2164.05 Determination of Enablement Based on Evidence as a Whole [R-08.2017]
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.
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.
The examiner must then weigh all the evidence before him or her, 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. 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.
2164.05(a) Specification Must Be Enabling as of the Filing Date [R-08.2017]
Whether the specification would have been enabling as of the filing date involves consideration of the nature of the invention, the state of the prior art, and the level of skill in the art. The initial inquiry is into the nature of the invention, i.e., the subject matter to which the claimed invention pertains. The nature of the invention becomes the backdrop to determine the state of the art and the level of skill possessed by one skilled in the art.
The state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains. The relative skill of those in the art refers to the skill of those in the art in relation to the subject matter to which the claimed invention pertains at the time the application was filed. See MPEP § 2164.05(b).
The state of the prior art provides evidence for the degree of predictability in the art and is related to the amount of direction or guidance needed in the specification as filed to meet the enablement requirement. The state of the prior art is also related to the need for working examples in the specification.
The state of the art for a given technology is not static in time. It is entirely possible that a disclosure which would not have been enabled if filed on January 2, 1990 might be enabled if the same disclosure had been filed on January 2, 1996. Therefore, the state of the prior art must be evaluated for each application based on its filing date.
35 U.S.C. 112 requires the specification to be enabling only to a person "skilled in the art to which it pertains, or with which it is most nearly connected." In general, the pertinent art should be defined in terms of the problem to be solved rather than in terms of the technology area, industry, trade, etc. for which the invention is used.
The specification need not disclose what is well-known to those skilled in the art and preferably omits that which is well-known to those skilled and already available to the public. In re Buchner, 929 F.2d 660, 661, 18 USPQ2d 1331, 1332 (Fed. Cir. 1991); Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384, 231 USPQ 81, 94 (Fed. Cir. 1986), cert. denied, 480 U.S. 947 (1987); and Lindemann Maschinenfabrik GMBH v. American Hoist & Derrick Co., 730 F.2d 1452, 1463, 221 USPQ 481, 489 (Fed. Cir. 1984).
The state of the art existing at the filing date of the application is used to determine whether a particular disclosure is enabling as of the filing date. Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1325-26 (Fed. Cir. 2004) (Stating that "a patent document cannot enable technology that arises after the date of application."). Information published for the first time after the filing date generally cannot be used to show what was known at the time of filing. In re Gunn, 537 F.2d 1123, 1128, 190 USPQ 402,405-06 (CCPA 1976); In re Budnick, 537 F.2d 535, 538, 190 USPQ 422, 424 (CCPA 1976) (In general, if an applicant seeks to use a patent to prove the state of the art for the purpose of the enablement requirement, the patent must have an issue date earlier than the effective filing date of the application.). While a later dated publication cannot supplement an insufficient disclosure in a prior dated application to make it enabling, an applicant can offer the testimony of an expert based on the publication as evidence of the level of skill in the art at the time the application was filed. Gould v. Quigg, 822 F.2d 1074, 1077, 3 USPQ2d 1302, 1304 (Fed. Cir. 1987).
In general, the examiner should not use post-filing date references to demonstrate that a patent is not enabled. Exceptions to this rule could occur if a later-dated reference provides evidence of what one skilled in the art would have known on or before the effective filing date of the patent application. In re Hogan, 559 F.2d 595, 605, 194 USPQ 527, 537 (CCPA 1977). If a publication demonstrates that those of ordinary skill in the art would find that a particular invention was not enabled years after the filing date, the publication would be evidence that the claimed invention was not possible at the time of filing. See In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513-14 (Fed. Cir. 1993) (The court found that an article published 5 years after the filing date of the application adequately supported the examiner’s position that the physiological activity of certain viruses was sufficiently unpredictable so that a person skilled in the art would not have believed that the success with one virus and one animal could be extrapolated successfully to all viruses with all living organisms. Accordingly, the court held that the applicant’s earlier-filed claims not limited to the specific virus or the specific animal were nonenabled).
2164.05(b) Specification Must Be Enabling to Persons Skilled in the Art [R-08.2017]
The relative skill of those in the art refers to the skill level of those in the art in the technological field to which the claimed invention pertains. Where different arts are involved in the invention, the specification is enabling if it enables persons skilled in each art to carry out the aspect of the invention applicable to their specialty. In re Naquin, 398 F.2d 863, 866, 158 USPQ 317, 319 (CCPA 1968).
When an invention, in its different aspects, involves distinct arts, the specification is enabling if it enables those skilled in each art, to carry out the aspect proper to their specialty. "If two distinct technologies are relevant to an invention, then the disclosure will be adequate if a person of ordinary skill in each of the two technologies could practice the invention from the disclosures." Technicon Instruments Corp. v. Alpkem Corp., 664 F. Supp. 1558, 1578, 2 USPQ2d 1729, 1742 (D. Ore. 1986), aff’d in part, vacated in part, rev’d in part, 837 F. 2d 1097 (Fed. Cir. 1987) (unpublished opinion), appeal after remand, 866 F. 2d 417, 9 USPQ 2d 1540 (Fed. Cir. 1989). In Ex parte Zechnall, 194 USPQ 461 (Bd. Pat. App. & Int. 1973), the Board stated "appellants’ disclosure must be held sufficient if it would enable a person skilled in the electronic computer art, in cooperation with a person skilled in the fuel injection art, to make and use appellants’ invention." 194 USPQ at 461.