PATENT OFFICEPROCEDURES

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ByDr. Gopakumar G. NairAdvisor to Pharmexcil, IndiaGopakumar Nair AssociatesUrl: www.gnaipr.netEmail: gopanair@gnaipr.netBengaluru, 18th November, 2010

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Filing of Patent Application

When to file :- Earliest – as provisional(First-to-File)

Could continue working & file complete specificationlater

Provisional Specification

- To establish PRIORITY DATE / establish earlyownership

- To pre-empt others

Complete Specification

- To be filed within 12 months of filing of ProvisionalApplication3

When to file :- Earliest – as provisional(First-to-File)

Could continue working & file complete specificationlater

Provisional Specification

- To establish PRIORITY DATE / establish earlyownership

- To pre-empt others

Complete Specification

- To be filed within 12 months of filing of ProvisionalApplication

Complete Specification

Title Technical Field Background and Prior Art Current Problem / Drawback / Gap Solution to the problem/ Improvement Summary of Invention Detailed Description Experiments/Trials/Examples

(incld. Tabular column, if any) Claims Abstract Drawings

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Title Technical Field Background and Prior Art Current Problem / Drawback / Gap Solution to the problem/ Improvement Summary of Invention Detailed Description Experiments/Trials/Examples

(incld. Tabular column, if any) Claims Abstract Drawings

Patent Specification - Techno-legal doc Unity Of Invention - Single Inventive

Concept Clarity of Disclosure - State Clearly

And Distinctly The NatureAnd Limits Of The Claims

Sufficiency Of Disclosure - Claimsshould be supported byWritten Description.

Biological Material - GeographicalOrigin

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Patent Specification - Techno-legal doc Unity Of Invention - Single Inventive

Concept Clarity of Disclosure - State Clearly

And Distinctly The NatureAnd Limits Of The Claims

Sufficiency Of Disclosure - Claimsshould be supported byWritten Description.

Biological Material - GeographicalOrigin

Pre / Post Grant Opposition & Revocation

Product claims …………

Process claims …………

Composition claims …………

Method of treatment …………

New physical forms withenhanced efficacy ………….

Living organisms …………. (except microorganisms)

Patent Claims In India

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Product claims …………

Process claims …………

Composition claims …………

Method of treatment …………

New physical forms withenhanced efficacy ………….

Living organisms …………. (except microorganisms)

Receiving Office - Delhi, Kolkata, Chennai,Mumbai.

Language of Filing - English or Hindi

Forms (2nd Schedule)

1 (Application for Grant of Patent),2 (Complete or Provisional Appln),3 (Statement & Undertaking u/s 8 ),5 (Declaration As to Inventorship) &26 (Power of Attorney)

Fees (1st Schedule)

Ratio of Fees – 1 : 4 (Natural Person : Others)

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Receiving Office - Delhi, Kolkata, Chennai,Mumbai.

Language of Filing - English or Hindi

Forms (2nd Schedule)

1 (Application for Grant of Patent),2 (Complete or Provisional Appln),3 (Statement & Undertaking u/s 8 ),5 (Declaration As to Inventorship) &26 (Power of Attorney)

Fees (1st Schedule)

Ratio of Fees – 1 : 4 (Natural Person : Others)

Prosecution of a Patent

1) Optional-Early PublicationOR

18 months publication (automatic)

2) Request for Examination

3) First Examination Report – Inventor’s contribution

4) Responses – to & fro

5) Acceptance for Grant OR Rejection

6) Patent Term – 20yrs from date of filing.

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1) Optional-Early PublicationOR

18 months publication (automatic)

2) Request for Examination

3) First Examination Report – Inventor’s contribution

4) Responses – to & fro

5) Acceptance for Grant OR Rejection

6) Patent Term – 20yrs from date of filing.

