Examination Issues in Herbal Medicines

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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 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

• 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

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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 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 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.

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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

• Websters dictionary defines extract as
  follows
• 1 a to draw forth (as by research) ltextract
  datagt b to pull or take out forcibly ltextracted
  a wisdom toothgt c to obtain by much effort from
  someone unwilling ltextracted a confessiongt 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