MPEP 2164.01(c)
How to Use the Claimed Invention

Ninth Edition of the MPEP, Revision 07.2022, Last Revised in February 2023

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2164.01(c)    How to Use the Claimed Invention [R-08.2017]

If a statement of utility in the specification contains within it a connotation of how to use, and/or the art recognizes that standard modes of administration are known and contemplated, 35 U.S.C. 112 is satisfied. In re Johnson, 282 F.2d 370, 373, 127 USPQ 216, 219 (CCPA 1960); In re Hitchings, 342 F.2d 80, 87, 144 USPQ 637, 643 (CCPA 1965); see also In re Brana, 51 F.3d 1560, 1566, 34 USPQ2d 1436, 1441 (Fed. Cir. 1995).

For example, it is not necessary to specify the dosage or method of use if it is known to one skilled in the art that such information could be obtained without undue experimentation. If one skilled in the art, based on knowledge of compounds having similar physiological or biological activity, would be able to discern an appropriate dosage or method of use without undue experimentation, this would be sufficient to satisfy 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. The applicant need not demonstrate that the invention is completely safe. See also MPEP §§ 2107.01 and 2107.03.

When a compound or composition claim is limited by a particular use, enablement of that claim should be evaluated based on that limitation. See In re Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991) (claiming a chimeric gene capable of being expressed in any cyanobacterium and thus defining the claimed gene by its use).

In contrast, when a compound or composition claim is not limited by a recited use, any enabled use that would reasonably correlate with the entire scope of that claim is sufficient to preclude a rejection for nonenablement based on how to use. If multiple uses for claimed compounds or compositions are disclosed in the application, then an enablement rejection must include an explanation, sufficiently supported by the evidence, why the specification fails to enable each disclosed use. In other words, if any use is enabled when multiple uses are disclosed, the application is enabling for the claimed invention.