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Unity of Invention Biotechnology Practice. Julie Burke USPTO TC1600 Special Program Examiner. Groups of Molecules PCT Rule 13.2 “Markush” Practice Example 17; Administrative Instructions Claim Order, Claim Breadth, Lack of Unity within a Claim and Tips Points of Contact.

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Unity of Invention Biotechnology Practice

Julie Burke

USPTO TC1600

Special Program Examiner


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Groups of Molecules

PCT Rule 13.2

“Markush” Practice

Example 17; Administrative Instructions

Claim Order, Claim Breadth,

Lack of Unity within a Claim and Tips

Points of Contact


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Molecules, grouped together, in the alternative, may share a common

Structure

Function

Source from which they were isolated or

Intended use


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Types of Nucleic Acid Molecule Groups common

DNA molecules cloned from a tissue human liver library or

small cell lung cancer

cDNAs cloned from a developmental stage mRNA expressed in

nematode ectoderm

Genes encoding proteins with same function tumor suppressors

Cell type specific gene regulatory elements G1 cell cycle promoters

Variants of a single gene polymorphisms or splice variants of cytokine X

cDNA which encodes one protein DNA encoding

SEQ ID NO:1


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Types of Protein Groups common

Proteins sharing a structural domain Zinc finger domain

Proteins sharing homology Protein 80% identical to

Protease XYZ

Protein sharing common function Antibodies that bind the

ABC antigen

Proteins with common structure Splice variants of a protein

Proteins in an art recognized class Threonine kinases

Proteins isolated from one source Liver cell surface proteins

Proteins isolated from an organism S. typhii proteins


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Example of molecules claimed in the alternative: common

Claim: An isolated molecule consisting of Formula 1-999 or 1000.

OR

Claim: An isolated nucleic acid molecule consisting of SEQ ID NO: 1-999 or 1000.

What is the technical feature that links the molecules?


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Groups of Molecules common

PCT Rule 13.2

“Markush” Practice

Example 17; Administrative Instructions

Claim Order, Claim Breadth and

Lack of Unity within a Claim

Points of Contact


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Claim: An isolated nucleic acid molecule consisting of common

SEQ ID NO: 1-999 or 1000, wherein the

nucleic acid molecule encodes a lymphokine.

PCT Rule 13.2, first sentence

 Is the function, encoding a lymphokine,

the technical feature which links the molecules?

PCT Rule 13.2, second sentence

Are lymphokine-encoding nucleic acid molecules a contribution over the prior art?


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Claim: An isolated commonrat liver kinase comprising SEQ ID NO: 101-199 or 200.

PCT Rule 13.2, first sentence

Is rat liver kinase the shared technical feature?

PCT Rule 13.2, second sentence

Is rat liver kinase a contribution over the prior art?


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Claim: An isolated commonDNA molecule consisting of

SEQ ID NO: 1-99 or 100 which is useful for

detecting Salmonella typhii strains.

PCT Rule 13.2, first sentence

Are the molecules linked by the technical feature

DNA molecule for detecting S. typhii?

PCT Rule 13.2, second sentence

Is this technical feature a contribution over the prior art?


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Groups of Molecules common

PCT Rule 13.2

“Markush” Practice

Example 17; Administrative Instructions

Claim Order, Claim Breadth,

Lack of Unity within a Claim and Tips

Points of Contact


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Claim: An isolated protein selected from the group consisting of SEQ ID NO: 1-99 and 100.

The disclosure teaches that SEQ ID NO: 1-100 are each 200 amino acids in length; each contain Protein XYZ that is 180 amino acids in length. The remaining 20 amino acids are N-terminal epitope tags to aid in purifying Protein XYZ and do not interfere with the enzymatic activity of Protein XYZ.

Is Protein XYZ the technical feature that links the claimed molecules?

Is Protein XYZ a contribution over the prior art? PCT Rule 13.2

Does the grouping meet the criteria for Markush Practice?AI, Annex B

Do the proteins

(A) have a common property or activity and

(B)(1) have a common structure present,

i.e, significant structural element or

(B)(2) belong to an art recognized class of compounds?


