Patenting: patentability requirements, patent drafting,

patent prosecution Silvia Valenza

Chemistry PhD

Qualified Italian and European Patent Attorney

Università di Trento

Crash Course 2018

23 May 2018

• Introduction to IP rights • Focus on patents

• Patentability requirements • Patentable subject-matters • Novelty • Inventive step • Suffciency of disclosure

• Patent drafting

• Patenting procedure

Content

Introduction to IP rights

One product, many IP rights

Copyright

Software

User manuals

Ringtones

Start-up tone

Images

Designs

Form of overall phone

Arrangement and shape of buttons

Position and shape of screen

© Nokia Corporation

Trade secrets

Some technical know-how kept

"in-house" and not published

Trade marks

NOKIA

Product "208"

Start-up tone

Patents and utility models

Data-processing methods

Operating system

Operation of user interface

Overview of intellectual property

Legal right What for? How?

Copyright Original creative or

artistic forms

Trade marks Distinctive identification of products or services

Use and/or registration

Registered

designs Registration*

Patents New inventions Application and

examination

Exists automatically

Trade secrets

External appearance

Valuable information

not known to the public

Reasonable efforts

to keep secret

Advantages • Exclusivity enables

investment and higher returns on investment

• Strong, enforceable legal right

• Makes invention tradable (licensing)

Advantages and disadvantages of patenting

Disdvantages • Reveals invention

to competitors (after 18 months)

• Can be expensive

• Patent enforceable only after grant (this can take 4-5 years)

Alternatives to patenting

• Cheap

• Prevents others from patenting the same invention

• Does not offer exclusivity

• Reveals the invention to competitors

Information disclosure (publishing)

• Cheap (but there is the cost of maintaining secrecy)

• Does not reveal the invention

• No protection against reverse-engineering/duplication of invention

• Difficult to enforce

• "Secrets" often leak quite fast

Secrecy (creating a trade secret)

• No effort required • Does not offer exclusivity

• Competitors will often learn details

Do nothing

• Protecting products and processes • Increasing turnover and profits

• Attracting investors

• Licensing

• Cross-licensing

• Blocking competitors

• Building reputation

How patents are used

Licensing income of US universities

Focus on what is a patent

• A patent is an exclusive right granted by a State for an invention that is new, involves an inventive step and is capable of industrial application

What is a patent ?

Patents are granted in nearly every country in the world!

• A legal title which grants the holder

• the exclusive right to prevent others from making, using or offering for sale, selling or importing a product that infringes his patent without his authorisation

PATENT OWNER’S PRERMISSION (except for private use or academic research)

• It is important to note that a patent does not grant the owner the “FREEDOM TO OPERATE” or the “right to exploit” the technology covered by the patent but only the right to exclude others.

• While this may seem a subtle distinction, it is essential in understanding the patent system and how multiple patents interact.

• In fact, patents owned by others may overlap, encompass or complement you own patent.

• You may, therefore, need to obtain a license to other people’s invention in order to commercialize your own patented invention and viceversa

What right a patent gives not ?

• A patent is an exclusive right granted by a State

• Nature of the monopoly: • Limits of right

• Territorial • in the country for which the patent was granted

• Duration • for a limited time (up to 20 years from the filing date).

• Technical scope • wording of the claims defines the boundaries of the right

Legal monopoly

• The disclosure of the invention is the price to be paid for the monopoly

• In return of finite period of exclusivity in your invention, you disclose it to the public

• patent offices publish applications after 18

months. At this stage they become visible

to everyone.

• so that others can learn from it and

improve upon it

Patent bargain

Reveal invention

(disclosure)

Get exclusivity (patent)

Patent applicant Public

The idea behind the patent system of the world is to encourage not just innovation, but the sharing of innovation.

Much information only available in patents

Published elsewhere Published

in patents

80% found only in patents!

Where do secretive competitors publish their R&D?

Solutions found in patent documents

10%

Protected

90%

Free to use

You can find many great solutions for free!

