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…

Grounds of appeal

[14] The appellant contends that the primary judge erred in finding that the respondent had discharged the onus of establishing the matters required under the relevant provision.

[15] It was submitted that his Honour failed to give adequate weight to the evidence of the second witness, and that the findings of fact were not reasonably open on the material before the Court.

[16] The respondent, for its part, submits that no error is disclosed, and that the conclusions reached were well within the range of outcomes available to the primary judge.

Consideration

[17] It is convenient to deal first with the question of construction, as the resolution of that issue informs the remaining grounds advanced by the appellant.

[18] For the reasons that follow, we are of the view that the appeal should be allowed in part and the matter remitted for further determination.

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Details

Case: [2004] APO 24
Decision Date: 9 September 2004

CaseChat Overview and Summary

Woo-Suk Hwang's patent application for a method of producing chimeric embryos by transferring the nucleus of a human cell into a bovine ovum was objected to by the examiner and ultimately refused by the Deputy Commissioner of Patents. The application, which claimed a method of generating a hybrid embryo using inter-species nuclear transplantation techniques, was contested on two main grounds: it was deemed contrary to section 18(2) of the Patents Act 1990, which excludes methods of generating a human being from patentability, and it contravened section 50(1)(a) of the same Act, which allows for the refusal of patent applications that would be contrary to law. The court found that the artificial activation of the ovum did not remove the process from the exclusion of section 18(2), and that the hybrid embryo produced, despite having bovine mitochondrial DNA, was still essentially human due to its nuclear DNA.

The Deputy Commissioner further determined that the invention was contrary to law as it involved creating a hybrid embryo, which is an offence under the Prohibition of Human Cloning Act 2002. The court noted that while the use of section 50(1)(a) is discretionary and rarely invoked, the prohibitions in the Cloning Act were unlikely to be ephemeral, making the application clearly contrary to law. The Deputy Commissioner concluded that the application should be refused as it was not only unpatentable under section 18(2) but also contrary to law under section 50(1)(a) of the Patents Act 1990, and these issues were not rectifiable through amendment. The application was thus refused on 9 September 2004.

Orders