Transcript Examination Issues in Natural Products

Examination Issues in
Herbal Medicines
Anne Marie Grunberg
SPE Art Unit 1638/1661
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Topics
Background of Herbal Medicines
Searching for Prior Art
Legal Standards
Claim Drafting
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Greece
Middle East
Herbals Around the World
China
India
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United States
Native Americans
passed along
medicinal knowledge
of indigenous
plants to the early
American settlers.
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Europe
In the beginning of the 18th century, Swedish Botanist Carl
Linnaeus developed the Latin Botanical Classification
system:
 Kingdom
 Phylum
 Class
 Order
 Family
 Genus
 Species
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Herbal Medicines in U.S. Patents
424/725-779:
• Plant material or plant extract of undetermined
constitution as an active ingredient (e.g., herbal
remedy, herbal extract, powder, oil, etc.).
514/783:
• Plant extract or plant material of undetermined
constitution as a nonactive ingredient.
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Examiner NPL search resources
Dictionaries
Handbooks
Formularies
Journals
Historical and Classical works
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Alternative search terms
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Arbre aux quarante ecus (forty coin tree)
eun-haeng (fossil tree)
ginan
icho
ityo
kew tree
maidenhair tree
pei-wen
Pterophyllus salisburiensis Nelson
Salisburia adiantifolia Smith
Salisburia macrophylla C. Koch
temple balm
tempeltrae
yin guo
yinhsing
olium ginkgo
Ginkgo folium ... gin-nan
ginkgoblatter
ginkgo balm
Ginkgo biloba
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Searching NPL databases
 STN or Dialog Index file
 Search query; obtain files with hits
 Search files with hits
 Remove duplicates
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Examples of frequently
used NPL databases
Agricola-agriculture, animal science
Biosis-biological and biomedical sciences
CAPlus/CASearch-chemistry, life sciences
Embase-clinical medicine, drugs
Medline-clinical medicine, life sciences,
biology
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Prosecution of Plant Extract
(Herbal) Applications
Restriction:
A Markush group of plant extracts recited in
a claim should be limited to extracts
derived from plants of the same botanical
family or genus.
Claims that alternatively recite a large
number of extracts derived from plants that
have little in common are likely to be
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subject to a restriction requirement.
Idiomatic Language
“Ginmei” (golden stripes on green-culm or stalk)
“Invigorates Qi”
“Expels heat from heart”
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Claim Language
The correct botanical name (Latin
Botanical) is written in italics with
the genus name capitalized, and
the species name all in lower case.
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Botanical Nomenclature
• Harpagophytum procumbens, also known as devil’s claw,
grapple plant, or wood spider.
• Larrea divaricata, also known as chaparral, creosote
bush, greasewood, stinkweed.
• Azadirachta indica, commonly known as neem and also
known as margosa, nim, nimba.
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Products of Nature are not
Patentable under
35 U.S.C. § 101
A composition comprising phytochemical X:
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An Enabling Disclosure
• It is important to sufficiently describe
how to make and use the claimed extract
or material.
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The plant name/names
The part/parts of the plant used
The type/types of solvent used
Extraction temperature and pH
Material used fresh or dried and/or chopped or
powdered
• Separation/fractionation/recovery/isolation steps
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The particular part of the plant from
which the extract is obtained is often
essential.
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Roots/rhizome/bulb: asparagus, beet, garlic, ginseng, Narcissus,
Polygonatum
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Leaves: aloe, Barosma, Betula, Camellia, Cassia, Ginkgo, Prunus
laurocerasus
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Bark: Canella, poplar, Prunus serotina, Quercus robur
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Flower: Artemisia, Arum, Prunus spinosa
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Fruit: Barberry, Vaccinium, Sorbus, Pyrus, Rhamnus
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Drafting Claims to a Plant
Extract
• Product-By-Process Claims
Steps used to produce herbal extracts:
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Collection/harvesting
Drying
Garbling
Grinding or mincing
Extraction
Concentration
Drying of extracts
Addition of excipients
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Common Types of Extracts
Herbal extracts are prepared with:
• Water
• Polar solvents
• Non-polar solvents
• Acids
• Bases
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Common Forms of Extracts
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Infusions
Decoctions
Tinctures
Juices
Syrups
Infused oils
Ointments
Creams
Capsules and powders
Poultices
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Examples of preferred claim
language
• An alcoholic extract of Narcissus bulb.
• An aqueous extract of a Palma fruit.
• A hot water extract obtained from the dried leaves of
Nepeta cataria.
• An extract from chopped fresh roots of Harpagophytum
procumbens, whereby the extract is obtained using a nonpolar solvent.
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Anticipation under
35 U.S.C. § 102
Webster’s dictionary defines ‘extract’ as
follows:
1 a : to draw forth (as by research) <extract data> b : to pull or
take out forcibly <extracted a wisdom tooth> c : to obtain by
much effort from someone unwilling <extracted a confession>
2 : to withdraw (as a juice or fraction) by physical or chemical
process; also : to treat with a solvent so as to remove a soluble
substance 3 : to separate (a metal) from an ore 4 : to
determine (a mathematical root) by calculation 5 : to select
(excerpts) and copy out or cite.
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Plant Extracts are Ubiquitous
An extract of Coffea arabica: Coffee
An extract of Camillia sinensis: Tea
An extract of broccoli: Soup
An extract of orange: Orange juice
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Obviousness under
35 U.S.C. § 103
As set forth in In re Kerkhoven, 626 F.2d 846, 850,
205 U.S.P.Q. 1069 (CCPA 1980), “It is prima
facie obvious to combine two compositions each
of which is taught by the prior art to be useful for
the same purpose, in order to form a third
composition which is to be used for the very
same purpose...the idea of combining them flows
logically from their having been individually
taught in the prior art”.
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Questions?
Anne Marie Grunberg
571-272-0975
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