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Patentability requirements

What exactly can be patented?

For an invention to be patented, it must usually be

new to the world (i.e. not available to the public anywhere in the world)

inventive (i.e. not an "obvious" solution), and

susceptible of industrial application

In most countries, patents are not granted for business methods or rules of games as such, or for methods of treatment, diagnostics and surgery on the human or animal body.

Patents protect inventions which solve technical problems:

products,

devices, systems processes,

methods, uses chemical substances,

pharmaceuticals

Non patentable subjects

• Discoveries, scientific theories & mathematical methods

• Aestethic creations

• Schemes, rules and methods for performing mental acts

• Computer programs

• Invention that may affect public order, good moral or public health

• Diagnostic, therapeutic and surgical methods of treatment for humans or animals

The reasoning behind this is that medical practitioners should not be hindered in their work by commercial evils such as patents.

This esclusion is valid for Europe but not for US.

Categories of inventions

• Product inventions • new chemical compound(s) • A new isomer (of a known compound) • A new polymorph (of a known compound) • A new formulation or composition • New chemical intermediate

• Process inventions • New method for synthesising a compound • New method for purifiying or separating • New method for analysing, testing or measuring something

• (eg. Screening assays)

• New use of a known compound • Eg. Second medical use

Pharma-biotech products

• Molecular assays (diagnosis, typization etc)

• Cellular assays (drug screening)

• Microorganisms

• Genetically modified microorganisms cells/animals/plants

• Drug candidates

• Engineered molecules (antibodies, hormones)

Patentability requirements

• Invention = new and inventive solution to a technical problem

•An invention must meet several requirements to be eligible for patent protection: • Consist of a patentable subject of matter • Is new (novelty requirement) • Involves an inventive step (non-obviousness requirement) • Is disclosed in a clear and complete maner in the patent

application (sufficiency of disclosure)

NOVELTY

• New at the date of filing the patent application

• New if it does not form part of the "state of the art"

• "State of the art" means everything made available to the public by means of • a written or oral description,

• by use, or in any other way,

• before the date of filing of the patent application.

What is a "new" invention?

• there are no restrictions whatever as to

• the geographical location where or

• the language or

• the manner

• in which the relevant information was made available to the public; also no age limit is stipulated for the documents or other sources of the information

ABSOLUTE NOVELTY

.

One single person (if skilled) is public

• Papers

• Patents applications • Also those still secret but filed before

the filing date of the application

• Internet

• Letters/emails

• Posters

• Abstracts

• Thesis

Written disclosures

• Lecture to a conference

• Thesis discussion

• Meeting (at least two persons)

• a conversation or a lecture or by means of radio, television or sound reproduction equipment (tapes and records)

Oral disclosures

• use • producing, offering, marketing or exploiting a product;

• applying a process

• or in any other way such as • Displays, demonstrations at exhibitions or in television

• also includes all possibilities which technological progress may offer

Use or any other ways

Prior use test: When, What,

How, Where,

by Whom

• No publication prior to filing • e.g. no article, press release, conference

presentation/poster/proceedings or blog entry

• No sale of products incorporating the invention prior to filing

• No lecture or presentation prior to filing • except under a non-disclosure agreement (NDA)

• Seek patent professional advice soon!

• File before others do!

What not to do when considering filing a patent application

Examination of novelty

1. Defining the state of the art

2. Determining the content of the relevant prior art

3. Ascertaining whether the invention in question differs from the prior art.

Prior art

Prior art

Prior art

Prior art

Prior art An invention (as defined by claims)

NOVELTY

• This first patentability criterion is reasonably objective and straightforward

• Each piece of prior art must be considered individually It is not permissible to combine separated items of prior art

together – i.e. the disclosure of a document must be considered in isolation

It is also not permissible to combine separate embodiments described in a single document (unless the combination is specifically suggested). – If several elements are disclosed in one document, but not as a

combination, the combination is new

• Provided none of the prior art describes precisely what you have done, and at least one difference can be identified, then your invention would be regarded as novel.

