When does a technical method become a (non-patentable) surgical procedure? The recent decision T 0941/24 in the Brainlab case provides vital clarity for the Medtech industry!

The Case: The Examining Division had refused an application for a medical tracking system. Their argument: The claim “encompassed” embodiments where sensors are attached to bone—a surgical intervention—making it excluded under Art. 53(c) EPC.

The Board of Appeal’s Ruling: The Board set aside the refusal, offering a more nuanced interpretation:

1. Redefining “Encompass”: The Board clarified that a claim does not fall under the surgical exclusion simply because one could conceive of a surgical implementation. Following G 1/07, “encompassing” a surgical step only applies if that step is an essential or implicit part of the claimed method.
2. No Implicit Surgery: If the claimed steps (e.g., determining data) are technically meaningful without an invasive procedure—such as using sensors on medical hardware instead of bone—the surgical step is not an implicit feature.
3. Passive vs. Active: The method was a “passive, one-time determination” of data. It did not require a functional link to a surgical effect to achieve its technical purpose.

The Bottom Line: This is a significant win for legal certainty in navigation and tracking systems! It confirms that the mere possibility of surgical use does not lead to exclusion, provided the claims are drafted precisely.

Strategic Analysis & Practical Guidance for Claim Drafting

Decision T 0941/24 highlights the critical importance of distinguishing between data processing and medical interaction. Below are the key practical takeaways for drafting and defending Medtech claims:

1. Eliminate Explicit and Implicit Surgical Steps

• Avoid Physical Attachment: Do not include steps like “attaching to bone” or “implanting into the body” in independent claims. In this case, the Board found Claim 7 acceptable because it did not explicitly recite any attachment to a target.
• Clean Up Dependent Claims: Be wary of dependent claims that define surgical embodiments. In T 0941/24, the applicant had to delete a dependent claim that specifically mentioned “attachment to a target” to overcome the exclusion.

2. Focus on Data and Navigation

• The “Passive” Approach: Frame the invention as a method of “acquiring and analyzing data” or “determining positions”. The Board noted that if the method works regardless of whether the sensors are attached to a patient or a piece of movable equipment (like a scanner), it is not inherently surgical.
• Functional Independence: Ensure the technical problem is solved by the data processing itself, not by the physical act of surgery.

3. Leverage the Interpretation of “Encompass” (G 1/07)

• The “Generic Feature” Argument: Use this decision to argue that a generic feature (e.g., “positioning a sensor”) only “encompasses” a surgical step if that step is a necessary implementation of the claim.
• If a person skilled in the art can implement the method in a non-surgical way (e.g., on a model or on external hardware), then the claim should not be excluded.

4. Optimize the Description and Disclosure

• Explicit Disclaimers: The Board looked favorably on the fact that the description stated the invention “solely relates to the step of navigating, tracking and verifying by acquiring and analyzing data”.
• Non-Surgical Examples: Always include embodiments in the description that do not involve a patient—such as tracking tools in a room or calibrating hardware—to prove the method’s non-surgical utility.
• Essential Features (Art. 84 EPC): To avoid “missing feature” objections, ensure the description supports the idea that attachment to the body is not an essential requirement for the tracking system to function.

Summary: As long as the claimed method remains a passive determination of data and lacks a functional link to a physical intervention on the patient, it can successfully bypass the Article 53(c) EPC exclusion.