RESTRICTING BETWEEN RESTRICTING BETWEEN PRODUCT and PRODUCT and PROCESS INVENTIONSPROCESS INVENTIONS

Bruce Campell

Supervisory Patent Examiner

Art Unit 1648

571-272-0974

5/31/07 BCP 2

Objectives

The objectives of this talk are to: Focus on process and product

inventions Provide ten TC1600 specific examples Review basic restriction guidelines

Burden- revised definition Independence- new FP 8.20.03 Distinction between products and

Methods of making Methods of using Methods of screening or

detecting

5/31/07 BCP 3

35 U.S.C. 10135 U.S.C. 101

““Whoever invents or discovers any Whoever invents or discovers any new and useful new and useful process,process, machinemachine, , manufacturemanufacture, or , or composition of mattercomposition of matter, , or any new and useful improvement or any new and useful improvement thereof, thereof, maymay obtain obtain aa patent therefor, patent therefor, subject to the conditions and subject to the conditions and requirements of this title”requirements of this title”

5/31/07 BCP 4

INVENTIONA

INVENTION A

DOUBLE PATENTING: STATUTORY TYPE

35 USC 101 NON-STATUTORY

Obviousness-type Double Patenting

PATENTFOR

INVENTIONA

PLURALDISTINCTINVENTIONS

RESTRICTION

35 U.S.C. 121

35 U.S.C. 101:WHOEVER INVENTS

…MAY RECEIVEA PATENT

PATENT APPLICATION

PATENTAPPLICATION

PATENTAPPLICATION

ONEPATENT

FORONE

INVENTION

5/31/07 BCP 5

What is RESTRICTION ?

Restriction is the practice of requiring an applicant to elect a single claimed invention (e.g., a combination or subcombination invention, a product or process invention, a species within a genus) for examination when two or more independent inventions and/or two or more distinct inventions are claimed in an application.

MPEP 802.02

5/31/07 BCP 6

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. 806.

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

To determine if process inventions are distinct, To determine if process inventions are distinct, it is important to compare theit is important to compare the

Claimed preamble,Claimed preamble,Claimed active steps and Claimed active steps and SpecificationSpecification

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

5/31/07 BCP 7

Claim 1. A method of reducing pain Claim 1. A method of reducing pain

by administering compound ABC to a patient suffering from by administering compound ABC to a patient suffering from a cold.a cold.

Claim 2. A method of reducing fever Claim 2. A method of reducing fever

by administering compound ABC to a patient suffering from by administering compound ABC to a patient suffering from a cold.a cold.

Claim 3. A method of reducing congestion Claim 3. A method of reducing congestion

by administering compound ABC to a patient suffering from by administering compound ABC to a patient suffering from a cold.a cold.

The specification teaches that compound ABC can be used to treat cold The specification teaches that compound ABC can be used to treat cold symptoms because it reduces the symptoms of pain, fever and/or symptoms because it reduces the symptoms of pain, fever and/or congestion. A patient suffering from a cold when treated with compound congestion. A patient suffering from a cold when treated with compound ABC would experience relief from all of these symptoms.ABC would experience relief from all of these symptoms.

Restriction among claims 1, 2 and 3 is not proper because claims 1, 2 and 3 Restriction among claims 1, 2 and 3 is not proper because claims 1, 2 and 3 require the same active step of administering compound ABC to the same require the same active step of administering compound ABC to the same patient and the specification teaches that compound ABC reduces pain, fever patient and the specification teaches that compound ABC reduces pain, fever

and congestion in a patient suffering from a cold.and congestion in a patient suffering from a cold.

Example I: Different Preambles, same active Example I: Different Preambles, same active step; Restriction Improperstep; Restriction Improper

5/31/07 BCP 8

Claim 1. A method of inhibiting leaf growth in a deciduous plant by Claim 1. A method of inhibiting leaf growth in a deciduous plant by administering the compound of Formula 1.administering the compound of Formula 1.

Claim 2. A method of enhancing needle longevity in a coniferous Claim 2. A method of enhancing needle longevity in a coniferous plant by plant by administering the compound of Formula 1.administering the compound of Formula 1.

The specification teaches that compound of Formula 1, when The specification teaches that compound of Formula 1, when applied to deciduous plants, reduces growth of new leaves applied to deciduous plants, reduces growth of new leaves but when applied to coniferous plants, lengthens the life of but when applied to coniferous plants, lengthens the life of the needles. the needles.

