804.02 Avoiding a Double Patenting Rejection [R-07.2022]
A rejection based on the statutory type of double patenting can be avoided by amending the conflicting claims so that they are not coextensive in scope. Where the conflicting claims are in one or more pending applications and a patent, a rejection based on statutory type double patenting can also be avoided by canceling the conflicting claims in all the pending applications. Where the conflicting claims are in two or more pending applications, a provisional rejection based on statutory type double patenting can also be avoided by canceling the conflicting claims in all but one of the pending applications. A terminal disclaimer is not effective in overcoming a statutory double patenting rejection.
The use of a 37 CFR 1.131(a) affidavit in overcoming a statutory double patenting rejection is inappropriate. In re Dunn, 349 F.2d 433, 146 USPQ 479 (CCPA 1965). Knell v. Muller, 174 USPQ 460 (Comm’r. Pat. 1971) (citing the CCPA decisions in In re Ward, 236 F.2d 428, 111 USPQ 101 (CCPA 1956); In re Teague, 254 F.2d 145, 117 USPQ 284 (CCPA 1958); and In re Hidy, 303 F.2d 954, 133 USPQ 650 (CCPA 1962)).
II. NONSTATUTORY
A rejection based on a nonstatutory type of double patenting can be avoided by filing a terminal disclaimer in the application or proceeding in which the rejection is made. In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Knohl, 386 F.2d 476, 155 USPQ 586 (CCPA 1967); and In re Griswold, 365 F.2d 834, 150 USPQ 804 (CCPA 1966). The use of a terminal disclaimer in overcoming a nonstatutory double patenting rejection is in the public interest because it encourages the disclosure of additional developments, the earlier filing of applications, and the earlier expiration of patents whereby the inventions covered become freely available to the public. In re Jentoft, 392 F.2d 633, 157 USPQ 363 (CCPA 1968); In re Eckel, 393 F.2d 848, 157 USPQ 415 (CCPA 1968); In re Braithwaite, 379 F.2d 594, 154 USPQ 29 (CCPA 1967). Note that a terminal disclaimer filed after the expiration of the reference patent is not effective to obviate a nonstatutory double patenting rejection. See Boehringer Ingelheim Int’l v. Barr Laboratories, 592 F.3d 1340, 93 USPQ2d 1417 (Fed. Cir. 2010). See also MPEP § 1490, subsection VI.A. A disclaimer filed in a reference patent that has an earlier expiration date and that disclaims the patentably indistinct claim(s) would have no impact on whether a nonstatutory double patenting rejection is proper in a patent that has, or an application for a patent that would have, a later expiration date. Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 967 n.5, 58 USPQ2d 1869, 1878 n.5 (Fed. Cir. 2001)(“A patent owner cannot avoid double patenting by disclaiming the earlier patent.”).
The use of a 37 CFR 1.131(a) affidavit in overcoming a double patenting rejection is inappropriate because the claim or claims in the application are being rejected over a patent which claims the rejected invention. In re Dunn, 349 F.2d 433, 146 USPQ 479 (CCPA 1965). 37 CFR 1.131(a) is inapplicable if the claims of the application and the patent are “directed to substantially the same invention.” It is also inapplicable if there is a lack of “patentable distinctness” between the claimed subject matter. Knell v.Muller, 174 USPQ 460 (Comm’r. Pat. 1971) (citing the court decisions in In re Ward, 236 F.2d 428, 111 USPQ 101 (CCPA 1956); In re Teague, 254 F.2d 145, 117 USPQ 284 (CCPA 1958); and In re Hidy, 303 F.2d 954, 133 USPQ 65 (CCPA 1962)).
A patentee or applicant may disclaim or dedicate to the public the entire term, or any terminal part of the term of a patent. 35 U.S.C. 253. The statute does not provide for a terminal disclaimer of only a specified claim or claims. The terminal disclaimer must operate with respect to all claims in the patent.
The filing of a terminal disclaimer to obviate a rejection based on nonstatutory double patenting is not an admission of the propriety of the rejection. Quad Environmental Technologies Corp. v. Union Sanitary District, 946 F.2d 870, 20 USPQ2d 1392 (Fed. Cir. 1991). In Quad Environmental Technologies, the court indicated that the “filing of a terminal disclaimer simply serves the statutory function of removing the rejection of double patenting, and raises neither a presumption nor estoppel on the merits of the rejection.”
A terminal disclaimer filed to obviate a nonstatutory double patenting rejection is effective only with respect to the application identified in the disclaimer, unless by its terms it extends to continuing applications. If an appropriate provisional nonstatutory double patenting rejection is made in each of two or more pending applications, the examiner should follow the practice set forth in MPEP § 804, subsection I.B.1. and subsection VI. below.
