Medical device patents are a subset of the biotechnology patents that we at Mutchler Patent love to draft, prosecute, and manage. The United States Patent and Trademark Office (“USPTO”) considers medical device patents to be the set of utility patents whose contents are drawn to the following classes of subject matter:
- Class 128 – Surgery, including all subclasses (USPTO Link)
- Class 433 – Dentistry (USPTO Link)
- Class 600 – Surgery (USPTO Link)
- Class 601 – Surgery: Kinesitherapy (USPTO Link)
- Class 602 – Surgery: Splint, Brace, or Bandage (USPTO Link)
- Class 604 – Surgery (USPTO Link)
- Class 606 – Surgery (USPTO Link)
- Class 607 – Surgery: Light, Thermal, and Electrical Application (USPTO Link)
- Class 623 – Prosthesis (i.e., artificial body members), Parts Thereof, or Aids and Accessories Therefor (USPTO Link)
- Class 227 – Elongated-member-driving apparatus (Subclasses 175.1-182.1 only) (USPTO Link)
- Class 323 – Electricity: Power Supply or Regulation Systems (Subclass 911 only) (USPTO Link)
- Class 351 – Optics: Eye Examining, Vision Testing and Correcting (Subclasses 200-247 only) (USPTO Link)
- Class 356 – Optics: Measuring and Testing (Subclasses 39-42 only) (USPTO Link)
- Class 362 – Illumination (Subclass 574 only) (USPTO Link)
- Class 378 – X-ray or Gamma Ray Systems or Devices (Subclasses 37, 38-40 only) (USPTO Link)
- Class 382 – Image Analysis (Subclasses 128-134 only) (USPTO Link)
- Class 422 – Chemical Apparatus and Process Disinfecting, Deodorizing, Preserving, or Sterilizing (Subclasses 44-48 only) (USPTO Link)
- Class 424 – Drug, Bio-affecting and Body Treating Compositions (Subclasses 9.1-9.81, 422-437, 443-449 only) (USPTO Link)
- Class 436 – Chemistry: Analytical and Immunological Testing (Subclasses 64, 65, 68, 69, 71, 811-814 only) (USPTO Link)
- Class 705 – Data Processing: Financial, Business Practice, Management, or Cost/Price Determination (Subclasses 2-3 only) (USPTO Link)
Generally, and in no particular order, the subject matter contained in those medical device patents falling within the above listed classes pertains to the following:
- Devices and methodology for treating and inspecting abnormal conditions such as diseases or injuries in humans and animals;
- Devices and methods for treating teeth or gums;
- Devices and methods for the replacing teeth;
- Prosthetic devices, including specialized elements thereof, accessories thereto, and operating devices therefor;
- Apparatuses for eye examination and testing;
- Health care management computer systems;
- Health care delivery or organization computer applications;
- Analytical and immunological disease testing;
- Chemical devices/methods for investigating body conditions or organ functions;
- Devices and methodology for blood testing;
- Methods and devices for medically-related imaging analysis;
- Active pharmaceutical ingredient delivery systems/compositions;
- Medicaments incorporated into bandages or dressings; and
- Compositions and nominal methods of using compositions for in vivo testing or in vivo diagnosis.
This list is, of course, non-exclusive. Medical device patents can be obtained for a wide variety of technologies that do not fall neatly into any of the above listed categories. The patent office uses its classification system mostly to make it easier for examiners to find potentially relevant pieces of prior art during examination, so classification is not hugely important. The list is provided merely to present some concrete examples for what type of subject matter a medical device patent may entail.
Considerations for Inventors Filing Applications for Medical Device Patents
Obtaining any patent is not easy. This is particularly true in the competitive field of medical technology, where money flows freely and in abundance. Individual inventors and early stage start-ups are at a marked disadvantage against established competitors with hundred-billion-dollar market caps and late-stage venture-backed unicorns with ten-figure valuations. Consequently, we suggest that our clients who desire to obtain medical device patents entertain several considerations before to launching blindly into the process.
Consideration 1: Do You Have Adequate Funding?
Obtaining even a single patent is expensive, and in the field of medical technology it is unlikely that a single patent will suffice long-term. Typically, the strategy is to begin with a comprehensive provisional application to procure an early priority date, and to then convert that provisional application into either multiple non-provisional applications or a single non-provisional from which multiple continuing applications (i.e., some combination of continuations, continuation-in-parts, and divisionals).
