2152.02 Prior Art Under AIA 35 U.S.C. 102(a)(1) (Patented, Described in a Printed Publication, or in Public Use, on Sale, or Otherwise Available to the Public) [R-08.2017]
[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 § 2131-MPEP § 2138 for examination of applications subject to pre-AIA 35 U.S.C. 102.]
Prior art documents and activities which may preclude patentability are set forth in AIA 35 U.S.C. 102(a)(1). Such documents and activities include prior patenting of the claimed invention, descriptions of the claimed invention in a printed publication, public use of the claimed invention, placing the claimed invention on sale, and otherwise making the claimed invention available to the public. MPEP §§ 2152.02(a)–2152.02(f) discuss each prior art document and activity that might preclude patentability under AIA in turn.35 U.S.C. 102(a)(1)
2152.02(a) Patented [R-11.2013]
[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 § 2131-MPEP § 2138 for examination of applications subject to pre-AIA 35 U.S.C. 102.]
AIA 35 U.S.C. 102(a)(1) indicates that a prior patent of a claimed invention will preclude the grant of a subsequent patent on the claimed invention. This means that if a claimed invention was patented in this or a foreign country before the effective filing date of the claimed invention, AIA 35 U.S.C. 102(a)(1) precludes the grant of a patent on the claimed invention. The effective date of the patent for purposes of determining whether the patent qualifies as prior art under AIA 35 U.S.C. 102(a)(1) is the grant date of the patent. There is an exception to this rule if the patent is secret as of the date the rights are awarded. See In re Ekenstam, 256 F.2d 321, 323, 118 USPQ 349, 353 (CCPA 1958); see also MPEP § 2126.01. In such situations, the patent is available as prior art as of the date the patent was made available to the public by being laid open for public inspection or disseminated in printed form. See In re Carlson, 983 F.2d 1032, 1037, 25 USPQ2d 1207 (Fed. Cir. 1992); see also MPEP § 2126. The phrase "patented" in AIA 35 U.S.C. 102(a)(1) has the same meaning as "patented" in pre-AIA 35 U.S.C. 102(a) and (b). For a discussion of "patented" as used in pre-AIA 35 U.S.C. 102(a) and (b), see generally MPEP § 2126.
Although an invention may be described in a patent and not claimed therein, the grant date would also be the applicable prior art date for purposes of relying on the subject matter disclosed therein as "described in a printed publication," provided that the patent was made available to the public on its grant date. Note that a U.S. patent that issues after the effective filing date of a claimed invention and is not available as prior art against that invention under AIA 35 U.S.C. 102(a)(1) could be available as prior art under AIA 35 U.S.C. 102(a)(2).
2152.02(b) Described in a Printed Publication [R-11.2013]
[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 § 2131-MPEP § 2138 for examination of applications subject to pre-AIA 35 U.S.C. 102.]
If a claimed invention is described in a patent, published patent application, or printed publication, such a document may be available as prior art under AIA 35 U.S.C. 102(a)(1). Both pre-AIA 35 U.S.C. 102(a) and (b) and AIA 35 U.S.C. 102(a)(1) use the term "described" with respect to an invention in a prior art printed publication. Likewise, AIA 35 U.S.C. 102(a)(2) uses that term with respect to U.S. patents, U.S. patent application publications, and WIPO published applications. Thus, the Office does not view the AIA as changing the extent to which a claimed invention must be described for a prior art document to anticipate the claimed invention under 35 U.S.C. 102.
