Medical Device Patent Attorneys

Torrey Pines Law Group's medical device patent attorneys have an excellent track record of representing medical device innovators. The firm's founder, Kevin Buckley, helped obtain FDA clearance for the first Artificial Intelligence device for the detection of cancer. The firm also has personnel having experience in medical device companies, specifically in product development and research & development. We know the design control/product development cycle for medical devices intimately (design input, design output, verification, validation, design transfer), often working with inventors early-on in the process when drafting provisional and utility patent applications.

As described by the FDA, medical devices are "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which ... do not achieve their purpose through chemical action" and are not metabolized by the body. Medical devices can similarly be divided into implantable devices, diagnostic equipment, and medical device software.

Whether the device is Class I, II, or III, Torrey Pines Law Group can assist in getting the invention patented. Oftentimes, potential licensors and investors in such technology want to know that the inventors “own” the technology via a patent (or at minimum a patent application). If you are seeking protection for CE mark, 510(k) (FDA cleared), PMA (FDA approved), or HCT/P products, our team is skilled in patenting these types of products.

The firm is especially adept at analyzing medical device improvements and work-arounds to establish novelty and non-obviousness in inventions. Many biotech, pharmaceutical, and software inventions can have medical device aspects, and Torrey Pines Law Group has experience with fleshing out those improvements and work-arounds, providing convincing arguments to patent examiners, ultimately strengthening patent applications.

Software as a Medical Device (SAMD)

Obtaining software patents has been difficult since the State Street Bank opinion of 1998 (149 F.3d 1368 (Fed. Cir. 1998)), and subsequently through Bilski v. Kappos, 561 U.S. 593 (2010), and Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014). Great care must be taken in drafting the claims to overcome 35 USC §101 rejections. The firm is adept at advising clients whether patent protection is a viable strategy or whether keeping trade secrets is the more practical approach.

Medical Implants

The firm has in-house experience with designing and developing implantable medical devices, from ideation to postmarket surveillance. Whether the implants are for orthopedic, cardiovascular, or neuronal purposes, Torrey Pines Law Group has the expertise to draft and prosecute patent applications of maximum effect.

Medical Diagnostics

Used to test samples of cells, tissues or bodily fluids, in vitro diagnostic equipment is a primary tool used in healthcare. The firm understands the complexity of such devices, which often have a software component. Devices used for analyte identification, gene sequencing, and ultrasound detection are all within the purview of the firm. Torrey Pines Law Group has the knowhow in house to quickly understand an inventor’s technology to write effective claims, protecting as much intellectual property as possible.

The IP attorneys, patent lawyers, engineers, scientists, and patent agents at Torrey Pines Law Group have also worked in a variety of medical device industries and have assisted with commercializing, researching, and developing technologies including: