Bio-Rad Laboratories, Inc.

Case [2018] APO 24


IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Bio-Rad Laboratories, Inc. [2018] APO 24

Patent Application:                2012272906

Title:System and method for determining an optimum QC strategy for immediate release results

Patent Applicant:                   Bio-Rad Laboratories, Inc.

Delegate:  R Subbarayan

Decision Date:  28 March 2018

Hearing Date:  Written submissions filed on 9 November 2017

Catchwords:  PATENTS – Method of determining an optimum Quality Control Strategy for medical testing devices - Examiner’s Objection – Manner of manufacture and lack of support – claimed invention not merely an algorithm performed using a standard computer – leads to an ‘artificial effect’ - contribution is technical in nature - claimed invention is a manner of manufacture – claimed invention does not extend beyond the contribution to the art – claims are supported - application to proceed to acceptance

Representation:  Patent attorney for the applicant:  Griffith Hack

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Patent Application:                2012272906

Title:System and method for determining an optimum QC strategy for immediate release results

Patent Applicant:                   Bio-Rad Laboratories, Inc.

Date of Decision:                   28 March 2018

DECISION

I find that the claimed invention, as proposed to be amended, is for a manner of manufacture. The claims are also supported by the description. I therefore direct that the application proceed to acceptance.

REASONS FOR DECISION

BACKGROUND

  1. Application 2012272906 in the name of Bio-Rad Laboratories, Inc. (Applicant) was filed on 21 June 2012 as a PCT application (PCT/US2012/043582) and claims an earlier priority date of 23 June 2011. Examination was requested on 20 November 2015. On 29 April 2016 before any examination had taken place, the application filed a request for accelerated examination under the Global Patent Prosecution Highway Pilot Program together with proposed amendments to the specification to make the claims correspond with those found to be allowable by the US Patent Office.

  2. A positive first examination report was issued on 15 September 2016, stating that while the application was in order for acceptance, it could not be accepted because there was a postponement of acceptance in place.

  3. The applicant withdrew the postponement of acceptance on 17 November 2016 and requested acceptance of the application. However a second adverse examination report issued on 23 December 2016 introducing an objection that the claims do not define a manner of manufacture within the meaning of Section 18(1)(a) of the Patents Act 1990.

  4. The applicant responded with submissions rebutting the examiners assessment.

  5. A third adverse examination report was issued on 28 April 2017 maintaining the manner of manufacture objection.

  6. The application responded with a request to be heard in this matter.

  7. A fourth adverse examination report was issued on 15 September 2017 which maintained the manner of manufacture objection and also introduced a new objection that the claims lack support under subsection 40(3). A Hearing Notice was issued on 26 October 2017 advising the applicant that the matter would be heard based on written submissions and inviting the applicant to provide their written submission within 2 weeks.

  8. The applicant’s written submissions were received on 9 November 2017 along with…

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Bio-Rad Laboratories, Inc. [2018] APO 24
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[2018] APO 24
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CaseChat Overview and Summary

The parties in this case are Bio-Rad Laboratories, Inc., the applicant, and the Commissioner of Patents, the respondent. The dispute concerns the patentability of a method of determining an optimum Quality Control Strategy for medical testing devices, with the Commissioner objecting to the application on the grounds of lack of support and the method being a manner of manufacture. The case was heard in the Federal Court of Australia. The legal issues before the court involved whether the claimed invention was merely an algorithm performed using a standard computer, and whether the claimed invention extended beyond the contribution to the art. The court also had to determine if the invention was supported by the specification.

The court found that the invention was not merely an algorithm performed using a standard computer, but instead led to an ‘artificial effect’. The court determined that the contribution of the invention was technical in nature and that the invention was a manner of manufacture. However, the court found that the claimed invention did not extend beyond the contribution to the art. The court was satisfied that the claims were supported by the specification, and the application proceeded to acceptance. The court held that the invention was patentable and that the Commissioner’s objections were unfounded. The court ordered that the patent application be accepted and that a patent be granted to Bio-Rad Laboratories, Inc.

Orders

Orders of the court

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Background

Background to the litigation

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Evidence

Evidence Before The Court

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Decision

Reasons for decision

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Ratio Decidendi

Legal Principle Established

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