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Claim: An isolated DNA molecule of Table 1. consisting of SEQ ID NO: 1-99 and 100.

Note: Table 1 recites 35 sequences, each of which vary from SEQ ID NO: 1 at a single nucleotide site.

Do the DNA molecules share a common structure or

belong to an art recognized class of compounds?

Is common structure a contribution over the prior art?

Do the DNA molecules share

a common property or activity?  


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Claim: An isolated DNA molecule of Table 1 wherein detection of the DNA molecule is diagnostic for cancer.

Note: Table 1 recites 35 sequences, each of which vary from SEQ ID NO: 1 at a single nucleotide site.

 Do the DNA molecules have a common structure present, or

belong to an art recognized class of compounds?

Is common structure a contribution over the prior art?

Do the DNA molecules share a common property or activity?


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Molecules Grouped by Structure of the DNA molecule is diagnostic for cancer.

Molecules Grouped by Structure

Molecules Grouped by Structure

Common Structure?

Common Structure?

Common Structure?

YES

YES

YES

Unity of Invention Lacking

Significant Structural Element?

NO

NO

NO

YES

YES

YES

Is Common Structure a

Contribution over the Prior Art?

Is Common Structure a

Contribution over the Prior Art?

Is Common Structure a

Contribution over the Prior Art?

YES

YES

YES

Do the molecules share a common property or activity?

Do the molecules share a common property or activity?

Do the molecules share a common property or activity?

Unity of Invention Present

Unity of Invention Present

Unity of Invention Present

YES

YES

YES


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Molecules Grouped by Function of the DNA molecule is diagnostic for cancer.

Do the molecules share a common property or activity?

YES

Unity of Invention Lacking

Is common property or activity

a Special Technical Feature?

NO

YES

Shared Common Structure, Significant Structural Element?

YES

Is the Common Structure a

Contribution over the Prior Art?

Unity of InventionPresent

YES


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Groups of Molecules of the DNA molecule is diagnostic for cancer.

PCT Rule 13.2

“Markush” Practice

Example 17 of Annex B of the

Administrative Instructions

Claim Order, Claim Breadth,

Lack of Unity within a Claim and Tips

Points of Contact


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Example 17; Annex B of the Administrative Instructions of the DNA molecule is diagnostic for cancer.

Scenario A

Claim 1. Isolated Protein X.

Claim 2. Isolated DNA encoding Protein X.

Wherein Protein X and DNA are a contribution over the prior art?

Scenario B

Claim 1. Isolated Protein X.

Claim 2. Isolated DNA encoding Protein X.

Wherein DNA or Protein X are NOT a contribution over the prior art?

Do the DNA and protein share a special technical feature?


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Variations of Example 17 of the DNA molecule is diagnostic for cancer. (cont.)

Scenario C

Claim 1: Isolated Protein X.

Claim 2: Isolated DNA encoding Protein X or variant DNA thereof.

Would the variant DNA necessarily encode Protein X?

Is a technical feature shared between Claims 1 and 2?

Scenario D

Claim 1: Isolated Protein X or a functional equivalent thereof.

Claim 2: Isolated DNA encoding protein X.

Could DNA of Claim 2 encode the functional equivalent of Protein X?

Is a technical feature shared between Claims 1 and 2?


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Groups of Molecules of the DNA molecule is diagnostic for cancer.

PCT Rule 13.2

“Markush” Practice

Example 17; Administrative Instructions

Claim Order, Claim Breadth,

Unity within a Claim & Tips

Points of Contact


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Importance of Claim Order of the DNA molecule is diagnostic for cancer.

37 C.F.R. 1.475(d)

If multiple products, processes of manufacture, or uses are claimed, the first invention of the category first mentioned in the claims of the application and the first recited invention of each of the other categories related thereto will be considered as the main invention in the claims, see PCT Article 17(3)(a) and § 1.476(c).


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When claims are presented in this order: of the DNA molecule is diagnostic for cancer.

Claim 1. A purified PQR molecule.  

Claim 2. A purified antibody that binds to PQR, produced by hybridoma ABC.

Claim 3. Method of making antibody of claim 1 by culturing hybridoma ABC.

