Unity of

The Main Points in Examination of Pesticide Applications

M.Sc. Karina Volkov, Ph.D. Nina Korbakov

November 2013

Contents:

Part I. Unity of Invention.

I. Section 8 IL Law.

II. Lack of Unity : “a priori”.

III. Lack of Unity : “posteriori”.

IV. Unity of invention. Particular Situations.

1. Markush formula.

2. Different categories of claim.

3. Process for preparation, intermediate and final product.

4. Compositions.

Part II. The main points in examination of methods and combinations for controlling pests.

Israel 2

Unity of Invention

Section 8 Israel Patent Law

A patent shall be granted for a single invention only.

Unity of invention exists only when there is a technical relationship among the claimed involving one or more of the same or corresponding special technical concepts.

Israel Patent Office 3 Unity of Invention

The expression “Special technical concept” is defined as meaning those technical concepts that define a contribution which each of the inventions, considered as whole, makes over the .

Special technical concept of the invention must involve and Inventive step over the prior art.

Israel Patent Office 4 Unity of Invention

Lack of Unity “a priori”

Claim 1. A+B Claim 2. A+C Claim 3. B+C

There is no subject matter common to all claims. A is common in claims 1 and 2, therefore Unity exists only for these claims.

Israel Patent Office 5 Unity of Invention

Lack of Unity “a priori”

Example.

Claim 1. A compound of formula (I)

(I) Claim 2. A compound of formula (II)

(II)

Compounds (I) and (II) have not a common significant structural element. There is lack of unity “a priori”.

Israel Patent Office 6 Unity of Invention

Lack of Unity “posteriori”

Claim 1. A+B Claim 2. A+C

A is a common concept (be it a single concept or a group of concepts) in claims 1 and 2. If A is known from the prior art, there is lack of unity “posteriori”, since A is not a technical concept that defines a contribution over the prior art.

Israel Patent Office 7 Unity of Invention

Lack of Unity “posteriori”

Example 1.

Claim 1. A compound of formula (I),

R1 H, hydroxy, C1-6 alkyl, R2, R3 and R4 H, halo, hydroxy, nitro.

(I) Prior art:

A compound (I) when R1-OH, R2-Hal, R3,R4-OH is known from the prior art. Therefore claim 1 is lack of unity “posteriori”.

Israel Patent Office 8 Unity of Invention

Lack of Unity “posteriori”

Example 2.

Claim 1. A compound of formula (I), X -H, C1-6 alkyl, S R1 - OH, amino, hydroxyl, C3-9 cycloalkyl. (I)

Prior art: A - 6-membered ring selected from aryl, heteroaryl,

R1 – OH, C1-6 alkyl, C4-6 alkenyl.

Compounds (I) and (II) have a same activity. (II)

The prior art describes the compound (II) when pyridyl exists instead thiopyran group, R1-OH, X – H. Therefore claim 1 is not inventive and lack of unity “posteriori”. Israel Patent Office 9 Unity of Invention

Unity of invention. Particular Situations

1. Markush formula. 2. Different categories of claims. 3. Process for preparation, intermediate and final product. 4. Compositions.

Israel Patent Office 10 Unity of Invention

1. Markush formula The alternatives of Markush formula are regarded as being of a similar nature where the following criteria are fulfilled:

1. All alternatives have a common significant structural element. Common significant structural element occupies a large portion of their structures.

R1,R2 are C1-6 alkyl,C2-6 alkenyl, C2-6 alkynyl,

R3,R4 are C3-6 cycloalkyl, aryl.

2. All alternatives have a common property or activity.

Israel Patent Office 11 Unity of Invention

1. Markush formula (cont.)

Claim 1. A compound of the formula A – B– C – D

A is selected from C1-6 alkyl, C1-6 alkenyl, optionally substituted C6-12 aryl, C5-C7 heterocycle having 1-3 heteroatoms selected from O and N;

B is selected from optionally substituted C6-12 aryl, C5-C7 heterocycle having 1-3 heteroatoms selected from O and N;

C is selected from C5-C8 saturated or unsaturated heterocycle having 1-4 heteroatoms selected from O, S or N; D is selected from C1-6 alkyl, C1-6 alkenyl, C3-6 cycloalkyl.

From the above formula no significant structural element can be readily arose and thus no special technical concept can be determined. Lack of unity exists between all of the various combinations.

