Transcript Chemical Claim Drafting

Chemical
Claim Drafting
Jackie Hutter, MS, JD
The Hutter Group, LLC
[email protected]
For Use in PTI Q1 2013 Training Course
Agenda
•
•
Session 1
o Review and consider chemical claim
drafting strategies
o Assign homework that encompasses
various strategies
Session 2
o Finish claim drafting strategies (if
necessary)
o Go over homework
o Considerations in Drafting
• Tips for doing efficient drafting
• Ensuring broadly construed claims
• Ensuring claims are valid
• Addressing likely grounds of rejection
• Some recommendations
o Use any extra time for questions
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2
General Considerations
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3
Keys to Strong Claim Drafting
• Standard approach
o Understand the invention
o Find the right words to claim
• Using context of rules,
statutes and court
decisions
o Consider how examiner will
respond
o Analyze enforceability
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4
Keys to Strong Claim Drafting
• Strategic approach
o Understand value of issued patent to
client
• Communicating clearly and aligning
expectations
o Analyze value chain to identify alternative
sources of value
• Ex: Adhesive invention
o Upstream chemical constituents
o Downstream methods, products
and uses
o Identify creative claim drafting strategies
to make prior art less relevant
• Functional claims
o Appreciate the trade-offs required to
obtain broad claims
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Types of Chemical Patent Claims
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Types of Chemical Claims
• What it is
o Chemical entity
o Composition
o Material
o Product
o Article
• How to make it
o Method of making
• How to use it
o Method of using
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What it is: New Chemical Entities
• A compound having the formula
Covers only what is specifically identified.
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What it is: New Chemical Entities
• A compound having the formula
Wherein X is selected from a group consisting of Cl, Br, F and I.
Covers all structures that have the specified X group of the
specified list of elements.
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What It Is: Compositions, Formulations
• Combinations including two or
more already known materials.
• Individually or in subcombinations may be public,
but if combination novel and
unobvious, they can be
patented.
• Often useful to include
“whereby” or “therein” claim to
enhance patentability
o Ex: to define novel and unobvious
functionality
o Discussed later.
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What it is: Compositions, Formulations
A composition comprising:
A) a hydrocarbon; and
B) a surfactant having the formula:
F3C(R)4CHF(R)10(ORR)x R2, wherein R1 is
either CH2 or CHF, R2 is either SH or OH,
and x is an integer from 3 to 9, with the
proviso that if x is an odd integer, then
R2 comprises an OH-containing group.
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What It Is: Compositions, Formulations
• A hair care product comprising
A, B and C.
• A hair care product comprising:
o
o
o
o
A at from about 20 to about 30 percent;
B at from about 20 to about 30 percent; and
C at from about 60 to about 40 percent,
where A, B and C are measured in percent
weight of the composition.
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What It Is: Compositions,
Formulations Example 1
What is claimed is
A shampoo composition
comprising:
a. from about 15 to about
25 % of alkyl ether sulphate;
b. from about 10% to about
15 % of dimethicone;
c. from about 2% to about
of imidazole;
d. water, wherein the % of
each component is on a
weight basis.
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What It Is: Compositions,
Formulations Example 2
What is claimed is
1. A shampoo composition comprising:
q) from about 20 to about 30% of at least one
Surfactant;
b) from about 5 to about 15% of at least one
conditioning agent; and
c) from about 1 to about 3% of at least one anti
fungal agent; and
d) water.
2. The composition of claim 1, wherein the antifungal
agent is selected from a group consisting of
pyrazole, imidazole, triazole, tetrazole and
pentazole.
3. The composition of claim 1 wherein the anti
fungal agent comprises imidazole.
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What It Is: Compositions,
Formulations Example 3
What is claimed is
1. A composition comprising
a) from about 20 to about 30% by
weight of at least one surfactant;
b) from about 5 to about 15% by weight
of at least one conditioning agent;
c) From about 1 to about 3% by weight
of at least one anti fungal agent; and
d) water
wherein the antifungal agent is selected
from the group consisting of pyrazole,
imidazole, triazole, tetrazole and
pentazole.
