restriction practice for combinations and subcombinations

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Restriction Practice Restriction Practice for for Combinations and Combinations and Subcombinations Subcombinations Julie Burke Quality Assurance Specialist 571-272-0512 [email protected]

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Restriction Practice for Combinations and Subcombinations. Julie Burke Quality Assurance Specialist 571-272-0512 [email protected]. Objectives for This Talk Restriction: Subcombinations Useable Together Related Combinations Combination/Subcombination - PowerPoint PPT Presentation

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Page 1: Restriction Practice for  Combinations and Subcombinations

Restriction Practice for Restriction Practice for Combinations and Combinations and SubcombinationsSubcombinations

Julie Burke

Quality Assurance Specialist

571-272-0512

[email protected]

Page 2: Restriction Practice for  Combinations and Subcombinations

12/07 BCP 2

Objectives for This Talk

Restriction:Restriction: Subcombinations Useable TogetherSubcombinations Useable Together Related CombinationsRelated Combinations Combination/Subcombination

Subcombination essential to combination.Subcombination essential to combination. Subcombination not essential to combination.Subcombination not essential to combination. Plural Combinations requiring a single subcombinationPlural Combinations requiring a single subcombination

Subcombination Not Claimed SeparatelySubcombination Not Claimed Separately Subcombination Claimed SeparatelySubcombination Claimed Separately

Plural subcombinations used in a single combinationPlural subcombinations used in a single combination

RejoinderRejoinderSummarySummary

Page 3: Restriction Practice for  Combinations and Subcombinations

12/07 BCP 3

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 independent or distinctdistinct 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

Page 4: Restriction Practice for  Combinations and Subcombinations

12/07 BCP 4

Distinction is typically a one-way test.Distinction is typically a one-way test.

Related inventions are distinct wherein at Related inventions are distinct wherein at least one invention is PATENTABLE OVER least one invention is PATENTABLE OVER THE OTHER. THE OTHER.

““PATENTABLE” means novel and nonobvious PATENTABLE” means novel and nonobvious over each other. over each other.

Two inventions may be distinct from each other Two inventions may be distinct from each other even if neither is unpatentable over the prior art. even if neither is unpatentable over the prior art.

MPEP 802.01MPEP 802.01(II)(II)

Page 5: Restriction Practice for  Combinations and Subcombinations

12/07 BCP 5

Objectives for This Talk

Restriction:Restriction: Subcombinations Useable TogetherSubcombinations Useable Together Related CombinationsRelated Combinations Combination/Subcombination

Subcombination essential to combinationSubcombination essential to combination Subcombination not essential to combinationSubcombination not essential to combination Plural Combinations requiring a single subcombinationPlural Combinations requiring a single subcombination

Subcombination Not Claimed SeparatelySubcombination Not Claimed Separately Subcombination Claimed SeparatelySubcombination Claimed Separately

Plural subcombinations used in a single combinationPlural subcombinations used in a single combination

RejoinderRejoinderSummarySummary

Page 6: Restriction Practice for  Combinations and Subcombinations

12/07 BCP 6

Subcombinations Useable Together: Subcombinations Useable Together: A/BA/B

A B

ABAB

The specification discloses combination AB.The specification discloses combination AB.

When A and B are claimed as separate When A and B are claimed as separate subcombinations, distinction between subcombinations subcombinations, distinction between subcombinations A and B may be shown using FP 8.16.A and B may be shown using FP 8.16.

FP 8.16 only requires the examiner to find a separate FP 8.16 only requires the examiner to find a separate use for one of the subcombinations.use for one of the subcombinations.

Page 7: Restriction Practice for  Combinations and Subcombinations

12/07 BCP 7

Example I: Subcombs Useable Together Example I: Subcombs Useable Together A/BA/B AA Claim 1. An polypeptide comprising a tumor associated targeting domain.Claim 1. An polypeptide comprising a tumor associated targeting domain.BB Claim 2. An polypeptide comprising a toxin.Claim 2. An polypeptide comprising a toxin.

The specification discloses that the tumor associated targeting domain and the toxin may be used The specification discloses that the tumor associated targeting domain and the toxin may be used together in a fusion protein for cancer therapy.together in a fusion protein for cancer therapy.

Claims 1 and 2 are drawn to subcombinations, disclosed as useable together.Claims 1 and 2 are drawn to subcombinations, disclosed as useable together.In this example, the fusion protein combination is not claimed.In this example, the fusion protein combination is not claimed.

Restriction between Claim 1 and Claim 2 may be proper because the tumor associated targeting Restriction between Claim 1 and Claim 2 may be proper because the tumor associated targeting domain may be combined with a label, for example, for separate use in a diagnostic method.domain may be combined with a label, for example, for separate use in a diagnostic method.

FP 8.16FP 8.16MPEP 806.05(d)MPEP 806.05(d)

Page 8: Restriction Practice for  Combinations and Subcombinations

12/07 BCP 8

Subcombinations Useable Together: Subcombinations Useable Together: BC/DEBC/DE

AA BB CC DD EE

ABAB BCBC CDCD DEDE

BCDEBCDE

The specification discloses the combination BCDE. The specification discloses the combination BCDE.

BC and DE are claimed as separate subcombinations.BC and DE are claimed as separate subcombinations.

Combination BCDE is not claimed.Combination BCDE is not claimed.

Page 9: Restriction Practice for  Combinations and Subcombinations

12/07 BCP 9

Example II: Subcombs Useable Together Example II: Subcombs Useable Together BC/DEBC/DE

BCBC Claim 1. A vaccine comprising a tetanus antigen and a botulism antigen. Claim 1. A vaccine comprising a tetanus antigen and a botulism antigen.DEDE Claim 2. A vaccine comprising a diptheria antigen and a measles antigen. Claim 2. A vaccine comprising a diptheria antigen and a measles antigen.

The discloses that the antigens are specific for four separate pathogens and The discloses that the antigens are specific for four separate pathogens and that they may be used on their own or in pairs or combined to form a that they may be used on their own or in pairs or combined to form a vaccine to immunize a subject against the four pathogens.vaccine to immunize a subject against the four pathogens.

Restriction between Claim 1 and Claim 2 may be proper because the Restriction between Claim 1 and Claim 2 may be proper because the subcombination of claim 1, for example, may be used on its own or in subcombination of claim 1, for example, may be used on its own or in combination with other antigens besides those recited in Claim 2.combination with other antigens besides those recited in Claim 2.

Page 10: Restriction Practice for  Combinations and Subcombinations

12/07 BCP 10

Objectives for This Talk

Restriction:Restriction: Subcombinations Useable TogetherSubcombinations Useable Together Related CombinationsRelated Combinations Combination/Subcombination

Subcombination essential to combinationSubcombination essential to combination Subcombination not essential to combinationSubcombination not essential to combination Plural Combinations requiring a single subcombinationPlural Combinations requiring a single subcombination

Subcombination Not Claimed SeparatelySubcombination Not Claimed Separately Subcombination Claimed SeparatelySubcombination Claimed Separately

Plural subcombinations used in a single combinationPlural subcombinations used in a single combination

RejoinderRejoinderSummarySummary

Page 11: Restriction Practice for  Combinations and Subcombinations

12/07 BCP 11

Related Combinations: Related Combinations: AB/BCAB/BC

AA BB CC

ABAB BCBC

AB and BC are related combinations.AB and BC are related combinations.

