804 Definition of Double Patenting [R-07.2022]

The doctrine of double patenting seeks to prevent the unjustified extension of patent exclusivity beyond the term of a patent. The public policy behind this doctrine is that:

The public should . . . be able to act on the assumption that upon the expiration of the patent it will be free to use not only the invention claimed in the patent but also modifications or variants which would have been obvious to those of ordinary skill in the art at the time the invention was made, taking into account the skill in the art and prior art other than the invention claimed in the issued patent.

In re Zickendraht, 319 F.2d 225, 232, 138 USPQ 22, 27 (CCPA 1963) (Rich, J., concurring). Double patenting results when the right to exclude granted in one patent is unjustly extended by the grant of another patent or patents. In re Van Ornum, 686 F.2d 937, 943-44, 214 USPQ 761, 766-67 (CCPA 1982).

Some commonality of inventorship or (deemed) ownership must exist between two or more patents or applications before consideration can be given to the issue of double patenting. For example, the patents or applications may have the same inventive entity. The patents or applications may also have at least one common (joint) inventor, which covers the situations where at least one patent or application names a sole inventor and the other patent(s) or application(s) names joint inventors and where all the patents or applications name joint inventors. For example, if one application names inventor A and the second application names joint inventors A and B, then the applications have one common (joint) inventor. As another example, if one application names joint inventors A and B and a second application names joint inventors A, B, and C, then the applications have two common joint inventors, and thus, have at least one common joint inventor. See 35 U.S.C. 100(f) for definition of “inventor” and 35 U.S.C. 100(g) for definition of “joint inventor”. Alternatively, the patents or applications may have a common applicant, and/or be commonly assigned/owned or non-commonly assigned/owned but subject to a joint research agreement as set forth in 35 U.S.C. 102(c) or in pre-AIA 35 U.S.C. 103(c)(2) and (3). To determine if subject matter excepted as prior art under 35 U.S.C. 102(b)(2)(C) or disqualified as prior art under pre-AIA 35 U.S.C. 103(c) may be considered for double patenting issues, see MPEP § 804.03.

There are generally two types of double patenting rejections. One is the “same invention” type double patenting rejection based on 35 U.S.C. 101 which states in the singular that an inventor “may obtain a patent.” The second is the “nonstatutory-type” double patenting rejection based on a judicially created doctrine grounded in public policy and which is primarily intended to prevent prolongation of the patent term by prohibiting claims in a second patent not patentably distinct from claims in a first patent. Since the doctrine of double patenting seeks to avoid unjustly extending patent rights at the expense of the public, the focus of any double patenting analysis necessarily is on the claims in the multiple patents or patent applications involved in the analysis.

The doctrine of nonstatutory double patenting also seeks to prevent 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) (citing Chisum, Patents, § 9.04(2)(b) (1981) ). A terminal disclaimer, submitted in compliance with 37 CFR 1.321(c) or (d) to overcome a double patenting rejection, includes a provision that the patent or any patent issuing from the application is only enforceable for and during such period that it is owned by the same party (or parties) that owns the other patents or applications, identified in the terminal disclaimer, that claim obvious variations of one invention. Van Ornum, 686 F.2d at 944-45, 214 USPQ at 767 (citing Chisum, Patents, § 9.04(2)(b) (1981)).

Nonstatutory double patenting includes rejections based on anticipation, a one-way determination of “obviousness,” or a two-way determination of “obviousness.” It is important to note that the “obviousness” analysis for “obviousness-type” double-patenting is “similar to, but not necessarily the same as, that undertaken under 35 U.S.C. 103.” In re Braat, 937 F.2d 589, 592-93, 19 USPQ2d 1289, 1292 (Fed. Cir. 1991) (citing In re Longi, 759 F.2d 887, 892 n.4, 225 USPQ 645, 648 n.4 (Fed. Cir. 1985)); Geneva Pharmaceuticals, 349 F.3d 1373, 1378 n.1, 68 USPQ2d 1865, 1869 n.1 (Fed. Cir. 2003). In addition, nonstatutory double patenting also includes rejections based on the equitable principle against permitting an unjustified timewise extension of patent rights. See In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968); see also subsection II.B.6, below.

The charts below are an overview of the treatment of applications having conflicting claims (e.g., where a claim in an application is not patentably distinct from a claim in a patent or another application). Note that although double patenting and unpatentability over prior art are two separate issues (for example, a double patenting reference that contains conflicting claims need not qualify as prior art), the charts speak to both issues when the reference is a patent or application for completeness. Specifically, the charts cover when two applications have claims to the same invention (Charts I-A) or to patentably indistinct inventions (Charts I-B) and when an application and a patent have claims to the same invention (Charts II-A) or to patentably indistinct inventions (Charts II-B). The charts also include first to invent (FTI) versions (i.e., Charts I-A_FTI, I-B_FTI, II-A_FTI, and II-B_FTI) for use when examining an application that is subject to 35 U.S.C. 102 and 103 in effect on March 15, 2013 (e.g., pre-AIA 35 U.S.C. 102 and 103) and America Invents Act (AIA) versions (i.e., Charts I-A_AIA, I-B_AIA, II-A_AIA, and II-B_AIA) for use when examining an application that is subject to 35 U.S.C. 102 and 103 in effect on March 16, 2013 (AIA 35 U.S.C. 102 and 103). Therefore, in certain situations, examiners may have to use the FTI versions of the charts for an earlier-filed application that is subject to pre-AIA 35 U.S.C. 102 and 103 and the AIA versions of the charts for the later-filed application that is subject to AIA 35 U.S.C. 102 and 103 or vice versa. The charts show possible rejections based upon an earlier-filed application or patent that may be applicable if the record supports such rejections. For example, examiners should determine if an earlier-filed application or patent is prior art under pre-AIA 35 U.S.C. 102(e) or 35 U.S.C. 102(a)(2) before making an anticipation or obviousness rejection based upon the earlier-filed application or patent.

