Election of Species Requirements – Markush Claims

I.

MARKUSH CLAIMS

A “Markush” claim recites a list of alternatively useable members.

In re Harnisch,

631 F.2d 716, 719-20, 206 USPQ 300, 303 (CCPA

1980);

Ex parte Markush,

1925 Dec. Comm'r Pat. 126, 127 (1924).

The listing of specified alternatives within a Markush claim is referred to as a

Markush group or a Markush grouping.

Abbott Labs v. Baxter Pharmaceutical

Products, Inc.,

334 F.3d 1274, 1280-81, 67 USPQ2d 1191, 1196 (Fed. Cir.

2003)(citing to several sources that describe Markush groups).

When examining a Markush claim, the examiner may

generally choose to require a provisional election of species from among patentably

indistinct species or patentably indistinct groups of species. See subsection III,

below. The applicant’s election serves as a starting point for the search and

examination of the claim.

See

MPEP §

2117

for a general discussion of Markush claims, guidance

and examples regarding the determination of whether a Markush grouping is proper, and

rejections on the basis that a claim contains an improper Markush grouping. A

rejection based on an improper Markush grouping should be made in an Office action on

the merits. In certain circumstances, both a provisional election of species

requirement and an improper Markush grouping rejection may apply to the same claim.

See

MPEP § 2111.03

, subsection II, and

MPEP §

2173.05(h)

for a discussion of Markush claims and

compliance with the definiteness requirement of

35 U.S.C.

112(b)

.

II.

PROPER MARKUSH

GROUPING

Pursuant to the

Supplementary Examination

Guidelines for Determining Compliance with 35 U.S.C. 112 and for Treatment of

Related Issues in Patent Applications

(

“Supplementary

Guidelines”

), 76 Fed. Reg. 7162 (February 9, 2011), a Markush grouping

is proper if: (1) the members of the Markush group share a “single structural

similarity,” and (2) the members share a common use.

Id.

(citing

In re Harnisch,

631 F.2d 716, 721-22, 206 USPQ 300, 305 (CCPA

1980))

etermining Compliance with 35 U.S.C. 112 and for Treatment of

Related Issues in Patent Applications

(

“Supplementary

Guidelines”

), 76 Fed. Reg. 7162 (February 9, 2011), a Markush grouping

is proper if: (1) the members of the Markush group share a “single structural

similarity,” and (2) the members share a common use.

Id.

(citing

In re Harnisch,

631 F.2d 716, 721-22, 206 USPQ 300, 305 (CCPA

1980)).

Where a Markush grouping describes part of a

combination or process, the members following “selected from the group consisting of”

(or a similar introductory phrase) must be substitutable, one for the other, with the

expectation that the same intended result would be achieved.

Multilayer

Stretch Cling Film Holdings, Inc. v. Berry Plastics Corp.,

831 F.3d

1350, 1357, 119 USPQ2d 1773, 1779 (Fed. Cir. 2016)(“It is generally understood that …

the members of the Markush group … are alternatively usable for the purposes of the

invention … .”)(citations omitted). Where a Markush grouping describes part of a

chemical compound, regardless of whether the claim is limited to a compound per se or

the compound is recited as part of a combination or process, the members following

“selected from the group consisting of” (or similar introductory phrase) need not

share a community of properties themselves; the propriety of the grouping is

determined by a consideration of the compound as a whole. See

Harnisch,

631 F.2d at 722, 206 USPQ at 305 (“in determining the

propriety of a Markush grouping the compounds must be considered as wholes and not

broken down into elements or other components”).

See

MPEP §

2117

for guidance and examples regarding the determination

of whether a Markush grouping is proper.

In accordance with the principles of compact

prosecution, if the examiner determines that one or more claims appear to include an

improper Markush grouping (see

MPEP § 2117

), the examiner should

require the applicant to elect a species

not

broken down into elements or other components”).

See

MPEP §

2117

for guidance and examples regarding the determination

of whether a Markush grouping is proper.

In accordance with the principles of compact

prosecution, if the examiner determines that one or more claims appear to include an

improper Markush grouping (see

MPEP § 2117

), the examiner should

require the applicant to elect a species. Note that if a written provisional election

of species requirement must be made separate from the first Office action on the

merits, it should not include a rejection on the basis of an improper Markush

grouping. Any appropriate improper Markush grouping rejection should be made in an

Office action on the merits.

III.

ELECTION OF SPECIES PRACTICE FOR

MARKUSH CLAIMS

A.