Distinction may be shown using FP 8.14.01, related products.Distinction may be shown using FP 8.14.01, related products.

Each combination requires “B” but is distinct from the other Each combination requires “B” but is distinct from the other combination because combination because

AB requires “A” which is not required for BC and

BC requires “C” that is not required for AB.

Page 12: Restriction Practice for  Combinations and Subcombinations

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Example III: Related Combinations Example III: Related Combinations AB/BCAB/BC ABAB Claim 1. A fusion protein comprising single chain antibody B and label A. Claim 1. A fusion protein comprising single chain antibody B and label A.BCBC Claim 2. A fusion protein comprising single chain antibody B and toxin C. Claim 2. A fusion protein comprising single chain antibody B and toxin C.

Claims 1 and 2 are drawn to related products that both require antibody B. Claims 1 and 2 are drawn to related products that both require antibody B.

Distinction between Claims 1 and 2 may be shown using FP 8.14.01: Distinction between Claims 1 and 2 may be shown using FP 8.14.01:

Claim 1 requires label A not disclosed as being required for Claim 1 requires label A not disclosed as being required for Claim 2. Claim 2. Claim 2 requires toxin C not disclosed as being required for Claim 1. Claim 2 requires toxin C not disclosed as being required for Claim 1.

FP 8.14.01FP 8.14.01MPEP 806.05(j)MPEP 806.05(j)

Page 13: Restriction Practice for  Combinations and Subcombinations

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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 independent or distinctdistinct 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

Page 14: Restriction Practice for  Combinations and Subcombinations

12/07 BCP 14

Distinction usually requires a one-way testDistinction usually requires a one-way test

Related inventions are distinct wherein Related inventions are distinct wherein at least one invention is PATENTABLE at least one invention is PATENTABLE OVER THE OTHER. OVER THE OTHER.

““PATENTABLE” means novel and PATENTABLE” means novel and nonobvious over each other. nonobvious over each other.

Two inventions may be distinct even if Two inventions may be distinct even if neither is unpatentable over the prior art. neither is unpatentable over the prior art.

MPEP 802.01MPEP 802.01(II)(II)

Page 15: Restriction Practice for  Combinations and Subcombinations

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Distinction between combination and Distinction between combination and subcombination is an exception to the one-subcombination is an exception to the one-

way tests.way tests.

See MPEP § 806.05(c) (combination and See MPEP § 806.05(c) (combination and subcombination) for an example of subcombination) for an example of when a two-way test is required for when a two-way test is required for distinctness.distinctness.

MPEP 802.02(II)MPEP 802.02(II)

Page 16: Restriction Practice for  Combinations and Subcombinations

12/07 BCP 16

Test For Distinctness Between Test For Distinctness Between Combination and SubcombinationCombination and Subcombination

The inventions are distinct if it can be shown that The inventions are distinct if it can be shown that the combination as claimed:the combination as claimed:

(A) does not require the particulars of the (A) does not require the particulars of the subcombination, as claimed, for patentability subcombination, as claimed, for patentability (to show novelty and unobviousness), (to show novelty and unobviousness), andand

(B) the subcombination, as claimed, can be (B) the subcombination, as claimed, can be shown to have utility either by itself or in shown to have utility either by itself or in another materially different combination. another materially different combination.

MPEP 806.05(c) FP 8.15.MPEP 806.05(c) FP 8.15.

Page 17: Restriction Practice for  Combinations and Subcombinations

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DefinitionsDefinitions

A A combinationcombination is an organization of which a is an organization of which a subcombination or element is a part. subcombination or element is a part.

A A subcombinationsubcombination is a part of a combination. is a part of a combination.

MPEP 806.05(a)MPEP 806.05(a)

Page 18: Restriction Practice for  Combinations and Subcombinations

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AbbreviationsAbbreviations

Combination ABsp (“sp” for “specific”)Combination ABsp (“sp” for “specific”)

Combination ABbr (“br” for “broad”)Combination ABbr (“br” for “broad”)

Subcombination Bsp (“sp” for “specific”) Subcombination Bsp (“sp” for “specific”)

Tip: Combination and subcombination Tip: Combination and subcombination must both be products or must both be must both be products or must both be processes.processes.

MPEP 806.05(a)MPEP 806.05(a)

Page 19: Restriction Practice for  Combinations and Subcombinations

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Two Options for Comb/Subcomb AnalysisTwo Options for Comb/Subcomb Analysis

1. 1. Identify the comb and subcomb claims.Identify the comb and subcomb claims.

2a.2a. Find broadest subcomb, as claimed Find broadest subcomb, as claimed separately.separately.

Find the broadest subcomb required by a comb Find the broadest subcomb required by a comb claim.claim.

If the comb requires a broader subcomb than If the comb requires a broader subcomb than subcomb as claimed separately, comb does not subcomb as claimed separately, comb does not require particulars of subcomb for patentability.require particulars of subcomb for patentability.

2b.2b. If the claim set includes claims to more than If the claim set includes claims to more than one subcomb, each subcomb claim may be used as one subcomb, each subcomb claim may be used as evidence that the comb does not require any evidence that the comb does not require any particular subcomb for patentability.particular subcomb for patentability.

3. 3. Provide another utility for subcomb.Provide another utility for subcomb.

4. 4. Show serious burden.Show serious burden.

Page 20: Restriction Practice for  Combinations and Subcombinations

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Objectives for This Talk

Restriction:Restriction: Subcombinations Useable TogetherSubcombinations Useable Together Related CombinationsRelated Combinations Combination/Subcombination

Subcombination essential to combinationSubcombination essential to combination Subcombination not essential to combinationSubcombination not essential to combination Plural Combinations requiring a single subcombinationPlural Combinations requiring a single subcombination

Subcombination Not Claimed SeparatelySubcombination Not Claimed Separately Subcombination Claimed SeparatelySubcombination Claimed Separately

Plural subcombinations used in a single combinationPlural subcombinations used in a single combination

RejoinderRejoinderSummarySummary

Page 21: Restriction Practice for  Combinations and Subcombinations

12/07 BCP 21

SUBCOMBINATION ESSENTIAL TO COMBINATIONSUBCOMBINATION ESSENTIAL TO COMBINATION ABsp/Bsp ABsp/Bsp No RestrictionNo Restriction

Where a combination as claimed requires the details of a Where a combination as claimed requires the details of a subcombination as separately claimed, there is usually subcombination as separately claimed, there is usually no evidence that combination ABsp is patentable no evidence that combination ABsp is patentable without the details of Bsp. without the details of Bsp.

The inventions are not distinct and a requirement for The inventions are not distinct and a requirement for restriction must not be made or maintained, even if the restriction must not be made or maintained, even if the subcombination has separate utility. subcombination has separate utility.

Page 22: Restriction Practice for  Combinations and Subcombinations

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Subcombination and Combination Subcombination and Combination ABsp/BspABsp/Bsp

BspBsp

ABspABsp

This situation can be diagrammed as combination ABsp (“sp” This situation can be diagrammed as combination ABsp (“sp” for “specific”), and subcombination Bsp. for “specific”), and subcombination Bsp.

Thus the specific characteristics required by the Thus the specific characteristics required by the subcombination claim subcombination claim

Bsp are also required by the combination claim. Bsp are also required by the combination claim.

