If a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent.

If both the application under examination and the reference application have the same patent term filing date, the provisional nonstatutory double patenting rejection made in each application should be maintained until it is overcome. Provisional nonstatutory double patenting rejections are subject to the requirements of 37 CFR 1.111(b). Thus, applicant can overcome a provisional nonstatutory double patenting rejection by filing a reply that either shows that the claims subject to the rejection are patentably distinct from the claims of the reference application, or includes a compliant terminal disclaimer under 37 CFR 1.321  that obviates the rejection. If the reply is sufficient, the examiner will withdraw the nonstatutory double patenting rejection in the application in which it was submitted.

If a provisional nonstatutory double patenting rejection is the only rejection remaining in an application, and that application has the later patent term filing date, the rejection should be maintained until applicant overcomes the rejection. Replies to overcome the rejection are discussed in subsection (ii) above.

If a decision by the Patent Trial and Appeal Board does not include an opinion on a provisional nonstatutory double patenting rejection, and includes a reversal of all other grounds as to a claim rejected based on provisional nonstatutory double patenting, and the applicant has not filed a proper terminal disclaimer, the examiner must act upon the provisional nonstatutory double patenting rejection. The examiner must first determine if any reference application used in the provisional nonstatutory double patenting rejection has issued as a patent. If the reference application has issued, the provisional rejection should be re-issued as a nonprovisional rejection and a terminal disclaimer should be required, for example, by using form paragraphs 8.33-8.39 as appropriate. See MPEP § 804, subsection II.B. The rejection may be made final, if otherwise appropriate. If the reference application has been abandoned or where the reference application has not matured to a patent and the provisional double patenting rejection is the only remaining rejection in the application, the examiner should withdraw the provisional rejection. See MPEP § 1214.06.

For design applications, patent term is measured from the issue date, and therefore, the determination of the patent term filing date is not necessary. If a provisional double patenting rejection (statutory or nonstatutory) is the only rejection remaining in the earlier filed of the two conflicting design applications, the examiner should withdraw that rejection and permit that application to issue as a patent. The examiner should maintain the provisional double patenting rejection in the later filed application and that rejection will be converted into a double patenting rejection when the allowed application issues as a patent unless the rejection has already been obviated. If both conflicting applications were filed on the same date, the provisional double patenting rejection made in each application should be maintained until it is overcome. See also MPEP § 804.03, subsection IV, to resolve issues in applications that name different inventors and claim indistinct inventions.

For double patenting analysis involving a utility or plant application filed prior to June 8, 1995, examiners should consult with their TQAS or SPE to determine if any of the provisional nonstatutory double patenting rejections should be withdrawn or not made. Likewise, for double patenting analysis for a utility or plant application and a reference design application or vice versa, examiners should consult with their TQAS or SPE to determine if any of the provisional nonstatutory double patenting rejections should be withdrawn or not made.

A terminal disclaimer cannot be filed to obviate a statutory double patenting rejection. A statutory double patenting rejection can be overcome by canceling or amending the conflicting claims so they are no longer coextensive in scope. A complete response to a statutory double patenting rejection is either a reply by applicant showing that the claims subject to the rejection are not the same as the reference claims, an amendment in response to the statutory double patenting rejection, or cancelation of the conflicting claims. Such a response is required even when the statutory double patenting rejection is provisional.

When two or more utility or plant patent applications, filed on or after June 8, 1995, each contain a provisional statutory double patenting rejection, and that is the only rejection remaining in the application having the earliest patent term filing date, the examiner should withdraw the rejection in the application having the earliest patent term filing date and permit that application to issue as a patent, thereby converting the provisional statutory double patenting rejection in the other application(s) into a statutory double patenting rejection when the application with the earliest patent term filing date issues as a patent.

If a provisional statutory double patenting rejection is the only rejection remaining in an application, and that application has a patent term filing date that is later than, or the same as, the patent term filing date of at least one of the reference application(s), the rejection should be maintained until applicant overcomes the rejection. In accordance with 37 CFR 1.111(b), applicant’s reply must present arguments pointing out the specific distinctions believed to render the claims, including any amended or newly presented claims, patentable over any applied references.

For design applications and utility or plant applications filed prior to June 8, 1995, see subsection I.B.1(c) above for guidance on maintaining or withdrawing provisional statutory double patenting rejections.

Double patenting may exist where a published patent application and an application share the same inventive entity, at least one common (joint) inventor, a common applicant, and/or a common owner/assignee. Double patenting may also exist where a published application and an application claim inventions resulting from activities undertaken within the scope of a joint research agreement as defined in 35 U.S.C. 102(c)  or pre-AIA 35 U.S.C. 103(c)(2) and (3). If the published application has not yet issued as a patent, the examiner is permitted to make a provisional rejection on the ground of double patenting when the published application has not been abandoned and claims pending therein conflict with claims of the application being examined. See the discussion regarding provisional double patenting rejections in subsection B. above.

