This claim was rejected by the examiner under 35 U.S.C. § 102 as being anticipated (i.e., 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:
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 (e.g., 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:
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:
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. However, there was 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.