2164.07 Relationship of Enablement Requirement to Utility Requirement of 35 U.S.C. 101 [R-11.2013]

The requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph as to how to use the invention is different from the utility requirement of 35 U.S.C. 101. The requirement of 35 U.S.C. 101 is that some specific, substantial, and credible use be set forth for the invention. On the other hand, 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph requires an indication of how the use (required by 35 U.S.C. 101) can be carried out, i.e., how the invention can be used.

If an applicant has disclosed a specific and substantial utility for an invention and provided a credible basis supporting that utility, that fact alone does not provide a basis for concluding that the claims comply with all the requirements of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. For example, if an applicant has claimed a process of treating a certain disease condition with a certain compound and provided a credible basis for asserting that the compound is useful in that regard, but to actually practice the invention as claimed a person skilled in the relevant art would have to engage in an undue amount of experimentation, the claim may be defective under 35 U.S.C. 112, but not 35 U.S.C. 101. To avoid confusion during examination, any rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, based on grounds other than “lack of utility” should be imposed separately from any rejection imposed due to “lack of utility” under 35 U.S.C. 101 and 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph.

I. WHEN UTILITY REQUIREMENT IS NOT SATISFIED

A.Not Useful or Operative

If a claim fails to meet the utility requirement of 35 U.S.C. 101 because it is shown to be nonuseful or inoperative, then it necessarily fails to meet the how-to-use aspect of the enablement requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. As noted in In re Fouche, 439 F.2d 1237, 169 USPQ 429 (CCPA 1971), if “compositions are in fact useless, appellant’s specification cannot have taught how to use them.” 439 F.2d at 1243, 169 USPQ at 434. The examiner should make both rejections (i.e., a rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph and a rejection under 35 U.S.C. 101) where the subject matter of a claim has been shown to be nonuseful or inoperative.

The 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, rejection should indicate that because the invention as claimed does not have utility, a person skilled in the art would not be able to use the invention as claimed, and as such, the claim is defective under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. A 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, rejection should not be imposed or maintained unless an appropriate basis exists for imposing a rejection under 35 U.S.C. 101. In other words, Office personnel should not impose a 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, rejection grounded on a “lack of utility” basis unless a 35 U.S.C. 101 rejection is proper. In particular, the factual showing needed to impose a rejection under 35 U.S.C. 101 must be provided if a 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, rejection is to be imposed on “lack of utility” grounds. See MPEP § 2107 – § 2107.03 for a more detailed discussion of the utility requirements of 35 U.S.C. 101 and 35 U.S.C. 112(a) or pre-AIA 112, first paragraph.

B.Burden on the Examiner

When the examiner concludes that an application claims an invention that is nonuseful, inoperative, or contradicts known scientific principles, the burden is on the examiner to provide a reasonable basis to support this conclusion. Rejections based on 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, and 35 U.S.C. 101 should be made.

Examiner Has Initial Burden To Show That One of Ordinary Skill in the Art Would Reasonably Doubt the Asserted Utility

The examiner has the initial burden of challenging an asserted utility. Only after the examiner has provided evidence showing that one of ordinary skill in the art would reasonably doubt the asserted utility does the burden shift to the applicant to provide rebuttal evidence sufficient to convince one of ordinary skill in the art of the invention’s asserted utility. In re Fisher, 421 F.3d 1365, 76 USPQ2d 1225 (Fed. Cir. 2005); In re Swartz, 232 F.3d 862, 863, 56 USPQ2d 1703, 1704 (Fed. Cir. 2000); In reBrana, 51 F.3d 1560, 1566, 34 USPQ2d 1436, 1441 (Fed. Cir. 1995) (citing In reBundy, 642 F.2d 430, 433, 209 USPQ 48, 51 (CCPA 1981)).

C.Rebuttal by Applicant

If a rejection under 35 U.S.C. 101 has been properly imposed, along with a corresponding rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, the burden shifts to the applicant to rebut the prima facie showing. In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992). There is no predetermined amount or character of evidence that must be provided by an applicant to support an asserted utility. Rather, the character and amount of evidence needed to support an asserted utility will vary depending on what is claimed (Ex parte Ferguson, 117 USPQ 229, 231 (Bd. App. 1957)), and whether the asserted utility appears to contravene established scientific principles and beliefs. In re Gazave, 379 F.2d 973, 978, 154 USPQ 92, 96 (CCPA 1967); In re Chilowsky, 229 F.2d 457, 462, 108 USPQ 321, 325 (CCPA 1956). Furthermore, the applicant does not have to provide evidence sufficient to establish that an asserted utility is true “beyond a reasonable doubt.” In re Irons, 340 F.2d 974, 978, 144 USPQ 351, 354 (CCPA 1965). Instead, evidence will be sufficient if, considered as a whole, it leads a person of ordinary skill in the art to conclude that the asserted utility is more likely than not true. See MPEP § 2107.02 for a more detailed discussion of consideration of a reply to a prima facie rejection for lack of utility and evaluation of evidence related to utility.

II. WHEN UTILITY REQUIREMENT IS SATISFIED

In some instances, the utility of the claimed invention will be provided, but the skilled artisan will not know how to effect that use. In such a case, no rejection will be made under 35 U.S.C. 101, but a rejection will be made under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. As pointed out in Mowryv.Whitney, 81 U.S. (14 Wall.) 620 (1871), an invention may in fact have great utility, i.e., may be “a highly useful invention,” but the specification may still fail to “enable any person skilled in the art or science” to use the invention. 81 U.S. (14 Wall.) at 644.