(or comprises one or more of . . . .)
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What it is: Genus/Species Claiming
• Genus/species
claiming is powerful
way to create new
category to define
invention to allow
broader scope for new
chemical entity
o “Patentee can be
his own
lexicographer”
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What it is: Genus/Species Claiming
• Traditional: Markush Group
• A compound having the formula:
• Wherein X is selected from a group consisting of Cl,
Br, F and I.
• Markush is closed ended which can be a problem.
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What it is: Genus/Species Claiming
• Alternative: Create new genus with open ended
species
• A compound having the formula:
• wherein X comprises Cl, Br, F or I.
• Allows flexibility to proviso out one or more of
chemical entities if prior art requires.
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What it is: Product by Process Claims
• Special case
o Not very common in independent form
• When the product cannot be
clearly defined and is best
defined by the process of
preparing the same
• Also, a claiming strategy that
can be helpful to strategically
eliminate prior art that would
appear close if affirmative
claim drafting used
• Note: Often used as
dependent claim from a
process but when used like
this, not a true pbp claim.
o Ex: The product prepared by the process
of claim 1.
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What it is: Product by Process Claims
• Example:
A composition formed by a process
comprising the steps of:
a) reacting a polymer with a
substance X to form a leaving group,
thereby forming a product of step a);
b) reacting the product of step a)
with a fluorinated amine, thereby
forming at least one product of step
b); and
c) reacting the product of step b)
with a halogenated compound
chosen from a halogenated
anhydride, a halogenated acetyl
chloride, a halogenated benzoyl
chloride, a halogenated arylamine,
and a halogenated diamine.
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What it is: Product by Property
• Special case: variation of
a functional
whereby/thereby clause.
• Use when specified
property appears to
provide patentable
distinction from prior art.
• Similar to functional
claiming.
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What it is: Product by Property
A composite wire
comprising a plurality of
continuous,
longitudinally aligned SiC
fibers in a
copper matrix, wherein
the metal matrix
composite wire has, at
about 25 °C, an average
tensile strength of at least
about 0.7 GPa.
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What it is: Fingerprint Claim
• Special case: when
the exact structure is
not known but the
characteristics of the
structure is sufficient to
distinguish the
compound from
existing prior art.
• Likely very narrow
because only covers
material with exact
fingerprint.
• Rarely used today.
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What it is: Fingerprint Claim
Ex: A chemical entity
characterized by:
a) a molecular weight of
300
b) a pH of 6.5;
c) a melting point of 150
deg. C; and
d) a boiling point of 2000
deg. C.
Ex:
A chemical entity having
the mass spectra of:
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What it is: Excluding Features
• Broad claims often
possible by excluding
single anticipating
feature from claim.
• Typically requires strong
knowledge of prior art.
o “Accidental anticipation.”
• If you don’t know
about single reference,
can address in
prosecution with good
drafting strategy that
allows proviso-ing out.
Excluded
from
invention
Claimed
invention
o Discussed later.
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What it is: Excluding Features
•
Ex: A flexible polyurethane
foam that is free of major
glass-rubber transition
between -100°C and +25°C.
•
Ex: A coated abrasive article
comprising
an abrasive layer secured to
a major
surface of a backing, the
abrasive layer
comprising binder and
abrasive grain, the
binder consisting essentially of
...
•
Excluded
from
invention
Claimed
invention
NOTE: Consisting essentially
of is a very powerful tool
during prosecution. Keep it in
your back pocket!
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What it is: Functional Language
• Can be very powerful
method to obtain broad
coverage to a product or
composition that does
something that creates
value for the relevant
consumer.
• Often difficult for examiner
to find prior art using this
method.
• Note: Must take care to
ensure definiteness after
Ariad v. Lilly, so requires
significant detail in
specification.
