804.01 Prohibition of Nonstatutory Double Patenting Rejections Under 35 U.S.C. 121 [R-10.2019]
35 U.S.C. 121 authorizes the Director to restrict the claims in a patent application to a single invention when independent and distinct inventions are presented for examination. The third sentence of 35 U.S.C. 121 prohibits the use of a patent issuing on an application in which a requirement for restriction has been made, or on an application filed as a result of such a requirement, as a reference against any divisional application in a nonstatutory double patenting rejection, if the divisional application is filed before the issuance of the patent. The 35 U.S.C. 121 prohibition applies only where the Office has made a requirement for restriction. The prohibition does not apply where the divisional application was voluntarily filed by the applicant and not in response to an Office requirement for restriction. The U.S. Court of Appeals for the Federal Circuit has concluded that the protection of 35 U.S.C. 121 does not extend to all types of continuing applications, stating that “the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications.” Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353, 1362, 86 USPQ2d 1001, 1007-1008 (Fed. Cir. 2008). Note that a patentee cannot retroactively recover the safe harbor protection of 35 U.S.C. 121 against nonstatutory double patenting by amending a patent that issued from a continuation-in-part application to only subject matter in the parent application and redesignating the CIP as a divisional of the parent application. See In re Janssen Biotech, Inc., 880 F.3d 1315, 1322, 125 USPQ2d 1525, 1529-30 (Fed. Cir. 2018)( “[A] patent owner cannot retroactively bring its challenged patent within the scope of the safe-harbor provision by amendment in a reexamination proceeding.”); G.D. Searle LLC v. Lupin Pharm., Inc., 790 F.3d 1349, 1355, 115 USPQ2d 1326, 1330 (Fed. Cir. 2015)(“Simply deleting that new matter from the reissue patent does not retroactively alter the nature of the [ ] application.”).
This apparent nullification of nonstatutory double patenting as a ground of rejection or invalidity in divisional applications imposes a heavy burden on the Office to guard against erroneous requirements for restrictions where the claims define essentially the same invention in different language and where acquiescence to the restriction requirement might result in the issuance of several patents for the same invention. “[I]f an examiner issues a restriction requirement between patentably indistinct claims, two patents may issue and prolong patent protection beyond the statutory term on obvious variants of the same invention. This prolongation would occur because § 121 would immunize the restricted application against nonstatutory double patenting rejections.” Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1379, 68 USPQ2d 1865, 1869 (Fed. Cir. 2003). “[W]hen the existence of multiple patents is due to the administrative requirements imposed by the Patent and Trademark Office, 35 U.S.C. Section 121 provides that the inventor shall not be prejudiced by having complied with those requirements. Thus when two or more patents result from a PTO restriction requirement, whereby aspects of the original application must be divided into separate applications, Section 121 insulates the ensuing patents from the charge of double patenting.” Applied Materials Inc. v. Advanced Semiconductor Materials, 98 F.3d 1563, 1568, 40 USPQ2d 1481, 1484 (Fed. Cir. 1996) (citing Studiengesellschaft Kohle mbH v. Northern Petrochemical Co., 784 F.2d 351, 354, 228 USPQ 837, 840 (Fed. Cir. 1986)).
The prohibition against holdings of nonstatutory double patenting applies to requirements for restriction between independent or distinct inventions, such as the related subject matter treated in MPEP § 806.04 through § 806.05(j), namely, between a combination and a subcombination thereof, between subcombinations disclosed as usable together, between a process and an apparatus for its practice, between a process and a product made by such process and between an apparatus and a product made by such apparatus, etc., so long as the claims in each application are filed as a result of such requirement.
The following are situations where the prohibition against nonstatutory double patenting rejections under 35 U.S.C. 121 does not apply:
- (A) The applicant voluntarily files two or more applications without a restriction requirement by the examiner. In order to obtain the benefit of 35 U.S.C. 121, claims must be formally entered, restricted in, and removed from an earlier application before they are filed in a divisional application . Geneva Pharms. Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1379, 68 USPQ2d 1865, 1870 (Fed. Cir. 2003) (For claims that were not in the original application and are first formally entered in a later divisional application, 35 U.S.C. 121 “does not suggest that the original application merely needs to provide some support for claims that are first entered formally in the later divisional application.” Id.); In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968).
