Avoiding a Double Patenting Rejection

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.

The use of a

37 CFR 1.131(a)

affidavit in

overcoming a statutory double patenting rejection is inappropriate.

In re

Dunn,

349 F.2d 433, 146 USPQ 479 (CCPA 1965).

Knell v.

Muller,

174 USPQ 460 (Comm’r. Pat. 1971) (citing the CCPA decisions in

In re Ward,

236 F.2d 428, 111 USPQ 101 (CCPA 1956);

In

re Teague,

254 F.2d 145, 117 USPQ 284 (CCPA 1958); and

In re

Hidy,

303 F.2d 954, 133 USPQ 650 (CCPA 1962)).

II.

NONSTATUTORY

A rejection based on a nonstatutory type of double patenting can be

avoided by filing a terminal disclaimer in the application or proceeding in which the

rejection is made.

In re Vogel,

422 F.2d 438, 164 USPQ 619 (CCPA

1970);

In re Knohl,

386 F.2d 476, 155 USPQ 586 (CCPA 1967); and

In re Griswold,

365 F.2d 834, 150 USPQ 804 (CCPA 1966). The use

of a terminal disclaimer in overcoming a nonstatutory double patenting rejection is

in the public interest because it encourages the disclosure of additional

developments, the earlier filing of applications, and the earlier expiration of

patents whereby the inventions covered become freely available to the public.

In re Jentoft,

392 F.2d 633, 157 USPQ 363 (CCPA 1968);

In re Eckel,

393 F.2d 848, 157 USPQ 415 (CCPA 1968);

In re Braithwaite,

379 F.2d 594, 154 USPQ 29 (CCPA 1967)

is

in the public interest because it encourages the disclosure of additional

developments, the earlier filing of applications, and the earlier expiration of

patents whereby the inventions covered become freely available to the public.

In re Jentoft,

392 F.2d 633, 157 USPQ 363 (CCPA 1968);

In re Eckel,

393 F.2d 848, 157 USPQ 415 (CCPA 1968);

In re Braithwaite,

379 F.2d 594, 154 USPQ 29 (CCPA 1967). Note

that a terminal disclaimer filed after the expiration of the reference patent is not

effective to obviate a nonstatutory double patenting rejection. See

Boehringer Ingelheim Int’l v. Barr Laboratories,

592 F.3d 1340,

93 USPQ2d 1417 (Fed. Cir. 2010). See also

MPEP § 1490

, subsection VI.A. A

disclaimer filed in a reference patent that has an earlier expiration date and that

disclaims the patentably indistinct claim(s) would have no impact on whether a

nonstatutory double patenting rejection is proper in a patent that has, or an

application for a patent that would have, a later expiration date.

Eli Lilly

& Co. v. Barr Labs., Inc.,

251 F.3d 955, 967 n.5, 58 USPQ2d 1869,

1878 n.5 (Fed. Cir. 2001)(“A patent owner cannot avoid double patenting by

disclaiming the earlier patent.”).

The use of a

37 CFR 1.131(a)

affidavit in

overcoming a double patenting rejection is inappropriate because the claim or claims

in the application are being rejected over a patent which claims the rejected

invention.

In re Dunn,

349 F.2d 433, 146 USPQ 479 (CCPA 1965).

37 CFR

1.131(a)

is inapplicable if the claims of the application and

the patent are “directed to substantially the same invention.” It is also

inapplicable if there is a lack of “patentable distinctness” between the claimed

subject matter.

Knell v.

Muller,

174 USPQ 460 (Comm’r. Pat. 1971) (citing the court

decisions in

In re Ward,

236 F.2d 428, 111 USPQ 101 (CCPA 1956);

In re Teague,

254 F.2d 145, 117 USPQ 284 (CCPA 1958); and

In re Hidy,

303 F.2d 954, 133 USPQ 65 (CCPA 1962))

re “directed to substantially the same invention.” It is also

inapplicable if there is a lack of “patentable distinctness” between the claimed

subject matter.

Knell v.

Muller,

174 USPQ 460 (Comm’r. Pat. 1971) (citing the court

decisions in

In re Ward,

236 F.2d 428, 111 USPQ 101 (CCPA 1956);

In re Teague,

254 F.2d 145, 117 USPQ 284 (CCPA 1958); and

In re Hidy,

303 F.2d 954, 133 USPQ 65 (CCPA 1962)).

A patentee or applicant may disclaim or dedicate to the public the

entire term, or any terminal part of the term of a patent.

35 U.S.C. 253

.

The statute does not provide for a terminal disclaimer of only a specified claim or

claims. The terminal disclaimer must operate with respect to all claims in the

patent.

The filing of a terminal disclaimer to obviate a rejection based on

nonstatutory double patenting is not an admission of the propriety of the rejection.