Page 23: Restriction Practice for  Combinations and Subcombinations

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Example IVa Comb/Subcomb Example IVa Comb/Subcomb ABsp/BspABsp/Bsp

BspBsp Claim 1. An isolated nucleic acid molecule having SEQ ID No 1.Claim 1. An isolated nucleic acid molecule having SEQ ID No 1.ABspABsp Claim 2. A transgenic plant comprising the nucleic acid molecule of Claim 2. A transgenic plant comprising the nucleic acid molecule of Claim 1. Claim 1.

Claim 1 is a subcombination drawn to a nucleic acid molecule.Claim 1 is a subcombination drawn to a nucleic acid molecule.Claim 2 is a combination of the plant and the nucleic acid molecule.Claim 2 is a combination of the plant and the nucleic acid molecule.

Both claims 1 and 2 require a nucleic acid molecule of equal breadth, i.e., Bsp.Both claims 1 and 2 require a nucleic acid molecule of equal breadth, i.e., Bsp.

From this claim set, there is no evidence that the combination does not require the specific From this claim set, there is no evidence that the combination does not require the specific characteristics of subcombination for its patentability.characteristics of subcombination for its patentability.

Claims 1 and 2 are NOT patentably distinct. Restriction would NOT be proper.Claims 1 and 2 are NOT patentably distinct. Restriction would NOT be proper.

Page 24: Restriction Practice for  Combinations and Subcombinations

12/07 BCP 24

Example IVb Comb/Subcomb Example IVb Comb/Subcomb ABsp/BspABsp/Bsp

BspBsp Claim 1. Antibody XYZ.Claim 1. Antibody XYZ.ABspABsp Claim 2. A fusion protein comprising antibody XYZ and Toxin A. Claim 2. A fusion protein comprising antibody XYZ and Toxin A.

Claim 1 is a subcombination drawn to a antibody XYZ.Claim 1 is a subcombination drawn to a antibody XYZ.Claim 2 is a combination of the antibody XYZ and Toxin A.Claim 2 is a combination of the antibody XYZ and Toxin A.

Both claims 1 and 2 require an antibody of equal breadth, i.e, Bsp.Both claims 1 and 2 require an antibody of equal breadth, i.e, Bsp.

In this claim set, the combination requires the specific characteristics of subcombination for In this claim set, the combination requires the specific characteristics of subcombination for its patentability.its patentability.

Claims 1 and 2 are NOT patentably distinct. Restriction would NOT be proper.Claims 1 and 2 are NOT patentably distinct. Restriction would NOT be proper.

Page 25: Restriction Practice for  Combinations and Subcombinations

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Objectives for This Talk

Restriction:Restriction: Subcombinations Useable TogetherSubcombinations Useable Together Related CombinationsRelated Combinations Combination/Subcombination

Subcombination essential to combinationSubcombination essential to combination Subcombination not essential to combinationSubcombination not essential to combination Plural Combinations requiring a single subcombinationPlural Combinations requiring a single subcombination

Subcombination Not Claimed SeparatelySubcombination Not Claimed Separately Subcombination Claimed SeparatelySubcombination Claimed Separately

Plural subcombinations used in a single combinationPlural subcombinations used in a single combination

RejoinderRejoinderSummarySummary

Page 26: Restriction Practice for  Combinations and Subcombinations

12/07 BCP 26

SUBCOMBINATION NOT ESSENTIAL TO COMBINATIONSUBCOMBINATION NOT ESSENTIAL TO COMBINATION ABbr/Bsp Restriction ProperABbr/Bsp Restriction Proper

Where a combination as claimed does not require the Where a combination as claimed does not require the details of the subcombination as separately claimed and details of the subcombination as separately claimed and the subcombination has separate utility, the inventions the subcombination has separate utility, the inventions are distinct.are distinct.

  This situation can be diagrammed as This situation can be diagrammed as

combination ABbr (“br” for “broad”), and combination ABbr (“br” for “broad”), and subcombination Bsp (“sp” for “specific”). subcombination Bsp (“sp” for “specific”).

Bbr indicates that in the combination the subcombination Bbr indicates that in the combination the subcombination is broadly recited and that the specific characteristics is broadly recited and that the specific characteristics required by the subcombination claim Bsp are not required by the subcombination claim Bsp are not required by the combination claim.required by the combination claim.

Page 27: Restriction Practice for  Combinations and Subcombinations

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SUBCOMBINATION NOT ESSENTIAL TO COMBINATIONSUBCOMBINATION NOT ESSENTIAL TO COMBINATION

Since claims to both the subcombination and Since claims to both the subcombination and combination are presented, the omission of combination are presented, the omission of details of the claimed subcombination Bsp in details of the claimed subcombination Bsp in the combination claim ABbr is evidence that the combination claim ABbr is evidence that the combination does not rely upon the the combination does not rely upon the specific limitations of the subcombination for specific limitations of the subcombination for its patentability. its patentability.

If subcombination Bsp has separate utility, the If subcombination Bsp has separate utility, the inventions are distinct.inventions are distinct.

Page 28: Restriction Practice for  Combinations and Subcombinations

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Subcombination and Combination Subcombination and Combination ABbr/BspABbr/Bsp

ABbrABbr evidence claimevidence claim

neither claim can depend on the neither claim can depend on the otherother

AA BspBsp

ABspABsp

Presence of claim to “ABbr” provides evidence that Presence of claim to “ABbr” provides evidence that the combination “ABsp” does not require “Bsp” for the combination “ABsp” does not require “Bsp” for patentability.patentability.

Page 29: Restriction Practice for  Combinations and Subcombinations

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Example V Comb/subcomb Example V Comb/subcomb ABbr/BspABbr/BspBspBsp Claim 1. Antibody XYZ.Claim 1. Antibody XYZ.ABbrABbr Claim 2. A fusion protein comprising an antibody which binds to a tumor associated Claim 2. A fusion protein comprising an antibody which binds to a tumor associated

antigen and a toxin. antigen and a toxin.

The specification discloses that Antibody XYZ binds to a specific tumor associated antigen XYZ.The specification discloses that Antibody XYZ binds to a specific tumor associated antigen XYZ.

Claim 2 is directed to a combination which requires any antibody that binds a tumor associated Claim 2 is directed to a combination which requires any antibody that binds a tumor associated antigen. Claim 2 requires an antibody which is broader in scope than that of claim 1.antigen. Claim 2 requires an antibody which is broader in scope than that of claim 1.

The combination ABbr does not requires the specific characteristics of subcombination Bsp for The combination ABbr does not requires the specific characteristics of subcombination Bsp for its patentability.its patentability.

If we can provide a separate use for the subcombination, distinction between Claims 1 and 2 If we can provide a separate use for the subcombination, distinction between Claims 1 and 2 may be shown using FP 8.15.may be shown using FP 8.15.

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FP 8.15 Combination-FP 8.15 Combination-SubcombinationSubcombinationInventions [1 ] and [2 ] are related as combination andInventions [1 ] and [2 ] are related as combination andsubcombination. Inventions in this relationship aresubcombination. Inventions in this relationship aredistinct if it can be shown that distinct if it can be shown that

(1) the combination as claimed does not require the (1) the combination as claimed does not require the particulars of the subcombination as claimed for particulars of the subcombination as claimed for patentability, patentability, and and

(2) that the subcombination has utility by itself or in (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). other combinations (MPEP § 806.05(c)).