The AIA versions of the charts provide that a (provisional) rejection under 35 U.S.C. 102(a)(2) should not be applied if the earlier-filed application or patent is not prior art in view of 35 U.S.C. 102(b)(2)(A) or (B). The evidence necessary to show that the disclosure is by the inventor or a joint inventor or another who obtained the subject matter disclosed from the inventor or a joint inventor, and is therefore not prior art in view of 35 U.S.C. 102(b)(2)(A), requires a case-by-case analysis, which depends on whether it is apparent from the disclosure itself or the patent application specification that the disclosure is an inventor-originated disclosure. In the situation where a previous public disclosure by the inventor or a joint inventor (or which originated with the inventor or a joint inventor) was not within the grace period but was effective to establish that an intervening disclosure was not 35 U.S.C. 102(a)(2) prior art in view of the exception of 35 U.S.C. 102(b)(2)(B), the previous inventor-originated public disclosure would qualify as prior art under 35 U.S.C. 102(a)(1) and no exception provision could possibly apply. See MPEP §§ 717et seq. and 2155et seq. for more information about the prior art exceptions under 35 U.S.C. 102(b)(2).

The AIA versions of the charts do not address the transition cases in which pre-AIA 35 U.S.C. 102(g) applies to applications subject to AIA 35 U.S.C. 102 and 103. See MPEP § 2159.03 to determine if an application is a transition application. Examiners should consult with a Technology Center Practice Specialist if an application is a transition application and the examiner finds potential pre-AIA 35 U.S.C. 102(g) issues.

Finally, the AIA versions of the charts also do not address rejections under 35 U.S.C. 101 and 115 for improper naming of inventor. Although the AIA eliminated pre-AIA 35 U.S.C. 102(f), the patent laws still require the naming of the actual inventor or joint inventors of the claimed subject matter. See 35 U.S.C. 115(a). In the rare situation where there is evidence on the record that the application does not name the correct inventorship, examiners should consult MPEP § 2157 to determine if a rejection under 35 U.S.C. 101 and 115 should be made.

See MPEP § 2258 for information pertaining to double patenting rejections in reexamination proceedings.

I. INSTANCES WHERE DOUBLE PATENTING ISSUE CAN BE RAISED

A double patenting issue may arise between two or more pending applications, or between one or more pending applications and a patent. A double patenting issue may likewise arise in a reexamination proceeding between the patent claims being reexamined and the claims of one or more applications and/or patents. Double patenting does not relate to international applications which have not yet entered the national stage in the United States.

A. Between Issued Patent and One or More Applications

Double patenting may exist between an issued patent and an application which share the same inventive entity, at least one common (joint) inventor, a common applicant, and/or a common owner/assignee. See In re Hubbell, 709 F.3d 1140, 1146-47, 106 USPQ2d 1032, 1037-38 (Fed. Cir. 2013) (in the context of an application and a patent that had two common joint inventors, but different inventive entities and no common owners or assignees, the court held that complete identity of ownership or inventive entities is not a prerequisite to a nonstatutory double patenting rejection). Double patenting may also exist where the inventions claimed in a patent and an application were made as a result of 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). Since the inventor/applicant/patent owner has already secured the issuance of a first patent, the examiner must determine whether the grant of a second patent would give rise to an unjustified extension of the rights granted in the first patent.

B. Between Copending Applications—Provisional Rejections

An examiner may become aware of two or more copending applications which share the same inventive entity, at least one common (joint) inventor, a common applicant, and/or a common owner/assignee, or that claim an invention 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), that would raise an issue of double patenting if one of the applications became a patent. Where this issue can be addressed without violating the confidential status of applications (35 U.S.C. 122), the courts have sanctioned the practice of making applicant aware of the potential double patenting problem if one of the applications became a patent by permitting the examiner to make a provisional rejection on the ground of double patenting. In re Mott, 539 F.2d 1291, 190 USPQ 536 (CCPA 1976); In re Wetterau, 356 F.2d 556, 148 USPQ 499 (CCPA 1966). An application that was published under 35 U.S.C. 122(b) without redactions can be utilized as a double patenting reference without violating the confidential status required by 35 U.S.C. 122. An unpublished application, or an application that has been published as redacted, can be utilized as a double patenting reference without violating the confidential status required by 35 U.S.C. 122 when it has at least one common (joint) inventor, applicant, assignee, or owner, or is deemed commonly owned (35 U.S.C. 102(c) or pre-AIA 35 U.S.C. 103(c)(2)) with the application under examination. See MPEP §§ 2136.01 and 2154.01(d) for information on provisional rejections based on prior art. The merits of such a provisional rejection can be addressed by both the applicant and the examiner without waiting for the first patent to issue.

A provisional double patenting rejection should be made and maintained by the examiner until the rejection has been obviated or is no longer applicable except as noted below.

1. Provisional Nonstatutory Double Patenting Rejections

A complete response to a nonstatutory double patenting (NSDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims, or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (see MPEP § 1490 for a discussion of terminal disclaimers). Such a response is required even when the nonstatutory double patenting rejection is provisional.

As filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary for further consideration of the rejection of the claims, such a filing should not be held in abeyance. Only compliance with objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated. Replies with an omission should be treated as provided in MPEP § 714.03. Therefore, an application must not be allowed unless the required compliant terminal disclaimer(s) is/are filed and/or the withdrawal of the nonstatutory double patenting rejection(s) is made of record by the examiner. See MPEP § 804.02, subsection VI, for filing terminal disclaimers required to overcome nonstatutory double patenting rejections in applications filed on or after June 8, 1995.

If two (or more) pending applications are filed, in each of which a rejection of one claimed invention over the other on the ground of provisional nonstatutory double patenting (NSDP) is proper, the provisional NSDP rejection will be made in each application. Where there are three applications containing claims that conflict such that a provisional NSDP rejection is made in each application based upon the other two, and it is necessary to file terminal disclaimers to overcome the rejections, it is not sufficient to file a terminal disclaimer in only one of the applications addressing the other two applications. Rather, an appropriate terminal disclaimer must be filed in at least two of the applications to require common ownership or enforcement for all three applications. A terminal disclaimer may be required in each of the three applications in certain situations. See subsections (a)-(c) below. See also MPEP § 1490, subsection VI.D.