Quad Environmental Technologies Corp. v. Union Sanitary

District,

946 F.2d 870, 20 USPQ2d 1392 (Fed. Cir. 1991). In

Quad Environmental Technologies,

the court indicated that the

“filing of a terminal disclaimer simply serves the statutory function of removing the

rejection of double patenting, and raises neither a presumption nor estoppel on the

merits of the rejection.”

A terminal disclaimer filed to obviate a nonstatutory double

patenting rejection is effective only with respect to the application identified in

the disclaimer, unless by its terms it extends to continuing applications. If an

appropriate provisional nonstatutory double patenting rejection is made in each of

two or more pending applications, the examiner should follow the practice set forth

in

MPEP §

804

, subsection I.B.1. and subsection VI. below.

35 U.S.C.

101

prevents two patents from issuing on the same invention.

“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)

tions, the examiner should follow the practice set forth

in

MPEP §

804

, subsection I.B.1. and subsection VI. below.

35 U.S.C.

101

prevents two patents from issuing on the same invention.

“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). Claims that differ from each other (aside from minor

differences in language, punctuation, etc.), whether or not the difference would have

been obvious, are not considered to be drawn to the same invention for double

patenting purposes under

35 U.S.C. 101

. In cases where the

difference in claims would have been obvious, terminal disclaimers are effective to

overcome nonstatutory double patenting rejections. Such terminal disclaimers must

include a provision that the patent shall be unenforceable if it ceases to be

commonly owned or enforced with the other application or patent. Note

37 CFR

1.321(c)

and

(d)

.

37 CFR 1.321(d)

sets forth the requirements for a terminal disclaimer where the claimed invention

resulted from activities undertaken within the scope of a joint research agreement.

It should be emphasized that a terminal disclaimer cannot be used to overcome a prior

art rejection under

35 U.S.C. 102

or

103

.

A nonstatutory double patenting rejection may also be

avoided if consonance between the originally restricted inventions is maintained in a

divisional application. “

Section 121

shields claims

against a double patenting challenge if consonance exists between the divided groups

of claims and an earlier restriction requirement.”

Geneva Pharmaceuticals

Inc. v. GlaxoSmithKline PLC,

349 F.3d 1373, 1381, 68 USPQ2d 1865, 1871

(Fed. Cir. 2003). “Consonance requires that the line of demarcation between the

‘independent and distinct inventions’ that prompted the restriction requirement be

maintained ... Where that line is crossed the prohibition of the third sentence of

Section 121 does not apply.”

Symbol Techs, Inc

requirement.”

Geneva Pharmaceuticals

Inc. v. GlaxoSmithKline PLC,

349 F.3d 1373, 1381, 68 USPQ2d 1865, 1871

(Fed. Cir. 2003). “Consonance requires that the line of demarcation between the

‘independent and distinct inventions’ that prompted the restriction requirement be

maintained ... Where that line is crossed the prohibition of the third sentence of

Section 121 does not apply.”

Symbol Techs, Inc. v. Opticon, Inc.,

935 F.2d 1569, 1579, 19 USPQ2d 1241, 1249 (Fed. Cir. 1991) (quoting

Gerber

Garment Technology Inc. v. Lectra Systems Inc.,

916 F.2d 683, 688, 16

USPQ2d 1436, 1440 (Fed. Cir. 1990)). “However, even if such consonance is lost,

double patenting does not follow if the requirements of

Section 121

are met or if the claims are in fact patentably distinct … The purpose of

Section

121

is to accommodate administrative convenience and to protect

the patentee from technical flaws based on this unappealable examination practice.”

Applied Materials Inc. v. Advanced Semiconductor Materials,

98

F.3d 1563, 1568, 40 USPQ2d 1481, 1484 (Fed. Cir. 1996).

III.

TERMINAL DISCLAIMER REQUIRED DESPITE REQUEST TO ISSUE ON COMMON ISSUE

DATE

Applicants are cautioned that reliance upon a common issue date

cannot effectively substitute for the filing of one or more terminal disclaimers in

order to overcome a proper nonstatutory double patenting rejection, particularly

since a common issue date alone does not avoid the potential problems of dual

ownership by a common assignee, or by parties to a joint research agreement, of

patents to patentably indistinct inventions. In any event, the Office cannot ensure

that two or more applications will have a common issue date.

IV

isclaimers in

order to overcome a proper nonstatutory double patenting rejection, particularly

since a common issue date alone does not avoid the potential problems of dual

ownership by a common assignee, or by parties to a joint research agreement, of

patents to patentably indistinct inventions. In any event, the Office cannot ensure

that two or more applications will have a common issue date.

IV.

