Patent decision
- BL number
- O/0472/26
- Hearing Officer
- Dr R Dinham
- Decision date
- 2 June 2026
- Person(s) or Company(s) involved
- INITIO HEALTH INC.
- Provisions discussed
- Patents Act 1977 sections 1(1)(b), 14(3), 14(5)(b) and 14(5)(c)
- Keywords
- Clarity, Inventive step, Sufficiency, Support
- Related Decisions
- None
Summary
The application relates to methods and a handheld system for determining fertility level in a female subject by measuring and analysing four hormone analytes (E3G, LH, PdG and FSH) from a biological sample over time and comparing these with predefined values.
The examiner objected under sections 14(5)(b), 14(5)(c), 14(3) and 1(1)(b), arguing that “fertility level” was unclear and inconsistently applied, that it was ambiguous whether all four analytes were required, that the specification did not enable the skilled person to use the four-analyte combination to determine fertility-related conditions without undue burden, and that the claimed subject-matter lacked an inventive step over prior multi-hormone methods. The applicant, on the other hand submitted that “fertility level” referred to the fertile window and related reproductive conditions, and that the skilled person would understand, using common general knowledge and time-series analysis of hormone levels, how to interpret changes in the four analytes to determine fertility outcomes.
The hearing officer held that the claims were unclear and unsupported due to inconsistencies in the meaning of the term “fertility level”, and whether all four analytes were required, with dependent claims extending to conditions (such as miscarriage risk, pregnancy and PMS) that did not fall within the proper scope of the term. The invention was also found to be classically insufficient, following Zipher Ltd v Marken Systems Ltd, because the specification did not disclose how the combined measurement of all four analytes across time could be used to determine and distinguish between the claimed conditions without undue burden, nor did it provide sufficient thresholds or guidance. While not fully analysed, the claimed subject-matter was considered prima facie obvious, the addition of FSH appearing to be an arbitrary extension of known techniques.
The application was therefore refused under s18(3).
Full decision O/0472/26 
457Kb
