Infant Formula HMO Composition for Allergic Sensitisation Prevention

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Solution Overview

Problem

There is a need for nutritional compositions, such as infant formulas, that can effectively prevent or reduce the development of allergic sensitization in infants, as existing formulations lack specific human milk oligosaccharides (HMOs) that have been shown to modulate allergic responses, and there is uncertainty over the optimal levels of these HMOs for efficacy.

Innovation Solution

Infant formulas containing intermediate levels of 2'-fucosyllactose (2'FL) and lacto-N-neotetraose (LNnT) are formulated to prevent allergic sensitization, with specific concentration ranges identified through analysis of breast milk and animal model studies.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If infant formulas contain high levels of HMOs (2'FL and LNnT), then the prevention of allergic sensitisation is improved, but the risk of adverse effects increases

Engineering Contradiction:
Improveprevention of allergic sensitisationVSAvoidadverse effects
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies parameter changes by optimizing the concentration levels of HMOs (2'FL and LNnT) to specific intermediate ranges (2'FL: 0.8-2.5 g/L, LNnT: 0.05-0.2 g/L) rather than using high or low doses. This parameter optimization resolves the contradiction by identifying that intermediate concentrations provide maximum protective effect while minimizing adverse effects, as demonstrated in animal model studies where intermediate dosing showed superior efficacy compared to low or high doses.

Inventive Principle:
Principle #35Parameter changes

2Object-affected harmful factors

If infant formulas contain low levels of HMOs (2'FL and LNnT), then adverse effects are reduced, but the prevention of allergic sensitisation is compromised

Engineering Contradiction:
Improveadverse effectsVSAvoidprevention of allergic sensitisation
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The patent resolves this contradiction by changing the parameter of HMO concentration from low levels to intermediate levels. The specified ranges (2'FL: 0.8-2.5 g/L, LNnT: 0.05-0.2 g/L) represent an optimized parameter window that simultaneously achieves adequate prevention of allergic sensitisation while maintaining safety by avoiding adverse effects associated with either insufficient or excessive dosing.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If infant formulas use synthetic HMOs, then the nutritional requirements are satisfied and allergic prevention is achieved, but the manufacturing complexity increases

Engineering Contradiction:
Improveallergic prevention efficacyVSAvoidmanufacturing complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent applies the copying principle by using synthetic HMOs (2'FL and LNnT) that replicate the structure and function of naturally occurring human milk oligosaccharides. This allows the formulation to copy the beneficial effects of breast milk HMOs without requiring actual human milk, thereby achieving allergic prevention efficacy while enabling standardized manufacturing processes.

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The patent optimizes manufacturing by specifying precise concentration parameters for synthetic HMOs (2'FL: 0.8-2.5 g/L, LNnT: 0.05-0.2 g/L). This parameter standardization simplifies manufacturing complexity by providing clear target concentrations for production, ensuring consistent efficacy while facilitating quality control and regulatory compliance.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentEP4084628B1Infant formula
Publication Date: 2025.10.15 SOCIETE DES PRODUITS NESTLE SA
  • EP4084628B1 patent drawingFigure 1
  • EP4084628B1 patent drawingFigure 2
  • EP4084628B1 patent drawingFigure 3

AI summary

An infant formula for use in preventing or reducing the occurrence of allergic sensitisation in an infant, wherein the infant formula comprises 0.8-2.5 g/L 2'-fucosyllactose (2'FL) and/or 0.05-0.2 g/L lacto-N-neotetraose (LNnT).