restriction practice for genus claims species claims linking claims and markush claims julie burke...

Restriction Practice for Restriction Practice for Genus Claims Genus Claims Species Claims Species Claims Linking Claims and Linking Claims and Markush Claims Markush Claims

Julie Burke

QAS/PM TC1600

BCP Slides for 3/6/07 2

Objectives

• Basis for Requiring Restriction• What is serious burden?• Genus Claims• Species Claims• Linking Claims• Markush Claims


Basic Restriction GuidelinesBasic Restriction Guidelines

Every restriction requirement has two Every restriction requirement has two criteria:criteria:

The inventions, as claimed, must be The inventions, as claimed, must be independent or distinct independent or distinct and and

There would be a serious burden on the There would be a serious burden on the examiner if restriction were not required.examiner if restriction were not required.

MPEP 803, subsection IMPEP 803, subsection I


What is “Serious Burden”?What is “Serious Burden”?

Basically, the search and Basically, the search and examination for one of the examination for one of the claimed inventions is not claimed inventions is not required for another of the required for another of the claimed inventions.claimed inventions.MPEP 808.02


Showing Serious Burden Showing Serious Burden The examiner must provide reasons why a The examiner must provide reasons why a

serious burden would exist in order to support serious burden would exist in order to support a restriction requirement.a restriction requirement.

A serious burden may be A serious burden may be prima facieprima facie shown if shown if the inventions have the inventions have separate classificationseparate classification or or separate status in the artseparate status in the art when the inventions when the inventions are classifiable together or a are classifiable together or a different field of different field of searchsearch as defined in MPEP 808.02. as defined in MPEP 808.02.

The The prima facieprima facie showing may be rebutted by showing may be rebutted by the applicant.the applicant.

MPEP 803MPEP 803


Showing Serious Burden Showing Serious Burden (cont.)(cont.)

Serious burden may be established based Serious burden may be established based on a different field of search if it is on a different field of search if it is necessary to search for one of the necessary to search for one of the inventions in a manner not likely to result inventions in a manner not likely to result in finding art pertinent to the other in finding art pertinent to the other invention(s), e.g.,invention(s), e.g., searching different classes/subclasses searching different classes/subclasses searching different electronic resources searching different electronic resources employing different search queriesemploying different search queries

A serious burden may be shown when the A serious burden may be shown when the inventions are classified together if the examiner inventions are classified together if the examiner can explain how the searches differ.can explain how the searches differ.

FP 8.21.03FP 8.21.03


Obvious variants are not distinct Obvious variants are not distinct inventionsinventions

Distinctness between related inventions Distinctness between related inventions requires that at least one invention would not requires that at least one invention would not have been obvious over the other (i.e., that have been obvious over the other (i.e., that the inventions are not obvious variants).the inventions are not obvious variants).

If the claims on their face are obvious over each other, If the claims on their face are obvious over each other, restriction is not proper. restriction is not proper.

For example of obvious variants, the application claims For example of obvious variants, the application claims a method of connecting two parts together. a method of connecting two parts together. In one embodiment, the method requires a screw.In one embodiment, the method requires a screw. In a second embodiment, the method requires a nail. In a second embodiment, the method requires a nail.

The examiner should group together embodiments The examiner should group together embodiments considered clearly unpatentable over each other; see considered clearly unpatentable over each other; see MPEP 806.04(h).MPEP 806.04(h).


When is Restriction Not an When is Restriction Not an Option?Option?

If the search and examination of all the claims in If the search and examination of all the claims in an application can be made an application can be made without serious without serious burdenburden, the examiner must examine all of the , the examiner must examine all of the claims on the merits, even if the claims are claims on the merits, even if the claims are drawn to independent or distinct inventions. drawn to independent or distinct inventions.

If there is an express admission that the claimed If there is an express admission that the claimed inventions are inventions are obvious over each otherobvious over each other within within the meaning of 35 U.S.C. 103, restriction should the meaning of 35 U.S.C. 103, restriction should not be required.not be required.

MPEP section 803MPEP section 803


When the inventions are When the inventions are not distinct as not distinct as claimedclaimed, restriction is never proper. MPEP , restriction is never proper. MPEP 806. For example:806. For example:

Claim 1. A transgenic animal comprising SEQ ID Claim 1. A transgenic animal comprising SEQ ID No 1.No 1.