Claim 4. Method of detecting cancer by using antibody of claim 1.

then lack of unity results in four groups

Group I, claims 1, drawn a PQR molecule. (First product)

Group II, claim 2, drawn an antibody. (Second Product)

Group III, claim 3, a method of making the antibody.

(Method of making the second product)

Group IV, claim 4, drawn a method of using the antibody.

(Method of using the second product)


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If the claim order is rearranged as follows: of the DNA molecule is diagnostic for cancer.

Claim 1. A purified antibody that binds to PQR, produced by hybridoma ABC.  

Claim 2. A purified PQR molecule. 

Claim 3. Method of making antibody of claim 1 by culturing hybridoma ABC.

Claim 4. Method of detecting cancer by using antibody of claim 1.

and if antibody is a contribution over the prior art,

then only Two Groups:

Group I, claims 1, 3-4, drawn an antibody, a method of making and a method of using the antibody. (First product & first methods)

Group II, claim 2, drawn PQR molecule. (Second Product)

Note: if the antibody is NOT a contribution over the prior art,

unity is lacking between the first product and first methods. PCT Rule 13.2


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Unity of Invention depends on Breadth of Claims of the DNA molecule is diagnostic for cancer.

Claim: An isolated molecule consisting of A, B, or C protein or fragment thereof.

A, B, and C share the special technical feature of a new ligase domain.

Identify the technical feature shared by all:

a fragment of A, B, or C protein.

Is this technical feature a contribution over the prior art?

Is any protein fragment a contribution over the prior art?

Structure & function are lacking with respect to the term “fragment.”


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 Unity of Invention Within a Claim of the DNA molecule is diagnostic for cancer.

PCT Rule 13.3 37 CFR 1.475(e)

The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim.


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Multiple inventions presented in a claim of the DNA molecule is diagnostic for cancer.

Claim 1. A purified molecule

selected from the group consisting of G, H or I.

If molecules G, H and I fail to share

a special technical feature then:

Group I, claim 1, in part, drawn to molecule G.

Group II, claim 1, in part, drawn to molecule H.

Group III, claim 1, in part, drawn to molecule I.


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Tips For Unity of Invention in Biotechnology Applications of the DNA molecule is diagnostic for cancer.

Present the main invention and its most preferred method of use at the top of the claim set.

If claiming multiple products, narrowly define the scope of the main invention so that the special technical feature is required for each product, for the first method of use and first method of making.

When claiming multiple products, present the special technical feature and common property/activity as a limitation in the claims.

Include SEQ ID NOs in claims reciting specific DNA or protein molecules.

Provide SEQ ID NOs for any shared significant structural element.

Be willing to elect additional inventions over the phone.

Protest may be filed within 15 days of receipt of the USPTO 210/299 or

within 30 days of receipt of the USPTO 408/499.


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Groups of Molecules of the DNA molecule is diagnostic for cancer.

PCT Rule 13.2

“Markush” Practice

Example 17, Administrative Instructions

Claim Order, Claim Breadth,

Lack of Unity within a Claim and Tips

Points of Contact


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Points of Contact of the DNA molecule is diagnostic for cancer.

for

Lack of Unity, PCT & 371 Questions

Examiner and SPE

TC1600 Special Program Examiners

Bill Dixon (703) 308-3824

Cecilia Tsang (703) 308-0254

Julie Burke (703) 308-7553

PCT Helpdesk (703) 305-3257

for PCT and 371 procedural questions and problems


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For help related to downloading PatentIn 3.1 call: of the DNA molecule is diagnostic for cancer.

General Information Services (GIS) at (800) 786-9199 or (703) 308-4357

For help related to using PatentIn 3.1 or to report problems encountered running the program call or email:

PatentIn Help Line at (703) 306-4119 (patin3help@uspto.gov)

For help related to sequence rule compliance call or email:

Robert A. Wax 703-308-4216 (robert.wax@uspto.gov)

As an alternative call or email:

Christopher Low 703-308-2923 (christopher.low@uspto.gov)

Mark Spencer 703-308-04266 (mark.spencer@uspto.gov)