PATENT OFFICE
PROCEDURES
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By
Dr. Gopakumar G. Nair
Advisor to Pharmexcil, India
Gopakumar Nair Associates
Url: www.gnaipr.net
Email: gopanair@gnaipr.net
Bengaluru, 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 specification
later
 Provisional Specification
- To establish PRIORITY DATE / establish early
ownership
- To pre-empt others
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 Complete Specification
- To be filed within 12 months of filing of Provisional
Application
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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 Patent Specification - Techno-legal doc
 Unity Of Invention - Single Inventive
Concept
 Clarity of Disclosure - State Clearly
And Distinctly The Nature
And Limits Of The Claims
 Sufficiency Of Disclosure - Claims
should be supported by
Written Description.
 Biological Material - Geographical
Origin
Pre / Post Grant Opposition & Revocation
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Patent Claims In India
 Product claims
…………

 Process claims
…………

 Composition claims
…………

 Method of treatment
…………

 New physical forms with
enhanced efficacy
………….

………….

 Living organisms
(except microorganisms)
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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)
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Prosecution of a Patent
1) Optional-Early Publication
OR
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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Fees
Ratio of Fees – 1 : 4 (Natural Person : Others)
A few examples :
Natural
person
Patent Application- Form 1 & 2
Rs.1000
Request for early publication
Rs.2500
(optional)
Request for Examination
Rs.2500
Maintenance Fee
3rd to 6th years
Rs.500
7th to 10th years
Rs.1500
11th to 15th years
Rs.3000
16th to 20th years
Rs.5000
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Others
Rs.4000
Rs.10000
Rs.10000
Rs.2000
Rs.6000
Rs.12000
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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Patent Filing Strategies
 Only National Filing
 Only Convention filing (US / EU etc.) (With permission)
 National + Convention Country
 National + US + EU
 Only PCT
 National + PCT
Any or all 142 States (With permission)
Any or all 142 States
Patents RIGHTS ARE TERRITORIAL
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CLAIM
DRAFTING
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Where To Begin
Meeting with inventors
Technical Draft & Experimental Results
or
Thesis / Dissertation
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What next
Preliminary Search –
Ask for more info –
Distinguish from Prior Art
No distinctive features
N[N/NO-IS/IA]
Return draft
Explain how to proceed
NOVEL/INVENTIVE
Start drafting
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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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Start Drafting
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 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 Invention
 Briefly 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 pharmaceutical
tablet formulations of clopidogrel
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Background
This section involves Discussion on
progression of technology.
Description of prior art i.e. the present state
of technology (state-of-art)
Discussion on existing problems in prior
art.
Possible solutions offered by present
invention.
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Summary of Invention
Discloses a gist of present invention.
Highlights “problems solved by present
invention.”
Reflects the broadest claim.
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Brief Description of Drawings
Drawings are provided for better
understanding of invention.
This section helps to identify the labels
and figures disclosed in
drawings.
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Detailed Description of
Invention
 Starts with general overview of invention.
 Narrows down to details of theory and all the
processes and methods for making and
using the invention.
 Invention described with help of preferred
embodiments (Best Mode).
 Alternative embodiments can be disclosed.
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Claims
 Describe the essential elements and legal
boundaries of an invention.
 Should be supported in entirety by
Specification.
 First claim or Independent claim is often the
broadest.
 “comprising of ” –preferred term.
 -------”characterised in that”-to distinguish
 Dependent claims expand, qualify, limit,
narrow, quantify the elements in
Claim 1.
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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 in
that”
3) Body or claim elements.
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Basic Types of Claims
Independent Claim.
Dependent Claims.
Omnibus Claim
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Independent Claim
Is the first claim.
Stands alone.
Often the broadest claim.
Broadly describes the invention thereby
preventing competitors to
circumvent the invention.
Prior Art and “inventiveness” determines
broadness of the Claim 1.
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Dependent Claims
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Depend on first claim.
Refer to important distinguishing features
of the invention as described in
Claim 1.
Claims often narrow-down the scope of
invention.
Subject to “Unity of Invention”, more than
one Independent Claim possible.
Claims must not be independent
sentences.
Relationships
Title (key element in brief) is related to /
similar to Claim 1
1) Abstract (differs only in language)
2) Technical field (this invention relates
to…..)
3) Summary (expanded claim 1 +
combined with key elements of
other important claims)
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Care & Caution
Language
Choice of ‘Tense’
Proof reading
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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 Claim
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Claim Drafting