Claim 2. A transgenic rodent comprising SEQ ID Claim 2. A transgenic rodent comprising SEQ ID No 1.No 1.

Claim 3. A transgenic mouse comprising SEQ ID Claim 3. A transgenic mouse comprising SEQ ID No 1.No 1.

Restriction among claims 1, 2 and 3 is not Restriction among claims 1, 2 and 3 is not proper because claims 1, 2 and 3 overlap in proper because claims 1, 2 and 3 overlap in scope as genus, subgenus and species claim. scope as genus, subgenus and species claim.



When the claims define the same essential When the claims define the same essential characteristics of a single disclosed characteristics of a single disclosed embodiment of an invention, restriction is not embodiment of an invention, restriction is not proper. MPEP 806.03 proper. MPEP 806.03

For example, the specification discloses a compound of formula 1 having an x-ray For example, the specification discloses a compound of formula 1 having an x-ray diffraction pattern depicted in Figure 12. diffraction pattern depicted in Figure 12.

Claim 1. A compound of formula 1.Claim 1. A compound of formula 1.Claim 2. A compound having the x-ray diffraction pattern as depicted in Fig 12.Claim 2. A compound having the x-ray diffraction pattern as depicted in Fig 12.

One should not restrict claim 1 from claim 2 as both claims merely define the same One should not restrict claim 1 from claim 2 as both claims merely define the same essential characteristics of a single disclosed embodiment of an invention.essential characteristics of a single disclosed embodiment of an invention.



What are Species?What are Species? Species are always specifically different Species are always specifically different

embodiments of an invention.embodiments of an invention.

Species typically are disclosed as Species typically are disclosed as examples or figures in the specification.examples or figures in the specification.

Species may be independent or related.Species may be independent or related.

MPEP 806.04(e).MPEP 806.04(e).


What is a Genus claim?What is a Genus claim?

A claim that encompasses two or more A claim that encompasses two or more disclosed embodiments (species) within disclosed embodiments (species) within its scope is considered to be a generic its scope is considered to be a generic or genus claim.or genus claim.

See MPEP 806.04(d) and 806.04(e) See MPEP 806.04(d) and 806.04(e) for further definition.for further definition.


Three Ways to Claim a GenusThree Ways to Claim a Genus

1. As a series of single species claims1. As a series of single species claimsClaim 1. An orange.Claim 1. An orange.Claim 2. A lemon.Claim 2. A lemon.

2. As a Markush claim reading upon plural species2. As a Markush claim reading upon plural speciesClaim 3. A citrus fruit selected from the Claim 3. A citrus fruit selected from the

group consisting of an orange or a lemon.group consisting of an orange or a lemon.

3. Encompassed by a linking claim which reads 3. Encompassed by a linking claim which reads upon but is not necessarily limited to plural upon but is not necessarily limited to plural species disclosed in the specification.species disclosed in the specification.

Claim 4. A citrus fruit.Claim 4. A citrus fruit.


Test for Distinctness Between Test for Distinctness Between SpeciesSpecies

Species are distinct when:Species are distinct when:

each species, as claimed, requires a each species, as claimed, requires a mutually exclusive characteristic not mutually exclusive characteristic not required for the other speciesrequired for the other species

ANDAND the species, as claimed, are not obvious the species, as claimed, are not obvious

variants of each other variants of each other

MPEP 806.04(f)MPEP 806.04(f)


Election of Species Election of Species When an election of species is appropriate, FP 8.01 or When an election of species is appropriate, FP 8.01 or

8.02 should be used to communicate the requirement. 8.02 should be used to communicate the requirement. The examiner explains why the species are The examiner explains why the species are independent or distinct in these form paragraphs. independent or distinct in these form paragraphs. Use form paragraph 8.01 when claims limited to

species are present Use form paragraph 8.02 when no claims limited to

species are presentA restriction requirement may contain a requirement A restriction requirement may contain a requirement

to elect a single invention and/or a provisional to elect a single invention and/or a provisional requirement to elect a species for examination requirement to elect a species for examination purposes. purposes.


Linking ClaimsLinking Claims Definition: Definition: A linking claim is a claim which, if A linking claim is a claim which, if

allowable, would prevent restriction between allowable, would prevent restriction between two or more otherwise properly divisible two or more otherwise properly divisible (restrictable) inventions. MPEP 809 and (restrictable) inventions. MPEP 809 and 809.03.809.03. Linking claims and linked inventions are usually either Linking claims and linked inventions are usually either

product claims linking properly divisible product inventions, product claims linking properly divisible product inventions, or process claims linking properly divisible process or process claims linking properly divisible process inventions. inventions.