The processes of claims 1 and 2 are specific for two different The processes of claims 1 and 2 are specific for two different types of plants and result in two different outcomestypes of plants and result in two different outcomes

Restriction between claims 1 and 2 may be proper.Restriction between claims 1 and 2 may be proper.

Example II: Different Preambles, same active Example II: Different Preambles, same active step; Restriction may be properstep; Restriction may be proper

5/31/07 BCP 9

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

MPEP 803MPEP 803

5/31/07 BCP 10

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

5/31/07 BCP 11

Showing Serious BurdenShowing Serious Burden Reasons must be provided why a serious Reasons must be provided why a serious

burden would exist if restriction were not burden would exist if restriction were not required.required.

A serious burden may be A serious burden may be prima facieprima facie shown if shown if one or more of the following reasons apply - one or more of the following reasons apply - that the inventions have: that the inventions have: (a) separate classification (a) separate classification (b) separate status in the art (b) separate status in the art (c) a different field of search (c) a different field of search (as defined in MPEP 808.02) (as defined in MPEP 808.02) (d) if the prior art applicable to one invention would (d) if the prior art applicable to one invention would

likely not be applicable to another invention, likely not be applicable to another invention, (e) the inventions are likely to raise different non-(e) the inventions are likely to raise different non-

prior art issues under 35 USC 101 and/or 35 USC prior art issues under 35 USC 101 and/or 35 USC 112, ¶ 1.112, ¶ 1.

MPEP 803, 808.02MPEP 803, 808.02

5/31/07 BCP 12

Showing Serious BurdenShowing 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

MPEP 808.02MPEP 808.02

5/31/07 BCP 13

Responding to applicant’s traversal re: Responding to applicant’s traversal re: burdenburden

Where the initial requirement is traversed, it Where the initial requirement is traversed, it should be reconsidered. If, upon should be reconsidered. If, upon reconsideration, the examiner is still of the reconsideration, the examiner is still of the opinion that restriction is proper, it should be opinion that restriction is proper, it should be repeated and made final in the next Office repeated and made final in the next Office action. (See MPEP § 803.01.) In doing so, action. (See MPEP § 803.01.) In doing so, the examiner should reply to the reasons or the examiner should reply to the reasons or arguments advanced by applicant in the arguments advanced by applicant in the traverse. traverse. MPEP 821.01MPEP 821.01

5/31/07 BCP 14

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 independentindependent or distinct or distinct and and

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

MPEP 803MPEP 803

5/31/07 BCP 15

Independent InventionsIndependent Inventions

Independent inventions have Independent inventions have no disclosed no disclosed relationship, relationship, i.e., they are unrelated.i.e., they are unrelated.

Product and process inventions are Product and process inventions are unrelated if it can be shown that unrelated if it can be shown that

the product cannot be used in the process the product cannot be used in the process

ANDAND the product cannot be made by the process. the product cannot be made by the process.

See MPEP § 802.01 and § 806.06; FP 8.20.03See MPEP § 802.01 and § 806.06; FP 8.20.03

5/31/07 BCP 16

Example III: Independent Example III: Independent Product and Process InventionsProduct and Process Inventions

Claim 1. An oligonucleotide molecule that hybridizes to a Claim 1. An oligonucleotide molecule that hybridizes to a polynucleotide having SEQ ID No 1 which encodes Protein XYZ.polynucleotide having SEQ ID No 1 which encodes Protein XYZ.

Claim 2. A process of inducing passive immunity by Claim 2. A process of inducing passive immunity by administering an antibody that binds to Protein XYZ.administering an antibody that binds to Protein XYZ.

The product of claim 1 is independent from the The product of claim 1 is independent from the process of claim 2 because the oligonucleotide of process of claim 2 because the oligonucleotide of claim 1 is neither used in nor made by the process claim 1 is neither used in nor made by the process of claim 2.of claim 2. See MPEP § 802.01 and § 806.06; FP 8.20.03See MPEP § 802.01 and § 806.06; FP 8.20.03

5/31/07 BCP 17

Independent Inventions Common in TC1600 Independent Inventions Common in TC1600 ApplicationsApplications

Product:Product:

Process of:Process of:

DNA that contains DNA that contains protein XYZ’s open protein XYZ’s open

reading framereading frame

Protein XYZProtein XYZ Antibody that Antibody that binds to protein binds to protein