Fees

Ratio of Fees – 1 : 4 (Natural Person : Others)

A few examples :Natural Othersperson

Patent Application- Form 1 & 2 Rs.1000 Rs.4000

Request for early publication Rs.2500 Rs.10000

(optional)

Request for Examination Rs.2500 Rs.10000Maintenance Fee3rd to 6th years Rs.500 Rs.20007th to 10th years Rs.1500 Rs.600011th to 15th years Rs.3000 Rs.1200016th to 20th years Rs.5000 Rs.20000

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Ratio of Fees – 1 : 4 (Natural Person : Others)

A few examples :Natural Othersperson

Patent Application- Form 1 & 2 Rs.1000 Rs.4000

Request for early publication Rs.2500 Rs.10000

(optional)

Request for Examination Rs.2500 Rs.10000Maintenance Fee3rd to 6th years Rs.500 Rs.20007th to 10th years Rs.1500 Rs.600011th to 15th years Rs.3000 Rs.1200016th to 20th years Rs.5000 Rs.20000

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Types Of Patent

Provisional Application

Complete Application

Convention Application

Application for Patent of Addition (CIP)

Cognate Application

Divisional Application

PCT International Application

PCT National Phase Application

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Provisional Application

Complete Application

Convention Application

Application for Patent of Addition (CIP)

Cognate Application

Divisional Application

PCT International Application

PCT National Phase Application

Patent Filing Strategies

Only National Filing

Only Convention filing (US / EU etc.)

National + Convention Country

National + US + EU

Only PCT

National + PCT

(With permission)

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Only National Filing

Only Convention filing (US / EU etc.)

National + Convention Country

National + US + EU

Only PCT

National + PCT

Any or all 142 States

Any or all 142 States

Patents RIGHTS ARE TERRITORIALPatents RIGHTS ARE TERRITORIAL

(With permission)

CLAIMDRAFTING

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CLAIMDRAFTING

Where To Begin

Meeting with inventors

Technical Draft & Experimental Results

or

Thesis / Dissertation

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Meeting with inventors

Technical Draft & Experimental Results

or

Thesis / Dissertation

What nextPreliminary Search –Ask for more info –

Distinguish from Prior Art

No distinctive featuresN[N/NO-IS/IA]

Return draftExplain how to proceed

NOVEL/INVENTIVE

Start drafting

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Preliminary Search –Ask for more info –

Distinguish from Prior Art

No distinctive featuresN[N/NO-IS/IA]

Return draftExplain how to proceed

NOVEL/INVENTIVE

Start drafting

How to Proceed

Explain elements of patentability

Novelty/Non-obviousness (inventive step)

What is not patentable

How to make “invention on hand”patentable

Create new results/data

Repeat step

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Explain elements of patentability

Novelty/Non-obviousness (inventive step)

What is not patentable

How to make “invention on hand”patentable

Create new results/data

Repeat step

Start DraftingRead Technical matter with Prior Art.

Find key features of invention.

Process/Product/new use/new application.

What constitutes the invention ?

What are the gaps/drawbacks in prior art ?

What problem is being solved ?

Start noting down the elements/keywords

(search once again) (and again)

Proceed with drafting

(Ask more questions; seek more data)

Proceed17

Read Technical matter with Prior Art.

Find key features of invention.

Process/Product/new use/new application.

What constitutes the invention ?

What are the gaps/drawbacks in prior art ?

What problem is being solved ?

Start noting down the elements/keywords

(search once again) (and again)

Proceed with drafting

(Ask more questions; seek more data)

Proceed

Field of InventionBriefly describes the area of technology in which

the invention falls.

Often not more then one or two sentences.

Useful in classification of patent.

Often starts “This invention relates to--”

Ex. This invention relates to pharmaceuticaltablet formulations of clopidogrel

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Briefly describes the area of technology in whichthe invention falls.

Often not more then one or two sentences.

Useful in classification of patent.

Often starts “This invention relates to--”

Ex. This invention relates to pharmaceuticaltablet formulations of clopidogrel

Background

This section involves Discussion onprogression of technology.

