2164.05 Determination of Enablement Based on Evidence as a Whole [R-07.2022]
Once the examiner has weighed all the evidence and established a reasonable basis to question the enablement provided for the claimed invention, the burden falls on applicant to present persuasive arguments, supported by suitable proofs where necessary, that one skilled in the art would be able to make and use the claimed invention using the application as a guide. In re Brandstadter, 484 F.2d 1395, 1406-07, 179 USPQ 286, 294 (CCPA 1973). The evidence provided by applicant need not be absolute but merely convincing to one skilled in the art, based on a preponderance of the evidence standard.
Applicant may submit factual affidavits under 37 CFR 1.132 or cite references to show what one skilled in the art knew at the time of filing the application. A declaration or affidavit is, itself, evidence that must be considered. The weight to give a declaration or affidavit will depend upon the amount of factual evidence the declaration or affidavit contains to support the conclusion of enablement. In re Buchner, 929 F.2d 660, 661, 18 USPQ2d 1331, 1332 (Fed. Cir. 1991) (Stating that an "expert’s opinion on [an] ultimate legal conclusion must be supported by something more than a conclusory statement"); cf. In re Alton, 76 F.3d 1168, 1174, 37 USPQ2d 1578, 1583 (Fed. Cir. 1996) (declarations relating to the written description requirement should have been considered).
Applicant should be encouraged to provide evidence demonstrating that the disclosure enables the claimed invention. In chemical and biotechnical applications, evidence actually submitted to the FDA to obtain approval for clinical trials may be submitted, but is not required. Considerations made by the FDA for approving clinical trials are different from those made by the USPTO in determining whether a claim is enabled. See Scott v. Finney, 34 F.3d 1058, 1063, 32 USPQ2d 1115, 1120 (Fed. Cir. 1994) ("Testing for full safety and effectiveness of a prosthetic device is more properly left to the [FDA]."). Once that evidence is submitted, it must be weighed with all other evidence according to the standards set forth above so as to reach a determination as to whether the disclosure enables the claimed invention.
To overcome a prima facie case of lack of enablement, applicant must present argument and/or evidence that the disclosure would have enabled one of ordinary skill in the art to make and use the claimed invention at the time of filing. This does not preclude applicant from providing a declaration after the filing date which demonstrates that the claimed invention works. However, the examiner should carefully compare the steps, materials, and conditions used in the experiments of the declaration with those disclosed in the application to make sure that they are commensurate in scope; i.e., that the experiments used the guidance in the specification as filed and what was well known to one of skill in the art at the time of filing. Such a showing also must be commensurate with the scope of the claimed invention, i.e., must reasonably enable the full scope of the claimed invention. See Pac. Biosciences of Cal., Inc. v. Oxford Nanopore Techs., Inc., 996 F.3d 1342, 1352, 2021 USPQ2d 519 (Fed. Cir. 2021) (The court found that undue experimentation was required to enable the full scope of the claims where there was ample evidence that relevant artisans would not know how to perform the claimed invention for more than a narrow range of the claimed scope of invention. Moreover, there was no evidence of actual reduction to practice to support patentee’s rebuttal of the lack of enablement determination).
The examiner must then weigh all the evidence of record, including the specification, any new evidence supplied by applicant, and any evidence and scientific reasoning previously presented in the rejection and then decide whether the claimed invention is enabled, based on a preponderance of the evidence standard. The examiner should never make this determination based on personal opinion. The determination should always be based on the weight of all the evidence of record.