The Patent Act sets forth the requirements for obtaining a patent. The claimed invention must be (1) eligible for patenting, (2) novel, (3) non-obvious, (4) enabled, and (5) described. Each of these requirements is evaluated from the perspective of a hypothetical person who knows everything described in the prior art but lacks the creative genius of an inventor (called a person of ordinary skill in the art).
The traditional rule for patent eligibility is that you can patent anything under the sun that was made by man. However, courts have created exceptions. You cannot patent laws of nature, natural phenomena or abstract ideas. These patent eligibility exceptions are an impediment to patenting diagnostic inventions. The Supreme Court has invalidated claims directed to a mutant DNA associated with breast cancer and the correlation between a biomarker and a disease.
For novelty, the examiner will search for a single prior art reference that discloses every element of the patent claim. If the examiner finds pertinent prior art, you will need to amend your claims until they’re novel.
For obviousness, the examiner will combine the teachings of two or more prior art references. An obviousness rejection can be overcome by showing that the references don’t disclose every element of the claim, or that a skilled person would not be motivated to combine the references or would not have a reasonable expectation of success. Alternatively, the applicant can demonstrate unexpected results that would not have been predicted from the prior art.
For enablement, the examiner asks whether the patent application fully explains how to make and use the claimed invention. The legal test is whether a skilled person can practice the full scope of the claim without undue experimentation. To make this determination, the examiner will analyze everything described in the patent application and compare it to the breadth of the claims, the nature of the invention, the state of the prior art, and the predictability of the field.
The written description requirement requires the claimed invention to be disclosed in the original application. A concept that’s not described in the original application is considered new matter. New matter can’t be claimed, even if it’s obvious based on what the application does disclose. Making the effort to prepare a complete patent application describing multiple variations of the invention will help avoid written description rejections.
For antibodies, the application must disclose the amino acid sequence of the claimed antibody. Under the written description requirement, you cannot claim an antibody by specifying the target that it binds to. This is a problem, because once a high value target is identified, it is routine to generate an antibody, and an independently generated antibody that binds to the target will have a different sequence.