INVERTED PYRAMID
- Broad to Narrow
- Generic to Specific
Broad Claim (Claim 1)
Narrow Claim
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Generic
Specific
Examples Of Innovation
Of Inventions
- Pencil
- Ink pen
- Ink-filled pen
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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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Claim Drafting
Merits/Demerits – Benefits/Disadvantages of Broad vs.
Narrow Claims.
Opportunity for broad claim.
Pencil
A writing implement comprising:
a structure causing a mark to be made on a surface,
wherein said structure causes said mark on said surface
upon physical contact with said surface, wherein said
structure companies a writing material which makes said
mark on said surface upon physical contact with said
surface, and wherein said writing material comprises a
solid material.
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Patent Office Requirements
Size, etc., of documents – (1) All documents and copies of
documents, except affidavits and drawings, sent to or left
at the patent office or otherwise furnished to the
Controller shall be written or typewritten or printed either
in Hindi or in English language (unless otherwise directed
or allowed by the Controller) in large and legible
characters with deep indelible ink with lines widely spaced
upon one side only of strong white paper of a size A-4 of
approximately 29.7 centimeters by 21 centimeters with a
margin of at least 4 centimeters on the top and left hand
part and part and 3 cm on the bottom and right hand part
thereof. Any signature which is not eligible or which is
written in a script other than Hindi or English shall be
accompanied by a transcription of the name either in
Hindi or in English in block letters:
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Patent Office Requirements
…..contd
Provided that any document including drawing, if any, may
also be filed in electronic form alongwith a copy of it on
white paper:
Provided further that in case the application for patent
discloses 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 the
appropriate office, if required by the Controller.
(3) Names and addresses of applicants and other persons
shall be given in full together with their nationality and such
other particulars, if any, as are necessary for identification.
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Enablement Requirements
Section 10 of Indian Patent Act, 1970
Section 112 Para. 6 of 35 USC
Written Description
Deposit and declaration of source for
Microorganism
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Examples of Claim 1
1. 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 herein
described and a predetermined amount of glatiramer acetate between 1 µg/ml
and 25 µg/ml from a reference batch;
b. incubating at least two samples, each of which contains a predetermined
number of cells from the primary culture such as herein described & a
predetermined amount of glatiramer acetate from the test batch;
c. determining for each sample in steps (a) and (b), the amount of cytokine
secreted by the cells in each sample after a predetermined time period of
incubation of such sample;
d. correlating the amounts of cytokine secreted by the samples incubated
with the test batch of glatiramer acetate with the amounts of cytokine such as
herein describe secreted by the samples incubated with the reference batch of
glatiramer acetate so as to determine the potency of the test batch of
glatiramer acetate relative to the reference batch of the glatiramer acetate,
wherein in each sample in steps (a) and (b), the predetermined number of
cells is substantially identical, and wherein for each sample containing a
predetermined amount of glatiramer acetate from the test batch there is a
corresponding reference sample containing a substantially identical
predetermined amount of glatiramer acetate from the reference batch.
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Examples of Claim 1
Claim 1. A pharmaceutical composition comprising:
(a) activated botulinum toxin type B; and (b) at least one
excipient; wherein at least 90% of said botulinum toxin type B is
nicked.
Claim 1. Biscuit comprising guar gum characterized in that said
guar gum is a native guar gum, with a length between 0.25 and 8
mm, a width between 0.18 and 2mm and an average length to
width ratio between 1.8 and 6.
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Claim 1. A facet-joint exercise device for massaging tissue around a
spinal column of a user, said facet-joint exercise device
characterized by: a pair of spheres mounted in a frame, the
frame having a mounting yoke; a track for mounting the frame to
a vertical support surface; and a means for adjustably securing
the frame to the track; wherein the spheres are mounted on a
shaft 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 1
Claim 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 heat
sensitivity.
Claim 1. A method for treating fibrosis in a mammal which comprises
administering to the mammal a cell which expresses and secretes the Flt3
ligand in an effective amount to treat fibrosis.
Claim 1. A method of extracting cardiac glycosides, comprising: intermixing a
cardiac glycoside plant species with aloe under conditions selected to form
an extraction mixture; conditioning the extraction mixture under
conditions selected to extract cardiac glycosides from said cardiac
glycoside plant species to thereby form a conditioned extraction mixture,
wherein the conditioned extraction mixture comprises residua] cardiac
glycoside plant species and a cardiac glycoside aloe mixture; separating at
least a portion of the cardiac glycoside aloe mixture from the residual
cardiac glycoside plant species to thereby form a cardiac glycoside aloe
extract, wherein the cardiac glycoside aloe extract comprises cardiac
glycosides extracted from said cardiac glycoside plant species; and wherein
said cardiac glycoside aloe extract is substantially free of the residual
cardiac glycoside plant species.
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