DISCLAIMING MULTIPLE DOUBLE PATENTING REFERENCES

If multiple conflicting patents and/or pending applications are

applied in nonstatutory double patenting rejections made in a single application,

then prior to issuance of that application, it is necessary to disclaim the terminal

part of any patent granted on the application which would extend beyond the

expiration date of each one of the conflicting patents and/or applications. A

terminal disclaimer fee is required for each terminal disclaimer filed. To avoid

paying multiple terminal disclaimer fees, a single terminal disclaimer based on

common ownership may be filed, for example, in which the term disclaimed is based on

all the conflicting, commonly owned nonstatutory double patenting references.

Similarly, a single terminal disclaimer based on a joint research agreement may be

filed, in which the term disclaimed is based on all the conflicting nonstatutory

double patenting references.

Each one of the commonly owned conflicting nonstatutory double

patenting references must be included in the terminal disclaimer to avoid the problem

of dual ownership of patents to patentably indistinct inventions in the event that

the patent issuing from the application being examined ceases to be commonly owned

with any one of the double patenting references that have issued or may issue as a

patent

one of the commonly owned conflicting nonstatutory double

patenting references must be included in the terminal disclaimer to avoid the problem

of dual ownership of patents to patentably indistinct inventions in the event that

the patent issuing from the application being examined ceases to be commonly owned

with any one of the double patenting references that have issued or may issue as a

patent. Note that

37 CFR 1.321(c)(3)

requires that a terminal disclaimer for

commonly owned conflicting claims “[i]nclude a provision that any patent granted on

that application or any patent subject to the reexamination proceeding shall be

enforceable only for and during such period that said patent is commonly owned with

the application or patent which formed the basis for the judicially created double

patenting.”

Filing a terminal disclaimer including each one of the conflicting

nonstatutory double patenting references is also necessary to avoid the problem of

separate enforcement of patents to patentably indistinct inventions by parties to a

joint research agreement.

37 CFR 1.321(d)

sets forth the

requirements for a terminal disclaimer where the claimed invention resulted from

activities undertaken within the scope of a joint research agreement.

V.

REQUIREMENTS OF A TERMINAL DISCLAIMER

A terminal disclaimer is a statement filed by an owner (in whole or

in part) of a patent or a patent to be granted that is used to disclaim or dedicate a

portion of the entire term of all the claims of a patent. The requirements for a

terminal disclaimer are set forth in

37 CFR 1.321

. Sample forms of a

terminal disclaimer, and guidance as to the filing and treatment of a terminal

disclaimer, are provided in

MPEP § 1490

.

VI.

TERMINAL DISCLAIMERS REQUIRED TO OVERCOME NONSTATUTORY DOUBLE PATENTING

REJECTIONS IN APPLICATIONS FILED ON OR AFTER JUNE 8, 1995

Public Law 103-465 (1994) amended

35 U.S.C

a patent. The requirements for a

terminal disclaimer are set forth in

37 CFR 1.321

. Sample forms of a

terminal disclaimer, and guidance as to the filing and treatment of a terminal

disclaimer, are provided in

MPEP § 1490

.

VI.

TERMINAL DISCLAIMERS REQUIRED TO OVERCOME NONSTATUTORY DOUBLE PATENTING

REJECTIONS IN APPLICATIONS FILED ON OR AFTER JUNE 8, 1995

Public Law 103-465 (1994) amended

35 U.S.C.

154(a)(2)

to provide that any patent issuing on a utility or

plant application filed on or after June 8, 1995 will expire 20 years from its actual

filing date, or, if the application claims the benefit of an earlier filed

application under

35 U.S.C. 120

,

121

, or

365(c)

, 20 years from the earliest filing date for which a

benefit under

35

U.S.C. 120

,

121

, or

365(c)

is

claimed. 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).”

Therefore, any patent issuing on a continuing utility or plant application filed on

or after June 8, 1995 will expire 20 years from the earliest filing date for which a

benefit is claimed under

35 U.S.C. 120

,

121

,

365(c)

, or

386(c)

, subject to the provisions

of

35 U.S.C.

154(b)

and

156

(providing for certain patent

term adjustments and extensions). Thus, situations will often arise in which two

copending applications subject to a provisional double patenting rejection will have

the same patent term filing date, and thus, potentially will have the same patent

term. Note that a benefit claim under

35 U.S.C. 120

,

121

,

365(c)

, or

386(c)

that meets the

requirements of

37 CFR 1.78

determines the twenty year patent term for utility

and plant applications filed on or after June 8, 1995

ch two

copending applications subject to a provisional double patenting rejection will have

the same patent term filing date, and thus, potentially will have the same patent

term. Note that a benefit claim under

35 U.S.C. 120

,

121

,

365(c)

, or

386(c)

that meets the

requirements of

37 CFR 1.78

determines the twenty year patent term for utility

and plant applications filed on or after June 8, 1995. For patent term, it is not

relevant if any claimed invention in the patent actually has

35 U.S.C.

112(a)

) support in an earlier application and is therefore

entitled to benefit of the earlier filing date for the purpose of avoiding prior art.