Overview

Markush claims recite a plurality of alternatively usable

substances or members. In most cases, a recitation by enumeration is used because

there is no appropriate or true generic language. A Markush claim may include

independent and distinct inventions. This is true where two or more of the members

are so unrelated and diverse that a prior art reference anticipating the claim

with respect to one of the members would not render the claim obvious under

35 U.S.C.

103

with respect to the other member(s). In applications

containing a Markush claim that encompasses at least two independent or distinct

inventions, the examiner may require a provisional election of a single species

(or grouping of patentably indistinct species) prior to examination on the merits,

with one exception. If the members of a proper Markush group are sufficiently few

in number or so closely related that a search and examination of the entire claim

can be made without serious burden, the examiner must examine all the members of

the Markush group in the claim on the merits, even though they may be directed to

independent and distinct inventions. In such a case, the examiner will not require

provisional election of a single species

kush group are sufficiently few

in number or so closely related that a search and examination of the entire claim

can be made without serious burden, the examiner must examine all the members of

the Markush group in the claim on the merits, even though they may be directed to

independent and distinct inventions. In such a case, the examiner will not require

provisional election of a single species. See

MPEP §

808.02

An election of species requirement is a type of

restriction requirement. An examiner should set forth a requirement for election

of a single disclosed species (or a grouping of patentably indistinct species) in

a Markush claim using form paragraph

8.01

when claims limited to species are present

or using form paragraph

8.02

when no species claims are present. See

MPEP §

808.01(a)

and

§ 809.02(a)

. If a Markush claim

depends from or otherwise requires all the limitations of another generic or

linking claim, see

MPEP § 809

.

Following election, the Markush claim will be

examined fully with respect to the elected species and further to the extent

necessary to determine patentability. Note that where a claim reads on multiple

species, only one species needs to be taught or suggested by the prior art in

order for the claim to be anticipated or rendered obvious. See, e.g.,

Fresenius USA, Inc. v. Baxter Int’l, Inc.,

582 F.3d 1288,

1298, 92 USPQ2d 1163, 1171 (Fed. Cir. 2009)(the entire element is disclosed by the

prior art if one alternative in the Markush group is in the prior art).

If the Markush claim is not allowable, the provisional election

will be given effect and examination will be limited to the Markush claim and

claims to the elected species, with claims drawn to species patentably distinct

from the elected species held withdrawn from further consideration

(the entire element is disclosed by the

prior art if one alternative in the Markush group is in the prior art).

If the Markush claim is not allowable, the provisional election

will be given effect and examination will be limited to the Markush claim and

claims to the elected species, with claims drawn to species patentably distinct

from the elected species held withdrawn from further consideration. As an example,

in the case of an application with a Markush claim drawn to the compound X-R,

wherein R is a radical selected from the group consisting of A, B, C, D, and E,

the examiner may require a provisional election of a single species, XA, XB, XC,

XD, or XE. The Markush claim would then be examined fully with respect to the

elected species and any species considered to be clearly unpatentable over the

elected species.

If on examination the elected species is found to

be anticipated or rendered obvious by prior art, the Markush claim and claims to

the elected species will be rejected, and claims to the nonelected species will be

held withdrawn from further consideration.

If the examiner determines that the elected species is allowable

over the prior art, the examination of the Markush claim will be extended. If

prior art is then found that anticipates or renders obvious the Markush claim with

respect to a

nonelected species,

the Markush claim shall be

rejected; claims to the nonelected species would still be held withdrawn from

further consideration. The prior art search will not be extended unnecessarily to

cover all nonelected species, and need not be extended beyond a proper Markush

grouping. See subsection III.C.2, below, for additional guidance.

Should applicant, in response to a rejection of a

Markush claim, overcome the rejection by amending the Markush claim to exclude the

species anticipated or rendered obvious by the prior art, the amended Markush

claim will be examined again. The examination will be extended to the extent

necessary to determine patentability of the Markush claim

ee subsection III.C.2, below, for additional guidance.

Should applicant, in response to a rejection of a

Markush claim, overcome the rejection by amending the Markush claim to exclude the

species anticipated or rendered obvious by the prior art, the amended Markush

claim will be examined again. The examination will be extended to the extent

necessary to determine patentability of the Markush claim. In the event prior art

is found during this examination that anticipates or renders obvious the amended

Markush claim, the claim will be rejected and the action can be made final unless

the examiner introduces a new ground of rejection that is neither necessitated by

applicant’s amendment of the claims nor based on information submitted in an

information disclosure statement filed during the period set forth in

37 CFR

1.97(c)

with the fee set forth in

37 CFR

1.17(p)

. See

MPEP § 706.07(a)

. Amendments

submitted after the final rejection further restricting the scope of the claim may

be denied entry if they do not comply with the requirements of

37 CFR

1.116

. See

MPEP § 714.13

.