Description of prior art i.e. the present stateof technology (state-of-art)

Discussion on existing problems in priorart.

Possible solutions offered by presentinvention.

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This section involves Discussion onprogression of technology.

Description of prior art i.e. the present stateof technology (state-of-art)

Discussion on existing problems in priorart.

Possible solutions offered by presentinvention.

Summary of Invention

Discloses a gist of present invention.

Highlights “problems solved by presentinvention.”

Reflects the broadest claim.

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Discloses a gist of present invention.

Highlights “problems solved by presentinvention.”

Reflects the broadest claim.

Brief Description of Drawings

Drawings are provided for betterunderstanding of invention.

This section helps to identify the labelsand figures disclosed indrawings.

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Drawings are provided for betterunderstanding of invention.

This section helps to identify the labelsand figures disclosed indrawings.

Detailed Description ofInvention

Starts with general overview of invention.

Narrows down to details of theory and all theprocesses and methods for making andusing the invention.

Invention described with help of preferredembodiments (Best Mode).

Alternative embodiments can be disclosed.

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Starts with general overview of invention.

Narrows down to details of theory and all theprocesses and methods for making andusing the invention.

Invention described with help of preferredembodiments (Best Mode).

Alternative embodiments can be disclosed.

Claims

Describe the essential elements and legalboundaries of an invention.

Should be supported in entirety bySpecification.

First claim or Independent claim is often thebroadest.

“comprising of ” –preferred term.

-------”characterised in that”-to distinguish

Dependent claims expand, qualify, limit,narrow, quantify the elements inClaim 1.

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Describe the essential elements and legalboundaries of an invention.

Should be supported in entirety bySpecification.

First claim or Independent claim is often thebroadest.

“comprising of ” –preferred term.

-------”characterised in that”-to distinguish

Dependent claims expand, qualify, limit,narrow, quantify the elements inClaim 1.

Element of a Claim

1) Preamble – Ex :-

(1)A process for preparation of (comprising)

(2) An anticancer oral dosage composition(comprising)

2) Transitional Phrases – including, consisting, using,employing, containing, composed of, constituted of.

Preferred Phrase – “comprising”

Limiting or Restrictive Phrase – “characterized inthat”

3) Body or claim elements.

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1) Preamble – Ex :-

(1)A process for preparation of (comprising)

(2) An anticancer oral dosage composition(comprising)

2) Transitional Phrases – including, consisting, using,employing, containing, composed of, constituted of.

Preferred Phrase – “comprising”

Limiting or Restrictive Phrase – “characterized inthat”

3) Body or claim elements.

Basic Types of Claims

Independent Claim.

Dependent Claims.

Omnibus Claim

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Independent Claim.

Dependent Claims.

Omnibus Claim

Independent Claim

Is the first claim.

Stands alone.

Often the broadest claim.

Broadly describes the invention therebypreventing competitors tocircumvent the invention.

Prior Art and “inventiveness” determines

broadness of the Claim 1.

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Is the first claim.

Stands alone.

Often the broadest claim.

Broadly describes the invention therebypreventing competitors tocircumvent the invention.

Prior Art and “inventiveness” determines

broadness of the Claim 1.

Dependent Claims

Depend on first claim.

Refer to important distinguishing featuresof the invention as described inClaim 1.

Claims often narrow-down the scope ofinvention.

Subject to “Unity of Invention”, more thanone Independent Claim possible.

Claims must not be independentsentences.

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Depend on first claim.

Refer to important distinguishing featuresof the invention as described inClaim 1.

Claims often narrow-down the scope ofinvention.

Subject to “Unity of Invention”, more thanone Independent Claim possible.

Claims must not be independentsentences.

Relationships

Title (key element in brief) is related to /similar to Claim 1

1) Abstract (differs only in language)

2) Technical field (this invention relatesto…..)