• If functional language is a
genus, you must disclose a
number of representative
species.
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What it is: Functional Language
Ex:
A conditioning composition
for use in
dentistry comprising an
essential oil in an amount
effective to alter at least
one of the
taste or smell of the
conditioning
composition.
Note: this is likely indefinite
even with a broad
disclosure in specification.
• Will need to include
actual range.
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What it is: Functional Language
A processed sugarbeet fiber
material
measured by having a wet
flavor profile
that has
a wet earthly flavor of up to
about 26 on a
scale of 0 to about 60;
…; and
a wet rancid flavor of up to
about 7 on a
scale of 0 to about 60.
NOTE: Highly
recommended to be
industry standard tests to
claim like this.
o Ex: ASTM, etc.
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What it is: Downstream/Upstream Products
• Creative method to
use for new way to
make old material
o Helpful when new raw
materials used that provide
lower cost, greater efficiency
etc.
• Also have successfully
used to obtain broad
coverage to a
commodity chemical
being used in new
environment
o Claimed effluent from plant as
novel compound
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What it is: Downstream/Upstream Products
Ex: Upstream product as
polymer precursor
A curable composition
comprising …
Ex: Downstream product as
the cured product of a
curable
composition comprising …
Or
A material obtained from a
curable composition
comprising …
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What it is: Kit Claims
• A kit for coloring and
decolorizing hair, the kit
comprising: a hair colorant
comprising …; and
a decolorizing agent
comprising ...
• Note: Rare that putting 2 or
more materials in kit form
would result in patentability.
• Note: Kit claims are used
more in EP practice. Required
for pharmaceutical
preparations.
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What it is: Referring to Figures in Claims
• A translucent ceramic article
comprising … and AlMgON,
wherein the AlMgON has a
composition within the
boundary defined by I, F, B, G,
H, and E or along the
boundary lines I-F,
F-B, B-G, G-H, H-E, and E-I of
FIG. 1 of the accompanying
drawing.
• Note: Not a fan of this
approach.
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How to Make It: Method Claims
• A process claim enumerates
the step wise process for
manufacturing the compound
or formulation
• Steps should be enumerated in
the logical order
o If steps can occur out of
order, need to say so in
specification
o If need order for
patentability, then need to
specify “in order” in the
claim
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How to Make It: Method Claims
• Novel and unobvious process often
gives rise to new compound which
may make process the best way to
achieve broad claims
o Compound only needs to be
absolutely novel
o Often used for
purification/extraction inventions
• Can be hard to demonstrate
patentability of process modification
without differentiation
o May have to specify the
importance of temperature, mixing
etc. so take care to include “pick
and choose” ranges
o “Consisting essentially of” can be
useful
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How to Make It: Method Claims
A process for making graphenol, the process comprising the
steps of:
a)providing a carbonaceous material;
b)extracting a humic acid solution from the carbonaceous
material via a basic solution, the basic solution having a
hydroxide concentration of at least about 0.005 moles per liter;
and
c)chemically reducing at least one of a carbonyl group portion
and a carboxylic acid group portion of the humic acid solution,
wherein the step of chemically reducing comprising the steps of:
i) placing the humic acid solution in a pressure reactor;
ii) adding a hydrogenation catalyst to the humic acid
solution;
iii) purging the pressure reactor with an inert gas;
charging the pressure reactor with hydrogen gas;
iv) heating the humic acid solution; and
v) removing the hydrogenation catalyst from the humic
acid solution, thereby producing a solution containing
graphenol.
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How to Make It: Method Claims
A method of purifying interesterified oils comprising
following steps of:
a) adding and mixing water into an interesterified oil
of animal/vegetable fat and oil in an amount of
about 0.30 to about 5.0 parts by weight per 100
parts by weight of the interesterified oil;
b) dehydrating the mixture of step (a);
c) adding an adsorbent after step (c), thereby
decolorizing the material from step(c); and
d) filtering the material from step (c),
thereby providing an interesterified oil substantially
free from soap and catalyst materials.
