On March 4, 2025, the Korean Intellectual Property Office ("KIPO") published its Examination Guidelines for Digital Healthcare Inventions ("Guidelines"), reflecting the growth of the global market for digital healthcare and the resulting increase in the number of domestic applications being filed in this area. Digital healthcare inventions encompass various technologies, including electrical and electronic technologies (sensors, devices for virtual reality, wearable devices), chemical and biotechnologies (genes, microbes, compounds for pharmaceuticals), medical technologies (treatment and diagnosis), and computer software technologies (big data, AI). This complexity has not only presented challenges for KIPO examiners handling patent examinations of such applications, but also for applicants in preparing their patent specifications. To enhance the predictability of examinations and to facilitate preparing such patent specifications, KIPO's Guidelines include discussion of the following key points: 

Ⅰ. Enablement Requirement (Article 42(3)(i))

1. Overview

• The specification and drawings must describe specific means and methods for practicing the claimed invention to allow a person of ordinary skill in the art ("POSITA") to easily practice the claimed invention in the field of digital healthcare.
• The specific means and methods required in the field of digital healthcare include "the type of healthcare-related data and the associated data acquisition technology," "digital technology for processing and analyzing data," and "digital device technology for providing healthcare services."
• Even if the specific means or methods are not expressly described in the specification, they may still be deemed sufficiently disclosed if a POSITA would have been able to discern them based on common technical knowledge at the time of filing the claimed invention.

2. Specific Examples

a. It is necessary to describe hardware or software that accomplishes the technical steps or functions of the claimed invention.

b. If a trained AI model is used as the main component, the correlation between the input data and the output data of the trained AI model should be specifically described. This may include the following:

1) A training data for training the AI model is specified,
2) There is a correlation between the characteristics of the training data to solve the technical problem of the claimed invention,
3) A training method of the AI model is specifically described, and
4) When the trained AI model for solving the technical problem of the claimed invention is generated by the training data and the training method, the correlation between the input and the output is specifically described.

c. When using a generative AI model based on a LLM, it is necessary to specifically describe training data and a method of obtaining the training data for performing training to fine-tune the general-purpose generative AI language model to achieve the objective of the claimed invention.

d. Where the output of the trained generative AI model obtained from a question input (prompt, command) of the trained generative AI model is the main component of the claimed digital healthcare invention, specific embodiments of appropriate questions to be input to achieve the objective of the claimed invention must be described.

e. If a medical technology is part of the claimed invention, it is necessary to describe the underlying medical technology to the extent that a POSITA would have been able to rely on the effect of the claimed invention. The underlying medical technology may be described as prior art, working examples, etc. in the specification.

Ⅱ. Clarity Requirement (Article 42(4)(ⅱ))

• The subject matter performing each step of the method of the claimed invention must be clearly described in the claims.
• The subject matter or category of the invention must be clearly described in the claims. If the preamble of a claim is described as "a program product," "a program output," "a program signal," "a program signal string," etc., then the category of the invention will be deemed unclear. 

Ⅲ. Novelty and Inventiveness Requirements (Articles 29 (1) and (2))

1. Overview

• Examiners examine inventions based on general novelty and inventiveness requirements. However, for digital healthcare inventions, the examination involves identifying a cited reference that has the same or similar technical objective as the claimed invention, focusing on the "health-related service field."
• When examining inventiveness of a claimed invention by combining two or more cited references, additional cited references, which are combined to overcome differences, may not necessarily pertain to the field of digital healthcare.
• In particular, of the main components of digital healthcare inventions, components involving data processing or analysis tools may be a general-purpose digital technology used in other application fields. Thus, examiners may examine the digital technology itself or the literature related to other application fields to which the digital technology is applied, as additional cited references.

2. Specific Examples

a. When the content (software) has a technical effect that achieves the claimed invention's objective as a whole in holistic combination with hardware:

• When assessing novelty and inventiveness, a comparison between the claimed invention and cited references must be made regarding the content.
• The constitutions of the content of the claimed invention are compared with the cited references, based on the theme (subject) or the principle of solving a common problem that was designed according to the objective and effect of the claimed invention.
• When the effect of the digital therapy device by the content described as a component of the claimed invention is described in the specification, inventiveness should be assessed by considering the differences from the content and the effects resulting from the content.

b. Simple design modifications according to specific applications in digital healthcare technology

• Even if the claimed invention is merely a design modification prompted by specific environmental changes in its applications while using the technical idea of cited references, provided it leads to an operational or functional change that produces an effect that exceeds the scope that would have been generally predictable by a POSITA, the claimed invention can be recognized as inventive.

c. Simple design modifications to online implementation of general assessments

• In general, the features of a claimed invention that simply implement commonly utilized procedures in psychological or cognitive assessments online using a well-known and commonly practiced design method are not recognized as technical features that create inventiveness.
• However, if a special technical idea is added as a component of the claimed features, inventiveness may be determined.

d. Simple addition of well-known and commonly practiced means or substitution by equivalents

• The addition of a well-known and commonly practiced technology that demonstrates a superior effect when holistically combined with other technical features can be recognized as inventive.

We trust that these Guidelines will be beneficial to companies and practitioners involved in applications for digital healthcare inventions in Korea.