Israel Patent Office 12 Unity of Invention

2. Different categories of claims.

An application includes different categories of claims (compound, process, use, kit). Unity of invention exists if claims are drawn to the following combinations of categories:

1. A compound and a process for the manufacture of said compound; 2. A compound, a process for the manufacture of said compound, and a use of the said compound; 3. A compound, a pharmaceutical composition comprising the said compound, a process for the manufacture of said compound, a use of the said compound, a use of the said pharmaceutical composition, a kit.

Israel Patent Office 13 Unity of Invention

2. Different categories of claims (cont.). Example

Claim 1. Compound A (Markush formula). Claim 2. Process for the preparation Compound A. Claim 3. The use of compound A for the preparation a pharmaceutical composition. Claim 4. A kit comprising a compound A. 1. Compound A is new. A is the special technical concept to all the claims. Unity exists between claims 1,2,3 and 4.

2. One of alternatives of Compound A is known in the art, therefore A is not be a common special technical concept to all claims. Unity of invention does not exists.

Israel Patent Office 14 Unity of Invention

3. Process for preparation, intermediate and final product. Unity of invention exists when the following two conditions are fulfilled:

1. The intermediate and final products have same essential structural element.

The term “intermediate” is intended to mean intermediate or starting products. Such products have the ability to be used to produce final products through a physical or chemical change in which the intermediate loses its identity.

2. The intermediate and final products are technically interrelated, this meaning that the final product is manufactured directly from the intermediate.

Israel Patent Office 15 Unity of Invention

4. Compositions.

The composition of a number of individual elements is claimed in a single claim, unity of invention exists, even if these individual elements seem unrelated when considered individually.

Example 1.

Claim 1: A composition comprising Compound A, B and C.

Unity of Invention exists, even if the compounds seem unrelated one to another, because the composition is novel and/or inventive over the prior art.

Israel Patent Office 16 Unity of Invention

4. Compositions.(cont.)

Example 2.

Claim 1. A composition comprising Compound A. Claim 2. A composition comprising Compound B. Claim 3. A composition comprising Compound A and Compound B.

A and B are known.

Compound A is a special technical concept and Compound B is another special technical concept.

Unity exists between claims 1 and 3 or between claims 2 and 3 but not between claims 1 and 2.

Therefore claims are separated to two inventions:

Invention I: Claim 1, Claim 3, relate to a composition comprising Compound A. Invention II: Claim 2, Claim 3, relate to a composition comprising Compound B.

Moreover, claims 1,2,3 do not meet requirements of Commissioner Circular M.N. 78.

Israel Patent Office 17 Unity of Invention

4. Compositions.(cont.)

Commissioner Circular M.N. 78, 2010.02.02

Number of independent claims limited to a) One or two independent claims for a product b) One or two independent claims for a method to manufacture the product c) One or two independent claims for a device producing the product d) One or two independent claims for a use of the product (Swiss-type)

Requirement : the independent claims relate to single invention (Section 8, Israeli Patent Law ).

Israel Patent Office 18 II. The main points in examination of methods and

combinations for controlling pests.

Compound A is new Method for controlling pests

Agricultural composition comprising a) compound A and b) compounds B,C or D (are known)

Compound A is known

Israel Patent Office 19 Example 1. (IL 192953)

Claim 1. The use of 3-pyridyl derivatives of formula I and/or 3-pyridyl derivatives of formula II

Rule 20(a)(3)

or a composition comprising (a) a compound of formula (I) and/or a compound of formula (II) and

(b) an agrochemicaly acceptable carrier

Rule 20(a)(3) for combating pests.

C. Circular M.N. 30

Israel Patent Office 20 Example 1. (IL 192953)

Commissioner Circular M.N. 30, 2004.08.17 1. Acceptable claims Swiss-type: e.g. “use of X in the manufacture/preparation of Y”. 2. Not acceptable claims: Claims referring to a product: e.g. “use of X as a paint” Claims referring to medical treatment: e.g. “use of X in the treatment of disease Y”.

Israel Patent Office 21 Example 1. (IL 192953)

Rule 20(a)(3) Israel Regulations :

Section (a)(3): claim defines an invention at essential and clear form

1. Two subject matters (use of compound and use of composition) are claimed in the same claim that is opposite to Rule 20(a)(3).

2. The definition “pest” is wide that is opposite to Rule 20(a)(3).

A pest is a plant or animal detrimental to humans or human concerns, alternative meanings include organisms that cause nuisance and epidemic disease.