While the conditions for patentability of AIA 35 U.S.C. 112(a) require a written description of the claimed invention that would have enabled a person skilled in the art to make as well as use the invention, the prior art provisions of AIA 35 U.S.C. 102(a)(1) and (a)(2) require only that the claimed invention is "described" in a prior art document (patent, published patent application, or printed publication). The two basic requirements that must be met by a prior art document in order to describe a claimed invention such that it is anticipated under AIA 35 U.S.C. 102 are the same as those under pre-AIA 35 U.S.C. 102. First, "each and every element of the claimed invention" must be disclosed either explicitly or inherently, and the elements must be "arranged or combined in the same way as in the claim." See In re Gleave, 560 F.3d 1331, 1334, 90 USPQ2d 1235, 1237-38 (Fed. Cir. 2009), citing Eli Lilly & Co. v. Zenith Goldline Pharms., Inc., 471 F.3d 1369, 1375, 81 USPQ2d 1324,1328 (Fed. Cir. 2006); Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1370, 88 USPQ2d 1751, 1759 (Fed. Cir. 2008); In re Bond, 910 F.2d 831, 832-33, 15 USPQ2d 1566, 1567 (Fed. Cir. 1990). Second, a person of ordinary skill in the art must have been enabled to make the invention without undue experimentation. See Gleave, 560 F.3d at 1334, 90 USPQ2d at 1238 (citing Impax Labs., Inc. v. Aventis Pharms. Inc., 545 F.3d 1312, 1314, 88 USPQ2d 1381, 1383 (Fed. Cir. 2008), and In re LeGrice, 301 F.2d 929, 940-44, 133 USPQ 365, 372 (CCPA 1962)). Thus, in order for a prior art document to describe a claimed invention such that it is anticipated under AIA 35 U.S.C. 102(a)(1) or (a)(2), it must disclose all elements of the claimed invention arranged as they are in the claim, and also provide sufficient guidance to enable a person skilled in the art to make the claimed invention. There is, however, no requirement that a prior art document meet the "how to use" requirement of 35 U.S.C. 112(a) in order to qualify as prior art. See Gleave, 560 F.3d at 1334, 90 USPQ2d at 1237-38; see also In re Schoenwald, 964 F.2d 1122, 1124, 22 USPQ2d 1671, 1673 (Fed. Cir. 1992) (holding that a claimed compound was anticipated even though the prior art reference did not disclose a use for the compound); Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373, 1380-81, 67 USPQ2d 1664, 1670 (Fed. Cir. 2003) (pointing out that actually reducing the invention to practice is not necessary in order for a prior art reference to anticipate); Impax Labs, 468 F.3d at 1382 (stating that "proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation"). Furthermore, compliance with the "how to make" requirement is judged from the viewpoint of a person of ordinary skill in the art, and thus does not require that the prior art document explicitly disclose information within the knowledge of such a person. See In re Donohue, 766 F.2d 531, 533, 226 USPQ 619, 621 (Fed. Cir. 1985).
There is an additional important distinction between the written description that is necessary to support a claim under 35 U.S.C. 112(a) and the description sufficient to anticipate the subject matter of the claim under AIA 35 U.S.C. 102(a)(1) or (a)(2). See Rasmussen v. SmithKline Beecham Corp., 413 F.3d 1318, 75 USPQ2d 1297 (Fed. Cir. 2005). To provide support for a claim under 35 U.S.C. 112(a), it is necessary that the specification describe and enable the entire scope of the claimed invention. However, in order for a prior art document to describe a claimed invention under AIA 35 U.S.C. 102(a)(1) or (a)(2), the prior art document need only describe and enable one skilled in the art to make a single species or embodiment of the claimed invention. See Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1562, 19 USPQ2d 1111, 1115 (Fed. Cir. 1991) ("As the court pointed out, ‘the description of a single embodiment of broadly claimed subject matter constitutes a description of the invention for anticipation purposes..., whereas the same information in a specification might not alone be enough to provide a description of that invention for purposes of adequate disclosure.’") (quoting In re Lukach, 442 F.2d 967, 970, 169 USPQ 795, 797 (CCPA 1971)); see also In re Van Langenhoven, 458 F.2d 132, 173 USPQ 426 (CCPA 1972), and In re Ruscetta, 255 F.2d 687, 118 USPQ 101 (CCPA 1958).
An anticipatory description it is not required in order for a disclosure to qualify as prior art, unless the disclosure is being used as the basis for an anticipation rejection. In accordance with pre-AIA case law concerning obviousness, a disclosure may be cited for all that it would reasonably have made known to a person of ordinary skill in the art. Thus, the description requirement of AIA 35 U.S.C. 102(a)(1) and (a)(2) does not preclude an examiner from applying a disclosure in an obviousness rejection under AIA 35 U.S.C. 103 simply because the disclosure is not adequate to anticipate the claimed invention.