Most kinds of Linking claims areMost kinds of Linking claims are Genus claims linking species claimsGenus claims linking species claims Subcombination claims linking plural combinations that Subcombination claims linking plural combinations that

require the subcombination.require the subcombination.

Restriction can be required when there are linking Restriction can be required when there are linking claims and claims to distinct inventions.claims and claims to distinct inventions.

If a linked invention is elected, the linking claims are If a linked invention is elected, the linking claims are examined with the elected invention.examined with the elected invention.


Example of a Linking Claim – Example of a Linking Claim – Genus claim linking species claimsGenus claim linking species claims

Claim 1. A composition for reducing HIV viral load in an HIV infected Claim 1. A composition for reducing HIV viral load in an HIV infected patient, comprising an agent inhibiting viral replication and a patient, comprising an agent inhibiting viral replication and a pharmaceutically acceptable carrier. pharmaceutically acceptable carrier. (genus linking claim) (genus linking claim)

Claim 2. The composition of claim 1, wherein the agent is a Claim 2. The composition of claim 1, wherein the agent is a polypeptide having the amino acid sequence of SEQ ID NO:2.polypeptide having the amino acid sequence of SEQ ID NO:2.

Claim 3. The composition of claim 1, wherein the agent is a Claim 3. The composition of claim 1, wherein the agent is a polynucleotide having the sequence of SEQ ID NO:5.polynucleotide having the sequence of SEQ ID NO:5.

Claim 4. The composition of claim 1, wherein the agent is 3,3’-Claim 4. The composition of claim 1, wherein the agent is 3,3’-methoxysilyl-3,3’-organophosphate.methoxysilyl-3,3’-organophosphate.

Restriction may be proper between claims 2, 3 and 4, howeverRestriction may be proper between claims 2, 3 and 4, howeverClaim 1 cannot be restricted from any of claims 2, 3 and 4.Claim 1 cannot be restricted from any of claims 2, 3 and 4.Claim 1 links claims 2, 3 and 4 and must be examined with the Claim 1 links claims 2, 3 and 4 and must be examined with the

elected claim 2, 3 or 4.elected claim 2, 3 or 4.


Claim 1. A kit comprising a first primer consisting of SEQ Claim 1. A kit comprising a first primer consisting of SEQ ID ID No 1 and a second primer consisting of SEQ ID No 2.No 1 and a second primer consisting of SEQ ID No 2.

Claim 2. A kit comprising a first primer consisting of SEQ Claim 2. A kit comprising a first primer consisting of SEQ ID ID No 1 and a second primer consisting of SEQ ID No 3.No 1 and a second primer consisting of SEQ ID No 3.

Claim 3. A primer consisting of SEQ ID No 1.Claim 3. A primer consisting of SEQ ID No 1.The specification discloses that a primer consisting ofThe specification discloses that a primer consisting of

SEQ ID No 1 can be used to detect HIV infection; SEQ ID No 1 can be used to detect HIV infection; SEQ ID No 2 can be used to detect influenza infection andSEQ ID No 2 can be used to detect influenza infection and SEQ ID No 3 can be used to detect hepatitis infectionSEQ ID No 3 can be used to detect hepatitis infection

Restriction between combination claims 1 and 2 may be proper. Restriction between combination claims 1 and 2 may be proper. Claim 3 cannot be restricted from claim 1 or claim 2; it is a Claim 3 cannot be restricted from claim 1 or claim 2; it is a linking claim that will be examined with the elected linking claim that will be examined with the elected combination. combination.

MPEP 806.05(c)(subsection III)MPEP 806.05(c)(subsection III)

Subcombination Linking Plural Subcombination Linking Plural CombinationsCombinations


Allowable Linking ClaimsAllowable Linking Claims When a linking claim is allowable, a restriction When a linking claim is allowable, a restriction

requirement between the inventions it links requirement between the inventions it links cannot be maintained.cannot be maintained. The restriction requirement should be withdrawn, The restriction requirement should be withdrawn,

even if claims to non-elected linked inventions have even if claims to non-elected linked inventions have been canceled.been canceled.