• If there are no differences, then the invention lacks novelty and so will be not patentable

Conformance of all features

• An invention lacks novelty if ,and only if, there is a complete conformance of all the features of the invention and one prejudicial disclosure.

The claims which define the invention are compared to the state of the art

(in the examples or detailed description)

Photographic identity

Equivalent wording

• In considering novelty, it should be borne in mind that a generic disclosure does not usually take away the novelty of any specific example falling within the terms of that disclosure, but that a specific disclosure does take away the novelty of a generic claim embracing that disclosure

• EXAMPLE: disclosure of copper takes away the novelty of metal as a generic

concept (but not the novelty of any metal other than copper).

• EXAMPLE: disclosure of rivets takes away the novelty of fastening means as a generic concept (but not the novelty of any fastening other than rivets).

• EXAMPLE: disclosure of the subset "vegetables“ deprived the wider set "fruits and plants" of novelty.

GENUS vs SPECIE

• Selection inventions deal with the selection of individual elements, sub-sets, or sub-ranges, which have not been explicitly mentioned, within a larger known set or range.

• Criteria for novelty: • narrow sub-range,

• sufficiently far removed from the preferred embodiments and the end points,

• the technical effects in the sub-range different from those in the broad range (purposive selection, new technical teaching)

Selection invention

A B *

A’ B’

A B *

A’ B’ NOVEL Not NOVEL

• A selection from a single list of specifically disclosed elements does not confer novelty. However, if a selection from two or more lists of a certain length has to be made in order to arrive at a specific combination of features then the resulting combination of features, not specifically disclosed in the prior art, confers novelty (the "two-lists principle").

• Examples of such selections from two or more lists are the selection of:

• (a) individual chemical compounds from a known generic formula whereby the compound selected results from the selection of specific substituents from two or more "lists“ of substituents given in the known generic formula. The same applies to specific mixtures resulting from the selection of individual components from lists of components making up the prior art mixture;

• (b) starting materials for the manufacture of a final product;

• (c) sub-ranges of several parameters from corresponding known ranges.

Selection invention

• A document discloses not only subject-matter therein expressly described but also any implicit features which is, to a person skilled in the art, derivable directly and unambiguously.

• EXAMPLE: use of a rubber as an elastic mean take away novelty of use of an elastic material.

• EXAMPLE: a known process for the production of a chemical substance takes away novelty of a claim directed to the substance

Implicit disclosure

Implicit features

• No: the materials used in the known application is not compatible with the new one

Mould for molten steel having an Y shape

Prior art: an ice tray having an Y shape

Prior art takes away the novelty?

Novel use

Use of substance X as an agent for reducing friction”

[known as a rust-inhibitor]

Use of substance Y as a fungicide”

[known as a growth-regulator]

ARE THESE CLAIMS NOVEL ?

The (new) technical effect associated with the new use

is the distinguishing (functional) technical feature

USE CLAIMS PROCESS/METHOD CLAIMS

Purpose related limitations

• for claims directed to a physical entity (i.e. product claim), non-distinctive characteristics of a particular intended use should be disregarded.

• EXAMPLE:

• Substance X is known as a dye

• Claim: Substance X for use as a catalyst

• Claim is NOT NOVEL

• unless the use referred to implies a particular form of the substance (e.g. the presence of certain additives) which distinguishes it from the known form of the substance.

• Claim: Use of substance X as a catalyst

• Claim is NOVEL (second non-medical use)

• methods of treatment, diagnostics and surgery on the human or animal body are excluded from patentability in EP (but not in US)

• However is patentable any substance or composition, comprised in the state of the art, for use in a method as above, provided that its use for any such method is not comprised in the state of the art.

• FIRST MEDICAL USE: A claim to a known substance or composition for the first use in surgical, therapeutic and/or diagnostic methods should be in a form such as:

• " Substance X for use as a medicament", or

• " Substance X for use as a therapeutic agent " or

• " Substance X for use as an active pharmaceutical ingredient (API) “ or

• " Substance X as an antibacterial agent " or

• " Substance X for treating disease Y".