Israel Patent Office 22 Example 1. (IL 192953)

Section 7(1) Rule 20(a)(3) Claim 2. A method for controlling pests comprising contacting the pests or their food supply, habitat, breeding ground or their locus with a pesticidally effective amount of composition or compound of formula I or II as defined in claims 1 or 2.

Rule 20(a)(3)

Section 7 Israel Patent Law (1) no patent shall be granted for a method of therapeutic treatment

on the human body.

Israel Patent Office 23 Example 1. (IL 192953)

Rule 20(a)(3)

Claim 3.

Rule 20(a)(3)

Claim 4.

Rule 20(a)(3)

Claims 2,3,4 are related to three different methods, therefore these claims do not meet requirements of Commissioner Circular M.N. 78.

Israel Patent Office 24 Example 1. (IL 192953)

Commissioner’s Circular M.N. 78, 2010.02.02

Number of independent claims limited to a) One or two independent claims for a product; b) One or two independent claims for a method to manufacture the product; c) One or two independent claims for a device producing the product; d) One or two independent claims for a use of the product (Swiss-type).

Requirement : the independent claims relate to single invention (Section 8, Israel Patent Law).

Israel Patent Office 25 Example 1. (IL 192953) Rule 20(a)(3) Claim 5.

Synergistic effect is an effect arising between two or more agents or substances that produces an effect greater than the sum of their individual effects.

The synergistic effect is not obvious and depends on chemical structure of the compound in the combination.

The specification does not consist the examples to synergistic mixture, the subject matter claimed in claim 5 is not supported by the specification as required by Section13(a).

Israel Patent Office 26 Example 1. (IL 192953)

Section 12 Israel Patents Law

(a) the specification shall include a title by which the invention can be identified, its description with drawings that may be necessary, and also a description of the manner in which the invention can be performed, enabling a skilled person to perform it.

Section 13 Israel Patents Law

(a) The specifications shall end with a claim or claims that define the invention, on condition that each said claim reasonably arise out of the subject described in the specification.

Israel Patent Office 27 Example 2. (IL 198637)

Rule 20(a)(3)

WO 2004080181 discloses pesticidal synergistic composition comprising specific insecticide and additional active compound such as propamocarb –HCl.

Israel Patent Office 28 Example 2. (IL 198637)

Pesticidal composition comprising propamocarb –HCl and additional insecticide is known from the prior art. Therefore claim 1 is lack of unity. Each separate invention comprises a composition of propamocarb –HCl and additional insecticide which is chosen from the list of insecticides in claim 2 according to their activity, which is described in the specification.(Section 8 Israel Patent law).

The definition of compound B is broad and contains all insecticides compounds except of flubendiamide. The specification does not involve the examples for possible compositions. It does not meet requirements of Section 13(a) Israel Patent Law.

Israel Patent Office 29 Example 2. (IL 198637)

Section 13(a)

Israel Patent Office 30 Example 2. (IL 198637)

Efficacy examples

Dependent claim 2 relates to a list of compound B : 1. the specification has not examples for all of claimed compounds, 2. flubendiamide is claimed, that is excluded by proviso from claim 1.

Claim 2 does not meet requirements of Section 13(a) Israel Patents law.

Israel Patent Office 31 Example 2. (IL 198637)

Synergistic activity of the claimed composition.

Specification describes that claimed composition of propamocarb –HCl with additional insecticide is synergistic in comparison to the single compound.

There are three examples only to specific compositions demonstrate the synergistic effect, although claims contains a big number of possibilities for compound B.

Therefore claims are not supported by the specification and do not meet requirements of Section 13(a) Israel Patent Law.

Israel Patent Office 32 Example 2. (IL 198637)

Claim 7. A composition according to claim 1 further comprising C) a further fungicide compound.

The specification contains the examples for the synergistic composition of A+B and there are no examples that relate to the composition A+B+C.

Claim 7 does not meet requirements of section 12(a), Israel Patent Law.

Claim 7 does not meet requirements of Section 13(a), Israel Patent Law.

Israel Patent Office 33 Conclusions :

The main points in the examination of the pesticide applications

1. Method of treatment. 2. Unity of invention. 3. Use claims. 4. Definition of terms. 5. Clarity of claims. 6. Supporting claim by the description.

Israel Patent Office 34 Thank you for your attention!

Israel Patent Office 35