Enablement Requirement for Patent Claims

The Enablement requirement for patent claims stems from the Written Description requirement of 35 USC 112.  In order to satisfy this requirement, the Written Description (Specification) must describe the claimed invention in sufficient detail to enable a Person of Ordinary Skill in the Art (POOSA) to determine that the patentee invented and claimed the invention. 

Often times, patentees seek to get as broad a claim as they can for their invention to try and increase the number of infringers and run afoul of 35 USC 112, 35 USC 102, and/or 35 USC 103.  The enablement requirment of section 112 means that an individual making broad claims must provide multiple embodiments of the claimed invention or general principles of how a single embodiment is applicable to other broadly claimed inventions.  In re Alonso, (Fed. Cir. 2008). 

In re Alonso, the USPTO rejected the patentee’s claim to other versions of an idiotypic monoclonal antibody (mAb) designed to treat neurofibrosarcoma in a human based on the fact that a single embodiment was insufficient for a POOSA to determine that the patentee was in possession of all the other versions of mAb’s.  The Federal Circuit stated that it must use the Substantial Evidence standard and under that standard if a reasonable mind would accept the evidence as adequate to support the conclusion, the Federal Circuit will affirm the PTO’s decision, if it is reasonable. 

The Federal Circuit may have found things differently, but found the PTO’s decision to be reasonable in light of the single embodiment of mAb.  The Federal Circuit went on to restate it’s holding in Noelle v. Lederman, 355 F.3d 1343, 1350 (Fed. Cir. 2004), that the patentee of a biotech invention cannot make a genus claim based on a limited number of species described in the specification.  There is often too much unpredictability in the results obtained from the species to put the POOSA on notice that the patentee has possession of the genus claim. 

This holding is not new law, but it reconfirms the importance of properly supporting the claimed embodiment within the specification and the dangers presented by an overly broad genus claim.

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