2152.02(c) In Public Use [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 § 2131-MPEP § 2138 for examination of applications subject to pre-AIA 35 U.S.C. 102.]
Public use rejections under 35 U.S.C. 102(a)(1) may be based on uses that are public anywhere in the world. While there is no requirement that the use or 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.
Under pre-AIA 35 U.S.C. 102(b), an invention that was "in public use" precluded the grant of a patent only if such public use occurred "in this country." See MPEP § 2133.03(d).
Under AIA 35 U.S.C. 102(a)(1), there is no geographic limitation on where prior public use or public availability occurs. Furthermore, a public use would need to occur before the effective filing date of the claimed invention to constitute prior art under AIA 35 U.S.C. 102(a)(1).
The pre-AIA case law also indicates that a public use will bar patentability if the public use occurs before the critical date and the invention is ready for patenting. Under pre-AIA 35 U.S.C. 102(b), the critical date is the date that is one year prior to the date of application for patent in the United States. See Invitrogen Corp. v. Biocrest Manufacturing. L.P., 424 F.3d 1374, 1379-80, 76 USPQ2d 1741, 1744 (Fed. Cir. 2005) and MPEP § 2133. Under pre-AIA 35 U.S.C. 102(b), the uses of an invention before the patent's critical date that constitute a "public use" fall into two categories: the use either "(1) was accessible to the public; or (2) was commercially exploited." See American Seating Co. v. USSC Group, Inc., 514 F.3d 1262, 1267, 85 USPQ2d 1683, 1685 (Fed. Cir. 2008) and MPEP § 2133.03(a). Whether a use is a pre-AIA 35 U.S.C. 102(b) public use also depends on who is making the use of the invention. "[W]hen an asserted prior use is not that of the applicant, [pre-AIA 35 U.S.C.] 102(b) is not a bar when that prior use or knowledge is not available to the public." See Woodland Trust v. Flowertree Nursery, Inc., 148 F.3d 1368, 1371, 47 USPQ2d 1363, 1366 (Fed. Cir. 1998). In other words, a use by a third party who did not obtain the invention from the inventor named in the application or patent is an invalidating use under pre-AIA 35 U.S.C. 102(b) only if it falls into the first category: That the use was accessible to the public. See MPEP § 2133.03(a), subsection II.C. On the other hand, "an inventor's own prior commercial use, albeit kept secret, may constitute a public use or sale under [pre-AIA 35 U.S.C.] 102(b), barring him from obtaining a patent." See Woodland Trust, 148 F.3d at 1370, 47 USPQ2d at 1366 and MPEP § 2133.03(a), subsection II.A. Also, an inventor creates a public use bar under pre-AIA 35 U.S.C. 102(b) when the inventor shows the invention to, or allows it to be used by, another person who is "under no limitation, restriction, or obligation of confidentiality" to the inventor. See American Seating, 514 F.3d at 1267 and MPEP § 2133.03(a), subsection II.B.
Further, under pre-AIA 35 U.S.C. 102(a), "in order to invalidate a patent based on prior knowledge or use" by another in this country prior to the patent's priority date, "that knowledge or use must have been available to the public." See Woodland Trust, 148 F.3d at 1370, 47 USPQ2d at 1366 and MPEP § 2132, subsection I. Patent-defeating "use," under pre-AIA 35 U.S.C. 102(a) includes only that "use which is accessible to the public." See id. (quoting Carella v. Starlight Archery, 804 F.2d 135, 139, 231 USPQ 644, 646 (Fed. Cir. 1986)).
As discussed previously, public use under AIA 35 U.S.C. 102(a)(1) is limited to those uses that are available to the public. The public use provision of AIA 35 U.S.C. 102(a)(1) thus has the same substantive scope, with respect to uses by either the inventor or a third party, as public uses under pre-AIA 35 U.S.C. 102(b) by unrelated third parties or others under pre-AIA 35 U.S.C. 102(a).