In the instant case, the combination as claimed does notIn the instant case, the combination as claimed does notrequire the particulars of the subcombination as claimedrequire the particulars of the subcombination as claimedbecause [3 ]. The subcombination has separate utilitybecause [3 ]. The subcombination has separate utility

such as [4 ].such as [4 ].

Page 31: Restriction Practice for  Combinations and Subcombinations

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SUBCOMBINATION NOT ESSENTIAL TO COMBINATIONSUBCOMBINATION NOT ESSENTIAL TO COMBINATION

ABsp/ABbr/Bsp Restriction ProperABsp/ABbr/Bsp Restriction Proper

The presence of a claim to combination ABsp does not alter The presence of a claim to combination ABsp does not alter the propriety of a restriction requirement properly made the propriety of a restriction requirement properly made between combination ABbr and subcombination Bsp. between combination ABbr and subcombination Bsp.

Claim ABbr is an evidence claim which indicates that the Claim ABbr is an evidence claim which indicates that the combination does not rely upon the specific details of combination does not rely upon the specific details of the subcombination for its patentability. the subcombination for its patentability.

If a restriction requirement can be properly made between If a restriction requirement can be properly made between combination ABbr and subcombination Bsp, any claim to combination ABbr and subcombination Bsp, any claim to combination ABsp would be grouped with combination combination ABsp would be grouped with combination ABbr.ABbr.

Page 32: Restriction Practice for  Combinations and Subcombinations

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Subcombination and Combination:Subcombination and Combination: ABbr/ABsp/BspABbr/ABsp/Bsp

ABbrABbr Groupings:Groupings:

Group I, ABbr and ABspGroup I, ABbr and ABsp

AA BspBsp Group II, BspGroup II, Bsp

ABspABsp

Group combination claims ABbr and ABsp together. Group combination claims ABbr and ABsp together. Presence of claim to “ABsp” does not require ABsp Presence of claim to “ABsp” does not require ABsp to be grouped with Bsp.to be grouped with Bsp.

Page 33: Restriction Practice for  Combinations and Subcombinations

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Subcombination and Combination:Subcombination and Combination: ABbr/ABsp/BspABbr/ABsp/Bsp

ABbrABbr Groupings:Groupings:

Group I, ABbr and ABspGroup I, ABbr and ABsp

AA BspBsp Group II, BspGroup II, Bsp

ABspABsp

If Group II is elected and Bsp found allowable, If Group II is elected and Bsp found allowable, consider claims to ABsp for rejoinder.consider claims to ABsp for rejoinder.

Page 34: Restriction Practice for  Combinations and Subcombinations

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Example VI: Comb/subcomb Example VI: Comb/subcomb ABbr/ABsp/BspABbr/ABsp/Bsp

BspBsp Claim 1. An isolated nucleic acid having SEQ ID NO:1.Claim 1. An isolated nucleic acid having SEQ ID NO:1.ABspABsp Claim 2. A non-human transgenic animal comprising the Claim 2. A non-human transgenic animal comprising the

nucleic acid of Claim 1.nucleic acid of Claim 1.ABbrABbr Claim 3. A non-human transgenic animal comprising a Claim 3. A non-human transgenic animal comprising a

nucleic nucleic acid that is at least 95% identical to the nucleic acid of Claim acid that is at least 95% identical to the nucleic acid of Claim 1. 1.

Combination Claim 3 “depends from” Claim 1 yet permits a nucleic acid Combination Claim 3 “depends from” Claim 1 yet permits a nucleic acid molecule that is broader in scope than subcombination claim 1.molecule that is broader in scope than subcombination claim 1.

Object to Claim 3 using FP 7.36.Object to Claim 3 using FP 7.36. 1

2 3

Page 35: Restriction Practice for  Combinations and Subcombinations

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Example VI: Example VI: ABbr/ABsp/BspABbr/ABsp/Bsp (cont.) (cont.)

BspBsp Claim 1. An isolated nucleic acid having SEQ ID No 1.Claim 1. An isolated nucleic acid having SEQ ID No 1.ABspABsp Claim 2. A non-human transgenic animal comprising the Claim 2. A non-human transgenic animal comprising the nucleic nucleic

acid of Claim 1.acid of Claim 1.ABbrABbr Claim 3. A non-human transgenic animal comprising a nucleic Claim 3. A non-human transgenic animal comprising a nucleic acid that acid that

is at least 95% identical to the nucleic acid of Claim 1. is at least 95% identical to the nucleic acid of Claim 1.

Claim 2 is narrower in scope than, and must be grouped with, Claim 3.Claim 2 is narrower in scope than, and must be grouped with, Claim 3.

Group I, Claim 1, drawn to a subcombination.Group I, Claim 1, drawn to a subcombination.Group II, Claims 2 and 3, drawn to a combination.Group II, Claims 2 and 3, drawn to a combination.

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Example VI: Example VI: ABbr/ABsp/BspABbr/ABsp/Bsp (cont.) (cont.)BspBsp Claim 1. An isolated nucleic acid having SEQ ID No 1.Claim 1. An isolated nucleic acid having SEQ ID No 1.ABspABsp Claim 2. A non-human transgenic animal comprising the Claim 2. A non-human transgenic animal comprising the nucleic acid of nucleic acid of

Claim 1.Claim 1.ABbrABbr Claim 3. A non-human transgenic animal comprising a nucleic Claim 3. A non-human transgenic animal comprising a nucleic acid that is at acid that is at

least 95% identical to the nucleic acid of Claim 1. least 95% identical to the nucleic acid of Claim 1.

Group I, Claim 1, drawn to a subcombination of SEQ ID No 1.Group I, Claim 1, drawn to a subcombination of SEQ ID No 1.Group II, Claims 2 and 3, drawn to a combination of SEQ ID NO 1 and an animal.Group II, Claims 2 and 3, drawn to a combination of SEQ ID NO 1 and an animal.

If we can provide another use for the nucleic acid, distinction between Group I and II may be If we can provide another use for the nucleic acid, distinction between Group I and II may be shown using FP 8.15. shown using FP 8.15.

If Group I is elected and found allowable, Claim 2 would be considered for rejoinder, per If Group I is elected and found allowable, Claim 2 would be considered for rejoinder, per MPEP 821.04(a).MPEP 821.04(a).

Page 37: Restriction Practice for  Combinations and Subcombinations

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Objectives for This Talk

Restriction:Restriction: Subcombinations Useable TogetherSubcombinations Useable Together Related CombinationsRelated Combinations Combination/Subcombination

Subcombination essential to combinationSubcombination essential to combination Subcombination not essential to combinationSubcombination not essential to combination Plural Combinations requiring a single subcombinationPlural Combinations requiring a single subcombination

Subcombination Not Claimed SeparatelySubcombination Not Claimed Separately Subcombination Claimed SeparatelySubcombination Claimed Separately

Plural subcombinations used in a single combinationPlural subcombinations used in a single combination

RejoinderRejoinderSummarySummary

Page 38: Restriction Practice for  Combinations and Subcombinations

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Plural Combinations, no Subcombination Claim: Plural Combinations, no Subcombination Claim: AB/CBAB/CB

BB no claim to Bno claim to B

ABAB CBCB

When a single subcombination is required by When a single subcombination is required by two or more combinations, the two or more combinations, the lack lack of a claim of a claim to the subcombination may be used as to the subcombination may be used as evidence that the subcombination is not evidence that the subcombination is not required for patentability of either required for patentability of either combination.combination.