35 U.S.C. 101 prevents two patents from issuing on the same invention. “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). Claims that differ from each other (aside from minor differences in language, punctuation, etc.), whether or not the difference would have been obvious, are not considered to be drawn to the same invention for double patenting purposes under 35 U.S.C. 101. In cases where the difference in claims would have been obvious, terminal disclaimers are effective to overcome nonstatutory double patenting rejections. Such terminal disclaimers must include a provision that the patent shall be unenforceable if it ceases to be commonly owned or enforced with the other application or patent. Note 37 CFR 1.321(c) and (d). 37 CFR 1.321(d) sets forth the requirements for a terminal disclaimer where the claimed invention resulted from activities undertaken within the scope of a joint research agreement. It should be emphasized that a terminal disclaimer cannot be used to overcome a prior art rejection under 35 U.S.C. 102 or 103.
A nonstatutory double patenting rejection may also be avoided if consonance between the originally restricted inventions is maintained in a divisional application. “Section 121 shields claims against a double patenting challenge if consonance exists between the divided groups of claims and an earlier restriction requirement.” Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1381, 68 USPQ2d 1865, 1871 (Fed. Cir. 2003). “Consonance requires that the line of demarcation between the ‘independent and distinct inventions’ that prompted the restriction requirement be maintained … Where that line is crossed the prohibition of the third sentence of Section 121 does not apply.” Symbol Techs, Inc. v. Opticon, Inc., 935 F.2d 1569, 1579, 19 USPQ2d 1241, 1249 (Fed. Cir. 1991) (quoting Gerber Garment Technology Inc. v. Lectra Systems Inc., 916 F.2d 683, 688, 16 USPQ2d 1436, 1440 (Fed. Cir. 1990)). “However, even if such consonance is lost, double patenting does not follow if the requirements of Section 121 are met or if the claims are in fact patentably distinct … The purpose of Section 121 is to accommodate administrative convenience and to protect the patentee from technical flaws based on this unappealable examination practice.” Applied Materials Inc. v. Advanced Semiconductor Materials, 98 F.3d 1563, 1568, 40 USPQ2d 1481, 1484 (Fed. Cir. 1996).
III. TERMINAL DISCLAIMER REQUIRED DESPITE REQUEST TO ISSUE ON COMMON ISSUE DATE
Applicants are cautioned that reliance upon a common issue date cannot effectively substitute for the filing of one or more terminal disclaimers in order to overcome a proper nonstatutory double patenting rejection, particularly since a common issue date alone does not avoid the potential problems of dual ownership by a common assignee, or by parties to a joint research agreement, of patents to patentably indistinct inventions. In any event, the Office cannot ensure that two or more applications will have a common issue date.
IV. DISCLAIMING MULTIPLE DOUBLE PATENTING REFERENCES
If multiple conflicting patents and/or pending applications are applied in nonstatutory double patenting rejections made in a single application, then prior to issuance of that application, it is necessary to disclaim the terminal part of any patent granted on the application which would extend beyond the expiration date of each one of the conflicting patents and/or applications. A terminal disclaimer fee is required for each terminal disclaimer filed. To avoid paying multiple terminal disclaimer fees, a single terminal disclaimer based on common ownership may be filed, for example, in which the term disclaimed is based on all the conflicting, commonly owned nonstatutory double patenting references. Similarly, a single terminal disclaimer based on a joint research agreement may be filed, in which the term disclaimed is based on all the conflicting nonstatutory double patenting references.
Each one of the commonly owned conflicting nonstatutory double patenting references must be included in the terminal disclaimer to avoid the problem of dual ownership of patents to patentably indistinct inventions in the event that the patent issuing from the application being examined ceases to be commonly owned with any one of the double patenting references that have issued or may issue as a patent. Note that 37 CFR 1.321(c)(3) requires that a terminal disclaimer for commonly owned conflicting claims “[i]nclude a provision that any patent granted on that application or any patent subject to the reexamination proceeding shall be enforceable only for and during such period that said patent is commonly owned with the application or patent which formed the basis for the judicially created double patenting.”
Filing a terminal disclaimer including each one of the conflicting nonstatutory double patenting references is also necessary to avoid the problem of separate enforcement of patents to patentably indistinct inventions by parties to a joint research agreement. 37 CFR 1.321(d) sets forth the requirements for a terminal disclaimer where the claimed invention resulted from activities undertaken within the scope of a joint research agreement.
V. REQUIREMENTS OF A TERMINAL DISCLAIMER
A terminal disclaimer is a statement filed by an owner (in whole or in part) of a patent or a patent to be granted that is used to disclaim or dedicate a portion of the entire term of all the claims of a patent. The requirements for a terminal disclaimer are set forth in 37 CFR 1.321. Sample forms of a terminal disclaimer, and guidance as to the filing and treatment of a terminal disclaimer, are provided in MPEP § 1490.