While it is certainly possible to strategically defer these costs (we at Mutchler Patent center our practice around doing exactly this for individuals and small businesses), inventors should still expect to spend at minimum (i) between $3,000 and $5,000 up front; (ii) between $5,000 and $25,000 at around the one-year mark; and (iii) an additional $5,000 to $50,000 (or more) in years two through five.
The specifics of this vary wildly on a case-by-case basis, but suffice it to say that obtaining a medical device patent is not cheap. Because larger competitors will have no trouble paying these fees, and further because cutting corners can be extremely damaging (see our article on Patent Drafting), it is important for inventors to first consider whether they have the requisite funding before plunging into the patent procurement process.
Consideration 2: What Does The End Game Look Like?
In his bestselling book on start-ups titled Zero to One, billionaire entrepreneur and legendary investor Peter Thiel (with whom we have no affiliation, apart from admiration) suggests that budding entrepreneurs approach business like chess and begin by studying the end game. In the field of medical devices, this is particularly important.
Is your aim to grow from $0 to $100,000,000 of revenue in five to seven years and go public? Are you seeking to position yourself for acquisition by a larger competitor? Do you just want a patent to add to your resume?
Whatever your end goal, it is important to tailor both your business and patent strategy to the end game from the get-go. A public company built around a single medical device has a lot more resting on the patent (preferably patents – plural!) underlying it than does an undergraduate biomedical engineering student looking to pad his resume for medical school. As such, it should come as no surprise that these two situations call for very different patent strategies.
It is important to consider your ideal end game from the very beginning before jumping into the process of obtaining a medical device patent so that your patent will sufficiently protect your invention.
Consideration 3: Is Your Medical Device Actually Patentable?
Particularly in view of the costs associated with patent procurement, it is important to consider whether a medical device is actually patentable before committing. Typically, the best way to go about this is via a prior art search performed by a dedicated search agent and done in conjunction with a patent lawyer.
The results of such a prior art search will usually come in the form of a list of prior art references with relevant portions excerpted. It is generally a good idea to go through this with a patent lawyer, who can provide additional insight regarding these search results.
Most commonly, medical device patents are rejected as unpatentable under one of 35 U.S.C. § 101, 35 U.S.C. § 102, and 35 U.S.C. § 103.
Rejections Under 35 U.S.C. § 101 in Medical Device Patents
35 U.S.C. § 101 requires that all patents claim patent eligible subject matter. In the specific context of medical device patents, rejections under 35 U.S.C. § 101 tend to manifest where the claimed invention is directed towards either an abstract idea or a natural phenomenon.
A recent slew of case law has emphasized two potential classes of medical devices as high risk for patent ineligibility: computer programs (which without “more” may be considered abstract ideas), and naturally occurring phenomenon (e.g., “CRISPR,” see Mayo v. Prometheus, 566 U.S. 66 (2012)). For inventions of either of these two varieties, patent eligibility could come down to claim construction.
Rejections Under 35 U.S.C. § 102 in Medical Device Patents
35 U.S.C. § 102 requires that the inventions claimed in medical device patents be novel. In other words, a claimed invention is unpatentable under § 102 if someone else has invented it already. Evidence the USPTO will look to for confirmation that an invention has already been invented by someone else includes printed publications, other patents (granted or not), public use, and public sale.
If the patent office finds evidence that someone else has already invented the sought-to-be-patented medical device, the only way to refute patent ineligibility is to provide convincing evidence that at least one claimed element was not disclosed in the cited prior art.
Rejections Under 35 U.S.C. § 103 in Medical Device Patents
35 U.S.C. § 103 requires that medical devices not be obvious variants of things others have already invented in order to be patentable. Evidence of obviousness under § 103 comes in the same flavors as under § 102, and an examiner will typically combine multiple such pieces of evidence to support an obviousness rejection under § 103.
If a § 102 novelty rejection is overcome by pointing out a claimed element that was not disclosed in the cited prior art reference, it is fair game for the examiner to combine the originally cited reference with a second reference which discloses the omitted feature § 103 obviousness rejection.
It is important to thoroughly consider the merits of a potential medical device patent relative to existing technology, because the same issues will come up if the patent is challenged after issuance. It is often better to get ahead of potential issues early, as doing so could facilitate more favorable outcomes down the line.
Closing Remarks on Medical Device Patents
Although the costs associated with securing a medical device patent can be quite high, as part of a comprehensive business strategy these costs can prove to be a valuable investment. In the United States, patent protections exclude others from using the claimed invention for 20 years, and provide for recovery should a competitor disregard these exclusions.