When a potential nonstatutory double patenting situation arises between two related patents (as in a reissue or reexamination), it is necessary to determine whether the patents are subject to the same patent term statutory law. Section 532(a)(1) of the Uruguay Round Agreements Act (URAA) (Pub. L. No. 103-465, 108 Stat. 4809, 4983 (1994)) amended 35 U.S.C. 154  to provide that the term of a plant or utility patent issuing from an original application filed on or after June 8, 1995, i.e., a post-URAA patent, begins on the date the patent issues and ends on the date that is twenty years from the date on which the application for the patent was filed in the United States or, if the application contains a specific reference to an earlier filed application or applications under 35 U.S.C. 120, 121, or 365(c), twenty years from the filing date of the earliest of such application(s) (excluding any terminal disclaimers or any patent term adjustment or extension). 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)." See MPEP § 2701.

A plant or utility patent that was in force on June 8, 1995, or that issued on an application that was filed before June 8, 1995, i.e., a pre-URAA patent, has a term that is the greater of twenty years from the date on which the application for the patent was filed in the United States or, if the application contains a specific reference to an earlier filed application or applications under 35 U.S.C. 120, 121, or 365(c), twenty years from the filing date of the earliest of such application(s) or seventeen years from the patent grant. Filing for reissue on or after June 8, 1995 of a patent issued on an original application filed prior to June 8, 1995 does not change the patent term of the patent or the reissued patent. See MPEP §§ 1405 and 2701 for more information.

"[T]he proper reference point for an obviousness-type double patenting inquiry is the expiration date of the patent in question." Novartis Pharms. v. Breckenridge Pharm., 909 F.3d 1355, 1362-63, 128 USPQ2d 1745, 1747 (Fed. Cir. 2018) (citing Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208, 1215, 110 USPQ2d 1551, 1558 (Fed. Cir. 2014)).

Where both the patent under examination (via a reexamination proceeding or a reissue application) and the reference patent are post-URAA, "an earlier-expiring patent can qualify as an obviousness-type double patenting reference for a later-expiring patent." Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208, 1217, 110 USPQ2d 1551, 1558 (Fed. Cir. 2014). See also Novartis Pharms. v. Breckenridge Pharm., 909 F.3d 1355, 1360, 128 USPQ2d 1745, 1747 (Fed. Cir. 2018) (Gilead "holds that a later-filed but earlier-expiring patent can serve as a double-patenting reference for an earlier-filed but later-expiring patent in the post-URAA context."). However, where at least one of the patent under examination (via a reexamination proceeding or a reissue application) or the reference patent is pre-URAA, the patent with the earlier issuance date is available as a reference against a patent with a later issuance date "because, under the law pre-URAA, the expiration date of the patent was inextricably intertwined with the issuance date." Id. at 1362, 128 USPQ2d at 1749. Based on the particular facts in Novartis, the court held that the post-URAA patent that expired prior to the pre-URAA patent is not a proper nonstatutory double patenting reference for the pre-URAA patent. Id. at 1367, 128 USPQ2d at 1752 ("To find that obviousness-type double patenting applies here because a post-URAA patent expires earlier would abrogate Novartis’s right to enjoy one full patent term on its invention."). An examiner should consult with the TC Quality Assurance Specialist if an otherwise proper nonstatutory double patenting rejection is not being made based on Novartis.

See MPEP § 804.05 for information regarding the impact of patent term extension on a double patenting analysis.

A double patenting issue may raise a substantial new question of patentability of a claim of a patent, and thus can be addressed in a reexamination proceeding. In re Lonardo, 119 F.3d 960, 966, 43 USPQ2d 1262, 1266 (Fed. Cir. 1997) (In giving the Director authority under 35 U.S.C. 303(a)  to determine the presence of a substantial new question of patentability, "Congress intended that the phrases ‘patents and publications’ and ‘other patents or publications’ in section 303(a)  not be limited to prior art patents or printed publications.") (emphasis added). Accordingly, if the same issue of double patenting was not addressed during original prosecution, it may be considered during reexamination.

Double patenting may exist where a reference patent or application and the patent under reexamination share the same inventive entity, at least one common (joint) inventor, a common applicant, and/or a common owner/assignee. Where the patent under reexamination was granted on or after December 10, 2004, double patenting may also exist where the inventions claimed in the reference and reexamination proceeding resulted from activities undertaken within the scope of a joint research agreement pursuant to 35 U.S.C. 102(c)  or pre-AIA 35 U.S.C. 103(c)(2) and (3), as applicable, and if evidence of the joint research agreement has been made of record in the patent being reexamined or in the reexamination proceeding. A double patenting rejection may NOT be made on this basis if the patent under reexamination issued before December 10, 2004. See MPEP § 804.03.

