Prohibition of Nonstatutory Double Patenting Rejections Under 35 U.S.C. 121

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USPTO MPEP › Chapter 0800 - Restriction in Applications Filed Under 35 U.S.C. 111; Double Patenting › MPEP § 804.01

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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

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

iced 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,

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.”

.);

In re

Schneller,

397 F.2d 350, 158 USPQ 210 (CCPA 1968)

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,

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.”

.);

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.

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

olding 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. 121

Bristol-Myers Squibb Co. v.

Pharmachemie BV,

361 F.3d 1343, 1348, 70 USPQ2d 1097, 1100 (Fed. Cir.

2004).

(F) The claims of the second application are drawn to the “same

invention” as the first application or patent.

Studiengesellschaft Kohle

mbH v. Northern Petrochemical Co.,

784 F.2d 351, 228 USPQ 837 (Fed.

Cir. 1986). A statutory double patenting rejection under

35 U.S.C.

101

should be made, thus it is not necessary to determine

whether the

35 U.S.C. 121

prohibition against making double patenting

rejections is applicable. “Same invention” means identical subject matter. See,

e.g.,

Miller v. Eagle Mfg. Co.,

151 U.S

esellschaft 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).