(a) Patent Term Filing Date for Original Utility or Plant Applications

The doctrine of double patenting seeks to prevent the unjustified extension of patent exclusivity beyond the term of a patent. For utility and plant patents issuing on applications filed on or after June 8, 1995, 35 U.S.C. 154(a)(2) provides that the patent term 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 one or more earlier-filed application(s) under 35 U.S.C. 120, 121, 365(c), or 386(c), twenty years from the filing date of the earliest such application. For a patent that issues on an international (PCT) application that entered the national stage under 35 U.S.C. 371, the date that the application was filed in the United States is the international filing date; see MPEP § 2701, subsection II. Thus, where there are two or more original applications (applications which are not reissue applications - see MPEP § 201.02) with conflicting (i.e., patentably indistinct) claims, it may be necessary to determine the respective date from which the twenty year term is measured in view of 35 U.S.C. 154(a)(2) (hereinafter referred to as the “patent term filing date”) for each of the applications which could potentially issue as patents.

The patent term filing date of an original utility or plant application filed on or after June 8, 1995 is the earliest of:

• (1) The actual filing date of the application; or
• (2) The filing date of the earliest application for which the application claims the benefit of an earlier filing date under 35 U.S.C. 120, 121, 365(c), or 386(c). See 37 CFR 1.78. See also MPEP § 211.

For example, if an original (non-reissue; see MPEP § 201.02) patent application has no specific reference to any earlier-filed application under 35 U.S.C. 120, 121, 365(c), or 386(c), then the patent term filing date is the date that the application was actually filed. However, if an original patent application does include one or more specific references to an earlier-filed application under 35 U.S.C. 120, 121, 365(c), or 386(c), then the patent term filing date is the filing date of the earliest reference application for which the benefit is properly claimed. See MPEP § 2701. For an application to properly claim the benefit of an earlier-filed application, it must meet the requirements of 37 CFR 1.78 (e.g., having a (joint) inventor in common, copendency, timeliness, and a proper reference). See 37 CFR 1.78 and MPEP § 211.01et seq. It does not require a determination that the earlier-filed application discloses the invention in a manner provided by 35 U.S.C. 112(a). In other words, the issue of entitlement of a claimed invention to the benefit of the filing date of an earlier-filed application does not affect the expiration date of a patent containing the claims, and therefore need not be considered when determining the patent term filing date for the purpose of a double patenting analysis.

The patent term filing date of a reissue application for purposes of nonstatutory double patenting analysis is the patent term filing date of the original application that resulted in the patent for which reissue is sought.

Benefit claims under 35 U.S.C. 119(e) and foreign priority claims under 35 U.S.C. 119(a)-(d) or (f), 365(a) or (b), or 386(a) or (b) are not taken into account when determining the term of an issued patent (see 35 U.S.C. 154(a)(2) and (a)(3)), and therefore, are not taken into account in determining the patent term filing date of an application.

(b) Provisional nonstatutory double patenting rejection is the only rejection remaining in a utility or plant application

Subsections (i)-(iv) below discuss examination procedures when two or more utility or plant patent applications, filed on or after June 8, 1995, contain provisional nonstatutory double patenting rejections over each of the other application(s). The explanations refer to pairs of applications, but also apply when more than two applications are involved.

(i) Application under examination has the earlier patent term filing date

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.

(ii) Application under examination has the same patent term filing date

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.

(iii) Application under examination has the later patent term filing date

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.

(iv) After Board decision not reaching provisional double patenting rejection

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.

(c) Design Applications and Utility or Plant Applications Filed Prior to June 8, 1995

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.

2. Provisional Statutory Double Patenting Rejections (35 U.S.C. 101)

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.

C. Between One or More Applications and a Published Application - Provisional 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.

D.Between a Patent and a Reissue Application or Patent under Reexamination

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.

E. Reexamination Proceedings

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 §§ 717.02et 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.

II. REQUIREMENTS OF A DOUBLE PATENTING REJECTION (INCLUDING PROVISIONAL REJECTIONS)

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).

A. Statutory Double Patenting — 35 U.S.C. 101

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.

B. Nonstatutory Double Patenting

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).

1. Construing the Claim Using the Reference Patent or Application Disclosure

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 to the genus of compounds in the context of a nonstatutory double patenting analysis. This would effectively result in treating the reference as prior art. Nevertheless, there may be cases in which permitting claims to a method of making a compound could essentially result in an unjustified timewise extension of the period of exclusivity for the compound itself. In such cases, the “Nonstatutory Double Patenting Rejection Based on Equitable Principles” discussed in paragraph II.B.6 below should be considered. Cf. Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003) (rejecting claims to methods of use over claims to compound based on unjustified timewise extension rationale).

The result in In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968) is consistent with the analysis set forth above. In Schneller, the examined claims were directed to a clip comprising ABCY and a clip comprising ABCXY; the reference patent claimed a clip comprising ABCX and disclosed an embodiment of a clip having ABCXY. The ABCXY clip disclosed in the reference patent falls within the scope of the reference patent claim to a clip “comprising ABCX.” Thus the disclosed embodiment of ABCXY may be relied upon to properly construe the scope of the reference claim and determine the propriety of a nonstatutory double patenting rejection against the examined claim. However, nonstatutory double patenting rejections based on Schneller will be rare. The Technology Center (TC) Director must approve any nonstatutory double patenting rejections based on Schneller. If an examiner determines that a double patenting rejection based on Schneller is appropriate, the examiner should first consult with the examiner's supervisory patent examiner (SPE). If the SPE agrees with the examiner then approval of the TC Director must be obtained before such a nonstatutory double patenting rejection can be made. See subsection II.B.6 below for a more detailed discussion.

Each nonstatutory double patenting situation must be decided on its own facts.

