Fletcher YoderEnablement and written description requirements with respect to claims are judged as of the priority date of a patent. A later existing state of art is not considered in the enablement analysis of a claim. Similarly, the written description requirement is in view of what is claimed and whether the specification reasonably conveys possession of the claimed subject matter as of the filing date of the patent.
Functional limitations in a claim to a composition of matter may result in claim breadth that is not fully enabled if undue experimentation is required to determine the scope of the functional limitations.
The Fed. Circuit invalidates claims under 35 U.S.C. § 112, 1st paragraph, finding that the specification does not enable a skilled artisan to practice the full breadth of ‘comprising’ claim scope.
The enablement requirement may be met by animal tests or in vitro data. Title 35 does not demand that human testing occur within the confines of Patent and Trademark Office proceedings.
When a patent specification only enables one of ordinary skill in the art to achieve a small subset of a claimed range without undue experimentation, the patentee is not entitled to claim an open-ended range.
An inventor avoids summary judgment for violation of the best mode requirement despite referring to a propriety product used in the preferred embodiment by a nonexistent trade name.
An “offer to sell … within the United States” occurs when a company makes an offer, whether made inside or outside of the United States, to sell a product that the buyer will use in the United States. In addition, an “offer to sell” occurs when the product specified in the contract infringes a patent, notwithstanding the state of the product ultimately delivered.
Evidence not submitted by an applicant during prosecution or appeal is not admissible as a matter of right, and may not be admissible at all in a subsequent court appeal. The Federal Circuit will likely apply an equity-like standard when considering the admissibility of such evidence.
The Federal Circuit finds that a stated hypothesis and proposed testing for a treatment method is not enough to establish utility.
The Federal Circuit continues to reinforce the requirement that the full scope of a claim be enabled for the claim to be valid under the first paragraph of 35 U.S.C. § 112. If a disclosure does not enable a device that is covered by a claim, an infringement action asserting that claim will likely result in its invalidation for lack of enablement.