The prior art exception under 35 U.S.C. 102(b)(2)(C)  or disqualification under pre-AIA 35 U.S.C. 103(c)  generally cannot be used to overcome a double patenting rejection, whether statutory or nonstatutory. However, since a secondary reference used to support an obviousness analysis for a nonstatutory double patenting rejection must be prior art, a reference excepted under 35 U.S.C. 102(b)(2)(C)  cannot be used as a secondary reference in a nonstatutory double patenting rejection. See MPEP §§ 717.02 et seq. and 2154.02(c) for more information on 35 U.S.C. 102(b)(2)(C)  and MPEP § 2146 for more information on pre-AIA 35 U.S.C. 103(c). See MPEP § 2258 for more information on making double patenting rejections in reexamination proceedings. Subsection II, below, describes situations wherein a double patenting rejection would be appropriate. In particular, see paragraph II.B. for the analysis required to determine the propriety of a nonstatutory double patenting rejection.

When a double patenting rejection is appropriate, it must be based either on statutory grounds or nonstatutory grounds. The ground of rejection employed depends upon the relationship of the inventions being claimed. Generally, a double patenting rejection is not permitted where the claimed subject matter is presented in a divisional application as a result of a restriction requirement made in a parent application under 35 U.S.C. 121.

Where the claims of an application are the same as those of a first patent, they are barred under 35 U.S.C. 101  - the statutory basis for a double patenting rejection. A rejection based on double patenting of the "same invention" finds its support in the language of 35 U.S.C. 101  which states that "whoever invents or discovers any new and useful process ... may obtain a patent therefor ..." (emphasis added). Thus, the term "same invention," in this context, means an invention drawn to identical subject matter. 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).

Where the claims of an application are not the "same" as those of a first patent, but the grant of a patent with the claims in the application would unjustly extend the rights granted by the first patent, a double patenting rejection under nonstatutory grounds is proper.

In determining whether a proper basis exists to enter a double patenting rejection, the examiner must determine the following:

• (A) Whether a statutory basis exists;
• (B) Whether a nonstatutory basis exists; and
• (C) Whether a nonstatutory double patenting rejection is prohibited by the third sentence of 35 U.S.C. 121  (see MPEP § 804.01; if such a prohibition applies, a nonstatutory double patenting rejection cannot be made).

Each determination must be made on the basis of all the facts in the application before the examiner. The charts in MPEP § 804 illustrate the methodology of making such a determination.

Domination and double patenting should not be confused. They are two separate issues. One patent or application "dominates" a second patent or application when the first patent or application has a broad or generic claim which fully encompasses or reads on an invention defined in a narrower or more specific claim in another patent or application. Domination by itself, i.e., in the absence of statutory or nonstatutory double patenting grounds, cannot support a double patenting rejection. In re Kaplan, 789 F.2d 1574, 1577-78, 229 USPQ 678, 681 (Fed. Cir. 1986); In re Sarett, 327 F.2d 1005, 1014-15, 140 USPQ 474, 482 (CCPA 1964). However, the presence of domination does not preclude a double patenting rejection. See, e.g., In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968); see also AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014).

In determining whether a statutory basis for a double patenting rejection exists, the question to be asked is: Is the same invention being claimed twice? 35 U.S.C. 101  prevents two patents from issuing on the same invention. "Same invention" means identical subject matter. 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).

A reliable test for double patenting under 35 U.S.C. 101  is whether a claim in the application could be literally infringed without literally infringing a corresponding claim in the patent. In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970). Is there an embodiment of the invention that falls within the scope of one claim, but not the other? If there is such an embodiment, then identical subject matter is not defined by both claims and statutory double patenting would not exist. For example, the invention defined by a claim reciting a compound having a "halogen" substituent is not identical to or substantively the same as a claim reciting the same compound except having a "chlorine" substituent in place of the halogen because "halogen" is broader than "chlorine." On the other hand, claims may be differently worded and still define the same invention. Thus, a claim reciting a widget having a length of "36 inches" defines the same invention as a claim reciting the same widget having a length of "3 feet."

If it is determined that the same invention is being claimed twice, 35 U.S.C. 101  precludes the grant of the second patent regardless of the presence or absence of a terminal disclaimer. Id.

Form paragraphs 8.30 and 8.31 (between an issued patent and one or more applications) or 8.32 (provisional rejections) may be used to make statutory double patenting rejections.

If the "same invention" is not being claimed twice, an analysis must be made to determine whether a nonstatutory basis for double patenting exists.

