whether it is reasonable to expect that what is illegal today will be illegal throughout the term of the patent. The invention claimed in the present case is very clearly contrary to the Prohibition of Human Cloning Act 2002. Furthermore, in my view the prohibitions in s.20 of that Act are of a nature such that the prohibition is unlikely to be ephemeral. Accordingly I am satisfied that this application should be refused under s.50(1)(a) of the Patents Act 1990 by reason of it being contrary to law.
Conclusion
I am satisfied that
· the invention claimed falls within the ambit of subject matter that is not patentable by reason of s.18(2) of the Patents Act 1990;
· the application is additionally one where acceptance should be refused by reason of it being contrary to law [s.50(1)(a)]; and
· these two difficulties are not capable rectification by way of amendment.
I refuse the application.
D Herald
Deputy Commissioner of Patents
9 September 2004
Patent attorneys for the applicant : Griffith Hack, Melbourne