Office Action Response Argument
(Enablement and Written Description Under Section 112(a))

Summary

This office action response template provides arguments that you may use when responding to a rejection of pending patent claims for lack of enablement or lack of adequate written description under 35 U.S.C. § 112(a). This template contains practical guidance and drafting notes. To prepare a complete response to an office action that includes a rejection of patent claims on the grounds of lack of enablement or insufficient written description, you may combine this template with the Patent Office Action Response template. Under 35 U.S.C. § 112(a) a patent specification must contain "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 make and use the invention. Section 112(a) has been interpreted by the Federal Circuit as requiring two distinct (but often overlapping) disclosures: (1) a disclosure that enables a person skilled in the art to make or use the invention of each claim, and (2) a written description of the invention of each claim sufficient to show that the inventor was in possession of the invention of each claim on the filing date. Both the enablement and written description requirements are part of the quid pro quo of the patent bargain (i.e., the inventor must provide a full public disclosure of the invention in return for a limited period of exclusivity). See AK Steel Corp. v. Sollac, 344 F.3d 1234, 1244, (Fed. Cir. 2003) (enablement) and Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1354, (Fed. Cir. 2010) (en banc) (written description). The standard for rejecting a patent claim for lack of enablement is rigorous. It requires concluding that a person skilled in the art would be unable to practice the invention without undue experimentation. The critical word here is "undue." Enablement is not precluded by the necessity for routine experimentation. In determining whether any required experimentation is undue, the examiner must consider the so-called Wands factors, which include the following: • The breadth of the claims • The nature of the invention • The state of the prior art • The level of ordinary skill in the art • The predictability or unpredictability of the art • The amount of direction or guidance provided by the inventor • The presence or absence of working examples • The quantity of experimentation needed to make or use the invention based on information contained in the disclosure. See In re Wands, 858 F.2d 731, 737, 8 USPQ 2d 1400, 1404 (Fed. Cir. 1988) (reversing the USPTO's determination that claims directed to methods for detection of hepatitis B surface antigens did not satisfy the enablement requirement). See also MPEP § 2164.01. The written description requirement is best understood as a safeguard against overclaiming. For example, a creative claim drafter may be tempted to claim beyond what the inventor actually invented. The requirement to provide a written description of the claimed subject matter serves to confine the claims to the invention that was in the possession of the inventor on the filing date (or actual date of invention for pre-AIA patents). See Ariad, 598 F.3d at 1352 ("[R]equiring a written description of the invention plays a vital role in curtailing claims … that have not been invented, and thus cannot be described.") The examiner's written description analysis must begin with a presumption that the specification includes an adequate written description of the claimed invention when the application is filed. However, notwithstanding this presumption, an examiner may still raise the question of whether the specification provides an adequate written description for a particular claim. Amending a claim or adding a new claim may raise an issue as to whether the claimed subject matter is adequately described in the specification. While the written description does not have to use the same words as the claims, newly added claims or claim limitations must be supported in the specification through express, implicit, or inherent disclosure. The examiner's written description analysis must comply with the rigorous standards laid out in MPEP § 2163. The examiner has the initial burden of presenting reasons why a person skilled in the art would not recognize that the written description of the invention contained in the specification provides support for the claims. The examiner must analyze the specification, and then, for each claim, determine what the claim, as a whole, covers. The examiner must then review the application to understand how the applicant provides support for the claimed invention, including each element or step. Next, the examiner must determine whether there is sufficient written description to inform a person skilled in the art that the applicant was in possession of the claimed invention, as a whole, at the time the application was filed. Not only must examiners follow each of these steps, but they must then present the reasons or evidence for why the written description standard is not met. See MPEP § 2163 for additional requirements, including the separate standards for originally-filed claims and claims that were amended or later inserted.