Any claim(s) depending from or otherwise requiring Any claim(s) depending from or otherwise requiring all the limitations of the allowable linking claim(s) will all the limitations of the allowable linking claim(s) will be be rejoinedrejoined and fully examined for patentability. and fully examined for patentability.

The Office must provide Applicant with an opportunity The Office must provide Applicant with an opportunity to reinstate canceled claims when a restriction to reinstate canceled claims when a restriction requirement is withdrawn based on the allowability of requirement is withdrawn based on the allowability of the linking claim.the linking claim.

MPEP 809.03 and 821.04(a)MPEP 809.03 and 821.04(a)


Practical Tips on Linking Practical Tips on Linking ClaimsClaims

When requiring a restriction involving When requiring a restriction involving linking claims per MPEP 809.03, the linking claims per MPEP 809.03, the linking claims should not appear in the linking claims should not appear in the list of claims for any particular group. list of claims for any particular group. The linking claims appear only in FP 8.12.The linking claims appear only in FP 8.12.

When requiring a restriction involving When requiring a restriction involving genus-species linking claims per MPEP genus-species linking claims per MPEP 809.02, there are no groupings and the 809.02, there are no groupings and the linking claims appear as the generic linking claims appear as the generic claims in FP 8.01.claims in FP 8.01.


Overview of Markush Overview of Markush ClaimsClaims

A Markush claim recites a plurality of alternatively usable substances or members.

Alternatives may be “selected from the group consisting of A, B and C.”

The group of alternatives A, B, and C is commonly referred to as a “Markush group”

See MPEP 803.02


Example of a Markush Claim

Claim 1: A polymer blend comprising a natural rubber and a thermoplastic elastomer wherein said elastomer is selected from the group consisting of polyurethane rubber, poly(styrene-butadiene) rubber and polyolefin rubber.

Markush

Group

In Pictorial representation, the area within the hexagon represents the polymer blend of a natural rubber and any thermoplastic elastomer.

Distinct species encompassed by claim 1: polyurethane rubber,poly(styrene-butadiene) rubber and polyolefin rubber.


Restriction of Markush ClaimRestriction of Markush Claim A Markush claim may include independent and distinct A Markush claim may include independent and distinct

inventions and be subject to restriction. MPEP 803.02inventions and be subject to restriction. MPEP 803.02

Restriction is proper where two or more members of Restriction is proper where two or more members of the group are so unrelated and diverse that a prior art the group are so unrelated and diverse that a prior art reference would anticipate the claim with respect to reference would anticipate the claim with respect to one of the members but would not render the claim one of the members but would not render the claim obvious with respect to the other members.obvious with respect to the other members.

If restriction is proper, then a provisional election of a If restriction is proper, then a provisional election of a single species may be required. FP 8.01 or 8.02.single species may be required. FP 8.01 or 8.02.


Markush Claim - Practical Tip Markush Claim - Practical Tip

If the members of the Markush group are If the members of the Markush group are sufficiently few in number or so closely related sufficiently few in number or so closely related that a search and examination of the entire that a search and examination of the entire claim can be made without serious burden, claim can be made without serious burden, the examiner must examine all the members the examiner must examine all the members of the Markush group in the claim on the of the Markush group in the claim on the merits, even though they may be directed to merits, even though they may be directed to independent and distinct inventions. independent and distinct inventions.

MPEP 803.02MPEP 803.02


Markush Claim - Practical Tip Markush Claim - Practical Tip Should the elected species be found allowable, the Should the elected species be found allowable, the

search/examination of the Markush type claim will be search/examination of the Markush type claim will be extended to determine the patentability of the claim, extended to determine the patentability of the claim, including the non-elected species.including the non-elected species.

Should the elected species be found not allowable, the Should the elected species be found not allowable, the provisional election will be given effect and provisional election will be given effect and examination limited to the elected species.examination limited to the elected species.

If examiner finds art on another species, the examiner If examiner finds art on another species, the examiner does NOT extend search to cover ALL the non-elected does NOT extend search to cover ALL the non-elected species.species.

See MPEP See MPEP 803.02803.02


Markush Claim - Practical Tip Markush Claim - Practical Tip

Should the examiner require election of a Should the examiner require election of a species recited in a Markush claim, and the species recited in a Markush claim, and the elected species is canceled in response to a elected species is canceled in response to a prior art rejection, such response is considered prior art rejection, such response is considered proper and the examination of the Markush proper and the examination of the Markush type claim will be extended to the non-elected type claim will be extended to the non-elected species to determine the patentability of the species to determine the patentability of the claim. The next Office action could be made claim. The next Office action could be made final if appropriate (MPEP 706.07(a)).final if appropriate (MPEP 706.07(a)).