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Plural Combinations, No Subcombination Claim: Plural Combinations, No Subcombination Claim: AB/CBAB/CB

BB Groupings:Groupings:Group I, ABGroup I, AB

ABAB CBCB Group II, CBGroup II, CB

Distinction between Group I and II can be Distinction between Group I and II can be shown using FP 8.14.01:shown using FP 8.14.01:

Group I requires “A” not required for Group I requires “A” not required for Group II.Group II.

Group II requires “C”, not required for Group II requires “C”, not required for Group I.Group I.

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Example VIII: Related Products Example VIII: Related Products AB/CBAB/CBABAB Claim 1. A non-human transgenic animal comprising the nucleic Claim 1. A non-human transgenic animal comprising the nucleic

acid acid having SEQ ID No 1.having SEQ ID No 1.CBCB Claim 2. A transgenic plant comprising the nucleic acid having Claim 2. A transgenic plant comprising the nucleic acid having

SEQ SEQ ID No 1.ID No 1.

Claims 1 and 2 are directed to distinct combinations that share a common Claims 1 and 2 are directed to distinct combinations that share a common subcombination B (SEQ ID NO 1).subcombination B (SEQ ID NO 1).

The shared subcombination B is not separately claimed.The shared subcombination B is not separately claimed.

Distinction between Claims 1 and 2 may be established because of their Distinction between Claims 1 and 2 may be established because of their mutually exclusive characteristics, using FP 8.14.01.mutually exclusive characteristics, using FP 8.14.01.

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Objectives for This Talk

Restriction:Restriction: Subcombinations Useable TogetherSubcombinations Useable Together Related CombinationsRelated Combinations Combination/Subcombination

Subcombination essential to combinationSubcombination essential to combination Subcombination not essential to combinationSubcombination not essential to combination Plural Combinations requiring a single subcombinationPlural Combinations requiring a single subcombination

Subcombination Not Claimed SeparatelySubcombination Not Claimed Separately Subcombination Claimed SeparatelySubcombination Claimed Separately

Plural subcombinations used in a single combinationPlural subcombinations used in a single combination

RejoinderRejoinderSummarySummary

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PLURAL COMBINATIONS REQUIRING A SUBCOMBINATION PLURAL COMBINATIONS REQUIRING A SUBCOMBINATION COMMON TO EACH COMBINATIONCOMMON TO EACH COMBINATION

When an application includes a claim to a single subcombination, When an application includes a claim to a single subcombination, and that subcombination is required by plural claimed and that subcombination is required by plural claimed combinations that are properly restrictable, the combinations that are properly restrictable, the subcombination claim is a linking claim and will be examined subcombination claim is a linking claim and will be examined with the elected combination (see MPEP § 809.03). with the elected combination (see MPEP § 809.03).

The subcombination claim links the otherwise restrictable The subcombination claim links the otherwise restrictable combination inventions and should be listed in form paragraph combination inventions and should be listed in form paragraph 8.12. 8.12.

The claimed plural combinations are evidence that the The claimed plural combinations are evidence that the subcombination has utility in more than one combination.subcombination has utility in more than one combination.

MPEP 803, subsection IMPEP 803, subsection I

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Plural Combinations and a Single Subcombination Plural Combinations and a Single Subcombination AB/CB/BAB/CB/B

BB llinking claiminking claim

ABAB CBCB

When a single subcombination is claimed and When a single subcombination is claimed and required by two or more combinations, the required by two or more combinations, the subcombination is a linking claim.subcombination is a linking claim.

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Plural Combinations and a Single Subcombination Plural Combinations and a Single Subcombination AB/CB/BAB/CB/B

BB Groupings:Groupings:Group I, ABGroup I, AB

ABAB CBCB Group II, CBGroup II, CB

Distinction between Group I and II can be Distinction between Group I and II can be shown using FP 8.14.01.shown using FP 8.14.01.

The linking claim “B” is placed in FP 8.12.The linking claim “B” is placed in FP 8.12.

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Plural Combinations and a Single Subcombination Plural Combinations and a Single Subcombination AB/CB/BAB/CB/B

BB Groupings:Groupings:Group I, ABGroup I, AB

ABAB CBCB Group II, CBGroup II, CB

The linking claim to subcombination B would The linking claim to subcombination B would be examined if either of Group I or II is be examined if either of Group I or II is elected.elected.

The linking claim to subcombination B is The linking claim to subcombination B is allowable, the restriction requirement allowable, the restriction requirement between Group I and II must be withdrawn.between Group I and II must be withdrawn.

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Example IX: Two combs and one subcomb Example IX: Two combs and one subcomb AB/CB/BAB/CB/B

BB Claim 1. An isolated nucleic acid having SEQ ID No 1. Claim 1. An isolated nucleic acid having SEQ ID No 1. ABAB Claim 2. A transgenic plant comprising the nucleic acid of Claim 1. Claim 2. A transgenic plant comprising the nucleic acid of Claim 1. CBCB Claim 3. A non-human transgenic animal comprising the nucleic acid Claim 3. A non-human transgenic animal comprising the nucleic acid of of

Claim 1. Claim 1.

Groupings:Groupings:

Group I, Claim 2, drawn to a transgenic plant comprising SEQ ID No 1.Group I, Claim 2, drawn to a transgenic plant comprising SEQ ID No 1.Group II, Claim 3, drawn to a non-human transgenic animal comprising SEQ ID No Group II, Claim 3, drawn to a non-human transgenic animal comprising SEQ ID No 1.1.

Distinction between Group I and II may be shown because of their mutually exclusive Distinction between Group I and II may be shown because of their mutually exclusive characteristics using FP 8.14.01. characteristics using FP 8.14.01.

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Example IX: Example IX: AB/CB/BAB/CB/B (cont) (cont)BB Claim 1. An isolated nucleic acid having SEQ ID NO:1. Claim 1. An isolated nucleic acid having SEQ ID NO:1. ABAB Claim 2. A transgenic plant comprising the nucleic acid of Claim 1. Claim 2. A transgenic plant comprising the nucleic acid of Claim 1. CBCB Claim 3. A non-human transgenic animal comprising the nucleic acid Claim 3. A non-human transgenic animal comprising the nucleic acid of of

Claim 1. Claim 1.

Claim 1 is a subcombination claim that is broader in scope than and links Groups I and II.Claim 1 is a subcombination claim that is broader in scope than and links Groups I and II.

List Claim 1 in FP 8.12 as a linking claim.List Claim 1 in FP 8.12 as a linking claim.

If either Group I or Group II is elected, Claim 1 would be examined, as a linking claim.If either Group I or Group II is elected, Claim 1 would be examined, as a linking claim.

If Claim 1 is allowable, the restriction requirement between Groups I and II would be If Claim 1 is allowable, the restriction requirement between Groups I and II would be withdrawn and non-elected invention would be examined.withdrawn and non-elected invention would be examined.