Note: Query whether this oil is absent materials that
would make the composition novel.
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Weighing Product vs. Method Claims
o In most situations, product claim is
highest value claim available
• Product can be protected
independent of the method used to
make it but method claim only
covers the exact method
o However, this not always true
• Must evaluate for each case
o Method claims are hard to police
• How do you know a competitor is
infringing?
o Often good to steer client away from
patenting only method claims
• “Opening the kimono” for free
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Method of Using Claims
o Protects how one uses a product
o New use provides novelty for old
product
o Typically not very broad if only covers
new use
• What if someone uses the product for
a different purpose?
o Exception: new drug treatment can be
valuable
• But still problem of non-infringing uses
o Difficult to obtain in post-KSR world
• If functionality of product is
transferrable, then examiner inclined
to find new use obvious
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Method of Using Claims
A method of using ozone contact to meet CTpool water values for Cryptosporidium
microorganism, the method comprising:
a. providing a pool filtration system with a total
filtration flow volume and flow rate, the
system including a contact vessel and a filter
downstream therefrom;
b. introducing ozone to the filtration flow volume
prior to contact with the vessel, the ozone
introduced at an average concentration of
about 0.5 mg/L to about 1.2 mg/L of water
volume; and
c. controlling the flow rate through the vessel to
contact the water volume for a time with the
ozone concentration to provide the system a
CT-value sufficient to inactivate the
microorganism.
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Considerations in Drafting:
Tips for doing efficient drafting
Ensuring broadly construed claims
Ensuring claims are valid
Addressing likely grounds of rejection
Some recommendations
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Drafting Tips: Save Time, Do Better Work
• Select an application template
that includes all features that you
are using on a regular basis
• Create boilerplate that works for
you
• “Steal from the best” by cutting
and pasting other patent
disclosures including similar subject
matter
o Especially useful when client gives you “skinny
disclosure”
o Paying you to protect originality of invention
not create original prose
o No copyright in US patent documents
• But, should recraft in your own words
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Drafting Tips: Save Time, Do Better Work
• Incorporation by reference is an
important tool for chemical
applications
• You may need information to
avoid prior art rejection
o Applies to published US patent applications
and issued US patents
o Does not apply to non-US patent documents
or other publications
o Avoid ambiguous incorporation by
reference by specifically identifying each
and every incorporation
• Counter argument: Don’t
highlight prior art
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Drafting Tips: Use Claim Organization
• Chemical claims lend
themselves to detailed
organization e.g., outline form
• Makes claimed invention
easier to follow
• Even if don’t want to help
examiner, organization often
helps YOU do a better job in
achieving broad claims
o Often you will find operational
and technical errors when
you organize
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Drafting Tips: Use Non-Limiting Limitations
•
•
•
•
•
Many are trained not to write lengthy
claims
o One qualitative measure of scope
is how long claims are
But you shouldn’t care how long claim
is if extra features do not limit claim
scope
o Toothpaste must have viscosity of
from x to y CPS to work, so it
doesn’t matter if parameter is
included
Good strategy because examiner less
worried about granting overly broad
claim if looks narrow
May allow claims with fewer
amendments
Recommendation: Consider putting in
numerous non-limiting limitations
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Drafting Tips: The Danger of
Claim Brevity at Filing
• Many draft very broad claims
thinking that they want so see
what the examiner thinks before
proposing a claim direction
• This sets up problem that
amendments will take claim in
direction that does not provide
commercially relevant scope
o Hit the wrong invention
target accurately
o “Mission drift”
• Recommendation: File case with
broadest claim that is allowable
based on knowledge of prior art
• Note: will have to have
knowledge of prior art
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Drafting Tips: A Word about Words
•
•
Avoid extraneous words in claims
o “in the range of”
o “in the amount of”
“About”
o Very powerful in broadening
construction for infringement
o Adds uncertainty to competitors’
decisions
o Use and ensure that you use
consistently
• If you do not, will not be given
flexibility
o There is no such thing as “about zero”
o I prefer to “approximately”
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Drafting Tips: A Word about Words
• Take care with phrases like
o “a majority/minority of”
o “at least”
• Use words of qualification
liberally, but take care to define
them in specification
o Substantially is a great one: instead of
specifying an absolute value or property,
can provide flexibility
o Boilerplate definitions likely not appropriate
because qualifying words should be defined
in context of prior art
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Drafting Tips: Excellence in Lexicography
• Chemical prosecution lends
itself to lexicography
o Create new terms/language
o BUT take care to ensure that claim terms
clearly and unambiguously defined in
the specification
• Good technique is to define
invention in terms of
functionality, such as strength
o Must be sure to use definite language
o Whether definite may be somewhat
unclear
o “Would a competitor be able to perform
the invention as claimed and
understand whether they infringe?”