2. Anticipation Analysis

A nonstatutory double patenting rejection is appropriate where a claim in an application under examination claims subject matter that is different, but not patentably distinct, from the subject matter claimed in a prior patent or a copending application. The claim under examination is not patentably distinct from the reference claim(s) if the claim under examination is anticipated by 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, 1052, 29 USPQ2d 2010, 2015-16 (Fed. Cir. 1993). This type of nonstatutory double patenting situation arises when the claim being examined is, for example, generic to a species or sub-genus claimed in a conflicting patent or application, i.e., the entire scope of the reference claim falls within the scope of the examined claim. In such a situation, a later patent to a genus would, necessarily, extend the right to exclude granted by an earlier patent directed to a species or sub-genus. In this type of nonstatutory double patenting situation, an obviousness analysis is not required for the nonstatutory double patenting rejection. The nonstatutory double patenting rejection in this case should explain the fact that the species or sub-genus claimed in the conflicting patent or application anticipates the claimed genus in the application being examined and, therefore, a patent to the genus would improperly extend the right to exclude granted by a patent to the species or sub-genus should the genus issue as a patent after the species or sub-genus.

The analysis required is different in situations where the claim in the application being examined (1) is directed to a species or sub-genus covered by a generic claim in a potentially conflicting patent or application, or (2) overlaps in scope with a claim in a potentially conflicting claim or claims of the patent or application but the potentially conflicting claims cannot be said to anticipate the examined claims. Both of these situations require an obviousness analysis unless one of ordinary skill in the art would, on reading the potentially conflicting patent or application, at once envisage the invention claimed in the examined application. See AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014). For example, in the genus-species situation, the examiner typically should explain why it would have been obvious to select the claimed species or sub-genus given the genus claimed in the potentially conflicting patent or application. See MPEP § 2131.02 and MPEP § 2144.08 for discussions of genus-species situations with respect to anticipation and obviousness, respectively. Note that the genus-species and overlapping subject matter scenarios discussed in this paragraph may result in nonstatutory double-patenting rejections based on the principle against unjustified timewise extension of patent rights, discussed below in paragraph II.B.6.

3. Obviousness Analysis

A nonstatutory double patenting rejection, if not based on an anticipation rationale or an “unjustified timewise extension” rationale, is “analogous to [a failure to meet] the nonobviousness requirement of 35 U.S.C. 103” except that the patent disclosure principally underlying the double patenting rejection is not considered prior art. In re Braithwaite, 379 F.2d 594, 154 USPQ 29 (CCPA 1967). Even though the specification of the applied patent or copending application is not prior art, it may still be used to interpret the applied claims. See paragraph II.B.1, above. The analysis employed with regard to nonstatutory double patenting is “similar to, but not necessarily the same as that undertaken under 35 USC § 103.” In re Braat, 937 F.2d 589, 592-93, 19 USPQ2d 1289, 1292 (Fed. Cir. 1991) (citing In re Longi, 759 F.2d 887, 892 n.4, 225 USPQ 645, 648 n.4 (Fed. Cir. 1985)); see also Geneva Pharmaceuticals, 349 F.3d at 1378 n.1, 68 USPQ2d at 1869 n.1 (Fed. Cir. 2003); In re Basell Poliolefine, 547 F.3d 1371, 1379, 89 USPQ2d 1030, 1036 (Fed. Cir. 2008).

In view of the similarities, the factual inquiries set forth in Graham v.John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966) that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 should be considered when making a nonstatutory double patenting analysis based on “obviousness.” See MPEP § 2141 for guidelines for determining obviousness. These factual inquiries are summarized as follows:

• (A) Determine the scope and content of a patent claim relative to a claim in the application at issue;
• (B) Determine the differences between the scope and content of the patent claim as determined in (A) and the claim in the application at issue;
• (C) Determine the level of ordinary skill in the pertinent art; and
• (D) Evaluate any objective indicia of nonobviousness.

Any nonstatutory double patenting rejection made under the obviousness analysis should make clear:

• (A) The differences between the inventions defined by the conflicting claims — a claim in the patent compared to a claim in the application; and
• (B) The reasons why a person of ordinary skill in the art would conclude that the invention defined in the claim at issue would have been an obvious variation of the invention defined in a claim in the patent.

Any secondary reference used to support an obviousness analysis for a nonstatutory double patenting rejection must be prior art under 35 U.S.C. 102 or pre-AIA 35 U.S.C. 102. See MPEP § 2120et seq. for more information on determining if a reference is prior art and MPEP § 2141, subsection II.A, for determining the scope and content of the prior art.

4. One-Way Test for Distinctness

If the patent term filing date of an application under examination is the same or later than that of a reference application or patent, only a one-way determination of distinctness is needed in resolving the issue of double patenting, i.e., whether the invention claimed in the application would have been anticipated by, or an obvious variation of, the invention claimed in the reference application or patent. See, e.g., In re Berg, 140 F.3d 1428, 1435, 46 USPQ2d 1226, 1231-32 (Fed. Cir. 1998). The court in Berg applied a one-way test where an applicant filed two separate applications even though all claims could have been filed in a single application, because the applicant’s action could have resulted in an improper timewise extension of rights if one patent expired later than the other. If a claimed invention in the application would have been obvious over a claimed invention in the patent, there would be an unjustified timewise extension of the patent and a nonstatutory double patenting rejection is proper. According to the Berg court, improperly extending the patent term “is precisely the result that the doctrine of obviousness-type double patenting was created to prevent.” Id. See also MPEP § 804, subsection II.B above.