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Example X: Example X: AB/CB/BAB/CB/B plus genus claim plus genus claim

BB Claim 1. An isolated nucleic acid having SEQ ID No 1.Claim 1. An isolated nucleic acid having SEQ ID No 1.XBXB Claim 2. A transgenic organism comprising nucleic acid of Claim 1.Claim 2. A transgenic organism comprising nucleic acid of Claim 1.ABAB Claim 3. A transgenic plant comprising the nucleic acid of Claim 2.Claim 3. A transgenic plant comprising the nucleic acid of Claim 2.CBCB Claim 4. A non-human transgenic animal comprising the nucleic acid Claim 4. A non-human transgenic animal comprising the nucleic acid of of

Claim 2.Claim 2.

Claim 1 is a subcombination claim.Claim 1 is a subcombination claim.

Claims 2, 3 and 4 are directed to combinations.Claims 2, 3 and 4 are directed to combinations.

Claim 2 is generic to claims 3 and 4.Claim 2 is generic to claims 3 and 4.

Claim 3 and 4 are distinct from each other.Claim 3 and 4 are distinct from each other.

2

1

3 4

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Example X: Example X: AB/CB/BAB/CB/B plus genus claim (cont.) plus genus claim (cont.)

BB Claim 1. An isolated nucleic acid having SEQ ID No 1.Claim 1. An isolated nucleic acid having SEQ ID No 1.XBXB Claim 2. A transgenic organism comprising the nucleic acid of Claim 1.Claim 2. A transgenic organism comprising the nucleic acid of Claim 1.ABAB Claim 3. A transgenic plant comprising the nucleic acid of Claim 1.Claim 3. A transgenic plant comprising the nucleic acid of Claim 1.CBCB Claim 4. A non-human transgenic animal comprising the nucleic acid of Claim 4. A non-human transgenic animal comprising the nucleic acid of

Claim 1.Claim 1.Groupings:Groupings:

Group I, Claim 3, drawn to a transgenic plant comprising SEQ ID No 1.Group I, Claim 3, drawn to a transgenic plant comprising SEQ ID No 1.Group II, Claim 4, drawn to a non-human transgenic animal comprising SEQ ID No 1.Group II, Claim 4, drawn to a non-human transgenic animal comprising SEQ ID No 1.

Distinction between Groups I and II may be shown because of their mutually exclusive Distinction between Groups I and II may be shown because of their mutually exclusive characteristics using FP 8.14.01. characteristics using FP 8.14.01.

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Example X: Example X: AB/CB/BAB/CB/B plus genus claim (cont.) plus genus claim (cont.)

BB Claim 1. An isolated nucleic acid having SEQ ID NO:1.Claim 1. An isolated nucleic acid having SEQ ID NO:1.XBXB Claim 2. A transgenic organism comprising nucleic acid of Claim 1.Claim 2. A transgenic organism comprising nucleic acid of Claim 1.ABAB Claim 3. A transgenic plant comprising the nucleic acid of Claim 1.Claim 3. A transgenic plant comprising the nucleic acid of Claim 1.CBCB Claim 4. A non-human transgenic animal comprising the nucleic acid Claim 4. A non-human transgenic animal comprising the nucleic acid of Claim 1.of Claim 1.

Claim 1 is a subcombination linking claim that should be placed in FP 8.12.Claim 1 is a subcombination linking claim that should be placed in FP 8.12.Claim 2 is a generic linking claim that should be placed in FP 8.12.Claim 2 is a generic linking claim that should be placed in FP 8.12.

If either of Groups I or II are elected, then claims 1 and 2 will be examined with the elected invention.If either of Groups I or II are elected, then claims 1 and 2 will be examined with the elected invention.

If claims 1 and 2 is allowable, the restriction requirement between Group I and Group II will be If claims 1 and 2 is allowable, the restriction requirement between Group I and Group II will be withdrawn and the non-elected invention rejoined.withdrawn and the non-elected invention rejoined.

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Objectives for This Talk

Restriction:Restriction: Subcombinations Useable TogetherSubcombinations Useable Together Related CombinationsRelated Combinations Combination/Subcombination

Subcombination essential to combinationSubcombination essential to combination Subcombination not essential to combinationSubcombination not essential to combination Plural Combinations requiring a single subcombinationPlural Combinations requiring a single subcombination

Subcombination Not Claimed SeparatelySubcombination Not Claimed Separately Subcombination Claimed SeparatelySubcombination Claimed Separately

Plural subcombinations used in a single combinationPlural subcombinations used in a single combination

RejoinderRejoinderSummarySummary

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Plural Subcombination Claims Considered As Plural Subcombination Claims Considered As Evidence ClaimsEvidence Claims

Where claims to two or more subcombinations are Where claims to two or more subcombinations are presented along with a claim to a combination that presented along with a claim to a combination that includes the particulars of at least two subcombinations, includes the particulars of at least two subcombinations, the presence of the claim to the second subcombination the presence of the claim to the second subcombination is evidence that the details of the first subcombination is evidence that the details of the first subcombination are not required for patentability (and vice versa). are not required for patentability (and vice versa).

For example, if an application claims ABC/B/C wherein ABC For example, if an application claims ABC/B/C wherein ABC is a combination claim and B and C are each is a combination claim and B and C are each subcombinations that are properly restrictable from subcombinations that are properly restrictable from each other, the presence of a claim to C provides each other, the presence of a claim to C provides evidence that the details of B are not required for the evidence that the details of B are not required for the patentability of combination ABC.patentability of combination ABC.

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Plural Subcombinations and a Shared CombinationPlural Subcombinations and a Shared Combination: : B/C/BCB/C/BC

BB CC two evidence claimstwo evidence claims

BCBC

When two or more subcombinations are When two or more subcombinations are separately claimed along with a claimed separately claimed along with a claimed combination, the presence of each combination, the presence of each subcombination claim may be used as evidence subcombination claim may be used as evidence that the combination does not require any either that the combination does not require any either subcombination for its patentability.subcombination for its patentability.

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Plural Subcombinations and a Shared Combination: Plural Subcombinations and a Shared Combination: B/C/BCB/C/BC

BB CC

BCBC BC is NOT a linking claimBC is NOT a linking claim

The BC combination claim is narrower in scope The BC combination claim is narrower in scope than the subcombination claim. than the subcombination claim.

Patentability of BC does not correlate one-to-one Patentability of BC does not correlate one-to-one with patentability of either B or C. with patentability of either B or C.

For these reasons, a claim to BC is NOT a linking For these reasons, a claim to BC is NOT a linking claim.claim.

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Plural Subcombinations and a Shared Combination: Plural Subcombinations and a Shared Combination: B/C/BCB/C/BC

BB CC Groupings:Groupings:

Group I, drawn to BGroup I, drawn to B

BCBC Group II, drawn to CGroup II, drawn to C

Group III, drawn to BC.Group III, drawn to BC.

Distinction between Groups I and II may be shown Distinction between Groups I and II may be shown using FP 8.16, subcombinations useable together.using FP 8.16, subcombinations useable together.

Distinction between Group III and Groups (I and II) Distinction between Group III and Groups (I and II) may be shown using FP 8.15, combination and may be shown using FP 8.15, combination and subcombination. subcombination.

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Plural Subcombinations and a Shared Combination: Plural Subcombinations and a Shared Combination: B/C/BCB/C/BC

BB CC Groupings:Groupings:

Group I, drawn to BGroup I, drawn to B

BCBC Group II, drawn to CGroup II, drawn to C

Group III, drawn to BC.Group III, drawn to BC.

