Guidelines

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.

¶ 8.38    Double Patenting - Nonstatutory (Based Solely on Improper Timewise Extension of Patent Rights) With a Patent

Claim [1] rejected on the ground of nonstatutory double patenting over claim [2] of U.S. Patent No. [3] since the claims, if allowed, would improperly extend the "right to exclude" already granted in the patent.

The subject matter claimed in the instant application is fully disclosed in the patent and is covered by the patent since the patent and the application are claiming common subject matter, as follows: [4]

Furthermore, there is no apparent reason why applicant was prevented from presenting claims corresponding to those of the instant application during prosecution of the application which matured into a patent. See In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968). See also MPEP § 804.

Examiner Note:

1. Form paragraph 8.33 must precede any one of form paragraphs 8.34 to 8.39 and must be used only ONCE in an Office action.

2. This form paragraph should only be used where approval from the TC Director to make a nonstatutory double patenting rejection based on In re Schneller has been obtained.

3. Use this form paragraph only when the subject matter of the claim(s) is fully disclosed in, and covered by at least one claim of, an issued U.S. Patent which is commonly owned or where there is at least one common (joint) inventor or a common applicant (35 U.S.C. 118 ).

4. In bracket 3, insert the number of the patent.

5. In bracket 4, insert a description of the subject matter being claimed which is covered in the patent.

6. A rejection should additionally be made under pre-AIA 35 U.S.C. 103(a)  using form paragraph 7.21.fti if:

a. evidence indicates that the patent is also prior art under pre-AIA 35 U.S.C. 102(f)  or (g)  (e.g., applicant has named the prior inventor in response to a requirement made using form paragraph 8.28.fti); and

b. the patent has not been disqualified as prior art in a pre-AIA 35 U.S.C. 103(a)  rejection pursuant to pre-AIA 35 U.S.C. 103(c).

7. For applications being examined under pre-AIA (first to invent) law: If the patent is prior art under pre-AIA 35 U.S.C. 102(e)  to the claimed invention, a rejection under pre-AIA 35 U.S.C. 102(e) /103(a)  may be made using form paragraph 7.21.02.fti. Rejections under pre-AIA 35 U.S.C. 102(e) /103(a)  should not be made or maintained if the patent 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.

8. For applications being examined under first inventor to file (FITF) provisions of the AIA: A rejection under 35 U.S.C. 102(a)(2)  or 35 U.S.C. 103  should also be made if appropriate.

¶ 8.39    Double Patenting - Nonstatutory (Based Solely on Improper Timewise Extension of Patent Rights) With Another Application

Claim [1] provisionally rejected on the ground of nonstatutory double patenting over claim [2] of copending Application No. [3]. This is a provisional double patenting rejection because the patentably indistinct claims have not in fact been patented.

The subject matter claimed in the instant application is fully disclosed in the referenced copending application and would be covered by any patent granted on that copending application since the referenced copending application and the instant application are claiming common subject matter, as follows: [4]

Furthermore, there is no apparent reason why applicant would be prevented from presenting claims corresponding to those of the instant application in the other copending application. See In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968). See also MPEP § 804.

Examiner Note:

1. Form paragraph 8.33 must precede any one of form paragraphs 8.34 to 8.39 and must be used only ONCE in an Office action.

2. This form paragraph should only be used where approval from the TC Director to make a nonstatutory double patenting rejection based on In re Schneller has been obtained.

3. Use this form paragraph only when the subject matter of the claim(s) is fully disclosed in, and covered by at least one claim of, another copending application (reference application) which is commonly owned, or where there is at least one common (joint) inventor or a common applicant (35 U.S.C. 118 ).

4. In bracket 3, insert the number of the reference application.

5. In bracket 4, insert a description of the subject matter being claimed which is covered in the reference application.

6. If the reference application is currently commonly assigned but the prosecution file of the application under examination does not establish that the patentably indistinct inventions were commonly owned at the time the later invention was made, form paragraph 8.28.fti may be used in addition to this form paragraph to resolve any issues relating to priority under pre-AIA 35 U.S.C. 102(f)  and/or (g).

7. For applications being examined under first inventor to file (FITF) provisions of the AIA: If the reference application is to a different inventive entity and is commonly assigned with the application under examination, form paragraph 8.28.aia should additionally be used if there is no evidence of common ownership not later than the effective filing date under 35 U.S.C. 100(i)  of the claimed invention. A rejection under 35 U.S.C. 102(a)(2)  or 35 U.S.C. 103  should also be made if appropriate.

8. A provisional double patenting rejection should also be made in the reference application.

9. A rejection should additionally be made under pre-AIA 35 U.S.C. 103(a)  using form paragraph 7.21.fti if:

a. evidence indicates that the reference application is prior art under pre-AIA 35 U.S.C. 102(f)  or (g)  (e.g., applicant has named the prior inventor in response to a requirement made using form paragraph 8.28.fti); and

b. the reference application has not been disqualified as prior art in a pre-AIA 35 U.S.C. 103(a)  rejection pursuant to pre-AIA 35 U.S.C. 103(c).