B.

Provisional Election of

Species

If a claim that includes a Markush grouping reads on

two or more patentably distinct inventions, a provisional election of species

requirement may be made at the examiner’s discretion. When making such a requirement,

the examiner will require the applicant to elect a species or group of patentably

indistinct species for initial search and examination. The examiner should not

require provisional election between species that are not patentably distinct, or

when the Markush group is proper and there would be no serious burden if the species

were searched and examined together. The examiner should not invite the applicant to

elect any group of species that would clearly be rejectable either as an improper

Markush grouping or under

35 U.S.C. 112(a)

if presented in

a separate claim

rovisional election between species that are not patentably distinct, or

when the Markush group is proper and there would be no serious burden if the species

were searched and examined together. The examiner should not invite the applicant to

elect any group of species that would clearly be rejectable either as an improper

Markush grouping or under

35 U.S.C. 112(a)

if presented in

a separate claim.

In accordance with current practice, when an examiner

chooses to require a provisional election of species, in most cases the examiner

should call the applicant to request a telephonic election. See

MPEP § 812.01

. If

the applicant elects by telephone, form paragraph

8.23

should be used in the next Office

action on the merits. The examiner should note whether the election was made with or

without traverse. If a rejection on the basis of an improper Markush grouping is to

be made, it should be done in the first Office action on the merits with the written

provisional election of species requirement.

If a written provisional election of species

requirement is made prior to the first Office action on the merits, it should not

include a rejection on the basis of an improper Markush grouping. Any appropriate

improper Markush grouping rejection should be made in an Office action on the merits.

If during prosecution a new claim is added that includes an improper Markush

grouping, or an existing claim is amended to include an improper Markush grouping,

the examiner may require provisional election of species at that time, in the same

action as any appropriate rejections . Include form paragraph

8.23.01

if the applicant declined to elect by telephone.

C.

Initial Examination of Elected

Species

1.

Rejection of Claims to Elected

Species

Examination on the merits begins after the

applicant’s election

s amended to include an improper Markush grouping,

the examiner may require provisional election of species at that time, in the same

action as any appropriate rejections . Include form paragraph

8.23.01

if the applicant declined to elect by telephone.

C.

Initial Examination of Elected

Species

1.

Rejection of Claims to Elected

Species

Examination on the merits begins after the

applicant’s election. If the elected species or group of patentably indistinct

species is anticipated by or obvious over the prior art, an appropriate art-based

rejection of any claim that reads on the elected species or group of patentably

indistinct species should be made. Non-prior art rejections that apply to the

elected species or group of patentably indistinct species should also be made. If

the election was made with traverse, it should be treated in accordance with

MPEP §

821.01

.

If the Markush grouping was improper, a rejection on

the basis of there being an improper Markush grouping should be made as described

in

MPEP § 2117

. The examiner should use form paragraph

8.40

to

make the improper Markush grouping rejection and to advise the applicant of the

species that do not belong to a proper Markush grouping that includes the elected

species. The form paragraph also serves to advise the applicant that a rejection

on the basis of there being an improper Markush grouping is an appealable rather

than a petitionable matter.

Example 1.

A claim is drawn to a proper Markush grouping of

species A, B, or C. The three species are patentably distinct, and the examiner

requires a provisional election. Species A is elected. The examiner rejects

species A over prior art, and indicates that species B and C have not been

searched and examined. Use form paragraph

8.01

or

8.02

as appropriate to set forth the election requirement.

Example 2.

A claim is drawn to a Markush grouping of

species A, B, C, D, or E. The five species are patentably distinct, and the

examiner requires a provisional election

on. Species A is elected. The examiner rejects

species A over prior art, and indicates that species B and C have not been

searched and examined. Use form paragraph

8.01

or

8.02

as appropriate to set forth the election requirement.

Example 2.

A claim is drawn to a Markush grouping of

species A, B, C, D, or E. The five species are patentably distinct, and the

examiner requires a provisional election. The grouping of species A, B, or C is

a proper Markush grouping. However, the grouping of species A, B, C, D, or E is

not a proper Markush grouping. Species A is elected. The examiner rejects

species A over prior art, and indicates that species B, C, D, and E have not

been searched and examined. Use form paragraph

8.01

or

8.02

as appropriate to set forth the election requirement. The examiner should also

reject the claim on the basis of there being an improper Markush grouping using

form paragraph

8.40

. The improper Markush grouping rejection

should indicate that species D and E do not belong to the proper Markush

grouping of species A, B, or C.

2.