If either of Group I or II is elected and found If either of Group I or II is elected and found allowable, claims to BC would be considered allowable, claims to BC would be considered for rejoinder, per MPEP 821.04(a).for rejoinder, per MPEP 821.04(a).

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Example XI: Two Subcombs and one comb Example XI: Two Subcombs and one comb B/C/BCB/C/BC

BB Claim 1. An isolated nucleic acid having SEQ ID NO:1.Claim 1. An isolated nucleic acid having SEQ ID NO:1.CC Claim 2. An isolated nucleic acid having SEQ ID NO:2.Claim 2. An isolated nucleic acid having SEQ ID NO:2.BCBC Claim 3. A transgenic plant comprising the nucleic acid of Claim 3. A transgenic plant comprising the nucleic acid of Claim Claim

1 and the nucleic acid of Claim 2.1 and the nucleic acid of Claim 2.

Claims 1 and 2 are both subcombination claims.Claims 1 and 2 are both subcombination claims.

Claim 3 is directed to a combination and depends upon both of claim 1 and claim Claim 3 is directed to a combination and depends upon both of claim 1 and claim 2.2.

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Example XI: Example XI: B/C/BCB/C/BC (cont.) (cont.)BB Claim 1. An isolated nucleic acid having SEQ ID NO:1.Claim 1. An isolated nucleic acid having SEQ ID NO:1.CC Claim 2. An isolated nucleic acid having SEQ ID NO:2.Claim 2. An isolated nucleic acid having SEQ ID NO:2.BCBC Claim 3. A transgenic plant comprising the nucleic acid of Claim 1 Claim 3. A transgenic plant comprising the nucleic acid of Claim 1 and the nucleic acid of Claim and the nucleic acid of Claim

2.2.

A multiple dependent claim must refer to the independent claim in the alternative only. Object to Claim 3 A multiple dependent claim must refer to the independent claim in the alternative only. Object to Claim 3 using FP 7.45.using FP 7.45.

Claim 3 may be amended as any of the following formats:Claim 3 may be amended as any of the following formats:

BCBC Claim 4. A transgenic plant comprising the nucleic acid of SEQ ID Claim 4. A transgenic plant comprising the nucleic acid of SEQ ID NO:1 and the nucleic acid NO:1 and the nucleic acid having SEQ ID NO:2.having SEQ ID NO:2.

BCBC Claim 5. A transgenic plant comprising the nucleic acid of Claim 1 Claim 5. A transgenic plant comprising the nucleic acid of Claim 1 and the nucleic acid having and the nucleic acid having SEQ ID NO:2.SEQ ID NO:2.

BCBC Claim 6. A transgenic plant comprising the nucleic acid of Claim 2 Claim 6. A transgenic plant comprising the nucleic acid of Claim 2 and the nucleic acid having and the nucleic acid having SEQ ID NO:1.SEQ ID NO:1.

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Example XIExample XI: B/C/BC: B/C/BC (cont.) (cont.)BB Claim 1. An isolated nucleic acid having SEQ ID No 1.Claim 1. An isolated nucleic acid having SEQ ID No 1.CC Claim 2. An isolated nucleic acid having SEQ ID No 2.Claim 2. An isolated nucleic acid having SEQ ID No 2.BCBC Claim 3. A transgenic plant comprising the nucleic acid of Claim 3. A transgenic plant comprising the nucleic acid of

Claim 1 and the isolated nucleic acid of Claim 2.Claim 1 and the isolated nucleic acid of Claim 2.

Groupings:Groupings:

Group I, Claim 1, drawn to subcombination of SEQ ID No 1.Group I, Claim 1, drawn to subcombination of SEQ ID No 1.Group II, Claim 2, drawn to subcombination of SEQ ID No 2.Group II, Claim 2, drawn to subcombination of SEQ ID No 2.Group III, Claim 3, drawn to combination of a transgenic plant comprising SEQ Group III, Claim 3, drawn to combination of a transgenic plant comprising SEQ

ID No 1 and SEQ ID No 2.ID No 1 and SEQ ID No 2.

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Example XI: Example XI: B/C/BCB/C/BC (cont.) (cont.)BB Group I, Claim 1, drawn to subcombination of SEQ ID No 1.Group I, Claim 1, drawn to subcombination of SEQ ID No 1.CC Group II, Claim 2, drawn to subcombination of SEQ ID No 2.Group II, Claim 2, drawn to subcombination of SEQ ID No 2.BCBC Group III, Claim 3, drawn to combination of a transgenic plant Group III, Claim 3, drawn to combination of a transgenic plant comprising SEQ ID comprising SEQ ID

NO:1 and SEQ ID NO:2.NO:1 and SEQ ID NO:2.

Distinction between Group I and Group II may be shown using FP 8.16, subcombinations Distinction between Group I and Group II may be shown using FP 8.16, subcombinations useable together if a separate use can be provided for one of the subcombinations.useable together if a separate use can be provided for one of the subcombinations.

Distinction between Group III and (Groups I and II) may be shown using FP 8.15, Distinction between Group III and (Groups I and II) may be shown using FP 8.15, subcombination/combination. Presence of both Claims 1 and 2 may be used as evidence subcombination/combination. Presence of both Claims 1 and 2 may be used as evidence that the patentability of Claim 3 does not depend upon the particulars of either of Claim 1 or 2.that the patentability of Claim 3 does not depend upon the particulars of either of Claim 1 or 2.

If either claims 1 or 2 is elected and found allowable, Claim 3 must be considered for rejoinder.If either claims 1 or 2 is elected and found allowable, Claim 3 must be considered for rejoinder.

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Objectives for This Talk

Restriction:Restriction: Subcombinations Useable TogetherSubcombinations Useable Together Related CombinationsRelated Combinations Combination/Subcombination

Subcombination essential to combinationSubcombination essential to combination Subcombination not essential to combinationSubcombination not essential to combination Plural Combinations requiring a single subcombinationPlural Combinations requiring a single subcombination

Subcombination Not Claimed SeparatelySubcombination Not Claimed Separately Subcombination Claimed SeparatelySubcombination Claimed Separately

Plural subcombinations used in a single combinationPlural subcombinations used in a single combination

RejoinderRejoinderSummarySummary

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Mid-Prosecution Rejoinder: Mid-Prosecution Rejoinder: When a Subcombination becomes essential to a combination. When a Subcombination becomes essential to a combination.

ABsp/ABbr/Bsp Restriction No Longer ProperABsp/ABbr/Bsp Restriction No Longer Proper

If the combination claims are amended after a If the combination claims are amended after a restriction requirement such that each restriction requirement such that each combination, as claimed, requires all the combination, as claimed, requires all the limitations of the subcombination as claimed, i.e., limitations of the subcombination as claimed, i.e., if the evidence claim ABbr is deleted or amended if the evidence claim ABbr is deleted or amended to require Bsp, the restriction requirement to require Bsp, the restriction requirement between the combination and subcombination between the combination and subcombination should not be maintained. should not be maintained.

If a claim to Bsp is determined to be allowable, any If a claim to Bsp is determined to be allowable, any claims requiring Bsp, including any combination claims requiring Bsp, including any combination claims of the format ABsp, must be considered for claims of the format ABsp, must be considered for rejoinder. See MPEP § 821.04.rejoinder. See MPEP § 821.04.