Similarly, even if the application under examination has the earlier patent term filing date, only a one-way determination of distinctness is needed to support a double patenting rejection in the absence of a finding: (A) that "the PTO is solely responsible for any delays" in prosecution of that application (In re Hubbell, 709 F.3d 1140, 1150, 106 USPQ2d 1032, 1039 (Fed. Cir. 2013)); and (B) that the applicant could not have filed the conflicting claims in a single (i.e., the earlier-filed) application ( In re Kaplan, 789 F.2d 1574, 229 USPQ 678 (Fed. Cir. 1986)). In Kaplan, a generic invention (use of solvents) was invented by Kaplan, and a species thereof (i.e., use of a specific combination of solvents) was invented by Kaplan and Walker. Multiple applications were necessary to claim both the broad and narrow inventions because at the time the applications were filed, 35 U.S.C. 116 did not expressly authorize filing a patent application in the name of joint inventors who did not make a contribution to the invention defined in each claim in the patent. Compare In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998), wherein the genus and species claims could have been filed in the same application.

Form paragraph 8.33 and the appropriate one of form paragraphs 8.34 - 8.37 may be used to make nonstatutory double patenting rejections based on anticipation or obviousness analyses. See subsection II.B.6, below, and form paragraphs 8.38 and 8.39 if the basis for the nonstatutory double patenting rejection is equitable principles.

5. Two-Way Test for Distinctness

If a reference patent has a later patent term filing date than the application under examination, the question of whether the timewise extension of the right to exclude granted by a patent is justified or unjustified must be addressed. A two-way test is to be applied only when the applicant could not have filed the claims in a single application and the Office is solely responsible for any delays. In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998) (“The two-way exception can only apply when the applicant could not avoid separate filings, and even then, only if the PTO controlled the rates of prosecution to cause the later filed species claims to issue before the claims for a genus in an earlier application . . . . In Berg’s case, the two applications could have been filed as one, so it is irrelevant to our disposition who actually controlled the respective rates of prosecution.” 140 F.3d at 1435, 46 USPQ2d at 1232); In re Hubbell, 709 F.3d 1140, 106 USPQ2d 1032 (Fed. Cir. 2013) ("[P]rosecution choices resulted in the foreseeable consequence that the ′685 patent issued before the application claims on appeal. Given these circumstances, and because it is undisputed that the PTO was not solely responsible for the delay, Hubbell is not entitled to a two-way obviousness analysis." 709 F.3d at 1150, 106 USPQ2d at 1039.); see also In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993) (in a situation where delayed issuance equated to later expiration, applicant’s voluntary decision to obtain early issuance of claims directed to a species and to pursue prosecution of previously rejected genus claims in a continuation is a considered election to postpone by the applicant and not administrative delay). Unless the record clearly shows administrative delay caused solely by the Office and that applicant could not have avoided filing separate applications, the examiner may use the one-way distinctness determination and shift the burden to applicant to show why a two-way distinctness determination is required.

When making a two-way distinctness determination, where appropriate, it is necessary to apply the obviousness analysis twice, first analyzing the obviousness of the application claims in view of the patent claims, and then analyzing the obviousness of the patent claims in view of the application claims. Where a two-way distinctness determination is required, a nonstatutory double patenting rejection based on obviousness is appropriate only where each analysis leads to a conclusion that the claimed invention is an obvious variation of the invention claimed in the other application/patent. If either analysis does not lead to a conclusion of obviousness, no double patenting rejection of the obviousness-type is made, but this does not necessarily preclude a nonstatutory double patenting rejection based on equitable principles. In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968).

Although a delay in the processing of applications before the Office that causes patents to issue in an order different from the order in which the applications were filed is a factor to be considered in determining whether a one-way or two-way distinctness determination is necessary to support a double patenting rejection, it may be very difficult to assess whether the administrative process is solely responsible for a delay in the issuance of a patent. On the one hand, it is applicant who presents claims for examination and pays the issue fee. On the other hand, the resolution of legitimate differences of opinion in an appeal process or the time spent in an interference proceeding can significantly delay the issuance of a patent. Nevertheless, the reasons for the delay in issuing a patent have been considered in assessing the propriety of a double patenting rejection. Thus, in Pierce v. Allen B. DuMont Laboratories, Inc., 297 F.2d 323, 131 USPQ 340 (3d. Cir. 1961), the court found that administrative delay may justify the extension of patent rights beyond 17 years but “a considered election to postpone acquisition of the broader [patent after the issuance of the later filed application] should not be tolerated.” In Pierce, the patentee elected to participate in an interference proceeding [after all claims in the application had been determined to be patentable] whereby the issuance of the broader patent was delayed by more than 7 years after the issuance of the narrower patent. The court determined that the second issued patent was invalid on the ground of double patenting. Similarly, in In re Emert, 124 F.3d 1458, 44 USPQ2d 1149 (Fed. Cir. 1997), the court found that the one-way test is appropriate where applicants, rather than the Office, had significant control over the rate of prosecution of the application at issue. In support of its finding that the applicants were responsible for delaying prosecution of the application during the critical period, the court noted that the applicants had requested and received numerous time extensions in various filings. More importantly, the court noted, after initially receiving an obviousness rejection of all claims, applicants had waited the maximum period to reply (6 months), then abandoned the application in favor of a substantially identical continuation application, then received another obviousness rejection of all claims, again waited the maximum period to reply, and then again abandoned the application in favor of a second continuation application substantially identical to the original filing. On the other hand, in General Foods Corp. v. Studiengesellschaft Kohle mbH, 972 F.2d 1272, 23 USPQ2d 1839 (Fed. Cir. 1992), the court did not hold the patentee accountable for a delay in issuing the first-filed application until after the second-filed application issued as a patent, even where the patentee had intentionally refiled the first-filed application as a continuation-in-part after receiving a Notice of Allowance indicating that all claims presented were patentable. Where, through no fault of the applicant, the claims in a later-filed application issue first, a nonstatutory double patenting rejection is improper, in the absence of a two-way distinctness determination, because the applicant does not have complete control over the rate of progress of a patent application through the Office. In re Braat, 937 F.2d 589, 19 USPQ2d 1289 (Fed. Cir. 1991). While acknowledging that allowance of the claims in the earlier-filed application would result in the timewise extension of an invention claimed in the patent, the court in Braat was of the view that the extension was justified under the circumstances, indicating that a nonstatutory double patenting rejection would be proper only if the claimed inventions were obvious over each other — a two-way distinctness determination.

