# Presentation: 184929

## 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

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

- Structure
- Function
- Source from which they were isolated or
- Intended use

**Notes:**
Rule 13.3

## Types of Nucleic Acid Molecule Groups

- 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

## Proteins isolated from an organism		S. typhii proteins 

- Proteins isolated from an organism		S. typhii proteins

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

- 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?

## PCT Rule 13.2

**PCT Rule 13.2**
- “Markush” Practice
- Example 17; Administrative Instructions
- Claim Order, Claim Breadth and
- 	Lack of Unity within a Claim
- Points of Contact

**Notes:**
Rule 13.3

## Claim:  An isolated nucleic acid molecule consisting of 

- 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?

## Claim:  An isolated rat 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?

## Claim:  An isolated DNA 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?

## “Markush” Practice

- 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

**Notes:**
Rule 13.3

## 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?

## Claim: An isolated DNA molecule of Table 1. 

- 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?

## 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?

## Slide 15

## Molecules Grouped by Function 

- Molecules Grouped by Function

- Shared Common Structure, Significant Structural Element?

- Is the Common Structure a
- Contribution over the Prior Art?

- Unity of Invention  Lacking

- Unity of Invention Present

- YES

- YES

- YES

- YES

- Do the molecules share a common property or activity?

- Is common property or activity
- a Special Technical Feature?

- NO

## Example 17 of Annex B of the

- 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

**Notes:**
Rule 13.3

## Example 17; Annex B of the Administrative Instructions  

**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?

## Variations of Example 17 (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?

## Claim Order, Claim Breadth,

- PCT Rule 13.2
- “Markush” Practice
- Example 17; Administrative Instructions
**Claim Order, Claim Breadth,**
**	****Unity within a Claim & Tips**
- Points of Contact

**Notes:**
Rule 13.3

## Importance of Claim Order

- 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).

## When claims are presented in this order:

- 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)

## If the claim order is rearranged as follows:

- 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

## Unity of Invention depends on Breadth of Claims

- 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.”

##  Unity of Invention Within a Claim

- 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.

**Notes:**
Rule 13.3

## Multiple inventions presented in a claim

- 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.

## Tips For Unity of Invention in Biotechnology Applications

- 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.

## Points of Contact 

- 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**

## Points of Contact 

**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

| 
Help - Sequences and Rules Compliance |
| --- |

- For help related to downloading PatentIn 3.1 call:
**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)**