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

allowable, would prevent restriction between two or allowable, would prevent restriction between two or more otherwise properly restrictable inventions. more otherwise properly restrictable inventions.

Linking claims and linked inventions are usually eitherLinking claims and linked inventions are usually either product claims linking properly restrictable product inventions, product claims linking properly restrictable product inventions,

oror process claims linking properly restrictable process inventions.process claims linking properly restrictable process inventions.

Most common types of linking claims are Most common types of linking claims are A genus claim linking species claims orA genus claim linking species claims or A subcombination claim linking plural combinationsA subcombination claim linking plural combinations

MPEP 809 and 809.03.MPEP 809 and 809.03.

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Rejoinder Practice: When Subcombination is ElectedRejoinder Practice: When Subcombination is Elected

A subcombination claim may be a linking claim.A subcombination claim may be a linking claim.

Upon determining that all claims directed to an Upon determining that all claims directed to an elected subcombination invention are elected subcombination invention are allowable, the examiner must reconsider the allowable, the examiner must reconsider the propriety of the restriction requirement.propriety of the restriction requirement.

If a subcombination is elected and determined to If a subcombination is elected and determined to be allowable, nonelected claims requiring all be allowable, nonelected claims requiring all the limitations of the allowable claim will be the limitations of the allowable claim will be rejoined in accordance with MPEP § 821.04.rejoined in accordance with MPEP § 821.04.

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Rejoinder Practice: When Combination is ElectedRejoinder Practice: When Combination is Elected

Upon determining that all claims directed to an Upon determining that all claims directed to an elected combination invention are allowable, elected combination invention are allowable, the examiner must reconsider the propriety of the examiner must reconsider the propriety of the restriction requirement.the restriction requirement.

Where the combination is allowable in view of Where the combination is allowable in view of the patentability of at least one of the the patentability of at least one of the subcombinations, the restriction requirement subcombinations, the restriction requirement between the elected combination and between the elected combination and patentable subcombination(s) will be patentable subcombination(s) will be withdrawn; furthermore, any subcombinations withdrawn; furthermore, any subcombinations that were searched and determined to be that were searched and determined to be allowable must also be rejoined. allowable must also be rejoined.

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Downstream Double Patenting ConcernsDownstream Double Patenting Concerns

FP 8.15, FP 8.16 and several rejoinder FPs end FP 8.15, FP 8.16 and several rejoinder FPs end with:with:

Applicant is advised that if any claim presented Applicant is advised that if any claim presented in a continuation or divisional application is in a continuation or divisional application is anticipated by, or includes all the limitations anticipated by, or includes all the limitations of, a claim that is allowable in the present of, a claim that is allowable in the present application, such claim may be subject to application, such claim may be subject to provisional statutory and/or nonstatutory provisional statutory and/or nonstatutory double patenting rejections over the claims of double patenting rejections over the claims of the instant application. the instant application.

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Objectives for This Talk

Restriction:Restriction: Subcombinations Useable TogetherSubcombinations Useable Together Related CombinationsRelated Combinations Combination/Subcombination

Subcombination essential to combinationSubcombination essential to combination Subcombination not essential to combinationSubcombination not essential to combination Plural Combinations requiring a single subcombinationPlural Combinations requiring a single subcombination

Subcombination Not Claimed SeparatelySubcombination Not Claimed Separately Subcombination Claimed SeparatelySubcombination Claimed Separately

Plural subcombinations used in a single combinationPlural subcombinations used in a single combination

RejoinderRejoinderSummarySummary

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Subcombinations Useable TogetherSubcombinations Useable Together

AA BB CC DD EE

ABAB BCBC CDCD DEDE

A and BA and B are subcombinations useable are subcombinations useable together.together.

FP 8.16; MPEP 806.05(d)FP 8.16; MPEP 806.05(d)

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Subcombinations Useable TogetherSubcombinations Useable Together

AA BB CC DD EE

ABAB BCBC CDCD DEDE

ABCDABCD

AB and CDAB and CD are subcombinations useable are subcombinations useable together.together.

FP 8.16; MPEP 806.05(d)FP 8.16; MPEP 806.05(d)

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Related CombinationsRelated Combinations

AA BB CC DD EE

ABAB BCBC CDCD DEDE

AB and BCAB and BC are considered related products. are considered related products.

FP 8.14.01; MPEP 806.05(j)FP 8.14.01; MPEP 806.05(j)

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One Subcombination and Two CombinationsOne Subcombination and Two Combinations

AA BB CC DD EE

ABAB BCBC CDCD DEDE

B is a subcombination that links claims to B is a subcombination that links claims to related products AB and BC.related products AB and BC.

FP 8.12 for linking claim “B”FP 8.12 for linking claim “B”

FP 8.14.01 to show distinction for AB and BC.FP 8.14.01 to show distinction for AB and BC.

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Two Subcombinations and A CombinationTwo Subcombinations and A Combination

AA BB CC DD EE

ABAB BCBC CDCD DEDE

B and C are plural subcombinations used in a B and C are plural subcombinations used in a claimed combination. claimed combination.

B and C may both be separately used as B and C may both be separately used as evidence that BC does not require either for evidence that BC does not require either for patentability.patentability.

FPs 8.15 and 8.16.FPs 8.15 and 8.16.

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Subcombination Elected and Allowable? Subcombination Elected and Allowable? Rejoin downwardRejoin downward

AA BB CC DD EE

ABAB BCBC CDCD DEDE

ABCABC BCDBCD CDECDE

ABCDEABCDE

If “C” is elected and found allowable, any claims If “C” is elected and found allowable, any claims requiring “C” must be considered for rejoinder per requiring “C” must be considered for rejoinder per MPEP 821.04(a).MPEP 821.04(a).

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Combination ABCDE Allowable Because of “A”?Combination ABCDE Allowable Because of “A”?Rejoin upwardRejoin upward

AA BB CC DD EE

ABAB BCBC CDCD DEDE

ABC ABD ABE ACD ADEABC ABD ABE ACD ADE

ABCDABCD ABDE ACDE ACEABDE ACDE ACE BCDEBCDE

ABCDEABCDE

If examination of “ABCDE” determines that subcombination A is If examination of “ABCDE” determines that subcombination A is novel and unobvious, the restriction requirement between the novel and unobvious, the restriction requirement between the subcombinations A, AB, ABC ABCD, ABCDE, etc, should be subcombinations A, AB, ABC ABCD, ABCDE, etc, should be reconsidered in terms of burden and withdrawn if no serious reconsidered in terms of burden and withdrawn if no serious

burden exists.burden exists.

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Objectives for This Talk

Restriction:Restriction: Subcombinations Useable TogetherSubcombinations Useable Together Related CombinationsRelated Combinations Combination/Subcombination

Subcombination essential to combinationSubcombination essential to combination Subcombination not essential to combinationSubcombination not essential to combination Plural Combinations requiring a single subcombinationPlural Combinations requiring a single subcombination

Subcombination Not Claimed SeparatelySubcombination Not Claimed Separately Subcombination Claimed SeparatelySubcombination Claimed Separately

Plural subcombinations used in a single combinationPlural subcombinations used in a single combination

RejoinderRejoinderSummarySummary

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Restriction Practice for Restriction Practice for Combinations and Combinations and SubcombinationsSubcombinations

Julie Burke

Quality Assurance Specialist

571-272-0512

[email protected]