Medical Devices

Patent strategy that accounts for the regulatory path.

A medical device portfolio is built alongside a regulatory submission, not after it. Design changes driven by a 510(k) or a PMA ripple straight into claim scope, and a portfolio that ignores that sequence protects a device that never ships.

Published patents in this area: 202
Professionals: 19

We prosecute and litigate across surgical instruments and robotics, implantable devices, catheters and delivery systems, diagnostic and therapeutic imaging, patient monitoring, drug delivery devices, and software as a medical device.

Digital health has pulled this area toward our software and machine learning practices — diagnostic algorithms, connected monitoring, and clinical decision support raise eligibility and data questions alongside the mechanical and materials questions the field has always had.

Filing alongside the regulatory path

Device design changes during regulatory review, and the changes are rarely cosmetic — a modified geometry, a different material, a narrowed indication. A claim set frozen at the pre-submission design can end up protecting a device that never reached market.

Keeping continuations pending through the regulatory process is the standard answer, and it works only if the original specification was written broadly enough to support the claims the final device will need.

Software as a medical device

Diagnostic algorithms and clinical decision support sit in the intersection of three difficult areas at once: Section 101 eligibility, enablement of a trained model, and a regulatory posture where the claimed indication and the patent claim have to be consistent with each other.

It is also where this practice most often works jointly with the software and machine learning groups, because treating it as a purely mechanical filing misses most of what is patentable.

Evidence

Patents we drafted in this area

Patents the firm prosecuted, drawn from its own published listing and from the USPTO's attorney-of-record index. A record, not a claim.

All patent listings

12,718,832Content output device, content output method, and computer program
12,700,493Automated imaging protocol management for hybrid modalities
12,672,844Ultrasound coexistence in a multi transducer fetal monitoring system
12,648,729Measurement apparatus, measurement method, and non-transitory storage medium
12,648,691Distance calculation device, distance calculation method, and distance calculation program
12,642,622Endodontic driving and operating device
12,622,761Fluid-driven robotic needle positioner for image-guided percutaneous interventions
12,605,481Adhesion preventing material for ophthalmic applications, and method for producing same