XYZXYZ

making DNAmaking DNA RelatedRelated Often IndependentOften Independent Often IndependentOften Independent

using DNAusing DNA RelatedRelated Related if process Related if process results in the proteinresults in the protein

Often IndependentOften Independent

making proteinmaking protein Related if process Related if process requires the DNArequires the DNA

RelatedRelated Related if process Related if process requires antibodyrequires antibody

using proteinusing protein Often IndependentOften Independent RelatedRelated Related if process Related if process requires antibodyrequires antibody

making antibodymaking antibody Often IndependentOften Independent Related if process Related if process requires the proteinrequires the protein

RelatedRelated

using antibodyusing antibody Often IndependentOften Independent Related if process Related if process requires the proteinrequires the protein

RelatedRelated

5/31/07 BCP 18

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

MPEP 803MPEP 803

5/31/07 BCP 19

Concepts Relevant to Determining Concepts Relevant to Determining DistinctnessDistinctness Between Product and Process Between Product and Process

InventionsInventions

Obvious VariantsObvious Variants

Materially DifferentMaterially Different

Mutually ExclusiveMutually Exclusive

5/31/07 BCP 20

Obvious variants are not distinct inventionsObvious variants are not distinct inventions

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).

5/31/07 BCP 21

What is “Materially Different”?What is “Materially Different”? Establishing distinction often requires showingEstablishing distinction often requires showing

the claimed product can be used in, or made by, a the claimed product can be used in, or made by, a materially different process than that claimed, or materially different process than that claimed, or

the claimed process can result in, or be performed with, the claimed process can result in, or be performed with, a materially different product than that claimed. a materially different product than that claimed.

Two products or two processes are “materially different” when Two products or two processes are “materially different” when they are independent or distinct from one another.they are independent or distinct from one another.

Burden on the examiner to provide a reasonable Burden on the examiner to provide a reasonable example of a materially different product/processexample of a materially different product/process Example need not be documentedExample need not be documented If applicant convincingly traverses the restriction If applicant convincingly traverses the restriction

requirement, a viable alternative process or product is requirement, a viable alternative process or product is needed to maintain the restriction.needed to maintain the restriction.

5/31/07 BCP 22

Claims to different species are Claims to different species are mutually exclusivemutually exclusive if one claim recites limitations disclosed for a first if one claim recites limitations disclosed for a first species but not a second, while a second claim species but not a second, while a second claim recites limitations disclosed only for the second recites limitations disclosed only for the second species and not the first. This may also be species and not the first. This may also be expressed by saying that to require restriction expressed by saying that to require restriction between claims limited to species, the claims between claims limited to species, the claims must must not overlap in scopenot overlap in scope. MPEP 806.04(f) . MPEP 806.04(f)

Related inventions in the same statutory class are Related inventions in the same statutory class are considered considered mutually exclusivemutually exclusive, or not overlapping , or not overlapping in scope, if a first invention would not infringe a in scope, if a first invention would not infringe a second invention, and the second invention would second invention, and the second invention would not infringe the first invention. MPEP 806.05not infringe the first invention. MPEP 806.05

What is “Mutually ExclusiveWhat is “Mutually Exclusive””

5/31/07 BCP 23

Establishing Distinctness Between Establishing Distinctness Between Related Inventions of Related Inventions of differentdifferent Statutory Statutory

Categories Categories (i.e., “Products” and “Processes”)(i.e., “Products” and “Processes”)

Process of using an apparatus & Process of using an apparatus & apparatus for its practice – See apparatus for its practice – See MPEP MPEP 806.05(e)806.05(e)

Process of making a product & product Process of making a product & product made by the process – See made by the process – See MPEP MPEP 806.05(f)806.05(f)

Product & process of using the product Product & process of using the product – See – See MPEP 806.05(h)MPEP 806.05(h)

5/31/07 BCP 24

Test for Distinctness between Test for Distinctness between Process and Apparatus for its PracticeProcess and Apparatus for its Practice

Test:Test: The process The process as claimedas claimed can be practiced by can be practiced by

an apparatus that is materially different an apparatus that is materially different from the claimed apparatus, or by hand; from the claimed apparatus, or by hand;

OROR The apparatus The apparatus as claimedas claimed can be used to can be used to

practice a process that is materially practice a process that is materially different from the claimed process.different from the claimed process.