10. For applications being examined under pre-AIA (first to invent) law: If the reference application is prior art under pre-AIA 35 U.S.C. 102(e)  to the claimed invention, use form paragraph 7.21.01.fti to additionally make a rejection under pre-AIA 35 U.S.C. 102(e) /103(a)  in the application with the later effective U.S. filing date. Rejections under pre-AIA 35 U.S.C. 102(e) /103(a)  should not be made or maintained if the reference application 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.

11. See MPEP § 1490 for guidance regarding terminal disclaimers and withdrawal of nonstatutory double patenting rejections when these are the only rejections remaining. Note especially that priority or benefit claims under 35 U.S.C. 119(a) and (e)  are not taken into account in determining which is the earlier-filed application for double patenting purposes.

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 § 2146 et 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 § 717.02 et 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 § 717.02 et 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.

804.01    Prohibition of Nonstatutory Double Patenting Rejections Under 35 U.S.C. 121 [R-07.2022]

35 U.S.C. 121  authorizes the Director to restrict the claims in a patent application to a single invention when independent and distinct inventions are presented for examination. The third sentence of 35 U.S.C. 121  prohibits the use of a patent issuing on an application in which a requirement for restriction has been made, or on an application filed as a result of such a requirement, as a reference against any divisional application in a nonstatutory double patenting rejection, if the divisional application is filed before the issuance of the patent. The 35 U.S.C. 121  prohibition applies only where the Office has made a requirement for restriction. The prohibition does not apply where the divisional application was voluntarily filed by the applicant and not in response to an Office requirement for restriction. The U.S. Court of Appeals for the Federal Circuit has concluded that the protection of 35 U.S.C. 121  does not extend to all types of continuing applications, stating that "the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications." Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353, 1362, 86 USPQ2d 1001, 1007-1008 (Fed. Cir. 2008). Note that a patentee cannot retroactively recover the safe harbor protection of 35 U.S.C. 121  against nonstatutory double patenting by amending a patent that issued from a continuation-in-part application to only subject matter in the parent application and redesignating the CIP as a divisional of the parent application. See In re Janssen Biotech, Inc., 880 F.3d 1315, 1322, 125 USPQ2d 1525, 1529-30 (Fed. Cir. 2018)( "[A] patent owner cannot retroactively bring its challenged patent within the scope of the safe-harbor provision by amendment in a reexamination proceeding."); G.D. Searle LLC v. Lupin Pharm., Inc., 790 F.3d 1349, 1355, 115 USPQ2d 1326, 1330 (Fed. Cir. 2015)("Simply deleting that new matter from the reissue patent does not retroactively alter the nature of the [ ] application.").

This apparent nullification of nonstatutory double patenting as a ground of rejection or invalidity in divisional applications imposes a heavy burden on the Office to guard against erroneous requirements for restrictions where the claims define essentially the same invention in different language and where acquiescence to the restriction requirement might result in the issuance of several patents for the same invention. "[I]f an examiner issues a restriction requirement between patentably indistinct claims, two patents may issue and prolong patent protection beyond the statutory term on obvious variants of the same invention. This prolongation would occur because § 121  would immunize the restricted application against nonstatutory double patenting rejections." Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1379, 68 USPQ2d 1865, 1869 (Fed. Cir. 2003). "[W]hen the existence of multiple patents is due to the administrative requirements imposed by the Patent and Trademark Office, 35 U.S.C. Section 121  provides that the inventor shall not be prejudiced by having complied with those requirements. Thus when two or more patents result from a PTO restriction requirement, whereby aspects of the original application must be divided into separate applications, Section 121  insulates the ensuing patents from the charge of double patenting." Applied Materials Inc. v. Advanced Semiconductor Materials, 98 F.3d 1563, 1568, 40 USPQ2d 1481, 1484 (Fed. Cir. 1996) (citing Studiengesellschaft Kohle mbH v. Northern Petrochemical Co., 784 F.2d 351, 354, 228 USPQ 837, 840 (Fed. Cir. 1986)).

The prohibition against holdings of nonstatutory double patenting applies to requirements for restriction between independent or distinct inventions, such as the related subject matter treated in MPEP § 806.04 through § 806.05(j), namely, between a combination and a subcombination thereof, between subcombinations disclosed as usable together, between a process and an apparatus for its practice, between a process and a product made by such process and between an apparatus and a product made by such apparatus, etc., so long as the claims in each application are filed as a result of such requirement.

The following are situations where the prohibition against nonstatutory double patenting rejections under 35 U.S.C. 121  does not apply:

  • (A) The applicant voluntarily files two or more applications without a restriction requirement by the examiner. In order to obtain the benefit of 35 U.S.C. 121, claims must be formally entered, restricted in, and removed from an earlier application before they are filed in a divisional application . Geneva Pharms. Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1379, 68 USPQ2d 1865, 1870 (Fed. Cir. 2003) (For claims that were not in the original application and are first formally entered in a later divisional application, 35 U.S.C. 121  "does not suggest that the original application merely needs to provide some support for claims that are first entered formally in the later divisional application." Id.); In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968).
  • (B) The claims of the application under examination and claims of the other application/patent are not consonant with the restriction requirement made by the examiner, since the claims have been changed in material respects from the claims at the time the requirement was made. For example, the divisional application filed includes additional claims not consonant in scope with the original claims subject to restriction in the parent. Symbol Technologies, Inc. v. Opticon, Inc., 935 F.2d 1569, 19 USPQ2d 1241 (Fed. Cir. 1991); Gerber Garment Technology, Inc. v. Lectra Systems, Inc., 916 F.2d 683, 16 USPQ2d 1436 (Fed. Cir. 1990). In order for consonance to exist, the line of demarcation between the independent and distinct inventions identified by the examiner in the requirement for restriction must be maintained. 916 F.2d at 688, 16 USPQ2d at 1440.
  • (C) The restriction requirement was withdrawn because the requirement was written in a manner which made it clear to applicant that the requirement was made subject to the nonallowance of generic or other linking claims and such generic or linking claims are subsequently allowed.
  • (D) The requirement for restriction (holding of lack of unity of invention) was only made in an international application by the International Searching Authority or the International Preliminary Examining Authority. However, the prohibition against nonstatutory double patenting rejections does apply to requirements for restriction (lack of unity of invention holdings) made in national stage applications submitted under 35 U.S.C. 371.
  • (E) The requirement for restriction was withdrawn, in its entirety or in pertinent part, by the examiner before the patent issues. With the withdrawal of the restriction requirement, the non-elected claims that are no longer withdrawn from consideration become subject to examination. "The restriction requirement disappears; it is as though it had not been made. With the disappearance of the restriction requirement, the need for a divisional application and the need for the [double patenting] prohibition also disappear."In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 132 (CCPA 1971). Note that a restriction requirement in an earlier-filed application does not carry over to claims of a continuation application in which the examiner does not reinstate or refer to the restriction requirement in the parent application. Reliance on a patent issued from such a continuation application to reject claims in a later-filed divisional application is not prohibited under 35 U.S.C. 121Bristol-Myers Squibb Co. v. Pharmachemie BV, 361 F.3d 1343, 1348, 70 USPQ2d 1097, 1100 (Fed. Cir. 2004).
  • (F) The claims of the second application are drawn to the "same invention" as the first application or patent. Studiengesellschaft Kohle mbH v. Northern Petrochemical Co., 784 F.2d 351, 228 USPQ 837 (Fed. Cir. 1986). A statutory double patenting rejection under 35 U.S.C. 101  should be made, thus it is not necessary to determine whether the 35 U.S.C. 121  prohibition against making double patenting rejections is applicable. "Same invention" means identical subject matter. See, e.g., Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957). The 35 U.S.C. 121  prohibition against certain nonstatutory double patenting rejections does not apply to statutory double patenting rejections under 35 U.S.C. 101  of claims to the "same invention."
  • (G) Where a requirement for restriction between a product, a process of making the product, and a process of using the product was made subject to the non-allowance of the product and the product is subsequently allowed. In this situation if any process claims are rejoined, the restriction requirement between the elected product and any rejoined process should be withdrawn in accordance with 37 CFR 1.141(b)  and MPEP § 821.04.
  • (H) The second application is a continuation-in-part (CIP) application that includes claims restricted from the original application. A CIP, by definition, is an application filed during the lifetime of an earlier application by at least one common (joint) inventor that repeats some substantial portion or all of the earlier application and adds matter not disclosed in the earlier application, i.e., the application in which the restriction requirement was originally made. 35 U.S.C. 121  refers specifically and only to divisional and original applications, and does not afford protection to CIP applications. Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353, 1362, 86 USPQ2d 1001, 1007-08 (Fed. Cir. 2008). See also In re Janssen Biotech, Inc., 880 F.3d 1315, 1322,125 USPQ2d 1525, 1529-30 (Fed. Cir. 2018) and G.D. Searle LLC v. Lupin Pharm., Inc., 790 F.3d 1349, 1355, 115 USPQ2d 1326, 1330 (Fed. Cir. 2015).

35 U.S.C. 121  does not prevent a double patenting rejection when the identical invention is claimed in the divisional application and the application/patent in which a restriction requirement was made. While identical claims should not arise if appropriate care is exercised in defining the independent and distinct inventions in a restriction requirement, if they do, the Office will make the statutory (35 U.S.C. 101 ) double patenting rejection because the patentee is entitled only to a single patent for an invention. As expressed in Studiengesellschaft Kohle, 784 F.2d at 361, 228 USPQ at 844, (J. Newman, concurring), "35 U.S.C. 121  of course does not provide that multiple patents may be granted on the identical invention."

804.02    Avoiding a Double Patenting Rejection [R-07.2022]

I.    STATUTORY

A rejection based on the statutory type of double patenting can be avoided by amending the conflicting claims so that they are not coextensive in scope. Where the conflicting claims are in one or more pending applications and a patent, a rejection based on statutory type double patenting can also be avoided by canceling the conflicting claims in all the pending applications. Where the conflicting claims are in two or more pending applications, a provisional rejection based on statutory type double patenting can also be avoided by canceling the conflicting claims in all but one of the pending applications. A terminal disclaimer is not effective in overcoming a statutory double patenting rejection.