Elected Species in Proper Markush

Grouping Allowable over the Prior Art

If the elected species or group of patentably

indistinct species is not anticipated by or obvious over the prior art, the

examiner should extend the search and examination to a non-elected species or

group of species that falls within the scope of a proper Markush grouping that

includes the elected species. The search and examination should be continued until

either (1) prior art is found that anticipates or renders obvious a species that

falls within the scope of a proper Markush grouping that includes the elected

species, or (2) it is determined that no prior art rejection of any species that

falls within the scope of a proper Markush grouping that includes the elected

species can be made. The examiner need not extend the search beyond a proper

Markush grouping

prior art is found that anticipates or renders obvious a species that

falls within the scope of a proper Markush grouping that includes the elected

species, or (2) it is determined that no prior art rejection of any species that

falls within the scope of a proper Markush grouping that includes the elected

species can be made. The examiner need not extend the search beyond a proper

Markush grouping. In other words, the examiner need not extend the search to any

additional species that do not share a single structural similarity and a common

use with the elected species (i.e., do not belong to the same recognized physical

or chemical class or to the same art-recognized class and/or do not have a common

use and/or do not share a substantial structural feature of a chemical compound

and a use that flows from the substantial structural feature). The examiner should

continue examination of the Markush claim to determine whether it meets all other

requirements of patentability (e.g.,

35 U.S.C. 101

and

112

, nonstatutory double patenting, and proper Markush

grouping).

In the interest of compact prosecution, the examiner

should ensure that the record is clear as to which species have been searched and

have been found allowable over the prior art. The examiner should indicate that

the provisional election of species requirement has been modified if additional

species beyond the elected species have been searched and determined to be

allowable over the prior art. The examiner should indicate that the provisional

election of species requirement has been withdrawn if the full scope of the

Markush grouping has been searched and been determined to be allowable over the

prior art. Note that the examiner can only make or maintain any restriction

requirement if there would be serious search and/or examination burden. Clarity of

the record with regard to the provisional election of species requirement is

critical to proper application of

35 U.S.C. 121

in later

divisional applications

the

Markush grouping has been searched and been determined to be allowable over the

prior art. Note that the examiner can only make or maintain any restriction

requirement if there would be serious search and/or examination burden. Clarity of

the record with regard to the provisional election of species requirement is

critical to proper application of

35 U.S.C. 121

in later

divisional applications.

If a Markush grouping as set forth in a claim is

proper and election of species has been required, the examiner must continue to

search the species of the claim unless the claim has been found to be unpatentable

over prior art. An examiner may not (such as by way of an Ex parte Quayle action

or a Notice of Non-Responsive Amendment) seek to require an applicant to limit the

scope of a claim that is directed to a proper Markush group to a subset of species

that falls within the scope of the claim in the absence of a rejection of the

claim for not complying with the requirements for patentability (e.g.,

35 U.S.C.

101

,

102

,

103

, and

112

, and nonstatutory double patenting).

D.

Final Rejection; Finality

of Election Requirement

An Office action may be made final if the

requirements of

MPEP

§§ 706.07

-

706.07(b)

are met. If a claim in

a first application recites a proper Markush grouping that encompasses patentably

distinct inventions, an examiner who has required a provisional election of

species need not continue to search the claim if the claim is rejected over prior

art in a proper final rejection. That is, in this circumstance, the applicant’s

election loses its provisional status and is given full effect under

35 U.S.C.

121

. Furthermore, if an applicant files a second application

that is a divisional application claiming benefit under

35 U.S.C.

120

of the first application, the

35 U.S.C.

121

shield may be applicable

laim if the claim is rejected over prior

art in a proper final rejection. That is, in this circumstance, the applicant’s

election loses its provisional status and is given full effect under

35 U.S.C.

121

. Furthermore, if an applicant files a second application

that is a divisional application claiming benefit under

35 U.S.C.

120

of the first application, the

35 U.S.C.

121

shield may be applicable. So long as the consonance

requirement is met, a claim in the divisional application to a previously

non-elected and unexamined embodiment may not be rejected on the ground of

non-statutory double patenting over an embodiment examined in the first

application. An amendment canceling the rejected species received after final

under

37 CFR

1.116

may typically be denied entry on the basis that it

would require further consideration and/or search. If the applicant’s provisional

election was made with traverse and the requirement has been made final, the

applicant may file a petition for review under

37 CFR 1.144

. See

MPEP §§ 818.01(c)

and

818.01(d)

.

Note that no Markush claim can be allowed until any

improper Markush grouping rejection has been overcome or withdrawn (see

MPEP § 2117

, subsection III), and all other conditions

of patentability have been satisfied.