MPEP 806.05(e); FP 8.17MPEP 806.05(e); FP 8.17

5/31/07 BCP 25

Example IV: Process can be practiced by a Example IV: Process can be practiced by a materially different apparatusmaterially different apparatus

Claim 1. A process for producing protein XYZ having SEQ ID Claim 1. A process for producing protein XYZ having SEQ ID No 1 comprising the step of using a chemical synthesizer to No 1 comprising the step of using a chemical synthesizer to create the amino-peptide bonds between individual amino create the amino-peptide bonds between individual amino acids as specified by the sequence of SEQ ID No 1, thus acids as specified by the sequence of SEQ ID No 1, thus forming the polypeptide having SEQ ID No 1.forming the polypeptide having SEQ ID No 1.

Claim 2. Isolated protein XYZ having SEQ ID No 1.Claim 2. Isolated protein XYZ having SEQ ID No 1.

The specification teaches that protein XYZ can be isolated The specification teaches that protein XYZ can be isolated from nature using column chromatography, made via from nature using column chromatography, made via recombinant DNA expression systems or chemically recombinant DNA expression systems or chemically synthesized.synthesized.

Because the protein can be made by materially different Because the protein can be made by materially different methods other than chemical synthesis, the process of claim methods other than chemical synthesis, the process of claim 1 and the product of claim 2 are distinct.1 and the product of claim 2 are distinct.

MPEP 806.05(e); FP 8.17MPEP 806.05(e); FP 8.17

5/31/07 BCP 26

Example V: Apparatus can be used to Example V: Apparatus can be used to

practice a materially different process.practice a materially different process.

Claim 1. A process for producing a protein comprising the step of using Claim 1. A process for producing a protein comprising the step of using a chemical synthesizer to create the amino-peptide bonds between a chemical synthesizer to create the amino-peptide bonds between individual amino acids as specified by a given sequence, thus forming individual amino acids as specified by a given sequence, thus forming the polypeptide having the given sequence.the polypeptide having the given sequence.

Claim 2. Isolated protein XYZ having SEQ ID No 1.Claim 2. Isolated protein XYZ having SEQ ID No 1.

The specification teaches that the chemical synthesizer can be The specification teaches that the chemical synthesizer can be programmed to produce any protein if given the protein’s amino acid programmed to produce any protein if given the protein’s amino acid sequence. sequence.

Human growth hormone of SEQ ID No 2 is materially different from Human growth hormone of SEQ ID No 2 is materially different from Protein XYZ having SEQ ID No 1. Because the process of Claim 1 can Protein XYZ having SEQ ID No 1. Because the process of Claim 1 can make materially different proteins, such as human growth hormone, make materially different proteins, such as human growth hormone, than the protein of claim 2, the process of claim 1 and the product of than the protein of claim 2, the process of claim 1 and the product of claim 2 are distinct.claim 2 are distinct.

MPEP 806.05(e); FP 8.17MPEP 806.05(e); FP 8.17

5/31/07 BCP 27

Test For Distinctness Between Test For Distinctness Between Process of Making and Product MadeProcess of Making and Product Made

Test:Test: The product The product as claimedas claimed can be made can be made

by a process that is materially different by a process that is materially different from the claimed process; from the claimed process;

OROR The process The process as claimedas claimed can be used to can be used to

make a product that is materially make a product that is materially different from the claimed product.different from the claimed product.

MPEP 806.05(f); FP 8.18MPEP 806.05(f); FP 8.18

5/31/07 BCP 28

Practical Tip on Practical Tip on Process of Making and Product Made Process of Making and Product Made

““Product-by-process” claims may be Product-by-process” claims may be restricted from process of making claims restricted from process of making claims if the product claimed in the “product-by-if the product claimed in the “product-by-process” claims can be made by another process” claims can be made by another materially different process than that materially different process than that claimed.claimed.

““Product-by process” claims should Product-by process” claims should generally be grouped with the product.generally be grouped with the product.

See MPEP 806.05(f)See MPEP 806.05(f)

5/31/07 BCP 29

Example VI: Product can be made by a Example VI: Product can be made by a materially different processmaterially different process

Claim 1. Compound XYZ having Formula 1.Claim 1. Compound XYZ having Formula 1. Claim 2. A process of making a compound XYZ having formula 1 by Claim 2. A process of making a compound XYZ having formula 1 by

isolating compound XYZ from isolating compound XYZ from lactobacilluslactobacillus..