See, however, In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998), wherein the claims at issue could have been filed in the same application. The Berg court explained, “Braat was an unusual case; moreover, its factual situation is not likely to be repeated since the 1984 Act [amending 35 U.S.C. 116, and permitting joint inventorship even though not all inventors contributed to each claim] went into effect.” 140 F.3d at 1433-34, 46 USPQ2d at 1230.

Form paragraph 8.33 and the appropriate one of form paragraphs 8.34-8.37 may be used to make nonstatutory double patenting rejections based on anticipation or obviousness analyses. See MPEP § 804, paragraph II.B.4, above. See paragraph II.B.6, below, and form paragraphs 8.38 and 8.39 if the basis for the nonstatutory double patenting rejection is equitable principles.

6. Nonstatutory Double Patenting Rejection Based on Equitable Principles

In some circumstances a nonstatutory double patenting rejection is applicable based on equitable principles. Occasionally the fundamental reason for nonstatutory double patenting – to prevent unjustified timewise extension of patent rights – is itself enforceable no matter how the extension is brought about. Examples of this occurred in In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968); and Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).

In In re Schneller, 397 F.2d 350, 158 USPQ 210, 216 (CCPA 1968), the court affirmed a double patenting rejection after summing up the situation as follows:

[I]n appellant’s own terms: The combination ABC was old. He made two improvements on it, (1) adding X and (2) adding Y, the result still being a unitary clip of enhanced utility. While his invention can be practiced in the forms ABCX or ABCY, the greatest advantage and best mode of practicing the invention as disclosed is obtained by using both inventions in the combination ABCXY. His first application disclosed ABCXY and other matters. He obtained a patent claiming [a clip comprising] BCX and ABCX, . . . so claiming these combinations as to cover them no matter what other feature is incorporated in them, thus covering effectively ABCXY. He now, many years later, seeks more claims directed to ABCY and ABCXY. Thus, protection he already had would be extended, albeit in somewhat different form, for several years beyond the expiration of his patent, were we to reverse.

397 F.2d at 355-56, 158 USPQ at 216 (emphasis in original).

The court recognized that “there is no double patenting in the sense of claiming the same invention because ABCX and ABCY are, in the technical patent law sense, different inventions. The rule against ‘double patenting,’ however, is not so circumscribed. The fundamental reason for the rule is to prevent unjustified timewise extension of the right to exclude granted by a patent no matter how the extension is brought about. To . . . prevail here, appellant has the burden of establishing that the invention claimed in his patent is ‘independent and distinct’ from the invention of the appealed claims…. [A]ppellant has clearly not established the independent and distinct character of the inventions of the appealed claims.” 397 F.2d at 354-55, 158 USPQ at 214-15 (emphasis in original). The court observed:

The controlling fact is that patent protection for the clips, fully disclosed in and covered by the claims of the patent, would be extended by allowance of the appealed claims. Under the circumstance of the instant case, wherein we find no valid excuse or mitigating circumstances making it either reasonable or equitable to make an exception, and wherein there is no terminal disclaimer, the rule against “double patenting” must be applied.

397 F.2d at 355, 158 USPQ at 215.

The decision in In re Schneller did not establish a rule of general application and thus is limited to the particular set of facts set forth in that decision. The court in Schneller cautioned “against the tendency to freeze into rules of general application what, at best, are statements applicable to particular fact situations.” Schneller, 397 F.2d at 355, 158 USPQ at 215. Nonstatutory double patenting rejections based on Schneller will be rare. The Technology Center (TC) Director must approve any nonstatutory double patenting rejections based on Schneller. If an examiner determines that a double patenting rejection based on Schneller is appropriate, the examiner should first consult with the examiner's supervisory patent examiner (SPE). If the SPE agrees with the examiner then approval of the TC Director must be obtained before such a nonstatutory double patenting rejection can be made.

A fact situation similar to that in Schneller was presented to a Federal Circuit panel in In re Kaplan, 789 F.2d 1574, 229 USPQ 678 (Fed. Cir. 1986). Kaplan had been issued a patent on a process of making chemicals in the presence of an organic solvent. Among the organic solvents disclosed and claimed as being useful were tetraglyme and sulfolane. One unclaimed example in the patent was specifically directed to a mixture of these two solvents. The claims in the application to Kaplan and Walker, the application before the Office, were directed to essentially the same chemical process, but requiring the use of the solvent mixture of tetraglyme and sulfolane. In reversing the double patenting rejection, the court stated that the mere fact that the broad process claim of the patent requiring an organic solvent reads on or “dominates” the narrower claim directed to basically the same process using a specific solvent mixture does not, per se, justify a double patenting rejection. The court also pointed out that the double patenting rejection improperly “used the disclosure of the appellants’ joint invention [solvent mixture] in the Kaplan patent specification as though it were prior art.” Kaplan, 789 F.2d at 1577, 229 USPQ at 681.

A significant factor in the Kaplan case was that the broad invention was invented by Kaplan, and the narrow invention (i.e., using a specific combination of solvents) was invented by Kaplan and Walker. Since these applications (as the applications in Braat) were filed before the Patent Law Amendments Act of 1984 (Public Law 98-622, November 8, 1984) amending 35 U.S.C. 116 to expressly authorize filing a patent application in the names of joint inventors who did not necessarily make a contribution to the invention defined in each claim in the patent, it was necessary to file multiple applications to claim both the broad and narrow inventions. Accordingly, there was a valid reason, driven by statute, why the claims to the specific solvent mixture were not presented for examination in the Kaplan patent application.

More recently, in Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003), the court applied nonstatutory double patenting to invalidate a claim without analyzing anticipation or obviousness. In this case, the earlier patent claimed a compound and the written description disclosed a single utility of that compound as administration to a human in amounts effective for inhibiting ß-lactamase. The later patent claimed nothing more than the earlier patent’s disclosed utility as a method of using the compound. Thus, the court found that the claims of the later patent and the claims of the earlier patent were not patentably distinct. The Geneva court relied on equitable principles, not an obviousness-type analysis, in reaching its conclusion. Id. at 1386, 68 USPQ2d at 1875 (quoting In re Byck, 48 F.2d 665, 666 (CCPA 1931)).

