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Examination Issues in Herbal Medicines

Anne Marie Grunberg

SPE Art Unit 1638/1661

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Topics

Background of Herbal MedicinesSearching for Prior ArtLegal StandardsClaim Drafting

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Greece Middle East

Herbals Around the WorldChina 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:

KingdomPhylumClassOrderFamilyGenusSpecies

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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

DictionariesHandbooksFormulariesJournalsHistorical and Classical works

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Alternative search terms

• 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 fileSearch query; obtain files with hitsSearch files with hitsRemove duplicates

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Examples of frequently used NPL databases

Agricola-agriculture, animal scienceBiosis-biological and biomedical sciencesCAPlus/CASearch-chemistry, life sciencesEmbase-clinical medicine, drugsMedline-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 subject to a restriction requirement.

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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.

• 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.

• Roots/rhizome/bulb: asparagus, beet, garlic, ginseng, Narcissus, Polygonatum

• Leaves: aloe, Barosma, Betula, Camellia, Cassia, Ginkgo, Prunus laurocerasus

• Bark: Canella, poplar, Prunus serotina, Quercus robur

• Flower: Artemisia, Arum, Prunus spinosa

• 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:• 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

• 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 non-polar 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: CoffeeAn extract of Camillia sinensis: TeaAn extract of broccoli: SoupAn 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