See

MPEP §

804

, subsection I.B.1(a).

There are at least two reasons for insisting upon a terminal

disclaimer to overcome a nonstatutory double patenting rejection in an application

subject to a 20-year term under

35 U.S.C. 154(a)(2)

. First,

35 U.S.C.

154(b)

includes provisions for patent term adjustment based

upon prosecution delays during the application process. Thus,

35 U.S.C. 154

does not ensure that any patent issuing on a continuing utility or plant application

filed on or after June 8, 1995 will necessarily expire 20 years from the earliest

filing date for which a benefit is claimed under

35 U.S.C.

120

,

121

,

365(c)

, or

386(c)

. However,

35 U.S.C. 154(b)(2)(B)

states

that no patent the term of which has been disclaimed beyond a specified date may be

adjusted under this section beyond the expiration date specified in the disclaimer.

As the presence of a terminal disclaimer affects whether the patent is granted an

adjustment, it is necessary that the terminal disclaimer be filed in the application

in order to accurately determine whether the patent is entitled to a term adjustment

term of which has been disclaimed beyond a specified date may be

adjusted under this section beyond the expiration date specified in the disclaimer.

As the presence of a terminal disclaimer affects whether the patent is granted an

adjustment, it is necessary that the terminal disclaimer be filed in the application

in order to accurately determine whether the patent is entitled to a term adjustment.

Second,

37 CFR

1.321(c)(3)

requires that a terminal disclaimer filed to

obviate a nonstatutory double patenting rejection based on commonly owned conflicting

claims include a provision that any patent granted on that application be enforceable

only for and during the period that the patent is commonly owned with the application

or patent which formed the basis for the rejection.

37 CFR 1.321(d)

sets forth the requirements for a terminal disclaimer where the claimed invention

resulted from activities undertaken within the scope of a joint research agreement

and limits enforcement of the patent only to that period when the patent and the

reference application or patent are not separately enforced. These requirements serve

to avoid the potential for harassment of an accused infringer by multiple parties

with patents covering the same patentable invention. See, e.g.,

In re Van

Ornum,

686 F.2d 937, 944-48, 214 USPQ 761, 767-70 (CCPA 1982). Not

insisting upon a terminal disclaimer to overcome a nonstatutory double patenting

rejection in an application subject to a 20-year term under

35 U.S.C.

154(a)(2)

would result in the potential for the problem that

37 CFR

1.321(c)(3)

was promulgated to avoid. Further, as a terminal

disclaimer is only effective in the application in which it is filed, it is necessary

to require that the terminal disclaimer be filed in each application and/or patent

that is subject to the common ownership requirement in order to provide complete

notice to the public of this obligation

sult in the potential for the problem that

37 CFR

1.321(c)(3)

was promulgated to avoid. Further, as a terminal

disclaimer is only effective in the application in which it is filed, it is necessary

to require that the terminal disclaimer be filed in each application and/or patent

that is subject to the common ownership requirement in order to provide complete

notice to the public of this obligation.

Accordingly, a terminal disclaimer under

37 CFR 1.321

is

required in an application to overcome a nonstatutory double patenting rejection,

even if the application was filed on or after June 8, 1995 and even if the

application claims the benefit under

35 U.S.C. 120

,

121

,

365(c)

, or

386(c)

of the filing date of the

patent or application which forms the basis for the rejection. Examiners should

respond to arguments that a terminal disclaimer under

37 CFR 1.321

should not be required in a continuing application filed on or after June 8, 1995 to

overcome a nonstatutory double patenting rejection due to the change to

35 U.S.C.

154

by citing to this section of the MPEP. See

Terminal Disclaimers Required to Overcome Judicially-Created Double

Patenting Rejections in Utility and Plant Applications Filed on or After June 8,

1995,

1202 OG 112 (September 30, 1997). See also

AbbVie Inc. v.

Kennedy Institute of Rheumatology Trust,

764 F.3d 1366, 112 USPQ2d 1001

(Fed. Cir. 2014).

If a terminal disclaimer is filed in an application in

which the claims are then canceled or otherwise shown to be patentably distinct from

the reference claims, the terminal disclaimer may be withdrawn before issuance of the

patent by filing a petition under

37 CFR 1.182

requesting

withdrawal of the recorded terminal disclaimer. A terminal disclaimer may not be

withdrawn after issuance of the patent. See

MPEP § 1490

, subsection VIII, for a

complete discussion of withdrawal of a terminal disclaimer.