A rejection based on nonstatutory double patenting is based on a judicially created doctrine grounded in public policy so as to prevent the unjustified or improper timewise extension of the right to exclude granted by a patent. In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969); In re White, 405 F.2d 904, 160 USPQ 417 (CCPA 1969); In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968); In re Sarett, 327 F.2d 1005, 140 USPQ 474 (CCPA 1964). A double patenting rejection also serves public policy interests by preventing the possibility of multiple suits against an accused infringer by different assignees of patents claiming patentably indistinct variations of the same invention. In re Van Ornum, 686 F.2d 937, 944-48, 214 USPQ 761, 767-70 (CCPA 1982).

A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985). In determining whether a nonstatutory basis exists for a double patenting rejection, the first question to be asked is: Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed in the patent? If the answer is yes, then a nonstatutory double patenting rejection may be appropriate. To decide the question above, the examiner should first construe the claim(s) in the application under examination and the claim(s) in the reference application or patent to determine what are the differences. Then the examiner should determine whether those differences render the claims patentably distinct using an anticipation analysis and/or an obviousness analysis. See Pfizer, Inc. v. Teva Pharms. USA, Inc., 518 F.3d 1353, 1363, 86 USPQ2d 1001, 1008 (Fed. Cir. 2008).

Nonstatutory double patenting also requires rejection of an application claim when the claimed subject matter is not patentably distinct from the subject matter claimed in a commonly owned patent, or a non-commonly owned patent but subject to a joint research agreement as set forth in 35 U.S.C. 102(c)  or pre-AIA 35 U.S.C. 103(c)(2) and (3), when the issuance of a second patent would provide unjustified extension of the term of the right to exclude granted by a patent. See Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 58 USPQ2d 1869 (Fed. Cir. 2001); Ex parte Davis, 56 USPQ2d 1434, 1435-36 (Bd. Pat. App. & Inter. 2000).

When considering whether the invention defined in a claim of an application would have been anticipated by or is an obvious variation of the invention defined in the claim of a patent or copending application, no part of the reference patent or application may be used as if it were prior art. General Foods Corp. v. Studiengesellschaft Kohle mbH, 972 F.2d 1272, 1281, 23 USPQ2d 1839, 1846 (Fed. Cir. 1992) ("Our precedent makes clear that the disclosure of a patent cited in support of a double patenting rejection cannot be used as though it were prior art, even where the disclosure is found in the claims"). This does not mean that one is precluded from all use of the reference patent or application disclosure to understand the meaning of the reference claims.

The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999) ("[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning."); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) ("Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings."). "The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ " Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364, 70 USPQ2d 1827, 1830 (Fed. Cir. 2004); see also MPEP § 2111.01. Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because only "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).

To avoid improperly treating what is disclosed in a reference patent or copending application as if it were prior art in the context of a nonstatutory double patenting analysis, the examiner must first properly construe the scope of the reference claims. The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02. If claims to the compound’s use and the compound were subject to a restriction requirement, and the compound was elected, a nonstatutory double patenting rejection may not be appropriate in a divisional application claiming the restricted compound’s use. See MPEP § 804.01. However, subject matter disclosed in the reference patent or application that does not fall within the scope of a reference claim cannot be used to support a nonstatutory double patenting rejection as this would effectively be treating the reference patent or application as prior art.

Properly construing the reference claims does not complete the nonstatutory double patenting analysis. It merely provides a determination as to how the earlier issued claim should be understood in making a nonstatutory double patenting rejection. To do a full analysis to determine whether a nonstatutory double patenting rejection should be made, one must go through the "anticipation analysis" and "obviousness analysis" noted below, and consider the "nonstatutory double patenting rejection based on equitable principles" discussed in subsection II.B.6 below.

In construing the claims of the reference patent or application, a determination is made as to whether a portion of the specification, including the drawings and claims, is directed to subject matter that is within the scope of a reference claim. For example, assume that the claim in a reference patent is directed to a genus of compounds, and the application being examined is directed to a species within the reference patent genus. If the reference patent discloses several species within the scope of the reference genus claim, that portion of the disclosure should be analyzed to properly construe the reference patent claim and determine whether it anticipates or renders obvious the claim in the application being examined. Because that portion of the disclosure of the reference patent is an embodiment of the reference patent claim, it may be helpful in determining the full scope and obvious variations of the reference patent claim. As an alternative example, assume that the claim in the reference patent is directed to a genus of compounds, and the application being examined is directed to a method of making compounds within the genus. Further assume that the reference patent discloses a nearly identical method of making compounds within the genus. Here, the disclosed method of making the compounds in the reference patent does not fall within the scope of the genus of compounds claimed in the reference. Thus, the reference disclosure directed to the method of making the compounds cannot be used to construe the claim