• In the above examples X is already known for an application in a different field than the medical field.

1st medical use

• If a specific substance X is already known in the medical field but not yet for the specific disease Z.

• Drafting of a second medical use : “Substance or composition X for use in treatment of disease Z”.

• Non allowable drafting of a second medical use: "Use of substance or composition X for the treatment of disease Y..." will be regarded as relating to a method for treatment explicitly excluded from patentability.

• In US • Use claims are not accepted, neither purpose related limitation to product claims

• Claim: A method for treating disease Z, said method comprising administering an effective amount of substance X to a subject in need thereof

2nd medical use

• If a product is new the process for making it is automatically new

• a new process for making a product does not render the product new

• If a new product cannot be described in term of structural features it can be described/claimed as a product-by-process (provided that it is novel and inventive i.e. it could be distinguished over the prior art)

• A higher degree of purity does not render a substance new • Unless you can prove that the previous attempts for obtaining a particular

degree of purity by conventional purification processes have failed

Product, process and product-by-process

Examination of novelty

1. Defining the state of the art

2. Determining the content of the relevant prior art

3. Ascertaining whether the invention in question differs from the prior art.

Prior art (A)

Prior art (A)

Prior art (A)

Prior art (Y)

Prior art (Y)

Prior art (X)

Prior art (X) Invention

(as defined by claims)

INVENTIVE STEP

• Novelty and inventive step are different criteria.

• The question – "is there inventive step?" – only arises if the invention is novel.

• An invention is considered to involve an inventive step (or to be non-obvious) when, relatively to the prior art, the invention would not be obvious to a person skilled in the particular field of technology.

• The term "obvious" means that which does not go beyond the normal progress (natural evolution) of technology but merely follows plainly or logically from the prior art, i.e. something which does not involve the exercise of any skill or ability beyond that to be expected of the person skilled in the art.

Inventive step

• should be presumed to be a skilled practitioner in the relevant field of technology, who is possessed of average knowledge and ability and is aware of what was common general knowledge in the art at the relevant date

• He should also be presumed to have had access to everything in the "state of the art", in particular the documents cited in the search report, and to have had at his disposal the means and capacity for routine work and experimentation which are normal for the field of technology in question.

The person skilled in the art

• Inventive step is a clearly subjective criterion; what may be obvious to one person may not be obvious to another.

• This is perhaps one of the most difficult matter that patent professional have to face with

• What is not qualified as inventive: • Mere change of size

• Making a product portable

• The reversal of parts

• The change of material

• The mere substitution by an equivalent part or function

Inventive step

• In order to assess inventive step in an objective and predictable manner, EPO applies the so-called "problem-and-solution approach":

EPO assessment of inventive step

CLOSEST PRIOR ART TECHNICAL PROBLEM ?

Obvious SOLUTION ?

Prior art (X)

Distinguishing features Tecnical effect

• (i) determining the "closest prior art“ • generally that which corresponds to a similar use and requires the minimum

of structural and functional modifications to arrive at the claimed invention

• (ii) establishing the "objective technical problem" to be solved • identify the distinguishing feature(s) of the claimed invention in terms of

features (either structural or functional) between the claimed invention and the closest prior art,

• identify the technical effect resulting from the distinguishing feature(s), and

• then formulate the technical problem

• (iii) considering whether or not the claimed invention, starting from the closest prior art and the objective technical problem, would have been obvious to the skilled person.

problem-and-solution approach

• In the context of the problem-solution approach, it is permissible to combine the disclosure of one or more documents, parts of documents or other pieces of prior art (e.g. a public prior use or unwritten general technical knowledge) with the closest prior art.