3) Summary (expanded claim 1 +combined with key elements ofother important claims)

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Title (key element in brief) is related to /similar to Claim 1

1) Abstract (differs only in language)

2) Technical field (this invention relatesto…..)

3) Summary (expanded claim 1 +combined with key elements ofother important claims)

Care & Caution

Language

Choice of ‘Tense’

Proof reading

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Language

Choice of ‘Tense’

Proof reading

Claim Drafting

Derive/Determine Keywords/Search

Distinguish Old from New

Prior Art Novelty

FOCUS – INVENTION – FEATURES

Property/Product/Process

Structure/Steps/Techniques/Concepts

“use of comprising”, “and/or”, “wherein”

separating “Preamble” from “Body”

Independent Claim

Dependent Claim30

Derive/Determine Keywords/Search

Distinguish Old from New

Prior Art Novelty

FOCUS – INVENTION – FEATURES

Property/Product/Process

Structure/Steps/Techniques/Concepts

“use of comprising”, “and/or”, “wherein”

separating “Preamble” from “Body”

Independent Claim

Dependent Claim

Claim Drafting

INVERTED PYRAMID- Broad to Narrow- Generic to Specific

Broad Claim (Claim 1) Generic

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Broad Claim (Claim 1)

Narrow Claim

Generic

Specific

Examples Of InnovationOf Inventions

- Pencil

- Ink pen

- Ink-filled pen

- Ball pen with cap

- push, expose and write

- click and withdraw

- turn on cap32

- Pencil

- Ink pen

- Ink-filled pen

- Ball pen with cap

- push, expose and write

- click and withdraw

- turn on cap

Claim Drafting

Caution

- Claim should not read on

(overlap) Prior Art

- Preferably not infringe

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Caution

- Claim should not read on

(overlap) Prior Art

- Preferably not infringe

Claim Drafting

Merits/Demerits – Benefits/Disadvantages of Broad vs.Narrow Claims.

Opportunity for broad claim.

PencilA writing implement comprising:

a structure causing a mark to be made on a surface,wherein said structure causes said mark on said surfaceupon physical contact with said surface, wherein saidstructure companies a writing material which makes saidmark on said surface upon physical contact with saidsurface, and wherein said writing material comprises asolid material.

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Merits/Demerits – Benefits/Disadvantages of Broad vs.Narrow Claims.

Opportunity for broad claim.

PencilA writing implement comprising:

a structure causing a mark to be made on a surface,wherein said structure causes said mark on said surfaceupon physical contact with said surface, wherein saidstructure companies a writing material which makes saidmark on said surface upon physical contact with saidsurface, and wherein said writing material comprises asolid material.

Patent Office Requirements

Size, etc., of documents – (1) All documents and copies ofdocuments, except affidavits and drawings, sent to or leftat the patent office or otherwise furnished to theController shall be written or typewritten or printed eitherin Hindi or in English language (unless otherwise directedor allowed by the Controller) in large and legiblecharacters with deep indelible ink with lines widely spacedupon one side only of strong white paper of a size A-4 ofapproximately 29.7 centimeters by 21 centimeters with amargin of at least 4 centimeters on the top and left handpart and part and 3 cm on the bottom and right hand partthereof. Any signature which is not eligible or which iswritten in a script other than Hindi or English shall beaccompanied by a transcription of the name either inHindi or in English in block letters:

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Size, etc., of documents – (1) All documents and copies ofdocuments, except affidavits and drawings, sent to or leftat the patent office or otherwise furnished to theController shall be written or typewritten or printed eitherin Hindi or in English language (unless otherwise directedor allowed by the Controller) in large and legiblecharacters with deep indelible ink with lines widely spacedupon one side only of strong white paper of a size A-4 ofapproximately 29.7 centimeters by 21 centimeters with amargin of at least 4 centimeters on the top and left handpart and part and 3 cm on the bottom and right hand partthereof. Any signature which is not eligible or which iswritten in a script other than Hindi or English shall beaccompanied by a transcription of the name either inHindi or in English in block letters:

Patent Office Requirements…..contd

Provided that any document including drawing, if any, mayalso be filed in electronic form alongwith a copy of it onwhite paper:

Provided further that in case the application for patentdiscloses sequence listing of nucleotides and/or amino acids,the same shall be filed in electronic form.