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Drafting Tips: Excellence in Lexicography
•
•
•
Words in a claim are generally given their ordinary
and customary meaning as understood by a person
of ordinary skill in the art when read in the context of
the specification and prosecution history.
Exceptions
o 1) when the patentee acts as his own
lexicographer, or
o 2) when the patentee disavows the full scope of a
claim term either in the specification or during
prosecution.
To act as his own lexicographer, a patentee must
“clearly set forth a definition of the disputed claim
term” other than its plain and ordinary meaning.
o For example, “Multiple embossed means …” or
“[t]he solubilizers suitable according to the
invention are defined below. ”
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Drafting Tips: Excellence in Lexicography
• Chemical prosecution lends
itself to lexicography
o Create new terms/language
o BUT take care to ensure that claim terms
clearly and unambiguously defined in
the specification
• Good technique is to define
invention in terms of
functionality, such as strength
o Must be sure to use definite language
o Whether definite may be somewhat
unclear
o “Would a competitor be able to perform
the invention as claimed and
understand whether they infringe?”
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Drafting Tips: Excellence in Lexicography
LIKELY NOT DEFINITE
•
Self-crimping fully drawn high
bulk yarns comprising fibre
forming bicomponent filaments
comprising two polymers having
different crystallizability or
differential orientation or
combination thereof, wherein
the yarns have crimp contraction
levels in the range of 5% to 52%
and a boil-off shrinkage of 5% to
52%.
DEFINITE
•
A flash fire and chemical barrier
composite fabric, comprising: a
flame resistant fibrous basic layer
having a side configured to face the
skin of a wearer and an opposing
side; a radiant heat and chemical
permeation barrier layer, the barrier
including a metalized chemical
permeation resistant polymeric film; a
clear heat sealable outer film layer
overlying the radiant barrier layer
providing a heat sealable outer
surface thereon, wherein the fabric is
configured to pass ASTM F1358
flammability test.
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Drafting Tips: Formulating Formulation Claims
•
•
Formulation claims (“recipes”) present a
special problem regarding the prior art
o Anticipation very likely, even thought
claim not remotely obvious
• Be aware of accidental
anticipation
o Use case law to deal with unknown
prior art
• Create new ranges in prosecution
• Provisos
• Some neat tricks in old cases
Best practices
o Take time and effort to split up the
ranges
• 20-50 percent becomes 20, 25, 30,
35, 40, 45 or 50 percent
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Drafting Strategies:
Picking and Choosing Ranges
• If you spend the time to
unpack ranges in the
specification, then can pick
and choose ranges to
address rejections.
o Menu approach: pick one from each
column to get around prior art
o But, must be in specification as filed
• Cannot add later
• Client typically will provide
only single range for a
formulation, so it’s up to you
to provide the alternatives.