As also discussed previously, once an examiner becomes aware that a claimed invention has been the subject of a potentially public use, the examiner should require the applicant to provide information showing that the use did not make the claimed process accessible to the public.
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.
2152.02(e) Otherwise Available to the Public [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 § 2131-MPEP § 2138 for examination of applications subject to pre-AIA 35 U.S.C. 102.]
AIA 35 U.S.C. 102(a)(1) provides a "catch-all" provision, which defines a new additional category of potential prior art not provided for in pre-AIA 35 U.S.C. 102. Specifically, a claimed invention is not entitled to a patent if it was "otherwise available to the public" before its effective filing date. This "catch-all" provision permits decision makers to focus on whether the disclosure was "available to the public," rather than on the means by which the claimed invention became available to the public or whether a disclosure constitutes a "printed publication" or falls within another category of prior art as defined in AIA 35 U.S.C. 102(a)(1). The availability of the subject matter to the public may arise in situations such as a student thesis in a university library (see, e.g., In re Cronyn, 890 F.2d 1158, 13 USPQ2d 1070 (Fed. Cir. 1989); In re Hall, 781 F.2d 897, 228 USPQ 453 (Fed. Cir. 1986); In re Bayer, 568 F.2d 1357, 196 USPQ 670 (CCPA 1978) and MPEP § 2128.01, subsection I.); a poster display or other information disseminated at a scientific meeting (see, e.g., In re Klopfenstein, 380 F.3d 1345, 72 USPQ2d 1117 (Fed. Cir. 2004), Massachusetts Institute of Technology v. AB Fortia, 774 F.2d 1104, 227 USPQ 428 (Fed. Cir. 1985), Jazz Pharm., Inc. v. Amneal Pharm., LLC, 895 F.3d 1347,127 USPQ2d 1485 (Fed. Cir. 2018), and MPEP § 2128.01, subsection IV.); subject matter in a laid-open patent application or patent (see, e.g., In re Wyer, 655 F.2d 221, 210 USPQ 790 (CCPA 1981); see also Bruckelmyer v. Ground Heaters, Inc., 445 F.3d 1374, 78 USPQ2d 1684 (Fed. Cir. 2006)); a document electronically posted on the Internet (see, e.g., Voter Verified, Inc. v. Premier Election Solutions, Inc., 698 F.3d 1374, 104 USPQ2d 1553 (Fed. Cir. 2012), In re Lister, 583 F.3d 1307, 92 USPQ2d 1225 (Fed. Cir. 2009), SRI Int'l, Inc. v. Internet Sec. Sys., Inc., 511 F.3d 1186, 85 USPQ2d 1489 (Fed. Cir. 2008), and MPEP § 2128); or a commercial transaction that does not constitute a sale under the Uniform Commercial Code (see, e.g., Group One, Ltd. v. Hallmark Cards, Inc., 254 F.3d 1041, 59 USPQ2d 1121 (Fed. Cir. 2001) and MPEP § 2133.03(e)(1)). Even if a document or other disclosure is not a printed publication, or a transaction is not a sale, either may be prior art under the "otherwise available to the public" provision of AIA 35 U.S.C. 102(a)(1), provided that the claimed invention is made sufficiently available to the public.
2152.02(f) No Requirement of "By Others" [R-11.2013]
[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 § 2131-MPEP § 2138 for examination of applications subject to pre-AIA 35 U.S.C. 102.]
A key difference between pre-AIA 35 U.S.C. 102(a) and AIA 35 U.S.C. 102(a)(1) is the requirement in pre-AIA 35 U.S.C. 102(a) that the prior art relied on was "by others." Under AIA 35 U.S.C. 102(a)(1), there is no requirement that the prior art relied upon be by others. Thus, any prior art which falls under AIA 35 U.S.C. 102(a)(1) need not be by another to constitute potentially available prior art. However, disclosures of the subject matter made one year or less before the effective filing date of the claimed invention by the inventor or a joint inventor or another who obtained the subject matter directly or indirectly from the inventor or a joint inventor may fall within an exception under AIA 35 U.S.C. 102(b)(1) to AIA 35 U.S.C. 102(a)(1).