Definition of Double Patenting

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USPTO MPEP › Chapter 0800 - Restriction in Applications Filed Under 35 U.S.C. 111; Double Patenting › MPEP § 804

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35 U.S.C. 101

Inventions Patentable.

Whoever invents or discovers any new and useful process, machine,

manufacture, or composition of matter or any new and useful improvement thereof, may

obtain a patent therefor, subject to the conditions and requirements of this title.

35 U.S.C. 121

Divisional Applications.

[

Editor Note:

Applicable to any patent application filed on or after September 16, 2012. See

pre-AIA 35

U.S.C. 121

for the law otherwise applicable.

]

If two or more independent and distinct inventions are

claimed in one application, the Director may require the application to be restricted to

one of the inventions. If the other invention is made the subject of a divisional

application which complies with the requirements of

section 120

it

shall be entitled to the benefit of the filing date of the original application. A

patent issuing on an application with respect to which a requirement for restriction

under this section has been made, or on an application filed as a result of such a

requirement, shall not be used as a reference either in the Patent and Trademark Office

or in the courts against a divisional application or against the original application or

any patent issued on either of them, if the divisional application is filed before the

issuance of the patent on the other application. The validity of a patent shall not be

questioned for failure of the Director to require the application to be restricted to

one invention.

pre-AIA 35 U.S.C. 121

Divisional Applications.

[

Editor Note:

Not applicable

to any

patent application filed on or after September 16, 2012. See

35 U.S.C.

121

for the law otherwise applicable.

]

If two or more independent and distinct inventions are claimed in one

application, the Director may require the application to be restricted to one of the

inventions. If the other invention is made the subject of a divisional application which

complies with the requirements of

section 120

of this title it shall

be entitled to the benefit of the filing date of the original application

applicable.

]

If two or more independent and distinct inventions are claimed in one

application, the Director may require the application to be restricted to one of the

inventions. If the other invention is made the subject of a divisional application which

complies with the requirements of

section 120

of this title it shall

be entitled to the benefit of the filing date of the original application. A patent

issuing on an application with respect to which a requirement for restriction under this

section has been made, or on an application filed as a result of such a requirement,

shall not be used as a reference either in the Patent and Trademark Office or in the

courts against a divisional application or against the original application or any

patent issued on either of them, if the divisional application is filed before the

issuance of the patent on the other application. If a divisional application is directed

solely to subject matter described and claimed in the original application as filed, the

Director may dispense with signing and execution by the inventor. The validity of a

patent shall not be questioned for failure of the Director to require the application to

be restricted to one invention.

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

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

plicant, 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

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

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

t 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 §§ 717

et seq.

and

2155

et 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

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

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

ions—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

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

.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

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

, 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 §

211.01

et 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.

sulted 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.

maining 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.

bmitted.

(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

.

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

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

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

pplication 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

ic

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))

tent.

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.”)

acts 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

one

common (joint) inventor, a common applicant, and/or a common owner/assignee. Where

the patent under reexamination was granted on or after December 10, 2004, double

patenting may also exist where the inventions claimed in the reference and

reexamination proceeding resulted from activities undertaken within the scope of a

joint research agreement pursuant to

35 U.S.C. 102(c)

or

pre-AIA 35

U.S.C. 103(c)(2) and (3)

, as applicable, and if evidence of the

joint research agreement has been made of record in the patent being reexamined or in

the reexamination proceeding. A double patenting rejection may NOT be made on this

basis if the patent under reexamination issued before December 10, 2004. See

MPEP §

804.03

.

The prior art exception under

35 U.S.C.

102(b)(2)(C)

or disqualification under

pre-AIA 35 U.S.C.

103(c)

generally cannot be used to overcome a double patenting

rejection, whether statutory or nonstatutory. However, since a secondary reference

used to support an obviousness analysis for a nonstatutory double patenting rejection

must be prior art, a reference excepted under

35 U.S.C.

102(b)(2)(C)

cannot be used as a secondary reference in a

nonstatutory double patenting rejection. See

MPEP §§

717.02

et seq.

and

2154.02(c)

for more information on

35

U.S.C. 102(b)(2)(C)

and

MPEP § 2146

for more information on

pre-AIA 35

U.S.C. 103(c)

. See

MPEP § 2258

for more information on

making double patenting rejections in reexamination proceedings. Subsection II,

below, describes situations wherein a double patenting rejection would be

appropriate. In particular, see paragraph II.B. for the analysis required to

determine the propriety of a nonstatutory double patenting rejection.

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

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)

roper 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

s, 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.

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.

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