• Relatively good arguments for inventive step or non-obviousness are: • Unexpected (good) results • A clear technical advantage over prior art • Synergistic effect • Against technical teaching • Long felt need for a solution to the problem • Overcoming a technical prejudice • Commercial success

• For being inventive an invention need to result surprising

Inventive step

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PATENT DRAFTING

The two function of a patent document

• A patent document – whether a published patent application or a granted patent – serves two distinct functions: • It discloses (describes) an invention

• It defines the scope of the legal monopoly

Wording is an hybrid betwen •Technical-scientific •Legal

According to the national law of most countries a patent application must disclose the invention in a manner sufficiently clear and complete for the invention to be reproduced by a person skilled in the specific technical field. In some countries, patent law requires that the inventor discloses the «best mode» for practising the invention.

PATENT APPLICATION STRUCTURE

• Bibliographic information • Inventor, proprietor, date of filing, technology class, etc.

• Abstract • Around 150 words as a search aid for other patent applications

• Description • Summary of prior art (i.e. the technology known most similar to the invention) • The problem that the invention is supposed to solve • A detailed explanation and at least one way of carrying out the invention (i.e

experimental section)

• Claims • Define the extent of patent protection

• Drawings • Illustrate the claims and description

Content of patent

• The application must contain "one or more claims".

• These must:

• (i) "define the matter for which protection is sought";

• (ii) "be clear and concise"; and

• (iii) "be supported by the description".

• Since the extent of the protection conferred by a European patent or application is determined by the claims (interpreted with the help of the description and the drawings), clarity of the claims is of the utmost importance

CLAIMS

• A detailed description of at least one way of carrying out the invention must be given.

• the description must disclose any feature essential for carrying out the invention in sufficient detail to render it apparent to the skilled person how to put the invention into practice.

• A single example may suffice, but where the claims cover a broad field, the application should gives a number of examples or describes alternative embodiments or variations extending over the whole area protected by the claims.

• the "whole area claimed" is to be understood as substantially any embodiment falling within the ambit of a claim.

Sufficiency of disclosure

• If an invention involves the use of biological material that is not available to the public and which can not be described in the patent application so as to allow the invention to be reproduced by a person skilled in the art, so that the requirement of the sufficiency of description:

• no later than the date of filing of the application, a sample of the biological material must have been deposited with a depository institution recognized in the Budapest Treaty of 28 April 1977; • must be available on request to any person from the date of publication of the

European patent application,

• the depository institution and the register number of the biological material deposited are indicated in the application

• the application filed provides all the relevant information available to the applicant on the characteristics of the biological material;

Sufficiency of disclosure (biotech)

• For many inventions, claims in more than one category are needed for full protection.

Categories of claims

PRODUCT /APPARATUS PROCESS/USE/method

Chemical compound or a mixture of compounds

physical entity (e.g. object, article, apparatus, machine, or

system of co-operating apparatus

applicable to all kinds of activities exercised upon material products, upon energy, upon other processes (as in control processes) or upon living things

“the use of substance X as an insecticide“ equivalent to

"a process of killing insects using substance X"

• A patent application will have one or more "independent" claims directed to the essential features of the invention (those necessary for achieving a technical effect underlying the solution of the technical problem). • A compound of formula (I)

• Any such claim may be followed by one or more claims concerning "particular embodiments" of that invention.

• Any claim which includes all the features of any other claim is termed a "dependent claim“ • Compound according to claim 1 wherein …

Independent and dependent claims

1

2

3 4 5

• In patent language the word "comprising“ requires to be interpreted by the broader meaning: "including", "containing" or "comprehending” • thus not excluding the presence of any additional component

• On the other hand, the terms "consisting of components A, B and C” • exclude the presence of any additional component

“comprising" vs. "consisting"

• Prepare an experimental part • Which discloses any feature essential for carrying out the invention in sufficient

detail to render it apparent to the skilled person how to put the invention into practice

• Highlight the distinguishing and the essential (structural) features of your invention

• Highlight the surprising results or the effects/advantages associated to the distinguishing/essential features

• Try to generalize your experimental part • Think about alternatives features (which could still work)

• Think about ranges and preferred sub-ranges (T, concentrations, pH, times, etc)