(2) Additional copies of all documents shall be filed at theappropriate office, if required by the Controller.

(3) Names and addresses of applicants and other personsshall be given in full together with their nationality and suchother particulars, if any, as are necessary for identification.

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Provided that any document including drawing, if any, mayalso be filed in electronic form alongwith a copy of it onwhite paper:

Provided further that in case the application for patentdiscloses sequence listing of nucleotides and/or amino acids,the same shall be filed in electronic form.

(2) Additional copies of all documents shall be filed at theappropriate office, if required by the Controller.

(3) Names and addresses of applicants and other personsshall be given in full together with their nationality and suchother particulars, if any, as are necessary for identification.

Enablement Requirements

Section 10 of Indian Patent Act, 1970

Section 112 Para. 6 of 35 USC

Written Description

Deposit and declaration of source forMicroorganism

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Section 10 of Indian Patent Act, 1970

Section 112 Para. 6 of 35 USC

Written Description

Deposit and declaration of source forMicroorganism

Examples of Claim 11. A process for measuring the potency of a test batch of glatiramer acetate

relative to the known potency of a reference batch which comprises:a. incubating at least five reference samples, each of which contains a

predetermined number of cells from the primary culture such as hereindescribed and a predetermined amount of glatiramer acetate between 1 µg/mland 25 µg/ml from a reference batch;

b. incubating at least two samples, each of which contains a predeterminednumber of cells from the primary culture such as herein described & apredetermined amount of glatiramer acetate from the test batch;

c. determining for each sample in steps (a) and (b), the amount of cytokinesecreted by the cells in each sample after a predetermined time period ofincubation of such sample;

d. correlating the amounts of cytokine secreted by the samples incubatedwith the test batch of glatiramer acetate with the amounts of cytokine such asherein describe secreted by the samples incubated with the reference batch ofglatiramer acetate so as to determine the potency of the test batch ofglatiramer acetate relative to the reference batch of the glatiramer acetate,wherein in each sample in steps (a) and (b), the predetermined number ofcells is substantially identical, and wherein for each sample containing apredetermined amount of glatiramer acetate from the test batch there is acorresponding reference sample containing a substantially identicalpredetermined amount of glatiramer acetate from the reference batch.

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1. A process for measuring the potency of a test batch of glatiramer acetaterelative to the known potency of a reference batch which comprises:

a. incubating at least five reference samples, each of which contains apredetermined number of cells from the primary culture such as hereindescribed and a predetermined amount of glatiramer acetate between 1 µg/mland 25 µg/ml from a reference batch;

b. incubating at least two samples, each of which contains a predeterminednumber of cells from the primary culture such as herein described & apredetermined amount of glatiramer acetate from the test batch;

c. determining for each sample in steps (a) and (b), the amount of cytokinesecreted by the cells in each sample after a predetermined time period ofincubation of such sample;

d. correlating the amounts of cytokine secreted by the samples incubatedwith the test batch of glatiramer acetate with the amounts of cytokine such asherein describe secreted by the samples incubated with the reference batch ofglatiramer acetate so as to determine the potency of the test batch ofglatiramer acetate relative to the reference batch of the glatiramer acetate,wherein in each sample in steps (a) and (b), the predetermined number ofcells is substantially identical, and wherein for each sample containing apredetermined amount of glatiramer acetate from the test batch there is acorresponding reference sample containing a substantially identicalpredetermined amount of glatiramer acetate from the reference batch.

Examples of Claim 1

Claim 1. A pharmaceutical composition comprising:(a) activated botulinum toxin type B; and (b) at least oneexcipient; wherein at least 90% of said botulinum toxin type B isnicked.