- (B) The claims of the application under examination and claims of the other application/patent are not consonant with the restriction requirement made by the examiner, since the claims have been changed in material respects from the claims at the time the requirement was made. For example, the divisional application filed includes additional claims not consonant in scope with the original claims subject to restriction in the parent. Symbol Technologies, Inc. v.Opticon, Inc., 935 F.2d 1569, 19 USPQ2d 1241 (Fed. Cir. 1991); Gerber Garment Technology, Inc. v. Lectra Systems, Inc., 916 F.2d 683, 16 USPQ2d 1436 (Fed. Cir. 1990). In order for consonance to exist, the line of demarcation between the independent and distinct inventions identified by the examiner in the requirement for restriction must be maintained. 916 F.2d at 688, 16 USPQ2d at 1440.
- (C) The restriction requirement was withdrawn because the requirement was written in a manner which made it clear to applicant that the requirement was made subject to the nonallowance of generic or other linking claims and such generic or linking claims are subsequently allowed.
- (D) The requirement for restriction (holding of lack of unity of invention) was only made in an international application by the International Searching Authority or the International Preliminary Examining Authority. However, the prohibition against nonstatutory double patenting rejections does apply to requirements for restriction (lack of unity of invention holdings) made in national stage applications submitted under 35 U.S.C. 371.
- (E) The requirement for restriction was withdrawn, in its entirety or in part, by the examiner before the patent issues. With the withdrawal of the restriction requirement, the non-elected claims that are no longer withdrawn from consideration become subject to examination. “The restriction requirement disappears; it is as though it had not been made. With the disappearance of the restriction requirement, the need for a divisional application and the need for the [double patenting] prohibition also disappear.”In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 132 (CCPA 1971). Note that a restriction requirement in an earlier-filed application does not carry over to claims of a continuation application in which the examiner does not reinstate or refer to the restriction requirement in the parent application. Reliance on a patent issued from such a continuation application to reject claims in a later-filed divisional application is not prohibited under 35 U.S.C. 121. Bristol-Myers Squibb Co. v. Pharmachemie BV, 361 F.3d 1343, 1348, 70 USPQ2d 1097, 1100 (Fed. Cir. 2004).
- (F) The claims of the second application are drawn to the “same invention” as the first application or patent. Studiengesellschaft Kohle mbH v. Northern Petrochemical Co., 784 F.2d 351, 228 USPQ 837 (Fed. Cir. 1986). A statutory double patenting rejection under 35 U.S.C. 101 should be made, thus it is not necessary to determine whether the 35 U.S.C. 121 prohibition against making double patenting rejections is applicable. “Same invention” means identical subject matter. See, e.g., Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957). The 35 U.S.C. 121 prohibition against certain nonstatutory double patenting rejections does not apply to statutory double patenting rejections under 35 U.S.C. 101 of claims to the “same invention.”
- (G) Where a requirement for restriction between a product, a process of making the product, and a process of using the product was made subject to the non-allowance of the product and the product is subsequently allowed. In this situation if any process claims are rejoined, the restriction requirement between the elected product and any rejoined process should be withdrawn in accordance with 37 CFR 1.141(b) and MPEP § 821.04.
- (H) The second application is a continuation-in-part (CIP) application that includes claims restricted from the original application. A CIP, by definition, is an application filed during the lifetime of an earlier application by at least one common inventor that repeats some substantial portion or all of the earlier application and adds matter not disclosed in the earlier application, i.e., the application in which the restriction requirement was originally made. 35 U.S.C. 121 refers specifically and only to divisional and original applications, and does not afford protection to CIP applications. Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353, 1362, 86 USPQ2d 1001, 1007-08 (Fed. Cir. 2008). See also In re Janssen Biotech, Inc., 880 F.3d 1315, 1322,125 USPQ2d 1525, 1529-30 (Fed. Cir. 2018) and G.D. Searle LLC v. Lupin Pharm., Inc., 790 F.3d 1349, 1355, 115 USPQ2d 1326, 1330 (Fed. Cir. 2015).
35 U.S.C. 121 does not prevent a double patenting rejection when the identical invention is claimed in the divisional application and the application/patent in which a restriction requirement was made. While identical claims should not arise if appropriate care is exercised in defining the independent and distinct inventions in a restriction requirement, if they do, the Office will make the statutory (35 U.S.C. 101) double patenting rejection because the patentee is entitled only to a single patent for an invention. As expressed in Studiengesellschaft Kohle, 784 F.2d at 361, 228 USPQ at 844, (J. Newman, concurring), “35 U.S.C. 121 of course does not provide that multiple patents may be granted on the identical invention.”