• Prepare a brief description of the state of the art • If possible identifying the closest prior art (possibly 1 or two pieces of prior art)

• Leave the claims drafting to the patent attorney

Inventor/researcher input for patent drafting

Patent procedure and territorial right

• Patent examiner

• Applicant

• Representative, either:

• a professional representative who is on a list maintained by the EPO (on national patent office) or

• a legal practitioner entitled to act in patent matters

Key people in the patent application procedure

• National patent offices • National patent valid only in the country where it is granted

• Non-residents can also apply for a patent

• One year of "priority" for subsequent applications

• European Patent Office • A European patent is equivalent to national patents in the countries where it is

granted (the applicant chooses the countries)

• Via the Patent Cooperation Treaty • Just one application for up to 152 countries

• After the initial application phase, the international application leads to multiple national patent examination procedures

• Decisions with cost implications can be delayed until 30-31 months after filing (e.g. choice of countries to file in)

• There is no such thing as an international patent!

Where to apply for a patent

The patent procedure at the UIBM

Application

Filing

Search

report

Publication

of application

Reply to

Serch Report Grant

Withdraw?

18 months

Approx. 3 years

21 months

9 months

Annuity fees

The patent procedure at the EPO

Application

filing

Search

report Publication

of application

Publication

of grant

Opposition

period

expires

Withdraw?

18 months

Approx. 3-5 years 9 months

A publication B publication

6 months

Examination

GB

DE

FR

IT

ES

AT

PT

Validation

(38+2 countries)

The PCT procedure (as first filing)

PCT first filing/

priority date

Publication

of application IPRP

18 months

30-31 months

Chapter I (ISR+WO) Chapter II

(optional)

Withdraw?

18 22 28 30 31

US EP

CN

CA

JP

AU

Search

report

6 months

The PCT procedure (as estention filing)

PCT filing Publication

of application IPRP

National

phases

18-19 months

Chapter I

(ISR+WO)

Chapter II

(optional)

12 months

(priority period)

12 18 22 28 30 31

US EP

CN

CA

JP

AU

National

1st Filing

Search

report Publication Reply to

Serch Report Grant

Extra-PCT countries Foreign filings

PCT 152 contracting states

There is no such thing as an international patent!

• Most relevant non-contracting states

Argentina 600 b$ g.d.p.

Venezuela 440 b$ g.d.p.

Pakistan 240 b$ g.d.p.

Kuwait 180 b$ g.d.p.

Bangladesh 130 b$ g.d.p.

Extra-PCT countries

• EPO 38 european countries (+2)

• EAPC 8 euro-asian countries

• OAPI 17 african French speaking countries

• ARIPO 19 african English speaking countries

• GCC 6 asian countries

Multinational patents

18 months publication = A publication

• Publication number • eg. WO2006008133

• Bibliographic data published

• Invention disclosed & publicly available • eg. in the hands of competitors

• Prior art effects • Eg. Can be cited against your own future application

• “provisional” protection • Deterrent for competitors • not yet granted • claims may yet change • Infringers can’t yet be sued

A1 – Publication with ISR

A2 – Publication without ISR

A3 – Publication of ISR

• New publication number

• Claims as granted • Often different to A claim

• Infringer can be sued

• PATENTABILITY • Is what you want to patent described anywhere in the text of the document?

• It has to be described in sufficient detail to allow the “average skilled reader” to put the idea into practice.

• It also has to be specifically mentioned, not merely embraced by a generic disclosure.

• In order to answer this question ignore the claims of the document • Better to look at the mother document = A publication

• FREEDOM-TO-OPERATE • Is what you want to do within the wording of the patent claims?

• For this purpose the description and examples are largely irrelevant

• Patent must be granted, enforced and valid • Look at B publications

Patentability vs Fredom-to-operate

Thank you for your kind attention

Silvia Valenza

PhD Chemistry – Qualified Italian and European Patent Attorney

s.valenza@ngpatent.it