Each double patenting situation must be decided on its own facts.

Form paragraph 8.38 (between an issued patent and one or more applications) or 8.39 (provisional rejection) may be used to make this type of nonstatutory double patenting rejection.

7. Design/Plant — Utility Situations

Double patenting issues may be raised where an applicant has filed both a utility patent application (35 U.S.C. 111) and either an application for a plant patent (35 U.S.C. 161) or an application for a design patent (35 U.S.C. 171). In general, the same double patenting principles and criteria that are applied in utility-utility situations are applied to utility-plant or utility-design situations. Double patenting rejections in utility-plant situations may be made in appropriate circumstances.

Although double patenting is rare in the context of utility versus design patents, a double patenting rejection of a pending design or utility application can be made on the basis of a previously issued utility or design patent, respectively. Carman Indus. Inc. v. Wahl, 724 F.2d 932, 220 USPQ 481 (Fed. Cir. 1983). The rejection is based on the public policy preventing the extension of the term of a patent. Double patenting may be found in a design-utility situation irrespective of whether the claims in the reference patent/application and the claims in the application under examination are directed to the same invention, or whether they are directed to inventions which are obvious variations of one another. In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).

In Carman Indus., the court held that no double patenting existed between a design and utility patent since the claims in the utility patent, drawn to the interior construction of a flow promoter, were not directed to the same invention or an obvious variation of the invention claimed in a design patent directed to the visible external surface configuration of a storage bin flow promoter. The majority opinion in this decision appears to indicate that a two-way distinctness determination is necessary in design-utility cases. 724 F.2d at 940-41, 220 USPQ at 487-88.

In Thorington, the court affirmed a double patenting rejection of claims for a fluorescent light bulb in a utility patent application in view of a previously issued design patent for the same bulb. In another case, a double patenting rejection of utility claims for a finger ring was affirmed in view of an earlier issued design patent, where the drawing in both the design patent and the utility application illustrated the same article. In re Phelan, 205 F.2d 183, 98 USPQ 156 (CCPA 1953). A double patenting rejection of a design claim for a flashlight cap and hanger ring was affirmed over an earlier issued utility patent. In re Barber, 81 F.2d 231, 28 USPQ 187 (CCPA 1936). A double patenting rejection of claims in a utility patent application directed to a balloon tire construction was affirmed over an earlier issued design patent. In re Hargraves, 53 F.2d 900, 11 USPQ 240 (CCPA 1931).

III. CONTRAST BETWEEN DOUBLE PATENTING REJECTION AND REJECTIONS BASED ON PRIOR ART

Rejections over a patent or another copending application based on double patenting or under 35 U.S.C. 102 or 103 are similar in the sense that both require comparison of the claimed subject matter with at least part of the content of another patent or application, and both may require that an anticipation or obviousness analysis be made. However, there are significant differences between a rejection based on double patenting and one based on prior art under 35 U.S.C. 102 or 103. “[O]bvious-type double patenting and [pre-AIA] §102(e)/§103 rejections may be analogous in the sense that an obviousness analysis is performed in both cases, but they are not analogous in terms of what is analyzed.” In re Bartfeld, 925 F.2d 1450, 1453, 17 USPQ2d 1885, 1888 (Fed. Cir. 1991).

One significant difference is that a double patenting rejection must rely on a comparison with the claims in an issued patent or pending application, whereas an anticipation or obviousness rejection based on the same patent or application under 35 U.S.C. 102 or 103 relies on a comparison with what is disclosed (whether or not claimed) in the same issued patent or pending application. In a 35 U.S.C. 102 or 103 rejection over a prior art patent, the reference patent is available for all that it fairly discloses to one of ordinary skill in the art, regardless of what is claimed. In re Heck, 699 F.2d 1331, 216 USPQ 1038 (Fed. Cir. 1983).

A second significant difference is that a terminal disclaimer cannot be used to obviate a rejection based on prior art under 35 U.S.C. 102 or 103 prior art, even though it may overcome a nonstatutory double patenting rejection. In re Bartfeld, 925 F.2d 1450, 17 USPQ2d 1885 (Fed. Cir. 1991). The purpose of a terminal disclaimer is to obviate a nonstatutory double patenting rejection by removing the potential harm to the public by issuing a second patent, and not to remove a patent as prior art. See, for example, Agrizap, Inc. v. Woodstream Corp., 520 F.3d 1337, 1344, 86 USPQ2d 1110, 1115 (Fed. Cir. 2008).

IV. DOUBLE PATENTING REJECTIONS AND PRIOR ART DISQUALIFICATION UNDER PRE-AIA 35 U.S.C. 103(c)

For pre-AIA applications filed on or after November 29, 1999 and for pre-AIA applications pending on or after December 10, 2004, a commonly assigned/owned patent or application may be disqualified as pre-AIA 35 U.S.C. 102(e) prior art in a pre-AIA 35 U.S.C. 103(a) rejection. See pre-AIA 35 U.S.C. 103(c)(1). For pre-AIA applications pending on or after December 10, 2004, a patent or application may be disqualified as pre-AIA 35 U.S.C. 102(e) prior art in a pre-AIA 35 U.S.C. 103(a) rejection if evidence of a joint research agreement pursuant to pre-AIA 35 U.S.C. 103(c)(2) and (3) is made of record in the application (or patent) being examined (or reexamined), and the conflicting claims resulted from a joint research agreement that was in effect on or before the date the later claimed invention was made. See MPEP § 2146et seq. for more information. The prior art disqualification under pre-AIA 35 U.S.C. 103(c) may also be applicable in post-grant Office proceedings if the application, which matured into the patent under reexamination or review, meets the above-mentioned conditions.