Claim 1. Biscuit comprising guar gum characterized in that saidguar gum is a native guar gum, with a length between 0.25 and 8mm, a width between 0.18 and 2mm and an average length towidth ratio between 1.8 and 6.

Claim 1. A facet-joint exercise device for massaging tissue around aspinal column of a user, said facet-joint exercise devicecharacterized by: a pair of spheres mounted in a frame, theframe having a mounting yoke; a track for mounting the frame toa vertical support surface; and a means for adjustably securingthe frame to the track; wherein the spheres are mounted on ashaft in the frame, so as to be freely rotatable about the shaft,and wherein the frame is height adjustable on the frame.

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Claim 1. A pharmaceutical composition comprising:(a) activated botulinum toxin type B; and (b) at least oneexcipient; wherein at least 90% of said botulinum toxin type B isnicked.

Claim 1. Biscuit comprising guar gum characterized in that saidguar gum is a native guar gum, with a length between 0.25 and 8mm, a width between 0.18 and 2mm and an average length towidth ratio between 1.8 and 6.

Claim 1. A facet-joint exercise device for massaging tissue around aspinal column of a user, said facet-joint exercise devicecharacterized by: a pair of spheres mounted in a frame, theframe having a mounting yoke; a track for mounting the frame toa vertical support surface; and a means for adjustably securingthe frame to the track; wherein the spheres are mounted on ashaft in the frame, so as to be freely rotatable about the shaft,and wherein the frame is height adjustable on the frame.

Examples of Claim 1Claim 1. A device for testing a heat sensitivity in teeth comprising: a base; and

a tip having a cushion, wherein the cushion comprises a heating element,and wherein the cushion conforms to a contour of a tooth tested for a heatsensitivity.

Claim 1. A method for treating fibrosis in a mammal which comprisesadministering to the mammal a cell which expresses and secretes the Flt3ligand in an effective amount to treat fibrosis.

Claim 1. A method of extracting cardiac glycosides, comprising: intermixing acardiac glycoside plant species with aloe under conditions selected to forman extraction mixture; conditioning the extraction mixture underconditions selected to extract cardiac glycosides from said cardiacglycoside plant species to thereby form a conditioned extraction mixture,wherein the conditioned extraction mixture comprises residua] cardiacglycoside plant species and a cardiac glycoside aloe mixture; separating atleast a portion of the cardiac glycoside aloe mixture from the residualcardiac glycoside plant species to thereby form a cardiac glycoside aloeextract, wherein the cardiac glycoside aloe extract comprises cardiacglycosides extracted from said cardiac glycoside plant species; and whereinsaid cardiac glycoside aloe extract is substantially free of the residualcardiac glycoside plant species.

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Claim 1. A device for testing a heat sensitivity in teeth comprising: a base; anda tip having a cushion, wherein the cushion comprises a heating element,and wherein the cushion conforms to a contour of a tooth tested for a heatsensitivity.

Claim 1. A method for treating fibrosis in a mammal which comprisesadministering to the mammal a cell which expresses and secretes the Flt3ligand in an effective amount to treat fibrosis.

Claim 1. A method of extracting cardiac glycosides, comprising: intermixing acardiac glycoside plant species with aloe under conditions selected to forman extraction mixture; conditioning the extraction mixture underconditions selected to extract cardiac glycosides from said cardiacglycoside plant species to thereby form a conditioned extraction mixture,wherein the conditioned extraction mixture comprises residua] cardiacglycoside plant species and a cardiac glycoside aloe mixture; separating atleast a portion of the cardiac glycoside aloe mixture from the residualcardiac glycoside plant species to thereby form a cardiac glycoside aloeextract, wherein the cardiac glycoside aloe extract comprises cardiacglycosides extracted from said cardiac glycoside plant species; and whereinsaid cardiac glycoside aloe extract is substantially free of the residualcardiac glycoside plant species.