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.
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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 (Patent Eligibility)
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 (Novelty)
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:
1. A system for loading bone morphogenetic material into a porous substrate, comprising:
a container comprising an entry port, at least one substrate cavity, and a top, side and bottom walls defining an inner surface of the container;
the entry port configured to receive the bone morphogenetic material;
the substrate cavity in communication with the entry port and having the porous substrate maintained under negative pressure; and
wherein a container volume is substantially the same as a volume of the porous substrate.
This claim was rejected by the examiner under 35 U.S.C. § 102 as being anticipated (that is, not novel) by the publication of a patent application. To overcome the 102 rejection, the claim was amended to read:
1. A system for loading bone morphogenetic material into a medical graft, comprising:
a hermetically sealed container comprising an entry port, at least one substrate cavity, and top, side and bottom walls defining an inner surface of the container,
a lip surrounding a periphery of the substrate cavity and the top wall is hermetically sealed to the lip adjacent the substrate cavity periphery;
the entry port configured to receive the bone morphogenetic material;
the substrate cavity in communication with the entry port and having the medical graft stored and maintained under negative pressure; and
wherein a container volume is substantially the same as a volume of the medical graft.
In the above amendment, detail (underlined) was added to the claim that narrowed the scope of the claim but provided elements that were not described in the publication that was cited by the examiner. This typical narrowing amendment adds detail described in the body (“specification”) of the patent application to the claim to distinguish the claim from the prior art cited by the examiner that anticipates the claim.
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.
35 U.S.C. § 103 (Obviousness)
A 103 rejection occurs if “the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art.” Typically, an examiner will combine two or more published references (for example, patents, patent applications or scientific articles), to essentially describe the claimed invention using elements described in the various references. To overcome a 103 rejection, similar to a 102 rejection, the claims are typically amended by adding narrowing or clarifying elements described in the specification of the patent application. The goal is to create claims that the combination of references does not teach or suggest.
An example of this occurred during the prosecution of the patent application that became US Patent 9,271,845 (titled “Programmable implants and methods of using programmable implants to repair bone structures” and assigned to 4Web Inc.). The examiner rejected the following original claim as being obvious under 35 U.S.C. § 103 because several prior art references, in combination, described each element of the claim:
1. An implant for interfacing with a bone structure, comprising:
a web structure comprising a plurality of struts joined at nodes, wherein the web structure is configured to interface with human bone tissue;
wherein a diameter and/or length of the struts and/or density of the web structure are predetermined such that when the web structure is in contact with the bone at least a portion of the struts create a microstrain in adhered osteoblasts.
After receiving the the 103 rejection the applicant amended the claim to add the underlined claim elements that were not described in the cited prior art, as follows:
1. An implant for interfacing with a bone structure, comprising:
a web structure comprising a plurality of struts joined at nodes to form a space truss comprising a plurality of planar truss units,
wherein the web structure is configured to interface with bone tissue, and
wherein the plurality of planar truss units are coupled to one another such that one or more planar truss units lie in a plane that is not substantially parallel to a plane of a planar truss unit that shares at least one strut with the one or more planar truss units;
wherein a diameter and/or length of the struts and/or density of the web structure are predetermined such that when the web structure is in contact with the bone at least a portion of the struts create a microstrain in adhered osteoblasts, bone matrix, or lamellar tissue.
All the underlined information was described in the specification of the patent application. This again shows that the specification should be as detailed as possible so that those details can be added to the claims if necessary to overcome a prior art (102 or 103) rejection.
35 U.S.C. § 112 (Written Description and Enablement)
Section 112 states that the application must have “a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same.”
Essentially, this means that an expert in the field of the invention should be readily able to practice the invention by reading the patent specification. To avoid 112 rejections, the specification should again be as detailed as possible, to be assured that the invention is described enough to enable an expert to practice the invention.
In many cases, such rejections have to do with a patent application’s written description requirement; the applicant must “convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention.” In ICU Medical v. Alaris Medical System (Fed. Cir. 2009), ICU Medical, during patent prosecution, amended claims to include “spikeless” valves. There was, however, only mention of medical valves with spikes in the specification of the application. For the claims to be valid, there would have had to be mention of spikeless claims in the specification.
In light of these four reasons for rejecting an application, companies must ensure that their patent applications contain enough detail to (a) enable an expert to practice the invention, and (b) draw upon in the event that more information needs to be added to the claims to overcome prior art rejections. Also, it is critical to read the claims carefully before submitting the patent application to make sure all elements are listed correctly and precisely.
Neil Thompson is a patent agent at Torrey Pines Law Group, PC and Elie Gendloff, PhD, JD is a patent attorney at Torrey Pines Law Group, PC.