An examiner should make both a pre-AIA 35 U.S.C. 102(e)/103(a) rejection and a double patenting rejection over the same reference when the facts support both rejections. See the charts in MPEP § 804 for an overview of possible rejections based on prior art as well as double patenting. Note that even if an earlier patent or application to another is disqualified as prior art in a pre-AIA 35 U.S.C. 103(a) rejection based on common ownership or a joint research agreement as discussed above, that patent or application may still form the basis of a double patenting rejection and is still available as prior art under pre-AIA 35 U.S.C. 102(e) to form the basis of an anticipation rejection. See MPEP § 804.03, subsection IV. If the examiner makes only one of these rejections when each is separately applicable, and if the next Office action includes the previously omitted rejection, then the next Office action cannot be made final. A prior art reference that anticipates or renders claimed subject matter obvious under pre-AIA 35 U.S.C. 102(e)/103(a) does not support a double patenting rejection where that subject matter is not claimed in the reference patent or application. For pre-AIA applications pending on or after December 10, 2004, rejections under pre-AIA 35 U.S.C. 102(e)/103(a) should not be made or maintained if the reference is disqualified under pre-AIA 35 U.S.C. 103(c) as prior art in a pre-AIA 35 U.S.C. 103(a) rejection. See MPEP § 2146.01 for information regarding when prior art is disqualified under pre-AIA 35 U.S.C. 103(c) based on common ownership or as a result of activities undertaken within the scope of a joint research agreement.

As an alternative to invoking the prior art disqualification under pre-AIA 35 U.S.C. 103(c)(1), the assignee could have taken some preemptive measures to avoid having a commonly assigned/owned copending application become prior art under pre-AIA 35 U.S.C. 102(e). The applications could have been filed on the same day, or copending applications could have been merged into a single continuation-in-part application and the parent applications abandoned. If these steps are undesirable or the first patent has issued, the prior art effect of the first patent may be avoided by a showing under 37 CFR 1.132 that any unclaimed invention disclosed in the first patent was derived from the inventor of the application before the examiner in which the pre-AIA 35 U.S.C. 102(e)/103(a) rejection was made. In re Katz, 687 F.2d 450, 215 USPQ 14 (CCPA 1982). See also MPEP § 716.10. It may also be possible for applicant to respond to a pre-AIA 35 U.S.C. 102(e)/103(a) rejection by showing, under 37 CFR 1.131(a), that the date of invention of the claimed subject matter was prior to the pre-AIA 35 U.S.C. 102(e) date of the reference patent which has been relied upon for its unclaimed disclosure. See MPEP § 715. See also 37 CFR 1.131(c) and MPEP § 718 for affidavits or declarations to disqualify a commonly owned patent as prior art under pre-AIA 35 U.S.C. 103(c).

V. DOUBLE PATENTING REJECTIONS AND PRIOR ART EXCEPTION UNDER 35 U.S.C. 102(b)(2)(C) and 102(c)

For AIA applications, subject matter in a commonly assigned/owned patent or application may be excepted as prior art under 35 U.S.C. 102(a)(2). See 35 U.S.C. 102(b)(2)(C). Also, if the requirements of 35 U.S.C. 102(c) are met, common ownership can be established by a joint research agreement. This prior art exception also applies in post-grant Office proceedings of patents if the patent under reexamination or review is subject to AIA 35 U.S.C. 102 and 103. See, e.g., MPEP § 2258, subsection I, for more information about which prior art regime applies in an ex parte reexamination. See also MPEP § 717.02et seq. for more information on the prior art exception for commonly owned or joint research agreement subject matter.

An examiner should make both a prior art rejection under either 35 U.S.C. 102(a)(2) or 103 and a double patenting rejection over the same reference when the facts support both rejections. See the charts in MPEP § 804 for an overview of possible rejections based on prior art as well as double patenting. If the prior art exception under 35 U.S.C. 102(b)(2)(C) is properly invoked, the excepted subject matter disclosed in the commonly owned or joint research agreement reference is not available as prior art under 35 U.S.C. 102(a)(2) for an anticipation and/or obviousness rejection, and also may not be used as a secondary reference in a nonstatutory double patenting rejection. However, the claims of a reference excepted under 35 U.S.C. 102(b)(2)(C) may still be the basis for a double patenting rejection, whether statutory or nonstatutory. See MPEP § 804.03, subsection IV. A prior art reference that anticipates or renders claimed subject matter obvious under 35 U.S.C. 102(a)(2) or 103 does not support a double patenting rejection where that subject matter is not claimed in the reference patent or application. Rejections under 35 U.S.C. 102(a)(2) or 103 should not be made or maintained if the reference is not prior art because of the exception under 35 U.S.C. 102(b)(2)(C). See MPEP § 717.02et seq. for information regarding when prior art meets the exception under 35 U.S.C. 102(b)(2)(C) and 102(c) based on common ownership or a joint research agreement.

VI. DOUBLE PATENTING REJECTIONS ONCE A JOINT RESEARCH AGREEMENT IS ESTABLISHED

Under both pre-AIA and AIA law, examiners cannot rely on the joint research agreement provisions to apply a nonstatutory double patenting rejection until applicant establishes the existence of a joint research agreement in accordance with 37 CFR 1.104(c)(4)(ii) or (c)(5)(ii). Therefore, it is not appropriate for an examiner to assume that the pre-AIA common ownership disqualification or the AIA common ownership exception applies merely on the basis of assignment information. If in reply to an Office action applying a prior art rejection, applicant establishes that the relied upon reference is not prior art under the joint research agreement provision of 35 U.S.C. 102(c), or disqualifies it as prior art under pre-AIA 35 U.S.C. 103(c), and a subsequent nonstatutory double patenting rejection based upon conflicting claims in the same reference is applied, the next Office action may be made final even if applicant did not amend the claims (provided the examiner introduces no other new ground of rejection that was not necessitated by either amendment or an information disclosure statement filed during the time period set forth in 37 CFR 1.97(c) with the fee set forth in 37 CFR 1.17(p)). The Office action is properly made final because the new nonstatutory double patenting rejection was necessitated by the applicant’s amendment of the application.

[top]