International Stem Cell Corporation - [2016] APO 52

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

International Stem Cell Corporation [2016] APO 52

Patent Application: (1) 2012216371
(2) 2013205483

Title:(1) Synthetic cornea from retinal stem cells
(2) Parthenogenic activation of human oocytes for the production of human embryonic stem cells

Patent Applicant: International Stem Cell Corporation

Delegate: S. Calanni

Decision Date: 16 August 2016

Hearing Date: Written submissions filed on 11 March 2016

Catchwords: PATENTS - examiner objection – s18(2) – methods that incorporate a step where a potential human being is produced – parthenogenic activation of human oocytes – invention does not represent a biological process for producing a human being

Representation: Freehills Patent Attorneys

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Patent Application: (1) 2012216371
(2) 2013205483

Title:(1) Synthetic cornea from retinal stem cells
(2) Parthenogenic activation of human oocytes for the production of human embryonic stem cells

Patent Applicant: International Stem Cell Corporation

Date of Decision: 16 August 2016

DECISION

The s18(2) objection in relation to 2013205483 has been overcome. Pursuant to regulation 13.4(1)(g), the application will not lapse for failure to gain acceptance until 3 months from the date of this decision.

The same reasoning extends to the s18(2) objection in relation to 2012216371, however that application has lapsed. In this instance the final date for acceptance cannot be altered because the request for examination for this application was filed before 15 April 2013.

REASONS FOR DECISION

Patent applications 2012216371 (the ‘371 application) and 2013205483 (the ‘483 application) were filed by International Stem Cell Corporation (the Applicant). The applications are divisional applications of 2006346492 and 2006304788, respectively, both of which lapsed through failure to gain acceptance within the prescribed period.
The Applicant requested examination of the ‘371 application on 27 February 2013, so the substantive amendments of the Patents Act 1990 (the Act) brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 do not apply to this application. In contrast, examination was request on 13 June 2014 for the ‘483 application, thus the above-mentioned amendments to the Act do apply to the ‘483 application.
The applications received first examination reports on 24 April 2014 and 2 June 2015 respectively. The sole outstanding objection in relation to the ‘371 application is that claims 1-30 define subject matter not patentable under s18(2). For the ‘483 application the outstanding objections are that claims 1 to 35 define subject matter not patentable under s18(2) and that claim 35 does not comply with subsection 40(3A). The present decision relates to the s18(2) matters only.
The matter was set for hearing on 31 March 2016. The applicant filed written submissions on 11 March 2016, however the hearing was vacated on 24 March 2016. Following further discussion and consideration of the written submissions, it was decided to proceed with the hearing based on the written submissions alone.

Although the ‘371 application was filed earlier, the technology referred to in that application is an extension of the technology described in the ‘483 application. For that reason, in the following consideration, I will…

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: [2016] APO 52
Decision Date: 16 August 2016

CaseChat Overview and Summary

The Australian Patent Office considered two patent applications filed by International Stem Cell Corporation, relating to the production of human embryonic stem cells and synthetic corneas from retinal stem cells. The applications, numbered 2012216371 and 2013205483, faced objections under section 18(2) of the Patents Act 1990, which prohibits the patenting of human beings and biological processes for their generation. The key issue was whether the methods described in the applications, which involve parthenogenic activation of human oocytes to produce blastocysts, constituted a biological process for generating a human being.

The delegate, S. Calanni, examined the applications in light of previous case law, specifically Fertilitescentrum AB and Woo-Suk Hwang, which established that a fertilized ovum and any subsequent developmental stages up to birth are considered human beings under section 18(2). The delegate found that while the parthenogenic blastocysts produced in the applications contain human nuclear DNA and share morphological similarities with blastocysts formed by natural fertilization, they lack paternal imprinting and cannot develop into a human being. Therefore, the processes described in the applications do not fall within the exclusion of section 18(2).

As a result, the objection under section 18(2) to the 2013205483 application was overcome, and the application will not lapse for failure to gain acceptance until three months from the date of the decision. However, the 2012216371 application had already lapsed prior to the filing of the written submissions, and its final date for acceptance could not be altered because the request for examination was filed before 15 April 2013.

Orders