VI. TERMINAL DISCLAIMERS REQUIRED TO OVERCOME NONSTATUTORY DOUBLE PATENTING REJECTIONS IN APPLICATIONS FILED ON OR AFTER JUNE 8, 1995
Public Law 103-465 (1994) amended 35 U.S.C. 154(a)(2) to provide that any patent issuing on a utility or plant application filed on or after June 8, 1995 will expire 20 years from its actual filing date, or, if the application claims the benefit of an earlier filed application under 35 U.S.C. 120, 121, or 365(c), 20 years from the earliest filing date for which a benefit under 35 U.S.C. 120, 121, or 365(c) is claimed. The Patent Law Treaties Implementation Act of 2012, Public Law 112-211, which implemented the provisions of the Hague Agreement, amended 35 U.S.C. 154(a)(2) to delete “section 120, 121, or 365(c)” and to insert “section 120, 121, 365(c), or 386(c)” and 35 U.S.C. 154(a)(3) to delete “section 119, 365(a), or 365(b)” and to insert “section 119, 365(a), 365(b), 386(a), or 386(b).” Therefore, any patent issuing on a continuing utility or plant application filed on or after June 8, 1995 will expire 20 years from the earliest filing date for which a benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c), subject to the provisions of 35 U.S.C. 154(b) and 156 (providing for certain patent term adjustments and extensions). Thus, situations will often arise in which two copending applications subject to a provisional double patenting rejection will have the same patent term filing date, and thus, potentially will have the same patent term. Note that a benefit claim under 35 U.S.C. 120, 121, 365(c), or 386(c) that meets the requirements of 37 CFR 1.78 determines the twenty year patent term for utility and plant applications filed on or after June 8, 1995. For patent term, it is not relevant if any claimed invention in the patent actually has 35 U.S.C. 112(a)) support in an earlier application and is therefore entitled to benefit of the earlier filing date for the purpose of avoiding prior art. See MPEP § 804, subsection I.B.1(a).
There are at least two reasons for insisting upon a terminal disclaimer to overcome a nonstatutory double patenting rejection in an application subject to a 20-year term under 35 U.S.C. 154(a)(2). First, 35 U.S.C. 154(b) includes provisions for patent term adjustment based upon prosecution delays during the application process. Thus, 35 U.S.C. 154 does not ensure that any patent issuing on a continuing utility or plant application filed on or after June 8, 1995 will necessarily expire 20 years from the earliest filing date for which a benefit is claimed under 35 U.S.C. 120, 121, 365(c) , or 386(c). However, 35 U.S.C. 154(b)(2)(B) states that no patent the term of which has been disclaimed beyond a specified date may be adjusted under this section beyond the expiration date specified in the disclaimer. As the presence of a terminal disclaimer affects whether the patent is granted an adjustment, it is necessary that the terminal disclaimer be filed in the application in order to accurately determine whether the patent is entitled to a term adjustment. Second, 37 CFR 1.321(c)(3) requires that a terminal disclaimer filed to obviate a nonstatutory double patenting rejection based on commonly owned conflicting claims include a provision that any patent granted on that application be enforceable only for and during the period that the patent is commonly owned with the application or patent which formed the basis for the rejection. 37 CFR 1.321(d) sets forth the requirements for a terminal disclaimer where the claimed invention resulted from activities undertaken within the scope of a joint research agreement and limits enforcement of the patent only to that period when the patent and the reference application or patent are not separately enforced. These requirements serve to avoid the potential for harassment of an accused infringer by multiple parties with patents covering the same patentable invention. See, e.g., In re Van Ornum, 686 F.2d 937, 944-48, 214 USPQ 761, 767-70 (CCPA 1982). Not insisting upon a terminal disclaimer to overcome a nonstatutory double patenting rejection in an application subject to a 20-year term under 35 U.S.C. 154(a)(2) would result in the potential for the problem that 37 CFR 1.321(c)(3) was promulgated to avoid. Further, as a terminal disclaimer is only effective in the application in which it is filed, it is necessary to require that the terminal disclaimer be filed in each application and/or patent that is subject to the common ownership requirement in order to provide complete notice to the public of this obligation.
Accordingly, a terminal disclaimer under 37 CFR 1.321 is required in an application to overcome a nonstatutory double patenting rejection, even if the application was filed on or after June 8, 1995 and even if the application claims the benefit under 35 U.S.C. 120, 121, 365(c), or 386(c) of the filing date of the patent or application which forms the basis for the rejection. Examiners should respond to arguments that a terminal disclaimer under 37 CFR 1.321 should not be required in a continuing application filed on or after June 8, 1995 to overcome a nonstatutory double patenting rejection due to the change to 35 U.S.C. 154 by citing to this section of the MPEP. See Terminal Disclaimers Required to Overcome Judicially-Created Double Patenting Rejections in Utility and Plant Applications Filed on or After June 8, 1995,1202 OG 112 (September 30, 1997). See also AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014).
If a terminal disclaimer is filed in an application in which the claims are then canceled or otherwise shown to be patentably distinct from the reference claims, the terminal disclaimer may be withdrawn before issuance of the patent by filing a petition under 37 CFR 1.182 requesting withdrawal of the recorded terminal disclaimer. A terminal disclaimer may not be withdrawn after issuance of the patent. See MPEP § 1490, subsection VIII, for a complete discussion of withdrawal of a terminal disclaimer.