Medical devices are expensive to develop. Obtaining maximum patent protection to safeguard the inventions developed with that expense is, therefore, imperative. To obtain maximum patent protection, claims in newly filed patent applications are necessarily broad. As such, those claims are typically initially rejected by the examining patent office. In fact, allowed applications receive at least one non-final rejection 80% of the time, and a final rejection 40% of the time. There may be an inclination for companies to provide less detail in an application to make it difficult to copy an invention, but a more detailed application makes it easier to overcome rejections.
In the United States Patent and Trademark Office (USPTO), claims may be rejected for a number of reasons, but four sections of Title 35 of the United States Code (35 U.S.C.) are key. Those sections are 35 U.S.C. § 101 (Patent Eligibility), 35 U.S.C. § 102 (Novelty), 35 U.S.C. § 103 (Obviousness), and 35 U.S.C. § 112 (Written Description and Enablement). Being aware of the requirements of those sections allows companies to know what to expect during the patent process and how to overcome rejections.
35 U.S.C. § 101
Section 101 addresses what is eligible to be patented. Any “new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof” is patentable. If an invention falls outside the scope of this list, then it is not eligible to be patented.
Although section 101 was historically not an issue for medical device patents, that is no longer the case when the medical device involves diagnostics. In Mayo v. Prometheus, 132 S. Ct. 1289 (2012), the US Supreme Court made clear that “correlations between the presence of a biological material and a disease are laws of nature.” Laws of nature are not a process, machine, manufacture, or composition of matter, and are thus not patent eligible.
35 U.S.C. § 102
Section 102 deals with the novelty of an invention, that is, does the invention already exist? If the invention was “patented, described in a printed publication, or in public use, on sale, or otherwise available to the public”, the invention is not novel and cannot be patented.
During the patent application prosecution process, a patent examiner at the USPTO examines the claims and conducts a search of prior art publications such as patents, patent applications and scientific articles to determine if there is a publication that describes the claimed invention. To reject an application based on 35 U.S.C. § 102 (a “102 rejection”), the patent examiner must find a publication that describes all of the elements of the claimed invention. As an example, the initially presented claim of a patent application that became US Pat. No. 8,080,060 (titled “Processes and systems for loading medical implants with simulative growth agents” and assigned to Alphatec Spine Inc.) was:
The above example shows that a patent application should provide as much detail as possible in describing the invention, since that detail may need to be added to the claims to overcome a novelty rejection based on prior art. Medical Plastics News