The specification teaches that compound XYZ can be purified and The specification teaches that compound XYZ can be purified and isolated from lactobacillus. The specification also provides the isolated from lactobacillus. The specification also provides the chemical structure of compound XYZ and a process for synthesizing chemical structure of compound XYZ and a process for synthesizing it.it.

Because the product of claim 1, Because the product of claim 1, as claimed,as claimed, can be made by a can be made by a process that is materially different from the claimed process, process that is materially different from the claimed process, the product of claim 1 is distinct from the process of claim 2.the product of claim 1 is distinct from the process of claim 2.

MPEP 806.05(f); FP 8.18MPEP 806.05(f); FP 8.18

5/31/07 BCP 30

Example VII: Process can make a materially Example VII: Process can make a materially different productdifferent product

Claim 1. An antibody which binds to the N-terminal of protein X.Claim 1. An antibody which binds to the N-terminal of protein X.Claim 2. A method of producing an antibody which binds to protein X, Claim 2. A method of producing an antibody which binds to protein X,

comprising the steps of immunizing a mouse with protein X, fusing comprising the steps of immunizing a mouse with protein X, fusing immunized B cells with myeloma cells to produce hybridomas, cloning immunized B cells with myeloma cells to produce hybridomas, cloning the hybridomas which produce protein X-specific antibodies and the hybridomas which produce protein X-specific antibodies and isolating the antibodies produced by the hybridomas.isolating the antibodies produced by the hybridomas.

The specification teaches that the N-terminus of protein X contains a The specification teaches that the N-terminus of protein X contains a targeting domain while the C-terminus of protein X contains an targeting domain while the C-terminus of protein X contains an activation domain shared by other members of that family. The activation domain shared by other members of that family. The specification teaches that some of the antibodies produced by the specification teaches that some of the antibodies produced by the method of claim 2 bind to the activation domain of protein X and not to method of claim 2 bind to the activation domain of protein X and not to the targeting domain, while antibodies which bind to the N-terminus are the targeting domain, while antibodies which bind to the N-terminus are specific for the targeting domain.specific for the targeting domain.

Because the process of claim 2, Because the process of claim 2, as claimed,as claimed, can produce antibodies to the can produce antibodies to the C-terminal of protein X, that are materially different from the antibodies C-terminal of protein X, that are materially different from the antibodies which bind to the N-terminus of protein X, the product of claim 1 is distinct which bind to the N-terminus of protein X, the product of claim 1 is distinct from the process of claim 2.from the process of claim 2.

MPEP 806.05(f); FP 8.18MPEP 806.05(f); FP 8.18

5/31/07 BCP 31

Test for Distinctness Between Test for Distinctness Between Product and Process of UsingProduct and Process of Using

Test:Test: The process of using the product The process of using the product as as

claimedclaimed can be practiced with another can be practiced with another materially different product, materially different product,

OROR The product The product as claimedas claimed can be used in can be used in

a materially different process.a materially different process.

MPEP 806.05(h); FP 8.20MPEP 806.05(h); FP 8.20

5/31/07 BCP 32

Example VIII: Process of using can be Example VIII: Process of using can be practiced with a materially different practiced with a materially different

productproductClaim 1. A method of detecting skin cancer comprising the step Claim 1. A method of detecting skin cancer comprising the step

of contacting cells with an agent that binds to melanoma cells.of contacting cells with an agent that binds to melanoma cells.Claim 2. An antibody that binds to the PDQ receptor found on Claim 2. An antibody that binds to the PDQ receptor found on

melanoma cells.melanoma cells.

The specification provides 4 agents which bind to the PDQ The specification provides 4 agents which bind to the PDQ receptor, including an antibody, a solubilized PDQ receptor, a receptor, including an antibody, a solubilized PDQ receptor, a compound having formula 1 and a lectin having Formula 2.compound having formula 1 and a lectin having Formula 2.

Because the method of claim 1, as claimed, can be practiced Because the method of claim 1, as claimed, can be practiced using a materially different agent, such as the solubilized using a materially different agent, such as the solubilized receptor, the compound having Formula 1 or the lectin having receptor, the compound having Formula 1 or the lectin having Formula 2, than the antibody of claim 2, the process of claim 1 Formula 2, than the antibody of claim 2, the process of claim 1 is distinct from the product of claim 2.is distinct from the product of claim 2.

