Examination Issues in Herbal Medicines

1. Examination Issues in Herbal Medicines Anne Marie Grunberg SPE Art Unit 1638/1661

2. Topics • Background of Herbal Medicines • Searching for Prior Art • Legal Standards • Claim Drafting

3. Greece Middle East Herbals Around the World China India

4. United States Native Americans passed along medicinal knowledge of indigenous plants to the early American settlers.

5. EuropeIn the beginning of the 18th century, Swedish Botanist Carl Linnaeus developed the Latin Botanical Classification system: • Kingdom • Phylum • Class • Order • Family • Genus • Species

6. 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.

7. Examiner NPL search resources • Dictionaries • Handbooks • Formularies • Journals • Historical and Classical works

8. 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

9. Searching NPL databases • STN or Dialog Index file • Search query; obtain files with hits • Search files with hits • Remove duplicates

10. 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

11. 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.

12. Idiomatic Language • “Ginmei” (golden stripes on green-culm or stalk) • “Invigorates Qi” • “Expels heat from heart”

13. 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.

14. 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.

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

16. 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

17. 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

18. 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

19. Common Types of Extracts Herbal extracts are prepared with: • Water • Polar solvents • Non-polar solvents • Acids • Bases

20. Common Forms of Extracts • Infusions • Decoctions • Tinctures • Juices • Syrups • Infused oils • Ointments • Creams • Capsules and powders • Poultices

21. 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.

22. 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.

23. 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

24. 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”.

25. Questions? Anne Marie Grunberg 571-272-0975