2152.02(d) On Sale [R-10.2019]
[Editor Note: This MPEP section is only applicable to applications subject to examination under the first inventor to file (FITF) provisions of the AIA as set forth in 35 U.S.C. 100 (note). See MPEP § 2159 et seq. to determine whether an application is subject to examination under the FITF provisions, and MPEP § 2133.03 et seq. for information about on sale in regard to applications subject to pre-AIA 35 U.S.C. 102.]
On sale rejections under 35 U.S.C. 102(a)(1) may be based on sales or offers for sale without regard to where the sale activity took place. While there is no requirement that the sale activity be by another, it should be noted that certain uses or sales are subject to the exceptions in 35 U.S.C. 102(b)(1), e.g., uses or sales by the inventor or a joint inventor (or have originated with the inventor) that precede the effective filing date by less than one year. See MPEP § 2154.02.
The pre-AIA case law indicates that on sale activity will bar patentability if the claimed invention was: (1) the subject of a commercial sale or offer for sale, not primarily for experimental purposes; and (2) ready for patenting. See Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 67, 48 USPQ2d 1641, 1646-47 (1998). Contract law and commercial law principles apply in order to determine whether a commercial sale or offer for sale occurred. Medicines Co. v. Hospira, Inc., 827 F.3d 1363, 1373, 119 USPQ2d 1329, 1336 (Fed. Cir. 2016) (en banc). In addition, the enablement inquiry is not applicable to the question of whether a claimed invention is "on sale" under pre-AIA 35 U.S.C. 102(b). See In re Epstein, 32 F.3d 1559, 1568, 31 USPQ2d 1817, 1824 (Fed. Cir. 1994). The phrase "on sale" in AIA 35 U.S.C. 102(a)(1) is treated as having the same meaning as "on sale" in pre-AIA 35 U.S.C. 102(b). For a discussion of "on sale" as used in pre-AIA 35 U.S.C. 102(b), see generally MPEP § 2133.03(b) et seq.
Under pre-AIA 35 U.S.C. 102(b), if an invention was "on sale," patentability was precluded only if the invention was on sale "in this country." See MPEP § 2133.03(d). Under AIA 35 U.S.C. 102(a)(1), there is no geographic limitation on where the sale or offer for sale may occur. When formulating a rejection, Office personnel should consider evidence of sales activity, regardless of where the sale activity took place.
The pre-AIA 35 U.S.C. 102(b) "on sale" provision has been interpreted as including commercial activity even if the activity is secret. See MPEP § 2133.03(b), subsection III.A. AIA 35 U.S.C. 102(a)(1) uses the same "on sale" term as pre-AIA 35 U.S.C. 102(b) and is treated as having the same meaning. In Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., 139 S.Ct. 628 (2019), the Supreme Court "determine[d] that Congress did not alter the meaning of ‘on sale’ when it enacted the AIA, [and held] that an inventor’s sale of an invention to a third party who is obligated to keep the invention confidential can qualify as prior art under [AIA 35 U.S.C.] § 102(a)." Id. at 634. Thus, a sale or offer for sale that does not disclose the subject matter of an invention or make the invention available to the general public may nevertheless qualify as prior art in an anticipation or obviousness rejection, regardless of whether the application or patent under consideration is subject to the FITF provisions of the AIA or the first to invent provisions of pre-AIA law.