examination issues in herbal medicines

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Examination Issues in Herbal Medicines. Anne Marie Grunberg SPE Art Unit 1638/1661. Topics. Background of Herbal Medicines Searching for Prior Art Legal Standards Claim Drafting. GreeceMiddle East Herbals Around the World China India. United States. - PowerPoint PPT Presentation

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  • Examination Issues in Herbal Medicines

    Anne Marie Grunberg SPE Art Unit 1638/1661

  • TopicsBackground of Herbal MedicinesSearching for Prior ArtLegal StandardsClaim Drafting

  • GreeceMiddle East

    Herbals Around the WorldChina India

  • United StatesNative Americans passed along medicinal knowledge of indigenousplants to the earlyAmerican settlers.

  • Europe In the beginning of the 18th century, Swedish Botanist Carl Linnaeus developed the Latin Botanical Classification system:KingdomPhylumClassOrderFamilyGenusSpecies

  • Herbal Medicines in U.S. Patents424/725-779: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.

  • Examiner NPL search resourcesDictionariesHandbooksFormulariesJournalsHistorical and Classical works

  • 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 balmGinkgo biloba

  • Searching NPL databases

    STN or Dialog Index fileSearch query; obtain files with hitsSearch files with hitsRemove duplicates

  • 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

  • Prosecution of Plant Extract (Herbal) ApplicationsRestriction:

    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.

  • Idiomatic Language

    Ginmei (golden stripes on green-culm or stalk)

    Invigorates Qi

    Expels heat from heart

  • Claim LanguageThe correct botanical name (Latin Botanical) is written in italics with the genus name capitalized, and the species name all in lower case.

  • Botanical NomenclatureHarpagophytum procumbens, also known as devils 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.

  • Products of Nature are not Patentable under 35 U.S.C. 101A composition comprising phytochemical X:

  • An Enabling Disclosure

    It is important to sufficiently describe how to make and use the claimed extract or material.

    The plant name/namesThe part/parts of the plant usedThe type/types of solvent used Extraction temperature and pHMaterial used fresh or dried and/or chopped or powderedSeparation/fractionation/recovery/isolation steps

  • 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

  • Drafting Claims to a Plant ExtractProduct-By-Process Claims

    Steps used to produce herbal extracts:Collection/harvestingDryingGarblingGrinding or mincingExtractionConcentrationDrying of extractsAddition of excipients

  • Common Types of ExtractsHerbal extracts are prepared with:WaterPolar solventsNon-polar solventsAcidsBases

  • Common Forms of ExtractsInfusionsDecoctionsTincturesJuicesSyrupsInfused oilsOintmentsCreamsCapsules and powdersPoultices

  • Examples of preferred claim languageAn 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.

  • Anticipation under 35 U.S.C. 102 Websters dictionary defines extract as follows:

    1 a : to draw forth (as by research) b : to pull or take out forcibly c : to obtain by much effort from someone unwilling 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.

  • Plant Extracts are Ubiquitous

    An extract of Coffea arabica: CoffeeAn extract of Camillia sinensis: TeaAn extract of broccoli: SoupAn extract of orange: Orange juice

  • 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.

  • Questions?Anne Marie Grunberg571-272-0975

    Explain that extracts were