MPEP 806.05(h); FP 8.20MPEP 806.05(h); FP 8.20

5/31/07 BCP 33

Example IX: The product Example IX: The product as claimedas claimed can can be used in a materially different processbe used in a materially different process

Claim 1. A composition comprising the compound of Formula 1.Claim 1. A composition comprising the compound of Formula 1. Claim 2. A method of enhancing needle longevity in a coniferous Claim 2. A method of enhancing needle longevity in a coniferous plants plants

by administering the compound of Formula 1.by administering the compound of Formula 1.

The specification teaches that compound of Formula 1, when applied The specification teaches that compound of Formula 1, when applied to deciduous plants, reduces growth of new leaves but when applied to deciduous plants, reduces growth of new leaves but when applied to coniferous plants, lengthens the life of the needles. to coniferous plants, lengthens the life of the needles.

Because the compound of claim 1, as claimed, can be used for a Because the compound of claim 1, as claimed, can be used for a materially different process, such as reducing the growth of new materially different process, such as reducing the growth of new leaves in deciduous plants, than the process of claim 2, the leaves in deciduous plants, than the process of claim 2, the product of claim 1 is distinct from the process of claim 2.product of claim 1 is distinct from the process of claim 2.

MPEP 806.05(h); FP 8.20MPEP 806.05(h); FP 8.20

5/31/07 BCP 34

Practical Tip – Distinction Between Practical Tip – Distinction Between Products and Processes of Screening or Products and Processes of Screening or

DetectingDetecting The outcome of a screening method or a detection The outcome of a screening method or a detection

method is typically method is typically informationinformation- knowledge that a - knowledge that a candidate compound has or lacks the desired candidate compound has or lacks the desired activity. activity.

A screening or detection method usually does not A screening or detection method usually does not result in the production, isolation or purification of result in the production, isolation or purification of the product possessing the desired activity.the product possessing the desired activity.

A screening or detection method usually does not A screening or detection method usually does not require the presence of the product possessing the require the presence of the product possessing the desired activity.desired activity.

As such, a process of screening or detecting is As such, a process of screening or detecting is often NOT a process of making or using the product often NOT a process of making or using the product which possesses the desired activity.which possesses the desired activity.

5/31/07 BCP 35

Example X: Restriction Between a Product Example X: Restriction Between a Product and Process of Screening for Activity of and Process of Screening for Activity of

the Productthe ProductClaim 1. A process of screening for an inhibitor of Enzyme LMN Claim 1. A process of screening for an inhibitor of Enzyme LMN

by testing candidate compounds for their ability to inhibit the by testing candidate compounds for their ability to inhibit the enzymatic activity of Enzyme LMN.enzymatic activity of Enzyme LMN.

Claim 2. A compound identified by the process of claim 1, Claim 2. A compound identified by the process of claim 1, wherein the compound has Formula 1.wherein the compound has Formula 1.

The specification teaches that a compound having Formula 1 can The specification teaches that a compound having Formula 1 can inhibit the enzymatic activity of Enzyme LMN.inhibit the enzymatic activity of Enzyme LMN.

The outcome of the process of claim 1 does not result in the The outcome of the process of claim 1 does not result in the production, synthesis, isolation or purification of the compound production, synthesis, isolation or purification of the compound having Formula 1. having Formula 1.

As such, the method of claim 1 is not a process of making or using As such, the method of claim 1 is not a process of making or using the compound of Claim 2. the compound of Claim 2.

The process and product are distinct. If the product elected and The process and product are distinct. If the product elected and found allowable, no need to rejoin the process as it does not depend found allowable, no need to rejoin the process as it does not depend from or require all the limitations of the product claim.from or require all the limitations of the product claim.

5/31/07 BCP 36

Practical Tip – Practical Tip – Restriction Between Products and Restriction Between Products and

ProcessesProcesses If the product invention is elected and found If the product invention is elected and found

allowable over the prior art, processes of allowable over the prior art, processes of making or using the allowable product would making or using the allowable product would ordinarily be novel and nonobvious. Claims to ordinarily be novel and nonobvious. Claims to the non-elected process(es) may be subject to the non-elected process(es) may be subject to “rejoinder”. See MPEP 821.04(b).“rejoinder”. See MPEP 821.04(b).

Notify applicants of potential opportunity for Notify applicants of potential opportunity for “rejoinder” via FP 8.21.04, which should be “rejoinder” via FP 8.21.04, which should be added to restriction requirements using either added to restriction requirements using either FP 8.18 or FP 8.20.FP 8.18 or FP 8.20.

5/31/07 BCP 37

Any questions?