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Drafting Strategies:
Picking and Choosing Ranges
• Example:
The individual foam cells comprising the foampaperboard laminates of the present invention can
be from about 40 to about 150 square microns on
average. Still further, the individual foam cells
comprising the foam-paperboard laminate of the
present invention can be from about 40, 50, 60, 70, 80,
90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190 or 200
square microns on average, where any value can
form an upper or a lower end point, as appropriate.
Yet further, at least about 90% or at least about 95% of
the individual foam cells conform to the specified size
range.
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Drafting Strategies: Provisos
A Cool Trick
• Allows you to specifically exclude a
single element from the claims
even if you did not exclude it in asfiled specification
• Helpful to avoid accidental
anticipation
• Ex: a paint set comprising red, blue,
orange, blue etc.
• Prior art discloses blue. Can
amend claims to exclude blue.
• NOTE: If not anticipated, generally
not obvious.
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Drafting Strategies: Functional
Whereby, Thereby Clauses
• A composition comprising:
a) from about 60 to about 75 %
SiO2;
• B) from about 5 to about 10 %
Al2O3;
• C) from about 5 to about10 %
P2O5; and
• D) from about 15 to about 30 %
of a metal oxide comprising one
or more of BaO, CaO, MgO,
thereby providing a material
having a melting point of greater
than about 800 degrees C.
• Note: even though this is open
ended, likely that examiner will
not think it too terribly broad.
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Drafting Strategies: Functional
Whereby, Thereby Clauses
Crystalline ceramic comprising:
at least about 50 percent Al2O3, at least
about 0.1 percent SiO2, and MgO in a
range from about 1 to about 14 percent,
wherein at least about 50 percent by
weight of the Al2O3 is alpha alumina, and
wherein the alpha alumina has an average
crystallite size of less than about 1
micrometer.
© Jackie Hutter, MS, JD For Use by Registered Students of PTI Q1 2013 Authorized Use Only
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New Chemical Entities:
Strategizing Election of Species
• Structural claiming can get very
complicated, especially for
pharmaceutical actives
o “Small molecule”
• Patentability typically requires
detailed review of chemical
databases
• Patent Office will generally require
election of species, so drafting must
take into account likely form that
Restriction Requirement will take
o Prioritize commercially relevant
groups of active moieties
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Some (Possibly Controversial) General Tips
•
•
•
•
Many what “not to do” rules based on a fear of
risk of adverse litigation consequences
o Ex: Discussion of prior art or elaboration of
features using data etc.
But, very few patents are ever litigated so
caution in drafting often misplaced when
client’s goal to obtain patent covering product
Detailed explanation often useful to support
broad claims
o Including discussion of prior art
Recommendation: balance competitive value
of broad issued claims with slight probability that
patent will be found invalid in litigation
o “If you’re worried about preserving litigation
arguments to score a win, the client’s
business goals have already been defeated,
unless litigation is your business model.”
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Some (Possibly Controversial) General Tips
Thoughts on summarizing the claims
• Many prosecutors learned to draft
summary of the invention that closely
tracks the claims as filed
o Sometimes going on for pages
• There is no requirement to include a
summary, and downsides to too much
detail are real e.g., claims that are
amended to not follow summary as
filed
• Recommendation: Prepare a “skinny”
summary that mentions claimed
features only broadly
© Jackie Hutter, MS, JD For Use by Registered Students of PTI Q1 2013 Authorized Use Only
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Some (Possibly Controversial) General Tips
•
•
•
Patent prosecutors tend to treat application
drafting as a legal process where success means
an issued patent. But very often, the client’s
goals do not align with the patent team’s
We need to understand how to better align our
efforts with client’s
Some (unfortunately) common occurrences:
o As-filed claims cover an invention, but not
the full scope of the innovation
• Competitors can then address the same
consumer need with non-infringing
alternative
o Claims are amended to obtain allowance
and no longer provide competitive effect
o By the time an Office Action/issuance is
received, client is no longer selling a relevant
product
© Jackie Hutter, MS, JD For Use by Registered Students of PTI Q1 2013 Authorized Use Only
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