MPEP 803.02 and MPEP 803.02 and 821.03821.03


Examination Practice for Markush Claim versus Linking ClaimExamination Practice for Markush Claim versus Linking Claim

Markush Claim Markush Claim MPEP MPEP 803.02803.02

Claim 1. A citrus fruit treated with Claim 1. A citrus fruit treated with fungicide XYZ, wherein the citrus fungicide XYZ, wherein the citrus

fruit is an orange or a lime.fruit is an orange or a lime.

Claim 2. The orange of claim 1.Claim 2. The orange of claim 1.

Claim 3. The lime of claim 1.Claim 3. The lime of claim 1.

Linking Claim Linking Claim MPEPMPEP 809809

Claim 1. A citrus fruit treated with fungicide XYZ.Claim 1. A citrus fruit treated with fungicide XYZ.Claim 2. The citrus fruit of claim 1, Claim 2. The citrus fruit of claim 1,

which is an orange.which is an orange.Claim 3. The citrus fruit of claim 1, Claim 3. The citrus fruit of claim 1,

which is a lime.which is a lime.

Distinct species encompassed by Markush claim 1: Orange treated with fungicide XYZ

Lime treated with fungicide XYZ

In Pictorial representation, the area within the hexagon represents the scope of Linking Claim 1, any citrus fruit treated with fungicide XYZ.


Examination Practice for Markush and Linking ClaimsExamination Practice for Markush and Linking Claims






Linking Claim MPEPLinking Claim MPEP 809809




For Markush Claims and Linking Claims:For Markush Claims and Linking Claims:

(1) If the species of claim 2 is elected,(1) If the species of claim 2 is elected,

claim 3 would be withdrawn from consideration.claim 3 would be withdrawn from consideration.

(2) If prior art is found against claim 2, (2) If prior art is found against claim 2,

both claims 1 and 2 would be rejected.both claims 1 and 2 would be rejected.








For Markush Claim Set:For Markush Claim Set:

(3A) If claim 2 is allowable, allow claim 2 and extend the search (3A) If claim 2 is allowable, allow claim 2 and extend the search and examination for the species of claim 3. and examination for the species of claim 3.

(3B) Search and examination is limited to species of the (3B) Search and examination is limited to species of the Markush group of claim 1.Markush group of claim 1.








For Markush Claim Set:For Markush Claim Set:

(4) If prior art is found against claim 3, (4) If prior art is found against claim 3,

bring claim 3 back into consideration and bring claim 3 back into consideration and

reject both claims 1 and 3 against the prior art. reject both claims 1 and 3 against the prior art.







For Linking Claim Set:For Linking Claim Set:

(3) If claim 2 is allowable, then allow claim 2. The examiner may (3) If claim 2 is allowable, then allow claim 2. The examiner may now extend the search and examination for now extend the search and examination for any speciesany species of citrus of citrus fruit encompassed by claim 1.fruit encompassed by claim 1.

Lemon treated with fungicide XYZ








(4A) If prior art is found, no matter that it is a species (4A) If prior art is found, no matter that it is a species otherother than than orange or lime, reject claim 1. Examiner is not required to orange or lime, reject claim 1. Examiner is not required to extend the search and examination to claim 3.extend the search and examination to claim 3.

Lemon treated with fungicide XYZ








(4B) If the prior art found is the species lime, (4B) If the prior art found is the species lime,

bring claim 3 back into consideration and bring claim 3 back into consideration and

reject both claims 1 and 3 against the prior art.reject both claims 1 and 3 against the prior art.

Claim 3, lime












For both Markush Claim Set and Linking Claim Set:For both Markush Claim Set and Linking Claim Set:

(5) If claim 1 is allowable, then allow claims 1, 2 and 3.(5) If claim 1 is allowable, then allow claims 1, 2 and 3.

Restriction Practice for Restriction Practice for Genus Claims Genus Claims Species Claims Species Claims Linking Claims and Linking Claims and Markush Claims Markush Claims Julie Burke

TC1600 QAS/PM

571-272-0512

[email protected]

restriction practice for genus claims species claims linking claims and markush claims julie burke...

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genus claims species

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